Category Archives: Vaccinations

Delta Variant Now Accounts for 83% of US Cases and Back to Mask Wearing, Even for Those Vaccinated!

Carolyn Crist reported that the nation’s top health officials said Tuesday that the Delta variant of the coronavirus is racing through the country and now is responsible for 83% of all U.S. cases.

That’s a massive increase from a week ago, when Delta was seen as responsible for just more than half of new cases, CDC Director Rochelle Walensky, MD, told a Senate committee.

And listen to her carefully…is she actually suggesting a Federal Mandate to vaccinate everyone???

“The best way to prevent the spread of COVID-19 variants is to prevent the spread of disease, and vaccination is the most powerful tool we have,” she said.

Meanwhile, several states in the South are reporting a large increase in COVID-19 cases, particularly in areas with low vaccination rates, according to The Atlanta Journal-Constitution.

Arkansas, Florida, and Missouri are reporting full-fledged outbreaks, and neighboring states such as Alabama, Georgia, Louisiana, Mississippi, Tennessee, and Texas are following behind.

“4th wave is here,” Thomas Dobbs, MD, the state health officer for Mississippi, wrote on Twitter on Monday.

Dobbs posted a graph of hospitalizations in Mississippi, which showed numbers climbing dramatically in July after hitting a low in May and June.

“Very sad indeed,” he wrote. “Didn’t have to be this way.”

Mississippi reported more than 2,300 new COVID-19 cases over the weekend, which is the state’s largest 3-day increase in cases since February, according to The Associated Press. Mississippi has one of the lowest COVID-19 vaccination rates in the country.

Florida has become one of the country’s biggest COVID-19 hot spots, now accounting for a fifth of new infections in the U.S., according to NBC News.

In Jacksonville, UF Health broke its record for hospitalized COVID-19 patients, jumping from 86 patients on Sunday to 126 on Monday.

“We’re gaining cases at such a rapid rate, we don’t really know where it’s going to stop,” Chad Neilsen, the director of infection prevention at UF Health, told NBC News.

“We aren’t even thinking a couple of months,” he said. “We’re thinking what’s going to immediately happen in the next week.”

Hospitals in Arkansas and Missouri are also preparing for a surge of patients that could strain staff and resources again, according to NBC News. If hospitalizations triple in the next 2 weeks, as projected by the University of Arkansas for Medical Sciences (UAMS), it could feel like the chaotic period at the end of 2020.

“Right now, we’re managing OK, but we’re in surge mode,” Steppe Mette, MD, the CEO of the UAMS Medical Center, told NBC News.

“We’re putting patients in physical locations where we weren’t putting them normally because of that demand,” he said.

At Houston Methodist Hospital in Texas, COIVD-19 hospitalizations have increased by 70% during the last week, according to the Houston Chronicle . On Monday, the hospital had 184 COVID-19 patients, which is double the number it had on July 1.

The Delta variant accounts for about 85% of the cases, and the hospital recorded its first hospitalization with the Lambda variant, the Chronicle reported. The Lambda variant, which was first identified in Peru, has been spreading throughout South America and is now reaching the U.S.

The Delta variant has been “running rampant” among unvaccinated people in Texas, Marc Boom, MD, the CEO of Houston Methodist, wrote in an email to hospital staff. The variant will account for nearly all COVID-19 cases in the area within the coming weeks, he said.

“It is the variant of concern in Houston,” he said. “What we’re seeing now is that Delta is far more infectious.”

Public health officials are grappling with the best way to move forward as cases and hospitalizations continue to rise. Increasing vaccinations is key, but mandating or guilting people into getting a shot would likely backfire, NBC News reported.

“People have heard our messages ad nauseam, but to see patients struggling to breathe and wishing they got vaccinated, that may make a difference,” Mette told the news outlet.

“Those are real people who are getting real sick,” he said.

What Evidence Do We Need to Move Forward With COVID Boosters?

Dr. Vinay Prasad noted that a few weeks ago, on Monday, employees of Pfizer met with high level executives in the Biden administration to discuss the role of boosters — a.k.a. a third vaccination with an mRNA vaccine for SARS-CoV-2. Some have speculated that, as with the first two doses, the emergency use authorization pathway will again be used to market boosters. With the rise of the Delta variant and others, enthusiasm in the media and the Twitter commentariat for boosters is growing. However, there are certain criteria that must be met before we jump on the booster bandwagon. Some of these criteria apply at home, and others apply abroad. What does stand out is that more data, real data, and an evaluation of several factors at home and abroad will be key in moving forward.

Abroad

As a general rule, if your goal is to avoid variants — or mutated versions of a virus — you want the virus to replicate less. When it comes to variants, it doesn’t matter where the virus does the replicating. In a globally connected world, it is only a matter of time before an advantageous mutation finds its way to all parts of the world. As such, we in the U.S., are only as safe as the least safe place in the world.

What this means is that before we shift our manufacturing capacity to develop boosters for the current variants, we must make a real effort to ensure that the vaccines we do have get distributed to the greatest number of global citizens who will take them. I argued in April that, practically, this means that children in high income nations should be vaccinated after older citizens globally – this same logic extends to boosters.

Before we shift our manufacturing to booster production, we should make sure that we have manufactured adequate supplies of the original vaccine for all global citizens. Moreover, we need to put effort toward solving the last mile problem: how to deliver very cold mRNA vaccines to places in the world where it is difficult to deliver and keep things very cold. This is a technological problem well within our scope.

Efforts to manufacture and deliver vaccine boosters to already vaccinated individuals in high-income nations cannot take priority and must not interfere with efforts to vaccinate at-risk individuals around the world. In fact, it is in our best interest to vaccinate those at-risk first. If we pursue boosters in the U.S. without helping the rest of the world, then we might as well get ready for the fourth, fifth, and sixth boosters. We will watch rising death tolls around the world, while worrying that yet new variants may end up on our shores.

At Home

Here in the U.S., there are also metrics that need to be met before we contemplate widespread dosing of hundreds of millions of people with booster shots. Specifically: show me the data! I have no doubt that a third mRNA shot will lead to higher neutralizing antibody titers. For that matter, I would guess six shots would outperform three on that metric. But the burden of evidence to accept boosters is not simply a change in antibody titer — or even demonstration of improved titers for rare variants.

We must show that boosters improve clinical endpoints before we ask Americans to roll up their sleeves again. A large randomized trial of vaccinated individuals powered for reduction in symptomatic SARS-CoV-2 or (better yet) severe COVID-19 is needed to justify the harms and inconvenience of boosters. If such a trial simply cannot be powered, or takes a very long time, due to the sparsity of serious infection in the U.S., then the argument for emergency use authorization is inherently flawed. When there’s too little disease to run the definitive trial, you are, by definition, no longer in an emergency. One way to solve this problem might be to deliver boosters only in elderly individuals or those who are immunocompromised. Here, a trial measuring COVID-19 outcomes may be possible.

Alternatively, a case for boosters can be made if evidence shows that boosters alter the epidemic course for a nation or the globe. Here, too, antibody titers are insufficient. Moreover, ironically, clinical trials would have to be larger and more complex to demonstrate this. For these reasons, I think the burden is on vaccine manufacturers to show that severe COVID-19 outcomes are averted.

Finally, we need to consider the second order effects of boosters. Would we gain more if we took the effort that would go into boosters and instead used it to try to increase vaccination uptake by those who are reluctant to get their first and second dose? Is the mere fact that news outlets and companies report the possible need for boosters a disincentive to be vaccinated? A skeptical person may now no longer see SARS-CoV-2 vaccines as the path out of the pandemic, but a recurring, and possibly someday yearly obligation that they may prefer to avoid altogether. We can’t ignore the potential impact of discussing boosters on vaccine acceptance.

Boosters Without Data

If we accept boosters in the U.S. while the rest of the world remains unvaccinated, and if we authorize them based on inevitable improved laboratory titers without clinical outcomes, we run the risk of creating a medical industrial perpetual motion machine.

We will continue to breed new variants outside of our nation, which will lead to calls for yet more boosters, and we will continue to get new boosters without any evidence they are necessary (i.e., lower severe COVID-19 outcomes). Our arms will ache, our hearts will hurt, our wallets will be empty, and so too will our brains, as we will have abandoned all principles of evidence-based medicine.

Lambda variant of COVID-19 identified at Texas hospital. Is it worse than delta?

Ryan W. Miller reported that a Houston hospital has its first case of the lambda variant of the coronavirus, but public health experts say it remains too soon to tell whether the variant will rise to the same level of concern as the delta variant currently raging across unvaccinated communities in the U.S.

About 83% of COVID-19 cases in the U.S. are from the delta variant and the vast majority of hospitalizations are among unvaccinated people, according to the Centers for Disease Control and Prevention.

The lambda variant, on the other hand, has been identified in less than 700 cases in the U.S. However, the World Health Organization in June called lambda a “variant of interest,” meaning it has genetic changes that affect the virus’ characteristics and has caused significant community spread or clusters of COVID-19 in multiple countries.

Dr. S. Wesley Long, medical director of diagnostic biology at Houston Methodist, where the case was identified, said while lambda has some mutations that are similar to other variants that have raised concern, it does not appear to be nearly as transmissible as delta.

“I know there’s great interest in lambda, but I think people really need to be focused on delta,” Long said. “Most importantly, regardless of the variant, our best defense against all these variants is vaccination.

What is the lambda variant and how is it different from the delta variant?

The lambda variant is a specific strain of COVID-19 with specific mutations. It’s one of a handful of variants identified by the WHO as variants of concern or interest. Many other variants have arisen since the outbreak was first detected in late 2019 in central China.

“The natural trajectory of viruses is that they have a tendency to have mutations, and whenever we have a significant mutation that changes the virus … we get a new variant,” said Dr. Abhijit Duggal, a staff ICU physician and director for critical care research for the medical ICU at the Cleveland Clinic.

Some of the lambda mutations occur in its spike protein, which is the part of the virus that helps it penetrate cells in the human body and is also what the vaccines are targeting.

Mutations occurring there and in other parts of lambda are similar to those in variants of concern, like alpha and gamma, Long said. But even gamma, which never took hold in the U.S. to the same level as alpha or delta, has more concerning mutations than lambda, Long said.

Duggal said there hasn’t been anything specific with the lambda variant to spark concern about it becoming the dominant variant in the U.S., but “watchful waiting and being cautious is going to be the most important thing at this point.”

Where was the lambda variant first identified?

The lambda variant was first identified in Peru in December 2020. Since April, more than 80% of sequenced cases in the country have been identified as the lambda variant.

As of June, the WHO said it had identified the lambda variant in 29 countries. Argentina and Chile have also seen rising lambda cases, the WHO said.

However, the variant hasn’t spread nearly to the same level on a global scale as the delta variant. Lambda may have become so widespread in parts of South America largely because of a “founder effect,” Long said, wherein a few cases of the variant first took hold in a densely populated and geographically restricted area and slowly became the primary driver for the spread locally over time.

Long compared lambda to the gamma variant, which first was detected in Brazil and spread in similar ways.

Are COVID-19 vaccines effective against the lambda variant?

Studies have suggested the vaccines currently authorized for use in the U.S. are highly effective at preventing severe COVID-19 and death across multiple variants.

Duggal said while there is no reason to believe the vaccines will be ineffective against the lambda variant, more data is need to know exactly how effective it will be. The efficacy may lower some, but hospitalization may still be largely preventable in variant cases with vaccination, he said.

Remember ‘Nothing in this world is 100%’: Those fully vaccinated against COVID-19 can be infected, but serious illness is rare.

However, a new study posted online Tuesday found the Johnson & Johnson vaccine was not as effective at preventing symptomatic disease when faced with the delta and lambda variants. The study was not yet peer reviewed or published in a journal, but it aligned with studies of the AstraZeneca vaccine that conclude one dose of the vaccine is 33% effective against symptomatic disease of the delta variant.

Vaccines made by Pfizer-BioNTech and Moderna have shown to keep similar levels of effectiveness against several of the variants of concern. But, just announced, a new preprint study conducted by Pfizer-BioNTech found its vaccine efficacy could drop down to 84% within 6 months.

Getting vaccinated still remains the most important factor in stopping the virus’ deadly effects and slowing down new variants, Long said.

Mutations occur in the coronavirus as it spreads from person to person. Vaccination can help prevent symptomatic disease and decrease the spread in communities with high vaccinations rates, which can then prevent mutations from occurring and new variants from arising, Duggal added.

Delta’s threat: CDC reveals data on why masks are important for the vaccinated and unvaccinated

More on the Delta mutated variant, which is becoming a real problem for the un vaccinated portion of our population and why wearing masks are important for all. Adrianna Rodriquez reported that The Centers for Disease Control and Prevention has had a busy week. 

Only a few days after announcing updated mask guidelines, the agency on Friday released new scientific data on the delta variant that gives a snapshot of how the highly contagious strain triggered a wave of coronavirus cases. 

The much-anticipated report comes a day after a presentation compiled by a doctor with the agency was leaked to the media and detailed the dangers of the delta variant and how mask-wearing is essential to bring it under control.

In a briefing Tuesday, CDC director Dr. Rochelle Walensky said the new data spurred the agency to take immediate action by recommending fully vaccinated people to wear mask indoors in public settings where coronavirus transmission is high. 

“The delta variant is showing every day its willingness to outsmart us and be an opportunist in areas where we have not shown a fortified response against it,” she said earlier this week. “This new science is worrisome and unfortunately warrants an update to our recommendations.”

Here’s everything to know about the delta variant and how it impacts fully vaccinated people. 

‘Pivotal discovery’: What the new data says about delta variant, transmission 

Fully vaccinated people made up nearly three-quarters of COVID-19 infections that occurred in a Massachusetts town during and after Fourth of July festivities, according to a CDC study published Friday in the agency’s Mortality and Morbidity Weekly Report.

Out of 469 cases that were identified in Barnstable County, Massachusetts, from July 3 to 17, the agency found 74% occurred in fully vaccinated people. The CDC sequenced samples taken from 133 patients and discovered 90% were caused by the delta variant. 

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with delta can transmit the virus,” Walensky said in a statement sent to USA TODAY on Friday. “This finding is concerning and was a pivotal discovery leading to the CDC’s mask recommendation.”

Health officials continue to reiterate the majority of COVID-19 transmission occurs among the unvaccinated, not fully vaccinated people.

“Vaccinated individuals continue to represent a very small amount of transmission occurring around the country,” Walensky said. “We continue to estimate that the risk of breakthrough infection with symptoms upon exposure to the delta variant is reduced by sevenfold. The reduction is twentyfold for hospitalizations and death.” 

Four fully vaccinated people between the ages of 20 and 70 were hospitalized, two of whom had underlying medical conditions. No deaths were reported.  

The study found 79% of patients with breakthrough infection reported symptoms including cough, headache, sore throat, muscle pain, and fever. 

Remember also that: Breakthrough COVID-19 infections after vaccination can lead to long-haul symptoms, Israeli study shows.

Of the 346 breakthrough infections, 56% of people were vaccinated with the Pfizer-BioNTech vaccine, 38% with Moderna and 7% with Johnson & Johnson. As of Friday, over 190 million doses of the Pfizer vaccine has been administered in the U.S., nearly 140 million of Moderna and 13.3 million of Johnson & Johnson, according to the CDC.

Health experts say the reason why more breakthrough infections occurred in the mRNA vaccines compared to the Johnson & Johnson vaccine is because more people in the U.S. received the Pfizer-BioNTech and Moderna vaccines. 

“When you look at the data, it may concern some people that there appears to be a higher rate of breakthrough COVID infections in people fully vaccinated with the Pfizer vaccine, however, as a percentage of people who are fully vaccinated, more people have been vaccinated with the Pfizer vaccine,” said Dr. Teresa Murray Amato, chair of emergency medicine at Long Island Jewish Forest Hills in Queens, New York.

“It still appears that all three of the current vaccines with emergency use administration authorization in the United States are safe and effective against the delta variant of the COVID-19 virus,” she added. 

While study authors say evidence suggests fully vaccinated people exposed to the delta variant can contract and spread the virus, it is not sufficient to determine the vaccines’ effectiveness against the highly contagious strain. 

Delta substantially more contagious than other variants

Although the study didn’t specify if fully vaccinated people can transmit the virus to other fully vaccinated people, health experts say they should wear a mask and socially distance largely to protect those who haven’t been vaccinated or who have a weakened immune system and can’t get full protection from the vaccine. 

“The data makes a pretty compelling justification for why we need to go back to mask wearing and other public health measures,” said Dr. Charles Chiu, an infectious disease specialist at the University of California, San Francisco. “I do think it’s because of the delta variant.”

The delta variant is known to be substantially more contagious than other variants – as contagious though deadlier than chicken pox, according to the CDC presentation. Among common infectious diseases, only measles is more contagious.

People may also be infectious for longer with the delta variant, 18 days instead of 13, the presentation says.

Vaccines remain effective at preventing hospitalization and death from COVID-19, though they worked better against the original strain and the alpha variant than they do against delta, data finds.

What do the CDC mask guidelines say?

The CDC is urging fully vaccinated Americans to wear masks indoors in areas of high or substantial coronavirus transmission. 

They’re also recommending universal indoor masking for all teachers, staff, students and visitors inside schools from kindergarten to 12th grade, regardless of vaccination status. That aligns closely with guidelines from the American Academy of Pediatrics, which recommended this month that anyone older than 2 be required to wear a mask in school. 

The CDC and the AAP are still urging that children return to full-time in-person learning in the fall.

The goal behind the guidance may be to protect both the fully vaccinated and the unvaccinated, health experts say, especially vaccinated people who may be immunocompromised and children under 12 who aren’t yet eligible to get their shot.

But the reality is there’s hardly any transmission among fully vaccinated people to truly affect community spread, they say.

“It makes sense why they did it, but I don’t think it’s going to make a major difference in the large surge that we’re having,” said Dr. Ashish Jha, dean of the Brown University School of Public Health in Providence, Rhode Island. “The real issue still is unvaccinated people who are not going around masked up. I have no reason to think that this guidance will get unvaccinated, unmasked people putting on masks. And that’s what we really need.”

Is there a test for the delta variant?

A traditional PCR test alone cannot differentiate the delta variant from the original virus.

The delta variant has distinctive mutations that serve as biological markers that can only be detected through genome sequencing.

Many U.S. laboratories sequence a small – but nationally representative – number of positive samples for epidemiological purposes. According to the CDC, more than 175,000 sequences have been collected through the agency’s surveillance program since Dec. 20.

People who test positive for COVID-19 aren’t made aware if they were infected by the delta variant, even if their sample was sequenced.

“Our patients will not learn if they have a variant or not,” said Dr. Christina Wojewoda, chair of College of American Pathologists Microbiology Committee. “It is for epidemiology purposes only and currently, there is no medical use for that result.”

However, the CDC said more than 80% of sequenced samples have the delta variant, which means people sick with COVID-19 were most likely infected with the highly contagious strain. 

“It is safe to assume in most places, if you are infected now, it is likely delta,” Wojewoda said. 

‘A Few Mutations Away’: The Threat of a
Vaccine-Proof Variant

Damian McNamara noted something that concerns me if we don’t get control of the virus using the best weapon that we have, vaccinations. The Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus…[becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Walensky told reporters on Tuesday. 

A new, more elusive variant could be “just a few mutations away,” she said.

We are already reporting the lambda variant and I predict that next will be the gamma and then the kapa variant.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the Division of Medical Toxicology at Rutgers New Jersey Medical School in Newark, told Medscape Medical News.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta — that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Ray, vice-chair of medicine for data integrity and analytics and professor in the Division of Infectious Diseases at Johns Hopkins School of Medicine in Baltimore, Maryland.

“The problem is if the virus changes in such a way that the spike protein — which the antibodies from the vaccine are directed against — are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”

Technology to the Rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Nelson and Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Ray said.

Mutations are not the only concern!

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Ray said.

Protected, for Now

Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

Records have been set nearly every day lately in Tokyo, but not all of them have been by athletes competing in the Olympics.

Japan’s capital has exceeded 4,000 coronavirus infections for the first time — 4,058 cases, to be exact. That’s a record high and nearly four times as many cases were reported just a week ago.

Tokyo set new case records every day from Monday to Wednesday, experiencing just a slight dip on Thursday, when they totaled 3,300 — still one of the city’s highest daily counts on record.

So, those of you, your friends, associates who haven’t been vaccinated, your best protection is still getting vaccinated.

Just do it, get vaccinated!

Continue with COVID-19 Precautions or Declare Pandemic Under Control, Anti-vaxers and the Delta Variant?

Damian McNamara reviewed some of the controversies regarding COVID-19 pandemic and our present status. Have we arrived at a much-anticipated tipping point in the COVID-19 pandemic in the United States? Or do we still have some time before we can return to some semblance of life as we knew it in 2019?

The CDC relaxation of masking and social distancing guidance for fully vaccinated Americans is one reason for optimism, some say, as is the recent milestone where we surpassed more than 50% of Americans vaccinated.

But it’s not all good news. “Right now, we are struggling with vaccine hesitancy,” Ali H. Mokdad, PhD, told Medscape Medical News.

“My concern now is people who don’t want the vaccine are looking around them and saying, ‘Oh we are in a very good position. Infections are down, more than 50% of Americans are vaccinated. Why do I need to get a vaccine?’ ” he said.

Another potential issue is waning immunity, added Mokdad, professor of health metrics sciences at the Institute for Health Metrics and Evaluation, University of Washington, Seattle. Companies are developing booster shots and Anthony Fauci, MD, the White House chief science advisor, said they may be required in the future.

Mokdad said this could add to vaccine hesitancy now. “Someone might think ‘Why should I take this vaccine when there is a new one coming up?’ If I wait for 2 months, I’ll get a new one.'”

“We can definitely be optimistic. Things are going in the right direction,” John Segreti, MD, told Medscape Medical News when asked to comment. “The vaccines seem to be working as well as advertised and are holding up in a real-world situation.”

However, “It’s too early to say it’s over,” he stressed.

“There is still moderate to substantial transmission in the community just about everywhere in the US. It might take a while until we see transmission rates declining to the point where the pandemic will be declared over,” added Segreti, hospital epidemiologist and medical director of infection control and prevention at Rush University Medical Center in Chicago, Illinois.

The global picture is another reason for pessimism, he said. “There is not enough vaccine for around the world. As long as there is uncontrolled transmission of coronavirus somewhere in the world, there is a greater chance for selecting out variants and variants that can escape the vaccine.”

“But overall I am much more optimistic than I was 6 months ago,” Segreti added.

Vaccines vs Variant

In a study evaluating two COVID-19 vaccines against the B.1.167.2 variant first reported in India, researchers evaluated data from Public Health England and reported reassuring news that the vaccines protected against this variant of concern. They studied the efficacy of the Pfizer/BioNTech and AstraZeneca/Oxford vaccines.

“After two doses of either vaccine there were only modest differences in vaccine effectiveness with the B.1.617.2 variant,” the researchers note. “Absolute differences in vaccine effectiveness were more marked with dose one. This would support maximizing vaccine uptake with two doses among vulnerable groups.”

The study was published online May 22 as a preprint on MedRxiv. It has not yet been peer reviewed.

The positive findings generated a lot of discussion on Twitter, with some still urging caution about celebrating the end of the pandemic. For example, a tweet from Aris Katzourakis, a paleo-virologist and researcher at the University of Oxford, United Kingdom, questioned how the results could be interpreted as good news “unless your priors were unreasonably catastrophic.”

“It depends on what happens to hospitalizations and deaths, as Andrew Pollard said this morning,” Charlotte Houldcroft, PhD, a post-doctoral research associate at Cambridge University in the UK, replied.

Houldcroft was referring to a comment this week from Andrew Pollard, MBBS, PhD, director of the Oxford Vaccine Group, who said if most people with COVID-19 are kept out of the hospital with the current vaccines “then the pandemic is over.”

Pollard also told The Guardian: “We can live with the virus; in fact, we are going to have to live with the virus in one way or another. We just need a little bit more time to have certainty around this.”

Seasonal Variation?

Others acknowledge that even though cases are dropping in the US, it could mean COVID-19 will transition to a seasonal illness like the flu. If that’s the case, they caution, a warm weather lull in COVID-19 cases could portend another surge come the winter.

But, Segreti said, it’s too early to tell.

“It’s reasonable to expect that at some point we will need a booster,” he added, but the timeline and frequency remain unknown.

Economic Indicators

The US economy is operating at 90% of where it was before the pandemic, according to the ‘Back to Normal Index’ calculated by CNN Business and Moody’s Analytics based on 37 national and seven state measures.

The index improved in 44 states in the week prior to May 26, which could also reflect an overall improvement in the COVID-19 pandemic.

State and federal unemployment numbers, job postings and hiring rates, and personal savings appear to be trending in a positive direction. In contrast, box office sales, hotel occupancy, and domestic air travel continue to struggle.

Explained: How to Talk to Anti-Vaxxers

Collectively, by turning around those who believe otherwise, we can save lives.

I am getting very tired of trying to convince people of the safety and need for vaccinations and then I reviewed this article. Erica Weintraub Austin and Porismita Borah helps us communicate with this population group. An estimated 24,000 to 62,000 people died from the flu in the United States during the 2019-20 flu season. And that was a relatively mild flu season, which typically starts in October and peaks between December and February.

The computer model predicted 300,000 deaths from COVID-19.

With the advent of flu season, and COVID-19 cases rising, a public health disaster even worse than what we’re now experiencing could occur this fall and winter. Two very dangerous respiratory diseases could be circulating at once.

This will put the general population at risk as well as the millions of people who have pre-existing conditions. Hospitals and health care workers would likely be overwhelmed again.

We are scholars from the Edward R. Murrow Center for Media & Health Promotion Research at Washington State University. As we see it, the only way out of the reopening and reclosing cycles is to convince people to get the flu vaccine in early fall – and then the COVID-19 vaccine when it’s available. Right now, up to 20 COVID-19 vaccine candidates are already in human trials. Chances seem good that at least one will be available for distribution in 2021.

But recent studies suggest that 35% might not want to get a COVID vaccine, and fewer than half received a flu vaccine for the 2019-2020 season.

Getting Coverage

To arrest the pandemic’s spread, perhaps 70% to 80% of the population must opt in and get the vaccine. They also need the flu shot to avoid co-infection which complicates diagnosis and treatment.

Achieving herd immunity is a steep climb. We conducted a national online survey, with 1,264 participants, between June 22 and July 18. We found that only 56% of adults said they were likely or extremely likely to get the COVID-19 vaccine. Westerners were most accepting (64%), followed by Midwesterners (58%), with Southerners (53%) and Northeasterners (50%) least likely.

Anti-vaxxers, promoting unlikely scenarios and outright falsehoods about vaccine risks, are not helping.

With all this in mind, we would like to share some myths and truths about how to increase rates of vaccinations.

Facts Don’t Convince People

People who support vaccination sometimes believe their own set of myths, which actually may stand in the way of getting people vaccinated. One such myth is that people respond to facts and that vaccine hesitancy can be overcome by facts.

That is not necessarily true. Actually, knowledge alone rarely convinces people to change behavior. Most decisions are informed – or misinformed – by emotions: confidence, threat, empathy and worry are four of them.

Another myth is that people can easily separate accurate information from the inaccurate. This is not always true, either. With so much misinformation and disinformation out there, people are often overconfident about their ability to discern good from bad. Our research during the H1N1 epidemic showed that overconfidence can lead to faulty conclusions that increase risk.

Also, it’s not always true that people are motivated to get accurate information to protect themselves and their loved ones. People are often too busy to parse information, especially on complicated subjects. They instead rely on shortcuts, often looking for consistency with their own attitudes, social media endorsements and accessibility.

And, to complicate matters, people will sometimes disregard additional fact checking that contradicts their political beliefs.

Assuming that people who get the flu vaccine will also get the COVID-19 vaccine is a mistake, too.

In our survey, 52% of respondents said they got a flu or other vaccine in the past year, but only 64% of those who got a vaccine in the past year said they were somewhat or extremely likely to get the COVID-19 vaccine. On the other hand, 47% who did not get a recent vaccine said they were somewhat or extremely likely to get the COVID-19 vaccine.

Ways that Do Help

Here are five things you can do to encourage your family, friends and neighbors to vaccinate and to seek out reliable information:

  1. Help them discern trustworthy news outlets from the rest. Is the outlet clearly identified? Does it have a good reputation? Does it present verifiable evidence to back up claims? It is hard to know whether a site is advancing a political agenda but check the “about” or “sponsors” type of links in the menu on the homepage to gain a bit more information. People should be particularly suspicious if the source makes absolutist claims or evokes stereotypes. An anger-provoking headline on social media might be nothing more than manipulative clickbait, intended to sell a product or profit in some way from a reader’s attention.
  2. Make trustworthy news sources accessible and consistent by putting them on your social media feeds. Community service centers are a good one. Partner with opinion leaders people already trust. Our survey respondents viewed local news and local health departments more useful than other outlets, although favorite sources vary with their age and political orientation.
  3. Provide clear, consistent, relevant reasons to get the vaccines. Don’t forget the power of empathy. Our survey says only 49% thought a COVID-19 vaccine would help them, but 65% believed it would help protect other people. Avoid the temptation to use scare tactics and keep in mind that negatively framed messages sometimes backfire.
  4. Remember that skepticism about vaccines did not happen overnight or entirely without cause. Research shows that mistrust of news media compromises confidence in vaccination. Many are also skeptical of Big Pharma for promoting drugs of questionable quality. The government must too overcome mistrust based on past questionable tactics, including “vaccine squads” targeting African Americans and immigrants. Honesty about past mistakes or current side effects is important. Some information about vaccines, widely disseminated in the past, were later revealed to be wrong. Although the evidence for the efficacy of vaccines is overwhelming, any missteps on this subject breed mistrust. One recent example: Two major studies about COVID-19 treatments were ultimately retracted.
  5. Let them know that science is the answer, but it requires patience to get it right. Scientific progress is made gradually, with course corrections that are common until they build to consensus.

And emphasize the things we are certain of: The pandemic is not going away by itself. Not all news outlets are the same. Both flu and COVID-19 shots are necessary. And vaccines work. Collectively, by turning around those who believe otherwise, we can save lives.

How to Talk to Someone Who’s Hesitant to Get the COVID-19 Vaccine

I really like this set evaluation and set of suggestions put together by Elaine K. Howley, for Dr. Gabriel Lockhart, a pulmonologist and critical care intensivist at National Jewish Health in Denver, the question of how best to approach loved ones who are vaccine hesitant hit very close to home.

Lockhart, who is also the director of the ICU for National Jewish Health, has been on the front lines of the pandemic since the beginning, traveling to New York a few times to help out during the peak of its COVID crisis. “I had a lot of first-hand experience with the disastrous outcomes of COVID,” he says.

That, plus his background in pulmonary critical care medicine, has led to his working with Gov. Jared Polis of Colorado as part of the Governor’s Expert Emergency Epidemic Response Committee medical advisory group in collaboration with the Colorado Department of Public Health to address the pandemic in Colorado. “My specific focus was on vaccine distribution,” he says, which is a “very personal topic” for him because he’s African-American and Hispanic.

Communities of color have been hit disproportionately hard by the pandemic, and deploying vaccines to populations that are more vulnerable has been a key component of public health messaging.

But many people in these (and other) communities are hesitant to take the vaccine. And for good reason – there’s a long history of mistrust between communities of color and American health institutions.

For some people of color, there are deep-seated and legitimate concerns that this could be a repeat of Tuskegee, Lockhart says, referencing the infamous “ethically unjustified” Tuskegee study, which intended to study untreated syphilis in Black men and involved misinformation, lack of informed consent and outright manipulation of participants.

Fearing this situation might be similar, with communities of color being misled in the name of medical studies, some people expressed to Lockhart that they felt like “lab rats.” These responses caused the advisory committee in Colorado to take a step back and evaluate how they would encourage people in these communities to take the vaccine.

