Tag Archives: COVID-19

The Pandemic is Over

This is my prediction that by the end of February or maybe March, as more and more of the population gets infected. However, due to the confusion promoted by the news reporters, as well as social media and changes seen in most pandemics the population has become confused.
All of a sudden there is the push to use N95 and KN95 masks as the effective face protection.
But listen here, the use of N95 and KN95 masks were always the most effective, but the scientists were “silenced” and as long as you were wearing some sort of face masks or facial coverings “everyone” was satisfied. But listen carefully, the cloth and paper masks never were and protection from any virus. Remember that viruses are measured in microns, not inches or millimeters, etc.
Also, as Omicron takes over, we are seeing the effects and power of the portion of the vaccinated. Yes, they will get sick, but many will be asymptomatic and therefore will never be counted as infected. Which is my biggest problem with the Administration sending out millions of home self-tests. So, they are going to send out 500 million to a population of about 400 million people, which means that you can use the test once. Many times, the tests will be read as negative due to the timing of the infection and then what.
Also, with self-testing, if your tests are positive, who will report their positive tests? Therefore, will our future data on which we make decisions be accurate? Actually, No and we are already seeing this happen with all the home self-tests already being sold. And then the “sick” patients should self-quarantine, that if they are honest and care about those around them and those who matter to them, or just care about society.
This new variant/mutation is more contagious, and our population is exhausted. If you don’t believe me just review the New Year’s Eve celebration from Nashville or New York city. The crowds were huge and there were very few masks being worn!
Omicron not peaking nationally yet, surgeon general says. COVID-19 is sending mixed messages. The U.S. is recording over 800,000 cases a day for the first time since the beginning of the pandemic, and hospitalizations are also setting records.
But New York State recorded only about 48,000 cases on Friday, almost a 47% drop from the previous week’s case count, Gov. Kathy Hochul said Saturday.
“We are turning the corner on the winter surge, but we’re not through this yet,” the governor said in a statement.
Minnesota also saw declining intensive-care hospitalizations for COVID-19, and cases have been falling in Washington D.C. and other cities in the eastern half of the country.
But New York’s declining trend is not indicative of the national COVID-19 portrait, Surgeon General Vivek Murthy warned on Sunday.
“The entire country is not moving at the same pace,” he told CNN host Jake Tapper.
Oklahoma and Georgia both saw over a 100% rise in weekly COVID-19 cases, a USA TODAY analysis of Johns Hopkins University data shows, while Colorado saw a 90% increase.
“We shouldn’t expect a national peak in the next coming days,” he said. “The next feel weeks will be tough.”
Also in the news:
The United States has reported its 850,000+ deaths, Johns Hopkins University data shows. The U.S. averaged 1,776 reported deaths per day over the last week.
The Biden administration on Wednesday will launch a website where Americans can order up to four free COVID-19 testing kits per person.
U.S. Rep. David Trone of Maryland announced that he has tested positive for COVID-19. Trone said he has received a booster and is experiencing “only minor symptoms,” according to The Washington Post.
Navajo Nation President Jonathan Nez has signed an executive order requiring all government workers on the tribe’s vast reservation to receive a booster shot.
Today’s numbers: The U.S. has recorded more than 65 million confirmed COVID-19 cases and more than 850,000 deaths, according to Johns Hopkins University data. Global totals: More than 326 million cases and over 5.5 million deaths. More than 208 million Americans – 62.9% – are fully vaccinated, according to the Centers for Disease Control and Prevention.
What we’re reading: Omicron is closing daycare centers in droves. Parents are “just trying to stay afloat.” USA TODAY’s Alia Wong explains.
US now averaging 800,000 new cases each day and stated that the total deaths are now over 900,000.
The United States is reporting more than 800,000 cases a day for the first time, even amid signs that America’s omicron wave is slowing down. The country reported 5.65 million cases in the week ending Saturday, a USA TODAY analysis of Johns Hopkins University data shows. The rapid acceleration of case reports continues despite a shortage of tests. Still, in just the last week the country has reported more cases than it did in March, April, May and June 2021 – combined.
About 158,500 Americans were reported hospitalized on Saturday. Hospitals in 46 states report rising numbers of patients; 34 states report rising death rates.
Mike Stucka noted that we continue to push mask mandates, social distancing, vaccinations, and possible additional lockdowns.
With the majority of really sick hospitalized patients, actually about 72%, were non-vaccinated.
I just had a young lady with four children who notified me earlier in the week that because she had a few home self-tests she tested her sons with two of the boys just having sniffles or a minor sore throat. And three tested positive. And I believe that this is going to be the majority of COVID positive patients, that is minimal or no symptoms and therefore, not self-quarantining and therefore becoming super-spreaders.
COVID Vaccines Are a Scientific Feat, but ‘Prevention’ Is a Misnomer
— In public messaging, semantics matter
Rossi A. Hassad, PhD reported that especially since the advent of the COVID-19 Omicron variant, and the increasing incidence of infection and reinfection among those fully vaccinated and boosted, I have heard from a number of people whose concerns reflect the following sentiment, “You recommended the vaccine to prevent COVID-19, I took it, and this is what I got (infected).”
Undoubtedly, these COVID-19 vaccines are a gift of life and continue to be safe and effective. Nonetheless, this sentiment is understandable, and in my assessment, it signals an urgent need for more precise labeling and messaging about the COVID-19 vaccines from the FDA.
On Dec. 10, 2020, at the invitation of the FDA, I gave a brief oral presentation at the open public session of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine. I ended my remarks as follows:
“In conclusion, the potential benefits of this vaccine outweigh the identified risks. Therefore, I support the issuance of an EUA with the stipulation that the vaccine can protect against symptomatic disease. But at this time, it is not known if it prevents infection and transmission.”
The COVID-19 vaccine clinical trials and the resulting evidence show that the vaccines significantly reduce the risk of severe illness, hospitalization, and death. Nonetheless, in the labeling of the vaccines, and messaging to healthcare providers and the general public, the FDA specified that the Pfizer-BioNTech, Moderna, and Janssen vaccines are indicated for the “prevention of COVID-19” — this may have fostered an unrealistic expectation of absolute protection or immunity against COVID-19. By scientific convention, a vaccine is generally characterized as a primary prevention measure for a specific disease: that is, “you can be exposed to it without becoming infected.”
Over the summer, on Aug. 2, 2021, I emailed FDA’s Acting Commissioner Janet Woodcock, MD, regarding the word prevention, which the FDA has used to characterize the scope of protection provided by the three COVID-19 vaccines in use in the U.S. I noted that the word prevention in this context seems to be a misnomer and can contribute to public confusion and vaccine hesitancy. In particular, in light of the increasing number of breakthrough cases, the public may be inclined to believe that the COVID-19 vaccines are losing effectiveness. I also urged the FDA to provide clarification to the public in this regard. Woodcock responded the same day as follows:
“Thank you for writing. We will take your suggestions into account. I agree that the expected results of vaccination are confusing for most people. It is very likely that vaccination prevents acquisition of infection in some people but not all vaccinated people and that some get symptomatic infection and rarely, severe disease, and this may be related in part to their overall immune system response, the variant they were exposed to, and the actual amount of exposure and the time since their last vaccination, among other things.”
Notably, in September 2021, the CDC tempered its definition of vaccination to reflect that vaccines produce “protection from a specific disease,” rather than “immunity to a specific disease.” (In either case, immunity was defined on the same CDC page as “protection from an infectious disease.”)
Woodcock’s response continues to reflect the performance of the COVID-19 vaccines. Prevention of COVID-19 is not the intended primary benefit of these vaccines. In fact, Woodcock and Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, recently made the point that most people will get COVID eventually. These vaccines continue to significantly reduce the risk of severe illness, hospitalization, and death — and that’s an amazing scientific feat amidst a deadly pandemic. Attention to timely and effective messaging to healthcare providers and the general public should be a top priority for the FDA. Semantics matter.
(When) to Boost or Not to Boost, That Is the Question
— Countless complex questions remain
John P. Moore, PhD noted that for several months, America has been in the vaccine-booster phase of the COVID-19 pandemic. Various aspects of booster policy have been controversial and/or confusing, and the public response to the need for boosters has been mixed. But what is the best way to continue to provide the sensible majority who trust in the lifesaving COVID-19 vaccines with the best protection in the coming months to years? At times, it seems as if some folks believe “a dose a day keeps the doctor away.” And a meme is now circulating of a “Pfizer Loyalty Card,” offering a free pizza after dose nine. While droll, might that actually happen? (Dose nine, that is).
While the strong protective efficacy of the mRNA vaccines was certainly not predicted early on in the global vaccine program, a basic understanding of vaccine immunology allowed us to predict that protective antibody titers would inevitably wane over a 6-month period and could be restored with a booster dose.
The Early Booster Debates
In summer 2021, data from Israel triggered discussions among policymakers, scientists, and company executives about the need for boosters in the U.S. The vaccine booster concept wasn’t — or shouldn’t have been — inherently controversial, particularly for individuals at high risk for COVID-19 complications. However, there were doubts about the arguably premature timing of, and rationale for, a broadly based boosting program. Arguments were also raised about using those doses in under-vaccinated countries instead, both on moral grounds and to prevent the emergence of even more troubling variants (e.g., Omicron…). Other debates centered on whether the goal was to protect against mild infections (which vaccines typically don’t do) or severe disease and death. These discussions generally faded away once it became clear that protection against severe infections was diminishing significantly for older individuals, and that fully vaccinated people could still transmit their infections to others. In addition, anxious members of the vaccine-embracing public, including members of the media, put pressure on the Biden administration. A vaccine boost became something that Jane Public and Ronnie Reporter wanted, and, frankly, expected.
Americans can now be boosted 5 months after their initial two mRNA vaccine doses of Moderna or Pfizer. The far fewer recipients of the Johnson & Johnson (J&J) vaccine are also being boosted, most opting for an mRNA dose as that provides a stronger antibody response.
But what’s next? Already, Israel is rolling out a fourth Pfizer dose and is therefore well on the way to handing over a slice of pizza. Should we do the same here, and if so, when? In the hope that any policy decisions will be science-based, I will review some of the knowns and unknowns. Whatever knowledge I possess has been significantly boosted by helpful discussions with world-class immunologist colleagues.
Determining the Right Booster Schedule
Most agree that dose three (i.e., the first boost) should not be given too early. The period between the second and third dose is critical to the maturation of the immune response and establishment of immunological memory. As the quantity of antibodies in the blood declines, their quality increases, including their ability to counter variants. While there is no “magic moment” for dose three, the original CDC recommendation for a 6-month gap for both mRNA vaccines and the recent revisions to 5 months are both about right.
But what about dose four and onwards? Is there a point when it is certainly needed? Here, we don’t have hard data, although there are early indications from Israel that the antibody responses to Pfizer dose three are now dropping. That should not be a surprise, based in part on decades of experience with attempts at an HIV-1 vaccine. As but one illustrative example, an HIV-1 “spike protein” vaccine was given seven times to humans over a 30-month period. After the first two immunizations, every subsequent one triggered a rapid rise in antibody levels, followed by a gradual decline at a similar rate each time. The titer pattern over time looked like saw teeth. In the period between boosts, the antibody levels didn’t disappear, but the boosted peak levels weren’t much higher each time — there were ever diminishing returns to the potency of each booster dose.
Perhaps we will see something different with the SARS-CoV-2 spike protein, and maybe the mRNA delivery method will be the charm — but I wouldn’t bet the farm on a dramatically different outcome to our experiences with the HIV-1 spike protein. In other words, boosting is likely to increase protective antibody levels in the short term but probably won’t be truly sustained (T-cell responses, which help to prevent severe disease, also wane but more slowly). If the pandemic persists, fairly regular boosting may therefore be needed, akin to the annual flu vaccines.
However, this scenario also invites more questions about the intervals between doses: the HIV-1 vaccine study discussed above used a 6-month interval between the later doses, probably because prior experience showed that was when the boosted titers dropped back to near baseline. The Israelis, however, are now giving the fourth Pfizer vaccine dose about 4 months after the third. Is that too soon for comfort? Well, for sure, it should be no sooner than that…and most immunologists I talked to favor a longer interval. Given the cost and logistics, some important decisions will need to be made soon.
Our political and public health leaders have much to consider and will need to decide whether there is a need to sustain a high level of protection against SARS-CoV-2 infection and mild COVID-19.
Will We Keep Boosting…Forever?
What about the future? There is nothing inherently problematic with giving regular, sensibly spaced vaccine doses from an immunology perspective. Different COVID-19 vaccines can clearly be mixed when given sequentially. A recent HIV-1 vaccine study in monkeys involved nine doses of mRNAs, proteins, and protein-nanoparticles over a ~14-month period in a heroic attempt to broaden the neutralizing antibody response (the major obstacle to a successful HIV-1 vaccine). Next-generation, more potent COVID-19 vaccines may eventually play an important role. We’ll also need to explore alternative ways to deliver vaccines, whether based on immunology or emerging technology. What happens should be dictated by the trajectory of the pandemic, including the evolution of yet more variants. So far, despite vaccine manufacturers going ahead with their own plans, the case for variant-specific vaccines has been weak. Although, it’s possible the need for them may change in the coming months as Omicron continues to spread; and now what about the new variant, Deltacron?
Boosting J&J Vaccine Recipients
Additional complications are at play too: What’s the right approach to boosting J&J vaccine recipients? They can receive a second dose 2 months after the first, but in most cases that dosing interval is many months longer (and, as noted, most opted for an mRNA boost at that point). When should they receive a third dose? For the mRNA vaccines, the critical period for immunological quality improvements is the ~6-month interval between doses two and three (see above), but when does that happen for the J&J vaccine? In the long and rather random interval between doses one and two? After dose two? Or both? Could a third dose in the near future be too soon for comfort? Having more data would help.
Factoring in Natural Immunity
We also need to consider how to — or whether to — factor in immune responses induced by vaccine breakthrough infections, which are becoming increasingly common. Although breakthrough Omicron infections are generally not severe, the viral antigens will surely trigger a boosting effect in vaccine-primed immune systems — some members of the public are now embracing this idea. And we know that vaccinating previously infected people generates particularly strong immune responses (“hybrid immunity”). We can expect a lot of data on this topic in the next month or so, but for now we have to speculate.
But what happens when vaccination precedes infection? Should a two-dose vaccine recipient who is then Omicron-infected receive a further vaccine dose and, if so, when? Similarly, what happens if a triply vaccinated person becomes infected? Given how mutated the Omicron spike-protein is, an infection with this variant is likely to trigger the production of antibodies that have a lesser impact on new variants that more closely resemble the ones that circulated in 2020-2021. They would, however, be better poised to counter any variants that emerge from the Omicron lineage, as would Omicron-based vaccine boosters. In short, we need to determine how to factor in the combination of vaccination and infection history, and also how the pandemic may further evolve, to devise an optimal boosting approach. There are important scenarios that policymakers and serious immunologists must ponder soon. Otherwise, far-reaching decisions will be taken on the fly, which is never ideal.
The U.S. is blessed with an abundance of COVID-19 vaccines and world-class scientists. Our complex scenarios merit the most qualified experts to figure out the best paths forward. I, for one, look forward to reading what might emerge. I need that guidance to answer with greater confidence the questions I am frequently asked by friends, colleagues, and random members of the public. “Winging it” is becoming as tiresome as it is tiring.
Now that we have two antiviral medications that can be taken after a patient gets infected, I predict that all will change and that by the middle of February the pandemic will be declared over and be classified as an endemic. That will mean that we will be” instructed” to simply get our “up-dated shots” yearly with our updated flu vaccinations.
Infact, Moderna is already working on a combined vaccine to include updated influenza and COVID vaccines, which would be “offered” yearly.
So, can we get back to normal? Maybe! We still have to continue to assess the use of vaccines to those under the age of 5 years old. Once we have critically evaluated and cleared vaccines and antiviral medications for these young potential patients, we will have a safer healthcare system to “return to normal”.
As nations decide to live with the virus, some disease experts warn of surrendering too soon. The coronavirus isn’t going away, but that doesn’t mean resistance is futile, scientists say.
Joel Achenbach wrote that Nations around the planet are making a subtle but consequential pivot in their war against the coronavirus: Crushing the virus is no longer the strategy. Many countries are just hoping for a draw.
It’s a strategic retreat, signaled in overt and subtle ways from Washington to Madrid to Pretoria, South Africa, to Canberra, Australia. Notably, few countries today outside of China — which is still locking down cities — cling to a “zero-covid” strategy.
The phrase often heard now in the United States and many other nations is “live with the virus.” That new stance is applauded by some officials and scientists and welcomed by people exhausted with the hardships and disruptions of this global health emergency entering its third year.
But there are also disease experts who fear the pendulum will swing too far the other way. They worry that many world leaders are gambling on a relatively benign outcome from this omicron variant surge and sending messages that will lead people who are normally prudent to abandon the social distancing and mask-wearing known to limit the pathogen’s spread. Epidemiologists say the live-with-it strategy underestimates the dangers posed by omicron.
“This notion of learning to live with it, to me, has always meant a surrendering, a giving up,” World Health Organization epidemiologist Maria Van Kerkhove said.
Virologist Angela Rasmussen of the University of Saskatchewan likewise fears that people are relaxing sensible precautions prematurely: “I understand the temptation to say, ‘I give up, it’s too much.’ Two years is a lot. Everybody’s sick of it. I hate this. But it doesn’t mean actually the game is lost.”
The WHO officially declared a public health emergency of international concern on Jan. 30, 2020, when there were 7,711 confirmed cases of covid-19 and 170 deaths in China, and another 83 cases scattered across 18 other countries — and no deaths.
Two years later, the virus has killed more than 5.5 million people, and the pandemic is ongoing. But the global health emergency has evolved — reshaped by the tools deployed to combat it, including vaccines. The virus itself and the disease it causes are now so familiar, they have lost some of their early spookiness.
No national leader would ever say that it’s time to quit the struggle, but the tone of the contest has changed, with little talk of beating, crushing, defeating the virus. SARS-CoV-2 is part of the world now, a “pantropic” virus that can infect people, deer, minks, rats and all sorts of mammals.
Many nations continue to impose mask requirements, vaccination mandates and travel restrictions. But few leaders in democratic societies have the political capital to take harsh measures to suppress transmission. Even the arrival of the ultra-transmissible omicron variant did not throw the world back into winter 2021, when the paramount goal remained stopping viral spread at all costs — much less back to spring 2020, when people were told to stay home, wipe down their groceries and not touch their face.
Even officials in Australia, long a fortress nation that sought to suppress the virus at all costs, have chosen to ease some mandates in recent weeks.
Tennis superstar Novak Djokovic — shown at a training session Jan. 11 in Melbourne, Australia — has been in a pitched battle with health authorities because he lacks required coronavirus vaccination credentials. (AP)
The country has gained global headlines for its treatment of unvaccinated tennis champion Novak Djokovic, who flew in for the Australian Open and immediately ran afoul of the government’s virus protocols, spending the better part of a week in a detention hotel. On Friday, Australia’s immigration minister canceled the player’s visa a second time.
