FDA authorizes Pfizer coronavirus vaccine for adolescents 12 to 15 years old

https://www.washingtonpost.com/health/2021/05/10/coronavirus-vaccine-for-kids/?fbclid=IwAR0RKJNrlP3TiTDrvPuczKSHIPmTRds8kdAepwOCSqlrzdDHgGcm9vlBYk8

FDA authorizes Pfizer COVID-19 vaccine in adolescents 12 and up

The Food and Drug Administration cleared the first coronavirus vaccine for emergency use in children as young as 12 on Monday, expanding access to the Pfizer-BioNTech shot to adolescents ahead of the next school year and marking another milestone in the nation’s battle with the virus.

The decision that the two-shot regimen is safe and effective for younger adolescents had been highly anticipated by many parents and pediatricians, particularly with the growing gap between what vaccinated and unvaccinated people may do safely. Evidence suggests that schools can function at low risk with prevention measures, such as masks and social distancing. But vaccines are poised to increase confidence in resuming in-person activities and are regarded as pivotal to returning to normalcy.

“Adolescents, especially, have suffered tremendously from the covid pandemic. Even though they’re less likely than adults to be hospitalized or have severe illness, their lives really have been curtailed in many parts of the country,” said Kawsar R. Talaat, an assistant professor of international health at the Johns Hopkins Bloomberg School of Public Health. “A vaccine gives them an extra layer of protection and allows them to go back to being kids.”

Expert advisers to the Centers for Disease Control and Prevention are scheduled to meet Wednesday to recommend how the vaccine should be used in that age group, and the vaccine can be administered as soon as the CDC director signs off on the recommendation.

In a news briefing Monday evening after the announcement, FDA officials said the Pfizer authorization for 12- to 15-year-olds was a straightforward decision because the data showed that the vaccine was safe and that the response to the vaccine was even better than among the 18- to 25-year-olds who got the shots.

Children rarely suffer serious bouts of covid-19, the illness caused by the coronavirus. But there is no way to predict the few who will become dangerously sick or develop a rare, dangerous inflammatory syndrome. Out of more than 581,000 covid-19 deaths in the United States, about 300 have been people under 18 — a tiny fraction of the total. But that exceeds the number of children who die in a bad flu season.

Children appear to be less efficient at spreading the virus, although their role in transmission is still not fully understood — another reason for pediatric vaccinations.

Clinicians also worry that with a new virus with many unknowns, the possibility exists for long-term impacts of infection, even from the mild or asymptomatic courses of illness common among children.

The Pfizer-BioNTech vaccine, already authorized for adolescents 16 and older, was the first to be tested in younger adolescents. The FDA’s decision will provide a potential path for other vaccine-makers to follow, most of which have launched or plan to initiate trials of their vaccines in teenagers and younger children.

The agency based its authorization on a trial of nearly 2,300 adolescents between 12 and 15 years old, half of whom received the same two-shot regimen shown effective and safe in adults. Researchers took blood samples and measured antibody levels triggered by the shots and foundstronger immune responses in the teens than those found in young adults. There were 16 cases of covid-19 in the trial, all of them among adolescents who received a placebo, suggesting the regimen offered similar protection to younger recipients as it does to adults.

Robert W. Frenck Jr., the researcher who led the adolescent trial at Cincinnati Children’s Hospital Medical Center, said the study was designed to test whether it triggered immune responses, not whether it prevented disease. But because of the number of children who became ill in the placebo arm of the trial, it also became evident the vaccine offered robust protection.

“That really points out how much covid there is in the adolescent community,” Frenck said.

The data has not been published or peer-reviewed, but Kathryn M. Edwards, a pediatric infectious-disease specialist at Vanderbilt University Medical Center, said the results announced by Pfizer were “pretty exciting — it looked very effective and the immune responses were really good.”

Edwards said she is comfortable the benefits of vaccinations are clear among teens, noting that while children, in general, are at lower risk of severe covid-19 than adults, older adolescents seem to be more like adults in their risk for covid-19 than the very youngest children.

Audrey Baker, 15, and Sam Baker, 12, rolled up their sleeves for shots in the Pfizer-BioNTech trial at Cincinnati Children’s Hospital Medical Center. Audrey said she had no hesitation about signing up, and misses little things about how life used to be — eating out in restaurants and seeing family.