Lockhart says his own mother was initially resistant to getting the shot. “She finally just recently got her second dose, but that took six to eight months of me pestering her to finally get that to happen,” he says.

For his part, Lockhart was cautious too. “I wasn’t going to take the vaccine and promote it to my family and friends and patients unless I was completely confident in its safety and efficacy.”

When the clinical trials concluded, he reviewed the data and soon felt 100% comfortable about the safety and efficacy of the vaccine. He got his shots in December, among the earliest wave of health care personnel who were able to access the protective inoculation.

Making the Case for Vaccination

Since then, Lockhart has gone on to spread the message that the vaccines are safe, effective and everyone who’s able should get inoculated. He’s also learned that there’s a distinction between people who can be swayed and those who can’t be.

“When I approach people, who are hesitant about the vaccine, I think it’s first important to distinguish between those who are vaccine hesitant and those who are anti-vaxxers. Because those are two different things, in my opinion,” he explains.

“Vaccine hesitancy means they’re open to hearing information and making an educated decision based on good quality information they receive. They may not be wanting to go blindfolded into taking the vaccine. But if they’re willing to hear that information, then they can make an educated decision from that point.”

On the other hand, he says “anti-vaxxers are going to be dead set, no matter what information you tell them. They’re always going to be coming up with a firehose of misinformation and leading you down a rabbit hole of tangential information that isn’t really useful, accurate or helpful when it comes to vaccines. I don’t typically engage that much with purely anti-vaxxers because there’s really not going to be a lot of gain from that population.”

However, educational efforts can go a long way toward convincing those who are hesitant but open to learning more to take the vaccine to protect themselves and their communities, Lockhart says.

Dr. Julita Mir, a practicing internist and infectious disease physician and chief medical officer of Community Care Cooperative (C3) in Boston, urges patience and compassion when talking with others about taking the vaccine. “For most people, it’s a matter of time. We all move at different paces and accepting others’ pace is key.”

Find Out Their Concerns


Because there can be so many different, highly personal reasons why someone might be hesitant to take the vaccine, “it’s best to approach people in a supportive and respectful manner, and make it clear that your goal is to understand what their concerns are,” says Dr. Richard Seidman, chief medical officer of L.A. Care Health Plan – the largest publicly operated health plan in the country.

“We can’t assume what others are thinking or feeling, so it’s best to ask. Once we understand others’ concerns more clearly, we’re better able to engage in a meaningful discussion to explore how to best address their concerns.”

Dr. Lisa Doggett, senior medical director for HGS AxisPoint Health, a care management services company based in Westminster, Colorado, and a newly appointed fellow with American Academy of Family Physicians’ Vaccine Science Fellowship, recommends asking “if there’s anything that might change their mind. If they say, ‘absolutely not,’ it’s probably a good idea to stop and agree to disagree. By continuing you’ll often force them to dig into their beliefs with even greater conviction.”

But, she adds, that if they show some glimmer that they might be willing to consider an alternate view point, “offer to provide one,” but first, “ask for permission. If they agree, proceed with care, stay calm and offer information that’s likely to be meaningful to that particular person.”

Dr. Charles Bailey, medical director for infection prevention at Providence St Joseph Hospital and Providence Mission Hospital in Orange County, California, agrees that coming from a “place of love” often is more fruitful when trying to convince someone to get vaccinated.

He recommends saying something along the lines of: “‘I’m concerned about your reluctance to get a COVID vaccination because I care about your health and safety.’ And before going directly to examples of who you know who’s gotten the vaccine and had no or minimal problems, try to ascertain from where the reluctance originates.”

Ask questions like: “‘What in particular makes you hesitant to get vaccinated at this time?’ Phrasing it in this way provides room for a subsequent change in their decision later as more information comes to light and/or more consideration has occurred,” he explains.

Lockhart recommends “really making sure it’s a two-way conversation” that involves specific reasons. With a full explanation of where that hesitancy comes from, he says it’s possible to provide the accurate and correct information that can help move people toward getting the vaccine.

Mir also recommends “leading by example” and getting vaccinated yourself. “People tend to trust and be influenced more so by those in their close circles.”

Doggett adds, “at all costs, avoid insults and demeaning language, which would be counterproductive. And have realistic expectations. Not everyone

Countering Common Vaccine Concerns


There are a wide variety of legitimate reasons why some people may be hesitant to take the COVID-19 vaccine. These may include:

  • Speed that the vaccine was developed.
  • Safety.
  • Misinformation or misunderstanding the science.
  • Side effects.
  • Distrust of science, the government or medical authorities.
  • Underlying conditions that they believe might make them more vulnerable.

Speed of Development
For some people, the concern is the speed with which the vaccine was developed and how “new” the mRNA technology being used in two of the three shots currently available in the U.S. seems. But Lockhart notes, this approach to developing vaccines “isn’t that new. We’ve had experience with mRNA technology for the last two decades.”

Primarily, it was studied for use in cancer treatment and has also been investigated for use in vaccines against influenza, rabies and Zika. With all this scrutiny, scientists have developed “a good sense of the side effect profile when it comes to mRNA technology.”

The speed with which these vaccines were made available stems from that past experience with mRNA technology and the all-hands-on-deck approach that global health authorities took early on to bring this burgeoning crisis under control.

Lockhart uses an analogy to explain how it all came together so quickly. “It’s like having six different construction companies that were all employed to build separate skyscrapers. They’re told a skyscraper typically takes two years to build. But then they’re all told, ‘Hey, we need all of you to focus on the same skyscraper and expedite the production. Pivot your focus all on the same skyscraper.’ So, yeah. It’s gonna happen a lot faster when you already have infrastructure in place that all comes together for a common cause.”

Despite this fast-tracking, Bailey notes that the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have been clear from the beginning that “no short cuts in safety were taken” in bringing these vaccines into use this quickly. “The rapid development was facilitated primarily by massive governmental investment in private-sector pharma companies as well as liability protections.”

All the normal safety steps were taken in developing these vaccines, and because this was such an urgent need and highly scrutinized, all the trials were conducted to the most stringent standards. All three currently available vaccines in the U.S. have been found to be safe and highly effective.

The numbers may paint a clearer picture. The Pfizer-BioNTech vaccine trial included more than 43,000 participants. Of the group that received the vaccine (rather than a placebo) only eight individuals developed COVID-19. That’s compared to 162 in the placebo group. Of those infections, 10 were severe, but only one of those occurred in the vaccinated group, and the other nine were in the placebo group.

The Moderna vaccine trial included more than 30,000 people, and only five cases of COVID-19 were reported in the group that received the vaccine versus 90 in the placebo group. Of those 90 cases, 30 were severe. There were no severe cases of COVID-19 reported in the vaccine group.

The Johnson & Johnson one-dose adenovirus vector vaccine was trialed in nearly 44,000 people in eight countries. There were 116 cases of COVID-19 in the vaccine group and 348 in the placebo group at least 14 days after vaccination. Of those, only two were severe among the vaccine group, compared to 29 in the placebo group. Seven people in the placebo group died of COVID-19, while none died in the vaccine group.

For all three vaccines, the Food and Drug Administration granted emergency use authorization because they were “at least 50% more effective than placebo in preventing COVID-19,” which is consistent with the organization’s guidelines for granting authorization. “A vaccine with at least 50% efficacy would have a significant impact on disease, both at the individual and societal level,” the FDA reports.

Some of the testing steps happened in tandem, which is part of how these companies were able to condense the timeline. There was also unprecedented collaboration across pharmaceutical companies. This helped move everything along faster.

“Just because they happened faster doesn’t mean it’s not a quality product,” Lockhart adds.

Safety
Concerns about safety are also common, Seidman says. For example, concerns about very rare blood clots caused the FDA to pause distribution of the Johnson & Johnson vaccine for 11 days in April to reevaluate the data. Putting a pause on a new vaccine or medication is not unusual, and it’s an example of the system working exactly as it should.

In this case, there were six reported cases of blood clots and one death related to the J&J vaccine. More than 6.8 million doses had been administered when the pause was initiated in mid-April. In other words, the chances of developing a blood clot from the J&J vaccine were observed to be quite literally less than one in a million. However, in an abundance of caution, the FDA paused use of the vaccine to reevaluate the data and found that “it’s a very, very small concern, and compared to the risk of blood clots with contracting COVID, it’s extremely small,” Lockhart says.

A November 2020 study conducted at UC San Diego Health and involving more than 8,000 patients diagnosed with COVID-19 noted that 20% of people hospitalized with severe COVID-19 will develop blood clots. For patients in the intensive care unit, the rate was 31%. The study also noted that blood clots led to an increased risk of death by 74%. So the risk of getting a blood clot from the vaccine is miniscule in comparison to the risk of getting a blood clot from COVID-19 itself.

Doggett notes that “nearly everything we do in medicine, and in life, carries some inherent risk. Medications have side effects; treatments and procedures can have unintended consequences. Sometimes the risks and benefits are nearly equal, and choosing the right path is difficult. However, with the COVID-19 vaccine, the risks of vaccine refusal are clear and are substantially greater, for almost everyone, than the very small risk of the vaccine.”

Physicians are constantly weighing the risk versus benefit of any intervention, and the COVID vaccines have been found to be very beneficial with exceedingly small risks.

Plus, there’s reassurance in numbers, Seidman says. “The fact is that nearly 150 million people have been vaccinated in the United States alone with very few serious side effects.” This is excellent evidence that the vaccines really are very safe.

“All approved vaccines have an excellent safety profile, which is regularly tested,” says Dr. Eyal Leshem, director of the Center for Travel Medicine and Tropical Diseases at the Sheba Medical Center and a clinical associate professor in Tel Aviv University School of Medicine in Israel. This means safety testing isn’t just a one-and-done situation. These vaccines are constantly being monitored and evaluated. Any adverse effects are being carefully recorded, and if a safety concern does arise, as did with the J&J vaccine, use will be halted until further investigation can be conducted.

“Medicine in general and vaccine safety assessment specifically are scientific disciplines,” Leshem adds, and the science is showing these vaccines to be extremely safe and effective.

Misinformation or Misunderstanding the Science
“If misinformation is fueling the reluctance, simply supplying accurate information may dispel the nonacceptance,” Bailey says. To dispel some of these myths:

  • These vaccines can’t give you COVID-19. The vaccines do not include any live virus and thus cannot give you COVID-19. The vaccine triggers the immune system to manufacture antibodies against the disease.
  • They can’t affect your fertility. The CDC reports that there’s currently “no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems.”
  • They don’t contain other substances or materials that are harmful or controlling. Several bizarre conspiracy theories floating around the internet have suggested that the vaccines contain microchips or other nefarious ingredients that could be used to control people. These ideas are completely false and not based in science or reality.
  • You should get vaccinated even if you had COVID-19. That’s because while having had the disease offers some protection against future infection, there’s not enough data about that level of protection to know when it tapers off or how protective it is. If you’ve recently had COVID-19, you can receive the first dose of the vaccine four weeks after the onset of symptoms. The second dose can be administered after you’ve completed your isolation period (about 10 days). If you received certain treatments for COVID, including convalescent plasma or antibody infusions, you’ll need to wait 90 days before you can take the vaccine.
  • These vaccines can’t change your DNA. Some people have misunderstood what mRNA is and how it works and believe that this approach can alter your DNA. But that’s not true. “There’s no interference of your DNA. The vaccine doesn’t affect your DNA at all,” Lockhart says.

The Moderna and Pfizer-BioNTech vaccines both use mRNA to stimulate the body to create the antibodies it needs to fight off infection from the coronavirus. mRNA is messenger RNA, and in this context, it refers to a piece of the virus’ spike protein. This molecule contains a a piece of genetic code that instructs your cells to create antibodies against the coronavirus. To do this, the mRNA doesn’t even enter the nucleus of the cell – the cell breaks it down and removes it after it’s finished using the instructions.

Side Effects
For some people, it’s a prior negative experience that’s driving their reluctance. In this case, whether the concern is a bad reaction to another vaccine or concerns about side effects that someone else has experienced, Bailey says discussing the facts around the statistics can help dispel some of that hesitation. He notes that the risk of severe side effects from the COVID vaccines is very low and much lower than the risk of getting COVID if you don’t get vaccinated.

Many people experience no side effects from any of these vaccines. But for others, after having one or both shots, they have reported experiencing:

  • Soreness, redness or swelling at the injection site.
  • Mild, flu-like symptoms, including a headache and body aches.
  • Tiredness.
  • Low-grade fevers.

Most of these side effects are mild and resolve quickly – within a day or two for most people. They’re also normal and signs that the vaccine is working to get your immune system ramped up to better meet the challenge if you’re exposed to the coronavirus in the future.

The most common side effects are also likely to be far less intense than if you were to get infected with COVID, so it’s worth it to feel a little lousy for a few hours – or even a couple days – after your shot if it means protecting yourself – and others – from a potentially far worse outcome if you caught the disease.

In very rare cases, some people have experienced more intense side effects including:

  • Severe allergic reactions including anaphylaxis. This has been observed in approximately two to five patients per million people vaccinated. This reaction also almost always occurred within 30 minutes after vaccination, which is why recipients are instructed to wait 15 to 30 minutes after each shot for observation.
  • Thrombosis with thrombocytopenia syndrome. Also called TTS, this condition involves blood clots with low platelets. This very rare syndrome has occurred almost exclusively in adult women younger than age 50 who received the J&J/Janssen vaccine. According to the CDC’s Vaccine Adverse Event Reporting System, as of May 11, 2021, more than 9 million doses of the J&J/Janssen vaccine had been given and 28 reports of TTS had been confirmed.

It’s important to underscore that these effects have been observed in a very small proportion of patients.

In addition, the CDC reports that there’s currently no evidence that there’s a causal link between the vaccine and any deaths apart from a “plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and a rare and serious event – blood clots with low platelets – which has caused deaths.” The CDC and the FDA are continuing to monitor all adverse events and deaths and are reporting such to the VAERS.

Distrust of Science, the Government or Medical Authorities
Seidman also notes that “many people just don’t like being told what to do, especially if the message is coming from the government.” This is where community-based initiatives to educate and provide vaccines to people where they are can be especially useful.

“I’ve been working on talking to several community groups and leaders so they can answer questions and disseminate this information to their communities,” Lockhart says. Talking with a trusted adviser, such as a church elder or a barber, may offer more reassurance to hesitant people than speaking with a doctor, he adds. “If I can get buy-in from those folks, I think that’s the best efficacy. We can get people to accept the true information about these vaccines” because it’s coming from a trusted community leader.

Doggett adds that “for those who are concerned about personal liberties, a message that will sometimes resonate is that vaccinating more people will help encourage the government to lift restrictions and increase freedom in the long run.”

Leshem notes that this has already happened in Israel, where as of May 10, 2021, nearly 63% of the population has been vaccinated against COVID-19. “As we’re now experiencing in Israel, when most of the population are vaccinated disease spread declines and it is possible to go back to living a normal life.”

Barriers to vaccination such as the long history of racism and, as Seidman explains, “government-sanctioned experimentation on low-income people of color that has eroded trust” may be more difficult to combat. Lockhart says that while these are very legitimate concerns, avoiding the vaccine is only going to worsen the disparity in outcomes between white communities and communities of color.

Again, community-based, grassroots outreach efforts may be better for convincing people who have this as their primary concern. There needs to be a re-establishment of trust with agencies and entities that purvey medical information and care. “My advice is to get the facts from a trusted source of truth, like your doctor or from your faith-based leaders. And be careful not to accept what you might hear or read in biased media sources,” Seidman says.

“Many people tend to trust their primary care doctors, and building on that trust to overcome vaccine hesitancy is important,” Doggett says. And across the board, she adds that “the medical community needs to communicate effectively and consistently about the safety of the vaccine to help improve vaccine acceptance.”

Underlying Conditions
For some people who are pregnant or have medical conditions, such as cancer, there’s been a lot of fear and confusion surrounding whether it’s safe to take a COVID-19 vaccine.

  • Cancer. The American Cancer Society reports that for most people with cancer or a history of cancer, the vaccine is safe and should be accepted, but individual cases may have other factors to consider, so talk with your oncologist.
  • Pregnancy. Though there has been some hesitation among pregnant people in taking the vaccine, studies have found that it’s safe and could actually protect your baby from contracting the virus after birth. The CDC’s V-safe COVID-19 Vaccine Pregnancy Registry is monitoring deployment of the vaccine in pregnant people. As of May 10, 2021, more than 110,000 pregnant people have been vaccinated. Talk with your obstetrician for advice tailored to your specific situation.
  • Immune disorders. If you have a chronic immune disorder or are taking medications that suppress the function of the immune system, you are eligible to get the vaccine. But you should talk with your health care provider about your situation.
  • Negative previous reactions to vaccines. If you’ve had a previous severe allergic reaction (anaphylaxis) you should not take the vaccine. If you have severe allergies to certain medications, latex, pets, foods or other environmental triggers, talk with your health care provider about whether it’s safe for you to take the vaccine.

“Referral to a family physician, nurse specialist or an infectious disease doctor can further help in more complicated cases, such as immune compromise, severe allergy or pregnancy,” Leshem says.

Why Vaccination Matters

The sooner everyone gets vaccinated, the better our chances of putting the pandemic completely behind us. “The COVID-19 vaccines are the best tool we have to get the pandemic under control, allowing us to get back to doing all of the things we need and want to do as individuals, families, business owners and as a community,” Seidman says. “Every additional person who gets vaccinated gets us one step closer to getting the virus under control.”

Still, as Doggett notes, “over a quarter of U.S. adults say they won’t get vaccinated. Their refusal makes it harder to stop the spread of the coronavirus, increasing infection rates and health care costs, and raising the risk of new, more dangerous variants. It also makes it more difficult for us to achieve herd immunity and effectively end the pandemic.”

This ongoing hesitancy to get vaccinated will drag out the pandemic and make it more difficult to resume life as usual, she says, because “the pandemic is far from over.”

In countries where vaccination rates are high, such as the UK, Israel and some parts of the U.S., cases are declining. “But rates of COVID-19 remain dangerously high in many parts of the world,” Doggett says. The higher these rates of infection, the more likely the virus will mutate into more dangerous strains that can undermine all the efforts over the past year to stamp out the pandemic.

“Even in the U.S., we’re still seeing tens of thousands of new cases every day and hundreds of deaths. The faster people get vaccinated, the faster we can stop the virus from spreading, and the sooner we can safely resume activities that many of us have given up during the pandemic, like travel, indoor dining and visiting family.”

The bottom line, she says, “getting vaccinated is the safest way to protect yourself and everyone around you from getting sick. It’s also an important way to stop the creation of new variants of the virus, that may be more virulent, more resistant to the vaccine and could extend the pandemic.”

Vaccine refusal, on the other hand, “will lead to higher health care costs, damage to the economy, and more people living with long-term COVID-19 complications, such as damage to the heart, lungs and brain that we’ve started to see in as many as a third of COVID-19 survivors.”

“Getting vaccinated is a personal decision,” Seidman notes. But choosing “not to get vaccinated is a decision that impacts everyone.”

Estimates of the number of people who need to be vaccinated to achieve herd immunity have typically ranged from 60% to 80% or so, but there are still many open questions about how durable immunity is and when we’ll have reached the threshold of protection.

In the meanwhile, getting vaccinated and convincing your friends and loved ones to do the same is our best means of moving out of this crisis. For his part, Seidman says “the COVID-19 vaccines are really a miracle of modern science. These vaccines are very safe and effective in preventing infection, hospitalizations and deaths from the worst pandemic in 100 years.”

And now with the Delta variant, Some areas of the U.S. could see “very dense outbreaks” of the Delta coronavirus variant throughout the summer and fall, particularly in states with low vaccination rates, according to CBS News.

The Delta variant, which was first identified in India, now makes up about 20% of new cases across the country. The variant has led to surges in parts of Missouri and Arkansas where people haven’t yet received a COVID-19 vaccine.

“It’s going to be hyper-regionalized, where there are certain pockets of the country where we can have very dense outbreaks,” Scott Gottlieb, MD, former commissioner of the FDA, said Sunday on CBS News’ “Face the Nation.”

“As you look across the United States, if you’re a community that has low vaccination rates and … low immunity from prior infection, the virus really hasn’t coursed through the local population,” he added. “I think governors need to be thinking about how they can build out health care resources in areas of the country where you still have a lot of vulnerability.”

Arkansas Gov. Asa Hutchinson, who spoke on “Face the Nation” before Gottlieb, also expressed concerns about the Delta variant. Arkansas has one of the lowest vaccination rates in the country, which Hutchinson attributed to vaccine hesitancy and conspiracy theories about the COVID-19 vaccines.

“The Delta variant is a great concern to us,” he said. “We see that impacting our increasing cases and hospitalizations.”

Hospital admissions increased 30% during the last week, and the University of Arkansas Medical Center reopened its COVID-19 ward. The state is offering incentives for people to get vaccinated, but they haven’t been successful, Hutchinson said. About 50% of adults are vaccinated, and public health officials want to move the needle higher.

“If incentives don’t work, reality will,” he said. “As you see the hospitalizations go up, the cases go up, I think you’ll see the vaccination rate increase as well.”

The Delta variant has been detected in 49 states and the District of Columbia, CBS News reported. The strain is more transmissible and can cause more severe COVID-19. The U.S. and other countries have marked the Delta variant as a “variant of concern” to monitor as the pandemic continues worldwide.

The Delta variant has become the dominant strain in the U.K. and now accounts for 95% of cases that are sequenced, according to the latest update from Public Health England. On Sunday, Gottlieb said the U.S. is about a month or two behind the U.K. with local surges in cases due to the variant.

“They’re seeing cases grow,” he said. “The vast majority are in people who are unvaccinated … the experience in the U.S. is likely to be similar.”

My friend and cartoonist just succumbed to his long battle with cancer. He will be missed by us all and I thank him for being my friend, patient and cartoonist.

Damian McNamara reviewed some of the controversies regarding COVID-19 pandemic and our present status. Have we arrived at a much-anticipated tipping point in the COVID-19 pandemic in the United States? Or do we still have some time before we can return to some semblance of life as we knew it in 2019?

The CDC relaxation of masking and social distancing guidance for fully vaccinated Americans is one reason for optimism, some say, as is the recent milestone where we surpassed more than 50% of Americans vaccinated.

But it’s not all good news. “Right now, we are struggling with vaccine hesitancy,” Ali H. Mokdad, PhD, told Medscape Medical News.

“My concern now is people who don’t want the vaccine are looking around them and saying, ‘Oh we are in a very good position. Infections are down, more than 50% of Americans are vaccinated. Why do I need to get a vaccine?’ ” he said.

Another potential issue is waning immunity, added Mokdad, professor of health metrics sciences at the Institute for Health Metrics and Evaluation, University of Washington, Seattle. Companies are developing booster shots and Anthony Fauci, MD, the White House chief science advisor, said they may be required in the future.

Mokdad said this could add to vaccine hesitancy now. “Someone might think ‘Why should I take this vaccine when there is a new one coming up?’ If I wait for 2 months, I’ll get a new one.'”

“We can definitely be optimistic. Things are going in the right direction,” John Segreti, MD, told Medscape Medical News when asked to comment. “The vaccines seem to be working as well as advertised and are holding up in a real-world situation.”

However, “It’s too early to say it’s over,” he stressed.

“There is still moderate to substantial transmission in the community just about everywhere in the US. It might take a while until we see transmission rates declining to the point where the pandemic will be declared over,” added Segreti, hospital epidemiologist and medical director of infection control and prevention at Rush University Medical Center in Chicago, Illinois.

The global picture is another reason for pessimism, he said. “There is not enough vaccine for around the world. As long as there is uncontrolled transmission of coronavirus somewhere in the world, there is a greater chance for selecting out variants and variants that can escape the vaccine.”

“But overall I am much more optimistic than I was 6 months ago,” Segreti added.

Vaccines vs Variant

In a study evaluating two COVID-19 vaccines against the B.1.167.2 variant first reported in India, researchers evaluated data from Public Health England and reported reassuring news that the vaccines protected against this variant of concern. They studied the efficacy of the Pfizer/BioNTech and AstraZeneca/Oxford vaccines.

“After two doses of either vaccine there were only modest differences in vaccine effectiveness with the B.1.617.2 variant,” the researchers note. “Absolute differences in vaccine effectiveness were more marked with dose one. This would support maximizing vaccine uptake with two doses among vulnerable groups.”

The study was published online May 22 as a preprint on MedRxiv. It has not yet been peer reviewed.

The positive findings generated a lot of discussion on Twitter, with some still urging caution about celebrating the end of the pandemic. For example, a tweet from Aris Katzourakis, a paleo-virologist and researcher at the University of Oxford, United Kingdom, questioned how the results could be interpreted as good news “unless your priors were unreasonably catastrophic.”

“It depends on what happens to hospitalizations and deaths, as Andrew Pollard said this morning,” Charlotte Houldcroft, PhD, a post-doctoral research associate at Cambridge University in the UK, replied.

Houldcroft was referring to a comment this week from Andrew Pollard, MBBS, PhD, director of the Oxford Vaccine Group, who said if most people with COVID-19 are kept out of the hospital with the current vaccines “then the pandemic is over.”

Pollard also told The Guardian: “We can live with the virus; in fact, we are going to have to live with the virus in one way or another. We just need a little bit more time to have certainty around this.”

Seasonal Variation?

Others acknowledge that even though cases are dropping in the US, it could mean COVID-19 will transition to a seasonal illness like the flu. If that’s the case, they caution, a warm weather lull in COVID-19 cases could portend another surge come the winter.

But, Segreti said, it’s too early to tell.

“It’s reasonable to expect that at some point we will need a booster,” he added, but the timeline and frequency remain unknown.

Economic Indicators

The US economy is operating at 90% of where it was before the pandemic, according to the ‘Back to Normal Index’ calculated by CNN Business and Moody’s Analytics based on 37 national and seven state measures.

The index improved in 44 states in the week prior to May 26, which could also reflect an overall improvement in the COVID-19 pandemic.

State and federal unemployment numbers, job postings and hiring rates, and personal savings appear to be trending in a positive direction. In contrast, box office sales, hotel occupancy, and domestic air travel continue to struggle.

Explained: How to Talk to Anti-Vaxxers

Collectively, by turning around those who believe otherwise, we can save lives.

I am getting very tired of trying to convince people of the safety and need for vaccinations and then I reviewed this article. Erica Weintraub Austin and Porismita Borah helps us communicate with this population group. An estimated 24,000 to 62,000 people died from the flu in the United States during the 2019-20 flu season. And that was a relatively mild flu season, which typically starts in October and peaks between December and February.

The computer model predicted 300,000 deaths from COVID-19.

With the advent of flu season, and COVID-19 cases rising, a public health disaster even worse than what we’re now experiencing could occur this fall and winter. Two very dangerous respiratory diseases could be circulating at once.

This will put the general population at risk as well as the millions of people who have pre-existing conditions. Hospitals and health care workers would likely be overwhelmed again.

We are scholars from the Edward R. Murrow Center for Media & Health Promotion Research at Washington State University. As we see it, the only way out of the reopening and reclosing cycles is to convince people to get the flu vaccine in early fall – and then the COVID-19 vaccine when it’s available. Right now, up to 20 COVID-19 vaccine candidates are already in human trials. Chances seem good that at least one will be available for distribution in 2021.

But recent studies suggest that 35% might not want to get a COVID vaccine, and fewer than half received a flu vaccine for the 2019-2020 season.

Getting Coverage

To arrest the pandemic’s spread, perhaps 70% to 80% of the population must opt in and get the vaccine. They also need the flu shot to avoid co-infection which complicates diagnosis and treatment.

Achieving herd immunity is a steep climb. We conducted a national online survey, with 1,264 participants, between June 22 and July 18. We found that only 56% of adults said they were likely or extremely likely to get the COVID-19 vaccine. Westerners were most accepting (64%), followed by Midwesterners (58%), with Southerners (53%) and Northeasterners (50%) least likely.

Anti-vaxxers, promoting unlikely scenarios and outright falsehoods about vaccine risks, are not helping.

With all this in mind, we would like to share some myths and truths about how to increase rates of vaccinations.

Facts Don’t Convince People

People who support vaccination sometimes believe their own set of myths, which actually may stand in the way of getting people vaccinated. One such myth is that people respond to facts and that vaccine hesitancy can be overcome by facts.

That is not necessarily true. Actually, knowledge alone rarely convinces people to change behavior. Most decisions are informed – or misinformed – by emotions: confidence, threat, empathy and worry are four of them.

Another myth is that people can easily separate accurate information from the inaccurate. This is not always true, either. With so much misinformation and disinformation out there, people are often overconfident about their ability to discern good from bad. Our research during the H1N1 epidemic showed that overconfidence can lead to faulty conclusions that increase risk.

Also, it’s not always true that people are motivated to get accurate information to protect themselves and their loved ones. People are often too busy to parse information, especially on complicated subjects. They instead rely on shortcuts, often looking for consistency with their own attitudes, social media endorsements and accessibility.

And, to complicate matters, people will sometimes disregard additional fact checking that contradicts their political beliefs.

Assuming that people who get the flu vaccine will also get the COVID-19 vaccine is a mistake, too.

In our survey, 52% of respondents said they got a flu or other vaccine in the past year, but only 64% of those who got a vaccine in the past year said they were somewhat or extremely likely to get the COVID-19 vaccine. On the other hand, 47% who did not get a recent vaccine said they were somewhat or extremely likely to get the COVID-19 vaccine.

Ways that Do Help

Here are five things you can do to encourage your family, friends and neighbors to vaccinate and to seek out reliable information:

  1. Help them discern trustworthy news outlets from the rest. Is the outlet clearly identified? Does it have a good reputation? Does it present verifiable evidence to back up claims? It is hard to know whether a site is advancing a political agenda but check the “about” or “sponsors” type of links in the menu on the homepage to gain a bit more information. People should be particularly suspicious if the source makes absolutist claims or evokes stereotypes. An anger-provoking headline on social media might be nothing more than manipulative clickbait, intended to sell a product or profit in some way from a reader’s attention.
  2. Make trustworthy news sources accessible and consistent by putting them on your social media feeds. Community service centers are a good one. Partner with opinion leaders people already trust. Our survey respondents viewed local news and local health departments more useful than other outlets, although favorite sources vary with their age and political orientation.
  3. Provide clear, consistent, relevant reasons to get the vaccines. Don’t forget the power of empathy. Our survey says only 49% thought a COVID-19 vaccine would help them, but 65% believed it would help protect other people. Avoid the temptation to use scare tactics and keep in mind that negatively framed messages sometimes backfire.
  4. Remember that skepticism about vaccines did not happen overnight or entirely without cause. Research shows that mistrust of news media compromises confidence in vaccination. Many are also skeptical of Big Pharma for promoting drugs of questionable quality. The government must too overcome mistrust based on past questionable tactics, including “vaccine squads” targeting African Americans and immigrants. Honesty about past mistakes or current side effects is important. Some information about vaccines, widely disseminated in the past, were later revealed to be wrong. Although the evidence for the efficacy of vaccines is overwhelming, any missteps on this subject breed mistrust. One recent example: Two major studies about COVID-19 treatments were ultimately retracted.
  5. Let them know that science is the answer, but it requires patience to get it right. Scientific progress is made gradually, with course corrections that are common until they build to consensus.

And emphasize the things we are certain of: The pandemic is not going away by itself. Not all news outlets are the same. Both flu and COVID-19 shots are necessary. And vaccines work. Collectively, by turning around those who believe otherwise, we can save lives.