But the other national story in Australia is a debate over the relaxed restrictions. National and state leaders had an agreement that strict measures would end when vaccination reached 80 percent of the eligible population. That threshold was reached months ago, and now more than 90 percent of the eligible population is vaccinated. Masks are still required in some indoor settings, and there are capacity limits, but opposition leaders and some experts have decried what they call the “let it rip” strategy.
“The decision to remove restrictions just as Omicron surged has cost us dearly,” declared a report from an independent group of experts called OzSAGE. “The ‘let it rip’ strategy and defeatist narrative that ‘we are all going to get it’ ignores the stark lived reality of the vulnerable of our society.”
In South Africa, where officials first sounded the alarm about omicron, the government in December eased protocols, betting that previous encounters with the virus have given the population enough immunity to prevent significant levels of severe illness. The omicron wave there subsided quickly with modest hospitalizations, and scientists think one reason is that so many people — close to 80 percent — had previously been infected by earlier variants.
Omicron also appears to be less virulent — less likely to cause disease. This heavily mutated coronavirus variant stiff-arms the front-line defense of antibodies generated by vaccines and previous infection but does not seem to be adept at invading the lungs or escaping the deeper defenses of the immune system.
In the ideal scenario, omicron’s alarming wave of infections will spike quickly, leaving behind a residue of immunity that will keep a broad swath of the population less vulnerable to future infections. This would be the last major, globally disruptive wave of the pandemic. The virus would still be around but would no longer be in a special category apart from other routinely circulating and typically nonfatal viruses such as influenza.
There are other scenarios less attractive. Scientists are quick to point out that they don’t know how long omicron-induced immunity lasts. The virus keeps mutating. Slippery variants packing a more powerful punch could yet emerge, and virologists say that contrary to what has sometimes been conjectured, viruses do not inexorably evolve toward milder strains.
But humans change, too. Outside of locked-down China, most people are no longer immunologically naive to the coronavirus. Scientists believe that’s a factor in omicron’s relatively low severity for individual patients. In the long term, humans and viruses tend to reach something like a stalemate. Only one disease-causing virus, smallpox, has ever been eradicated.
In the short term, experts believe omicron is essentially unstoppable but of limited threat to individuals even as it causes societal chaos. Ali Mokdad, an epidemiologist at the University of Washington’s Institute for Health Metrics and Evaluation, said he believes that about half of the U.S. population will be infected with omicron during the next three months, with most cases asymptomatic.
“There’s no way to stop its spread — unless we do measures like China is doing, and you and I know very well that’s not possible in the United States,” Mokdad said.
‘New normal’
There is no unified global response to the pandemic. Despite calls to “follow the science,” scientific research cannot dictate the best policy for some of the stickiest issues — such as when to open schools to in-person learning, or who should be prioritized for vaccines, or whether people who have no symptoms should be regularly tested.
The national strategies typically reflect elements of a country’s culture, wealth, government structure, demographics and underlying health conditions. Also, geography: New Zealand has managed to record only a few dozen deaths from covid-19, one of the lowest per capita death tolls on the planet, by leveraging its isolation in the South Pacific.
Japan, Singapore and South Korea, nations with a long history of mask-wearing and aggressive measures to suppress epidemics, have managed to keep the virus largely in check without draconian lockdowns or major sacrifices to their economies.
Peru, hammered by the variants dubbed lambda and gamma before the delta and omicron waves arrived, has had the deadliest pandemic per capita, according to the Johns Hopkins University coronavirus tracking site. The nations of Eastern Europe, with older populations and high vaccine skepticism, are not far behind.
Countries have different and sometimes unreliable ways of documenting the pandemic, but some general trends are clear. Among the wealthiest nations, the United States — where the pandemic is thoroughly polarized, misinformation is rampant, and a significant fraction of the public has resisted vaccination — has had an unusually deadly pandemic. According to the Hopkins tracker, the United States ranks 21st in reported deaths per capita. Britain is not much better at 28th, while Canada is 82nd.
A group of doctors who advised President Biden during the presidential transition have urged a reset of the strategy to recognize the “new normal” of the virus, which has little chance of being eradicated and will probably continue to cause typically mild illness and require vaccination boosters at a frequency yet to be determined.
Biden took office nearly a year ago vowing to crush the pandemic, having won the presidency in part by emphasizing a more aggressive posture against the contagion than President Donald Trump. Biden’s administration pushed vaccination hard and saw millions of people a day roll up their sleeves during the spring. On July 4, after caseloads had dropped, he assembled a crowd on the South Lawn for a celebration of independence from the virus.
But the surge of infections and deaths from the delta variant proved that celebration to be premature, and the Centers for Disease Control and Prevention revised its guidelines, saying even those people fully vaccinated should resume wearing masks indoors. The delta wave began to subside in the fall, but then omicron, crammed with mutations that make it wildly more transmissible and evasive of immunity, erupted in late November.
Biden’s omicron strategy is not significantly different from what he employed against previous variants. On Dec. 2, he detailed his plans by first announcing what he would not do: “lockdowns.” He vowed to distribute 500 million rapid tests and doubled the number in recent days. His covid task force continues to emphasize the importance of vaccines, therapeutics and testing rather than restrictions on mobility and gatherings.
Fatalism and fatigue
The strategic shift toward the live-with-it strategy in many nations, including the United States, has often gone without formal acknowledgment from national leaders. Spain is one of the exceptions: Prime Minister Pedro Sánchez has said he wants the European Union to stop tracking covid as a separate disease and recognize that it is becoming an endemic pathogen.
Across the Pyrenees, French nightclubs closed as omicron swept through. Indoor masking is required, regardless of vaccination status. In bars, patrons are not allowed to consume alcohol while standing up. France, like Italy and many other European countries, has leaned heavily on vaccine passports.
French President Emmanuel Macron is blunt about his desire to make life uncomfortable for the unvaccinated by limiting their ability to go into public places. In a newspaper interview, he used graphic language that has been translated into English as “I really want to piss them off.”
Many global leaders, including those in the United States and Europe, have focused on vaccination as the key to mitigating the pandemic. The vaccines do lower the risk of severe illness. What they do not do as well is stop transmission and mild infection. The speed of omicron’s spread is the key factor in the equation that determines how much pressure it will put on hospitals — which are currently seeing record numbers of covid patients in the United States.
“If we just completely let everything go and allow the omicron epidemic to run its natural course, we’ll completely overrun our health system and be left in a situation potentially worse than what we experienced in early 2020,” said James Lawler, co-director of the University of Nebraska Medical Center’s Global Center for Health Security.
He is not seeing the precautions he saw early in the pandemic, when he was among the first disease experts to sound an alarm about the extreme transmissibility of the coronavirus. Earlier this week, he went to a grocery store and was virtually alone in wearing a mask. That’s the norm, he said, in Omaha.
“There’s not a mandate,” he said. “Across the entire experience of humanity, we should have learned by now the only way to get high levels of compliance like this is to make it mandatory. That’s what happened with seat belts.”
After Lawler made those comments, a county health commissioner imposed a mask mandate covering Omaha, but the Nebraska Attorney General filed a lawsuit to block it.
There is fatalism mixing with pandemic fatigue and, in some countries, science denial or ideological rejection of the restrictions and mandates that many public health experts consider to be common sense measures in a pandemic. And anecdotally, people may rationally feel the battle is lost, the virus has won.
Public health officials warn that this is a dangerous attitude. It’s true that for an individual, risk might be low. But when a virus spreads as quickly as omicron does, the equation suddenly spits out alarming results — millions of people sick at once, many of them with underlying conditions that have already put them on the edge of a cliff and vulnerable to a shove.
Rasmussen, the University of Saskatchewan virologist, is among the experts who think people have misunderstood the concept of endemicity — which is the point at which a virus continues to circulate at low levels but is not generating epidemic-level outbreaks. She fears some people hear the “endemic virus” talk as a sign that resistance is futile.
“People think that means we just give up,” she said. “They think ‘endemic’ means that we’re all going to get covid eventually. I’m hearing people say, ‘Why not just get it over with now, and I’ll be bulletproof?’ None of this is what endemicity means.”
Endemic COVID doesn’t mean it’s harmless or we give up, just that it’s part of life
Catherine Bennett discusses the eventual change in her article. We have experienced many bumps in the road since 2020 and one would have to be extremely brave to predict what the pandemic may throw at us next.
But in terms of the endgame, many experts believe COVID will eventually become an endemic disease. However, what this actually means is a source of considerable confusion. One of the main reasons for this is a misunderstanding of endemicity itself, and what COVID being an endemic disease would actually look like in the real world.
Let’s break it down. What does ‘epidemic’ actually mean? A disease is either epidemic or endemic. The most straightforward explanation of an epidemic disease is that it’s one in which the number of cases in the community is unusually large or unexpected. When this occurs, it signals a need for public health action to bring disease transmission under control.
In the case of a pandemic—a worldwide epidemic—this occurs on a much larger scale. Depending on the infectiousness and severity of the disease, it can represent a global public health emergency, as we’ve seen with COVID.
When you have the emergence of a completely new virus like SARS-CoV-2 that has the potential to cause severe illness while also being highly transmissible, the lack of any immunity among the population results in the drivers for disease spread being incredibly strong.
A disease being epidemic indicates there’s an imbalance between these drivers of disease spread and the factors limiting spread in the community. In short, it means the drivers for disease spread overpower the factors limiting spread. As such, the disease spreads like a raging bushfire. It’s explosive and hard to bring under control once it has seeded.
From epidemic to endemic
However, over time, the underlying forces driving an epidemic alter. As immunity begins to increase across the population—ideally in a controlled way by vaccination, but also by natural infection—the pathogen starts to run out of fuel and its ability to transmit falls. Pathogens can include a variety of microorganisms, such as viruses, bacteria and parasites. In this case, let’s assume we’re talking about a virus.
On top of immunity, we can also reduce a virus’ ability to spread by behavior changes, such as 1 / 3 limiting contact with others, mask wearing and improved hand hygiene. In addition to lowering the virus’ ability to transmit, immunity also reduces its ability to cause disease, meaning fewer people become really sick or die.
And finally, if we are lucky, over longer periods of time, the virus may also evolve to become intrinsically less severe. When will the COVID-19 pandemic end?
The net result of this is we move from an imbalance in terms of the forces driving disease to a steadier state of equilibrium. Instead of explosive and unpredictable disease spread, we reach a point where the presence of circulating disease represents a lower threat to the community than it did at the beginning of an epidemic.
Transmission becomes more predictable, but not necessarily constant—we may still see some waves, especially seasonally. But these are expected and manageable. In short, we start to live alongside the virus.
This is what we mean by an endemic disease. Examples of endemic diseases include the common cold, influenza and HIV/AIDS. Endemic doesn’t mean we drop our guard. The discussion around COVID becoming endemic becomes even more complicated by very different views about what this actually translates to in practice.
It’s important to emphasize it doesn’t mean we drop our guard, surrender to the virus or downgrade the threat the virus poses to individuals and the community. We remain vigilant and respond to surges in cases when they occur, doing what’s needed to keep transmission as low as possible.
Importantly, a disease being considered endemic doesn’t mean we consider it mild. It just means it remains a part of our lives, and therefore we still protect the vulnerable from severe illness, as we do with other diseases. It’s crucial we understand living with the virus isn’t the same thing as ignoring the virus. Instead, it represents an adjustment in the way in which we respond to the disease.
It’ll be a bumpy ride. It’s also important to highlight this transition may not necessarily be smooth and there will no doubt be challenges along the way. One of the main obstacles we’re going to face is the possible emergence of new variants and how these will impact the infectiousness and severity of the disease.
In order to reduce the likelihood of new variants emerging, it’s vital we really step up our rollout of vaccines globally to reduce virus transmission. To aid us in our transition to this next stage of the pandemic, we will, thankfully, be able to draw on many new weapons which are in the pipeline. This includes next-generation vaccines which will be more effective against the latest variants, or universal vaccines that cover all variants. We expect new vaccines will also be better at controlling transmission.
We’ll also have ever-improving treatments, and better infection prevention and control engineered for specific environments. The big question, of course is when will this transition to endemicity happen? Many experts, 2 / 3 believe huge strides will be made along this path in 2022.
It has been reported by the WHO that Omicron sub-variant has been found in 57 countries. A sub-variant of the highly contagious Omicron coronavirus strain, which some studies indicate could be even more infectious than the original version, has been detected in 57 countries, the WHO said Tuesday.
The fast-spreading and heavily mutated Omicron variant has rapidly become the dominant variant worldwide since it was first detected in southern Africa 10 weeks ago. In its weekly epidemiological update, the World Health Organization said that the variant, which accounts for over 93 percent of all coronavirus specimens collected in the past month, counts several sub-lineages: BA.1, BA.1.1, BA.2 and BA.3.
The BA.1 and BA.1.1—the first versions identified—still account for over 96 percent of all the Omicron sequences uploaded to the GISAID global science initiative, it said. But there has been a clear rise in cases involving BA.2, which counts several different mutations from the original including on the spike protein that dots the virus’s surface and is key to entering human cells.
“BA.2- designated sequences have been submitted to GISAID from 57 countries to date,” The WHO said, adding that in some countries, the sub-variant now accounted for over half of all Omicron sequences gathered. The UN health agency said little was known yet about the differences between the sub-variants, and called for studies into its characteristics, including its transmissibility, how good it is at dodging immune protections and its virulence. Several recent studies have hinted that BA.2 is more infectious than the original Omicron.
Maria Van Kerkhove, one of the WHO’s top experts on COVID, told reporters Tuesday that information about the sub-variant was very limited, but that some inital data indicated BA.2 had “a slight increase in growth rate over BA.1”
Omicron in general is known to cause less severe disease than previous coronavirus variants that have wreaked havoc, like Delta, and Van Kerkhove said there so far was “no indication that there is a change in severity” in the BA.2 sub-variant. She stressed though that regardless of the strain, COVID remained a dangerous disease and people should strive to avoid catching it. “We need people to be aware that this virus is continuing to circulate and its continuing to evolve,” she said. “It’s really important that we take measures to reduce our exposure to this virus, whichever variant is circulating.”
Merck to Deliver 3.1 million Treatment Courses of COVID Antiviral
Ralph Ellis reported that a little more than a month after receiving FDA authorization, Merck has delivered 1.4 million courses of its COVID-19 antiviral pill in the United States and expects to deliver its total commitment of 3.1 million treatment courses soon, company CEO Rob Davis said on CNBC.
Merck has also shipped 4 million courses of the pill, molnupiravir, to 25 nations across the world, he said. “We’ve shown that molnupiravir works against Omicron, which is important against that variant,” Davis said Thursday morning. “And obviously we’ll have to see how this plays out and what is the initial uptake, but right now we feel we’re off to a good start.”
In June the U.S. government agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and in November agreed to buy an additional 1.4 billion courses for $1 billion.
The FDA granted emergency use authorization in late December to two antivirals for people who contract COVID: Merck’s molnupiravir and Paxlovid, which is produced by Pfizer. The drugs are designed for people with mild or moderate COVID who are more likely to become seriously ill — mainly people 65 and older or people who have chronic illnesses such as heart disease, lung disease, diabetes, obesity, or compromised immune systems.
Both antivirals require a five-day course of treatment. Merck’s is for adults ages 18 and older, and Pfizer’s for anyone age 12 and up. In clinical trials, molnupiravir reduced the risk of hospitalization or death in Covid patients by 30% but slashed the risk of dying by 90%, Davis said.
“The fact that molnupiravir does reduce the risk of death by 90%, we could have a meaningful impact in helping patients,” he said. Davis told CNBC that Merck sold $952 million in molnupiravir pills in the fourth quarter and is on track to rack up an extra $5 billion to $6 billion in sales in 2022.
Last week, Merck said laboratory studies showed molnupiravir was active against the Omicron variant. In December, Pfizer said preliminary lab studies also suggest the pill will hold up against the Omicron variant.
WHO official sees ‘plausible endgame’ to pandemic; Medicare to provide up to 8 free tests per month: COVID updates
John Bacon,Jorge L. Ortiz and Celina Tebor wrote in USA Today that the director of the World Health Organization’s Europe office said Thursday that coronavirus deaths are starting to plateau, and the continent faces a “plausible endgame” to the pandemic.
Dr. Hans Kluge said there is a “singular opportunity” for countries across Europe to take control of COVID-19 transmission as a result of three factors: high levels of immunization because of vaccination and natural infection, the virus’s tendency to spread less in warmer weather and the lower severity of the omicron variant. Data in the U.S. is similar to the data from Europe, providing similar hope.
“This period of higher protection should be seen as a cease-fire that could bring us enduring peace,” Kluge said.
At WHO’s Geneva headquarters, director-general Tedros Adhanom Ghebreyesus warned that the world as a whole is far from exiting the pandemic.
“We are concerned that a narrative has taken hold in some countries that because of vaccines, and because of omicron’s high transmissibility and lower severity, preventing transmission is no longer possible and no longer necessary,” Tedros said. “Nothing could be further from the truth.”
So, with the announcement that Pfizer has submitted their studies on 6 months to 5-year vaccine approval, the antivirals and the vaccine statistics, that the change to COVID-19 to be transitioned to the classification as an Endemic is right around the corner.
And lastly-
US Exiting ‘Full-Blown Pandemic Phase’ of COVID, Fauci Says
Carolyn Crist wrote the latest prediction from Dr. Fauci. The U.S. is heading in a positive direction in the pandemic as COVID-19 cases and hospitalizations decline, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.
Vaccination rates, treatments, and prior infections will make the coronavirus more manageable in 2022, Fauci told the Financial Times. Broad mandates and mitigation protocols will begin to be lifted.
“As we get out of the full-blown pandemic phase of COVID-19, which we are certainly heading out of, these decisions will increasingly be made on a local level rather than centrally decided or mandated,” he told the newspaper. “There will also be more people making their own decisions on how they want to deal with the virus.”
The U.S. is reporting an average of 240,000 new COVID-19 cases per day, according to the data tracker from The New York Times. That’s a 63% decline from the previous 2 weeks.
About 100,000 people are hospitalized due to COVID-19, according to the latest data from the U.S. Department of Health and Human Services. That’s also down 28% in the past 2 weeks.
At the same time, about 2,600 deaths are being reported each day, the newspaper reported, which is the highest level seen in the U.S. in a year.
Fauci said COVID-19 restrictions around the U.S. will end soon. He didn’t give a specific timeline but said it was likely to happen in 2022.
Some states have already begun to lift pandemic rules as COVID-19 cases subside. California, Connecticut, Delaware, Oregon, and New Jersey announced on Monday that they would lift mask mandates for schools and other public spaces throughout February and March. On Wednesday, New York Gov. Kathy Hochul dropped New York’s mask mandate as well.
At the same time, Fauci stressed that the coronavirus won’t be wiped out and people will have to learn to live with it. Health officials may soon reach an “equilibrium” where they don’t need to monitor infection levels as closely, he said.
“I hope we are looking at a time when we have enough people vaccinated and enough people with protection from previous infection that the COVID restrictions will soon be a thing of the past,” he said.
And I believe that we are just about there!