“I just trusted the science,” Audrey said. “I knew it was tested in adults. I was really just joining, hoping that maybe I could get vaccinated and help out science.”

Sam said he was more hesitant, in part because participating meant many follow-up lab tests. But he decided to do it and thinks he may have gotten the vaccine in the trial because he developed a headache and fever after his second dose.

Their mother, Rachel Baker, said she felt relief because of Sam’s symptoms.

The biggest benefit has been that I feel a weight off my shoulders,” Rachel said. “We haven’t changed how we do anything. … We’re still masking, we’re still social distancing, but we’re a bit calmer about it all.”

H. Cody Meissner, a pediatrician at Tufts Medical Center and a member of an external advisory committee to the FDA, said he thinks a pediatric vaccine is needed. But he said he would like to see more safety data because the messenger RNA technology at the core of vaccines from Pfizer-BioNTech and the biotechnology company Moderna does not have a long, established safety record, and its first large-scale use began in December.

Meissner abstained from the December vote that overwhelmingly recommended authorization of the Pfizer-BioNTech vaccine for people 16 and older, because he thought the vaccine should be authorized in people 18 and older.

“For those who are eager to get it, it’s important for them to understand that this is very rarely a severe disease in young adolescents, number one, and this is an entirely new vaccine,” Meissner said. “I just don’t want people to get too swept up in fear of hospitalization and death from covid-19 for the first few decades of life.”

But many other physicians take comfort knowing that 250 million shots of messenger RNA vaccine have been given in the United States alone. Serious side effects, such as a risk of anaphylaxis, are extremely rare. Because the trial in teens was an “immune bridging” trial designed to test whether the vaccine triggered immune responses similar to those in adults, researchers did not need to recruit tens of thousands of people to see if those who received a vaccine were protected against illness. The immune bridging technique is commonly used to expand access to vaccines that have been proved effective and safe to adolescents or other populations.

The expansion of eligibility to children will probably ignite debates in families about when to get vaccinated, and among policymakers about whether it should be required.

Dorit Reiss, a law professor focused on vaccine policy at the University of California Hastings College of Law, said she thinks it is unlikely children will be mandated to receive a coronavirus shot until the vaccines win full approval and not just emergency use authorization.

She predicted that acceptance of the vaccine will evolve as more children are vaccinated and depend on the state of the pandemic. She noted that when vaccines are introduced, the rollout often starts slowly before accelerating.

“Nervousness about a new vaccine is normal, especially when it’s for kids,” Reiss said. “Parents that are nervous now might feel different in a few months, once their friends’ kids have gotten vaccinated. And the views of the kids are also going to matter — if teens are going to think this is going to make their lives easier.”

Opening up vaccinations to children may sharpen a debate unfolding globally about the equity of vaccine access. Talaat said that while she can’t wait for her kids to have access to a vaccine, she is troubled by the global inequities as high-risk front-line workers or older people still don’t have access to vaccines in countries where the coronavirus is out of control.

Moderna announced Thursday that an initial analysis of its teen trial found its vaccine was 96 percent effective among participants who received at least one dose. Moderna is in discussions with regulators about the data. Pfizer-BioNTech and Moderna are testing their vaccines in children as young as infants. Johnson & Johnson is planning pediatric trials of its single-shot vaccine.

Trials in younger children are expected to take longer, because researchers must step down gradually in age and determine a safe and effective dose. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said data from tests in children as young as 2 years old may be available by September or October, with data on children as young as 6 months possible by the end of the year.

Within each age category, a separate risk-benefit assessment may take place. In the youngest children, given the low risk from the coronavirus, side effects may figure more prominently into the analysis, for example. Researchers may end up choosing a lower dose of vaccine. The understanding of children’s role in transmission may also evolve and help guide vaccine use and public policy.

“We are proceeding carefully, cautiously,” Edwards said. “We’re using the same rigid guidelines we use in all vaccines, and we take this very seriously. I think as time goes on and more information becomes available, some of the questions may be easier to address.”

WHO classifies triple-mutant COVID-19 variant from India as global health risk

WHO classifies triple mutant COVID-19 variant in India as global health risk  - The Filipino Times

The World Health Organization said Monday that the coronavirus variant first identified in India last year will be reclassified as a “variant of concern,” indicating that it has become a global health threat.

