FDA meeting puts Biden’s plan to combat virus at risk

A key part of President Joe Biden‘s plan to combat Covid is in jeopardy as a Food and Drug Administration vaccine advisory committee meets Friday to debate and vote on Pfizer and BioNTech‘s application to offer booster shots to the general public.

The vote by the agency’s Vaccines and Related Biological Products Advisory Committee – scheduled for around 2:30 p.m. ET – comes as some scientists, including at least two at the FDA, say they aren’t entirely convinced every American who has received the Pfizer vaccine needs extra doses at this time.

In documents released ahead of the advisory committee meeting, FDA scientists declined to take a stance on whether to back third shots, saying U.S. regulators haven’t independently reviewed or verified all the available data to support the use of boosters. They also appeared to be skeptical about some of the data provided, including widely cited efficacy numbers out of Israel, where researchers there have released observational studies showing the effectiveness of the Pfizer vaccine against infection waned over time.

It sets the stage for a tense meeting Friday as the Biden administration has said it wants to begin offering booster shots to the general public as early as next week, pending authorization from the FDA. The move is part of the administration’s broader plan to confront a higher number of Covid cases in the U.S. fueled by the fast-spreading delta variant.

The nation’s top health regulators, including CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock and White House chief medical advisor Dr. Anthony Fauci, already endorsed Biden’s booster plan in August. While the FDA hasn’t always followed the advice of its committee, it often does. The agency surprised investors and the public earlier this year when it departed from the advice of its independent panel of outside experts to approve Biogen’s Alzheimer’s drug.

If the committee does not deliver a favorable vote, it could force the Biden administration to shift gears on its plan, perhaps limiting third shots to certain groups of Americans, such as those age 65 and older who are known to be at higher risk of severe illness, said Lawrence Gostin, director of the World Health Organization Center on National and Global Health Law.

The FDA group could give Biden’s booster plan a “cool reception,” Gostin said. “While there is good evidence of potentially waning vaccine immunity, two mRNA doses are holding up robustly by preventing serious disease, hospitalizations and deaths.”

The vote puts the committee in an “awkward position” as the administration has already announced they would begin distributing boosters the week of Sept. 20, said Dr. Bruce Farber, chief of infectious disease at Northwell Health.

“I’m sure they’re not going to be unanimous at all in what they’ve said because we already know they’re not unanimous,” he said.

Scientists and other health experts had already been critical of Biden’s move to boost all…