How to Talk to Someone Who’s Hesitant to Get the COVID-19 Vaccine

I really like this set evaluation and set of suggestions put together by Elaine K. Howley, for Dr. Gabriel Lockhart, a pulmonologist and critical care intensivist at National Jewish Health in Denver, the question of how best to approach loved ones who are vaccine hesitant hit very close to home.

Lockhart, who is also the director of the ICU for National Jewish Health, has been on the front lines of the pandemic since the beginning, traveling to New York a few times to help out during the peak of its COVID crisis. “I had a lot of first-hand experience with the disastrous outcomes of COVID,” he says.

That, plus his background in pulmonary critical care medicine, has led to his working with Gov. Jared Polis of Colorado as part of the Governor’s Expert Emergency Epidemic Response Committee medical advisory group in collaboration with the Colorado Department of Public Health to address the pandemic in Colorado. “My specific focus was on vaccine distribution,” he says, which is a “very personal topic” for him because he’s African-American and Hispanic.

Communities of color have been hit disproportionately hard by the pandemic, and deploying vaccines to populations that are more vulnerable has been a key component of public health messaging.

But many people in these (and other) communities are hesitant to take the vaccine. And for good reason – there’s a long history of mistrust between communities of color and American health institutions.

For some people of color, there are deep-seated and legitimate concerns that this could be a repeat of Tuskegee, Lockhart says, referencing the infamous “ethically unjustified” Tuskegee study, which intended to study untreated syphilis in Black men and involved misinformation, lack of informed consent and outright manipulation of participants.

Fearing this situation might be similar, with communities of color being misled in the name of medical studies, some people expressed to Lockhart that they felt like “lab rats.” These responses caused the advisory committee in Colorado to take a step back and evaluate how they would encourage people in these communities to take the vaccine.

Lockhart says his own mother was initially resistant to getting the shot. “She finally just recently got her second dose, but that took six to eight months of me pestering her to finally get that to happen,” he says.

For his part, Lockhart was cautious too. “I wasn’t going to take the vaccine and promote it to my family and friends and patients unless I was completely confident in its safety and efficacy.”

When the clinical trials concluded, he reviewed the data and soon felt 100% comfortable about the safety and efficacy of the vaccine. He got his shots in December, among the earliest wave of health care personnel who were able to access the protective inoculation.

Making the Case for Vaccination

Since then, Lockhart has gone on to spread the message that the vaccines are safe, effective and everyone who’s able should get inoculated. He’s also learned that there’s a distinction between people who can be swayed and those who can’t be.

“When I approach people, who are hesitant about the vaccine, I think it’s first important to distinguish between those who are vaccine hesitant and those who are anti-vaxxers. Because those are two different things, in my opinion,” he explains.

“Vaccine hesitancy means they’re open to hearing information and making an educated decision based on good quality information they receive. They may not be wanting to go blindfolded into taking the vaccine. But if they’re willing to hear that information, then they can make an educated decision from that point.”

On the other hand, he says “anti-vaxxers are going to be dead set, no matter what information you tell them. They’re always going to be coming up with a firehose of misinformation and leading you down a rabbit hole of tangential information that isn’t really useful, accurate or helpful when it comes to vaccines. I don’t typically engage that much with purely anti-vaxxers because there’s really not going to be a lot of gain from that population.”

However, educational efforts can go a long way toward convincing those who are hesitant but open to learning more to take the vaccine to protect themselves and their communities, Lockhart says.

Dr. Julita Mir, a practicing internist and infectious disease physician and chief medical officer of Community Care Cooperative (C3) in Boston, urges patience and compassion when talking with others about taking the vaccine. “For most people, it’s a matter of time. We all move at different paces and accepting others’ pace is key.”

Find Out Their Concerns


Because there can be so many different, highly personal reasons why someone might be hesitant to take the vaccine, “it’s best to approach people in a supportive and respectful manner, and make it clear that your goal is to understand what their concerns are,” says Dr. Richard Seidman, chief medical officer of L.A. Care Health Plan – the largest publicly operated health plan in the country.

“We can’t assume what others are thinking or feeling, so it’s best to ask. Once we understand others’ concerns more clearly, we’re better able to engage in a meaningful discussion to explore how to best address their concerns.”

Dr. Lisa Doggett, senior medical director for HGS AxisPoint Health, a care management services company based in Westminster, Colorado, and a newly appointed fellow with American Academy of Family Physicians’ Vaccine Science Fellowship, recommends asking “if there’s anything that might change their mind. If they say, ‘absolutely not,’ it’s probably a good idea to stop and agree to disagree. By continuing you’ll often force them to dig into their beliefs with even greater conviction.”

But, she adds, that if they show some glimmer that they might be willing to consider an alternate view point, “offer to provide one,” but first, “ask for permission. If they agree, proceed with care, stay calm and offer information that’s likely to be meaningful to that particular person.”

Dr. Charles Bailey, medical director for infection prevention at Providence St Joseph Hospital and Providence Mission Hospital in Orange County, California, agrees that coming from a “place of love” often is more fruitful when trying to convince someone to get vaccinated.

He recommends saying something along the lines of: “‘I’m concerned about your reluctance to get a COVID vaccination because I care about your health and safety.’ And before going directly to examples of who you know who’s gotten the vaccine and had no or minimal problems, try to ascertain from where the reluctance originates.”

Ask questions like: “‘What in particular makes you hesitant to get vaccinated at this time?’ Phrasing it in this way provides room for a subsequent change in their decision later as more information comes to light and/or more consideration has occurred,” he explains.

Lockhart recommends “really making sure it’s a two-way conversation” that involves specific reasons. With a full explanation of where that hesitancy comes from, he says it’s possible to provide the accurate and correct information that can help move people toward getting the vaccine.

Mir also recommends “leading by example” and getting vaccinated yourself. “People tend to trust and be influenced more so by those in their close circles.”

Doggett adds, “at all costs, avoid insults and demeaning language, which would be counterproductive. And have realistic expectations. Not everyone

Countering Common Vaccine Concerns


There are a wide variety of legitimate reasons why some people may be hesitant to take the COVID-19 vaccine. These may include:

  • Speed that the vaccine was developed.
  • Safety.
  • Misinformation or misunderstanding the science.
  • Side effects.
  • Distrust of science, the government or medical authorities.
  • Underlying conditions that they believe might make them more vulnerable.

Speed of Development
For some people, the concern is the speed with which the vaccine was developed and how “new” the mRNA technology being used in two of the three shots currently available in the U.S. seems. But Lockhart notes, this approach to developing vaccines “isn’t that new. We’ve had experience with mRNA technology for the last two decades.”

Primarily, it was studied for use in cancer treatment and has also been investigated for use in vaccines against influenza, rabies and Zika. With all this scrutiny, scientists have developed “a good sense of the side effect profile when it comes to mRNA technology.”

The speed with which these vaccines were made available stems from that past experience with mRNA technology and the all-hands-on-deck approach that global health authorities took early on to bring this burgeoning crisis under control.

Lockhart uses an analogy to explain how it all came together so quickly. “It’s like having six different construction companies that were all employed to build separate skyscrapers. They’re told a skyscraper typically takes two years to build. But then they’re all told, ‘Hey, we need all of you to focus on the same skyscraper and expedite the production. Pivot your focus all on the same skyscraper.’ So, yeah. It’s gonna happen a lot faster when you already have infrastructure in place that all comes together for a common cause.”

Despite this fast-tracking, Bailey notes that the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have been clear from the beginning that “no short cuts in safety were taken” in bringing these vaccines into use this quickly. “The rapid development was facilitated primarily by massive governmental investment in private-sector pharma companies as well as liability protections.”

All the normal safety steps were taken in developing these vaccines, and because this was such an urgent need and highly scrutinized, all the trials were conducted to the most stringent standards. All three currently available vaccines in the U.S. have been found to be safe and highly effective.

The numbers may paint a clearer picture. The Pfizer-BioNTech vaccine trial included more than 43,000 participants. Of the group that received the vaccine (rather than a placebo) only eight individuals developed COVID-19. That’s compared to 162 in the placebo group. Of those infections, 10 were severe, but only one of those occurred in the vaccinated group, and the other nine were in the placebo group.

The Moderna vaccine trial included more than 30,000 people, and only five cases of COVID-19 were reported in the group that received the vaccine versus 90 in the placebo group. Of those 90 cases, 30 were severe. There were no severe cases of COVID-19 reported in the vaccine group.

The Johnson & Johnson one-dose adenovirus vector vaccine was trialed in nearly 44,000 people in eight countries. There were 116 cases of COVID-19 in the vaccine group and 348 in the placebo group at least 14 days after vaccination. Of those, only two were severe among the vaccine group, compared to 29 in the placebo group. Seven people in the placebo group died of COVID-19, while none died in the vaccine group.

For all three vaccines, the Food and Drug Administration granted emergency use authorization because they were “at least 50% more effective than placebo in preventing COVID-19,” which is consistent with the organization’s guidelines for granting authorization. “A vaccine with at least 50% efficacy would have a significant impact on disease, both at the individual and societal level,” the FDA reports.

Some of the testing steps happened in tandem, which is part of how these companies were able to condense the timeline. There was also unprecedented collaboration across pharmaceutical companies. This helped move everything along faster.

“Just because they happened faster doesn’t mean it’s not a quality product,” Lockhart adds.

Safety
Concerns about safety are also common, Seidman says. For example, concerns about very rare blood clots caused the FDA to pause distribution of the Johnson & Johnson vaccine for 11 days in April to reevaluate the data. Putting a pause on a new vaccine or medication is not unusual, and it’s an example of the system working exactly as it should.

In this case, there were six reported cases of blood clots and one death related to the J&J vaccine. More than 6.8 million doses had been administered when the pause was initiated in mid-April. In other words, the chances of developing a blood clot from the J&J vaccine were observed to be quite literally less than one in a million. However, in an abundance of caution, the FDA paused use of the vaccine to reevaluate the data and found that “it’s a very, very small concern, and compared to the risk of blood clots with contracting COVID, it’s extremely small,” Lockhart says.

A November 2020 study conducted at UC San Diego Health and involving more than 8,000 patients diagnosed with COVID-19 noted that 20% of people hospitalized with severe COVID-19 will develop blood clots. For patients in the intensive care unit, the rate was 31%. The study also noted that blood clots led to an increased risk of death by 74%. So the risk of getting a blood clot from the vaccine is miniscule in comparison to the risk of getting a blood clot from COVID-19 itself.

Doggett notes that “nearly everything we do in medicine, and in life, carries some inherent risk. Medications have side effects; treatments and procedures can have unintended consequences. Sometimes the risks and benefits are nearly equal, and choosing the right path is difficult. However, with the COVID-19 vaccine, the risks of vaccine refusal are clear and are substantially greater, for almost everyone, than the very small risk of the vaccine.”

Physicians are constantly weighing the risk versus benefit of any intervention, and the COVID vaccines have been found to be very beneficial with exceedingly small risks.

Plus, there’s reassurance in numbers, Seidman says. “The fact is that nearly 150 million people have been vaccinated in the United States alone with very few serious side effects.” This is excellent evidence that the vaccines really are very safe.

“All approved vaccines have an excellent safety profile, which is regularly tested,” says Dr. Eyal Leshem, director of the Center for Travel Medicine and Tropical Diseases at the Sheba Medical Center and a clinical associate professor in Tel Aviv University School of Medicine in Israel. This means safety testing isn’t just a one-and-done situation. These vaccines are constantly being monitored and evaluated. Any adverse effects are being carefully recorded, and if a safety concern does arise, as did with the J&J vaccine, use will be halted until further investigation can be conducted.

“Medicine in general and vaccine safety assessment specifically are scientific disciplines,” Leshem adds, and the science is showing these vaccines to be extremely safe and effective.

Misinformation or Misunderstanding the Science
“If misinformation is fueling the reluctance, simply supplying accurate information may dispel the nonacceptance,” Bailey says. To dispel some of these myths:

  • These vaccines can’t give you COVID-19. The vaccines do not include any live virus and thus cannot give you COVID-19. The vaccine triggers the immune system to manufacture antibodies against the disease.
  • They can’t affect your fertility. The CDC reports that there’s currently “no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems.”
  • They don’t contain other substances or materials that are harmful or controlling. Several bizarre conspiracy theories floating around the internet have suggested that the vaccines contain microchips or other nefarious ingredients that could be used to control people. These ideas are completely false and not based in science or reality.
  • You should get vaccinated even if you had COVID-19. That’s because while having had the disease offers some protection against future infection, there’s not enough data about that level of protection to know when it tapers off or how protective it is. If you’ve recently had COVID-19, you can receive the first dose of the vaccine four weeks after the onset of symptoms. The second dose can be administered after you’ve completed your isolation period (about 10 days). If you received certain treatments for COVID, including convalescent plasma or antibody infusions, you’ll need to wait 90 days before you can take the vaccine.
  • These vaccines can’t change your DNA. Some people have misunderstood what mRNA is and how it works and believe that this approach can alter your DNA. But that’s not true. “There’s no interference of your DNA. The vaccine doesn’t affect your DNA at all,” Lockhart says.

The Moderna and Pfizer-BioNTech vaccines both use mRNA to stimulate the body to create the antibodies it needs to fight off infection from the coronavirus. mRNA is messenger RNA, and in this context, it refers to a piece of the virus’ spike protein. This molecule contains a a piece of genetic code that instructs your cells to create antibodies against the coronavirus. To do this, the mRNA doesn’t even enter the nucleus of the cell – the cell breaks it down and removes it after it’s finished using the instructions.

Side Effects
For some people, it’s a prior negative experience that’s driving their reluctance. In this case, whether the concern is a bad reaction to another vaccine or concerns about side effects that someone else has experienced, Bailey says discussing the facts around the statistics can help dispel some of that hesitation. He notes that the risk of severe side effects from the COVID vaccines is very low and much lower than the risk of getting COVID if you don’t get vaccinated.

Many people experience no side effects from any of these vaccines. But for others, after having one or both shots, they have reported experiencing:

  • Soreness, redness or swelling at the injection site.
  • Mild, flu-like symptoms, including a headache and body aches.
  • Tiredness.
  • Low-grade fevers.

Most of these side effects are mild and resolve quickly – within a day or two for most people. They’re also normal and signs that the vaccine is working to get your immune system ramped up to better meet the challenge if you’re exposed to the coronavirus in the future.

The most common side effects are also likely to be far less intense than if you were to get infected with COVID, so it’s worth it to feel a little lousy for a few hours – or even a couple days – after your shot if it means protecting yourself – and others – from a potentially far worse outcome if you caught the disease.

In very rare cases, some people have experienced more intense side effects including:

  • Severe allergic reactions including anaphylaxis. This has been observed in approximately two to five patients per million people vaccinated. This reaction also almost always occurred within 30 minutes after vaccination, which is why recipients are instructed to wait 15 to 30 minutes after each shot for observation.
  • Thrombosis with thrombocytopenia syndrome. Also called TTS, this condition involves blood clots with low platelets. This very rare syndrome has occurred almost exclusively in adult women younger than age 50 who received the J&J/Janssen vaccine. According to the CDC’s Vaccine Adverse Event Reporting System, as of May 11, 2021, more than 9 million doses of the J&J/Janssen vaccine had been given and 28 reports of TTS had been confirmed.

It’s important to underscore that these effects have been observed in a very small proportion of patients.

In addition, the CDC reports that there’s currently no evidence that there’s a causal link between the vaccine and any deaths apart from a “plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and a rare and serious event – blood clots with low platelets – which has caused deaths.” The CDC and the FDA are continuing to monitor all adverse events and deaths and are reporting such to the VAERS.

Distrust of Science, the Government or Medical Authorities
Seidman also notes that “many people just don’t like being told what to do, especially if the message is coming from the government.” This is where community-based initiatives to educate and provide vaccines to people where they are can be especially useful.

“I’ve been working on talking to several community groups and leaders so they can answer questions and disseminate this information to their communities,” Lockhart says. Talking with a trusted adviser, such as a church elder or a barber, may offer more reassurance to hesitant people than speaking with a doctor, he adds. “If I can get buy-in from those folks, I think that’s the best efficacy. We can get people to accept the true information about these vaccines” because it’s coming from a trusted community leader.

Doggett adds that “for those who are concerned about personal liberties, a message that will sometimes resonate is that vaccinating more people will help encourage the government to lift restrictions and increase freedom in the long run.”

Leshem notes that this has already happened in Israel, where as of May 10, 2021, nearly 63% of the population has been vaccinated against COVID-19. “As we’re now experiencing in Israel, when most of the population are vaccinated disease spread declines and it is possible to go back to living a normal life.”

Barriers to vaccination such as the long history of racism and, as Seidman explains, “government-sanctioned experimentation on low-income people of color that has eroded trust” may be more difficult to combat. Lockhart says that while these are very legitimate concerns, avoiding the vaccine is only going to worsen the disparity in outcomes between white communities and communities of color.

Again, community-based, grassroots outreach efforts may be better for convincing people who have this as their primary concern. There needs to be a re-establishment of trust with agencies and entities that purvey medical information and care. “My advice is to get the facts from a trusted source of truth, like your doctor or from your faith-based leaders. And be careful not to accept what you might hear or read in biased media sources,” Seidman says.

“Many people tend to trust their primary care doctors, and building on that trust to overcome vaccine hesitancy is important,” Doggett says. And across the board, she adds that “the medical community needs to communicate effectively and consistently about the safety of the vaccine to help improve vaccine acceptance.”

Underlying Conditions
For some people who are pregnant or have medical conditions, such as cancer, there’s been a lot of fear and confusion surrounding whether it’s safe to take a COVID-19 vaccine.

  • Cancer. The American Cancer Society reports that for most people with cancer or a history of cancer, the vaccine is safe and should be accepted, but individual cases may have other factors to consider, so talk with your oncologist.
  • Pregnancy. Though there has been some hesitation among pregnant people in taking the vaccine, studies have found that it’s safe and could actually protect your baby from contracting the virus after birth. The CDC’s V-safe COVID-19 Vaccine Pregnancy Registry is monitoring deployment of the vaccine in pregnant people. As of May 10, 2021, more than 110,000 pregnant people have been vaccinated. Talk with your obstetrician for advice tailored to your specific situation.
  • Immune disorders. If you have a chronic immune disorder or are taking medications that suppress the function of the immune system, you are eligible to get the vaccine. But you should talk with your health care provider about your situation.
  • Negative previous reactions to vaccines. If you’ve had a previous severe allergic reaction (anaphylaxis) you should not take the vaccine. If you have severe allergies to certain medications, latex, pets, foods or other environmental triggers, talk with your health care provider about whether it’s safe for you to take the vaccine.

“Referral to a family physician, nurse specialist or an infectious disease doctor can further help in more complicated cases, such as immune compromise, severe allergy or pregnancy,” Leshem says.

Why Vaccination Matters

The sooner everyone gets vaccinated, the better our chances of putting the pandemic completely behind us. “The COVID-19 vaccines are the best tool we have to get the pandemic under control, allowing us to get back to doing all of the things we need and want to do as individuals, families, business owners and as a community,” Seidman says. “Every additional person who gets vaccinated gets us one step closer to getting the virus under control.”

Still, as Doggett notes, “over a quarter of U.S. adults say they won’t get vaccinated. Their refusal makes it harder to stop the spread of the coronavirus, increasing infection rates and health care costs, and raising the risk of new, more dangerous variants. It also makes it more difficult for us to achieve herd immunity and effectively end the pandemic.”

This ongoing hesitancy to get vaccinated will drag out the pandemic and make it more difficult to resume life as usual, she says, because “the pandemic is far from over.”

In countries where vaccination rates are high, such as the UK, Israel and some parts of the U.S., cases are declining. “But rates of COVID-19 remain dangerously high in many parts of the world,” Doggett says. The higher these rates of infection, the more likely the virus will mutate into more dangerous strains that can undermine all the efforts over the past year to stamp out the pandemic.

“Even in the U.S., we’re still seeing tens of thousands of new cases every day and hundreds of deaths. The faster people get vaccinated, the faster we can stop the virus from spreading, and the sooner we can safely resume activities that many of us have given up during the pandemic, like travel, indoor dining and visiting family.”

The bottom line, she says, “getting vaccinated is the safest way to protect yourself and everyone around you from getting sick. It’s also an important way to stop the creation of new variants of the virus, that may be more virulent, more resistant to the vaccine and could extend the pandemic.”

Vaccine refusal, on the other hand, “will lead to higher health care costs, damage to the economy, and more people living with long-term COVID-19 complications, such as damage to the heart, lungs and brain that we’ve started to see in as many as a third of COVID-19 survivors.”

“Getting vaccinated is a personal decision,” Seidman notes. But choosing “not to get vaccinated is a decision that impacts everyone.”

Estimates of the number of people who need to be vaccinated to achieve herd immunity have typically ranged from 60% to 80% or so, but there are still many open questions about how durable immunity is and when we’ll have reached the threshold of protection.

In the meanwhile, getting vaccinated and convincing your friends and loved ones to do the same is our best means of moving out of this crisis. For his part, Seidman says “the COVID-19 vaccines are really a miracle of modern science. These vaccines are very safe and effective in preventing infection, hospitalizations and deaths from the worst pandemic in 100 years.”

And now with the Delta variant, Some areas of the U.S. could see “very dense outbreaks” of the Delta coronavirus variant throughout the summer and fall, particularly in states with low vaccination rates, according to CBS News.

The Delta variant, which was first identified in India, now makes up about 20% of new cases across the country. The variant has led to surges in parts of Missouri and Arkansas where people haven’t yet received a COVID-19 vaccine.

“It’s going to be hyper-regionalized, where there are certain pockets of the country where we can have very dense outbreaks,” Scott Gottlieb, MD, former commissioner of the FDA, said Sunday on CBS News’ “Face the Nation.”

“As you look across the United States, if you’re a community that has low vaccination rates and … low immunity from prior infection, the virus really hasn’t coursed through the local population,” he added. “I think governors need to be thinking about how they can build out health care resources in areas of the country where you still have a lot of vulnerability.”

Arkansas Gov. Asa Hutchinson, who spoke on “Face the Nation” before Gottlieb, also expressed concerns about the Delta variant. Arkansas has one of the lowest vaccination rates in the country, which Hutchinson attributed to vaccine hesitancy and conspiracy theories about the COVID-19 vaccines.

“The Delta variant is a great concern to us,” he said. “We see that impacting our increasing cases and hospitalizations.”

Hospital admissions increased 30% during the last week, and the University of Arkansas Medical Center reopened its COVID-19 ward. The state is offering incentives for people to get vaccinated, but they haven’t been successful, Hutchinson said. About 50% of adults are vaccinated, and public health officials want to move the needle higher.

“If incentives don’t work, reality will,” he said. “As you see the hospitalizations go up, the cases go up, I think you’ll see the vaccination rate increase as well.”

The Delta variant has been detected in 49 states and the District of Columbia, CBS News reported. The strain is more transmissible and can cause more severe COVID-19. The U.S. and other countries have marked the Delta variant as a “variant of concern” to monitor as the pandemic continues worldwide.

The Delta variant has become the dominant strain in the U.K. and now accounts for 95% of cases that are sequenced, according to the latest update from Public Health England. On Sunday, Gottlieb said the U.S. is about a month or two behind the U.K. with local surges in cases due to the variant.

“They’re seeing cases grow,” he said. “The vast majority are in people who are unvaccinated … the experience in the U.S. is likely to be similar.”

My friend, former patient and cartoonist, Rick Kollinger, succumbed to his long battle with cancer picture him at the Golden Gates with a sketchpad in hand waiting to draw all of those that he surely will meet, possible insult, and entertain. I and many others will miss you.

Happy Fourth of July to ALL! Let us reflect on the history and the future of our great country. Take a moment to consider what we all have achieved this past year and focus on what we can accomplish in our future.

The Pandemic Will Likely End In One Of These Four Ways; Social Media and More About Vaccines.

I am getting really frustrated having to try to convince friends and patients of the value of vaccinations for Covip-19. Vaccinations promise an end to the coronavirus pandemic in the US. What kind of ending, though, is up to us?

I “loved” the excuse that she knew that the GOVERNMENT was putting tracers in the vaccines to track our every move and racist thoughts.

And with the cases and deaths due to COVID increasing in such very high numbers, while Israel as a country is the only country that has reached herd immunity. Their vaccinations are over 80% of their population and their new cases are so very low.

Reporter Dan Vergano noted that if the White House’s vision goes according to plan, vaccinations will end the pandemic in the US in time for 4th of July fireworks. Or the pandemic won’t end, and these shots will be the first of many we’ll get for years. Or they’ll offer a brief summer respite — before a more severe version of the coronavirus catches fire.

A return to a life resembling normalcy looks closer than ever now that, as of Monday, vaccines are available to every adult in America. Around 80 million people are already fully vaccinated, and President Joe Biden said on Wednesday that the US has already reached his goal of 200 million shots in the first 100 days of his administration, eight days early.

But with half of the population still unvaccinated and COVID-19 cases once more rising, just how close are we to the pandemic ending, both in the US and across the world?

Whether the pandemic ends in the US by Independence Day — or much further in the future — will depend on the vaccines, the virus, and decisions people make, experts say. The big questions include how long the vaccines’ protection lasts, how well they fight off new coronavirus variants, and whether the entire globe can hold off these emerging threats. Then there’s the X factor of how many people will be willing to get shots.

The benchmark for a successful vaccination campaign has long been considered to be “herd immunity” — having enough people vaccinated to keep sick ones from sparking outbreaks. That might require 80% of US adults getting vaccinated, according to infectious disease researcher William Schaffner of the Vanderbilt University School of Medicine.

Other experts have urged Americans to not obsess over herd immunity. “I can’t say it’s going to be ‘this’ percent,” Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said this month, although he has previously floated percentages ranging from 70% to 85%. “We’ll know it when we see it. It’ll be obvious.”

Getting to that turning point could take very different routes, experts told BuzzFeed News. Although the summer everyone hopes for is within reach, worse outcomes are also possible. At this pivotal moment in the crisis, a lot depends on how willing people are to help themselves by continuing to wear masks and isolating until they are fully vaccinated — and to help people around the world get vaccinated too.

“It depends on decisions we make,” Lauren Ancel Meyers, a University of Texas epidemiologist, said this month at a Stanford University symposium about herd immunity.

Here are four ways that the pandemic could end in the US.

1. The Better Ending: Vaccination Returns Life Close to “Normal”

By June, most US adults get vaccinated. The shots halt the spread of SARS-CoV-2, even the more transmissible variants. And people feel safe shopping, traveling, and visiting each other, almost like they did before the pandemic.

This is the best outcome — and it isn’t completely far-fetched. Half of US adults have received at least one shot. Even with Johnson & Johnson’s vaccine paused, more than 3 million shots are being administered a day; at that rate, every adult American could receive one by late June.

Israel offers a glimpse of this future. There, a fast-paced campaign had immunized more than half of the population by mid-April. The results have been striking in the country of 9 million, with new cases falling to around 200 a day, 2% of the January peak. Starting this weekend, an outdoor mask mandate will be lifted.

White House / Via whitehouse.gov

White House COVID-19 briefing slide, showing case drop with 62% vaccination

Similarly, in the US, new cases among nursing home residents dropped by 96% and deaths by 91% between December, when vaccinations started, and March. After a slow start, more than 4.8 million people in nursing facilities have received at least one shot.

Although case numbers have increased in recent weeks, Deepta Bhattacharya, an immunologist at the University of Arizona College of Medicine, predicts “a smaller bump over the next couple months that should by the summer settle down to a pretty low level of cases.”

That doesn’t mean that masking would stop. It’s worth noting that the declines in both Israel and nursing homes happened while restrictions were maintained. Under current US plans, young teens won’t start getting shots until the fall and elementary school–age children in the winter of 2022, meaning that their schools will likely keep face coverings, some virtual classes, and other restrictions for the foreseeable future.

But most partial or full closures of shops, restaurants, universities, and bars could end this summer if US cases fall like they did in Israel.

The bottom line is that the Pfizer and Moderna vaccines, which make up the great majority of US shots, have proven 90% effective in real-world studies against COVID-19. Although some people have gotten infected despite vaccination, their numbers are small: about 6,000 cases out of 84 million fully vaccinated people, or .007%, according to CDC data.

“It is not unexpected — the vaccine is not 100% protective,” Scott Lindquist, a Washington state health department official, said in a recent press briefing about “breakthrough” infections there. “But what we saw were mostly very mild symptoms, if any at all.”

And existing vaccines appear to protect against new coronavirus variants, such as the B.1.1.7 strain, according to CDC data. “If you lose a little bit of protection to a variant, but the vaccine still keeps you safe, that’s still a good result,” Bhattacharya said. Vaccines aside, he noted that a sizable chunk of the population — more than 1 in 5 Americans by one recent estimate — also has some natural immunity from past infections, though studies suggest that this protection likely isn’t as long-lasting or robust as vaccination.

“I do think we’ll be OK by the summer,” said the immunologist, who is personally planning to travel to see his family in cities across the country. “Tickets booked for early July!”

In this future, the coronavirus cools down enough to be managed like the measles: a virus tamed by a vaccine that is added to childhood shot regimens, with occasional outbreaks in unvaccinated communities.

2. A Mixed Ending: Defanging, Not Defeating, the Virus

Mass vaccination delivers yet another future: the death rate from COVID-19 drops drastically, because the shots prevent severe and fatal illness, but outbreaks continue, largely among pockets of unvaccinated people, including younger people who are less targeted for vaccines or less worried about getting sick in the first place.

“A more realistic scenario is that older, more vulnerable individuals will receive a disproportionate number of doses,” said infectious disease modeler Jack Buckner of the University of California, Davis, by email. “Under these conditions additional outbreaks are more likely but the case fatality rate would be lower.”

Last month, CDC Director Rochelle Walensky was asked whether a sharp decline in death rates, with case numbers remaining high over the summer, might lessen the public’s urgency to get vaccinated. She called it a concern, but noted that children are dying of COVID-19, albeit very rarely, and that long-term complications from infections, also known as “long COVID,” plague even people with mild cases. A recent study from Sweden, for example, found 1 in 10 healthcare workers who had mild cases have felt effects, like loss of smell and taste, fatigue, and breathing problems, for months after.

“We’re going to defang the virus rather than defeat it.”

In this mixed scenario, we dodge a summer surge of deaths, but outbreaks occur in some counties or states. Herd immunity is also never quite reached in this future, because variants circle the globe every year like variations of the seasonal flu. Post–mass vaccination, the coronavirus would then enter a “mild endemic state,” where SARS-CoV-2 is reduced to a childhood cold, said Harvard epidemiologist Marc Lipsitch at the recent Stanford symposium about herd immunity. “We’re going to defang the virus rather than defeat it,” he said. “We’ll make it a nuisance that makes people a bit ill, rather than something that kills people in large numbers and causes the hospital system to groan under the weight.”

A related possibility is that vaccination only delivers immunity for a year or two and requires regular booster shots for older and younger people alike, which the heads of Pfizer and Moderna have told investors might be the case. (On Sunday, Fauci said on NBC’s Meet the Press that the FDA and CDC — not vaccine makers — will decide by fall about boosters.)

“Even if we reach the herd immunity threshold in the US or in rich countries, this virus is going to continue to circulate,” said Lipsitch.

Right now, doses are only promised on the order of hundreds of millions, and the planet is home to 7.8 billion people. The World Health Organization has warned that global under vaccination would be a catastrophic moral failure, prolonging coronavirus transmission around the world.

3. A Worse Ending: A Fourth Surge for the Summer

The better outcomes are far from inevitable. White House officials regularly say that the US is in a race between vaccination and more contagious coronavirus variants. In this scenario, we lose the race. The result: a fourth surge.

The reasons for worry are plain in case numbers that have stopped declining and are instead trending upward again, now averaging around 67,000 newly-reported infections a day. The more transmissible and dangerous B.1.1.7 coronavirus strain is quickly becoming the predominant one nationwide, now accounting for 26% of all new cases.