The B.1.617 variant has been found to spread more easily than the original virus, with some evidence indicating that it may evade some of the protections provided by the vaccines, according to a preliminary study. But the shots are still considered effective. The agency will provide more details on Tuesday.

The highly contagious, triple-mutant variant is also the fourth variant to be designated as a global concern, prompting enhanced tracking and analysis. The other variants are those first detected in Britain, South Africa and Brazil.

“We are classifying this as a variant of concern at a global level,” said Maria Van Kerkhove, WHO technical lead on COVID-19, per Reuters. “There is some available information to suggest increased transmissibility.”

A variant is labeled as “of concern” if it is shown to be more contagious, more deadly or more resistant to current vaccines and treatments, according to the WHO.

The global agency said the predominant lineage of B.1.617 was first identified in India in December, although an earlier version was spotted in October 2020.

The variant has already spread to other countries, and many nations – including the U.S. – have moved to end or restrict travel from India.

“Even though there is increased transmissibility demonstrated by some preliminary studies, we need much more information about this virus variant and this lineage and all of the sub-lineages,” said Maria Van Kerkhove, the WHO’s technical lead for COVID-19.

India reported a record-high of daily coronavirus cases, averaging about 391,000 new daily cases and about 3,879 deaths per day, according to Johns Hopkins University data.

More than a year into the pandemic, we’re still figuring out what risks we’re willing to take

Charting the pandemic over the next 12 months — and beyond - STAT

When the Centers for Disease Control and Prevention last week issued guidelines for what vaccinated people can safely do, the agency employed the word “risk” 43 times.

The word often carried a modifier, like so: increased risk, residual risk, low risk, potential risk, minimal risk, higher risk. The CDC did not define “low,” “minimal” or “higher,” instead using broad brushstrokes to paint a picture of post-vaccination life.

For example: “Indoor visits or small gatherings likely represent minimal risk to fully vaccinated people.”

On Wednesday, CDC director Rochelle Walensky said she could not give a definitive answer to what a “small” gathering is, because there are too many variables.

“If we define a small- and medium-sized gathering, we actually also have to define the size of the space that it’s in, the ventilation that is occurring, the space between people. And so, I think we should get back to the the general concepts,” Walensky said.

The situation has left people where they’ve been since the start of the pandemic: forced to play the role of amateur epidemiologist.

In the early days of the pandemic, we wondered if we could catch the coronavirus from a passing jogger and if our groceries, fresh from the store and resting on the kitchen counter, threatened to kill us. Science has attenuated some of our earliest fears. But more than a year into this crisis, we’re still trying to perform complicated risk calculations while relying on contradictory research and shifting CDC guidance.

Risk analysis is not something humans are necessarily good at. We rely on anecdotes more than scientific data. The questions we ask rarely have a simple yes or no answer. Risk tends to be on a sliding scale. Outside of self-isolation, there is no obvious way to drive the risk of viral transmission to zero, nor is risky behavior guaranteed to result in a dire outcome. We have no choice but to live probabilistically.

The risk landscape keeps changing as well. The virus is mutating, and there are many different variants in circulation. Many people are now fully vaccinated, some only partially vaccinated (in between shots, for example), some unvaccinated and some armored with a level of immunity through natural infection. Add the extreme variation in disease severity because of age and underlying conditions, and the risk equations get so long we may run out of chalkboard.

The restrictions imposed by governments have sometimes made little sense. Casinos were open before schools in some states. Mask mandates outdoors remained in place even when indoor dining became permitted.

“It seems to me if we are going to have indoor dining, we should have mask-free jogging,” Harvard epidemiologist Marc Lipsitch said in an email.

One thing that is incontrovertibly true: The coronavirus vaccines are remarkably safe and effective, and people should get vaccinated if possible.

“These are off-the-scale good,” said Amesh Adalja, an infectious-disease doctor and senior scholar at the Johns Hopkins Center for Health Security. “These are much better than vaccines that we rely on every year, like the flu vaccine.”

Even for people sold on vaccines, there remain lingering questions about what is and isn’t safe, and what is and isn’t the proper way to go about daily life in an increasingly vaccinated society. Here, we present some answers, with the caveat that our knowledge of the coronavirus, SARS-CoV-2, is still evolving, as is the virus itself.

Q: Why do I still need to wear a mask after I’m fully vaccinated?

