FDA to sidestep advisers on boosters-for-all approval

The agency confirms that a decision on booster eligibility is expected to be made without the input of its panel of outside experts

Hattie Pierce, 75,  gets a Pfizer COVID-19 vaccine booster shot from Dr. Tiffany Taliaferro at the Capitol Hill Safeway in Washington on Oct. 4. (Tom Williams/CQ Roll Call file photo)
Hattie Pierce, 75, gets a Pfizer COVID-19 vaccine booster shot from Dr. Tiffany Taliaferro at the Capitol Hill Safeway in Washington on Oct. 4. (Tom Williams/CQ Roll Call file photo)
Posted November 17, 2021 at 6:01am

The Food and Drug Administration’s committee of outside experts is not planning to meet to discuss the data on Pfizer’s request for authorization of boosters-for-all, which federal officials are expected to greenlight this week, as they have for other critical decisions on COVID-19 vaccines. 

The move signals that the Biden administration is willing to forge ahead without the signoff of the FDA’s scientific advisers, who twice voted to reject boosters for the young and healthy who don’t face high exposure risks, as pockets of the country show foreboding signs of a coming winter wave.

After CQ Roll Call reported Tuesday that an advisory meeting was unlikely, the agency confirmed that a decision on eligibility for boosters is expected to be made without the input of the committee.

“The agency has previously convened the VRBPAC for extensive discussions regarding the use of boosters for COVID-19 vaccines and, after review of the request, we have concluded that it does not raise questions that would benefit from additional discussion by the members of the committee,” said FDA spokeswoman Abby Capobianco. “While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible.”  

The lack of a meeting of the panel, known as the Vaccines and Related Biological Products Advisory Committee, also means that emerging data on breakthrough cases won’t be hashed out in full view of the American public. Some clarity may be provided by a meeting of the Centers for Disease Control and Prevention’s own independent advisers on Nov. 19, although they do not typically weigh in on the same questions.

The timing of the CDC advisory meeting suggests that the FDA and CDC will likely decide to allow boosters for all U.S. adults this week.

By circumventing the FDA advisory committee, the Biden administration would accomplish what it set out to do as far back as July. President Joe Biden announced in August, before FDA had a chance to review any data, that additional shots would be available around Sept. 20 if the agency agreed. 

Already, at least four jurisdictions — New York City, California, Colorado and New Mexico — have moved ahead with booster shots for all adults despite the committee’s advice and the FDA’s decision not to authorize them. 

Those moves by government officials threaten to undercut the influence of the independent advisers and the FDA. Booster shots were previously cleared by the committee and FDA for people who work in front-line jobs, live in congregate settings, are 65 and older, have underlying health conditions or received a Johnson & Johnson shot.

“What I would really like to see is a clear description of what it is we want from this vaccine, what is the goal for this vaccine,” said advisory committee member Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Hundreds of millions of doses bought

The Biden White House this summer elected to purchase another 200 million doses permitted under an agreement with Pfizer first inked in 2020, bringing its total purchase to 500 million doses. According to the pharmaceutical company, the delivery was expected to begin in October, with 110 million doses expected to be delivered by the end of the year. 

Pfizer and partner BioNTech announced the results of a clinical trial in late October that showed a booster dose administered 11 months after a second dose improved vaccine efficacy. Out of the 10,000 participants, split into placebo and booster groups, just five cases of symptomatic disease occurred in the booster group, compared with 109 cases in the non-boosted group. 

Researchers monitored patients for safety for another 2.5 months, similar to the original vaccine trial. 

FDA is likely to make a determination on boosters-for-all based on that data. Typically with prior COVID-19 vaccine decisions, though, the public was able to hear or see through the advisory committee meeting epidemiological data suggesting why certain vaccine decisions are necessary. 

While the FDA does not consult its advisory committee on every decision, the circumvention of the committee skips over a debate about how to deploy vaccine resources that remain in low supply around the globe. And the public won’t receive key information about how top public health officials are thinking about the chances of a winter surge and how boosters might help.

“At least the initial data from Israel did suggest it cut down on infections,” said Jesse Goodman, a former FDA chief scientist. “During a pandemic we’re having trouble getting control of, that itself may be helpful ultimately. But there should be a discussion.”

‘Sporadic and haphazard’

Offit added it’s not unusual to expect the protection against mild cases provided by neutralizing antibodies to wane, especially because the clinical trials tested people’s immunity for a median of two months, likely at the peak of the vaccine-acquired immunity.

“I think we created an unreasonable expectation for what efficacy means for this vaccine early on. I wish we had provided more anticipatory guidelines for what you could expect over time,” Offit said. “If the goal is to keep neutralizing antibody titers up, after the third dose it will still come down. … It won’t be the last dose.”

U.S. policy “seems so sporadic and haphazard at some level,” Offit said.

Some studies, including data from Wisconsin and England, indicate that the vaccine may be less effective in stopping the spread of the highly contagious delta variant. Still, some committee members are optimistic that a third dose will be a “true boost” that improves protection long term.

“This is the real crux of the issue: Do we need to boost now to protect against all disease, or wait and only hit the ‘boost’ button when levels of protection against severe disease wane further?” said Paul Spearman, director of the division of infectious diseases at Cincinnati Children’s Hospital Medical Center. “I personally think we should boost everyone, because the primary two-dose series is much inferior to the level of immunity that is achieved after a third dose.”

The hope among some experts in vaccine distribution is simpler: that removing any restrictions on who gets a booster will encourage more uptake. 

“Making boosters available broadly would clear up consumer confusion and just generally make logistics easier,” said Claire Hannan, executive director of the Association of Immunization Managers.

But others question whether more testing and education aimed at unvaccinated Americans would be a better use of resources. 

“Ongoing protection of initial vaccines against severe infection without a booster and the probability of higher booster uptake in regions with high initial uptake suggest that the magnitude of additional societal benefit with a booster-for-all policy will be small,” Harvard Medical School professors Ameet Sarpatwari and Emily Hyle, Harvard health policy professor Ankur Pandya and Sturm College of Law at the University of Denver health policy professor Govind Persad wrote in the Annals of Internal Medicine. “Without ... a transparent approach to decision making, limited resources may be suboptimally used and public trust damaged.”

Meanwhile, Pfizer CEO Albert Bourla acknowledged in a call with investors earlier this month that the demand for boosters from wealthy countries is likely to continue to crowd out low- and middle-income countries that can’t match the purchasing power of countries like the United States. 

“Predominantly, right now, we have already signed orders for [2022], and those are with high-income countries,” Bourla said. “We are negotiating right now with a few middle-income countries, and with even fewer low-income countries.”

White House chief medical adviser Anthony Fauci indicated Monday that the U.S. government is working with COVID-19 vaccine makers to increase their manufacturing capacity, but details are scarce. 

Fauci also said at the Bipartisan Policy Center event that he thinks holiday gatherings of vaccinated people are generally safe. But he also suggested boosters are key to suppressing a post-holiday surge. 

“If you get vaccinated and your family’s vaccinated, you can feel good about enjoying a typical Thanksgiving, Christmas with your family and close friends,” Fauci said. But he also suggested wearing a mask in crowded indoor places. “This will end. How quickly we get to the end depends on us. How well we get vaccinated, how well we get boosted.”