President Joe Biden’s push to begin offering third doses of
The meeting is taking place as an extraordinary public debate plays out among administration officials, pharmaceutical executives, scientists, public health experts and global activists about whether boosters are even needed, and whether those doses would do more good being sent to poorer nations whose residents haven’t received even a single shot.
The proceedings, which began early Friday and are expected to wrap up with a committee vote in the late afternoon, will feature presentations from Pfizer, the FDA and Centers for Disease Control and Prevention, and scientists from Israel and the U.K.
The White House’s
“If the advisory committee votes not to support boosters, this will put the administration in an awkward position,” said
The agency isn’t obligated to follow the recommendations of the panel, called the Vaccines and Related Biological Products Advisory Committee, though it typically does. A decision from the FDA on whether to clear the supplemental shot could come soon after the meeting concludes on Friday.
Pfizer and its partner,
But some scientists and even two top FDA officials have questioned evidence supporting the need for a third dose. Covid-19 vaccines work well and governments would be better served to focus on immunizing the unvaccinated, according to review published Monday in The Lancet
Among the scientists behind the Lancet article were Marion Gruber, who now leads the FDA’s vaccines review office, and her deputy, Philip Krause. Both have said they would
Global health leaders have also called for more equitable distribution of doses. Dozens of countries have such limited access to the vaccines that they have
However, global vaccination coverage is outside the remit of the meeting, according to Baylor.
“I don’t think the consideration of global vaccination will impact the FDA’s ruling; however, global coverage may come up,” he said.
The second test for the Biden administration will come next week. A panel of outside experts who advise the CDC on how best to administer new vaccines will meet Sept. 22-23.
Friday’s meeting is also happening at a time when the FDA is without a permanent leader during a crucial period for big decisions, such as whether vaccines should be authorized for children under age 12.
The outcome of the booster decisions is critical for Pfizer, as it will shape the long-term marketplace for what’s become the biggest-selling drug in the world. Pfizer said in July it expects its vaccine to generate $33.5 billion in revenue this year, putting it on course to become one of the best-selling medicines of all time.
The same goes for
“A third shot is likely, both for Pfizer and Moderna vaccination, and that should continue to support very high sales we would project through 2023,” said
The concern is that with global vaccine inequity, variants more virulent than the current delta strain could emerge in vulernable populations.
“I hope we can’t get a variant more transmissible than this,” Gandhi said. “But it is possible.”
(Updates with start of FDA advisory meeting in third paragraph)
To contact the editors responsible for this story:
© 2021 Bloomberg L.P. All rights reserved. Used with permission.