A: You don’t need to wear a mask outdoors when fully vaccinated, except in crowds (such as at a sports stadium or a concert), nor do you have to wear one indoors among other vaccinated people or members of your own household.

But there are situations where you still need to mask up. You could still get infected with the coronavirus, and although it would most likely be mild or asymptomatic, you could transmit the virus to another person. Again, the odds of that happening are low, and there is encouraging data from Israel that suggests vaccinations dramatically reduce community spread.

But remember: A vaccination campaign is not simply about protecting the vaccinated individual. The goal is to build immunity broadly. Moreover, many communities still require masks in public settings — so it’s the law. It’s also polite — you don’t want to make people guess if you’ve been vaccinated or not. That probably will change when infection rates plummet and vaccinations are far more widespread.

“It is also a show of solidarity that we are still in this together,” said Maria Van Kerkhove, technical lead for the World Health Organization’s covid-19 response. “It’s about you and your community, your family, your friends, your workplace, your loved ones. It’s not just about you.”

At some point, viral transmission will plummet. We’re a long way from that point. As long as the virus is circulating in our communities, we need to use what we can to limit the spread and drive down the infection rate.

“Because [the vaccines] are not perfect, that’s precisely why we are urging people to be cautious,” Surgeon General Vivek H. Murthy said in a recent White House covid-19 task force news briefing. “We have great confidence in vaccines. We understood they are not perfect.”

Q: If you’re vaccinated, are you definitely protected against the coronavirus?

A: You’re very likely protected from symptomatic illness. That’s why Adalja, echoing the consensus, said, “These vaccines are something that will change your life.”

In clinical trials, the Pfizer and Moderna vaccines were about 95 percent effective in blocking symptomatic illness after two shots. The one-shot Johnson & Johnson vaccine was not quite as effective but just as good at preventing severe illness and death — which is the highest public health priority in a pandemic like this.

Q: But aren’t there also breakthrough infections?

A: As of April 26, the CDC had documented 9,245 breakthrough infections among fully vaccinated people. But look at the denominator: Those cases were among more than 95 million people. That’s fewer than 1 in 10,000 people vaccinated. (The agency noted that this is probably an undercount because of lack of testing and surveillance.) Of those rare breakthrough cases known to the CDC, 27 percent were asymptomatic and only 9 percent required hospitalization.

Adalja said people need to focus on probabilities and not anecdotes.

“This is kind of a cognitive bias that people have with many kinds of risk. It’s just like when there’s a shark attack in Australia. How much coverage does that get?” he said.

Q: Should people who got the Johnson & Johnson vaccine worry about blood clots?

A: If you notice unusual and serious side effects, such as severe headaches, contact your doctor. But the risk is extremely low. Federal regulators reauthorized the use of the vaccine after a 10-day pause, having found 15 cases of a serious clotting disorder among the 7 million people who had received the vaccine at that time. By any calculation, the risk of a bad vaccine reaction is much less than the risk of getting a serious case of covid-19.

Paul A. Offit, a pediatrician at Children’s Hospital of Philadelphia who is an expert on vaccination, suggests that the Johnson & Johnson coronavirus vaccine suffers from bad timing. Had it been approved first, before the Pfizer and Moderna vaccines, its many virtues would have been celebrated and the rare side effects minimized.

He noted that the Johnson & Johnson vaccine is “refrigerator stable” for up to five weeks. The vaccine is appealing to public health officials because it’s one-and-done and can be more easily deployed in remote locations and in places where recipients are homebound.

Q: How long will natural or vaccine-induced immunity last?

A: No one knows, but the initial evidence is encouraging, said Alessandro Sette, a professor of immunology at the La Jolla Institute for Immunology. A research paper published by Sette and fellow researchers in January showed that 90 percent of people who recovered from a coronavirus infection had robust levels of immunity eight months after they became sick. Immunity did not suddenly drop after eight months — that was merely the limit of the research period.

“Ninety percent having a good immune response also means 10 percent don’t. That is a reason for vaccinating and being careful even if you had the disease,” Sette said.

Immunity post-vaccination also appears durable, and there is less variability in levels of antibodies and other immune system cells following a vaccination than following a natural infection, Sette said.

Because this is a novel disease, and vaccines have not been widely deployed for very long, it is too soon to know how long antibodies will last. But Sette pointed out that the immune system has other weapons against invasive viruses, including “killer T-cells,” which continue to be able to recognize infected cells and kill them, preventing viral replication.

