NEWS

FDA Panel Advises Against COVID Boosters for General Population

Two ampules of COVID-19 vaccine next to a syringe on a blue background.

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Key Takeaways

  • An advisory panel for the Food and Drug Administration (FDA) has recommended against giving third doses of the Pfizer COVID-19 vaccine to all eligible adults.
  • Instead, the panel is recommending that booster doses be given to people at high risk for severe COVID illness, and to people age 65 and older.
  • The FDA does not have to accept an advisory panel’s recommendations and is likely to delay a decision until after an advisory panel for the Centers for Disease Control and Prevention (CDC) makes its recommendations in the coming week.

On September 17, an advisory committee to the Food and Drug (FDA) Administration voted 16 to 2 against approving booster doses of Pfizer’s COVID-19 vaccine for all adults ages 16 and older. It did, however, recommend boosters for certain people—including those at high risk for serious illness and people over the age of 65.

The committee meeting came in response to Pfizer’s application for approval of its boosters to the FDA.

However, it was held at a time of increased interest in boosters within the medical community and the general population, largely because of reports of “breakthrough” infections in fully vaccinated people.

Here’s what you should know about the recommendations.

What Did the Panel Decide?

The committee did not vote to approve boosters for all eligible people.

It did unanimously recommend booster shots for people age 65 and older and for adults at risk of severe COVID, to be given six months after these individuals became fully vaccinated (had the second of the two-dose Pfizer vaccine series).

An informal poll conducted by the panel chair also found that the group supported giving booster doses to people at high risk of getting COVID, including teachers and health care workers.

Will the FDA Follow the Recommendations?

The FDA is not required to accept the recommendations of its advisory panels, but it often does. Several public health experts and panelists expressed comfort with the committee’s narrower vote.

“I’m relieved,” Leana Wen, MD, an emergency physician and visiting professor of health policy and management at the George Washington University’s Milken School of Public Health in Washington, D.C., tells Verywell. “This is a good middle ground and gives discretion to clinicians and patients to decide who is high risk. That level of individual decision-making is key. For example, who’s to say that a 42-year-old with diabetes and heart disease shouldn’t get a booster dose any more than a healthy 65-year old?”

What Did Researchers Present?

During the meeting, Peter Marks, MD, PhD, director of FDA’s Center for Biologics Research and Evaluation, said that “we know that there may be differing opinions about the interpretation of the data regarding the potential need for additional doses, and we strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex and evolving.”

Data from Israel (which has had success vaccinating many of its eligible citizens) was prominent during the committee meeting.

One of the studies cited, published last week in the New England Journal of Medicine, found lower rates of infection among people age 60 and older who received booster doses compared to people who did not. However, a committee presenter faulted the study for only having 12 days of follow-up.

Other panel members expressed concerns that there was a lack of data on side effects in young people. While younger people are less likely to get severely ill if they get COVID, some of them—particularly young men—appear to be at a higher risk of developing a rare inflammatory heart condition called myocarditis after getting vaccinated.

However, recent research has also shown that the risk of myocarditis is far higher in people who get COVID than it is in people who get vaccinated against it.

Archana Chatterjee, MD, PhD, dean of Chicago Medical School at Rosalind Franklin University in North Chicago, said that they have “major concerns with extrapolating [findings] from older adults to 16 and 17-year-olds.”

Data from the Centers for Disease Control and Prevention (CDC) that was presented to the panel showed that the authorized vaccines are still effective against severe disease including in people age 75 and older.

Will the Guidelines Get More Specific? 

Originally, the Biden Administration had announced that booster shots would be available to all vaccinated Americans the week of September 20. However, “based on a thorough review of the evidence,” the plan’s timetable—and who it includes—will not be finalized until after an advisory panel to the CDC meets this week.

Leana Wen, MD

This is a good middle ground and gives discretion to clinicians and patients to decide who is high risk. That level of individual decision-making is key.

— Leana Wen, MD

Albert Monto, MD, professor of epidemiology at the University of Michigan School of Public Health and chairman of the FDA advisory committee, said during the meeting that the CDC committee will likely “fine-tune the recommendations.” 

Gregory Poland, MD, head of the Vaccine Research Group at the Mayo Clinic in Rochester, Minnesota, tells Verywell that these meetings will bring “much more robust discussion, more expertise, and knowledge.”

When Will the FDA Decide?

The FDA has not said when it will make a decision but it will likely come after the CDC gets its recommendations later this week.

What About Other Vaccines?

During last week’s hearing, the panel only considered a Pfizer booster. It is expected to review applications for Moderna and Johnson & Johnson boosters in the coming weeks.

Are People Getting Boosters Anyway?

While agencies are still discussing all boosters, some people are not waiting for government agencies to make a decision.

In mid-August, the FDA authorized third doses for immunocompromised people. However, data from the CDC shows that at least a million people without known health conditions that put them at risk have requested and received a booster shot.

Anecdotally, many people have simply shown up at pharmacies (which get reimbursed for any vaccine that they give) and asked for a shot.

Signing up online also seems to work. For example, when scheduling a vaccine on the CVS website, the portal asks consumers if they are immunocompromised, but does not require them to show proof.

During a reporter’s briefing last week Ashish Jha, MD, MPH, Dean of the Brown University School of Public Health, noted that he had recently attended a private outdoor event and was surprised by how people there said that they had already received a booster.

At a briefing on Friday (the same time as the FDA committee meeting on boosters) CDC Director Rochelle Walensky, MD, MPH, was asked by a reporter about the increasing number of “reports of people walking into vaccination sites and getting boosters, even if they’re not eligible yet.”

Walensky replied that the CDC is “closely working with jurisdictions to make sure that they understand what is in their provider agreements and what is currently indicated for a…third dose.”

Will Boosters Be Available Before Cases Spike?

Even though COVID cases are dropping at the national level, some states still have high rates of cases and hospitalizations, which is fueling continued interest in booster shots.

Poland says that cases may ramp up in the fall and winter as people spend more time indoors; for example, kids going back to work and some employees heading back to the office. It’s also because the prevailing Delta variant is highly infectious and some people have become more relaxed about taking precautions, such as masking and social distancing.

Chris Pernell, MD, a fellow of the American College of Preventive Medicine, tells Verywell that patients should ask their primary care providers about boosters and follow the guidance of medical organizations.

“We really need to get this right,” says Pernell. “It is important for public health communications to be as clear and straightforward as possible.”

What This Means For You

If you have been fully vaccinated with the Pfizer or Moderna COVID vaccines and meet certain criteria (for example, being immunocompromised because you had an organ transplant) you do not have to wait for the FDA and CDC to make a decision about boosters, as third doses are approved and already available in many places.

For older adults and others who are deemed at risk for severe COVID illness, the FDA’s decision about boosters will likely come after the CDC panel makes its recommendations.

If you got the Johnson & Johnson vaccine, know that data and discussion on booster doses are expected in the coming weeks.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

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  2. Barda N, Dagan N, Ben-Shlomo Y, et al. Safety of the BNT162b2 mRNA Covid-19 vaccine in a nationwide setting. N Engl J Med. 2021;385(12):1078-1090. doi:10.1056/NEJMoa2110475