“We remain in a complicated stage,” the CDC’s Walensky said Monday. “On the one hand, more people in the United States are being vaccinated every single day and at an accelerated pace. On the other hand, cases and hospitalizations are increasing in some areas of the country, and cases among younger people who have not yet been vaccinated are also increasing.”

If the US falls behind on vaccinations, then a second lockdown period might result. Rising hospital admissions could lead governors and mayors to shutter bars, restaurants, and stores once again.

“We are in real risk of throwing away all the gains we have made, and losing another summer,” Debra Furr-Holden, a Michigan State University epidemiologist, told BuzzFeed News.

Her state, as well as the rest of the Upper Midwest and the Northeast, is in the thick of massive outbreaks right now. Some counties reopened bars, gyms, and restaurants too early, Furr-Holden believes, which in her view should serve as a warning to the rest of the country.

Although 74% of US adults say they want a shot, up from half in September, that’s still not enough to achieve herd immunity, some suggest. “We have to get about 80% of adults vaccinated,” said Schaffner, the infectious disease specialist at Vanderbilt. “We’ve never done that with any vaccine in the United States.”

Some areas of the country are also much more resistant to vaccination than others. In states like Tennessee, Kentucky, Alabama, and Mississippi, as many as 37% of people tell pollsters they don’t want a shot. Politics clearly plays a role. Older, rural conservatives express the most hesitation, and their fears are reinforced by misinformation and fearmongering on right-wing cable channels.

“We are running into people who have expressed some hesitancy, so we have to listen to them and address their concerns,” said Schaffner, who is based in Nashville. Walensky acknowledged this week that “the administration of vaccines across the country is not uniform.”

But Andy Slavitt, the senior White House COVID-19 adviser, said he was unwilling to entertain the idea of the federal vaccination campaign shifting doses to parts of the country clamoring for shots and sending less to ones in areas where they go unused. “We are not going to quote-unquote ‘punish’ less-ready areas,” Slavitt told BuzzFeed News during a briefing this week. The key, he said, is to convey to people that while vaccines were hard to get during the initial rollout, there are now more than 60,000 vaccination sites nationwide, and at least one of them is within 5 miles of where 95% of the population lives.

Whether enough Americans will take that message to heart remains to be seen. If not, we may only reach herd immunity after another painful surge.

4. The Bad Ending: After the Summer, Global Variants Revive the Pandemic

Then there’s the worst-case scenario. In a mostly unvaccinated world, a new and more deadly coronavirus variant — or variants — overpowers vaccines and restarts the global pandemic all over again. The US, along with everyone else, has to begin again with new vaccines.

“Coronavirus mutates a lot — they can do it in humans, they can do it in animals — and the question is how important are these mutants going to be,” Stanford University infectious disease expert Julie Parsonnet said at the herd immunity symposium held at her university. “We don’t live just in Palo Alto, or just in California, or just in the United States. We live in a world where there are a lot of unvaccinated people, and as long as we don’t focus on the world more globally, we’re going to have problems.”

For now, the available vaccines are effective against the variants circulating in the US. But experts are surprised at the speed at which more transmissible ones have arisen, said Bhattacharya of the University of Arizona. Their arrival reflects just how widely the coronavirus has spread from host to host, each acting as a lab for new mutations to emerge.

“The places where the variants are growing, they’re not growing because they are evading the immune system, they are going nuts because there aren’t enough people that are immune,” Bhattacharya said. “Obviously this isn’t the best situation, because the longer you let this go, the better the odds that you will get some weird thing that will eventually start to grow out because it can evade the immune system.”

Last week, the White House announced a $1.7 billion effort to detect such new strains. Pfizer, Moderna, and other vaccine makers are already testing prototype booster shots that are designed explicitly against variants, such as the B.1.1.7 strain.

In the face of this threat, a recent risk analysis led by George Ioannou, an expert on veteran care at the University of Washington, offers a framework for who should get prioritized for vaccines. To prevent deaths as much as possible, people with the most severe risk factors, such as diabetes, heart failure, or kidney failure, should be given shots first, this work suggests. At the same time, if there is enough supply, vaccines should be administered as quickly and widely as possible to combat the new variants.

“You really don’t want that threat just hanging around,” Bhattacharya said.

But even in this worst case, the silver lining is that the coronavirus has nevertheless proven amenable to vaccination, he and other experts noted, unlike HIV, which for decades has thwarted vaccines. A coronavirus strain that evades the current vaccines will almost certainly be susceptible to shots that have yet to be designed.

That means vaccines will at some point deliver an end to the pandemic, no matter how many changes in work, school, and daily life it leaves behind, said Yale sociologist Nicholas Christakis, author of Apollo’s Arrow: The Profound and Enduring Impact of Coronavirus on the Way We Live.

“Eventually it will return to normal,” Christakis told BuzzFeed News. “Plagues end — they just do.”

Social Media: A Parasite on Our Pandemic Mental Health

Doctor Vinay Prasad reported that recently, a physician colleague of mine, someone whom I’ve met in person and with whom I’ve shared a laugh, began to tweet increasingly hostile barbs about me. In a certain respect, it was a typical social media interaction — an uncharitable reading of one’s point of view and a scornful reply. But it was also unusual, as we have met in person, face to face.

In my experience, online anger like this is summoned only when the other person has been depersonalized — just a face dissociated from a person. I’d rarely experienced it from someone who I knew in real life. Just as I started to wonder what might be going on, a mutual friend called to say they had seen the out-of-character barbs. Apparently, this colleague has been suffering from a serious medical illness and was going through a hard time. By the end of the call, I was left feeling sympathetic.

Later that day, I noticed that a professor whose tweets I greatly enjoyed had shut down their account. Poof! They, and their astute comments, were gone entirely. I sent them a note, mostly to let them know that I had been affected by their sharp thinking over the years, and was sorry to see them go. The person wrote back that the growing hostility had driven them away. Every time they said anything, they felt mobbed by a sea of increasingly angry voices. They didn’t need the stress.

Finally, the same day, a colleague from another university called me to ask for some advice. She had been on Twitter, and was troubled by increasingly hostile and negative feedback. The specifics were ugly, and I could tell from the tone in her voice that my colleague was pained. I gave the few tips I know and went for a long run to think.

What Is Going On?

In the best of times, social media is a double-edged sword. It is a great way to get a message to many people, but it is de-personal, and driven by the economy of attention. Anger, disgust, and outrage are the emotions that engage and addict the users. People, good people, can become disinhibited and say things they don’t truly mean, or would never say in real life. Of course, this is during the best of times.

We are not in the best of times. People have been cut off from friends, family, and co-workers, and many are living in isolation. In fact, it is the loneliest year in human history. The largest number of people in history (billions) have deprived themselves of, at least some, social interactions. Mental health is suffering, and physicians, healthcare workers, researchers are suffering alongside everyone else. When we are tired and angry we are not our best selves, and paired with the algorithms of social media, it is a recipe for disaster.

Where Are We Now?

Every day people go online and the difficulties of the last year loom large in our minds — over 500,000 dead Americans, disjointed and often incoherent policy responses, the list goes on. Some are angry that we didn’t do more, sooner. Others are angry about interventions and restrictions that were broadly implemented that might not have helped, and even hurt. Both groups might be right: we were unwilling to do some things that might have helped, and simultaneously pursued other interventions that didn’t, and unfortunately hurt less-fortunate Americans. It will take years to tease these apart, as I have written. Regardless, we are angry. So, we go online looking to vent that anger. If we felt the bigger error was not enough restrictions, we get angry when someone is critical of restrictions. And if vice versa, we find a different scapegoat. A philosopher recently told me, we get most angry when other people don’t follow restrictions that we are able to follow.

The angry train goes off the rails when we invent motivations for others. Folks who share our point of view are always good people who want to save lives, and folks who disagree with us are people indifferent to human beings, grifters, ideologues, or attention-seekers. But, if one steps back, how can that possibly be? Surely people on all sides of an issue — whether that be school reopening or best vaccination practices — have varied reasons for holding their view. A tiny fraction may have some ulterior motive, but surely the vast majority hold their view for the same reason folks who disagree hold their view — an alternative interpretation of facts and values. I suspect a year from now the idea that the world is full of strictly good and bad people will look particularly ridiculous.

How Can We Make It Better?

I don’t know how we can improve the situation on social media, and more critically, reverse the anguish so many are facing in real life — but I do have some tips about how we might help ourselves.

1. Get offline. The professor who deleted their account had the right idea. Each of us has to decide if social media serves our purposes and makes us better informed or happier, but probably all of us should use it less. Read it less, and post less.

2. Mute all notifications. I did this a few years ago, and I quickly found more joy in my life. Say what you have to say, and let it go. No need to reply to anyone, and the easiest way is to set the accounts to never disturb you again.

3. Don’t reply to others. If you read a point of view you disagree with, what value is there in replying to the other person? Just state your point of view in your terms on your feed. No need to pick a fight. Just make your point on your terms.

4. If you are having a hard time at home or work, don’t use social media. It is hard enough to manage when you wake up in a good mood, but when you are feeling tired, scared, afraid or sick, it is too much. Corollary: If you love someone, and they are hurting, suggest they do the same.

5. Meet or call someone every day. Social media thrives from our loneliness — it’s a cheap way to feel less lonely in the loneliest year of human history. But it is a neon light to the sun. Call someone. Visit someone. Interact more in real life.

6. Tell someone you don’t know you appreciate their thoughts. Perhaps the best thing we can do to combat negative emotions is to give some positive feedback to folks we appreciate. I have sent some emails to people, but perhaps I am not thinking big enough. I plan to go on social media and talk openly about people whose thinking delighted me over this last year. It is the least I can do to combat the animosity.

Toward More Productive Dialogue

When we are feeling powerless, getting angry at someone is seductive. It is a way to channel and reorient your energy. Unfortunately, it leaves all involved worse off. Instead, consider using your energy to articulate or refine your perspective, to push for positive change. That doesn’t mean that there are not real errors — but jumping on a single tweet by a minor character in a drama is unlikely to be the change-maker. My tips are just suggestions, but all meant to re-orient the compass toward productive dialogue.

Scientists Reveal How the AstraZeneca Vaccine Causes Unusual Clots

Brenda Goodman reported that scientists in Germany say they’ve worked out the two-step mechanism by which the AstraZeneca vaccine causes rare but devastating blood clots that gobble up the body’s supply of platelets.

So far, European regulators have reported more than 220 cases of unusual blood clots and low levels of platelets in patients who received the vaccine, called Vaxzevria, which was developed with funding from Operation Warp Speed as part of the race to develop a suite of vaccines to protect people from COVID-19. Vaxzevria has not yet been authorized for use in the United States.

“This is, in my opinion, rock-solid evidence,” said Andreas Greinacher, MD, head of the Institute of Immunology and Transfusion Medicine, University Hospital Greifswald, Germany, who was among the first scientists in the world to link the rare clots to antibodies against the platelet factor 4 protein.

Greinacher said he found the same mechanism using three different technologies to gather evidence: dynamic light scattering, super-resolution microscopy, and electron microscopy.

“This is what scientists usually think is confirmatory evidence,” he said in a call with reporters hours after publishing his study as a preprint ahead of peer review on the Research Square server.

Greinacher said he felt an urgent need to get the information out as soon as possible. He said his team had worked around the clock for 5 weeks to get answers, “because we are in the middle of the vaccination campaign. This was the driving force for us and the big motivation to provide these data as fast as any other possible,” he told reporters on the call.

Greinacher said that he believes the mechanism linking the vaccine with the rare clotting reactions is likely to apply to other vaccines that also use adenoviruses to ferry instructions for making the virus’s spike protein into cells.

“My assumption is, and that’s a hypothesis, that this is a class effect of vaccines using adenovirus,” he said. He added that he could not be certain because he only studied reactions to the Vaxzevria vaccine. But previous studies have shown that adenoviruses can cause the type of platelet activation he saw in the reactions he studied.

Greinacher said that he had worked out an agreement with Johnson & Johnson about an hour before the call to collaborate on studying its COVID-19 vaccine. The company had previously been unwilling to share information, he said.

At least seven cases of the same pattern of unusual clots have been documented in people who received the one-dose Johnson & Johnson vaccine, which also uses an adenovirus as its delivery vehicle. Over 7 million Johnson & Johnson vaccines have been given in the United States so far.

While the reactions are extremely rare, they can be serious. One person, a 45-year-old woman in Virginia, has died. That led the US Centers for Disease Control and Prevention and the US Food and Drug Administration to call for a pause on administering the Johnson & Johnson vaccine last week. The company also announced that it would hold clinical trials to get more answers about the reactions.

In his new study, Greinacher and colleagues describe a cascade of events that has to happen in the body before the vaccines broker these large clots. He explained that while everyone has the basic immune machinery that leads to the unusual clots, it is almost always kept in balance. The body uses a series of checks to prevent any step in the process from getting out of control.

In some cases, however, there’s a perfect storm where each stage progresses to the next and the end result is very hard to control. That autoimmune attack, which causes the body to go into a hyper-clotting state, typically burns itself out after a few weeks. So if patients can get rapid treatment, the condition nearly always goes away.

He said he only knew of one case of an autoimmune syndrome like this lasting 10 years, but that was in a patient who had taken the blood thinner heparin, which can cause a nearly identical syndrome.

Two-Step Process Leads to Clots

In the first step, the adenovirus shell in the vaccine, along with proteins from the cells where the vaccine is grown, come into contact with platelets from the blood.

Platelets are best known as colorless cell fragments that rush to the site of an infection or injury, helping the blood congeal to stop bleeding; they also play a key role in the body’s immune response.

When activated, they surround invaders like bacteria and change shape to release chemical signals they store in granules.

When platelets are activated en masse, as can happen rarely after a person takes the blood thinner heparin or gets the Vaxzevria vaccine, they release a flood of these signals, Greinacher explained. These blaring signals recruit an ancient and hard-to-control branch of the immune response.

“Imagine this is like a dragon in the cave who was sleeping for a long time [but] which now got alerted by someone’s throwing a stone on it,” he said. The chemical signals awaken B-cells that then produce massive amounts of antibodies against the platelet factor 4 protein, which helps coordinate blood clotting.

The body erroneously thinks it is reacting to massive amounts of pathogens in the body, so the immune system overshoots. The antibodies bind the platelets, the platelets recruit white blood cells, and “then the whole thing is exploding,” he said.

The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the Vaxzevria vaccine.

EDTA is not listed as an ingredient in the Johnson & Johnson vaccine.

EDTA opens junctions between cells that form the walls of blood vessels, causing them to become leaky. This allows the giant complexes formed by proteins and platelets to enter the blood circulation, where they — on very rare occasions — trigger that bodywide alarm.

Asked if he thought there was anything that could be done to make the vaccine safer, Greinacher said his first thought would be to try to get rid of the EDTA, which causes the second step in the process. But he said he was not a vaccine developer and didn’t know how important it might be to its formulation.

Why might the Johnson & Johnson vaccine lead to similar types of clots, even though it doesn’t contain EDTA? Greinacher speculated that size might play a role.

When this reaction occurs in patients who have taken heparin, the size of the heparin molecule matters. With unfractionated heparin, the longest kind of molecule, the reaction is 10 times more common than when patients take smaller low-molecular weight heparins.

Other vaccines might form smaller antibody-protein complexes that generate smaller warning signals, making the reaction less likely.

As for why the reaction appeared to be more common in women, Greinacher said he was growing skeptical that there is a large gender bias. He pointed out that most of the first vaccine recipients in Europe had been healthcare workers, who are disproportionately women.

He noted that women might be slightly more susceptible because of hormones and because women are more likely to develop autoimmune diseases, but that the risk was probably more balanced between men and women than it first seemed.

“It’s not a disease of young women,” he said.

Several European countries have changed or abandoned their use of the AstraZeneca vaccine.

Last week, Denmark said it would no longer include Vaxzevria as part of its vaccination program. Italy has recommended that AstraZeneca vaccine only be used in people over age 60. UK officials said people under age 30 should be offered an alternative.

Meanwhile, the European Medicines Agency said a warning about the risk of blood clots and low platelets should be added to product information for the Johnson & Johnson vaccine.

ACIP Green-Lights J&J Vax for All Adults

Finally, Molly Walker reported that the pause is lifted, and Johnson & Johnson’s COVID-19 vaccine is once again recommended for adults, according to the CDC’s Advisory Committee on Immunization Practices (ACIP).

In a 10-4 vote, with one abstention, ACIP said in updated interim guidance that the Johnson & Johnson vaccine is recommended under FDA emergency use authorization (EUA) for all adults.

They ultimately decided that including a separate warning on the vaccine, as well as in an FDA EUA fact sheet and materials on the CDC website, was sufficient. One choice the committee chose not to vote on would have added language that women under age 50 should be aware of the increased risks of rare clotting events, and may opt for a different authorized COVID-19 vaccine. The committee agreed that any further qualifiers would be too cumbersome for local jurisdictions to implement and might contribute to vaccine hesitancy.

Johnson & Johnson researchers unveiled a proposed warning that the FDA agreed to add to the vaccine’s current EUA. It warns about the risks of thrombosis with thrombocytopenia syndrome (TTS), and recommends that clinicians consult with the published American Society of Hematology guidance for diagnosis and treatment of the condition.

ACIP member Grace Lee, MD, of Stanford University School of Medicine, said that putting a qualifier for any demographic group would be “extremely confusing,” because every ACIP recommendation “is a benefit/risk balance.”

The committee believed that the benefits of one-dose vaccination outweighed the risks, as it makes this vaccine available for vulnerable populations, including people experiencing homelessness, incarcerated populations, and home-bound populations.

The “no” votes came from members who felt that younger women would not be adequately informed about the risks of this rare adverse event by a warning label and EUA fact sheet.

“I did not object to the recommendation. I objected to the absence of any kind of guidance from us,” said ACIP member, Sarah Long, MD, of Drexel University College of Medicine in Philadelphia. “This is an age group that is most at risk and is getting the vaccine predominantly to save other people’s lives. I’m very sorry we haven’t chosen to put up front the knowledge we have that … there are options.”

ACIP chair, José Romero, MD, ultimately voted yes, but added that he thought there was a bit of a “selective interpretation” in terms of how much younger women would be informed. He urged vaccination sites to have a second vaccine available so that younger women are not forced to shop for vaccines.

“These events are rare, but they are serious,” Romero said.

The American Medical Association (AMA) reiterated their support for the Johnson & Johnson vaccine and pledged to help inform patients about the rare adverse events.

“The AMA will continue to work with the FDA and the [CDC] to ensure physicians and patients are aware of the rare, but increased risk of [TTS] in women under the age of 50, as well as the appropriate treatment, so they can act quickly,” said AMA president Susan Bailey, MD, in a statement.

On April 13, CDC and FDA agreed to a “pause” on use of Johnson & Johnson’s COVID-19 vaccine out of an abundance of caution. At that point, there were six cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, one fatal. ACIP met on April 14, but agreed to wait to vote until more data accrued on the available cases, including potential risk factors.

As of April 21, the number of cases rose to 15, with three deaths. Seven patients remain hospitalized, including four in the ICU, while five were discharged home.

Thirteen of these cases were in women ages 18-49, with two in women older than 50. Based on these data, Tom Shimabukuro, MD, of the CDC, estimated that the rate of TTS was 7.0 per million doses in younger women, and 0.9 per million in older women. Seven cases of 15 were among women ages 30-39.

While all cases were in women, Shimabukuro noted that some data were still under review, “including potentially male cases,” although as of now, there were no cases reported in men.

Median patient age was 37, with a median time to onset of 8 days following vaccination. While 12 cases were CVST, three were other forms of thrombosis. Seven patients had obesity, while two patients apiece reported oral contraceptive use, hypothyroidism, or hypertension. No patients had established coagulation disorders.

All patients had thrombocytopenia, with 10 patients having severe thrombocytopenia, or platelet levels under 50,000. Of the 11 patients where a platelet factor 4 heparin-induced thrombocytopenia ELISA antibody test was performed, all were positive. Four patients did not have available results. Seven patients with CVST experienced intracerebral hemorrhage.

Non-heparin anticoagulants were used to treat 12 patients and intravenous immunoglobulin to treat eight patients, while platelet transfusion was used for seven patients and heparin for six patients. Shimabukuro noted that the six patients received heparin prior to the CDC Health Alert about treating this condition.

Shimabukuro said that cases under investigation may increase, as researchers plan to broaden their case definition to harmonize with the draft Brighton Collaboration case definition for TTS. This could include other thrombotic events, including venous thromboembolism, deep vein thrombosis, pulmonary embolism, ischemic stroke, and acute myocardial infarction.

As I try to conquer my depression in my interaction with some of my patients who refuse to get vaccinated, I wonder if we, our country will ever reach herd immunity as Israel has accomplished. I am trying to figure out whether it is worth keeping these patients in my practice due to my concern for my staff, my other patients and our families.

Please get vaccinated!!

Throw Away Your Mask After COVID Vaccination or Not, What about the Mutations and Infection after Vaccination?

As our national mortality statistics reach over 500,000 and a third vaccine has been approved by the FDA I thought that we should examine the use of masks, etc. after vaccinations. This is an important question especially considering the increasing findings of more viral mutants.

 Recently, a spirited discussion was sparked on social media: is it acceptable to relax masking 14 days after the second COVID-19 vaccine dose? Doctor Vinay Prasad and Doctor David Aronoff, in this post will discuss the advice as to whether to continue wearing masks as well as social distancing, etc. after one completes their vaccination.

Doctor Prasad starts off by noting that having spent some time thinking about the topic, and discussing with colleagues, I have reached two conclusions. First, it is a tradeoff with residual uncertainties, and reasonable people can disagree. But also, I favor the view that generally, 14 days after vaccination, we can relax some restrictions.

The caveats

It is important to be upfront with the caveats. Everything I say applies to average people in the community — I am not speaking about enhanced precautions in high-risk settings like nursing homes or medical centers. My argument is contingent on there being no “vaccine escape,” that is, no mutation in the coronavirus that markedly reduces vaccine efficacy. If that happens, may God help us. I am not sure we will make it.

Finally, my argument is appropriate for most places and most times, but if health systems are overwhelmed, e.g., as we saw in places like southern California or New York City, it might be reasonable to temporarily increase precautions. Additionally, my guiding principle does not apply to businesses, such as grocery stores or pharmacies, which can and will enforce their own policies.

Now, having said that: for most people, once you get 14 days out of your second dose of vaccine, I believe you can ease up on masking or another restriction, such as visiting a loved one for lunch or having more than one person visit a nursing home at the same time, or a small gathering of vaccinated people for dinner without masks.

The data

There are three lines of evidence that I wish to offer for my claim. First, consider the efficacy of the vaccine. The efficacy of the two mRNA vaccines is superb, offering 95% reduction in the rate of acquisition of symptomatic COVID-19 in randomized trials. That is a remarkable result. But the key statistic here is one step beyond the vaccine efficacy. If you get two doses of the vaccine, and if you remain asymptomatic 14 days after the second dose, what is the probability you will develop COVID-19? For Moderna, the answer is there is a 99.92% chance that you won’t. Only 12 cases occurred after this time in 14,550 actively vaccinated people in the trial, while the control arm experienced nearly 3.5% cumulative incidence. For Pfizer, only eight cases occurred amongst people who had completed a second dose and went 7 days without symptoms, again a 99.95% chance of not getting COVID if one remained asymptomatic a week after the second dose. In other words, if you get 14 days past the second dose, and feel fine, the likelihood you will get COVID-19 in these studies is very low. Some argue that in the real world — where folks are not as motivated as trial participants — the rate of SARS-CoV-2 acquisition might be higher, and thus relaxing rules riskier. But this logic cuts both ways: if people in the real world are less compliant, then the rules might be relaxed no matter what we say.

Next, consider the risk of spreading SARS-CoV-2 to others. That risk is in part driven by symptomatic infections which are exceedingly rare after second doses. Risk of spreading is diminished by the brisk immune response that occurs after symptomatic infection once someone is vaccinated. In the Moderna study, there were 30 cases of severe COVID overall and zero in the vaccination arm. Less symptomatic and less severe COVID will result in a lower propensity to propagate SARS-CoV-2. Moreover, studies of both recombinant antibody products speed viral clearance from airways. If the body is primed to manufacture anti-spike antibodies through vaccination, there is likely a similar rapid clearance and subsequent reduction in infectiousness occurs.

What about asymptomatic infection and so-called silent spread? In the Moderna trial, swabs taken from asymptomatic participants as they were receiving dose 2 showed a roughly 60% reduction in PCR positivity. It is likely that a second dose and longer asymptomatic period will result in greater reduction in PCR positivity. Preliminary data from AstraZeneca’s ChAdOx1 vaccine also showed reduced in asymptomatic PCR detection. In short, it is highly likely that receipt of vaccination and a 14-day asymptomatic period afterward results in both personal protection and reduced likelihood of ongoing viral propagation.

Third, what is the effect size of masks? More correctly — what is the effect size of masks 14 days after a vaccine with 95% efficacy? What is the effect of masks if PCR positivity is only 1 in 1,000 amongst asymptomatic people? I think we must confront a forgotten truth. Masks make sense not because we have perfect randomized controlled trial data showing they protect the wearer, or others, but based on bio-plausibility, and the precautionary principle, they were a reasonable public health measure to incorporate.

Authors of a 2020 update to the Cochrane review wrote, “Compared to no masks there was no reduction of influenza-like illness (ILI) cases (risk ratio 0.93, 95% CI 0.83-1.05) or influenza (risk ratio 0.84, 95% CI 0.61-1.17) for masks in the general population, nor in healthcare workers (risk ratio 0.37, 95% CI 0.05-2.50).” But the truth is none of these trials perfectly fits the moment. And we never did a cluster RCT of cloth masks — as they are used in the politically torn U.S. — to clarify the effect size with SARS-CoV-2.

The truth is I wear a cloth mask and I quite like it. But I have seen no data that can tell me the added benefit of masks 14 days after vaccination with 95% efficacy. It’s the biological equivalent of asking what happened before the Big Bang. If you ask, what is the evidence that it’s safe to stop wearing a mask, I say, what is the evidence that it’s still beneficial?

This same line of thinking applies to other restrictions that could be eased instead. What evidence supports restricting nursing home visitors, if all parties are vaccinated and masked? What evidence supports banning a small dinner, if everyone has had the vaccine? There is no evidence that supports these continued prohibitions.

Knowing these three facts allows us to put it all together. Is it reasonable to tell someone that, if they are asymptomatic 14 days after the second vaccine, they are highly unlikely to get COVID-19, and also less likely to spread the virus — both by having less severe disease, less asymptomatic carriage, clearing virus faster, stronger antibody responses, and fewer symptomatic cases? Absolutely, is my view.

It is then reasonable to say that the theoretical benefit of the mask may be so small that easing up on its use is fine. Alternatively, you might keep the mask, but ease up on something else, and, to be honest, most people might actually prefer a different concession. You might choose to see family instead, or have a gathering with your vaccinated friends. Getting vaccinated is like getting a stack of tickets at Chuck E. Cheese — you get to decide what to trade them in for!

The politics/sociology

Some contend my stance will undermine efforts to normalize masks, send mixed messages to the public. That’s possible, but it is also possible that my message empowers and excites people to get vaccinated, which is the only viable path out of the nightmare we find ourselves in. I think the less scientists manipulate their statements while trying to guess the response the better. I have tried to be fully transparent in my thinking on this topic. None of us knows the second or third order effects. If we distort the facts and bang on harder about prolonged mask use or other restrictions, will the world actually be better? Or will we provoke a deep backlash that has been brewing for some time? Do we risk losing some folks who might otherwise get vaccinated? I am not an incarnation of God, so I don’t know. I worry that the likes and retweets on social media encourage the fearful message rather than the correct one.

Public health experts have reminded me to talk about despair. We are all facing it, and when you clamp down on a society with restrictions, a free society can only bear it for so long. There must be a path out of it, and easing restrictions — particularly when the burden may outweigh the unproven, theoretical, and at best highly marginal benefit — is a great way to renew optimism. Folks who spend time doing boots on the ground public health share their view with me that this is a great place to start.

The last objection I want to discuss is that my policy is not the safest policy. It is not absolute safety. Indeed, I acknowledge this is true. But I disagree that wearing a mask is absolute safety. I disagree that only one nursing home visitor is the safest policy, and only having a picnic outside is safest. Only truly becoming a hermit is absolute safety. Lock yourself in home, and get all foodstuffs delivered. When you go out, always wear an N95, and do this even a year or two after vaccination. After all, who knows if the vaccine will wear off? None of us really wants absolute safety. We seek reasonable safety, and I will defend the proposition that is achieved merely by a prolonged asymptomatic period after second vaccination and after that something can be relaxed — and there are several options.

The end of COVID

COVID-19 will someday no longer be the topic of daily and breathless news coverage. The virus may always circulate, and some people may always get sick, but the real end will be when we stop thinking about it every moment of every day. That’s how this pandemic will end. Not with a bang, but a whimper.

People need to know that there is light at the end of the tunnel because there is.

Vaccination in the absence of viral escape is the way out of this. Once a person is a sufficient time and distance away from the second shot, and if they are feeling well, we can start to view them differently. They are less a vector for the transmission of a plague, and more a real person — with hopes and wants and desires and seeking connection. In such a moment, if they remove their mask to share a smile with me, I can promise you, I will lower my mask, and smile back.

And Opposing View-Now Is Not the Time to Relax COVID Restrictions

Doctor David Aronoff counters the argument with the facts that the COVID-19 pandemic has now raged on for more than a year. In the U.S., we have documented more than 24.5 million cases and 400,000 COVID-19-related deaths, with between 3,000 and 4,000 people dying each day. The CDC projects we will reach nearly 500,000 total deaths within the next month. COVID-19-related hospitalizations remain at an all-time high. America continues to suffer through a third wave of disease activity that has dwarfed the peaks of the Spring and Summer of 2020.

And, while COVID-19 is beating down on us, it could be worse, believe it or not. We have learned much about how the SARS-CoV-2 virus spreads, easily, through our breath from one person to another. Most nefarious has been the extent to which transmission occurs silently, moving from infected individuals who feel well, look well, and have no idea that they are infected. However, we know that maintaining our distance from others protects against transmission, as does the use of cloth face-coverings. It has been through social distancing and mask use that we have, in the absence of vaccination and herd immunity, been able to limit the damage done by this horrible infectious disease.

Clearly, vaccines against SARS-CoV-2 are the light at the end of the tunnel, assuming that viral mutations do not escape our vaccines sooner than we can put out the fire. With estimates that more than 60% of the population will need to have immune protection against SARS-CoV-2 to benefit from herd immunity, we have a long way to go. While less than 10% of the U.S. population has been formally diagnosed with COVID-19, a recent estimate suggested that by November of 2020 we were at about 15% of the U.S. population immune to the virus. And while that figure may now exceed 20%, this leaves more than 250 million Americans without immune protection, and falls short of the roughly 200 million people who might need to be immune for herd immunity to take hold.

Vinay Prasad, MD, MPH, has authored a thoughtful, evidence-based commentary, making a strong case for why we can relax some restrictions following successful immunization against SARS-CoV-2. He succinctly lays out an argument about why and how immunization, in the absence of vaccine-escaping virus mutants, will confer strong enough protection to render tight adherence to wearing masks and other restrictions unnecessary. And, while I think he has the right idea (I would love to see more people’s faces right now and share a meal with my friends), it is premature to suggest that now is that time. It is OK for us to hold differing opinions (that’s what we do). Two well-intentioned scientists can both look at the same data and reach different policy conclusions. So, let me focus on the case for keeping our masks on, even as we roll our sleeves up. The same logic holds for other restrictions.

