[CNBC Television] FDA VRBPAC member on the decision to recommend booster shots for the 65+ age group
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Dr. Ofer Levy, Director of the Precision Vaccines Program at Boston Children’s Hospital and a voting member of the FDA’s VRBPAC Advisory Committee, joins Worldwide Exchange to discuss the committee’s recommendation regarding booster shots. For access to live and exclusive video from CNBC subscribe to CNBC PRO:
An influential Food and Drug Administration advisory committee on Friday rejected a proposal to distribute booster shots of Pfizer and BioNTech’s Covid-19 vaccine to the general public, paring back those plans to unanimously recommend the third shots to people age 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 panel voted 16-2 against distributing the vaccines to Americans 16 and older, before unanimously embracing an alternate plan to give boosters to older Americans and those at a high risk of suffering from 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 decision by the FDA’s Vaccines and Related Biological Products Advisory Committee comes 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 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.
“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.
The committee vote was expected 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 entirely convinced 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 recommend 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 said.
In a paper published days before the advisory committee meeting, a leading group of scientists said available data showed vaccine protection against severe disease persists, even as the effectiveness against mild disease wanes over time. The authors, including two high-ranking FDA officials and multiple scientists from the World Health Organization, argued Monday in the medical journal The Lancet that widely distributing booster shots to the general public is not appropriate at this time.
In outlining plans last month to start distributing boosters as early as next week, Biden administration officials cited three CDC studies that showed the vaccines’ protection against Covid diminished over several months. Senior health officials said at the time they worried protection against severe disease, hospitalization and death “could” diminish in the months ahead, especially among those who are at higher risk or were inoculated during the earlier phases of the vaccination rollout.
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