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.”

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.

UK issues anaphylaxis warning on Pfizer vaccine after adverse reactions

https://www.reuters.com/article/health-coronavirus-britain-vaccine/update-5-uk-to-refine-allergy-warning-on-pfizer-vaccine-sparked-by-two-adverse-reactions-idUSL8N2IP307

UK issues anaphylaxis warning on Pfizer vaccine after adverse reactions -  YouTube

Britain’s medicine regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving fuller guidance on an earlier allergy warning about the shot.

Starting with the elderly and frontline workers, Britain began mass vaccinating its population on Tuesday, part of a global drive that poses one of the biggest logistical challenges in peacetime history.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said there had been two reports of anaphylaxis and one report of a possible allergic reaction since rollout began.

“Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine,” MHRA Chief Executive June Raine said in a statement.

“Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks… You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness.”

Anaphylaxis is an overreaction of the body’s immune system, which the National Health Service describes as severe and sometimes life-threatening.

The fuller guidance, clarifying that the main risk was from anaphylaxis specifically, was issued after consulting experts on allergies. The MHRA had initially advised anyone with a history of a “significant allergic reaction” not to take the shot.

Pfizer and BioNTech said they were supporting the MHRA’s investigation.

Last week, Britain’s MHRA became the first in the world to approve the vaccine, developed by Germany’s BioNTech and Pfizer, while the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.

A top U.S. official said on Wednesday that Americans with known severe allergic reactions may not be candidates for Pfizer’s COVID-19 vaccine until more was understood about what had happened.

Canada’s health ministry said it would look at the reported adverse reactions in Britain, but said adverse events were to be expected and would not necessarily change the risk/benefit of the shot, after the country approved the vaccine.

ALLERGIC REACTION

MHRA chief Raine told lawmakers such allergic reactions had not been a feature of the Pfizer’s clinical trials.

Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials, which is reflected in the MHRA’s emergency approval protocol.

However, the allergic reactions may have been caused by a component of Pfizer’s vaccine called polyethylene glycol, or PEG, which helps stabilise the shot and is not in other types of vaccines.

Imperial College London’s Paul Turner, an expert in allergy and immunology, who has been advising the MHRA on their revised guidance, told Reuters: “As we’ve had more information through, the initial concern that maybe it affects everyone with allergies is not true.”

“The ingredients like PEG which we think might be responsible for the reactions are not related to things which can cause food allergy. Likewise, people with a known allergy to just one medicine should not be at risk,” Turner told Reuters.

The EMA said in an email that all quality, safety and efficacy data would be taken into account in assessing the vaccine, including data generated outside the EU.

In the United States, the FDA released documents on Tuesday in preparation for an advisory committee meeting on Thursday, saying the Pfizer vaccine’s efficacy and safety data met its expectations for authorization.

The briefing documents said 0.63% of people in the vaccine group and 0.51% in the placebo group reported possible allergic reactions in trials, which Peter Openshaw, professor of experimental medicine at Imperial College London, said was a very small number.

“The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well,” he said.

However, Gregory Poland, a virologist and vaccine researcher with the Mayo Clinic in Rochester, Minnesota, said that the MHRA and NHS had overreacted initially.

“I would not have broadened to the degree they did,” he said.

“It’s reasonable to let the world know about this, and to be aware of it in terms of people who have had reactions like this to vaccines. I think to say medicines, foods or any other allergies is past the boundary of science.”

Demand for COVID Vaccines Expected to Get Heated — And Fast

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.

But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.

“People talk about the anti-vaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”

Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, director of the division of medical ethics at New York University School of Medicine.

“I think that’s going to flip the trust issue,” he said.

The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups — from those representing home-based health workers and community health centers to patients with kidney disease — were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.

“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.

Certainly, some consumers remain wary, said Rupali Limaye, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.

“There will be people who will say, ‘I will wait a little bit more for safety data,” Limaye said.

But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Offit, who sits on the FDA advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.

He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.

“That was a highly desired vaccine,” Offit said. “I think in many ways that might happen here.”

Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the U.S. and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.

Even before any vaccine is available, some people are trying to boost their chances of access, said Dr. Allison Kempe, a professor of pediatrics at the University of Colorado School of Medicine and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”

That likely will include emotional debates over how, when and to whom next doses should be distributed, said Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” — a broad and ill-defined category — as well as 53 million adults age 65 and older.

“We’re going to have some fights about high-risk groups,” said Caplan of NYU.

The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?

Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”

Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.

“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus or subway,” Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”

But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.

“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Limaye said.

“We’re all seeing this now,” said Kempe. “Even deniers are beginning to see what this illness can do.”

