Category Archives: New Mutated Viral Strains

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

White House / Via whitehouse.gov

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Social Media: A Parasite on Our Pandemic Mental Health

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

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

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

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

What Is Going On?

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

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

Where Are We Now?

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

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

How Can We Make It Better?

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

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

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

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

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

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

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

Toward More Productive Dialogue

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

Scientists Reveal How the AstraZeneca Vaccine Causes Unusual Clots

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Two-Step Process Leads to Clots

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

ACIP Green-Lights J&J Vax for All Adults

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Please get vaccinated!!

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.