FDA Throws Wrench In Biden's Plans As They Reject His 'Promise' To America

Written By BlabberBuzz | Sunday, 19 September 2021 16:45

An influential Food and Drug Administration advisory board on Friday dismissed an offer to send booster shots of Pfizer and BioNTech’s Covid-19 vaccines to the general public, bringing back those plans to unanimously recommend the third shots to people aged 65 and older and other vulnerable Americans.

“It’s likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don’t think we’re there yet in terms of the data,” said Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital.

The council voted 16-2 against administering the vaccines to Americans 16 and older, before collectively covering another form of method to administer boosters to older Americans and those at a high risk of experiencing severe illness if they get the virus. That’s previously included people with diabetes, heart disease, obesity and other so-called comorbidities.

Pfizer’s stock closed down 1.3%, while shares of BioNTech fell 3.6%.

The nonbinding resolution by the FDA’s Vaccines and Related Biological Products Advisory Committee comes as the Biden administration has said it aspires to begin offering booster shots to the general public as early as next week, pending permission from U.S. health regulators. While the agency hasn’t always followed the advice of its committee, it often does. A final FDA decision could come in a matter of hours. The Centers of Disease Control and Prevention has scheduled a two-day meeting next week to discuss plans to distribute the third shots in the U.S.

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“We are not bound at FDA by your vote, just so you understand that. We can tweak this as need be,” Dr. Peter Marks, the agency’s top vaccine regulator, reminded the panel after the votes. He asked the group for suggestions on what other populations the FDA should consider for boosters, like front-line health workers and other occupations that face more exposure to Covid.

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The board vote was set to be a controversial one as some scientists, including two senior FDA officials who were involved in the meeting Friday, have said they aren’t completely persuaded every American who has received the Pfizer vaccine needs extra doses right now.

White House chief medical advisor Dr. Anthony Fauci said he wasn’t surprised they didn’t support the shots for people 16 and older. Fauci, who has publicly backed boosters, hesitated in an interview Friday on “Closing Bell” to guess what the committee would ultimately decide.

“I don’t want to get ahead of the advisory committee at the time that they’re deliberating,” he replied.

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