FDA COMMITTEE VOTES FOR BOOSTERS
65-plus, high-risk cases are now closer to getting third shots
Members of an FDA advisory committee voted unanimously to authorize Pfizer booster shots for use in people age 65-plus and high-risk patients following a prior failed vote to approve third shots for all people 16 and up.
The Vaccines and Related Biological Products Advisory Committee met for more than eight hours on Friday to discuss boosters, and the final vote could be amended to include health care workers and other workers who face a high risk of exposure.
Members had originally voted on a different measure on Friday, which was to approve Pfizer boosters in everyone age 16 and older.
Among 18 VRBPAC members, 16 voted no to that question, citing concerns over lack of data, a small sample size for safety and absolutely no data on boosters in kids age 16 and 17.
They also debated just how much coronavirus immunity has waned, questioning studies from Israel that seemed to serve as Pfizer’s basis for pushing boosters.
VRBPAC Member Dr. Archana Chatterjee had said, “I have major concerns with regard to the extrapolation of data from much older populations to 16- and 17year-olds. We have no data on the safety in this population at all…and that concerns me significantly.”
But the committee went back to the drawing board to amend the question.
They altered the measure to include specifics on age group and risk factors. They also changed from voting to recommend approval of the boosters, to just giving the shots emergency use authorization.
VRBPAC member Dr. Michael Kurilla said he liked the new wording, but added that there are still a lot of outstanding questions that remain when it comes to boosters.
An EUA allows the use of medical products under emergency circumstances, such as the pandemic. Full Food and Drug Administration approval is much more rigorous and considered the gold standard.
The VRBPAC vote doesn’t mean boosters are now available for people. Next week, the Advisory Committee on Immunization Practices, which is convened by the Centers for Disease Control and Prevention, will meet.
That committee will hammer out the rollout and see if boosters should be offered to any additional groups. After that, CDC Director Dr.
Rochelle Walensky will need to sign off before eligible Americans can get a third dose.
Friday’s vote could derail President Joe Biden’s plan to offer boosters to all Americans starting next week, which Walensky and Acting FDA Commissioner Janet Woodcock endorsed.
Intense debate over boosters has heated up in recent months, with some health experts, including the World Health Organization, asking that countries pause boosters so that the doses can be given to countries who need it most.