Q: Do the vaccines work against these new virus variants? And shouldn’t we be worried about a new variant that has even scarier, vaccine-evading mutations?

A: The immune response generated by vaccines is sufficiently protective against coronavirus variants to prevent most people from getting seriously ill.

Infectious-disease experts do worry about future mutations that could allow the virus to exhibit vaccine evasion. That said, there are limits to how much the virus can mutate — how much it can change its structure — and still function, according to Sette.

“The virus has to walk a tightrope,” he said. The virus can mutate to escape the effect of a specific antibody, but “it can’t change too much.”

He added, “While the virus has surprised us this year in a number of ways, the data we’ve seen so far does not suggest there’s an infinite number of ways the virus can mutate and escape immune recognition and still be as infectious.”

Q: When will we reach herd immunity?

A: No one knows what level of immunity would throttle virus transmission, and it probably varies from one environment to another and from one season of the year to another. But in the United States, at least, vaccinations have already had an effect. The virus increasingly is slamming into immune-system walls. Eventually, with enough vaccinations, most of the people who get infected will be dead-end alleys for the virus.

The virus appears destined to pop up in smaller outbreaks that could be more easily contained. But the virus won’t disappear, especially because it continues to spread at catastrophic rates in many countries that have low levels of vaccination. The only infectious disease-causing virus ever eradicated is smallpox.

For now, successful navigation of the pandemic may simply mean taking steps to reduce the threat of a serious case of covid-19 (as best as anyone can determine it) to the level of other threats that we typically tolerate, and which don’t tend to keep us awake at night.

Taking a deeper look at vaccine hesitancy

https://mailchi.mp/097beec6499c/the-weekly-gist-april-30-2021?e=d1e747d2d8

The American public’s attitude toward COVID-19 vaccination has evolved rapidly since the end of last year. The share of adults who report they have either already been vaccinated or intend to get the vaccine as soon as possible continues to rise (currently about 62 percent), while the share who say they will “wait and see” continues to shrink (now 17 percent). Importantly, however, the share who say they will either “definitely not” get vaccinated or only do so “if required” (currently 20 percent) has remained stubbornly consistent since December.

As the US reaches a vaccine tipping point, with more COVID vaccines available than people willing to be vaccinated, it will be important to understand this vaccine-hesitant population more clearly. A recent consumer segmentation analysis found that this group falls into four major behavioral profiles, shown on the right side of the graphic above. 

The next phase of vaccine rollout must specifically address the key concerns of individuals in each of these different segments. For example, the “watchful” group, the easiest to persuade, will likely respond to a more transparent vaccination process and the amplification of positive vaccination testimonials. On the other hand, “system distrusters,” generally comprised of younger, lower-income minorities, would benefit most from hearing community leaders discuss vaccine safety. Unfortunately, the largest segment of vaccine-hesitant Americans, the “misinformation believers”, will also be the most difficult to turn. These individuals are more likely to hold rigid, politically driven beliefs.

While countering misinformation by leveraging trusted influencers may help convince some, this group may be the hardest to persuadealthough their participation will be crucial to hitting any goal of “herd immunity” by this fall.

Cartoon – Anti-Vaccine or Pro-Disease?

Vaccine hesitancy among the top 10 global health threats

The partisan divide in coronavirus vaccinations is widening

One hesitates to elevate obviously bad arguments, even to point out how bad they are. This is a conundrum that comes up a lot these days, as members of the media measure the utility of reporting on bad faith, disingenuous or simply bizarre claims.

If someone were to insist, for example, that they were not going to get the coronavirus vaccine solely to spite the political left, should that claim be elevated? Can we simply point out how deranged it is to refuse a vaccine that will almost certainly end an international pandemic simply because people with whom you disagree think that maybe this is a good route to end that pandemic? If someone were to write such a thing at some attention-thirsty website, we certainly wouldn’t want to link to it, leaving our own readers having to figure out where it might be found should they choose to do so.

In this case, it’s worth elevating this argument (which, to be clear, is actually floating out there) to point out one of the myriad ways in which the effort to vaccinate as many adults as possible has become interlaced with partisan politics. As the weeks pass and demand for the vaccine has tapered off, the gap between Democratic and Republican interest in being vaccinated seems to be widening — meaning that the end to the pandemic is likely to move that much further into the future.