First, given how active COVID-19 is right now we need to be doing everything in our power to slow its spread. Lives hang in the balance. I really like the Swiss Cheese model of pandemic defense, popularized by Australian virologist Ian Mackay, PhD, which demonstrates the concept that each measure we implement to interrupt the SARS-CoV-2 pandemic is imperfect yet when layered together they cooperatively reduce transmission risk.

Even immunization is not a perfect defense. Thus far, SARS-CoV-2 vaccination has not been shown to eliminate the risk that someone will get infected or pass the virus on to others. Studies published to date on the Moderna and Pfizer-BioNTech mRNA vaccines show clear protection against developing symptomatic COVID-19. But they also show that some vaccinated people still develop symptomatic disease. And, given what we know about the disease in non-immune people, symptomatic infections represent a fraction of total infections. This predicts that despite immunization some people will develop asymptomatic infection. Do I think that SARS-CoV-2 immunization will significantly protect people against both asymptomatic and symptomatic COVID-19? Yes. Do I think the risk to an individual will be zero following successful immunization? No. Stated differently, removing masks from vaccinated people (or relaxing social distancing) is likely to increase the risk for propagating COVID-19 compared to maintaining these restrictions. And, even if that incremental risk is small, why take it, given where we are with the disease now?

There will be a time when immune people can let their guards down, allowing even non-immune people to do the same (a benefit of herd immunity). But that time is not now.

The issue of wearing masks has been a contentious one, not helped by mixed messaging from leaders in the federal and state government. This has translated into story after story of difficulty convincing people of the public health benefit of wearing face-coverings. What we do not need are more people out and about in public spaces without masks, which sends the wrong message at the wrong time. We cannot know if an unmasked person is unvaccinated or simply an anti-masker. Why provide fuel for people to skirt mask policies based on stating they have been vaccinated, when they might not have been? And the same holds for hosting dinner parties or participating in other gatherings.

To safely advise people that once they are immunized, they can leave their masks at home and relax other infection control measures we need to record sustained decreases in disease activity, hospitalizations, and deaths, to the point where leading infectious disease and public health experts are comfortable recommending that we can de-escalate these interventions. We also need to ensure widespread vaccine uptake, particularly among Black, indigenous, and people of color, who have been disproportionately harmed by COVID-19. Recent data show that Black Americans, for example, are getting vaccinated at lower rates than white Americans.

We remain in the thick fog of a true healthcare emergency and need to be doing all we can, especially the simple things, to shut it down. Now is not the time to let up on masking, even for the relatively few who have been immunized. Abandoning mask-wearing and social distancing, even in immunized persons, is not the right thing to recommend, yet. We need masks on and sleeves up.

COVID-19 Variants: ‘The Virus Still Has Tricks Up Its Sleeve’

Now more on the counterpoint reported by Molly Walker who interviewed Dr. Warner Greene as followed: We are honored to be joined once again by Dr. Warner Greene. He’s senior investigator at Gladstone Institutes and a professor at University of California San Francisco. As we’ve discussed, COVID-19 variants are very much in the news. Can we go over what is the latest news about the variants, even today? What do we know about them and what’s the latest that’s been happening?

Variants are very much in the news. What we’re seeing is the slow but steady evolution of the coronavirus. There are now four major variants that are of concern. And, in fact, they call them variants of concern. The first recognized was the U.K. variant, recognized in the south of the United Kingdom. It has an increased transmission efficiency. And there are some reports that it may be somewhat more virulent, particularly in men over the age of 60.

Of even greater concern is the South African variant, which contains mutations that confer resistance to certain monoclonal antibodies, like one of the two monoclonal antibodies developed by Regeneron. The Eli Lily monoclonal antibody doesn’t seem to work against the South African variant and vaccine efficiency is also reduced with the South African variant.

Similarly, the Brazilian variant has basically the same set of mutations that are conferring antibody resistance, causing real concern. What it means for the vaccines, etc.: I think that both the South African and the Brazilian variants are a major concern. And it is possible that those variants as they spread, and they are in the United States now, we may need to revise the vaccines to account for these types of variants. That’s not clear yet, but better to be prepared, in case we do need to revise the vaccine.

And then there’s a fourth type of variant, which is just kind of emerging, less well-studied at this point, but out of California. So clearly there, the virus is searching for a lock and key mechanism trying to search for ways to allow itself to replicate better. We’re applying immune pressure. So, it’s mutating away from some of that immune pressure, and that’s why this antibody resistance is emerging.

So, what types of mutations does the SARS-CoV-2 virus have to go through to make it a variant?

Well, for example, the South African variant has 27 mutations, nine of which occur in the spike protein. The spike is the protein on the surface that binds to the ACE2 receptor and allows entry and fusion into the host cell. And, of course, that’s where most of the vaccines are focused, is on the spike. That’s where the monoclonal antibody therapeutics are focused, on the spike. And so the virus is looking for ways to avoid these types of immune pressures and it’s making mutations in its receptor binding domain and the internal domain that confer resistance to certain types of neutralizing antibodies.

Given that recent studies from Novavax and Johnson & Johnson last week found somewhat reduced clinical efficacy of vaccines against these variants, what type of booster modification is required for vaccines in order to better combat them with the mRNA and the viral vector vaccines? Is it different, is it the same?

I think the booster that, for example, Moderna and Pfizer are now working on is to take the genetic sequence of the variant and use that as the immunogen. So, there is a mutation at position 484 that is absolutely key for this loss of antibody protection. You would introduce an RNA that now has that same mutation at position 484 into the vaccine to create a vaccine that is really tailored to take that particular type of virus out. And that mutation is shared between the South African and the Brazilian variants.

And so it wouldn’t require a different type, depending on the type of vaccine, it would just be the same type of reformulation. It wouldn’t be mRNA, different than a viral vector, it would just be a different formula. It’s not anything to do with the type of vaccine. It still would be an mRNA-based vaccine. It would just contain a different RNA or more likely it will be a multi-valent vaccine that would be original virus, as well as a new virus.

It’s not clear exactly how that would be administered. It may be that we want to boost immunity against the old virus, as well as the new virus, so we would use a multi-valent approach in that case. But the mRNA vaccine platform is quite amenable to this type of updating. That’s a real advantage, much more so than the adenoviral vectors, the virus-delivered vaccines. It’s a more complicated process there.

If we could just look at the vaccines as we have them now against this wild-type strain, if for some reason we didn’t have any boosters, what type of progress could we make against the pandemic? Can we vaccinate our way out of the pandemic, even if we don’t have these boosters? Have these variants prevented that?

To be clear, these variants, the Brazilian and the South African variants, are only compromising the neutralizing antibody response against the coronavirus. The T-cell immune response presumably is fully intact and remains unevaluated. So it’s quite possible that these vaccines will stand up better than we expect or predict. Clearly the U.K. variant does not appear to be a threat, although the recent acquisition of the neutralizing mutation at 484 causes concern that the virus is evolving. Even the U.K. variant is evolving.

I would say that the one thing that is disturbing to me, or that causes me pause is the story in Manaus, Brazil. Manaus is in the Amazon basin, they had a huge outbreak in the spring. It was thought, as reported, that there would probably be herd immunity within the community up to about 75%. Then this variant comes in to the community and it’s just sweeping through, causing re-infection or what appears to be re-infection.

Now did the original immunity wane and these people were all sensitive? Is it just that the variant is able to avoid both the T-cell and the antibody response that was present in the herd in Manaus? That kind of real-time experiment is concerning in terms of the spread of this virus. And I think data like that and what’s going on in South Africa is what’s really prompting the vaccine companies to get prepared now. We don’t know the full dimensions of the problem, but better to overprepare at this point in time.

So, given what happened in Brazil, do you think that’s evidence of viral escape?

Certainly, the South African and Brazilian variants, the mutations they are acquiring in their spike protein are examples of escape from the antibody neutralization. These are mutating principal antibody-binding sites that are responsible for neutralization, so that these variants are emerging under the influence of immune pressure. It’s harder to get around the T-cell immunity though, because T-cell immunity differs from person to person based on the composition of our HLA genes and our immune response. And T-cells are really the major defense mechanism against viruses, so let’s hope that our T-cells fill in for any gaps that the antibodies might come up a little short on.

I’m not sure exactly what has happened in Manaus, whether there was really ever herd immunity, whether it’s waned, but I do know that the variant there is hitting hard. So, that’s a big question mark. I think Brazil holds the answers to a lot of the future of this pandemic. We need to understand precisely what is going on there.

What do we need to be studying in Brazil specifically? And what type of data would we need to be looking at and tracking, what types of real-world studies and epidemiological studies would you like to see out of what’s happening in Brazil to help us going forward?

I would like to know whether or not there was real herd immunity. Before this new variant began to spread, was there clear evidence of a good antibody response and retention of durable antibody responses against the original strain of “wild-type” virus. So, if, in fact, there was an intact immune response, and this virus was able to overwhelm that response, well that’s not good news, but if the response had waned or had never really developed fully, then that’s a less daunting problem.

Now on the positive side, you look at the Johnson & Johnson vaccine, it’s not the world’s best at preventing you from becoming infected with or developing minor respiratory symptoms. But even with the South African variant, this vaccine protects you from severe disease, having to go to hospital and dying. And frankly, that’s what we want from a vaccine. That is fantastic. You may have a runny nose or a mild upper respiratory tract infection, but you’re not going to develop life-threatening pneumonia and require hospitalization, intubation, etc. And I’d sign up for that type of vaccine any day.

All we have from the mRNA vaccines from Pfizer and Moderna are these kinds of in vitro and in lab studies that if you expose them to these variants, this is what they’ll do, but do we need some type of clinical efficacy? Would you say at this point that we don’t have evidence of clinical efficacy against the variants with these two vaccines that are currently being distributed?

Exactly. The mRNA vaccines are not being tested extensively in areas where the variants are prospering, but one of the trial sites for Johnson & Johnson was in South Africa. So, they were able to see how their vaccines stood up against that variant and it fared very well in terms of prevention of serious disease.

When do you think that we are going to get these types of studies? Is that something that we’re going to see as the vaccine trials kind of evolve, and are we going to be able to get that from the mRNA vaccines? Are we just going to not know what their clinical efficacy is until we get a booster, we’re just going to only have the lab evidence?

It’s likely that the virus is probably replicating at higher levels or more virus is replicating in terms of country here in the United States than almost anywhere else in the world, in terms of the breadth of cases that we’ve had, etc. We just simply do not have the genomic surveillance types of apparatus to necessarily detect these variants. For example, we’re just now detecting the California variants. There may be many variants in the United States. We do know that the Brazilian, as well as the South African, variants are in the United States, and it’s possible that there is community spread of these variants. So, we just have to really ramp up our sequencing efforts to really track what’s happening within our pandemic within the country and what types of viruses that we’re dealing with.

And it’s in that kind of setting as variants begin to hold sway. For example, it’s suggested that the U.K. variant will become dominant in the United States by March. So, our prediction is that the current vaccines will do very well against that variant. Now, if that variant is replaced by, for example, a South African variant, which is more immunologically daunting, well then, we’re going to have to see how the mRNA vaccines hold up against that. And it’s that kind of real-world information that’s going to inform whether or not we need to boost the immune system with a third shot.

Are the variants occurring in regions due to the similarities in the genome of the regional population, causing the viral RNA to mutate in a specific direction, and do antigen tests pick up variants?

No, the antigen tests will not pick up the variants. You really have to do the sequencing to find these mutations. So, it’s clear that the virus has a set of mutations and it’s trying different combinations. All the virus wants to do is to replicate better. The U.K. variant has one mutation in the receptor binding domain, which confers tighter binding to the ACE2 receptor and a higher level of transmission by 40% to 70%. And that’s the variant that may become dominant here in the United States by March. In contrast, the South African and the Brazilian variants, they not only have the same mutation that the U.K. variant does, they’ve added to it. They’ve added at least two additional mutations that really take out these neutralizing antibodies.

Now, did these two variants arise independently? Some would say yes. I don’t think that we know precisely because one person coming from South Africa carrying the virus could seed the virus in Brazil. So, we don’t know, but there are subtle differences. The virus is working toward a solution here for avoiding the antibodies.

Now, another question is, is the virus throwing everything at us right now that it’s got? Is this it and can we expect a pretty much static situation from here on out? And, you know, I don’t think so. I think the virus still has tricks up its sleeve, and will continue to evolve as we put additional immune pressures on it. So, that would be my guess, but we’re right at the cusp of the evolving science. And to think that where we were a year ago with no defense, no innate or no intrinsic immunity to this virus, and nothing really therapeutic or preventive. And now we’re in a situation where we have multiple, highly effective vaccines. It’s a true triumph of science.

Can you go into how else the virus could mutate? Is there any way that it could mutate that T-cell immunity that we have that would be compromised? Is that possible or is it just not that complex a virus?

Yeah, there may be the emergence of escape mutations that escape a cytotoxic T-cell, CD8 T-cell responses, or CD4 helper T-cell responses. We could certainly see that and it’s much harder to monitor for those types of immune reactions. So, certainly, like you get immune escape against antibodies, you can have immune escape against T-cell immunity as well.

California man tests positive for COVID-19 weeks after second jab: report

Edmund DeMarche reported that a California man said he was diagnosed with COVID-19 three weeks after he received his second dose of the vaccine, reports said.

CBS Los Angeles reported that Gary Micheal, who lives in Orange County’s Lake Forest, found out he had the virus after being tested for an unrelated health concern. His symptoms are relatively minor, the report said.

He received the Pfizer vaccine, the report said. Patch.com reported that he got his first dose on Dec. 28 and his second jab on Jan. 18.

Dr. Anthony Fauci, the country’s leading infectious-disease scientist, said the latest evidence indicates that the two vaccines being used in the U.S. — Pfizer’s and Moderna’s — are effective even against the new variants.

A doctor interviewed in the CBS report said that he was not surprised to hear about Michael’s diagnosis.

“I think I’ve heard of six or seven independent cases over the last three weeks of individuals that have been vaccinated with different timelines that have tested positive, and I think we’re going to continue to see that more and more,” Dr. Tirso del Junco Jr., chief medical officer of KPC Health, told the station.

Fauci has estimated that somewhere between 70% and 85% of the U.S. population needs to get inoculated to stop the pandemic that has killed close to 470,000 Americans.

And Now Four people in Oregon who received both doses of vaccine test positive for coronavirus

Minyvonne Burke reported that four people in Oregon have tested positive for the coronavirus after receiving both doses of the Covid-19 vaccine, health officials said.

There are two cases each in Yamhill and Lane counties, the state’s Health Authority said in a series of tweets on Friday. The cases are either mild or asymptomatic.

“We are working with our local and federal public health partners to investigate and determine case origin,” the agency said. “Genome sequencing is underway, and we expect results next week.”

The agency referred to the individuals who tested positive as “breakthrough cases,” meaning that they got sick with the virus at least 14 days after receiving both doses.

The Health Authority said more breakthrough cases could pop up.

“Clinical trials of both vaccines presently in use included breakthrough cases. In those cases, even though the participants got Covid, the vaccines reduced the severity of illness,” the agency said in a tweet.

“Based on what we know about vaccines for other diseases and early data from clinical trials, experts believe that getting a Covid-19 vaccine may also help keep you from getting seriously ill even if you do get the virus. … Getting as many Oregonians as possible vaccinated remains a critical objective to ending the pandemic.”

The agency’s announcement came the same day its health officer said there has been a decline of daily Covid-19 cases over the past several weeks. As of Friday, there were 149,576 cases in the state, according to the department’s count.

“These decreases are a testament to the actions all Oregonians are taking to slow the spread of Covid-19 and the sacrifices made – thank you,” health officer Dean Sidelinger said at a news conference Friday.

Another breakthrough case was reported in North Carolina, according to NBC affiliate WCNC-TV in Charlotte. The state’s Department of Health and Human Services told the outlet that the person had mild symptoms and did not need to be hospitalized.

The Centers for Disease Control and Prevention has said that quarantining is not necessary for fully vaccinated people within three months of having received their last doses as long as they do not develop any symptoms.

They do, however, still need to practice certain safety measures such as wearing face masks, social distancing, and avoiding crowds or poorly ventilated spaces.

“Fully vaccinated” means at least two weeks have passed since a person has completed their vaccination series and now we have the addition of the Johnson and Johnson vaccine, which is a single dose with less effectivity but about the same activity of our yearly flu vaccine.

So, as I have said before, continue to wear your masks, whether one, two, three or whatever the number of masks that we are going to be advised with future “scientific” evidence.

Another New COVID Strain Is in the US; Will Present Vaccines Work with these New Strains, Pandemic Strategies Including New Migrants and What Happened to Merck’s Vaccine?

This has been an interesting few week and almost led me to close my office and retire. We had a patient come in the office and complete the questionnaire and “by-pass” our screening procedures, lying to us about his exposure to the COVID-19 virus. He just visited his brother the two days before the days office visit and lied to us, saying that he had no recent exposure, etc. However, a week later he called our office to allow notification that his COVID test was positive.

The thing that angered me and my staff more was that the patient waited a number of days to notify, besides lying to us about his exposure. This led us to close the office, cancel all patients until we could have a complete cleaning of the office and all get COVID tested.

Luckily, we all tested negative and all my staff and I had at least had our first vaccine doses. If we had tested positive, we would have to notify all the patients that were seen in the office between his visit and the day that we closed the office.

What an irresponsible set of actions and my fear is that this goes on in many situations because many of our patients, etc. are selfish and irresponsible and don’t care about anyone else except themselves…and they think the virus is all a lie, util one of their family members or close friends dies. How totally stupid and disgusting!! 

John Johnson wrote that the virus continues to mutate quickly. Anyone tracking the news is familiar with the new UK strain that is moving around the globe and threatens to become the dominant strain in the US soon. Now, health authorities in California have identified yet another strain that has popped up in about a dozen counties, reports the Los Angeles Times. Coverage on that and more:

  • California strain: The variant has been linked to large outbreaks in Santa Clara County and smaller outbreaks elsewhere. It’s still too early to say whether the new strain is more contagious or more lethal than the first forms of COVID that emerged, but studies on that are being prioritized. Bottom line: “This virus continues to mutate and adapt, and we cannot let down our guard,” says Dr. Sara Cody, Santa Clara County health officer.
  • A lament: In a New York Times op-ed, Ezra Klein runs through the coming COVID changes under the Biden administration. They include plans to get vaccinations organized on a mass scale, along with expanded testing and contract tracing. It’s all pretty basic stuff, he writes, which has him astonished that the Trump administration hasn’t done these things yet. “That it is possible for Joe Biden and his team to release a plan this straightforward is the most damning indictment of the Trump administration’s coronavirus response imaginable.”
  • Hopeful trend: US deaths are about to pass 400,000, but one medical expert spies a positive trend in the new data as well. “Over the last four days for the first time in months, we’ve seen a steady decline … a thousand per day fewer hospitalizations in the United States,” Dr. Jonathan Reiner of George Washington University tells CNN. “We’ve seen the same trend in new cases.” The next two months will likely be brutal, he adds, “but there is a ray of sunshine” as vaccinations continue.
  • Hopeful, II: In “The Morning” newsletter at the Times, David Leonhardt is tired of the “they’re only 95% effective” drumbeat, and he’s not alone. “It’s driving me a little bit crazy,” Dr. Ashish Jha of the Brown School of Public Health tells Leonhardt. Dr. Aaron Richterman of the University of Pennsylvania adds, “We’re underselling the vaccine.” As Leonhardt explains and doctors emphasize, the vaccine will save your life, even if you’re in that other 5%. To wit, of 32,000 people who got the Pfizer and Moderna vaccines in trials, only one person suffered a severe COVID case.

Migrant caravan demands Biden administration ‘honors its commitments’

Now, a real challenge for the new Biden administration. Adam Shaw noted that a migrant caravan moving from Honduras toward the U.S. border is calling on the incoming Biden administration to honor what it says are “commitments” to the migrants moving north, amid fears of a surge at the border when President-elect Joe Biden enters office.

More than 1,000 Honduran migrants moved into Guatemala on Friday without registering, The Associated Press reported. That is part of a larger caravan that left a Honduran city earlier in the day.

The outlet reported that they are hoping for a warmer reception when they reach the U.S. border, and a statement issued by migrant rights group Pueblo Sin Fronteras, on behalf of the caravan, said it expects the Biden administration to take action.

“We recognize the importance of the incoming Government of the United States having shown a strong commitment to migrants and asylum seekers, which presents an opportunity for the governments of Mexico and Central America to develop policies and a migration management that respect and promote the human rights of the population in mobility,” the statement said. ” We will advocate that the Biden government honors its commitments.” 

Biden has promised to reverse many of Trump’s policies on border security and immigration. He has promised to end the Migrant Protection Protocols (MPP), which keeps migrants in Mexico as they await their hearings. The Trump administration has said the program has helped end the pull factors that bring migrants north, but critics say it is cruel and puts migrants at risk. 

Biden has also promised a pathway to citizenship for those in the country illegally and a moratorium on deportations by Immigration and Customs Enforcement (ICE). The migrants’ group also pointed to promises to end the asylum cooperative agreements the administration made with Northern Triangle countries.

“A new United States Government is an opportunity to work with the Mexican Government to develop a cooperation plan with Central America to address the causes of migration, together with civil society organizations, as well as an opportunity to increase regional cooperation regarding the persons in need of protection, and to dismantle illegal and inhuman programs such as Remain in Mexico, the United States’ Asylum Cooperation Agreements with El Salvador, Guatemala and Honduras, as well as the Title 42 expulsions by the United States authorities,” it said, referring to the Centers for Disease Control (CDC) order that allows the U.S. to quickly remove migrants on public health grounds.

Biden officials, however, have been keen to send the message to migrants that it will not mean open borders overnight.

“Processing capacity at the border is not like a light that you can just switch on and off,” incoming Biden domestic policy adviser Susan Rice told Spanish wire service EFE. “Migrants and asylum seekers absolutely should not believe those in the region peddling the idea that the border will suddenly be fully open to process everyone on Day 1. It will not.” 

“Our priority is to reopen asylum processing at the border consistent with the capacity to do so safely and to protect public health, especially in the context of COVID-19,” she said. “This effort will begin immediately but it will take months to develop the capacity that we will need to reopen fully.”

It is unclear how far the migrants will get, and Guatemalan and Mexican governments have indicated they intend to turn them back. But the caravan comes amid fears that the new outlook on immigration and asylum from the Biden administration will fuel a surge at the border.

Acting Customs and Border Protection (CBP) Commissioner Mark Morgan said on “America’s News HQ” on Saturday that the caravan could include more than 5,000 migrants and blamed the tone from the incoming administration.

“We’re looking at two groups that are well over five thousand. And one of those groups have already gotten through the Guatemala border. And they’re on their way to El Rancho, which is about the located centrally in Guatemala,” he said. “It’s coming. It’s already started, just as we promised and anticipated it would with this rhetoric from the new administration on the border.”

President Trump warned this week that ending his policies and increasing incentives would lead to “a tidal wave of illegal immigration, a wave like you’ve never seen before” and that there were already signs of increased flows.

“They’re coming because they think that it’s a gravy train at the end,” he said. “It’s going to be a gravy train. Change the name from the caravans, which I think we came up with, to the gravy train because that’s what they’re looking for — looking for the gravy.”

Biden transition official tells migrant caravans: ‘Now is not the time’ to come to US

Yael Halon reported further on the migration noting that a migrant caravan moving from Honduras toward the U.S. border called on the incoming Biden administration to honor their “commitments” to the migrants moving north, citing the incoming administration’s vow to ease Trump’s restrictions on asylum.

But on Sunday, an unnamed Biden transition official said that migrants hoping to claim asylum in the U.S. during the first few weeks of the new administration “need to understand they’re not going to be able to come into the United States immediately,” NBC News reports. 

More than 1,000 Honduran migrants moved into Guatemala on Friday without registering as part of a larger caravan that left a Honduran city earlier in the day.

The Associated Press reported that they are hoping for a warmer reception when they reach the U.S. border, and a statement issued by migrant rights group Pueblo Sin Fronteras, on behalf of the caravan, said it expects the Biden administration to take action.

The Biden transition official, however, warned migrants against coming to the U.S. during the early days of the new administration, telling NBC that while “there’s help on the way,” now “is not the time to make the journey.” 

“The situation at the border isn’t going to be transformed overnight,” the official told the outlet.

“We have to provide a message that health and hope is on the way, but coming right now does not make sense for their own safety…while we put into place processes that they may be able to access in the future,” the official said.

President-elect Joe Biden has promised to reverse many of Trump’s policies on border security and immigration. He has promised to end the Migrant Protection Protocols (MPP), which keeps migrants in Mexico as they await their political asylum hearings. The Trump administration has said the program has helped end the pull factors that bring migrants north, but critics say it is cruel and puts them at risk. 

Biden has also promised a pathway to legal permanent residency for those in the country illegally and a moratorium on deportations by Immigration and Customs Enforcement (ICE). The migrants’ group also pointed to promises to end the asylum cooperative agreements the administration made with Northern Triangle countries.

President Trump warned last week that ending his policies and increasing incentives would lead to “a tidal wave of illegal immigration, a wave like you’ve never seen before,” claiming that there were already signs of increased flows.

AMA President: Biden Team Must Create National Pandemic Strategy

Ken Terry stated that now that the campaign is over, that the incoming Biden administration must formulate an effective national strategy for the COVID-19 pandemic, said Susan R. Bailey, MD, president of the American Medical Association (AMA), in a speech delivered today at the National Press Club in Washington, DC.

Bailey noted that America’s fight against the pandemic is in a critical phase, as evidenced by the escalation in cases, hospitalizations, and deaths in recent weeks. Emergency departments and ICUs are overwhelmed; many frontline clinicians are burned out; and the state- and local-level mechanisms for vaccine distribution have been slow and inconsistent, she said.

“The most important lesson for this moment, and for the year ahead, is that leaving state and local officials to shoulder this burden alone without adequate support from the federal government is not going to work,” Bailey emphasized.

She called on the Biden administration, which takes over next week, to “provide states and local jurisdictions with additional resources, guidance, and support to enable rapid distribution and administration of vaccines.”

In addition, she said, the incoming administration needs to develop a more robust, national strategy for continued COVID-19 testing and PPE production “by tapping into the full powers of the Defense Production Act.”

Biden Vaccine Distribution Policy

In a question-and-answer period following her speech, however, Bailey said she opposed the president-elect’s decision to release nearly all available vaccine supplies immediately, rather than hold back some doses for the second shots that the Pfizer and Moderna vaccines require. On Tuesday, the Trump administration announced that it plans to do the same thing.

“We’re a little bit concerned about the announcement that [the Department of Health & Human Services] will not hold back vaccine doses to make sure that everyone who’s gotten their first dose will have a second dose in reserve,” Bailey said. “We don’t have adequate data to tell us that one dose is sufficient — we don’t think it is — and how long you can wait for the second dose without losing the benefits of the first dose.”

She added that it’s not recommended that people mix the two vaccines in the first and second doses. “Since the Pfizer vaccine has such rigid storage requirements, I want to make sure there’s plenty of vaccine for frontline healthcare workers who got the Pfizer vaccine because it was the first one to come out in December. I want to make sure they get their second dose on time and [do] not have to wait.”

Bailey said she hoped there will be plenty of vaccine supply. But she suggested that state and local health authorities be in communication with the federal government about whether there will be enough vaccine to guarantee people can get both doses.

Bolstering Public Health

In her speech, Bailey outlined five areas in which steps should be taken to improve the health system so that it isn’t overwhelmed the next time the US has a public health crisis:

  • Restore trust in science and science-based decision making. Make sure that scientific institutions like the Centers for Disease Control and Prevention and the Food and Drug Administration are “free from political pressure, and that their actions are guided by the best available scientific evidence.”
  • Ensure that the health system provides all Americans with affordable access to comprehensive healthcare. Bailey wasn’t talking about Medicare for All; she suggested that perhaps there be a second enrollment period for the Affordable Care Act’s individual insurance exchanges.
  • Work to remove healthcare inequities that have hurt communities of color, who have been disproportionately impacted by the pandemic. She referred to a recent AMA policy statement that recognized racism as a public health threat.
  • Improve public health domestically and globally. Among other things, she noted, the public health infrastructure needs to be revitalized after “decades of disinvestment and neglect,” which has contributed to the slow vaccine rollout.
  • Recognize the global health community and restore America’s leadership in global efforts to combat disease, which are critical to preventing future threats. She praised Biden for his promise that the US will rejoin the World Health Organization.

At several points in her presentation, Bailey rejected political interference with science and healthcare. Among other things, she said public health could be improved by protecting the doctor-patient relationship from political interference.

Answering a question about how to separate politics from the pandemic, she replied, “The key is in sticking to the science and listening to our public health authorities. They all have to deliver the same message. Also, leaders at all levels, including in our communities, our schools, churches and college campuses, should wear masks and socially distance. This isn’t about anything other than the desire to get out of the pandemic and get our country on the right track again. Masks shouldn’t be political. Going back to school shouldn’t be political. Taking a certain medication or not shouldn’t be political. We need to stick to the science and listen to our public health authorities. That’s the quickest way out.”

Asked when she thought that life might get back to normal again in the US, Bailey said a lot depends on the extent of vaccine uptake and how much self-discipline people exhibit in following public health advice. “I think we’re looking at the end of this year. I’m hopeful that by fall, things will have opened up quite a bit as the Venn diagrams of those who’ve gotten vaccines grow larger.”

Merck Ends Development of Two Potential COVID-19 Vaccines

Tom Murphy, AP Health Writer, pointed out that the drug maker, Merck, said Monday that it will focus instead on studying two possible treatments for the virus that also have yet to be approved by regulators. The company said its potential vaccines were well tolerated by patients, but they generated an inferior immune system response compared with other vaccines.

Merck was developing one of the potential vaccines with France’s Pasteur Institute based on an existing measles vaccine. The French institute said it will keep working on two other vaccine projects using different methods.

Merck entered the race to fight COVID-19 later than other top drug makers.

It said last fall that it had started early-stage research in volunteers on potential vaccines that require only one dose. Vaccines developed by Pfizer and Moderna were already in late-stage research at that point.

The Food and Drug Administration allowed emergency use of both the Pfizer and Moderna vaccines late last year. Each requires two shots.

Five potential vaccines have reached late-stage testing in the United States, the final phase before a drug maker seeks approval from regulators. Results from a single-dose candidate developed by Johnson & Johnson are expected soon.

Since vaccinations began in December, nearly 22 million doses have been delivered to people nationwide, according to the Centers for Disease Control and Prevention. Nearly 6% of the population has received at least one dose.

A total of 3.2 million people, or 1% of the population, have received both doses required for those vaccines.

More than 419,000 people in the United States and 2 million globally have died due to the coronavirus, according to Johns Hopkins University.

The government is paying Merck & Co. about $356 million to fast-track production of one of its potential treatments under Operation Warp Speed, a push to develop COVID-19 vaccines and treatments. The money will allow the Kenilworth, New Jersey, company to deliver up to 100,000 doses by June 30, if the FDA clears the treatment for emergency use.

The treatment, known as MK-7110, has the potential to minimize the damaging effects of an overactive immune response to COVID-19. This immune response can complicate the life-saving efforts of doctors and nurses.

Merck said early results from a late-stage study of that drug showed a more than 50% reduction in the risk of death or respiratory failure in patients hospitalized with moderate or severe COVID-19. The company expects full results from that study in the first quarter.

Merck’s other potential treatment is an oral antiviral drug.

Merck said it will focus COVID-19 research and manufacturing efforts on two investigational medicines: MK-7110 and MK-4482, which it now calls molnupiravir. Molnupiravir, which is being developed in collaboration with Ridgeback Bio, is an oral antiviral being studied in both hospital and outpatient settings. If these oral antiviral drugs are effective this will be a real advancement in the treatment of COVID-19. Merck said a phase 2/3 trial of the drug is set to finish in May, but initial efficacy results are due in the first quarter and will be made public if clinically meaningful. 

