The Union Democrat

FDA to sidestep advisers on COVID booster eligibilit­y

- By EMILY KOPP Cq-roll Call

WASHINGTON — 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-forall, 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 frontline 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.

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.”

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 vaccineacq­uired 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.

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