Consider, for example, the rate of completed vaccinations by county, according to data compiled by CovidActNow. You can see a slight correlation between how a county voted in 2020 — the horizontal axis — and the density of completed vaccinations, shown on the vertical. There’s a greater density of completed vaccinations on the left side of the graph than on the right.

If we shift to the percentage of the population that’s received even one dose of the vaccine, the effect is much more obvious.

This is a relatively recent development. At the beginning of the month, the density of the population that had received only one dose resulted in a graph that looked much like the current density of completed doses.

If we animate those two graphs, the effect is obvious. In the past few weeks, the density of first doses has increased much faster in more-Democratic counties.

If we group the results of the 2020 presidential contest into 20-point buckets, the pattern is again obvious.

It’s not a new observation that Republicans are less willing to get the vaccine; we’ve reported on it repeatedly. What’s relatively new is how that hesitance is showing up in the actual vaccination data.

A Post-ABC News poll released on Monday showed that this response to the vaccine holds even when considering age groups. We’ve known for a while that older Americans, who are more at risk from the virus, have been more likely to seek the vaccine. But even among seniors, Republicans are significantly more hesitant to receive the vaccine than are Democrats.

This is a particularly dangerous example of partisanship. People 65 or older have made up 14 percent of coronavirus infections, according to federal data, but 81 percent of deaths. That’s among those for whom ages are known, a subset (though a large majority) of overall cases. While about 1.8 percent of that overall group has died, the figure for those aged 65 and over is above 10 percent.

As vaccines have been rolled out across the country, you can see how more-heavily-blue counties have a higher density of vaccinations in many states.

This is not a universal truth, of course. Some heavily Republican counties have above-average vaccination rates. (About 40 percent of counties that preferred former president Donald Trump last year are above the average in the CovidActNow data. The rate among Democratic counties is closer to 80 percent.) But it is the case that there is a correlation between how a county voted and how many of its residents have been vaccinated. It is also the case that the gap between red and blue counties is widening.

Given all of that, it probably makes sense to point out that an argument against vaccines based on nothing more than “lol libs will hate this” is an embarrassing argument to make.

COVID-19 Is Still Devastating the World—Especially India

The pandemic won’t end for anyone until it ends for everyone. That sentiment has been repeated so many times, by so many people, it’s easy to forget it’s not just a cliche—particularly if you live in one of the wealthy countries, like the U.S. and Israel, that has made significant moves toward what feels like an end to the COVID-19 era.

Israel, for example, has fully vaccinated more than half of its population and about 90% of its adults 50 and older are now immune to the virus—enough that the country is “busting loose” and “partying like it’s 2019,” as the Washington Post put it last week. The U.S. is a bit further behind, with nearly 30% of its population fully vaccinated, but the possibility of a post-pandemic reality is already coming into focus. While daily case counts remain high, they are far lower than they were even a few months ago—about 32,000 diagnoses were reported on April 25, compared to daily tallies well above 250,000 in January. Deaths have also trended downward for most of 2021. The U.S. Centers for Disease Control and Prevention has relaxed its guidance on travel and indoor gatherings, and some states have repealed mask mandates and other disease precautions.

But while people in certain affluent countries celebrate a return to vacations and parties, COVID-19 remains a dire threat in many nations around the world—nowhere more so than India. For five days in a row, the country has set and reset the global record for new cases in a single day, tallying about 353,000 on April 26.

By official counts, about 2,000 people in India are dying from COVID-19 every day as hospitals grow overtaxed and oxygen supplies run short. Experts say the true toll is likely even higher than that. People are dying as they desperately seek treatment, and crematoriums nationwide are overwhelmed.

It can be difficult to grapple with that devastating reality when people in countries like the U.S. are reuniting with loved ones and cautiously emerging from lockdown. How can both scenarios be happening at once? The answer, as it often has during the pandemic, lies in disparity. As of April 26, 83% of vaccinations worldwide had been given in high- and upper-middle-income countries, according to a New York Times data analysis. In the developing world, many countries are preparing for the reality that it could take until 2022 or even 2023 to reach vaccination levels already achieved by richer countries today. Even in India, one of the world’s leading vaccine manufacturers, fewer than 10% of people have gotten a vaccine—a cruel irony, as people in India die in the streets while those thousands of miles away celebrate receiving their second doses.