What makes a Bad Vaccine?

A Covid-19 vaccine, amazingly, is close. Why am I so worried?

A mere six months after identifying the SARS-CoV-2 virus as the cause of Covid-19, scientists are on the precipice of a having a vaccine to fight it. Moderna and the National Institutes of Health recently announced the start of a Phase 3 clinical trial, joining several others in a constructive rivalry that could save millions of lives.

It’s a truly impressive a feat and a testament to the power of basic and applied medical sciences. Under normal circumstances, vaccine approvals are measured in decades. Milestones that once took months or years have been achieved in days or weeks. If these efforts are successful, the Covid-19 vaccine could take a place alongside the Apollo missions as one of history’s greatest scientific achievements.

I’m optimistic. And yet, as someone who studies drug development, I want to temper expectations with a dose of realism and perhaps a bit of angst. Behind the proud declarations, many science and medical professionals have been whispering concerns. These whispers have escalated into a murmur. It’s time to cry them loudly:

Hey, Food and Drug Administration: Don’t be rash! Premature approval of a sub-standard Covid-19 vaccine could have dire implications, and not just for this pandemic. It could harm public health for years, if not generations, to come.

Unfortunately, elements now in place make such a disastrous outcome not only possible but in fact quite likely. Specifically, the FDA and its staff of chronically overworked and underappreciated regulators will face enormous public and political pressure to approve a vaccine. Whether or not one worries about an “October surprise” aimed at the upcoming election, regulators will be pressed hard. Some will stand firm. Some may resign in protest. But others could break and allow a bad vaccine to be released.

What makes a “bad vaccine”? Insufficient protection against the disease it is designed for, unwanted side effects, or some combination of the two. If an approved Covid-19 vaccine turns out to be ineffective, this could unintentionally promote wider spread of the disease by individuals who presume they were protected from it. Likewise, a negative experience with one vaccine might discourage the use of other vaccines that are far more safe and effective, whether they are for Covid-19 or other vaccine-preventable diseases.

Some things take time. Under normal circumstances, ensuring that a vaccine’s effects are safe and durable requires years of study and monitoring. And there is some evidence that natural immune responses to SARS-CoV-2 infection could be transient, making sustained investigation all the more necessary. A merely short-term effect could encourage vaccinated individuals to resume risky behaviors, which would all but guarantee that the epidemic endures. And if unintended side effects turn out to include, for instance, chronic inflammatory or autoimmune disease, a bad vaccine could impart lifelong damage.

But wait, there’s worse! A bad Covid-19 vaccine could further undermine confidence in the many safe, reliable vaccines already in our public health arsenal. Vaccine skepticism and anti-science bias, propagated by B-list celebrities and Russian troll farms, have been gaining strength all year. Combined with disappointing Covid-19 outcomes, such malign forces could facilitate the reemergence of once-vanquished foes — polio, measles, mumps, rubella, diphtheria, whooping cough, and tetanus — that once killed multitudes of children each year.

These are enormous risks. Placing all of our bets on a small set of untried vaccine technologies would be gobsmackingly foolish. Yet this is exactly what we are now doing. Most of the high-profile names capturing headlines are pursuing comparatively minor variations on a theme of genetic vaccines (those delivered via DNA or RNA). If one approach happens to work, the odds are higher the others will work as well. Disappointing results from one candidate, though, might presage failure across the board.

Rather than investing in a balanced portfolio of vaccines with different approaches — not to mention different therapies, devices, and diagnostics for treating Covid-19 — too many observers, too many companies, and too many governmental officials seem to be narrowly focused on hopes for a “savior” vaccine. Were that savior to fail, our national morale, already low, could plummet even further.

Don’t get me wrong. I, along with millions of Americans, want a Covid-19 vaccine. But we deserve one that’s been proven to be safe and effective.

It’s not too late to take a deep breath and devise a strategy to balance short- and long-term goals, including vaccination, improved diagnostics, and existing and novel treatments. We must support the FDA and hope that its scientists and physicians retain the strength and conviction to resist approving a substandard vaccine.

For encouragement, we should look to Frances Oldham Kelsey, a veritable patron saint of the FDA. In 1960, during her first month working for the agency, Kelsey was asked to approve a sedative called Kevadon, which had the potential to generate billions in revenue. Despite enormous pressure, Kelsey spotted a risk for toxicity and dug in her heels. She refused to rubber stamp the approval. Her actions saved the lives of countless babies. Kevadon, better known as thalidomide, proved to be one of the most dangerous and disfiguring drugs in history.

Kelsey passed away in 2015 at the age of 101. We must pray that her spirit inspires a new generation of FDA leaders with the courage to say, “No.”