Merck said results from a phase 3 study of MK-7110, an immune modulator being studied as a treatment for patients hospitalized with severe COVID-19, are expected in the first quarter. In December, the company announced a deal to supply MK-7110 to the U.S. government for up to about $356 million. (Reporting by Deena Beasley Editing by Shri Navaratnam)

Moderna Study: Vaccine Effective vs COVID Variants

With the weekly announcement of new mutant strains of the COVID virus we are all wondering whether the vaccine that are being administered will be effective against the new strains. Carolyn Crist noted that as mutated strains of the coronavirus represent new threats in the pandemic, vaccine makers are racing to respond.

Moderna, whose two-dose vaccine has been authorized for use in the U.S. since Dec. 18, said Monday that it is now investigating whether a third dose of the vaccine will work to prevent the spread of a variant first seen in South Africa, while it also tests a new vaccine formula for the same purpose.

“Out of an abundance of caution and leveraging the flexibility of our mRNA platform, we are advancing an emerging variant booster candidate against the variant first identified in the Republic of South Africa into the clinic to determine if it will be more effective … against this and potentially future variants,” Moderna CEO Stephane Bancel said in a statement.

Moderna on Monday also said its COVID-19 vaccine could protect against the U.K. strain but that it is less effective against the strain identified in South Africa.

Pfizer and BioNTech, whose vaccine were also authorized in December, announced last week that their COVID-19 vaccine creates antibodies that could protect vaccine recipients from the coronavirus variant first identified in the United Kingdom.

“This is not a problem yet,” Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNBC.

“Prepare for it. Sequence these viruses,” he said. “Get ready just in case a variant emerges, which is resistant.”

There were at least 195 confirmed cases of patients infected with the U.K. variant in the U.S. as of Friday, according to the CDC. No cases from the South African variant have been confirmed in the U.S. To try and prevent the variant from entering the country, President Joe Biden plans to ban travel from South Africa, except for American citizens and permanent residents.

The U.S. has reported more than 25 million total COVID-19 cases, according to data from Johns Hopkins University, marking another major milestone during the pandemic.

That means about 1 in 13 people in the U.S. have contracted the virus, or about 7.6% of the population.

“Twenty-five million cases is an incredible scale of tragedy,” Caitlin Rivers, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told The New York Times. She called the pandemic one of the worst public health crises in history.

After the first U.S. case was reported in January 2020, it took more than 9 months to reach 10 million cases in early November. Numbers rose during the holidays, and 10 million more cases were reported by the end of the year. Following a major surge throughout January, with a peak of more than 300,000 daily cases on some days, the U.S. reached 25 million in about 3 weeks.

Hospitalizations also peaked in early January, with more than 132,000 COVID-19 patients in hospitals across the country, according to the COVID Tracking Project. On Sunday, about 111,000 patients were hospitalized, which is the lowest since mid-December.

The U.S. has also reported nearly 420,000 deaths. As recently as last week, more than 4,400 deaths were reported in a single day, according to the COVID Tracking Project. Deaths are beginning to drop but still remain above 3,000 daily deaths.

The University of Washington’s Institute for Health Metrics and Evaluation released a new projection last week that said new cases would decline steadily in coming weeks. New COVID-19 cases have fallen about 21% in the last 2 weeks, according to an analysis by The New York Times.

“We’ve been saying since summer that we thought we’d see a peak in January, and I think that, at the national level, we’re around the peak,” Christopher J.L. Murray, MD, director of the institute, told the newspaper.

At the same time, public health officials are concerned that new coronavirus variants could lead to an increase again. Murray said the variants could “totally change the story.” If the more transmissible strains spread quickly, cases and deaths will surge once more.

“We’re definitely on a downward slope, but I’m worried that the new variants will throw us a curveball in late February or March,” Rivers told the newspaper.

So, next, when we get vaccinated do we need to wear masks and continue social distancing?

We will explore that set of questions next.

U.S. Hits Highest 1-Day Toll from Coronavirus With 3,054 Deaths, Hospitalizations and Answers to the Questions About the Vaccines

I have rewritten this post about 15 times but finally decided with the approval of the Pfizer vaccine for emergency use that I needed to answer a number of questions. So, here we go.

Vanessa Romo reported on the Covid Tracking Project and found that the coronavirus pandemic has pushed the U.S. past another dire milestone Wednesday, the highest daily death toll to date, even while the mortality rate has decreased as health experts learn more about the disease.

The Covid Tracking Project, which tracks state-level coronavirus data, reported 3,054 COVID-19 related deaths — a significant jump from the previous single-day record of 2,769 on May 7.

The spread of the disease has shattered another record with 106,688 COVID-19 patients in U.S. hospitals. And overall, states reported 1.8 million tests and 210,000 cases. According to the group, the spike represents more than a 10% increase in cases over the last 7 days.

Additionally, California nearly topped its single-day case record at 30,851. It is the second highest case count since December 6, the organization reported.

The staggering spike in fatalities and infections has overwhelmed hospitals and intensive care units across the nation, an increase attributed by many experts to people relaxing their precautions at Thanksgiving.

New Data Reveal Which Hospitals Are Dangerously Full. Is Yours?

Audrey Carlsen reported that Health care workers at United Memorial Medical Center in Houston face another full-throttle workday last week.

The federal government on Monday released detailed hospital-level data showing the toll COVID-19 is taking on health care facilities, including how many inpatient and ICU beds are available on a weekly basis.

Using an analysis from the University of Minnesota’s COVID-19 Hospitalization Tracking Project, NPR has created a tool that allows you to see how your local hospital and your county overall are faring. 

It focuses on one important metric — how many beds are filled with COVID-19 patients — and shows this for each hospital and on average for each county.

The ratio of COVID-19 hospitalizations to total beds gives a picture of how much strain a hospital is under. Though there’s not a clear threshold, it’s concerning when that rate rises above 10%, hospital capacity experts told NPR.

Anything above 20% represents “extreme stress” for the hospital, according to a framework developed by the Institute for Health Metrics and Evaluation at the University of Washington.

If that figure gets to near 50% or above, the stress on staff is immense. “It means the hospital is overloaded. It means other services in that hospital are being delayed. The hospital becomes a nightmare,” IHME’s Ali Mokdad told NPR.

At Hospitals, A Race to Save ‘Hundreds of Thousands’ Of Lives with New Vaccine

Sarah McCammon noted that lately, Jon Horton has been dreaming about freezers.

“I was opening the freezer and I was taking something out of the freezer and putting it in something else,” Horton said. “And it was just like — whew!”

And not just an ordinary freezer. Horton is pharmacy operations director at Sentara — a health care network based in Norfolk, Va.

Sentara officials are working out every detail of the logistics involved in rolling out the coronavirus vaccine from Pfizer, which has to be kept at nearly minus 100 degrees Fahrenheit or risk losing effectiveness.

“At a certain point, you’re just trying to figure out what needs to be done next,” Horton said during an interview with NPR at Sentara Norfolk General Hospital. “So, you’re focusing on this process, and as you open up that door, you learn a little more.”

As federal regulators prepare to meet Thursday to consider whether they’ll approve Pfizer’s brand-new coronavirus vaccine, employees like Horton are preparing to receive the vaccine at hospitals around the United States.

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The Sentara health system has four of the ultracold freezers that the vaccine requires, including one obtained through collaboration with a local medical school.

“We usually just deal with freezing temperatures, you know, a typical freezer,” said Tim Jennings, Sentara’s chief pharmacy officer. “That’s why we had to actually go out and acquire a special freezer for this.”

For sites that don’t, there’s dry ice. Jennings opens a big blue bin full of it, which resembles white “cheese doodles,” he notes.

There’s little room for error here: The vaccines must be monitored to make sure the temperature is stable each step of the way. And they’re in short supply right now; the first shipment from Pfizer is expected to include only about 72,000 doses for all of Virginia, a state of more than 8 million people.

Michelle Hood, chief operating officer at the American Hospital Association, said health care administrators across the country are gearing up for a major logistical undertaking.

“We’ve never done anything like this as a country or in the world, as significant as this exercise is,” Hood said. “And everything is new.”

The first vaccines will go mostly to front-line health care workers at the highest risk of exposure.

That’s where Mary Morin, a vice president in charge of employee vaccination at Sentara, comes in. She has a lot to think about as well.

“I did wake up last night and I’m going, ‘Oh, my God,’ ” Morin said.

Morin, whose background is as a registered nurse, has to turn Centers for Disease Control and Prevention guidelines about who should be first in line for the coronavirus vaccine into a real-life plan for her hospital workers.

“A front door to the hospital is the emergency department. You may have a security guard there. They’re patient facing. They’re forward facing,” she said. “So, it’s the staff — it isn’t just the nurses and the physicians.”

Unlike the flu shot, Sentara officials say, the coronavirus vaccine will be optional for staff. Large studies indicate the Pfizer vaccine is about 95% effective with few side effects. But it’s brand-new, and convincing people to take it may be a challenge.

The challenge ahead for hospital staff members like Jennings is making sure the vaccine is properly stored and administered to those who are willing and able to take the first doses. If the vaccine receives federal approval, officials say it could start being given to health care workers within days.

“We realize if we do this right, we could save thousands of lives,” Jennings said, “if not hundreds of thousands.”

The Covid-19 Vaccine: When Will It Be Available for You?

I was included in the set of clinical trials for the COVID-19 vaccine. But I was just notified that I was being “kicked out” due to the fact that the Committee wanted to make sure that I was vaccinated and not having the possibility of being given the placebo as per the trials due to the fact as a physician I am seeing cancer patients daily.

Vaccines, especially as one is already approved by the FDA and the other should be approved for emergency use this coming week.

I thought that I would review a number of questions that many have regarding the new vaccines.

First U.S. rollouts of doses could start in December, with health-care workers, older Americans likely to take priority

Peter Loftus and Betsy McKay reported that Pfizer Inc.  and its partner, BioNTech SE, have asked the U.S. Food and Drug Administration to authorize use of their coronavirus vaccine, and an FDA decision could come as soon as this weekend. Moderna Inc.  has made a similar request for its shot, and other vaccines could follow. The first rollouts could begin within days.

Here is what we know and don’t know about how, and when, the vaccine will get to you.

How will the Covid-19 vaccines be approved, and who decides who will get them?

The FDA will determine whether to authorize Covid-19 vaccines for use. An FDA advisory committee of outside experts voted Thursday in favor of Pfizer’s request for authorization of its vaccine. The FDA is expected to decide imminently.

The FDA has scheduled a Dec. 17 advisory committee meeting to consider Moderna’s request for authorization. A separate advisory committee to the U.S. Centers for Disease Control and Prevention has voted to recommend that health workers and residents of nursing homes and other long-term care facilities be first in line for the limited number of doses. The same committee will hold additional votes on which groups should be next in line. But governors can make the final call within their states.

How will the vaccines be distributed?

The federal government has a contract with McKesson Corp. to be a centralized distributor of Covid-19 vaccines, with the exception of Pfizer’s. Pfizer has set up its own distribution network. Federal health officials say initial doses would be shipped within 24 hours of any FDA authorization, and immunizations could begin within about 48 hours. The federal government also has partnerships with national pharmacy chains CVS and Walgreens to vaccinate residents and staff at long-term care facilities.

Some experts say it could take more than 48 hours for dosing to begin, as hospital workers and others get used to procedures for opening specialized, temperature-controlled boxes of vaccine vials and learn the risks and benefits of the shots.

“Many providers are going to need a few days to get it up and running, if not a week,” said Claire Hannan, executive director of the Association of Immunization Managers, whose members run state, territorial and local vaccination programs.

What logistics are in place to deliver the vaccines?

McKesson, the centralized distributor for vaccines other than Pfizer’s, also will receive and package kits of medical supplies needed to administer the Covid-19 vaccine, such as needles and syringes and alcohol prep pads. It will send the kits and vials of the vaccine out to pharmacies, doctors’ offices and other facilities, at a minimum of 100 doses per order, based on order information supplied by the CDC.

Pfizer plans to use its own distribution centers and ship its vaccine in specially designed reusable containers that can keep thousands of doses at the ultracold temperatures required for it.

How many doses will be available at first?

The initial expected supply of Pfizer’s vaccine after authorization is about 6.4 million doses, according to Gen. Gustave Perna, chief operating officer of the U.S. government’s Operation Warp Speed initiative.

Of this, about 2.9 million doses will be shipped within 24 hours. A federal official said Wednesday that an additional 2.9 million doses would be held back and shipped about three weeks later for those initial vaccine recipients to get the second of the two-dose regimen. Another 500,000 doses from the initial supply would be held in reserve in case any problems arise, the official said. If Moderna’s vaccine is authorized, officials estimate the initial allocation will be about 12.5 million, which may also be sent in separate shipments to accommodate the second injection.

Including that initial supply, federal officials have estimated there would be enough doses to vaccinate 20 million Americans in December.

How many doses will be available next year?

Federal officials have estimated there could be enough to vaccinate about 30 million people in the U.S. in January and then about 50 million in February, with more in the months following. Globally, Pfizer expects to produce up to 1.3 billion doses in 2021 and Moderna expects up to 1 billion.

Who will get the first doses?

The first doses will likely go to health-care workers and residents of nursing homes and other long-term care facilities, which together number about 24 million. After that, the CDC vaccine advisory committee is considering recommending that essential workers such as teachers, police and food workers get vaccinated, followed by adults with underlying conditions that put the at high risk, and seniors age 65 and older.

The committee hasn’t completed its recommendation beyond the first phase, and decisions on which groups get vaccinated when could depend in part on the particular vaccine and what its data show about effectiveness among different age groups or health conditions.

Is there any debate about who should get vaccinated first?

Yes. Some health officials and experts believe health-care workers should be vaccinated first, while others are advocating for the most vulnerable—older Americans—to be first in line. And some state governors have singled out occupations such as teachers that should be at or near the top of the list. There is a similar debate about whether non-health-care essential workers such as teachers and police should be ahead of adults with high-risk medical conditions and people age 65 and over who aren’t in congregate settings.

When can the general public expect to have access?

Secretary of Health and Human Services Alex Azar said he expects there to be enough vaccine doses starting in the second quarter of 2021 so that anyone who wants a vaccine can get it. Other federal health officials have said in the spring or summer. The timeline could change if manufacturing doesn’t go as planned.

How will vaccine doses be allocated to U.S. states?

For the initial supplies, the federal government plans to allocate doses to states proportionally based on the size of their adult populations. It is unclear how long the federal government would stick with population-based proportions and how it would allocate supplies later.

How do states decide to distribute doses?

State, territorial and some local immunization programs, working with the CDC, have drawn up plans to distribute doses within their jurisdictions and to conduct vaccination campaigns. These plans include identifying facilities where vaccination campaigns can be conducted, enrolling them and ensuring the necessary equipment is in place to conduct them. States also have estimated their populations of high-priority groups like health-care workers.

Does the vaccine work the same way in all population groups?

Pfizer and Moderna haven’t yet provided full breakdowns of vaccine efficacy by age and race or ethnicity, but the companies have said efficacy was consistent across these groups.

Does everyone get the same dose regardless of age or other demographic?

Yes.

Coronavirus Daily Briefing and Health Weekly

How many people need to get vaccinated to stop the pandemic in the U.S.?

Moncef Slaoui, chief adviser to Operation Warp Speed, has said if 70% of the population were immunized, that level would achieve herd immunity, based on the approximately 95% effectiveness of both the Pfizer and Moderna vaccines.

A vaccine would need to be at least 80% effective, with about 75% of a population receiving it, to extinguish an epidemic without any other public-health measures, according to a study published in October in the American Journal of Preventive Medicine.

Reaching those levels of immunization would require educating millions of Americans about the safety and effectiveness of vaccines and confronting a strong antivaccine movement, said Peter Hotez, a vaccine scientist at the Baylor College of Medicine and an author of the paper. Those are steps the government hasn’t taken yet, he said. “To use a vaccine to eliminate this virus—it is a really high bar,” he said.

One open question is how effective the vaccines are at preventing people from transmitting the virus to others, Dr. Hotez said. Both vaccines were tested primarily for their effectiveness at preventing people from becoming ill. They are expected to be evaluated for effectiveness at preventing infection regardless of symptoms, but those data haven’t been released yet.

What is herd immunity?

Epidemiologists estimate that between 60% and 70% of a population needs to develop an immune response to the virus to reach “herd immunity,” a state in which enough people have either been infected or vaccinated to stop transmission of the virus. Some epidemiologists say herd immunity to Covid-19 might be achieved at a lower threshold of 50%.

When the vaccines are widely available, how will I get the shot?

Federal officials say they want to make getting a Covid-19 vaccine as easy as going to a pharmacy to get a flu shot. The government has formed partnerships with about 60% of U.S. pharmacies to administer Covid-19 vaccines to the broader population after high-priority groups are vaccinated. Manufacturers would ship doses to distributors to get them to hospitals, pharmacies, nursing homes and other administration sites, as determined by state and federal plans. Pfizer’s vaccine requires ultracold shipping and storage, while Moderna’s can be shipped at higher—though still freezing—temperatures. After thawing, doses can be kept in refrigerators for certain periods.

How many doses will I need?

Vaccines from Pfizer, Moderna and AstraZeneca PLC are given in two doses, three or four weeks apart. Federal and state officials are planning to issue reminders to people to come back for their second doses. A Johnson & Johnson vaccine is being tested as a single dose, but the company hasn’t yet reported how well that works.

How much does it cost? Will insurance cover it?

Both the Trump administration and President-elect Joe Biden have said the vaccine would be free of charge to all Americans, with administration fees billed to private or government insurance plans or to a special government relief fund for the uninsured.

Does it have to be a needle?

The vaccines closest to authorization are given as injections. Merck & Co. is exploring an oral formulation of a Covid-19 vaccine, but it isn’t expected to be available in the near term.

Should I get a vaccine if I’ve already been infected?

You can still benefit from the vaccine, the CDC says. Scientists don’t yet know how long someone is protected from getting sick again once they have had Covid-19. There is some evidence that natural immunity doesn’t last long.

How long does immunity last after vaccination?

The median follow-up period in the large clinical trials was only about two months after vaccination, so it isn’t yet known how long protection will last beyond that.

Will my child be able to get vaccinated? Has it been tested in children?

Children likely won’t get vaccinated until later because they are much less likely to have severe Covid-19 than adults. Pfizer has requested U.S. authorization of use of the vaccine in people 16 and older. Pfizer and Moderna have started to test the vaccine in children as young as 12, and other companies also plan to test their Covid-19 vaccines in children.

Can I stop wearing a mask after getting a COVID-19 vaccine?

Moncef Slaoui, head of the U.S. vaccine development effort, has estimated the US could reach herd immunity by May, based on the effectiveness of the Pfizer and Moderna vaccines if enough people are vaccinated

Can I stop wearing a mask after getting a COVID-19 vaccine?

No. For a couple reasons, masks and social distancing will still be recommended for some time after people are vaccinated.

To start, the first coronavirus vaccines require two shots; Pfizer’s second dose comes three weeks after the first and Moderna’s comes after four weeks. And the effect of vaccinations generally isn’t immediate.

People are expected to get some level of protection within a couple of weeks after the first shot. But full protection may not happen until a couple weeks after the second shot.

It’s also not yet known whether the Pfizer and Moderna vaccines protect people from infection entirely, or just from symptoms. That means vaccinated people might still be able to get infected and pass the virus on, although it would likely be at a much lower rate, said Deborah Fuller, a vaccine expert at the University of Washington.

And even once vaccine supplies start ramping up, getting hundreds of millions of shots into people’s arms is expected to take months.

Fuller also noted vaccine testing is just starting in children, who won’t be able to get shots until study data indicates they’re safe and effective for them as well.

Moncef Slaoui, head of the U.S. vaccine development effort, has estimated the country could reach herd immunity as early as May, based on the effectiveness of the Pfizer and Moderna vaccines. That’s assuming there are no problems meeting manufacturers’ supply estimates, and enough people step forward to be vaccinated.

FDA panel endorses Pfizer coronavirus vaccine for emergency use.

Thomas Barrabi reported that the U.S. Food and Drug Administration advisory panel voted Thursday to endorse the Pfizer-BioNTech coronavirus vaccine, clearing the way for FDA leaders to authorize emergency mass distribution amid an ongoing surge of COVID-19 cases across the country. And Friday it was official that the Pfizer vaccine is approved for emergency use.

Vaccine shipments would begin within hours of the FDA’s decision, which could come by as early as Friday, with the first vaccinations to follow soon afterward. Pfizer’s vaccine will be available in limited quantities, with initial doses earmarked for frontline health care workers and high-risk patients.

In November, Pfizer announced that its coronavirus vaccine was 95 percent effective and has not displayed any major side effects.

The advisory panel, comprised of outside experts, based its decision on data from clinical trials. Members were asked to vote on “whether the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older” based on the totality of available evidence.

Some committee members raised concerns about the wording of the question and whether trials have provided enough information regarding the vaccine’s effects on people aged 16 and 17 years old. The committee opted to vote on the question as it was originally worded.

Of the committee’s 23 members, 17 voted to recommend the vaccine and four voted against the recommendation. One member abstained in its endorse

Pfizer is one of several companies in the final stages of development. The FDA is expected to decide whether to approve a vaccine developed by Moderna for mass use later this month. Johnson & Johnson and AstraZeneca also have vaccines in the works.

More than 290,000 Americans have died from COVID-19 since the pandemic began. More than 15.4 million cases have been reported.

Convincing people to get COVID vaccine is vital — here’s how to do it

Dr. Austin Baldwin and Jasmin from Fox News makes us aware that the decision by the Food and Drug Administration Friday night to issue an emergency use authorization for Pfizer’s COVID-19 vaccine is a critical breakthrough in the battle against the disease that has infected more than 15.7 million Americans and killed nearly 300,000.

The FDA ruling that the Pfizer vaccine is safe and effective is just a first step in a massive rollout of the vaccine. Now the enormous task of distributing the vaccine around the nation begins.

But a crucial obstacle to widespread vaccinations will be public hesitancy to take the vaccine, driven by doubts, fears, and misinformation spreading throughout the nation and the world.

The same challenge will face other vaccines now awaiting approval in the U.S. and vaccines distributed globally. Gaining public acceptance for the Pfizer vaccine and other vaccines is vital, because we won’t end the worst global health crisis in a century until the majority of the world’s 7.7 billion people are vaccinated against COVID-19. The disease has infected more than 70 million people around the world and killed nearly 1.6 million.

Behavioral science will be as important to vaccine acceptance as basic science was to vaccine development. If government and health care leaders take the right approach to educating the public about the vaccines, we can create a pathway for the public to assess options and choose to get vaccinated. Given the accelerated development of the Pfizer vaccine and other vaccines not yet approved, convincing people that the vaccines are safe and effective is critical.

The World Health Organization identified vaccine hesitancy as a top global health threat in 2019 — just months before the COVID-19 outbreak. An Axios-Ipsos survey found that only half of Americans say they are likely to get a COVID-19 vaccine as soon as it is available. These numbers are even lower among African Americans, at just more than a quarter. Why?

Historically, minority communities have been suspicious of new health technologies and biomedical research due to past unethical experimentation on African Americans and Native Americans.

Given that African Americans are hardest hit by COVID-19, public health officials must respond to these concerns. Beliefs in vaccine conspiracies and rumors that the government is cutting corners in testing and development must also be addressed if we are to achieve herd immunity, the threshold of 70 percent of the population needed in order for person-to-person transmission to be largely eliminated.

As plans are developed to roll out the Pfizer vaccine and later other COVID-19 vaccines throughout the nation, public health officials and other health care leaders should consider three steps.

Transparency to build trust

Leaders at all levels of government and the health care community must be upfront that science is always evolving and that knowledge about the vaccines will continue to accumulate.

Communications should stress that the Pfizer vaccine and the Moderna vaccine (not yet approved) are 90 to 95% percent effective. It’s also important to emphasize that while the development, testing, and approval processes for vaccines have been accelerated, no steps were skipped.

When people are asked if they’re willing to get a vaccine that is “more than 90% effective” or one that has been “proven safe and effective,” willingness to be vaccinated increases to 65 to 70%.

Transparency also means being upfront about potential side effects of vaccines. These include possible arm soreness (as with most vaccines) and possible fatigue a day or two after vaccination. If people expect knowledge to evolve and believe public health leaders will be upfront, reports of new side effects are less likely to undermine confidence and trust.

 Active engagement with vaccine information

Communications about the vaccines should pose questions such as: “How will my family and I benefit from the vaccine?” or “If I don’t get a vaccine and then later get COVID-19, to what extent would I regret that decision?”

Such questions lead people to more actively engage with the information rather than simply being told that the vaccine is safe.

We took this approach when we developed an app and website to address parental hesitancy about the HPV vaccine among diverse populations. We are now working to adapt this approach to provide information on COVID-19 vaccines.

Interactive technology makes it more likely that people will become engaged in the decision to be vaccinated and be motivated to follow through to get the required second dose. 

Meeting different informational needs and styles of decision-making among people 

Some people will want detailed information to weigh the scientific evidence before being vaccinated against COVID-19. Others will want information mediated through a trusted source, like health care providers, faith-based leaders and public figures.

To accommodate different needs and maintain transparency, educational materials should provide information in a stepped manner. Basic information from trusted sources is presented first. This is followed by more detailed information using different media such as print, video and formats such as personal stories and graphics to explain numbers and risk.

Websites and apps that enable people to navigate to their level of desired information provide another level of empowerment. We found our app’s stepped approach led previously hesitant parents to be 2.5 times more likely to decide in favor of the HPV vaccine.

Our major investments in vaccine development and testing will fall short of achieving their potential impact unless the public takes the COVID-19 vaccines. We must work proactively to communicate better than ever before.

So, as I have said before about the flu vaccine, if it is offered to you, get the COVID-19 vaccine and be part of the solution to ending this Pandemic.

And wear the Damn MASKS, as Governor Hogan keeps telling us!

Amid a public health crisis, Americans’ views on health care policy haven’t changed, survey says; And What will Biden do to Healthcare?

Rebecca Morin reported that over the past several weeks, the majority of Americans have had to alter their lives due to the coronavirus pandemic.

Face masks have become part of most people’s daily wardrobe. Social distancing restrictions are still being ordered in many of the states. And millions have lost their jobs, as well as their health insurance. 

Now that Joe Biden has been declared the next president, we need to consider what I have been saying, that if we have learned nothing else, a form of universal affordable health care is a necessity.

Despite the changes, the majority of Americans’ long-held beliefs surrounding health care haven’t changed, according to a new survey.

About half of Americans – 51% – said they agree that government-run health insurance should be provided to all Americans, according to a survey from the Democracy Fund + UCLA Nationscape Project. That’s just a 1 percentage point less than in February.

“The events themselves have not driven people to some radical new conclusions about whether the government should be providing certain types of services,” said Robert Griffin, research director for the Democracy Fund Voter Study Group. “These are not attitudes that have suddenly changed overnight in response to political events that have occurred.”

The new survey comes amid a public health crisis, where most of the United States was closed down for more than a month to help limit the spread of the coronavirus. Over the past couple of months, more than 36 million people have sought jobless benefits. The Labor Department said Thursday that about 3 million Americans filed initial unemployment benefit claims last week.

Are lockdowns being relaxed in my state? Here’s how America is reopening amid the coronavirus pandemic.

Half the states across the nation have also begun loosening social distancing restrictions over the past several weeks. Experts show that the curve showing the rate of new cases may be flattening, but they are estimating at least 60,000 more people will die from coronavirus by August. 

The Democracy Fund + UCLA Nationscape Project is a large-scale study of the American electorate. Throughout the 2020 election cycle, the researchers aim to conduct 500,000 interviews about policies and the presidential candidates. This survey was conducted between April 29 and May 6, with 6,366 Americans surveyed. There is a margin of error of plus or minus 2.1 percentage points.

Another policy view that hasn’t seen a lot of change? Subsidizing health insurance for lower-income people who are not receiving Medicare or Medicaid.

Sixty-three percent of Americans said that they agree with that – a 2 percentage-point drop from February. 

However, a majority of Americans believe there should be more short-term aid for those in need during the coronavirus pandemic, according to an analysis on Nationscape Insights, a project of Democracy Fund, UCLA, and USA TODAY. 

Pandemic protocols: Safety measures vary from the White House to the Supreme Court

Griffin noted that during the pandemic, Americans are “much more flexible in terms of thinking about what types of policies they might consider,” even if their attitudes about basic policies haven’t shifted much.

Seventy-nine percent of Americans strongly or somewhat support increasing spending on health insurance and food aid for the poor during the coronavirus pandemic. When broken down between Democrats and Republicans, the majority of both also support to increase spending.

The coronavirus pandemic also hasn’t affected long-standing political norms for Republicans and Democrats, according to the survey.

Sixty-nine percent of Democrats said they agree with providing government-run health insurance to all Americans. In February, that number was at 68%. In terms of agreeing on subsidizing health insurance for lower income people who are not receiving Medicare or Medicaid, Democrats are at 78%, a 2-percentage point drop from February.

For Republicans, the numbers don’t change drastically either. Thirty percent of Republicans agree to providing government-run health insurance to all Americans, compared with 33% in February. There was also a three-point drop from February to May among Republicans when asked if they agree on subsidizing health insurance for lower income people who are not receiving Medicare or Medicaid, from 53% to 50%. 

Biden Wants to Lower Medicare Eligibility Age To 60, But Hospitals Push Back

Phil Galewitz reported that President-elect Joe Biden’s plan to lower the eligibility age for Medicare is popular among voters but is expected to face strong opposition on Capitol Hill.

Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60. Is this the first step to Medicare-for-All?

But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.

Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals — a powerful political force — are poised to derail any effort. Hospitals fear adding millions of people to Medicare will cost them billions of dollars in revenue.

“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.

Medicare reimbursement rates for patients admitted to hospitals are on average half what commercial or employer-sponsored insurance plans pay.

“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.

Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.

“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.

Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a Kaiser Family Foundation tracking poll from January 2019. (Kaiser Health News is an editorially independent program of the Kaiser Family Foundation.)

Although opposition from the hospital industry is expected to be fierce, it is not the only obstacle to Biden’s plan.

Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to pay hospitals and nursing homes fully for inpatient care for Medicare beneficiaries.

It’s also unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act (if the Supreme Court strikes down part or all of the law in a current case), expanding Obamacare subsidies and lowering drug costs.

Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.

To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.

The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.

“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.

The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, but full benefits depend on the year you were born, ranging from age 66 to 67.

While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.

Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.

Avalere says 3.2 million people in that age group buy coverage on the individual market.

While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.

About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out of pocket.

Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.

Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.

“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.

President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.

Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and their workplace health coverage.

Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.

Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.

“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”

Biden has room on health care, though limited by Congress

Biden’s proposals for a public health insurance option and empowering Medicare to negotiate prescription drug prices seem out of reach

President-elect Joe Biden is unlikely to get sweeping health care changes through a closely divided Congress, but there’s a menu of narrower actions he can choose from to make a tangible difference on affordability and coverage for millions of people.

With the balance of power in the Senate hinging on a couple of Georgia races headed to a runoff, and Democrats losing seats in the House, Biden’s proposals for a public health insurance option and empowering Medicare to negotiate prescription drug prices seem out of reach. Those would be tough fights even if Democrats controlled Congress with votes to spare.

But there’s bipartisan interest in prescription drug legislation to limit what Medicare recipients with high costs are asked to pay, and to restrain price increases generally. Biden also could nudge legislation to curb surprise medical bills over the finish line.

Moreover, millions of people already eligible for subsidized coverage through “Obamacare” remain uninsured. A determined effort to sign them up might make a difference, particularly in a pandemic. And just like the Trump administration, Biden is expected to aggressively wield the rule-making powers of the executive branch to address health insurance coverage and prescription drug costs.