To truly defeat COVID-19, we must reckon with that cognitive dissonance, says Dr. Rahel Nardos, who is originally from Ethiopia and now works in the University of Minnesota’s Center for Global Health and Social Responsibility. As an immigrant and global health physician who lives in the U.S., Nardos says she inhabits two worlds: one in which the U.S. may feasibly vaccinate at least 70% of its population this year, and another in which many countries struggle to inoculate even 20% of their residents in the same time frame.

“It’s a huge disparity,” Nardos says. “We need to get out of our silos and start talking to each other and hearing each other.”

That’s imperative, first and foremost because it could save lives. More than 13,000 people around the world died from COVID-19 on April 24. Remaining vigilant about disease prevention and monitoring, and working to distribute vaccines in countries that desperately need them to fight back COVID-19 surges, could help prevent more deaths in the future. That’s especially critical for developing countries, many of which are so overwhelmed by COVID-19 that nearly all other aspects of health care have suffered. “We may be looking at five, 10 years before they can get back to their baseline, which wasn’t that great to begin with,” Nardos says.

There’s also a global health argument for distributing vaccines more equitably. Infectious diseases do not respect borders. If even one country remains vulnerable to COVID-19, that could allow the virus to keep spreading and mutating, potentially evolving to such a point that it could infect people who are vaccinated against original strains of the disease. Already, vaccine makers are exploring the possibility of booster shots to add extra protection against the more transmissible variants currently circulating in various parts of the world.

We aren’t at that point yet; currently authorized vaccines appear to hold up well against these variants. But if the virus keeps spreading for years in some areas, there’s no telling what will happen, says Jonna Mazet, an epidemiologist and emerging infectious disease expert at the University of California, Davis.

Evolution of those new strains could go into multiple directions. They may evolve to cause more severe or less severe disease. Some of the variants [could be] more concerning for young people,” Mazet says. “The whole dynamics of the disease change.”

And if the virus is mutating somewhere, chances are good it will eventually keep spreading in multiple areas, Mazet says. “Unless or until we have a major shift, we are still going to have large parts of every country that have a susceptible population,” she says. “The virus is going to find a way.”

The only way to stop a virus from mutating is to stop giving it new hosts, and vaccines help provide that protection. COVAX—a joint initiative of the World Health Organization; Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations; and UNICEF—was meant to ensure that people in low-income countries could get vaccinated at the same time as people in wealthier ones. COVAX is providing free vaccines to middle- and low-income countries, using funds gained through purchase agreements and donations from richer countries. But supply and funding shortages have made it difficult for the initiative to distribute vaccines as quickly as it intended to. Many of the doses it planned to disseminate were supposed to have come from the Serum Institute of India, which delayed exporting doses in March and April as India focused on domestic vaccine rollout to combat its COVID-19 surge at home.

In the meanwhile, many poorer countries have been unable to vaccinate anywhere close to as many people as would be required to reach herd immunity. That will almost surely improve as new vaccines are authorized for use by regulators around the world, and as manufacturers scale up production, but those moves may be months away.

COVAX is also developing a mechanism through which developed countries could donate vaccine doses they don’t need. Some wealthy countries, including the U.S. and Canada, have contracts to purchase more than enough doses to vaccinate their entire populations, and have signaled their intent to eventually donate unneeded supplies—but timing is everything. That is, these countries will likely only donate once they are sure their own populations have been vaccinated at a level that ensures herd immunity.

On April 25, the Biden Administration said the U.S. would provide India with raw supplies for making AstraZeneca’s vaccine, as well as COVID-19 tests and treatments, ventilators, personal protective equipment, and funding. That’s a significant shift, since the export of raw vaccine materials was previously banned, but it still doesn’t provide India with ready-to-go vaccines. That step may be next, though. The U.S. will export as many as 60 million doses of AstraZeneca’s vaccine once the shot clears federal safety reviews, the Associated Press reports.

Gian Gandhi, UNICEF’s COVAX coordinator for supply, says he fears many wealthy countries’ vaccine donations may not come until late in 2021, just when global supply is expected to ramp up. That may cause a bottleneck effect: all doses may come in at once, rather than at a slow-but-steady pace that allows countries with smaller health care networks to distribute them. “We need doses now, when we’re not able to access them via other means,” Gandhi says.