COVID Hospitalizations in the US Soar to More Than 100,000, Vaccines and The Idiocy regarding Ivermectin!

Ralph Ellis reminded us that more than 100,000 people in the United States were hospitalized with COVID-19 this past few weeks — a figure not reported since late January, when vaccines were not widely available.

Statistics from the U.S. Department of Health and Human Services showed 100,317 COVID hospital patients on Wednesday, a figure that grew to 101,050 on Thursday. 

That’s about six times the number of COVID hospitalizations from about nine weeks ago, CNN says.

The HHS data shows COVID hospitalizations are highest across the Southeast, with more than 16,800 patients in Florida, 14,000 in Texas, 6,200 in Georgia, 3,000 in Alabama, and 2,300 in Missouri.

In comparison, California, the most populous state, has about 8,700 people hospitalized with COVID, the HHS said.

Alarmingly, many of these COVID patients are severely ill. About 30% of the nation’s intensive care unit beds are now occupied by COVID patients, HHS data shows.

Infections, deaths, and hospitalizations have increased since early summer as the Delta variant spread across the nation, especially in places with low vaccination rates. 

Health experts have said the majority of the hospitalized people are unvaccinated. Research shows that vaccinated people who become infected with the Delta variant generally don’t become as sick as unvaccinated people.

Paul Offit, MD, an FDA vaccine advisory committee member, said the current availability of the vaccine makes the high number of hospitalizations especially tragic.

“The numbers now…are actually in many ways worse than last August,” Offit said on CNN. “Last August, we had a fully susceptible population, (and) we didn’t have a vaccine. Now, we have half the country vaccinated…but nonetheless the numbers are worse. The Delta variant is one big game changer.”

Sources:

U.S. Department of Health and Human Services: “Hospital Utilization.”

CNN: “With more than 100,000 people in the hospital with Covid-19 in the US, this August is worse than last, expert says.”

From Cancer to COVID: Is There a Fix for Willful Medical Ignorance?

Dr. H. Jack West pointed out something very interesting as he relayed an observation. He patient saw a patient for a second opinion after developing metastatic disease, but he’d initially been diagnosed with locally advanced non–small cell lung cancer (NSCLC). His oncologist had appropriately proposed treatment with concurrent chemoradiation followed by durvalumab. He listened to the rationale and the evidence, but he refused to pursue it, favoring alternative medicine instead.

A repeat scan several months later showed obvious progression. Even though it was potentially treatable — including with curative intent — he demurred again.

Several months down the line, he developed back pain heralding a new spinal metastasis. Only then did he accept that perhaps conventional, evidence-based anticancer therapy was worth pursuing. Of course, by that time the window of opportunity to treat with the hope of cure had closed.

But in other ways, it isn’t too late for him. He can at least benefit from subsequent treatments for advanced NSCLC. Too many other patients I’ve seen have eschewed conventional medicine so long that their poor performance status precludes standard therapies that would have been effective had they pursued them as something other than a final act of desperation.

Corollaries to Coronavirus                                                                                                                 Though this dynamic has existed for decades in oncology, the current rejection of the coronavirus vaccine, on a massive scale involving a significant minority of the US population, is a reflection of this same willful ignorance.

In 2008, I started a nonprofit organization — the Global Resource for Advancing Cancer Education — dedicated to providing free, timely, and credible information to cancer patients and caregivers around the world.

It was based on the premise that if the lay public had access to the best information — in other words, the same content that informs experts and defines optimal patient management — patients would then be able to pursue these treatments to the extent that they were broadly available. And although this service and a growing number of similar efforts have since generated a virtual army of sophisticated patients (who have since become an important force in and of themselves), it has been humbling to recognize that this approach can’t help the many people who denigrate the very pursuit of evidence-based medicine.

The widespread rejection of COVID vaccines brings this into high relief for a couple of reasons. First, the selfishness of those who reject the vaccine affects not only the individual who makes that choice but the broader public. Their decision not only puts them at risk but also the unwitting person exposed to them later. At least with cancer, poor choices only affect those making them.

Another reason that COVID vaccination is such a flashpoint: everyone, including every public figure, now makes a public declaration of their support or suspicion of science and evidence-based medicine. And we are seeing an alarming fraction of people with access to very good information rejecting the evidence and our best opportunity to control the pandemic.

I am particularly disheartened that those who reject the science aren’t prone to change their views with better educational efforts. I recognize that there is a spectrum of resistance and that some of our colleagues have convinced family members and patients to reverse their prior anti-vaccine stance; but I wish it wasn’t so hard to overcome people’s biases against the establishment — biases that lead not only to self-harm but danger to the broader public.

We need to do more to understand what leads people to reject science, because it’s clearly not just ignorance and lack of better information. We have to recognize that this phenomenon is now a leading bottleneck in the progress of modern medicine, both in oncology and other settings.

I would love to learn what others think, including successes and more optimistic views — or to simply vent your frustrations with these issues.

Helping Patients Understand Breakthrough COVID Benefits Us All –Here’s how to approach the conversation.

I have been asked these questions multiple times about breakthrough infections from Covid by my patients and I thought that this would be a good time to review, especially recently with infection numbers and the discussion regarding booster shots. Dr. Gary C. Steben pointed out that the recent change in masking guidance from the CDC and reinstated public health measures from local and state governments have been met with frustration and defiance, with people understandably questioning why they got vaccinated if they have to go back to masking and distancing anyway. The answer is in the degree of exposure to SARS-CoV-2, and the explanation lies in the way vaccines work. We can help our patients understand this with three talking points:

1. The antibody levels in the bloodstream are completely helpless at preventing infection (saying it that way seems to get everybody’s attention!)

Neutralizing virus particles from the environment is the sole responsibility of the vaccine-induced antibodies in our respiratory, GI, and ocular secretions — our “frontline” defensive antibodies in our saliva, tears, nasal secretions, and pulmonary mucus. When exposed to airborne virus particles, these antibodies attach to the spike protein of SARS-CoV-2, physically preventing it from latching on to the ACE2 receptor on the surface of our respiratory epithelium and gaining entry to those cells to cause an infection. But that’s all we’ve got — if we are exposed to so many virus particles that all the antibodies in these secretions have attached themselves to virus particles, yet we continue to expose ourselves to new particles faster than we transport more antibodies into these secretions, our antibody defense gets overwhelmed, we inhale or come in contact with more virus particles than we are able to neutralize, and we get infected.

2. Circulating antibodies help to contain the infection

Once infected, the virus takes over the machinery of our cells to make more virus particles and release them, and that’s where our circulating vaccine-induced antibodies come in. They latch on to these newly minted particles to prevent them from infecting adjacent cells and from being exhaled. Therein, unfortunately, lies one of the Delta variant’s strong suits — it can reproduce itself so rapidly that our antibodies don’t slow it down much, and we see that when infected, vaccinated people are shedding virus similarly to unvaccinated folks.

3. Our vaccine-induced T-cell immunity limits disease severity

The third element of the response to the vaccine that you don’t hear as much about is the T-cell immunity that is induced. This arm of the immune system kills off our own infected cells — they’re a lost cause anyway, and will need to be replaced — and thereby limits the extent of disease. That’s why the vaccines remain effective at limiting the severity of disease, and the reason why we don’t see many vaccinated people among the hospitalized even as the number of vaccinated people infected with the Delta variant increases. That’s also why it’s so critical to get vaccinated — the vaccines are extremely effective at preventing severe illness and death from COVID-19. But it is not in the T-cell job description to go after viruses themselves. Vaccine-induced T-cells do not provide protection against getting infected; they only mitigate severity once infected.

So, the CDC revised its masking guidance because, as we’re seeing in places like Provincetown and Milwaukee’s Deer District, vaccinated people can both get and spread SARS-CoV-2. More and more vaccinated people are getting infected because they’re interpreting vaccination as carte blanche to return to pre-pandemic life without restriction and are exposing themselves to massive viral loads that overwhelm their immunity. Every single vaccinated person I spoke with during a telemedicine visit in July who got themselves infected at a Bucks championship game told me they would have taken more precautions had the meaning of vaccination been explained to them as I have above.

These principles add to the arguments surrounding whether to administer a third dose, as recently discussed. Many studies have shown that neutralizing antibody titers decline only slowly over months, while we continue to see blunted disease severity in those vaccinated individuals who get infected. Moreover, breakthrough infections are not only occurring in older people who are far out from their second dose. This suggests breakthrough infections may occur not so much because of waning immunity, but because of people’s behavior that exposes them to overwhelming viral loads, especially in the face of the new variants. If that’s the case, a third dose without behavior modification may not be enough to promote sufficient disease containment. We need data from our contact tracers on the circumstances under which breakthrough infections occurred to better inform the decision on a third dose.

I believe history will judge our response to the pandemic harshly for its reliance on mandates more than education. We physicians were not consulted appropriately early on in the pandemic for our expertise and community respect to help shape local and regional procedures tailored to maximize disease containment while mitigating economic impact. There remains no coordinated effort to promote local physician involvement in mitigation strategies, and we are seeing the fallout from that in the current surge. So we must take it upon ourselves to do everything we can to educate our patients by promoting evidence-based containment measures and offering common-sense explanations for COVID-19 and the vaccines.

This is the most important public health crisis of our careers and lifetimes, and the urgency of this situation will reach a whole new level if post-acute COVID syndrome (PACS) turns out to be a virus-triggered autoimmune response that intensifies with subsequent infections. I sure hope that will not be the case and there is no evidence for that yet, but we physicians don’t have the luxury of waiting to find out. We need to leverage the respect we’ve earned among our communities to do what we can to transcend the rhetoric and misinformation, and minimize the worsening catastrophe that we know COVID-19 can become. Now.

Anti-parasite drug for animals ivermectin flying off store shelves as COVID spikes- Ivermectin dispensing by retail pharmacies has increased’ the CDC says. After many hours of “discussions” with friends who have decided not to get vaccinated and instead an anti-parasitic drug used on horses, cows, sheep and dogs, I thought that it would be worth a discussion. Daniella Genovese reported that despite strict warnings from federal health officials, consumers around the country are still trying to get their hands on a drug commonly used to treat or prevent parasites in animals in order to protect themselves against the coronavirus.

The drug, ivermectin, has been reportedly flying off stores shelves in multiple states, including Texas and Oklahoma, even though it has not been approved for treating or preventing COVID-19 in humans. “Ivermectin dispensing by retail pharmacies has increased, as has use of veterinary formulations available over the counter but not intended for human use,” the Centers for Disease Control and Prevention said Thursday. “FDA has cautioned about the potential risks of use for prevention or treatment of COVID-19.

Earlier this month, the FDA said it has seen a “growing interest” in the drug and already received multiple reports of “patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses.” 