With COVID-19 surging across the country, Biden’s top health care priority is whipping the federal government’s response into shape. In his victory speech Saturday, he pledged to “spare no effort, or commitment, to turn this pandemic around.” He appointed a pandemic task force to develop “an action blueprint” that could be put into place on Inauguration Day.

On broader health policy issues, Biden has signaled he will stick with his robust campaign platform, which called for covering all Americans by building on the Affordable Care Act, adding a new public insurance option modeled on Medicare and lowering the eligibility age for Medicare.

“We’re going to work quickly with the Congress to dramatically ramp up health care protections, get Americans universal coverage, lower health care costs, as soon as humanly possible,” the president-elect said earlier this week.

Progressives who drive the Democratic Party’s health care agenda say Biden must try as hard as he can to deliver, no matter if Sen. Mitch McConnell, R-Ky., remains majority leader of the Senate.

“I would vote for anything that improves health care for the American public, but what we need to do is push boldly and clearly for progressive policies,” said Rep. Ro Khanna, D-Calif., first vice chair of the Congressional Progressive Caucus.

Khanna says he’d like to see a President Biden calling out McConnell in public. “Right at the State of the Union, he should say, ‘One person potentially stands in the way of this, and that is Mitch McConnell,’” said Khanna.

Not in the real world, Republicans say.

They say the only way Democrats could get a big health care bill through is to first win the two Senate seats in Georgia and then rely on a special budget procedure that would allow them to pass legislation in the Senate on a simple majority vote. Either that or change Senate rules to abolish the filibuster. None of that can be done with a snap of one’s fingers.

“I put the odds of large-scale comprehensive health care reform at almost zero,” said Brendan Buck, who served as a top adviser to former House Speaker Paul Ryan, R-Wis.

Biden’s to-do list on health care begins with new hires and a rewrite of Trump administration policies.

Democrats have a deep talent pool he can tap for top jobs. Among the leading contenders for health secretary is former Surgeon General Vivek Murthy, who is a co-chair of Biden’s coronavirus task force. North Carolina state health secretary Dr. Mandy Cohen, another Obama administration alum, is also being promoted.

The rewrite project involves rescinding regulations and policies put in place by the Trump administration that allowed states to impose work requirements on Medicaid recipients, barred family planning clinics from referring women for abortions, made it easier to market bare-bones health insurance and made other changes.

But Biden can also use the government’s rule-making powers proactively. Prescription drugs is one area. The Trump administration was unable to finalize a plan to rely on lower overseas prices to limit what Medicare pays for some drugs. It’s a concept that Democrats support and that Biden may be able to put into practice.

On Capitol Hill, there doesn’t seem to be a clear path.

A Republican advocate for action to curb prescription drug costs, Sen. Chuck Grassley of Iowa, is expected to take on a new role in the next Congress, with less direct influence over health care issues.

A factor that may work in Biden’s favor is that many Republicans want to change the subject on health care. Exhaustion has set in over the party’s decade long campaign to overturn the Affordable Care Act, which has left the main pillars of former President Barack Obama’s health law standing, while knocking off some parts.

Though not ready to embrace the ACA, “Republicans have tired of banging their heads against the wall in an effort to get rid of it,” said Buck.

Brian Blase, a former Trump White House health care adviser, says he thinks there is potential on prescription drugs.

“Biden, I think, will be pragmatic in this area,” Blase said.

He expects a Biden administration to wield its rule-making powers aggressively, looking at international prices to try to limit U.S. prescription drug costs.

Coronavirus relief legislation could provide an early vehicle for some broader health care changes.

Former Health and Human Services Secretary Kathleen Sebelius, who oversaw the rollout of the ACA under Obama, says it’s not a question of all or nothing.

“Will it be as much progress as if we had had a big Senate win?” she asked.

It may not look that way.

“But can he make progress? I think he can.”

What You Need to Know About the ‘90% Effective’ COVID-19 Vaccine

There is promise—but there are also questions.

Marty Munson noted that on  Monday, a COVID-19 vaccine made by the drug company Pfizer in conjunction with BioNTech made headlines. An early analysis released by the drug maker suggested that the vaccine could be more than 90 percent effective in preventing COVID-19.

No doubt it’s promising news—in fact, a CNN report says that Anthony Fauci, M.D., the nation’s top infectious diseases expert, texted CNN and called it “extraordinarily good news.”

The early analysis is of a trial that involved nearly 44,000 subjects; half receiving a placebo and the other half receiving a two-dose regimen of the new vaccine. The report says that 94 people got COVID-19. It’s not clear how many of those received a placebo and not the vaccine, but it would have to be most of them for the reports to claim more than 90 percent efficacy.

The excitement among scientists and the financial sector isn’t just about the robustness of the results. This vaccine uses a new technology, known as mRNA, a gene-based drug technology that has never been used in a vaccine before. So, the potential success of this drug is also a huge success for science. The Wall Street Journal quotes Professor John Bell, a UK health-policy advisor involved in the Oxford-AstraZeneca vaccine as saying, “the most important message is that you can make a vaccine against this critter.”

What it means so far

The news is encouraging, but the vaccine is not a panacea yet. The New York Times pointed out on Tuesday that “independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected. And no one knows how long the vaccine’s protection might last.”

Data hasn’t been released on whether any people in the trial developed milder forms of COVID-19, what kind of side effects are associated with it, and how long protection might last. A few more considerations that moderate enthusiasm for the results: The results were released by the company, not in a medical journal, and the trial hasn’t concluded, so the numbers may change, The New York Times report points out.

If the company does receive emergency authorization of the vaccine after it collects the required amount of safety data, there are still questions and concerns about whether it is effective in all populations, how much vaccine the company can produce and how quickly, who would get it first, how it will be transported and delivered and whether people will accept the vaccine and get it when it’s offered.

What else to know

The news is promising and especially with the latest information regarding the Moderna vaccine, but there’s more data to come out, and many more problems need to be solved before a vaccine is a reality for most Americans. The pandemic is far from over, and this news doesn’t change that yet. So for now, at a time when there have been about 110,000 COVID-19 cases a day surging in the U.S., it’s still important to wear masks and continue to use social distancing measures and common sense. It seems that we are all forgetting common sense.

So, as my favorite candidate for the presidency. Governor Larry Hogan, says-Wear the damn masks and…get your flu shots!!!!

Also, I have included a cartoon from Rick Kollinger who has suffered a setback in his fight with his cancer. But after my visit with him, and my harassment he has attempted to draw a few more cartoons for me and his fans. Thank you Rick and please get better!


 [r1]

Time to prepare for an even more deadly pandemic and Trump’s Healthcare Plan

What a confusing time and how disappointed can one be when one candidate running for President convinces a group of physicians to complain about Trump’s response to the Pandemic. I am embarrassed to say that they are in the same profession that I have been so proud to call my own. Can you blame the President for the pandemic as all the other countries that are experiencing the increased wave of COVID? Can you blame Trump for the lack of PPE’s when former President Obama and yes, Vice President Biden refused to restock the PPE’s used for the other SAR’s viruses?  What a pathetic situation where the average American is so hateful and, yes, the word is stupid, and with no agreement in our Congress except to make us all hate them. Where is the additional financial support, the stimulus package promised, for the poor Americans without jobs and huge debts? This is a difficult situation when we have such poor choices for the most important political office and can’t see through the media bias.

I just had to get all that off my chest as I am like many very frustrated. How did we get here and who do we believe as we hear more about Biden’s connection with his son’s foreign dealings?

Thomas J. Bollyky and Stewart M. Patrick reported that the winner of the presidential election, whether that is Donald Trump or Joe Biden, will need to overcome the COVID-19 pandemic — the worst international health emergency since the 1918 influenza outbreak — and also begin preparing the United States and the world for the next pandemic.

Think it is too soon to worry about another pandemic? World leaders have called the coronavirus outbreak a “once-in-100-year” crisis, but there is no reason to expect that to be true. A new outbreak could easily evolve into the next epidemic or a pandemic that spreads worldwide. As lethal as this coronavirus has been, a novel influenza could be worse, transmitting even more easily and killing millions more people.

Better preparation must begin with an unvarnished assessment of what has gone wrong in the U.S. and in the global response to the current pandemic and what can be done to prepare for the next one when it strikes, as it inevitably will.

Preparedness needs to start with investment. Despite multiple recent threats, from SARS (2003) to H5N1 (2007) to H1N1 (2009) to Ebola (2013-2016); many blue ribbon reports and numerous national intelligence assessments; international assistance for pandemic preparedness has never amounted to more than 1% of overall international aid for health.

The United States devoted an even smaller share of its foreign aid budget in 2019 — $374 million out of $39.2 billion — to prepare for a pandemic that has now cost the country trillions of dollars. Meanwhile, funding for the Centers for Disease Control and Prevention’s support to states and territories has fallen by more than a quarter since 2002. Over the last decade, local public health departments have cut 56,360 staff positions because of lack of resources.

Preparation isn’t only about investing more money. It is also about embracing the public health fundamentals that allowed some nations to move rapidly and aggressively against the coronavirus. The United States has been hard hit by this pandemic, but all countries were dealt this hand.

But we can do better. Here are four measures, outlined in a new report from the Council on Foreign Relations, that would make Americans and the rest of the world safer.

First, the United States must remain a member of the World Health Organization, while working to reform it from within. The agency is hardly perfect, but it prompted China to notify the world of the coronavirus and it has coordinated the better-than-expected response to the pandemic in developing nations. Yet, the agency has no authority to make member states comply with their obligations and less than half of the annual budget of New York-Presbyterian Hospital. The WHO needs more dedicated funding for its Health Emergencies Program and should be required to report when governments fail to live up to their treaty commitments.

Second, we need a new global surveillance system to identify pandemic threats, one that is less reliant on self-reporting by early affected nations. An international sentinel surveillance network, founded on healthcare facilities rather than governments, could regularly share hospitalization data, using anonymized patient information. Public health agencies in nations participating in this network, including the CDC, can assess that data, identify unusual trends and more quickly respond to emerging health threats.

The U.S. should take the lead in forming a coalition to work alongside the WHO to develop this surveillance network. We should also work with like-minded G-20 partners, as well as private organizations, in this coalition to reduce unnecessary trade and border restrictions; increase the sharing of vaccines, therapeutics and diagnostics; and work with international financial institutions to provide foreign aid and debt relief packages to hard-hit nations.

Third, responding to a deadly contagion requires a coordinated national approach. Too often in this pandemic, in the absence of federal leadership, states and cities competed for test kits and scarce medical supplies and adopted divergent policies on reopening their economies. The next administration needs to clarify the responsibilities of the federal government, states and 2,634 local and tribal public health departments in pandemic preparedness and response. Elected leaders, starting with the president, must also put public health officials at the forefront of communicating science-based guidance and defend those officials from political attacks.

Finally, the U.S. must do better by its most exposed and vulnerable citizens. More than 35% of deaths in the U.S. from COVID-19 have been nursing home residents. Many others have been essential workers, who are disproportionately Black and Latinx and from low-income communities. Federal, state and local governments should direct public health investments to these groups as a matter of social justice and preparedness for future threats.

All of this will require leadership and marshaling support at home and abroad. The next president need not be doomed to replay this current catastrophe — provided he acts on the tragic lessons learned from the COVID-19 pandemic.

In search of President Trump’s mysterious health care plan

Hunter Walker responded to questions about President Trump’s healthcare plan noting that President Trump’s health care plan has become one of the most highly anticipated, hotly debated documents in Washington. And depending on whom you ask, it might not exist at all. 

The contents — and the whereabouts — of the health plan have been a growing mystery since 2017, when efforts to pass a White House-backed replacement for Obamacare stalled in the Senate. Since then, Trump has repeatedly vowed to unveil a new health plan. In July, it was said to be two weeks away. On Aug. 3, Trump said the plan would be revealed at the end of that month. Last month, White House press secretary Kayleigh McEnany said it would be released within two weeks. At other points, Trump has suggested the plan is already complete. That shifting schedule has lent Trump’s health plan an almost mythical status.

Let me state here that if President Trump doesn’t win this election his lack of a healthcare plan as well as the blame for the pandemic will be the deciding reason that even previous GOP supporters will vote for Biden. Hard to believe, right? In fact, weeks to months ago I related the need for the President to release his healthcare plan to further prove to the voters that he is fulfilling his promises.

The mystery surrounding the president’s vision for health care has added urgency because the Supreme Court is currently scheduled to hear oral arguments in a case that could decide the future of former President Barack Obama’s signature health care law on Nov. 10, exactly one week after the election. That case was brought by Republican attorneys general and joined by the Trump administration. The argument that Obamacare is unconstitutional could lead to the current health care framework being struck down, but Trump has yet to present an alternative. 

With both the election and the court date looming, questions about Trump’s health care plan have intensified on the campaign trail. And the White House’s answers have only added to the uncertainty. 

During the first presidential debate last month, Trump was pressed by Fox News moderator Chris Wallace about the fact he has “never in these four years come up with a plan, a comprehensive plan, to replace Obamacare.”

“Yes, I have,” Trump replied. “Of course, I have.”

He was apparently referring to the Republican tax bill passed in 2017 that eliminated the tax penalty for individuals who did not purchase health insurance, or obtain it through their jobs or government assistance. That so-called individual mandate was a critical part of the Affordable Care Act, more commonly known as Obamacare, meant to ensure that even healthy people would buy health insurance and spread the costs out across the population. Other parts of the Affordable Care Act remain in place, but the Republican lawsuit argues that without the mandate the entire program should be overturned. 

That could end the most popular feature of Obamacare: the requirement that insurance companies provide affordable coverage for preexisting conditions. While Trump has repeatedly insisted, he wants to maintain that protection, any details of his plan or evidence of how he would do it have remained elusive.  

During the final debate last week, Democratic nominee Joe Biden argued that the administration “has no plan for health care.”

“He’s been promising a health care plan since he got elected. He has none,” Biden said of Trump. “Like almost everything else he talks about, he does not have a plan. He doesn’t have a plan. And the fact is, this man doesn’t know what he’s talking about.” 

The issue also came up during the vice-presidential debate on Oct. 7, when Vice President Mike Pence said, “President Trump and I have a plan to improve health care and protect preexisting conditions for every American.” 

“Obamacare was a disaster, and the American people remember it well,” Pence said.

But Trump seemed to admit during last week’s debate that his plan is more of a dream than a concrete proposal. 

“What I would like to do is a much better health care, much better,” he said, adding, “I’d like to terminate Obamacare, come up with a brand-new, beautiful health care.”

However, by the end of last weekend, the idea of a written, completed Trump health plan was back on the table — literally. 

During the president’s contentious “60 Minutes” interview that aired on Sunday, host Lesley Stahl asked Trump about his repeated promises of a health plan coming imminently.

“Why didn’t you develop a health plan?” Stahl asked.  

“It is developed,” Trump responded. “It is fully developed. It’s going to be announced very soon.”

And after Trump ended the interview and walked out on Stahl, McEnany, the White House press secretary, came in and handed the “60 Minutes” correspondent a massive binder.

“Lesley, the president wanted me to deliver his health care plan,” McEnany said. “It’s a little heavy.” 

Indeed, Stahl struggled with the huge book. The situation seemed reminiscent of other instances where Trump tried to dissuade debate by presenting massive piles of paper that didn’t stand up to scrutiny, and it sparked speculation that the contents of the massive binder were blank. However, the conservative Washington Examiner newspaper subsequently reported it contained more than 500 pages comprising “13 executive orders and 11 other pieces of healthcare legislation enacted under Trump.”

Stahl was unimpressed. After perusing the gigantic tome, she declared, “It was heavy, filled with executive orders, congressional initiatives, but no comprehensive health plan.”

McEnany took issue with that assessment and shot back with a tweet that declared, “@60Minutes is misleading you!!”

“Notice they don’t mention that I gave Leslie 2 documents: a book of all President @realDonaldTrump has done & a plan of all he is going to do on healthcare — the America First Healthcare Plan which will deliver lower costs, more choice, better care,” the press secretary wrote.

McEnany had implied one of Washington’s most wanted documents was printed, bound and ready for review. It even had a name! Were we really this close to seeing the Trump health plan?

Not exactly. 

After Yahoo News requested a copy of the “health care plan” that she presented to Stahl, McEnany provided a statement detailing the contents of the enormous binder.

“The book contains all of the executive orders and legislation President Trump has signed,” McEnany said.

She credited those actions with “lowering health care premiums and drug costs” compared with where they were under Obama and Vice President Biden. Trump has previously claimed premiums and costs have gone down during his administration, but these assertions aren’t entirely backed up by the data. And many of Trump’s executive orders on health care have been largely symbolic. 

McEnany also provided us with a copy of the second document that she described on Twitter and Stahl had supposedly ignored. It was a 10-page report (including front and back covers) with a large-print, bullet-pointed list of highlights from Trump’s previous actions on health care and slogans making promises for the future. 

“The America First Healthcare Plan lays out President Trump’s second term vision animated by the principles that have brought us lower cost, more choice and better care,” McEnany said. 

The White House’s immense binder clearly didn’t contain Trump’s “health care plan” as McEnany declared during the dramatic on-camera delivery. But it did hold a fragment of the president’s policy vision. 

Perhaps more pieces of the puzzle could be found on Capitol Hill. After all, in April 2019, Trump proclaimed on Twitter that “the Republicans … are developing a really great HealthCare Plan.” That comment followed reports that a group of Republican senators including Mitt Romney of Utah, John Barrasso of Wyoming, Rick Scott of Florida and Bill Cassidy of Louisiana were working on drafting a proposal. Trump said this plan would “be far less expensive & much more usable than ObamaCare.” The president further suggested it would be complete and ready to be voted on “right after the election.”

So, is there a finished plan floating around Capitol Hill ready to make its debut in a matter of weeks? No.

A Republican Senate source who has been privy to the talks told Yahoo News that a group of GOP senators including Romney, Barrasso, Lindsey Graham of South Carolina and Senate Health Committee Chairman Lamar Alexander of Tennessee have been “exploring” an alternative to Obamacare “over the course of the past year and a half.” However, with the coronavirus pandemic and a Supreme Court confirmation dominating the agenda, the source, who requested anonymity to discuss the deliberations, suggested the planning had stalled.

“I don’t think they’ve talked about this stuff for months now due to other pressing issues,” the source said of the health care planning.

The source predicted that activity on health care would not resume until the outcome of the election and the Supreme Court’s Obamacare case are clear. 

“Depending on how things in November shake out and … what the Supreme Court does with the ACA, maybe those discussions will be revived,” the source said. “But there really has not been much going on of late.”

Nevertheless, the source contended that, even though there is no finished plan, Trump and his Republican allies on the Hill have made some real progress toward “a potential plan that would preserve private insurance but also seek to lower costs.” They suggested Senate efforts to lower drug prices and end surprise medical billing are part of the “frameworks,” as are some of the executive orders issued by Trump.

“There have been sort of piecemeal efforts in this area. … The executive branch has done what they can do within their authority to try to lower costs,” the source said. “There just hasn’t been … a wholesale piece of legislation or framework that everyone has coalesced around. That’s just something that has not come together.”

In the end, perhaps the truest answer to the ongoing mystery of Trump’s proposed Obamacare replacement came from the president himself during the “60 Minutes” interview. In the conversation, Trump suggested that his health plan exists in a realm beyond the bounds of space and time.

“A new plan will happen,” he said. “Will and is.” 

As you can tell from the lead in to this post, that many of us who can really think and put enough words together to make a understandable sentence our choices are not good but it is really important for us all to go and turn out to vote, either in person, with masks in place and socially distancing or by mail in or drop off ballots.

Also, make sure you all get your new flu shots!!

What would a Biden economy look like, and what will healthcare go from here? Also, When Should We Get Vaccinated for the Flu?

As I listened to the Democratic convention, I was horrified by the hate against President Trump, and the in general. My wife doesn’t want me to say it, but the average citizen, especially the socially and history ignorant citizens are basically stupid and believes those of the liberal democrats. As an Independent I don’t believe. But I thought that I would skip the updates regarding the Corvid pandemic and consider the economy and healthcare with former Vice President Biden in control. Oh, Horror!

The Week Staff wrote that if you’re wondering what a Biden presidency would mean for the economy, look to Biden’s last financial crisis, said Jeffrey Taylor at Bloomberg. In 2009, as vice president, Biden approached the crisis from a middle-class, Rust Belt viewpoint, aggressively pushing for an auto bailout while championing tighter restrictions on banks and arguing against Wall Street in key debates. While today’s situation is obviously different from the Great Recession, Biden sees “common threads” that could help him pursue an agenda focused on addressing income inequality and promoting public works. His top priority is a massive $3.5 trillion infrastructure, manufacturing, and clean-energy program “that appears likely to grow substantially if he is elected.” He plans to pay for the program by raising the corporate tax rate from 21 percent to 28 percent and increasing taxes on wealthy real-estate investors. In the wake of the pandemic, Biden has “edged away from the moderate economic approach he advocated last year,” but he is still not likely to “embrace punitive demands from the Left.”

“There is nothing ‘moderate’ about Biden’s tax plan,” said Mark Bloomfield and Oscar Pollock at The Wall Street Journal. For taxpayers with income above $1 million, Biden wants to tax capital gains as ordinary income. Combined with an upper-income tax increase, that would make top capital gains tax surge from the current 20 percent to 43 percent, exceeding the rate in “every one of the 10 largest economies.” We are not going to compete with China by adopting “tax policies that discourage those who are best able to invest, take risks, and start companies.”

Certain industries are sure to be in Biden’s crosshairs, said Anne Sraders at Fortune​. “Trump’s fight to lower drug prices will likely be carried on,” meaning “potential headwinds for Big Pharma.” And energy and “environment-sensitive industries” such as oil and gas production could underperform under a Democratic administration. But the naming of Kamala Harris as his vice-presidential nominee “might actually be good for Big Tech” because of her ties to Silicon Valley. For the first time in a decade, Wall Street donors are actually giving more to Democrats than to Republicans, said Jim Zarroli at NPR. Trump “still has friends in finance,” but many investors have “soured on his management style,” which makes it hard for them to make long-term plans.

Whatever the outcome, investors are starting to worry about “stock-market mayhem” surrounding the November election, said Gunjan Banerji and Gregory Zuckerman at The Wall Street Journal. “Markets tend to be volatile ahead of elections,” but pessimism about what might unfold appears “even more intense this time around.” One adviser is urging clients to insure themselves against losses by buying options that will profit if the S&P 500 index plunges more than 25 percent through December; other firms are telling clients to bet on gold. The behind-the-scenes anxiety is unfolding even as markets hit a record high. “October and November tend to be the wildest months of the year” in any case, and market uncertainty could skyrocket if in the days after the election there is no clear winner.

Here’s Where Joe Biden Stands on Every Major Healthcare Issue

Lulu Chang reviewed Biden’s stand on healthcare. The stage is set, the players have been finalized, and the countdown has begun in earnest. In less than three months, voters across the United States will head to the polls (or mail in their ballots) to elect their president.

The Democrats recently finalized their ticket, making history with the inclusion of Kamala Harris as Joe Biden’s vice-presidential pick, making her the first African American and Asian woman to appear on a major party ticket. Over the course of the next several weeks, the Biden and Harris team will make clear their platforms and policy suggestions to win over voters. I’ll discuss Harris’s stand on health in the next section of this post. And of course, in the face of a global pandemic, high on the list of priorities for many Americans is the Democratic nominee’s position on healthcare.

We’ve put together a list of where Joe Biden stands on every major health issue to help you make a more informed decision as you mail in your ballot or head to the polls in a few short months.

Medicare

  • No Medicare for All
  • Lower age to 60 (currently 65)
  • Add a public option

Biden supports making Medicare, the federal health insurance program for folks older than 65 and certain younger Americans with disabilities, more readily accessible to a greater swath of the population. He does not, however, support Medicare for All, which would offer complete health care to all Americans regardless of age without out-of-pocket expenses. Instead, Biden advocates for lowering the eligibility age for Medicare to 60, which would certainly expand the program’s reach.

In addition, Biden wants to add a public option to American healthcare, which was discussed during the writing of the Affordable Care Act, but ultimately passed over. A public option would allow folks to select into government-run insurance—like Medicare—instead of a private insurance plan. This too would allow a greater proportion of the population to access government-run healthcare options. As Biden explains on his campaign website, “If your insurance company isn’t doing right by you, you should have another, better choice…The Biden Plan will give you the choice to purchase a public health insurance option like Medicare. As in Medicare, the Biden public option will reduce costs for patients by negotiating lower prices from hospitals and other health care providers.”

Undocumented Immigrants

  • Allow undocumented immigrants to buy into a public option

The Biden Plan emphasizes the importance of providing affordable healthcare to all Americans, “regardless of gender, race, income, sexual orientation, or zip code.” But it is not only Americans who Biden seeks to cover under his policies—rather, his plan would allow undocumented immigrants to purchase the public option, though it would not be subsidized.

Affordable Care Act

  • Strengthen the ACA
  • Increase subsidies
  • Bring back the individual mandate

The Affordable Care Act was passed under the Obama administration, so it comes as little surprise that Biden wants to bring back many of the provisions from the bill that were dismantled under the Trump administration. As he notes in his official platform, Biden seeks to “stop [the] reversal of the progress made by Obamacare…[and will] build on the Affordable Care Act with a plan to insure more than an estimated 97% of Americans.”

This would involve increasing tax credits in order to reduce premiums and offer coverage to a greater swath of Americans. In particular, Biden wants to do away with the 400% income cap on tax credit eligibility, and lower the limit on cost of coverage from today’s 9.86% to 8.5%. In effect, that means that no one purchasing insurance would have to spend any more than 8.5% of their income on health insurance.

Biden would also bring back the individual mandate, which is a penalty for not having health insurance. Trump eliminated this element of the Affordable Care Act in 2017, but Biden claims that the mandate would be popular “compared to what’s being offered.”

Are you kidding? Remember the burden on our healthy young newly employed or new business owners!

Prescriptions

  • Lower prescription drug pricing

The prices of prescription drugs have skyrocketed in recent years, making big pharma companies a common target among presidential candidates. Biden promises to “stand up to abuse of power by prescription drug corporations,” condemning “profiteering off of the pocketbooks of sick individuals.”

The Biden Plan includes a repeal of the exception that allows pharmaceutical companies to avoid negotiations with Medicare over drug prices. Today, nearly 20% of Medicare’s spending is allocated toward prescription drugs; lowering this proportion could save an estimated $14.4 billion in medication costs alone.

Furthermore, Biden would limit the prices of drugs that do not have competitors by implementing external reference pricing. This would involve the creation of an independent review board tasked with evaluating the value of a drug based on the average price in other countries. Biden would also limit drug price increases due to inflation, and allow Americans to buy imported medications from other countries (provided these medications are proven to be safe). Finally, Biden would eliminate drug companies’ advertising tax breaks in an attempt to further lower costs.

Abortion

  • Expand access to contraception
  • Protect a woman’s right to choose

Joe Biden has been infamously inconsistent in his position on abortion; decades ago, Biden supposed a constitutional amendment allowing states to reverse Roe v. Wade. As a senator, Biden voted to ban certain late-term abortions as recently as 2003. But his official position as the Democratic nominee is to protect a woman’s right to an abortion, and increase access to birth control across the spectrum.

Under the Biden Plan, the proposed public option would “cover contraception and a woman’s constitutional right to choose.” Biden would seek to “codify Roe v. Wade” and put an end to state laws that hamper access to abortion procedures, including parental notification requirements, mandatory waiting periods, and ultrasound requirements.

Biden would also restore federal funding for Planned Parenthood, reissuing “guidance specifying that states cannot refuse Medicaid funding for Planned Parenthood and other providers that refer for abortions or provide related information.”

Surprise Billing

  • Stop surprise billing

Surprise billing, as the name suggests, allows healthcare providers to send patients unexpected out-of-network bills, often in large sums. Biden’s plan would prevent this practice in scenarios where a patient cannot decide what provider he or she uses (as is often the case in emergency situations or ambulance transport). While ending surprise billing could save Americans some $40 billion annually, it is not entirely clear how Biden would end surprise billing.

The plan suggests that Biden would address “market concentration across our health care system” by “aggressively” using the government’s antitrust authority. By promoting competition, Biden hopes to reduce prices for consumers, and more importantly, improve health outcomes. Next is Kamala’s stand on healthcare.

Kamala Harris’ Stance on Healthcare Is Pretty Different from Biden’s

Katherine Igoe noted that healthcare is also an issue that sees a lot of variety across Democratic candidates, ranging from a single-payer healthcare system (meaning that all health insurance is covered through the government, and everyone is covered) to a more hybrid approach that doesn’t exclude private healthcare companies (half of the American population is currently enrolled in private plans).

At least according to her stance in the past, Harris favors the latter, hybrid approach—and it’s quite different from what Biden has proposed. What is her take, and how may her stance have shifted?

As a presidential candidate, Harris proposed Medicare for All.

The issue is personal for Harris. Citing her mother’s terminal cancer diagnosis, she’s said that her interest in improving coverage comes from that relationship: “She got sick before the Affordable Care Act became law, back when it was still legal for health insurance companies to deny coverage for pre-existing conditions. I remember thanking God she had Medicare…As I continue the battle for a better health care system, I do so in her name.”

The details can vary, but the basics of Medicare for All would be to vastly expand the government’s role to include everyone’s healthcare needs. By making Medicare more robust, the program would work to reduce costs for the insured, increase coverage to include those who were previously excluded, and expand upon existing plans in an effort to allow people to keep their existing doctors. But unlike other, more extreme proposals, Harris’ plan would subsequently allow private insurers to participate—in a similar way to the current framework of Medicare Advantage. “Essentially, we would allow private insurance to offer a plan in the Medicare system, but they will be subject to strict requirements to ensure it lowers costs and expands services,” she explained.

The candidates’ stances have had to incorporate what governmental influence would do to the private market, and Harris didn’t favor a plan that would abolish private insurance. She had initially expressed support for something along that lines, but then changed that stance; her perspective on the subject has evolved. She’s also proposed a decade-long “phase-in” period for this new Medicare plan to be put in place.

When they were both presidential candidates, Biden and Harris clashed over healthcare—she said his plan would leave Americans without coverage, he dismissed her plan as nonsensical.

Biden’s take on healthcare is vastly different.

Biden worked with President Obama on the Affordable Care Act (ACA), and thus his plans for healthcare would be to expand upon and further develop the ACA, while protecting it from current attacks. People could choose a public plan (i.e., they wouldn’t be mandated to join Medicare) and the government would provide tax benefits. “It would also cap every American’s health-care premiums at 8.5 percent of their income and effectively lower deductibles and co-payments. Biden recently said he also wants to lower the Medicare enrollment age by five years, to 60.”

The plan would separately take on exorbitant pharmaceutical pricing, which is another hot-button issue that hasn’t had any resolution. Multiple bills have been debated in Congress but the House’s recently passed bill is heavily opposed by Republicans.

Harris wasn’t the only one to criticize Biden on his plan, which may still exclude many from coverage. But now that the two are running mates, they may need to come up with a cohesive strategy that incorporates both of their stances (or, Harris may have to adopt a more moderate approach).

Harris has proposed several healthcare solutions for COVID-19.

Harris has been active in proposing economic relief towards individuals, families, and businesses during the pandemic, and healthcare is no exception. She’s proposed the COVID-19 Racial and Ethnic Disparities Task Force Act, which (among other things) would be designed to address barriers to equitable health care and medical coverage. This is one of the area’s in which she’s pledged to act towards racial justice—and it may be another area in which her stance impacts the Biden-Harris platform.