The global situation is also critical now. Worldwide, more than 5.2 million cases and 83,000 deaths were reported during the week leading up to April 18. Indian hospitals are so overrun, crowds have formed outside their doors and desperate families are trying to source their own oxygen. Hospitals in Brazil are reportedly running out of sedatives. Iran last week broke daily case count records three days in a row. Countries across Europe remain under various forms of lockdown. Vaccines won’t change those realities immediately—but without them, the global community stands little chance of containing COVID-19 worldwide.

Entering a new phase of the vaccine rollout

https://mailchi.mp/da8db2c9bc41/the-weekly-gist-april-23-2021?e=d1e747d2d8

Why some Americans are hesitant to receive the COVID-19 vaccine - Vital  Record

With more than 222M Americans having received at least one dose of COVID vaccine, and 27.5 percent of the population now fully vaccinated, we are now nearing a point at which vaccine supply will exceed demand, signaling a new phase of the rollout.

This week, for the first time since February, the daily rate of vaccinations slowed substantially, down about 11 percent from last week on a seven-day rolling average. Several states and counties are dialing back requests for new vaccine shipments, and the New York Times reported that some local health departments are beginning to shutter mass vaccination sites as appointment slots go unfilled.

On Friday, the White House’s COVID response coordinator, Jeff Zients, said that the Biden administration now expects “daily vaccination rates will fluctuate and moderate,” after several weeks of accelerating pace. In every state, everyone over the age of 16 is now eligible to be vaccinated, but experts expect that demand from the “vaccine-eager” population will run out over the next two weeksnecessitating a more aggressive campaign to distribute vaccines in hard-to-reach populations, and to convince vaccine skeptics to get the shot.

Vaccine hesitancy, like so many other issues related to the COVID pandemic, has now become starkly politicized—one recent survey found that 43 percent of Republicans “likely will never get” the vaccine, as opposed to only 5 percent of Democrats. Another 12 percent of those surveyed, regardless of party identification, say they plan to “see how it goes” before getting the vaccine, a subset that will surely be unnerved by continued doubts about the safety of the Johnson & Johnson (J&J) vaccine.

An expert advisory panel on Friday recommended that use of the J&J shot be resumed, but advised that a warning be included about potential risk of rare blood clots in women under 50. The first three months of the COVID vaccination campaign have been a staggering success—but getting from 27 percent fully vaccinated to the 80 percent needed for “herd immunity” will likely be a much tougher slog.

U.S. lifts pause on Johnson & Johnson’s coronavirus vaccine

The CDC and FDA on Friday lifted the recommended pause on use of Johnson & Johnson’s coronavirus vaccine, saying the benefits of the shot outweigh the risk of a rare blood clot disorder.

Why it matters: The move clears the way for states to immediately resume administering the one-shot vaccine.

  • The Johnson & Johnson shot had been seen as an important tool to fill gaps in the U.S. vaccination effort. But between the pause in its use and repeated manufacturing problems, its role in that effort is shrinking.

Driving the news: J&J shots have been paused for about two weeks, in response to reports that they may have caused serious blood clots in a small number of patients.

  • Only six people had experienced those blood clots at the time of the pause. The CDC said Friday that there have been nine additional cases.
  • Regulators said the number is small enough to safely resume the use of J&J’s vaccine.

What they’re saying: Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work — identifying even these small number of cases,” said acting FDA Commissioner Janet Woodcock.

  • “We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices,” she said.
  • “We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality.”

What’s next: Regulators said health care providers administering the shot and vaccine recipients should review revised fact sheets about the J&J vaccine, which includes information about the rare blood clot disorder.

  • That heightened attention is important because the standard treatment for blood clots can make this particular type of clot worse.

Yes, but: J&J was already a relatively small part of the overall domestic vaccination effort, in part because the company missed some of its early manufacturing targets.

  • Multiple problems have since emerged at a Baltimore facility that makes a key ingredient for the vaccine, which could sideline production for weeks.

Blood Clots, FDA Approval, and the AstraZeneca Covid Vaccine

Blood Clots, FDA Approval, and the AstraZeneca Covid Vaccine - YouTube

There’s a lot of anxiety about the AstraZeneca vaccine thanks to recent reports of incomplete data, as well as reports on blood clot risks. Let’s take a look at both issues in context, understanding the efficacy data before and after numbers were updated, and understanding blood clot risk in relation to other common situations where blood clots are a potential concern.