However, over a dozen stores in the Dallas and Fort Worth, Texas area have sold out of the medicine, The Dallas Morning News reported.  Noah Krzykowski, who manages the Irving Feed Store in Irving, Texas, told the outlet that he is seeing droves of new customers in search of the product.  “You can tell the difference between someone who has cattle and someone who doesn’t,” Krzykowski told the Morning News. “And we’re seeing a lot of people right now who don’t have cattle.” Meanwhile, Alex Gieger, who manages the Red Earth Feed and Tack in Oklahoma City, Kansas, told KOCO that the store has been flooded with requests for the drug. 

Scott Schaeffer, managing director of the Oklahoma Center Poison and Drug Information, told FOX Business they have already received seven calls this month regarding ivermectin. This is up from three calls in July.  “We’re more concerned that people are taking medication without the input of their physician/prescriber, and that there is no reliable evidence that ivermectin is effective for the treatment or prevention of COVID,” Schaeffer said. 

Ivermectin tablets are only approved by the FDA “to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms,” the agency said. According to the FDA, some forms of ivermectin are also approved to treat parasites like head lice and for skin conditions like rosacea while other forms are “used in animals to prevent heartworm disease and certain internal and external parasites.” 

The FDA said consumers should never use medications intended for animals. “It’s important to note that these products are different from the ones for people, and safe when used as prescribed for animals, only,” the FDA said. 

US Plans COVID-19 Booster Shots at 6 Months Instead of 8: WSJ

The Reuters Staff reported that U.S. health regulators could approve a third COVID-19 shot for adults beginning at least six months after full vaccination, instead of the previously announced eight-month gap, the Wall Street Journal reported on Wednesday.

Approval of boosters for three COVID-19 shots being administered in the United States — those manufactured by Pfizer Inc and partner BioNTech SE, Moderna Inc and Johnson & Johnson — is expected in mid-September, the report said, citing a person familiar with the plans.

Pfizer and BioNTech have already started the application process for the approval of its booster shot in people 16 and older, saying it spurs a more than three-fold increase in antibodies against the coronavirus.

Earlier this week, U.S. regulators granted full approval to Pfizer’s two-dose vaccine. Moderna said on Wednesday it has completed the real-time review needed for a full approval for its jab in people 18 and above.

White House spokeswoman Jen Psaki said in her daily briefing that any such development would be under the purview of the Centers for Disease and Control and Prevention (CDC).

The CDC said the government’s plan to administer booster shot depends on pending action from the Food and Drug Administration and recommendation to it from the Advisory Committee on Immunization Practices.

The FDA, however, reiterated its joint statement from last week that said the government was gearing up to roll out the third shot from mid-September to Americans who had their initial course of two-dose vaccines made by Moderna and Pfizer more than eight months ago.

The rollout would start if the FDA and the CDC decide that boosters are needed, U.S. officials had said.

But the next question is:

Are We Jumping the Gun on COVID Boosters?- Efficacy, safety, and ethical questions linger

Dr. Vinay Prasad points out that over the last weeks, the topic of COVID-19 booster shots — a third dose of mRNA vaccine for healthy Americans — has been thrust into the spotlight. The surgeon general, CDC director, Anthony Fauci, MD, and President Biden have announced that they wish for boosters to be available by late September for healthy adults who are 8 months out from their original two-dose series. While this will be contingent on an FDA evaluation to determine the “safety and effectiveness of the third dose,” a clear path forward has already been set. And just like everything else throughout the course of the pandemic, the choice has been made with a dearth of data and an abundance of political pressure.

Diminishing vaccine effectiveness supposedly makes the case for boosters. But there are two big questions here: First, what is current vaccine effectiveness? And second, what justifies boosters? Let’s consider these in turn.

What Is Vaccine Effectiveness Now?

We have to be honest, many vaccine effectiveness studies are poorly done. All studies compare the rate of getting a breakthrough infection among vaccinated people against the rate of infection in unvaccinated people. But there are some issues with this approach. First, as time goes on, more unvaccinated people have had and recovered from COVID-19 (and these individuals may be less likely to go on to get a shot). This means that their risk of getting COVID-19 a second time is far less than the typical unvaccinated person who has never been sick. Even if vaccines “work” as well as before, this factor alone will result in the appearance of diminishing vaccine effectiveness.

Second, the order of vaccination in all nations is non-random. The folks who got vaccinated first are often the oldest and most vulnerable people with frailty and senescent immune systems. Vaccine effectiveness after 6 months, 8 months, and 12 months increasingly compares older, frailer people who got vaccinated first against unvaccinated people. These older people may always have a slightly higher risk of breakthrough infections. This bias will also give the false appearance of diminishing vaccine effectiveness.

A third consideration: We’re looking at vaccine effectiveness, but for what? People don’t want to get severely ill from SARS-CoV-2 and don’t want to die, but it might be too much to ask that vaccines prevent the nucleotide sequence of SARS-CoV-2 from ever being in your nose. In other words, vaccine effectiveness against severe disease may be much higher than vaccine effectiveness against asymptomatic or mild infection. This matters a great deal — if the vaccines continue to be highly effective against risk of severe illness and death, is it really worth boosting people in the U.S. right now?

And putting this all together, the best estimates of vaccine effectiveness do, in fact, still show high protection against severe disease and death.

What Justifies Boosters?

No matter what vaccine effectiveness is against preventing COVID-19 illness generally, the important question for boosters is whether they further lower the risk of severe disease or death. The only way to show this is through randomized controlled trials of the size and duration to measure that outcome. It is entirely possible that vaccine effectiveness is not perfect over time, or slightly lower than initial trials, but it’s also possible that boosters do not further reduce the risk of SARS-CoV-2. Only trials can answer this.

While emerging data from Israel suggest boosters may diminish the risk for COVID-19 infection and severe illness in people 60 and older, the data are not based on the types of studies we need. Pfizer has only submitted early trial results to the FDA to support their boosters, with phase III trial data forthcoming. But again, the data may be insufficient if severe outcomes are not captured.

Moreover, we have to consider the risk of new, compounding, and worse toxicity. Randomized trials and close observation will be needed to exclude worse safety signals, particularly increases in myocarditis and pericarditis. These rare adverse events are more common after the second mRNA dose — will they be even more common after dose three?

In short, diminished vaccine effectiveness does not make the case for boosters. A reduction in severe outcomes makes the case for boosters, but we have no such data to date.

Global Equity

There’s also the ethical question of how a wealthy nation can give its inhabitants a third dose when there are literally billions of vulnerable older people around the world who have not gotten any doses. The World Health Organization has begged nations not to do this, and history will judge us poorly if we pursue this. It is a human rights violation to direct limited mRNA supply and capabilities to third doses in the U.S. when the world remains vulnerable. Moreover, it is self-defeating. We are not safe from global variants.

Take a Step Back

Decisions about boosters have to be based in science and made by vaccine regulators. They should not be subject to the pressure of manufacturers, politicians, or political appointees. They should not be rushed. On Sunday television, Surgeon General Vivek Murthy, MD, was specifically asked if the third shot was safe. His response: “the plan is contingent on that…”

Excuse me? We don’t know that to be true, and yet, our top medical and public health experts are pushing for boosters? Drug safety expert Walid Gellad, MD, MPH, tweeted: “It was irresponsible to push for boosters in healthy people before safety review.”

Two days after the White House’s announcement, two people with knowledge of the FDA’s deliberation told The Washington Post that the agency was investigating myocarditis signal with the Moderna vaccination. Canadian data suggest the risk may be 2.5 times that of Pfizer’s vaccine. The timing of this internal information leaking to reporters naturally leads me to wonder if reviewers in the agency are attempting to counteract political pressure, and create space to conduct a thorough review of booster data.

Boosters are an important medical question. Their approval must have a favorable safety and efficacy profile. Only randomized trials measuring severe disease can show that. Still, recently the FDA that boosters for Pfizer is only recommended for people over 65 and those compromised.

Let’s wait for the next set of data from the Moderna post vaccination studies, which is expected by the end of November.

203 Doctors Told Us What They Actually Think Of COVID Vaccines, And Everyone Should Hear Their Answers

A growing refrain among vaccine skeptics is that they won’t get vaccinated against COVID-19 because a handful of health scientists have told them they don’t have to.

Robert Malone, the self-proclaimed inventor of mRNA technology back in the 1980s, has been among those celebrated by the far right for voicing unproven concerns about COVID-19 vaccines to his 280,000-plus Twitter followers. While it’s easy to explain away an embittered, bruised-ego scientist, it’s much harder to dismiss the significant majority of healthcare professionals who support the vaccines and the preponderance of evidence backing them up.

Enter the anti-vaxxer’s latest unfounded claim: that most public health officials secretly don’t support vaccines. In fact, a friend of mine recently made a stunning declaration that she wholeheartedly believes: “Most experts are too afraid to speak up, but I suspect 9 out of 10 doctors would advise against COVID vaccines if you asked them privately.”

Though I could have readily dismissed such a callous and unsubstantiated statement, the journalist in me began to wonder whether I should.

After all, if a meaningful percentage of individuals with legitimate infectious disease and vaccination expertise were concerned, that would be worth reporting. Besides, I’d asked her to question her convictions, so shouldn’t I be willing to do the same?

With that in mind, I began researching epidemiologists, virologists, health department directors, pediatricians, infectious disease experts, and public health officials. I deemed it important to find such people in all 50 states and in counties that leaned both left and right in case politics had tainted anyone’s objectivity.

No one directed me where I should look nor which experts I could turn to; and I steered clear of anyone I’d seen making regular cable news appearances to ensure I was getting fresh perspectives from experts who may not have already spoken up.

In my research, I identified more than 200 such individuals, and, in the interest of taking up as little of their limited time as possible, decided to ask them all the same two yes or no questions with an invitation to elaborate if they chose to.

I also wanted them to know they could answer freely, so I offered anonymity — a condition that some appreciated and others waived.

My two questions were simply whether they believed the benefits of COVID-19 vaccinations outweigh any potential harms, and whether they’d recommended the shots to their own children if they had any in the 12–18-year-old age groups. Responses began pouring in almost immediately.

Over the next few days, I heard back from 203 of the doctors I’d reached out to. If my friend’s unfounded suspicions were correct, 183 of them should have recommended against vaccination.

Turns out the actual number against COVID vaccines was zero. And the number of vaccine experts who recommended the shots to me in our private, one-on-one interactions was a whopping 203.

None of the 203 responders raised a single concern about COVID vaccines for adults or for children. “The benefits outweigh the extremely rare harms by many miles,” one biostatistics researcher told me.

What’s more, many of the responders had a lot to say about the type of public health official who would use their academic credibility to steer people away from COVID-19 vaccines.

Abner told me she doesn’t actually know of any public health officials who have advocated against the vaccines; rather, the handful of fringe persons who have gained notoriety doing so are actually “lab scientists without any public health or epidemiological expertise. Being an expert in one area of science or medicine does not confer expertise in others.”

One health department director in Idaho put it even more bluntly: “Any public health official who discourages vaccination isn’t concerned about public health at all.”

CORRECTED-COVID SCIENCE-mRNA vaccines trigger backup immune response; some cancer drugs may help

Nancy Lapid summarized of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review.

Antibodies wane but other immune defenses remain alert.

A new study may help explain why mRNA vaccines by Pfizer/BioNTech and Moderna are more effective at preventing hospitalizations and deaths than they are at preventing infection. Test-tube experiments on blood samples from 61 fully vaccinated adults showed that by six months, vaccine-induced antibodies that can immediately neutralize the virus had declined. But so-called memory B cells, which produce new antibodies if they encounter the virus later on, had increased and become better at recognizing viral variants, according to a report posted on Monday on bioRxiv https://bit.ly/3zoCSAY ahead of peer review. “Your immune system has a backup,” said study leader John Wherry of the University of Pennsylvania Perelman School of Medicine. B-cell production of antibodies might take a few days to get underway, but then these memory B cells “kick into action and prevent severe disease,” Wherry added.

Early data favors certain cancer treatments during pandemic

Certain cancer drugs may help protect patients with malignancies from being infected with the new coronavirus, preliminary data suggests. The drugs, known as mTOR/PI3K inhibitors and antimetabolites, target the parts of cells that the virus uses to enter and make copies of itself, including a “gateway” protein on cell surfaces called angiotensin-converting enzyme 2 (ACE2). The study of 1,701 cancer patients found that after taking underlying risk factors into account, patients treated with mTOR/PI3K inhibitors or ACE2-lowering antimetabolites were 47% less likely to test positive for the virus than patients who received other drug therapies. Gemzar (gemcitabine) from Eli Lilly appeared to be particularly promising, according to the report in JAMA Oncology https://bit.ly/38icqN6 on Thursday. The study does not prove that the drugs lowered infection rates, however, and much more research is needed to confirm their potential for protecting cancer patients from the coronavirus.

One in four infected LA residents had been vaccinated

From May through July 2021, as the Delta variant spread, 43,127 residents of Los Angeles County in California were diagnosed with SARS-CoV-2 infections. One in four had been fully vaccinated, though these patients had lower rates of hospitalization (3.2% versus 7.6%), intensive care (0.5% versus 1.5%) and need for machines to help with breathing (0.2% versus 0.5%) than unvaccinated patients, public health officials reported on Tuesday in the U.S. Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report https://bit.ly/2XWWZIx. During the study period, the prevalence of the Delta variant rose from less than 9% to at least 87%, the authors note. As of July 25, hospitalization rates were 29 times higher for unvaccinated patients, they estimated, “indicating that COVID-19 vaccination protects against severe COVID-19 in areas with increasing prevalence of the SARS-CoV-2 Delta variant.”

Infectious disease expert: Americans must ‘recalibrate’ vaccine expectations

Tim O’Donnell reiterated what I have been trying to educate my patients and friends that COVID-19 vaccines won’t eliminate the coronavirus, “no matter how many booster shots the United States gives,” Céline R. Gounder writes for The Atlantic. But that’s no reason to panic or lose confidence in them.

Grounder, an infectious disease specialist and epidemiologist at New York University’s Grossman School of Medicine and Bellevue Hospital in New York City, thinks public health messaging got out of hand early on during the vaccine drive, especially when the Centers for Disease Control and Prevention published real-world evidence that showed that two doses of the Pfizer and Moderna vaccines were 90 percent effective at preventing infections, as opposed to just disease. After that, folks got excited, believing that full vaccination status meant you could only very rarely get infected or transmit the disease. But now that the efficacy appears to be lower, there’s a lot of anxiety.

Grounder tried to ease that, explaining that vaccines are typically more effective at protecting against infection outright when battling viruses that have longer incubation periods, like measles and smallpox. In those cases, the body is trained to kick the virus out before it can really establish itself. But the coronavirus and influenza, for example, don’t take as long to start replicating and can do so before a vaccinated defense system revs up. Once it does, though, the virus doesn’t have much room to operate and is usually blocked from progressing in the lungs and causing serious damage.

With that in mind, Grounder says Americans simply need to “recalibrate our expectations about what makes a vaccine successful.” While “the public discussion of the pandemic has become distorted by a presumption that vaccination can and should eliminate COVID-19 entirely,” that’s not an attainable standard, she argues. And it’s one that makes “each breakthrough infection” look “like evidence that the vaccines are not working,” even though they’re performing “extremely well” and reducing what may have been serious infections to either mild or asymptomatic ones. Read Grounder’s full piece at The Atlantic.

Let us take a few moments of silence for the service men and women and the other civilians who lost their lives last week to the horror of the ISIS bomber.

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!

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.

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!!

Election 2020: What Exactly Is Joe Biden’s Healthcare Plan? And Really, Telehealth to Care for Our Patients?

So, first I wanted to relate an experience, which exemplifies the failure of telehealth, or maybe the failure of healthcare workers who are taking advantage of the “new” health care system of patient care.

Consider the case a two weeks ago. As I was about to operate on a cancer surgery patient, I was asked to evaluate a patient healthcare conundrum. One of our nurse teammate’s husband was sick and no one knew what was the problem. He had lost 23 pounds over 3 ½ weeks, was dehydrated, appetite, sore throat, weak and needed to go to the emergency room multiple times for intravenous fluids. Each time he was told that they were very sorry but they had no idea what the problem was.

His Primary care physician would not see him in person, and he had another telehealth visit, which he was charged for and was prescribed an antibiotic with no improvement.

I asked if he had a COVID test which he did and it was negative.

I then asked if I could examine him or if she had any pictures. She had pictures, with no skin rashes except I noticed something interesting on the intraoral pictures, which showed left sided ulcers on his cheeks, left lateral posterior tongue and palate, again-only on the left side.