It’s crucial to get a flu shot this year amid the coronavirus pandemic, doctors say

I just received my yearly flu vaccination this past Wednesday and I have been advising all my patients to get their flu shots now! Adrianna Rodriquez that the message to vaccinate is not lost on Americans calling their doctors and pharmacists to schedule a flu shot appointment before the start of the 2020-2021 season. 

Experts said it’s crucial to get vaccinated this year because the coronavirus pandemic has overwhelmed hospitals in parts of the country and taken the lives of more than 176,000 people in the USA, according to Johns Hopkins data.

It’s hard to know how COVID-19 will mix with flu season: Will mask wearing and social distancing contain flu transmission as it’s meant to do with SARS-CoV-2? Or will both viruses ransack the nation as some schools reopen for in-person learning? 

“This fall, nothing can be more important than to try to increase the American public’s decision to embrace the flu vaccine with confidence,” Centers for Disease Control and Prevention Director Robert Redfield told the editor of JAMA on Thursday. “This is a critical year for us to try to take flu as much off the table as we can.”

Here’s what doctors say you should know about the flu vaccine as we approach this year’s season: 

Who should get the vaccine?

The CDC recommends everyone 6 months and older get a flu vaccine every year. State officials announced Wednesday the flu vaccine is required for all Massachusetts students enrolled in child care, preschool, K-12 and post-secondary institutions.

“It is more important now than ever to get a flu vaccine because flu symptoms are very similar to those of COVID-19, and preventing the flu will save lives and preserve health care resources,” said Dr. Lawrence Madoff, medical director of the Bureau of Infectious Disease and Laboratory Sciences at the Massachusetts Department of Public Health.

When should I get my flu shot? 

Dr. Susan Rehm, vice chair at the Cleveland Clinic’s Department of Infectious Diseases, said patients should get the influenza vaccine as soon as possible.

CVS stores have the flu vaccine in stock, and it became available Monday at Walgreens.

“I plan to get my flu shot as soon as the vaccines are available,” Rehm said. “My understanding is that they should be available in late August, early September nationwide.”

Other doctors recommend that patients get their flu shot in late September or early October, so protection can last throughout the flu season, which typically ends around March or April. The vaccine lasts about six months.

The CDC recommends people get a flu vaccine no later than the end of October – because it takes a few weeks for the vaccine to become fully protective – but encourages people to get vaccinated later rather than not at all.

Healthy people can get their flu vaccine as soon as it’s available, but experts recommend older people and those who are immunocompromised wait until mid-fall to get their shots, so they last throughout the flu season.

What is the high-dose flu shot for seniors? 

People over 65 should get Fluzone High-Dose, or FLUAD, because it provides better protection against flu viruses.

Fluzone High-Dose contains four times the antigen that’s in a standard dose, effectively making it a stronger version of the regular flu shot. FLUAD pairs the regular vaccine with an adjuvant, an immune stimulant, to cause the immune system to have a higher response to the vaccine. 

Research indicates that such high-dose flu vaccines have improved a patient’s protection against the flu. A peer-reviewed study published in The New England Journal of Medicine and sponsored by Sanofi, the company behind Fluzone High-Dose, found the high-dose vaccine is about 24% more effective than the standard shot in preventing the flu.

An observational study in 2013 found FLUAD is 51% effective in preventing flu-related hospitalizations for patients 65 and older. There are no studies that do a comparative analysis between the two vaccines.

Is the flu vaccine safe?

According to the CDC, hundreds of millions of Americans have safely received flu vaccine over the past 50 years. Common side effects for the vaccine include soreness at the injection spot, headache, fever, nausea and muscle aches.

Dr. William Schaffner, professor of infectious diseases at the Vanderbilt Medical Center in Nashville, Tennessee, emphasized that these symptoms are not the flu because the vaccine cannot cause influenza.

“That’s just your body working on the vaccine and your immune response responding to the vaccine,” he said. “That’s a small price to pay to keep you out of the emergency room. Believe me.”

Some studies have found a small association of the flu vaccine with Guillain-Barré syndrome (GBS), but Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, said there’s a one in a million chance of that happening.

Not only is the flu vaccine safe, but the pharmacies, doctors offices and hospitals administering it are also safe.

Horovitz and Schaffner said hospitals take all the necessary precautions to make sure patients are protected against COVID-19. Some hospitals send staff out to patients’ cars for inoculation while others allow them to bypass the waiting room. Doctors offices require masks and social distancing, and they are routinely disinfected.

“Call your health care provider to make sure you can get in and out quickly,” Schaffner advised. “It’s safe to get the flu vaccine and very important.”

Will it help prevent COVID-19?

Experts speculate any vaccine could hypothetically provide some protection against a virus, but there’s little data that suggests the flu vaccine can protect against the coronavirus, SARS-CoV-2, which causes COVID-19.

“We don’t want to confuse people of that … because there’s simply no data,” Schaffner said. “Flu vaccine prevents flu; we’re working on a coronavirus vaccine. They’re separate.”

A study in 2018 found that the flu vaccine reduces the risk of being admitted to an ICU with flu by 82%, according to the CDC.

“People perhaps forget that influenza is something that we see every year,” Rehm said. “Tens of thousands of people die of influenza ever year, including people who are very healthy, and hundreds of thousands of people are hospitalized every year.”

Doctors said it will be even more hectic this year because some flu and COVID-19 symptoms overlap, delaying diagnosis and possibly care.

What can we expect from this year’s flu season and vaccine?

“Even before COVID, what we say about the flu is that it’s predictably unpredictable,” Rehm said. “There are some years that it’s a light year and some years that it’s horrible.”

Flu experts said they sometimes look at Australia’s flu season to get a sense of the strain and how it spreads, because winter in the Southern Hemisphere started a few months ago. 

According to the country’s Department of Health surveillance report, influenza has virtually disappeared: only 85 cases in the last two weeks of June, compared with more than 20,000 confirmed cases that time last year.

“Australia has had a modest season, but they were very good at implementing COVID containment measures, and of course, we’re not,” Schaffner said. “So we’re anticipating that we’re going to have a flu season that’s substantial.”

The CDC said two types of vaccines are available for the 2020-2021 season: the trivalent and quadrivalent. Trivalents contain two flu A strains and one flu B strain and are available only as high-dose vaccines. Quadrivalents contain those three strains plus an additional flu B strain, and they can be high- or standard-dose vaccines. I made sure that I received the quadrivalent vaccine.

Though some doctors may have both vaccines, others may have only one, depending on their supply chain. Natasha Bhuyan, a practicing family physician in Phoenix, said people should get whatever vaccine is available.

“Vaccines are a selfless act. They’re protecting yourself and your friends through herd immunity,” she said. “Any vaccine that you can get access to, you can get.”

Horovitz said vaccine production and distribution have been on schedule, despite international focus on coronavirus vaccine development. He has received his shipment to the hospital and plans to administer the vaccine with four strains closer to the start of the season.

“I don’t think anything suffered because something else was being developed,” he said. “(The flu vaccine) has been pretty well established for the last 20 to 30 years.”

Producers boosted supplies of the flu vaccine to meet what they expect will be higher demand. Vaccine maker Sanofi announced Monday that it will produce 15% more vaccine than in a normal year.

Redfield told JAMA the CDC arranged for an additional 9.3 million doses of low-cost flu vaccine for uninsured adults, up from 500,000. The agency expanded plans to reach out to minority communities.

What about the nasal spray instead of the shot? 

After the swine flu pandemic in 2009, several studies showed the nasal spray flu vaccine was less effective against H1N1 viruses, leading the CDC and the Advisory Committee on Immunization Practices to advise against it.

Since the 2017-2018 season, the advisory committee and the CDC voted to resume the recommendation for its use after the manufacturer used new H1N1 vaccine viruses in production.

Though agencies and advisory committees don’t recommend one vaccine over the other, some pediatricians argue the nasal spray is easier to administer to children than a shot.

Other doctors prefer the flu shot because some of the nasal spray side effects mimic respiratory symptoms, including wheezing, coughing and a runny nose, according to the CDC. Horovitz said anything that presents cold symptoms should probably be avoided, especially among children who are vectors of respiratory diseases.

“Giving them something that gives them cold (symptoms) for two or three days may expel more virus if they’re asymptomatic with COVID,” he said.

So, get vaccinated!!

Mood darkens in Sweden as high death rate raises tough questions over lack of lockdown, and Now A Second Wave and a Possible Kids’ Epidemic!

Richard Orange noted that Sweden, in deference to the rest of the countries believing in the strategy to lockdown their populace, decided not to use stay-at-home or lockdowns except for the elderly.  Sweden’s opposition has attacked the government for its handling of the coronavirus pandemic, with the stubbornly high death rate fueling questions over the decision not to impose a lockdown. 

Jimmie Akesson, the leader of the populist Sweden Democrats, first called for Anders Tegnell, the architect of Sweden’s less restrictive coronavirus strategy, to resign. The attacks continued in heated televised leaders’ debate on Sunday night.  

“The strategy in Sweden was not to try to hold back the infection, but instead to try to limit it at the same time as protecting risk groups,” Mr Akesson wrote in a debate article in the Dagens Nyheter newspaper.

“By that measure, it has failed miserably. Anders Tegnell should therefore resign. Only then will he show the Swedish people that he takes responsibility for the mistakes FHM [Public Health Agency of Sweden] has made.”

During a party leaders’ debate on Sunday evening, Ebba Busch-Thor, leader of the Christian Democrat party, blamed Sweden’s strategy – and by extension the government that allowed it – for some of the 4,659 deaths due to the virus. 

“What we can say about Sweden is that many of those who are mourning over those they have lost this spring are doing so because Sweden knowingly and deliberately allowed a large spread of the infection,” she said.  

Ulf Kristersson, the leader of the Moderate Party, the biggest party on the Centre-Right, held back from joining Mrs. Busch-Thor’s attack on the strategy, instead attacking the implementation of it.

“I had no problem with the strategy. It was a bit slow but, when it was in place, I had nothing against it,” he said. “But the government didn’t put any power behind the words.”

The Prime Minister, Stefan Lofven, continued to back Sweden’s strategic decision not to impose a lockdown, instead laying the blame for the death rate on failures within elderly care. 

“I think the strategy is the right one,” he said. “But it has transpired that that very many people, in certain areas, have died in elderly care. There’s no doubt that elderly care needs to be improved.” 

Mr Akesson faced an immediate counter-attack from Johan Carlsson, the director of FHM, who dismissed his call as “almost pathetic”. 

Dagens Nyheter’s political commentator Ewa Stenberg wrote on Sunday that the debate marked an end to the “borgsfred”, or “castle truce”, in Sweden.

“The tone was harsh and quite contrary to how it was when the virus hit the country. Then all the parties backed the government’s decision to let the Public Health Authority take the lead,” she wrote.

However, the return of political opposition does not yet seem to reflect a loss of support for the government among the public.

Kids During Lockdown: Is Another Epidemic About to be Revealed?

Ingrid Walker-Descartes noted that even in non-pandemic years, the summertime “back-to-school” rush of appointments in many pediatric practices can be a logistical challenge. This year could be even more hectic after many families delayed routine appointments during quarantine. Hoping to return to their routines, children and teens will need vaccines, physical exams for sports clearances and school forms, and all the regular developmental and emotional surveillance that is so important to keep them healthy.

As pediatricians, we should be adding another layer to our checklists in these visits this year. For many children, this visit may be the first time in weeks or months that someone outside their immediate family has had eyes on them.

We must be careful to listen, very carefully, to what the children and parents tell us, both in their words and in other signs. How has the family coped with the stress of being stuck at home? Are there financial struggles? Food insecurity? Other stresses? As a child abuse pediatrician, I know all of these things can put tremendous stress on a family, and ultimately can lead to a child being maltreated or abused. We have a real opportunity right now to intervene and provide critical support to families, and to protect children.

Sadly, we know from previous disasters that during these times of intense emotional and economic stress, rates of child abuse and neglect increase. Injuries and deaths among infants due to abusive head trauma increase during times of economic stress, and scattered reports among physicians at children’s hospitals in various states are reporting that is happening now, too. For example, a hospital in Fort Worth, Texas, and a hospital in Philadelphia, are reporting an increase in the number of severe physical abuse cases. Many times, this abuse occurs when a parent or caregiver is frustrated or at the “end of their rope,” and in a moment of anger, makes a devastating choice that injures a child.

For the past few months, during sheltering in place, children have lacked many of the people who often step forward as protectors — the aunt they may confide in, a teacher who sees a bruise, or a physician who notices an injury where there reasonably should be none. Reports to child abuse hotlines and child protective services have declined during the pandemic, but this is not necessarily because fewer children are being injured. We know that teachers and school counselors are the most frequent reporters of suspected abuse, and for months children have not had access to these trusted protectors. Many of them have not seen their pediatrician, either. These combined realities have left some of our most vulnerable children without several much-needed layers of protection.

As a pediatrician who specializes in diagnosing abuse and protecting children from further abuse, I am well versed in talking with children to understand what happened to cause their injuries. Some may convey lessons learned from their choices made due to curiosity or naivete. Others struggle to elaborate on marks or scars made in anger by a caregiver. Post COVID-19, it will be important for all pediatricians to have a careful approach as they are talking with families, listening and observing to understand what children experienced during the pandemic, and how we can help them and their families be safe and healthy.

Some families may benefit from a referral to a nutrition program, caregiver support program, parental counseling, or other resources. In other cases, a pediatrician may notice a sign of potential abuse that should be reported to the relevant child protection agencies. This is always difficult, but it can be the first step to making sure a child is safe and protected while a family gets the support they need.

The American Academy of Pediatrics (AAP) recently provided a webinar guide on how to identify child abuse during the pandemic, and additional resources are provided on the AAP website, including a list of child abuse programs across the country to help support you in this difficult role.

The stress on families and children will not end when the stay-at-home orders lift. Let’s be prepared to help all our children emerge healthy and strong, and ready to learn.

CDC wants states to count ‘probable’ coronavirus cases and deaths, but most aren’t doing it

Reinhard, Emma Brown Reis Thebault and Lena H. Sun reported that fewer than half the states are following federal recommendations to report probable novel coronavirus cases and deaths, marking what experts say is an unusual break with public health practices that leads to inconsistent data collection and undercounts of the disease’s impact.

A Washington Post review found that the states not disclosing probable cases and deaths include some of the largest: California, Florida, North Carolina and New York. That is one reason government officials and public health experts say the virus’s true toll is above the U.S. tally as of Sunday of about 1.9 million coronavirus cases and 109,000 deaths — benchmarks that shape policymaking and public opinion on the pandemic.

The U.S. Centers for Disease Control and Prevention works closely with a group of health officials called the Council of State and Territorial Epidemiologists to issue guidelines for tracking certain illnesses. The guidelines are voluntary, though states generally comply. The goal: solid comparisons between states and accurate national statistics that inform public health decision-making.

In April, as coronavirus infections multiplied and laboratory testing was limited, the CSTE and the CDC advised states to count both probable cases and deaths — where symptoms and exposure pointed to infection — along with those confirmed by tests.

Yet weeks after the guidance was handed down to standardize coronavirus reporting, a Post review found states as of early June counting cases and deaths in all sorts of ways.

At least 24 states are not heeding the national guidelines on reporting probable cases and deaths, despite previously identifying probable cases in other national outbreaks, including H1N1 flu during the country’s last pandemic in 2009.

The failure of many states to document probable coronavirus cases and deaths is “historic in many ways because there are lots of probable case classifications and probables are regularly and normally reported on,” said Janet Hamilton, the CSTE executive director. “We are definitely concerned about the undercounting of covid-19 deaths and cases.”

New Jersey says it began reporting probable cases and deaths to the CDC on May 15 but does not disclose them publicly on its website. Georgia says it tracks the information internally but is not reporting those numbers on its website or to the CDC.

“We do have intentions of sharing them but not yet,” said Nancy Nydam, a spokeswoman for the Georgia Department of Public Health, who said as of late May the department had tracked 1,658 probable cases and potentially dozens of probable deaths.

Officials in Montana, Rhode Island and the District of Columbia say they haven’t reported any probable cases or deaths because they have not had any, citing low numbers or the wide availability of testing.

Seven states did not respond to The Post’s requests for a breakdown of cases and death counts. Five of those are not reporting probable cases or deaths, according to data the CDC began publishing June 2. South Dakota reports probable deaths but not cases.

Officials in the remaining 17 states say they are reporting probable and confirmed coronavirus cases and deaths on their websites and to the CDC. Some states distinguish between probable and confirmed while others group them.

In some states not reporting probable cases, officials cite the demands of an unprecedented crisis in which Americans press for daily updates from public health data systems that are chronically underfunded and outdated.

In Washington state, where many of the nation’s first deaths occurred, health department spokeswoman Lisa Stromme Warren said documenting probable cases and deaths “is one of many urgent priorities.” The state has identified about 100 people whose death certificates list covid-19 but were never tested, so they are not included in the public death count or reported to the CDC.

“We suspect that we are actually more likely to be undercounting deaths than overcounting them,” Katie Hutchinson, the health department’s health statistics manager, said during a recent briefing.

CDC spokeswoman Kristen Nordlund said that the agency is working with health departments to improve the flow of data. “In pandemic circumstances, such as with covid-19, collecting complete information on each case is challenging,” Nordlund said. “The current case and deaths counts reported to CDC are likely an undercount.”

During the H1N1 flu pandemic, states initially counted probable and confirmed cases individually. But about three months into the outbreak, the CDC said those individual counts represented “only a fraction of the true burden” of the disease. The agency stopped collecting individual case reports and instead began publishing estimates based on hospitalizations, symptoms and other data.

The CDC is planning to come up with similar estimates for the coronavirus but has no immediate plans to stop counting individual cases. “CDC is actively working on a model to address and assess the true burden of covid-19 in the U.S.,” Nordlund said.

All eyes on numbers

For government officials assessing how quickly to reopen the economy and individuals deciding what risks to take, their daily judgment calls are based, in part, on the case and death counts publicized on television and computer screens.

That has propelled the pandemic counts into the contentious political arena, where some allies of President Trump and conservative voices on social media have claimed that the covid-19 death toll is inflated. The debate over whether counts of probables are crucial or misleading extends beyond the nation’s capital.

In Illinois, two Republican lawmakers and three businesses have sued the Democratic governor over coronavirus disaster orders. A spokeswoman for the health department, Melaney Arnold, said the state is not divulging probable deaths on its website “because there is concern from the public that the number of deaths is being inflated. . . . We need the public to have confidence in the data and therefore are reporting only those deaths that are laboratory confirmed.”

The state website lists about 5,700 deaths as of June 5, excluding the approximately 185 probable deaths tracked internally as of that day and reported to the CDC.

But a resident looking at a state chart and then turning to the CDC might not find the same numbers. The newly posted CDC table does not reflect the probables that officials in some states said they have reported. Officials say that’s because the reports sent to the CDC include those with confirmed cases in one figure and because the national update can run slightly behind state websites.

Since the 1950s, CSTE has recommended which diseases states should track and what those reports to the federal government should look like. The CDC works closely with the epidemiologists’ council and adopts its guidelines to “enable public health officials to classify and count cases consistently across reporting jurisdictions,” according to the CDC website.

States usually follow these recommendations and report the incidence of dozens of different diseases to the CDC, with some exceptions. A state may not report cases of a disease that does not occur within its borders, yet may track another illness found only in its part of the country.

Hawaii, for example, does not report Lyme disease, as every other state does, but it does report hallucinogenic fish poisoning.

“It’s more of a handshake agreement between the states and CDC that we will send you the data in this way so that you can then aggregate it,” said Kathy Turner, Idaho’s deputy epidemiologist. “In general, there’s no argument. We all do it because we realize the importance of being able to look at a disease on a national level.”

Some reportable diseases rarely result in deaths, so CSTE directives have typically focused on how to count cases, not fatalities. Then came the coronavirus and a mushrooming death toll. The CDC acknowledged in early April that the death count was an “underestimation” because it included only fatalities in which the virus was laboratory confirmed. Testing shortages, people dying at home or in nursing homes, and spotty postmortem testing meant victims were overlooked.

“When the outbreak first started and we were all just counting lab-confirmed cases by default, it became clear that we were not going to be able to describe the burden of the pandemic because so many people were not being tested,” said Turner, lead author of the CSTE statement on covid-19.

“We usually don’t approach a death separately from a case, but in this situation, we decided it was needed,” she said.

The CSTE recommended reporting probable and confirmed cases and deaths on April 5. The CDC’s written response to the recommendations, which was shared with The Post, said the agency “concurs” and that adoption by states is “very important” for covid-19 record-keeping. On April 14, the CDC noted on its website that the national tally includes probables, although the agency did not at that time provide a state-by state breakdown. The CDC also modified the form states use for coronavirus reports, adding boxes that can be checked to indicate a “lab-confirmed” case or “probable” case.

Probable cases were defined as showing symptoms and having contact with an infected person, or meeting one of those criteria and testing positive for coronavirus antibodies, rather than for the virus itself. Probable deaths meant those who were never tested for the virus but whose death certificates listed covid-19 as the cause of death or a significant condition contributing to death.

The CSTE statement also says that confirmed and probable counts should be included in the tallies “released outside the public health agency,” which could mean a state website or written report, according to the organization.

“When states are using different approaches, it always begs the question: ‘Why does one state choose one over another? Why a more conservative approach over a more sensitive one?’’’ asked Lorna Thorpe, director of the division of epidemiology at NYU Grossman School of Medicine. “That’s the reason we have standards and guidance that are technically sound.”

Information varies

The erratic reporting of coronavirus cases and deaths means that what residents can learn about the extent of the pandemic in their community varies widely.

Ohio was one the first states to begin disclosing probable cases and deaths in early April. “It usually is a given when CSTE makes a recommendation like that,” said Brian Fowler, chief data officer for the Ohio Department of Health. “When they made that recommendation, we looked at it and said, okay, well this is what we need to use.”

As of June 5, Ohio’s website showed 2,117 confirmed deaths and 222 probables. By breaking out the numbers separately, Fowler said, “you can’t be accused of hiding information and you can’t be accused of inflating numbers — it’s all out there.”

The transition to counting probables was not “a huge lift,” Fowler said. Epidemiologists at the health department were already reviewing all suspected coronavirus cases.

Some health officials were candid about how adding probable deaths would boost the overall tally. “I want to make sure that everyone understands that these are not new deaths,” Indiana Health Commissioner Kristina Box said at an April 20 news conference. “Rather, we are capturing the deaths that have occurred really since this pandemic began.” Box suggested other states would do the same: “Indiana — like every other state — will include these deaths in our reporting in order to better capture the toll that covid-19 has truly taken.”

One week earlier, Michigan officials had said they intended to begin disclosing probable cases and deaths. When the state finally began doing that on June 5, more than 5,000 cases and 200 deaths were added to coronavirus totals.

California’s state health department is reviewing the process to track probable deaths and “working to provide as much data as possible about COVID 19 while ensuring that the data are valid and useful for understanding the pandemic,” according to a May 20 email to The Post.

Hilda Solis, a supervisor in Los Angeles County who represents a heavily Hispanic and impoverished district, said she was surprised that the state is not following national recommendations on counting coronavirus deaths. She has called for more post-mortem testing by the medical examiner. “A lot of people are dying at home. Poor people are dying at home. Homeless people are dying,” said Solis, a former U.S. labor secretary under President Barack Obama. “I do believe covid-19 is being underreported and that we need to take more responsibility.”

The scale of undercounting that results from reporting only confirmed cases became clear when New York City on April 14 added more than 3,700 probable deaths to its numbers, sending the city’s tally over 10,000.

The city that sits at the epicenter of the pandemic in the United States still is not counting probable cases, however. New York Gov. Andrew M. Cuomo, a Democrat praised for his command of daily news briefings during the pandemic, has indicated skepticism about recording probable cases. “Probable is different than confirmed,” he said at a news conference in late May. “Probable is ‘probable, but I have to check, I don’t know, I have to do further testing.’ We’ve had many cases that were probable coronavirus and turned out not to be coronavirus and that’s why they call them probable.” Covid-19 websites for New York and New Jersey include probable deaths at nursing homes, but those numbers are not included in the states’ overall death totals. A spokesperson for North Carolina’s health department said the state is not reporting probables because of wariness about the reliability of antibody tests, and because of concerns that the CSTE’s definition of a probable case is overly broad. Officials in Florida did not respond to repeated requests for comment about why the state isn’t following federal guidelines.

People behind ‘probables’

Behind each probable death is a person. Barnes O’Neal, 83, checked into the Brightmoor Nursing Center in Georgia in March to recover from a 10-day hospitalization. Less than a month into his stay at the facility about 40 miles south of Atlanta, a coronavirus outbreak forced a lockdown. O’Neal developed a fever and pneumonia. His daughter, Natalie Turner, pleaded with her father’s caretakers and the state health department for a coronavirus test. She said she wanted his illness on the record.

On April 20, just hours after Turner had spoken with him by phone, O’Neal died. He was never tested, but Turner said his doctor told her there was “zero doubt” it was covid-19 and wrote it on her father’s death certificate.

Still, her father, a frequent volunteer at the local soup kitchen, would not be included in the death toll on the state website because he was never tested. “It’s just important to me because my dad’s life counted,” Turner said. “I feel like there’s a face behind every statistic, and that’s forgotten many times.”

And now the pandemic’s overall death toll in U.S. has exceeded 100,000, but what are the real numbers?

Second U.S. Virus Wave Emerges as Cases Top 2 Million

Emma Court and David Baker noted that a second wave of coronavirus cases is emerging in the U.S., raising alarms as new infections push the overall count past 2 million Americans. Texas on Wednesday reported 2,504 new coronavirus cases, the highest one-day total since the pandemic emerged. A month into its reopening, Florida this week reported 8,553 new cases — the most of any seven-day period. California’s hospitalizations are at their highest since May 13 and have risen in nine of the past 10 days.

A fresh onslaught of the novel coronavirus is bringing challenges for residents and the economy in pockets across the U.S. The localized surges have raised concerns among experts even as the nation’s overall case count early this week rose just under 1%, the smallest increase since March.

“There is a new wave coming in parts of the country,” said Eric Toner, a senior scholar at the Johns Hopkins Center for Health Security. “It’s small and it’s distant so far, but it’s coming.”

Though the outbreaks come weeks into state reopenings, it’s not clear that they’re linked to increased economic activity. And health experts say it’s still too soon to tell whether the massive protests against police brutality that have erupted in the past two weeks have led to more infections.

In Georgia, where hair salons, tattoo parlors and gyms have been operating for a month and a half, case numbers have plateaued, flummoxing experts.

Puzzling differences show up even within states. In California, which imposed a stay-at-home order in late March, San Francisco saw zero cases for three consecutive days this week, while Los Angeles County reported well over half of the state’s new cases. The White House Coronavirus Task Force has yet to see any relationship between reopening and increased cases of Covid-19, Food and Drug Administration Commissioner Stephen Hahn said on a podcast.

But in some states, rising numbers outpace increases in testing, raising concerns about whether the virus can be controlled. It will take a couple of weeks to know, Toner said, but by then “it’s going to be pretty late” to respond.

Since the pandemic initially swept the U.S. starting early this year, 2 million people have been infected and more than 112,000 have died.

After a national shutdown that arrested the spread, rising illness had been expected as restrictions loosened. The trend has been observed across 22 states in recent weeks, though many increases are steady but slow.

In New York, the state hardest hit by Covid-19, Governor Andrew Cuomo only recently started reopening by region. New York City, the epicenter, began the first of four phases Monday.

“We know as a fact that reopening other states, we’re seeing significant problems,” Cuomo said Tuesday. “Just because you reopen does not mean you will have a spike, but if you are not smart, you can have a spike.”

Experts see evidence of a second wave building in Arizona, Texas, Florida and California. Arizona “sticks out like a sore thumb in terms of a major problem,” said Jeffrey Morris, director of the division of biostatistics at University of Pennsylvania’s Perelman School of Medicine.

Arizona Spike

Arizona’s daily tally of new cases has abruptly spiked in the last two weeks, hitting an all-time high of 1,187 on June 2.

This week, its Department of Health Services urged hospitals to activate emergency plans. Director Cara Christ, told a Phoenix television station that she was concerned about the rising case count and percentage of people tested who are found to be positive.

Valleywise Health, the public hospital system in Phoenix, has seen an increase in Covid-19 cases during the past two weeks. It’s expanded its intensive-care capacity and those beds are 87% full, about half with Covid patients, according to Michael White, the chief medical officer.

White said Valleywise has adequate protective gear for staff, but hospitals aren’t getting their entire orders. A surge in Covid cases could put that supply under stress, he said.

The increase in transmission follows steps to resume business and public life as well as the riots and protests.

“Within Phoenix, we’ve been more relaxed than I’ve seen in some of the other parts of the country,” White said, with some people disregarding advice to wear masks and maintain six feet of distance from others. “People are coming together in environments where social distancing is challenging.”

Texas on Wednesday reported a 4.7% jump in hospitalizations to 2,153, the fourth consecutive daily increase. The latest figures showing an escalation came as Governor Greg Abbott tweeted a public service announcement featuring baseball legend Nolan Ryan urging Texans to wash their hands and to not be “a knucklehead.”

Abbott was criticized for an aggressive reopening last month. Mobile-phone data show activity by residents is rebounding toward pre-Covid levels, according to the Children’s Hospital of Philadelphia’s PolicyLab.

That could reflect a perception that the virus wasn’t “ever a big threat,” said Morris, who recently moved to Philadelphia after 20 years in Houston.

Florida’s health department said in a statement that it attributes the increase in cases to “greatly expanded efforts in testing,” and noted that overall positivity rates remain low, at about 5.5%.

Bucking the trend is Georgia, which was the first U.S. state to reopen. Covid cases there have plateaued. Despite local outbreaks in the state, “their sea levels did not rise,” said David Rubin, director of the PolicyLab, which has been modeling the virus’ spread. “They’ve kind of held this fragile equilibrium.”

Creeping In

California was the earliest state to shut down its economy over the coronavirus, after one of the nation’s first outbreaks in the San Francisco Bay Area. It has been slower than most to reopen.

Even so, the state has also seen the number of people hospitalized with Covid-19 rebound in the past two weeks, as commerce accelerates. Case counts are climbing too, although officials attribute that to increased testing and say it’s a sign of preparation.

In part, rising numbers represent the virus spreading into places that largely avoided the first round of infections, including rural Imperial County in California’s southeastern desert. Yet the contagion remains present in places that bore the brunt of the first wave, including Los Angeles County. Hospitalizations there are lower than at the start of May, but deaths remain stubbornly high, with 500 in the past week alone.

Barbara Ferrer, Los Angeles County public health director, said the region has likely not seen the end of the first wave. And despite concerns about infections coming out of mass demonstrations in the sprawling city, she thinks the reopening of the economy will have a bigger impact.

“We’re not at the tail end of anything,” Ferrer said. “We never had a huge peak. We’ve kind of been within this band. We’re not in decline, we’re kind of holding our own in ways that protect the health-care system.” But, she added, “go to Venice and see the crowds, and you’ll understand why I have concerns.”

Another Onslaught

The U.S. has long been bracing for another wave, but future outbreaks are likely to take a different shape. Social distancing and mask-wearing, as well as careful behavior by individuals, are likely to have staying power even as economies reopen.

Experts are steeling for autumn, when changes in weather and back-to-school plans could have damaging repercussions.

“The second wave isn’t going to mirror the first wave exactly,” said Lance Waller, a professor at Emory University’s Rollins School of Public Health in Atlanta. “It’s not snapping back to exactly the same thing as before, because we’re not exactly the way we were before.”

Daniel Lucey, a fellow at the Infectious Diseases Society of America, compared the virus’ new paradigm with a day at the beach: The U.S. has been bracing for another “high tide” like the one that engulfed New York City. Today is a low tide, but “the waves are always coming in.”