I asked if this was true in that the ulcers were only on one side of his mouth? When his wife responded with a yes to the question I then responded that he had intraoral shingles involving the nerve to the tongue, cheek, palate ( glossophyngeal nerve ) and sometimes also affected additional nearby cranial nerve, which is probably why he was having some of his stomach problem. She thought that was interesting and wanted to know what to do since he was about to have some gallbladder studies.

I outlined a treatment plan and low and behold he is getting better. My question is why didn’t anyone in the doc’s office or ER never complete a thorough physical exam? Oh, wait- how does one do a complete physical exam through the telehealth system? What about heart or lung disease patients, how does a nurse or physician listen to their heart or lungs, etc?? Are we physicians forgetting our teachings and training regarding the proper approach to physical diagnosis?

And now what about Biden’s proposal for health care?

Leigh Page pointed out that physicians — like all Americans — are trying to size up Joe Biden’s healthcare agenda, which the Democratic presidential nominee has outlined in speeches and on his official website.

Many healthcare professionals, patients, and voters of all political stripes think our current healthcare system is broken and in need of change, but they don’t agree on how it should change. In Part I of this article, we take a look at Biden’s proposals for changing the US healthcare system. Then, we include comments and analysis from physicians on both sides of the fence regarding the pros and cons of these proposed healthcare measures.

Part 1: An Overview of Biden’s Proposed Healthcare Plan

Biden’s proposed healthcare plan has many features. The main thrust is to expand access to healthcare and increase federal subsidies for health coverage.

If elected, “I’ll put your family first,” he said in a speech in June. “That will begin the dramatic expansion of health coverage and bold steps to lower healthcare costs.” He said he favored a plan that “lowers healthcare costs, gets us universal coverage quickly, when Americans desperately need it now.”

Below are Biden’s major proposals. They are followed by Part 2, which assesses the proposals on the basis of comments by doctors from across the political spectrum.

Biden Says We Should Restore the ACA

At a debate of the Democrat presidential candidates in June 2019, Biden argued that the best way to expand coverage is “to build on what we did during the Obama administration,” rather than create a whole new healthcare system, as many other Democratic candidates for president were proposing.

“I’m proud of the Affordable Care Act,” he said a year later in his June 2020 speech. “In addition to helping people with preexisting conditions, this is the law that delivered vital coverage for 20 million Americans who did not have health insurance.”

At the heart of the ACA are the health insurance marketplaces, where people can buy individual insurance that is often federally subsidized. Buyers select coverage at different levels ― Gold, Silver, and Bronze. Those willing to pay higher premiums for a Gold plan don’t have high deductibles, as they would with the Silver and Bronze plans.

Currently, federal subsidies are based on premiums on the Silver level, where premiums are lower but deductibles are higher than with the Gold plan. Biden would shift the subsidies to the Gold plan, where they would be more generous, because subsidies are pegged to the premiums.

In addition, Biden would remove the current limit on subsidies, under which only people with incomes less than 400% of the federal poverty level qualify for them. “Many families making more than 400% of the federal poverty level (about $50,000 for a single person and $100,000 for a family of four), and thus not qualifying for financial assistance, still struggle to afford health insurance,” the Biden for President website states.

Under the Biden plan, there would still be a limit on insurance payments as a percentage of income, but that percentage would drop, meaning that more people would qualify. Currently, the level is 9.86% or more of a person’s income; Biden would lower that level to 8.5%.

“We’re going to lower premiums for people buying coverage on their own by guaranteeing that no American ever has to spend more than 8.5% of their income on health insurance, and that number would be lower for lower-income people,” Biden said in the June speech.

Add a Public Option, but Not Medicare for All

In the primary, Biden parted company from rivals who backed Medicare for All, a single-payer health system that would make the government pay for everyone’s healthcare. “I understand the appeal of Medicare for All,” he said in a video released by his campaign. “But folks supporting it should be clear that it means getting rid of Obamacare, and I’m not for that.” But he nor anyone else who supported Obamacare has come up with a way to finance this type of healthcare system.

However, Biden embraced a “public option” that would allow people to buy into or be subsidized into “a Medicare-like” plan. It is unclear how similar the public option would be to regular Medicare coverage, but the Biden campaign has made it clear that it would not take funds from the Medicare trust fund, which is expected to start losing funds by 2026.

The more than 150 million Americans who have employer-sponsored insurance could keep it, but they could still buy into the public option if they wanted to. In addition, the public option would automatically enroll ― at no cost to them ― some 4.8 million low-income Americans who were excluded from the ACA’s Medicaid expansion when many states chose to opt out of the Medicaid expansion.

In addition, the 37 states that participate in expanded Medicaid could switch coverage to the new public option, provided that they continue to pay their current share of the costs. (In June, Oklahoma became the 37th state to allow the expansion, following the results of a ballot measure.)

“We need a public option now more than ever, especially when more than 20 million people are unemployed,” Biden said in the June speech. “That public option will allow every American, regardless of their employment status, the choice to get a Medicare-like plan.”

Lower the Medicare Age

In spring 2020, Biden proposed lowering the age to qualify for Medicare from 65 to 60. This provision is not included among the official policies listed on the Biden for President website, but it has been cited by many, including the Biden-Sanders Unity Task Force.

This provision would bring almost 23 million people into Medicare, including 13.4 million from employer-sponsored coverage, according to one analysis. It’s not clear whether these people would buy into Medicare or simply be covered. Their care would not be paid for by the Medicare Trust Fund but would use tax dollars instead. Oh, finally, we find out that our taxes would go up. How much is the problem as we consider all the other programs that Biden and Harris have promoted.

Provide Relief in the Covid-19 Pandemic

Biden would cover the cost of COVID-19 testing and the cost of health coverage for people laid off during the pandemic.

“Testing unequivocally saves lives, and widespread testing is the key to opening our economy again,” Biden said in his June speech. “To fix the economy, we have to get control over the virus.”

Prescription Drug Reform

Biden would repeal a Bush-era exception that bars the Medicare program from negotiating prescription drug prices for the Part D prescription drug benefit. “There’s no justification for this except the power of prescription drug lobbying,” the Biden for President website states.

In addition, Biden’s prescription drug reform plan would do the following:

• Limit launch prices for drugs. The administration would establish an independent review board that would assess the value of new drugs and would have the power to set limits on their prices. Such drugs are “being abusively priced by manufacturers,” the Biden for President site says.

• Limit price increases to inflation. As a condition of participation in government programs, drug prices could not rise more than the general inflation rate. Biden would impose a tax penalty on drug makers whose prices surpassed inflation.

• Allow consumers to buy prescription drugs from other countries. Biden would allow consumers to import prescription drugs from other countries, provided the US Department of Health and Human Services certifies that those drugs are safe.

• Stop tax breaks for pharma ads: Biden would drop drug makers’ tax breaks for advertising, which amounted to $6 billion in 2016.

Stop Surprise Billing

Biden proposes to stop surprise billing, which occurs when patients receive care from a doctor or hospital that is not in their insurer’s network. In these situations, patients can be surprised with very high bills because no payment limit has been negotiated by the insurer.

Twenty-eight states have enacted consumer protections to address surprise medical billing, but Congress has not passed such a measure. One proposed solution is to require payers to pay for out-of-network services on the basis of a benchmark, such as the average Medicare rate for that service in a specific geographic area.

Closely Monitor Healthcare Mergers

Biden would take a more active stance in enforcing antitrust laws against mergers in the healthcare industry.

“The concentration of market power in the hands of a few corporations is occurring throughout our health care system, and this lack of competition is driving up prices for consumers,” the Biden for President website states.

Overhaul Long-term Care

Biden’s latest plan calls for a $775 billion overhaul of the nation’s caregiving infrastructure. Biden says he would help create new jobs, improve working conditions, and invest in new models of long-term care outside of traditional nursing homes.

Restore Funding for Planned Parenthood

Biden would reissue guidance barring states from refusing Medicaid funding for Planned Parenthood and other providers that refer for abortions or that provide related information, according to the Biden for President website. This action would reverse a Trump administration rule.

Boost Community Health Centers

Biden promises to double federal funding for community health centers, such as federally qualified health centers, that provide care to underserved populations.

Support Mental Health Parity

Biden says he supports mental health parity and would enforce the federal mental health parity law and expand funding for mental health services.

Part 2: Physicians’ Opinions on Biden’s Healthcare Plans: Pro and Con

Biden’s plans to expand coverage are at the heart of his healthcare platform, and many see these as the most controversial part of his legislative agenda.

Biden’s Medicare expansion is not Medicare for All, but it can be seen as “Medicare for all who want it.” Potentially, millions of people could enter Medicare or something like Medicare. If the Medicare eligibility age is dropped to 60, people could switch from their employer-sponsored plans, many of which have high deductibles. In addition, poor people who have no coverage because their states opted out of the Medicaid expansion would be included.

The possibility of such a mass movement to government-run healthcare alarms many people. “Biden’s proposals look moderate, but it is basically Medicare for All in sheep’s clothing,” said Cesar De Leon, DO, a family physician in Naples, Florida, and past president of the county’s medical society.

Reimbursements for Doctors Could Fall- No, Will Fall!

A shift of millions of people into Medicare would likely mean lower reimbursements for doctors. For example, the 13.4 million people aged 60 to 65 who would switch from employer-sponsored coverage to Medicare would be leaving some of the best-paying insurance plans, and their physicians would then be reimbursed at Medicare rates.

“Biden’s plan would lower payments to already cash-strapped doctors and hospitals, who have already seen a significant decrease in reimbursement over the past decade,” De Leon said. “He is trying to win the support of low-income voters by giving them lower healthcare prices, which doctors and hospitals would have to absorb.

“Yes, the US healthcare system is dysfunctional,” De Leon added, “but the basic system needs to be fixed before it is expanded to new groups of people.”

The American Association of Neurological Surgeons/Congress of Neurological Surgeons warns against Biden’s proposed government-run system. “We support expanding health insurance coverage, but the expansion should build on the existing employer-based system,” said Katie O. Orrico, director of the group’s Washington office. “We have consistently opposed a public option or Medicare for All.

“Shifting more Americans into government-sponsored healthcare will inevitably result in lower payments for physicians’ services,” Orrico added. “Reimbursement rates from Medicare, Medicaid, and many ACA exchange plans already do not adequately cover the costs of running a medical practice.”

Prospect of Higher Taxes- Absolutely, grab your wallets and your retirement funds!!

Paying for ambitious reforms means raising taxes. Biden’s plan would not make the Medicare trust fund pay for the expansions and would to some extent rely on payments from new beneficiaries. However, many new beneficiaries, such as people older than 60 and the poor, would be covered by tax dollars.

Altogether, Biden’s plan is expected to cost the federal government $800 billion over the next 10 years. To pay for it, Biden proposes reversing President Trump’s tax cuts, which disproportionately helped high earners, and eliminating capital gains tax loopholes for the wealthy.

“Rather than tax the average American, the Democrats will try to redistribute wealth,” De Leon said.

“The elephant in the room is that taxes would have to be raised to pay for all these programs,” said Gary Price, MD, president of the Physicians Foundation. Because no one likes higher taxes, he says, architects of the Biden plan would try to find ways to save money, such as tamping down reimbursements for physicians, to try to avoid a public backlash against the reforms.

“Physicians’ great fear is that efforts to keep taxes from getting too high will result in cutting physician reimbursement,” he said.

Impact of COVID-19

Perhaps an even larger barrier to Biden’s health reforms comes from the COVID-19 crisis, which didn’t exist last year, when health reform was the central issue in the presidential primary that pitted Biden against Vermont Senator Bernie Sanders, the chief proponent of Medicare for All.

“The top two issues on voters’ minds right now are the pandemic and the economy,” said Daniel Derksen, MD, a family physician who is professor of public health policy at the University of Arizona in Tucson. “Any other concerns are pushed down the list.”

The COVID-19 crisis is forcing the federal government to spend trillions of dollars to help businesses and individuals who have lost income because of the crisis. Will there be enough money left over to fund an ambitious set of health reforms?

“It’s not a good time to start reforms,” warned Kevin Campbell, MD, a cardiologist in Raleigh, North Carolina. “Given the current pressures that COVID-19 has placed on physicians, healthcare systems, and hospitals, I don’t believe that we can achieve meaningful change in the near term.”

However, supporters of Biden’s reforms think that now, during the COVID-19 crisis, is precisely the right time to enact healthcare reform. When millions of Americans lost their jobs because of the pandemic, they also lost their insurance coverage.

“COVID-19 has made Biden’s healthcare agenda all the more relevant and necessary,” said Don Berwick, MD, who led the Center for Medicare & Medicaid Services (CMS) under President Obama. “The COVID-19 recession has made people more aware of how vulnerable their coverage is.”

Orrico at the neurosurgeons group acknowledges this point. “The COVID-19 pandemic has exposed some cracks in the US healthcare system,” she said. “Whether this will lead to new reforms is hard to say, but policymakers will likely take a closer look at issues related to unemployment, health insurance coverage, and healthcare costs due to the COVID-19 emergency.”

Many Physicians Want Major Reform

Although many doctors are skeptical of reform, others are impatient for reform to come and support Biden’s agenda ― especially its goal to expand coverage.

“Joe Biden’s goal is to get everyone covered,” said Alice Chen, MD, an internist who is a leader of Doctors for Biden, an independent group that is not part of the Biden campaign. “What brings Democrats together is that they are united in the belief that healthcare is a right.”

In January, the American College of Physicians (ACP) endorsed both Medicare for All and the public option. The US healthcare system “is ill and needs a bold new prescription,” the ACP stated.

The medical profession, once mostly Republican, now has more Democrats. In 2016, 35% of physicians identified themselves as Democrats, 27% as Republicans, and 36% as independents.

Many of the doctors behind reform appear to be younger physicians who are employed by large organizations. They are passionate about reforming the healthcare system, and as employees of large organizations, they would not be directly affected if reimbursements fell to Medicare levels ― although their institutions might subsequently have to adjust their salaries downward.

Chen, for example, is a young physician who says she has taken leave from her work as adjunct assistant clinical professor of medicine at the University of California, Los Angeles, to raise her young children.

She is the former executive director of Doctors for America, a movement of thousands of physicians and medical students “to bring their patients’ experiences to policymakers.”

“Doctors feel that they are unseen and unheard, that they often feel frankly used by large health systems and by insurance companies,” Chen said. “Biden wants to hear from them.”

Many idealistic young physicians look to health system leaders like Berwick. “I believe this nation needs to get universal coverage as fast as we can, and Biden’s policies present a path to get there,” the former CMS director said. “This would be done chiefly through Biden’s public option and his plans to expand coverage in states that have not adopted the ACA Medicaid expansion.”

But what about the potential effect of lowering reimbursement rates for doctors? “The exact rates will have to be worked out,” Berwick said, “but it’s not just about who pays physicians, it’s about how physicians get paid.” He thinks the current fee-for-service system needs to be replaced by a value-based payment system such as capitation, shared savings, and bundled payments.

The Biden-Sanders Task Force

Berwick was a member of the Biden-Sanders Unity Task Force, which brings together supporters of Biden and Sanders to create a shared platform for the Biden campaign.

The task force issued a report in early July that recommended a variety of healthcare reforms in addition to expanding access to care. One of them was to find ways to address the social determinants of health, such as housing, hunger, transportation, and pollution, which can harm health outcomes.

Chen specifically cites this provision. “We need to focus on the social determinants of heath and try to encourage better health,” she said. “I remember as a doctor advising a patient who was a young mother with several small children that she needed to exercise more. She asked me, ‘When am I supposed to exercise, and who will watch my kids?’ I realized the predicament that she was in.”

Price is also glad to see the provision in Biden’s plan. “Social determinants of health has been a key focus of the Physicians Foundation,” he said. “To my knowledge, this is the first time that a political candidate’s healthcare policy has included this point.

“Physicians are not in control of the social determinants of health, even though they affect their reimbursements,” he said. Under Medicare’s Merit-based Incentive Payment System, for example, doctors are penalized when their patients don’t meet certain health standards, such as when diabetes patients can’t get their A1C levels under control, he says.

However, Price fears that Biden, in his efforts to make peace with Sanders supporters, may have to some degree abandoned his moderate stance on health reform.

Is the Nation Ready for Another Health Reform Battle?

Clearly, many Democrats are ready to reform the system, but is the nation ready? “Are American voters ready for another major, Democratic-led health reform initiative?” asked Patricia Salber, MD, an internist and healthcare consultant who runs a blog called The Doctor Weighs In.

“I’ve been around long enough to remember the fight over President Clinton’s health plan and then President Obama’s plan,” she said. Each time, she says, there seemed to be a great deal of momentum, and then there was a backlash. “If Biden is elected, I hope we don’t have to go through the same thing all over again,” Salber said.

Derksen believes Biden’s proposed healthcare reforms could come close to rivaling President Obama’s Affordable Care Act in ambition, cost, and controversy.

He shares Biden’s goal of extending coverage to all ― including paying the cost of covering low-income people. But the result is that “Biden’s agenda is going to be a ‘heavy lift,’ as they say in Washington,” he said. “He has some very ambitious plans to expand access to care.”

Derksen speaks from experience. He helped draft part of the ACA as a health policy fellow in Capitol Hill in 2009. Then in 2011, he was in charge of setting up the ACA’s insurance marketplace for the state of New Mexico.

Now Biden wants to begin a second wave of health reform. But Derksen thinks this second wave of reform could encounter opposition as formidable as those Obama faced.

“Assuming that Biden is elected, it would be tough to get this agenda passed ― even if he had solid Democratic majorities in both the House and Senate,” said Derksen,

According to polls by the Kaiser Family Foundation (KFF), 53% of Americans like the ACA, while 37% dislike it ― a split that has been relatively stable for the past 2 years, since the failed GOP effort to repeal the law.

In that KFF poll, the public option fared better ― 68% of Americans support the public option, including 42% of Republicans. These numbers help explain why the Biden campaign moved beyond its support of the ACA to embrace the public option as well.

Even when Democrats gain control of all the levers of power, as they did in 2009, they still have a very difficult time passing an ambitious healthcare reform bill. Derksen remembers how tough it was to get that massive bill through Congress.

The House bill’s public option might have prevailed in a reconciliation process between the two bills, but that process was cut short when Sen. Ted Kennedy died and Senate Democrats lost their filibuster-proof majority. The bill squeaked through as the Senate version, without the public option.

The ACA Has Survived-But at What Cost?

The ACA is much more complex piece of legislation than the public option.

“The ACA has survived for a decade, despite all efforts to dismantle it,” Salber said. “Biden wants to restore a law that the Republicans have been chipping away at. The Republicans eliminated the penalty for not having coverage. Think about it, a penalty of zero is not much of a deterrent.”

It was the loss of the ACA penalty in tax year 2019 that, paradoxically, formed the legal basis for the latest challenge of the ACA before the Supreme Court, in a suit brought by the Trump administration and 18 Republican state attorneys general.

The Supreme Court will make its ruling after the election, but Salber thinks the suit itself will boost both Biden and the ACA in the campaign. “I think most people are tired of all the attempts to repeal the ACA,” she said.

“The public now thinks of the US healthcare system as pathetically broken,” she added. “It used to be that Americans would say we have the best healthcare system in the world. I don’t hear that much anymore.”

Physicians who oppose the ACA hold exactly the opposite view. “Our healthcare system is in shambles after the Obamacare fiasco,” Campbell said. “Even if Biden has a Democrat-controlled House and Senate, I still don’t think that there would be enough votes to pass sweeping changes to healthcare.”

Biden Could Choose Issues Other Than Expanding Access

There are plenty of proposals in the Biden healthcare plan that don’t involve remaking the healthcare system.

These include making COVID-19 testing free, providing extra funding for community health centers, and stopping surprise billing. Proposals such as stepping up antitrust enforcement against mergers would involve administrative rather than Congressional action.

Some of these other proposals could be quite expensive, such as overhauling long-term care and paying for health insurance for laid-off workers. And another proposal ― limiting the prices of pharmaceuticals ― could be almost as contentious as expanding coverage.

“This proposal has been talked about for many years, but it has always met with strong resistance from drug makers,” said Robert Pearl, MD, former CEO of the Permanente Medical Group and now a faculty member at Stanford School of Medicine and Graduate School of Business.

Pearl thinks the first item in Biden’s drug plan ― to repeal a ban against Medicare negotiating drug prices with drug makers ― would meet with Congressional resistance, owing to heavy lobbying and campaign contributions by the drug companies.

In addition, Pearl thinks Biden’s plans to limit drug prices ― barring drug makers from raising their prices above the general inflation rate and limiting the launch prices for many drugs ― enter uncharted legal waters and could end up in the courts.

Even Without Reform, Expect Lower Reimbursements

Although many doctors are concerned that Biden’s healthcare reforms would reduce reimbursements, Pearl thinks reimbursements will decline even without reforms, owing in part to the COVID-19 pandemic.

Employer-based health insurance has been the bedrock of the US healthcare system, but Pearl says many employers have long wanted to get rid of this obligation. Increasingly, they are pushing costs onto the employee by raising deductibles and through premium sharing.

Now, with the pandemic, employers are struggling just to stay in business, and health insurance has truly become a financial burden, he says. In addition, states will be unable to balance their budgets and will try to reduce their Medicaid obligations.

“Before COVID-19 hit, healthcare spending was supposed to grow by 5% a year, but that won’t happen for some time into the future,” Pearl said. “The COVID economic crisis is likely to continue for quite some time, forcing physicians to either accept much lower payments or find better ways to provide care.”

Like Berwick, Pearl believes healthcare will have to move to value-based payments. “Instead of producing more services, doctors will have to preserve resources, which is value-based healthcare,” he said. The primary form of value-based reimbursement, Pearl thinks, will be capitation, in which physicians agree to quality and service guarantees.

Even steadfast opponents of many of Biden’s reforms foresee value-based payments taking off. “Certainly, there are ways to improve the current healthcare system, such as moving to value-based care,” said Orrico at the neurosurgeons’ group.

In short, a wide swath of observers agree that doctors are facing major changes in the payment and delivery of healthcare, regardless of whether Biden is elected and succeeds with his health agenda.

Notice that no one has mentioned tort reform in healthcare. Why Not???????

Trump health officials “not aware” of how he would replace Obamacare; and what about the Vaccines?

Trump health officials “not aware” of how he would replace Obamacare; and what about the Vaccines?

It is truly amazing how out of touch the GOP and, I believe President Trump is, on health care, especially “after” or during this COVID pandemic. Consider the amount of monies spent on caring for the millions of patients diagnosed with COVID-19. One must remember that due to the EMTALA Act, which ensures public access to emergency services regardless of ability to pay. Think of all the COVID testing and ICU care that has been provided for all that needed it. This experience, etc. should convince, even the clueless that we need a type of universal health care policy.

They, the GOP and the President, promised us all that they would create, provide a wonderful healthcare for all, better than Obamacare. But have they? No!

And now is the time to produce a well-designed alternative, or consider Obamacare as a well thought out program, except for the lack of financial sustainability. And guess what happened after I had a phone call with a member of the Trump administration. He asked me what I thought Trump’s chances of winning re-election. I responded that I thought he had about a 20% chance of getting re-elected. He pressed me as what I thought that would increase his chances. My response was to finally reveal their, the GOP/Trump’s

, plan and I suggested that they should adopt the Affordable Care Act but outline a plan to sustainably finance the healthcare plan.

My suggestion- embrace the Affordable Care Act as a good starting point and use a federal sales tax to finance it instead of putting the onus on the young healthy workers.

 At a hearing on the coronavirus response, Senator Dick Durbin asked the Trump administration’s top health officials about the president’s comments touting a plan to replace the Affordable Care Act, also known as Obamacare. They said they did not know about such a plan.

And a Republican victory in Supreme Court battle could mean millions lose health insurance in the middle of a pandemic.

John T. Bennett noted that Ruth Bader Ginsburg, Barack Obama, Donald Trump and Mitch McConnell could soon be forever linked if the late Supreme Court justice’s death leads to the termination of the 44th president’s signature domestic policy achievement: the Affordable Care Act

All sides in the coming battle royal over how to proceed with filling the high court seat she left behind are posturing and pressuring, floating strategic possibilities and offering creative versions of history and precedent. Most Republicans in the Senate want to hold a simple-majority floor vote on a nominee Mr. Trump says he will announce as soon as this week before the end of the calendar year. Democrats say they are hypocrites because the blocked a Barack Obama high court pick during his final year.

It appears Democrats have only extreme options as viable tactics from preventing confirmation hearings and a floor vote before this unprecedented year is up. Speaker Nancy Pelosi on Sunday refused to rule bringing articles of impeachment against the president or even William Barr, his attorney general whom the Democrats say has improperly used his office to help Mr. Trump’s friends and use federal law enforcement unjustly against US citizens.

Unless Ms Pelosi pulls that politically dangerous lever, the maneuvering of the next few weeks most likely will end after Congress returns after the 3 November election with a high court with a 6-3 conservative bend. Analysts already are warning that conservatives appear months away from being able to partially criminalize abortion and also take down the 2011 Affordable Care Act, also known as Obama care.

Democrats have sounded off since Ms. Ginsburg’s death to warn that millions of Americans could soon lose their health insurance, especially those with pre-existing conditions. Last year, 8.5m people signed up for coverage using the Affordable Care Act, according to the Congressional Budget Office.

“Healthcare in this country hangs in the balance,” Joe Biden, who is the Democratic nominee for president and was vice president when Mr. Obama signed the health plan now linked to his name into law, said on Sunday.

Mr. Biden accused Republicans of playing a “game” by rushing the process to replace Ms. Ginsburg on the court because they are “trying to strip healthcare away from tens of millions of families.”

Doing so, he warned, would “strip away their peace of mind” because insurance providers would no longer be required to give some Americans policies. Should a 6-3 court decide to uphold a lower court’s ruling that the 2011 health law be taken down, those companies would “drop coverage completely for folks with pre-existing conditions,” Mr. Biden warned in remarks from Philadelphia.

“If Donald Trump has his way, the complications from Covid-19 … would become the next deniable pre-existing condition for millions of Americans.” That means they would lose their health insurance and be forced to either pay for care out of their pocket or use credit lines. Both could force millions into medical bankruptcy or otherwise create dire financial hardships.

Mr. Trump about a month ago promised to release a new healthcare plan that, if ever passed by both chambers of Congress and signed into law, would replace Obamacare.

So far, however, he has yet to unveil that alleged plan.

Trump Press Secretary Kayleigh McEnany told reporters last week that the White House’s Domestic Policy Council is leading the work on the plan. But when pressed for more details, she chose to pick a fight with a CNN reporter.

“I’m not going to give you a readout of what our healthcare plan looks like and who’s working on it,” Ms. McEnany said. “If you want to know, if you want to know, come work here at the White House.”

When pressed, Ms. McEnany said “stakeholders here in the White House” are working on a plan the president has promised for several years. “And, as I told you, our Domestic Policy Council and others in the White House are working on a healthcare plan,” she insisted, describing it as “the president’s vision for the next five years.”

The president frequently mentions healthcare during his rowdy campaign rallies, but only in general terms. He promises a sweeping plan that will bring costs down across the board and also protect those with pre-existing conditions. But he mostly brings it up to hammer Mr. Obama and Mr. Biden for pushing a flawed law that he has been forced to tinker with to make it function better for consumers.

Broad brush

His top spokeswoman echoed those broad strokes during a briefing on Wednesday. “In aggregate, it’s going to be a very comprehensive strategy, one where we’re saving healthcare while Democrats are trying to take healthcare away,” she told reporters. “We’re making healthcare better and cheaper, guaranteeing protections for people with preexisting conditions, stopping surprise medical billing, increasing transparency, defending the right to keep your doctor and your plan, fighting lobbyists and special interests, and making healthier and making, finding cures to diseases.”

If there is a substantive plan that would protect millions with pre-existing conditions and others affected by Covid-19, it would have made a fine backbone of Mr. Trump’s August Republican National Committee address in which he accepted his party’s presidential nomination for a second time. But healthcare was not the major focus, even though it ranks in the top two issues – along with the economy – in just about every poll that asks voters to rank their priorities in deciding between Mr. Trump and Mr. Biden.

If there is a coming White House healthcare plan that would protect those with pre-existing conditions and prevent millions from losing coverage as the coronavirus pandemic is ongoing, the president is not using his campaign rallies at regional airport hangars to describe or promote it.

“We will strongly protect Medicare and Social Security and we will always protect patients with pre-existing conditions,” said at a campaign stop Saturday evening in Fayetteville, North Carolina, before pivoting to a completely unrelated topic: “America will land the first woman on the moon, and the United States will be the first nation to land an astronaut on Mars.”

The push to install a conservative to replace the liberal Ms. Ginsburg and the lack of any expectation Mr. Trump has a tangible plan has given Democrats a new election-year talking point less than two months before all votes must be cast.

“Whoever President Trump nominates will strike down the Affordable Care Act,” Hawaii Democratic Senator Mazie Hirono told MSNBC on Sunday. “It will throw millions of people off of healthcare, won’t protect people with pre-existing conditions. It will be disastrous. That’s why they want to rush this.”

 About 1 In 5 Households in U.S. Cities Miss Needed Medical Care During Pandemic

Patti Neighmond noted that when 28-year-old Katie Kinsey moved from Washington, D.C., to Los Angeles in early March, she didn’t expect the pandemic would affect her directly, at least not right away. But that’s exactly what happened.

She was still settling in and didn’t have a primary care doctor when she got sick with symptoms of what she feared was COVID-19.

“I had a sore throat and a debilitating cough,” she says, “and when I say debilitating, I mean I couldn’t talk without coughing.” She couldn’t lie down at night without coughing. She just wasn’t getting enough air into her lungs, she says.

Kinsey, who works as a federal consultant in nuclear defense technology, found herself coughing through phone meetings. And then things got worse. Her energy took a dive, and she felt achy all over, “so I was taking naps during the day.” She never got a fever but worried about the coronavirus and accelerated her effort to find a doctor.

No luck.

She called nearly a dozen doctors listed on her insurance card, but all were booked. “Some said they were flooded with patients and couldn’t take new patients. Others gave no explanation, and just said they were sorry and could put me on a waiting list.” All the waiting lists were two to three months’ long.

Eventually Kinsey went to an urgent care clinic, got an X-ray and a diagnosis of severe bronchitis — not COVID-19. Antibiotics helped her get better. But she says she might have avoided “months of illness and lost days of work” had she been able to see a doctor sooner. She was sick for three months.

Kinsey’s experience is just one way the pandemic has delayed medical care for Americans in the last several months. A poll of households in the four largest U.S. cities by NPR, the Robert Wood Johnson Foundation and Harvard’s T.H. Chan School of Public Health finds roughly one in every five have had at least one member who was unable to get medical care or who has had to delay care for a serious medical problem during the pandemic (ranging from 19% of households in New York City to 27% in Houston).

We had people come in with heart attacks after having chest pain for three or four days, or stroke patients who had significant loss of function for several days, if not a week.

There were multiple reasons given. Many people reported, like Kinsey, that they could not find a doctor to see them as hospitals around the U.S. delayed or canceled certain medical procedures to focus resources on treating COVID-19.

Other patients avoided critically important medical care because of fears they would catch the coronavirus while in a hospital or medical office.

“One thing we didn’t expect from COVID was that we were going to drop 60% of our volume,” says Ryan Stanton, an emergency physician in Lexington, Ky., and member of the board of directors of the American College of Emergency Physicians.

“We had people come in with heart attacks after having chest pain for three or four days,” Stanton says, “or stroke patients who had significant loss of function for several days, if not a week. And I’d ask them why they hadn’t come in, and they would say almost universally they were afraid of COVID.”

Stanton found that to be particularly frustrating, because his hospital had made a big effort to communicate with the community to “absolutely come to the hospital for true emergencies.”

He describes one patient who had suffered at home for weeks with what ended up being appendicitis. When the patient finally came to the emergency room, Stanton says, a procedure that normally would have been done on an outpatient basis “ended up being a very much more involved surgery with increased risk of complications because of that delay.”

The poll finds a majority of households in leading U.S. cities who delayed medical care for serious problems say they had negative health consequences as a result (ranging from 55% in Chicago to 75% in Houston and 63% in Los Angeles).

Dr. Anish Mahajan, chief medical officer of the large public hospital Harbor-UCLA Medical Center in Los Angeles, says the number of emergencies showing up in his hospital have been down during the pandemic, too, because patients have been fearful of catching the coronavirus there. One case that sticks in his mind was a middle aged woman with diabetes who fainted at home.

“Her blood sugar was really high, and she didn’t feel well — she was sweating,” the doctor recalls. “The family called the ambulance, and the ambulance came, and she said, ‘No, no, I don’t want to go to the hospital. I’ll be fine.’ “

By the next day the woman was even sicker. Her family took her to the hospital, where she was rushed to the catheterization lab. There doctors discovered and dissolved a clot in her heart. This was ultimately a successful ending for the patient, Mahajan says, “but you can see how this is very dangerous — to avoid going to the hospital if you have significant symptoms.”

He says worrisome reports from the Los Angeles County coroner’s office show the number of people who have died at home in the last few months is much higher than the average number of people who died in their homes before the pandemic.

“That’s yet another signal that something is going on where patients are not coming in for care,” Mahajan says. “And those folks who died at home may have died from COVID, but they may also have died from other conditions that they did not come in to get cared for.”

Like most hospitals nationwide, Harbor-UCLA canceled elective surgeries to make room for coronavirus patients — at least during the earliest months of the pandemic, and when cases surged.

In NPR’s survey of cities, about one-third of households in Chicago and Los Angeles and more than half in Houston and New York with a household member who couldn’t get surgeries or elective procedures said it resulted in negative health consequences for that person.

“Back in March and April the estimates were 80[%] to 90% of normal [in terms of screenings for cancer]” at Memorial Sloan Kettering Cancer Center in New York, says Dr. Jeffrey Drebin, who heads surgical oncology there.

“Things like mammograms, colonoscopies, PSA tests were not being done,” he says. At the height of the pandemic’s spring surge in New York City, Drebin says, he was seeing many more patients than usual who had advanced disease.

“Patients weren’t being found at routine colonoscopy,” he says. “They were coming in because they had a bleeding tumor or an obstructing tumor and needed to have something done right away.”

In June, during patients’ information sessions with the hospital, Drebin says patients typically asked if they could wait a few months before getting a cancer screening test.

“In some cases, you can, but there are certainly types of cancer that cannot have surgery delayed for a number of months,” he explains. With pancreatic or bladder cancer, for example, delaying even a month can dramatically reduce the opportunity for the best treatment or even a cure.

Reductions in cancer screening, Drebin says, are likely to translate to more illness and death down the road. “The estimate,” he says, “is that simply the reduction this year in mammography and colonoscopy [procedures] will create 10,000 additional deaths over the next few years.”

And even delays in treatment that aren’t a matter of life and death can make a big difference in the quality of a life.

For 12-year-old Nicolas Noblitt, who lives in Northridge, Calif., with his parents and two siblings, delays in treatment this year have dramatically reduced his mobility.

Nicolas has cerebral palsy and has relied on a wheelchair most of his life. The muscles in his thighs, hips, calves and even his feet and toes get extremely tight, and that “makes it hard for him to walk even a short distance with a walker,” says his mother, Natalie Noblitt. “So, keeping the spasticity under control has been a major project his whole life to keep him comfortable and try to help him gain the most mobility he can have.”

Before the pandemic, Nicolas was helped by regular Botox injections, which relaxed his tight muscles and enabled him to wear shoes.

As Nicolas says, “I do have these really cool shoes that have a zipper … and they really help me — because, one, they’re really easy to get on, and two, they’re cool shoes.” Best of all, he says they stabilize him enough so he can walk with a walker.

“I love those shoes and I think they sort of love me, too, when you think about it,” he tells NPR.

Nicolas was due to get a round of Botox injections in early March. But the doctors deemed it an elective procedure and canceled the appointment. That left him to go months without a treatment.

His muscles got so tight that his feet would uncontrollably curl.

“And when it happens and I’m trying to walk … it just makes everything worse,” Nicolas says, “from trying to get on the shoes to trying to walk in the walker.”

Today he is finally back on his Botox regimen and feeling more comfortable — happy to walk with a walker. Even so, says his mom, the lapse in treatment caused setbacks. Nicolas has to work harder now, both in day-to-day activities and in physical therapy.

‘Warp Speed’ Officials Debut Plan for Distributing Free Vaccines

Despite the president’s statements about military involvement in the vaccine rollout, officials said that for most people, “there will be no federal official who touches any of this vaccine.”

Katie Thomas reported that Federal officials outlined details Wednesday of their preparations to administer a future coronavirus vaccine to Americans, saying they would begin distribution within 24 hours of any approval or emergency authorization, and that their goal was that no American “has to pay a single dime” out of their own pocket.

The officials, who are part of the federal government’s Operation Warp Speed — the multiagency effort to quickly make a coronavirus vaccine available to Americans — also said the timing of a vaccine was still unclear, despite repeated statements by President Trump that one could be ready before the election on Nov. 3.

“We’re dealing in a world of great uncertainty. We don’t know the timing of when we’ll have a vaccine, we don’t know the quantities, we don’t know the efficacy of those vaccines,” said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services. “This is a really quite extraordinary, logistically complex undertaking, and a lot of uncertainties right now. I think the message we want you to leave with is, we are prepared for all of those uncertainties.”

The officials said they were planning for initial distribution of a vaccine — perhaps on an emergency basis, and to a limited group of high-priority people such as health care workers — in the final three months of this year and into next year. The Department of Defense is providing logistical support to plan how the vaccines will be shipped and stored, as well as how to keep track of who has gotten the vaccine and whether they have gotten one or two doses.

However, Mr. Mango said that there had been “a lot of confusion” about what the role of the Department of Defense would be, and that “for the overwhelming majority of Americans, there will be no federal official who touches any of this vaccine before it’s injected into Americans.”

Army Lt. Gen. Paul Ostrowski said Operation Warp Speed was working to link up existing databases so that, for example, a patient who received a vaccine at a public health center in January could go to a CVS pharmacy 28 days later in another state and be assured of getting the second dose of the right vaccine.

Three drug makers are testing vaccine candidates in late-stage trials in the United States. One of those companies, Pfizer, has said that it could apply for emergency authorization as early as October, while the other two, Moderna and AstraZeneca, have said they hope to have something before the end of the year.

Coronavirus vaccine study by Pfizer shows mild-to-moderate side effects

Pfizer Inc said on Tuesday participants were showing mostly mild-to-moderate side effects when given either the company’s experimental coronavirus vaccine or a placebo in an ongoing late-stage study.

The company said in a presentation to investors that side effects included fatigue, headache, chills and muscle pain. Some participants in the trial also developed fevers – including a few high fevers. The data is blinded, meaning Pfizer does not know which patients received the vaccine or a placebo. Kathrin Jansen, Pfizer’s head of vaccine research and development, stressed that the independent data monitoring committee “has access to unblinded data so they would notify us if they have any safety concerns and have not done so to date.”

The company has enrolled more than 29,000 people in its 44,000-volunteer trial to test the experimental COVID-19 vaccine it is developing with German partner BioNTech. Over 12,000 study participants had received a second dose of the vaccine, Pfizer executives said on an investor conference call.

The comments follow rival AstraZeneca’s COVID-19 vaccine trials being put on hold worldwide on Sept. 6 after a serious side effect was reported in a volunteer in Britain.

AstraZeneca’s trials resumed in Britain and Brazil on Monday following the green light from British regulators, but remain on hold in the United States.

Pfizer expects it will likely have results on whether the vaccine works in October. “We do believe – given the very robust immune profile and also the preclinical profile … that vaccine efficacy is likely to be 60% or more,” Pfizer’s Chief Scientific Officer Mikael Dolsten said.

Rushing the COVID-19 Vaccine Could Have Serious and Fatal Side Effects

Jason Silverstein noted that States have been told by the Centers for Disease Control and Prevention they should prepare for a coronavirus vaccine by “late October or early November,” according to reports last Wednesday. But an untested coronavirus vaccine may have serious and fatal side effects, could even make the disease worse, and may very well have an effect on the election.

What’s the worst that could happen if we give an untested vaccine to millions of people?

We received a reminder today, when one of the leading large coronavirus vaccine trials by AstraZeneca and Oxford University was paused due to a “suspected serious adverse reaction.” There are eight other potential coronavirus vaccines that have reached Phase 3, which is the phase that enrolls tens of thousands of people and compares how they do with the vaccine against people who only get a placebo. Those eight include China’s CanSino Biologics product that was approved for military use without proper testing back in July, and Russia’s coronavirus vaccine that has been tested in only 76 people.

If the CDC distributes an untested coronavirus vaccine this Fall, it would be the largest drug trial in history—with all of the risks and none of the safeguards.

“Approving a vaccine without testing would be like climbing into a plane that has never been tested,” said Tony Moody, MD, director of the Duke Collaborative Influenza Vaccine Innovation Centers. “It might work, but failure could be catastrophic.”

One concern about this vaccine is that it’s tracking to be an “October surprise.” From Henry Kissinger’s “peace is at hand” speech regarding a ceasefire in Vietnam less than two weeks before the 1972 election to former FBI Director James Comey’s letter that he would reopen the investigation into Hillary Clinton’s emails, October surprises have always had the potential to shift elections. But never before have they had the potential to catastrophically shift the health of an already fragile nation.

If there is an October surprise in the form of an untested coronavirus vaccine, it won’t be the first time that a vaccine was rushed out as a political stunt to increase an incumbent president’s election chances.

What happened with the last vaccine rush?

On March 24, 1976, in response to a swine flu outbreak, President Gerald Ford asked Congress for $135 million for “each and every American to receive an inoculation.”

How badly did the Swine Flu campaign of 1976 go? Well, one of the drug companies made two million doses of the wrong Swine Flu vaccine, vaccines weren’t exactly effective for people under 24, and insurance companies said, no way, they didn’t want to be liable for the science experiment of putting this vaccine into 120 million bodies.

By December, the Swine Flu vaccination program was suspended when people started to develop Guillain-Barré Syndrome, a rare neurological condition whose risk was seven times higher in people who got the vaccine and which paralyzed more than 500 people and killed at least 25.

What else can go wrong when vaccines are rushed

“Vaccines are some of the safest medical products in the world, but there can be serious side effects in some instances that are often only revealed by very large trials,” said Kate Langwig, Ph.D., an infectious disease ecologist at Virginia Tech.

One of the other possible side effects is known as vaccine enhancement, the very rare case when the body makes antibodies in response to a vaccine but the antibodies help a second infection get into cells, something that has been seen in dengue fever. “The vaccine, far from preventing Covid-19, might turn out to make a patient’s disease worse,” said Nir Eyal, D.Phil., a bioethics professor at Rutgers University.

We do not know whether a coronavirus vaccine might cause vaccine enhancement, but we need to. In 1966, a vaccine trial against respiratory syncytial virus, a disease that many infants get, caused more than 80 percent of infants and children who received the vaccine to be hospitalized and killed two.

All of these risks can be prevented, but safety takes patience, something that an American public which has had to bury more than 186,000 is understandably short on and Trump seems to be allergic to.

“To put this into perspective, the typical length of making a vaccine is fifteen to twenty years,” said Paul Offit, MD, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. Offit’s laboratory developed a vaccine for rotavirus, a disease that kills infants. That process began in the 1980s and wasn’t completed until 2006. The first scientific papers behind the HPV vaccine, for example, were published in the early 1990’s, but the vaccine wasn’t licensed until 2006.

An untested vaccine may also prove a deadly distraction. “An ineffective vaccine could create a false sense of security and perhaps reduce the emphasis on social distancing, mask wearing, hand hygiene,” said Atul Malhotra, MD, a pulmonologist at the UC San Diego School of Medicine.

Other issues with inadequately tested vaccines

Even worse, an untested vaccine may have consequences far beyond the present pandemic. Even today, one poll shows that only 57% of people would take a coronavirus vaccine. (Some experts argue that we need 55 to 82% to develop herd immunity.)

If we don’t get the vaccine right the first time, there may not be enough public trust for a next time. “Vaccines are a lot like social distancing. They are most effective if we work cooperatively and get a lot of people to take them,” said Langwig. “If we erode the public’s trust through the use of unsafe or ineffective vaccines, we may be less likely to convince people to be vaccinated in the future.”

“You don’t want to scare people off, because vaccines are our way out of this,” said Dr. Offit.

So, how will you be able to see through the fog of the vaccine war and know when a vaccine is safe to take? “Data,” said Dr. Moody, “to see if the vaccine did not cause serious side effects in those who got it, and that those who got the vaccine had a lower rate of disease, hospitalization, death, or any other metric that means it worked. And we really, really want to see that people who got the vaccine did not do worse than those who did not.

And finally, don’t forget to get your Flu vaccine, now!

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!!

Pandemic fears are boosting demand for trustworthy news; And What Have We Learned from Sweden’s Experience?

During these last few months of the pandemic one of my concerns is the lack consistent reliable data with which the media pundits of all sorts deliver their predictions and many times with false knowledge and predictions. Question, what is the correct social distancing length? Studies keep on changing! One of the key features of the web is its ability to turn regular people into citizen journalists. The cost of publishing text on the web is almost nil. The barriers to entry in the media industry are low, too. And many readers are not picky about where their news comes from: the stories that go viral can come from amateur scribes or veteran ones, media startups or established outfits. But this is not always the case. New research suggests that when a crisis hits, readers turn to reliable sources.

In 2018 Paul Resnick and James Park, two researchers at the University of Michigan, devised a pair of tools for measuring the popularity of English-language news stories on Facebook and Twitter. The first, dubbed the “Mainstream Quotient”, measured the proportion of highly-shared links that came from mainstream news sources, such as the New York Times, the BBC and, yes, The Economist. The second, the “Iffy Quotient”, measured the share originating from less trustworthy sources, based on ratings provided by NewsGuard, a company that tracks misinformation published online.

Both indices have shifted significantly during the pandemic. Beginning in February, when the coronavirus started to spread outside China, traffic to traditional media outlets and news sites surged, whereas dodgier sites attracted fewer readers. The Mainstream Quotient rose steadily during this period, a phenomenon Messrs Resnick and Park call a “flight to quality”. The Iffy Quotient, meanwhile, tumbled. The drop was particularly steep during March, when many countries instituted lockdown measures (see chart).

The researchers argue that consumers seek out reliable news sources during times of uncertainty, in the same way that fearful investors turn to gold. Whether these patterns will last remain unclear. The Iffy Quotient has already started to creep back up, for both Facebook and Twitter. And recent efforts by social-media platforms to crack down on fake news may prove only temporary. Once the pandemic subsides, demand for unreliable news may return to pre-covid levels. For now, at least, the flight to quality has taken off.

Pandemic Spike in Telehealth Levels Off

Crystal Phend of MedPage pointed out that Telehealth’s early bonanza during the pandemic has given way to persistently elevated use in primary care, a Department of Health and Human Services (HHS) report showed.

Analysis of Medicare fee-for-service (FFS) data showed an increase in Medicare primary care visits from 0.1% of all primary care in February to 43.5% in April, representing an increase from about 2,000 to 1.28 million telehealth visits per week.

Meanwhile, there was a “precipitous” drop in in-person visits for primary care in mid-March as COVID-19 took hold in the U.S., then a rise from mid-April through May, according to the report from the Office of the Assistant Secretary for Planning and Evaluation.

Use of telehealth in primary care “declined somewhat but appears to have leveled off at a persistent and significant level by the beginning of June,” the report noted. It still accounted for 22.7% of Medicare beneficiaries’ primary care visits as of June 3rd.

Overall, weekly primary care visit rates have not yet returned to pre-pandemic levels.

“Based on early experience with Medicare primary care telehealth at the start of the COVID-19 public health emergency, there is evidence that Medicare’s new telehealth flexibilities played a critical role in helping to maintain access to primary health care services — when many beneficiaries and providers were concerned with transmission of COVID-19,” the authors noted. “The stable and sustained use of telehealth after in-person primary care visits started to resume in mid-April suggests there may be continued demand for telehealth in Medicare, even after the pandemic ends.”

The findings overall match those from healthcare provider databases suggesting a 60% to 70% drop in health care office visits, partially offset by telehealth visits, with the start of the pandemic. Drug market research firm IQVIA has reported from physician surveys that about 9% of patient interactions were via telehealth prior to the pandemic but 51% during the shutdown, with expectation of a 21% rate after the pandemic, the HHS report noted.

There have been calls for Medicare to make the loosened rules around telemedicine permanent, and some legislative movement in that direction, but private insurers have signaled the opposite.

Fred Pelzman, MD, an internal medicine physician at Weill Cornell Medicine in New York City (and MedPage Today columnist), said an informal survey of his patients indicated they would be willing to do up to 50% of their care via video tools.

“We went from a handful of video visits in our practice to several thousand over the course of the months,” he said. “It’s a great way to take care of people, kept a lot of people safe, we think. What has happened is that as we started to open our practice back up again and offer appointments, the floodgates have opened and patients are declining video visits.”

Those patients opting for in-person visits tend to be older, braving what feels like a quiet time in the pandemic for the state to take care of necessary visits, he noted. “I think ultimately that we’ll plateau. It will probably come down a little more.”

The study included Medicare FFS Part B claims from January through May 2020 for primary care services along with preliminary Medicare Part B primary care claims data up to June 3. Primary care services included evaluation and management, preventive services, and advance care planning.

Telehealth usage increased most in urban counties early in the pandemic and saw smaller declines in May compared with rural counties across the country. Among cities, Boston had the greatest proportion of primary care visits by telehealth (73.1%) and Phoenix the lowest (37%).

Notably, the rate “was not strongly associated with differences in COVID-19 severity across cities as measured by rate of hospitalizations per thousand Medicare FFS beneficiaries,” the report pointed out.

I read an article predicting that telehealth visits are the future of medicine. This is truly worrisome due to the many incorrect diagnoses as well as poor control of chronic diseases that I have seen coming through my office alone. Physical diagnosis is made by looking at the patient, listening to the patient, hearing what the patient is really saying, touching the patient and using the different diagnostic tools such stethoscopes, ophthalmoscopes, otoscopes, percussion hammers, etc. to make the correct diagnoses and to follow our patients. How is that done virtually? The only ones benefitting the most from these virtually visits are the practices and the electronic medical record companies selling the practices additional software to utilize telehealth. And patients are finding that not all telehealth “visits” are paid for by their insurance companies.

How Did Sweden Flatten Its Curve Without a Lockdown?

One expert credits a “good-enough strategy”; others worry that it won’t last. Who is correct?

Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage reported that

Despite never implementing a full-scale lockdown, Sweden has managed to flatten its curve, prompting its health leadership to claim victory — but others question the cost of the strategy, as the country has a far higher death toll than its Scandinavian neighbors.

In late July, Sweden’s 7-day moving average of new cases was about 200, down from a peak of around 1,140 in mid-June. Its daily death totals have been in the single digits for two weeks, well below its mid-April peak of 115 deaths in a single day.

However, on a per-capita basis, Sweden far outpaces its Scandinavian neighbors in COVID deaths, with 567 deaths per million people compared with Denmark’s 106 deaths per million, Finland’s 59 deaths per million, and Norway’s 47 deaths per million. The Swedish figure is closer to Italy’s 581 deaths per million.

While the positive trends have led Anders Tegnell, PhD, chief epidemiologist at the Swedish Public Health Agency and architect of Sweden’s coronavirus strategy, to state that the “Swedish strategy is working,” others have criticized the approach, including two dozen Swedish academics who published a recent USA Today editorial.

“In Sweden, the strategy has led to death, grief, and suffering,” they wrote. “On top of that, there are no indications that the Swedish economy has fared better than in many other countries. At the moment, we have set an example for the rest of the world on how not to deal with a deadly infectious disease.”

The Swedish Public Health Agency has not openly stated that herd immunity was its goal, though many suspect that this was the intention. Tegnell told reporters last week he thought the recent trends indicated that immunity was now widespread in the country. But with rates of antibody positivity around 10%, that seems impossible. (Officials at the agency did not respond to MedPage Today‘s request for comment.)

So how has Sweden managed to get its outbreak under control?

Behavior Change

While Sweden didn’t officially lock down, many in the country have described a locked-down “feeling” that has eased in the summer months.

At the start of the outbreak, only high schools and universities closed; daycare and elementary schools have been open. Businesses have also remained open, but typically at reduced hours, and restaurants have functioned at reduced capacity.

Swedes have been asked to keep their distance in public, refrain from non-essential travel, and work from home when possible. Gatherings of more than 50 people are also banned. People age 70 and over are advised to stay away from others as much as possible.

Masks were never required and aren’t commonly worn.

This response hasn’t changed over time, through the June surge and into today’s decline, so there’s no definitive explanation for the flattening, though, and experts have several theories.

“Swedes in general have changed their behavior to a great extent during the pandemic and the practice of social distancing as well as physical distancing in public places and at work has been widespread,” said Maria Furberg, MD, PhD, an infectious diseases expert at Umea University Hospital in northeastern Sweden.

“During the months of March to early June, all shops were practically empty, people stopped dining with friends, and families stopped seeing even their closest relatives,” Furberg told MedPage Today. “A lock-down could not have been more effective. Handwashing, excessive use of hand sanitizers, and staying home at the first sign of a cold became the new normal very quickly.”

Mozhu Ding, PhD, an epidemiologist at the famed Karolinska Institute, said the decline is “likely to be a combination of measures taken by individuals, businesses and a widespread information campaign launched by the government.”

“Even without a strict lockdown order, many businesses allowed employees to work from home, and universities are offering distance courses to the students,” Ding told MedPage Today. “Individuals are also taking personal hygiene more seriously, as items like hand sanitizers and single-use gloves are often sold out in pharmacies and grocery stores.”

Immunity

Experts told MedPage Today there weren’t clear data to prove Tegnell’s assertion of widespread immunity in Sweden.

Furberg said there is likely “some sort of unspecific immunity that protects parts of the population from contracting COVID-19” but it’s not necessarily secondary to SARS-CoV-2 exposure.

For instance, a study by the Karolinska Institute and Karolinska University Hospital recently found that about 30% of people with mild or asymptomatic COVID showed T-cell-mediated immunity to the virus, even though they tested negative for antibodies.

“This figure is [more than] twice as high as the previous antibody tests, meaning that the public immunity to COVID-19 is probably much higher than what antibody studies have suggested,” Ding told MedPage Today. “This is of course very good news from a public health perspective, as it shows that people with negative antibody test results could still be immune to the virus at a cellular level.”

Indeed, T-cell immunity is coming into focus as a potentially important factor in COVID infection. A paper published in Nature in mid-July found that among 37 healthy people who had no history of either the first or current SARS virus, more than half had T cells that recognized one or more of the SARS-CoV-2 proteins.

Another 36 people who had mild-to-severe COVID-19 were all found to have T-cell responses to several SARS-CoV-2 proteins, and another 23 people who had SARS-CoV-1 (the virus responsible for the SARS outbreak in 2003) all had lasting memory T cells — even 17 years later — that also recognized parts of SARS-CoV-2.

It could be that T cell immunity is the result of a previous infection with common cold coronaviruses, but this hasn’t yet been established; nor is it certain that T cell immunity is driving Sweden’s decline in COVID cases.

Path Forward

Summertime is another factor that may account for the decline, which began around late June — not directly because of the weather, but social factors related to it.

Swedes are “outdoors more, and students are not at school,” said Anne Spurkland, MD, a professor of immunology at the University of Oslo in Norway.

Also, “perhaps Sweden has finally gotten better control over the disastrous spread of the virus in nursing homes which to some extent can explain their relatively high death rates,” Spurkland told MedPage Today. About half of Sweden’s 5,730 deaths occurred among those in elder care homes.

Norway is still requiring that Swedes quarantine for 10 days when coming into Norway, and Denmark has not fully reopened its borders to its neighbor yet either.

That doesn’t bode well for the Swedish economy. If the goal of avoiding a lockdown was to spare economic woe, its success has been limited.

According to Business Insider, “international tourism and trade are decimated. … Sweden’s National Institute of Economic Research predicts Sweden’s GDP will fall 5.4% in 2020, after predicting a 1% rise [in] December 2019. It also expects unemployment to rise around three percentage points, to 9.6%, between the end of 2019 and the end of 2021.”

Spurkland said it’s still “too early yet to conclude whether the Swedish approach was the wisest over all,” as it remains to be seen whether Norway and other countries that did lock down will avoid a second wave of infections in the fall.

Yet she cautions that choosing to take on a higher case load may have health consequences far beyond the immediate infection.

“What we have learned these months is that COVID-19 is not only about death, it is also about ill health,” Spurkland said. “Quite a number of people going through the infection have long-term symptoms, that may be stopping them from resuming their daily life. We do not know yet how large a proportion of those who get the virus will fall into this category, but it is certainly a concern.”

“So, when deciding on taking a herd immunity approach to handle a totally new virus we do not know anything about,” she said, “the Swedish government has also unknowingly put the general population at risk for much long-term ill-health caused by the virus.”

Furberg doesn’t see it that way: “I am very proud of the way Swedes have adapted to the restrictions and regulations and I believe the Public Health Agency of Sweden has picked a good-enough strategy for our country.”

What Americans Need to Understand About the Swedish Coronavirus Experiment

Sweden made headlines for never shutting down. Here’s what’s really happening there.

Matthew Zeitlin pointed out that Tooutsiders, life in Stockholm, Sweden, appears perfectly normal: Walk down a cobblestone street, and you may see two friends sitting at a cafe enjoying the spring air or a group of kids kicking a soccer ball in the park. Cars and bicyclists may zip by; a family may walk past you on their afternoon stroll.

Whereas most of the Western world has been in lockdown for weeks, Sweden has opted to forgo any sort of shelter-in-place policy in response to the coronavirus and instead allow businesses and parks to stay open and groups of under 50 to gather.

That’s not to say the country hasn’t been proactive at all. The policy in effect in Sweden is similar to what had been implemented in much of the United States before shelter-in-place orders were issued — and the one that will soon be in place in states that reopen. The Swedish government has recommended that people wash their hands frequently, maintain social distance, work from home if they can, and those who are elderly or more susceptible to Covid-19 stay home. The government recommended that universities switch to online teaching; they quickly followed course. Social distance is required by law in restaurants, and bar service is banned. The government changed its sick leave rules to encourage anyone who is feeling symptoms to stay home. “Instead of saying ‘close down all of society,’ we have looked at society and closed down… aspects of society,” where the disease is most likely to spread, Anders Tegnell, the epidemiologist at Sweden’s Public Health Agency in charge of recommending policy to the government, told The Daily Show. “I think that’s had a great effect.”

Sweden may not be so much an alternative, as a glimpse of the future.

Sweden’s approach has been hailed by critics of American and European pandemic policies as a less restrictive — and less economically devastating — alternative to state or national shutdowns, but it’s also been lambasted by others as an unnecessarily risky strategy that has led Sweden to have the highest Covid-19 death toll among the Nordic nations. As more and more areas of the United States reopen, Sweden may not be so much an alternative as a glimpse of the future.

As of Sunday afternoon, the country had 25,921 confirmed cases and3,220deaths, according to the Johns Hopkins Coronavirus Resource Center. These are much higher figures than those of the country’s neighbors, but lower than those in some other wealthy Western European countries on both an overall and population-adjusted basis. Sweden also has suffered problems familiar to residents of countries that have had more severe outbreaks and stricter policies. Nursing homes have been hard hit, and Tegnell described Sweden’s failure to protect nursing home residents as its greatest shortcoming so far. Immigrant and ethnic minority communities also have suffered, due in part to their larger households. Just over half of all households in Sweden in 2016 consisted of only one person, while immigrants were substantially more likely than native-born residents to live in overcrowded conditions or multigenerational household.

Even with the less aggressive containment measures, the economic effects of the virus have been severe for the country. Sweden’s National Institute for Economic Research projected that gross domestic product would contract by 7% in 2020 and the unemployment rate would rise to just over 10%. The large fall in consumer and business confidence, the institute said in a release, point “to a rapid and severe downturn, not least in large parts of the service sector.”

“The economy will shrink both due to a drop in exports and is already contracting due to lower consumption. But the underlying causes differ: The export sector is mostly affected by the international situation, whereas the drop in consumption is directly related to the government’s recommendation of social distancing,” said Lina Maria Ellegård, an economist at Lund University.

In the first three months of the year, the Swedish economy contracted by less than 1% — less than the United States’ fall — but the production of both goods and services declined in March. The car industry — one of Sweden’s major export sectors — along with real estate, hospitality, and restaurants led the way.

That’s because even without lockdowns or orders, the behavior of Swedes still changed — to an extent. According to data collected by Google and Apple, Swedes have cut back on their travel to places like stores and restaurants and decreased their use of transit-like buses substantially, though not as dramatically as their Nordic neighbors in Denmark. Still, travel over the Easter holiday fell by 90%, Tegnell said on The Daily Show.

Multiple experts in Sweden I spoke to agreed that because a recommendation made by Swedish leadership is culturally viewed as more of a demand, the freedoms allowed have not resulted in free-for-alls. “There’s a basic misconception that there’s one big huge after-ski party,” said Lars Trägårdh, a Swedish historian. “That’s not true.”

Sweden’s voluntary restrictions policy is made possible by the high levels of trust throughout Swedish society. “We have a lot of social trust and a lot of trust in the institutions, and the institutions have confidence in the citizens,” said Trägårdh. “That’s why we decided to have this voluntary approach as opposed to one that’s more hardcore.”

The photos circulating online don’t fully represent the broader reality on the ground either. “I’ve seen pictures in the newspapers and news media of what looks to be crowded restaurants in Stockholm. What I’ve seen is mostly pretty sparse restaurants. Every other table is empty, and there’s very little business,” said Bo Becker, an economist at the Stockholm School of Economics. “Life doesn’t go on as usual, but maybe the lockdown is less severe than in other countries.”

But even if Sweden’s policy of allowing businesses to open and people to move out and about is not that different from some policies American states have or will soon implement, there’s been one major difference: the schools. Schools for children up to age 15 have remained open, all the way down to daycares and preschool. “That makes a world of difference,” Trägårdh told me. “It’s a gender issue.”

Sweden has one of the highest rates of female participation in the labor force for rich countries. Forcing young children to stay home would put many mothers in a bind or even knock them out of the workforce entirely.

“Closing down schools works well if you are in a well-to-do, middle-class family that has a house and a garden and can afford to have one person staying at home,” Trägårdh said. “That may not look like a doable proposition if you are a single parent or do not make a lot of money.”

Shutting down daycare and schools could increase risk as well, Erik Angner, a philosopher and economist at Stockholm University, explained, by leading working parents to turn to their own parents for help. “If you close daycares, then either one parent has to stop working or grandma or grandpa shows up,” he said. But since the elderly are most at risk, it was even more important to keep schools and daycares open

As other countries work through their peak infections, they will have to figure out how to reach a new status quo where the disease’s spread is still slow but restrictions can be lightened. “Now that everybody else is starting to shift toward opening up, people are talking about Sweden,” said Trägårdh. “Other Nordics are realizing you can’t keep schools closed forever. We’re in the long run here. It’s not a 60-meter race, it’s more like a marathon.”

While Sweden has a higher death rate than its Nordic neighbors and other wealthy European nations like Germany, it has been lower than rates in the Netherlands, France, and the United Kingdom. According to the Financial Times’ figures, Sweden has seen an 18% jump in excess deaths since the start of the outbreak, while Denmark has seen a 5% rise. Excess deaths in England and Wales are up 37%.

“The data out of Finland, Norway, and Denmark looks much better,” said Angner. “But everything will hinge on what will happen next.”

There’s some evidence that Sweden has managed to take the heaviest blow from the virus already — about a fourth or fifth of the population of Stockholm may have been infected, which would put the infection rate at a level similar to that found in New York City, which has had many more deaths and been under a near-total lockdown for almost two months. On Tuesday, health officials in Stockholm said the number of new deaths linked to Covid-19 was slowly decreasing from one week to the next.

The Swedish example carries both optimistic and pessimistic tidings for the United States as it embraces a partial, scattered reopening cheered on by the White House. It suggests that, even without punitive mandates, people can and will take measures to keep themselves safe from the disease. But even though people are protecting themselves without formal orders, the economy will be only slightly better off than it was under lockdown. Meanwhile, the American push to reopen is being driven by distrust of the government combined with the absence of robust safety-net programs to stem the economic bleeding. In the American context, Sweden’s example may be no example at all.

As a paper that was just accepted for publication, written by this author and two coauthors, we need reliable data to evaluate our progress as well as our failures to predict, based on appropriate statistical models and in order to lead us all in the correct path for future strategies for this pandemic and future crises.