sammuel
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F.D.A. Advisory Panel Recommends Pfizer Boosters for Older People and Others at High Risk
The committee said there was insufficient evidence to recommend third shots for all adult recipients of the vaccine, as Pfizer had requested.
WASHINGTON — A key advisory panel to the Food and Drug Administration overwhelmingly rejected recommending Pfizer booster shots for most recipients of the company’s coronavirus vaccine, instead endorsing them only for people who are 65 or older or at high risk of severe Covid-19, and received their second dose at least six months ago.
The vote — the first on boosters in the United States — was a blow to the Biden administration’s strategy to make extra shots available to most fully vaccinated adults in the United States eight months after they received a second dose. The broader rollout was to start next week.
Committee members appeared dismissive of the argument that the general population needed booster shots, saying the data from Pfizer and elsewhere still seemed to show two shots protected against severe disease or hospitalization and did not prove a third shot would stem the spread of infection. Some also criticized a lack of data that an additional injection would be safe for younger people.
“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health.
But the panel’s final recommendation left some room for the White House to argue that the core of its booster strategy remained intact. Depending on how “at high risk” is defined, tens of millions of Americans could conceivably wind up eligible for additional shots of the Pfizer vaccine.
The committee of largely outside experts voted 16 to 2 against a Pfizer booster for people 16 and older after a tense daylong public discussion that put divisions in the agency and the administration on public display. Officials from the Centers for Disease Control and Prevention and the National Institutes of Health joined infectious disease experts and doctors in voting against additional shots for such a broad swath of the population.
the rest here :
www.nytimes.com
F.D.A. Advisory Panel Recommends Pfizer Boosters for Older People and Others at High Risk
The committee said there was insufficient evidence to recommend third shots for all adult recipients of the vaccine, as Pfizer had requested.
WASHINGTON — A key advisory panel to the Food and Drug Administration overwhelmingly rejected recommending Pfizer booster shots for most recipients of the company’s coronavirus vaccine, instead endorsing them only for people who are 65 or older or at high risk of severe Covid-19, and received their second dose at least six months ago.
The vote — the first on boosters in the United States — was a blow to the Biden administration’s strategy to make extra shots available to most fully vaccinated adults in the United States eight months after they received a second dose. The broader rollout was to start next week.
Committee members appeared dismissive of the argument that the general population needed booster shots, saying the data from Pfizer and elsewhere still seemed to show two shots protected against severe disease or hospitalization and did not prove a third shot would stem the spread of infection. Some also criticized a lack of data that an additional injection would be safe for younger people.
“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health.
But the panel’s final recommendation left some room for the White House to argue that the core of its booster strategy remained intact. Depending on how “at high risk” is defined, tens of millions of Americans could conceivably wind up eligible for additional shots of the Pfizer vaccine.
The committee of largely outside experts voted 16 to 2 against a Pfizer booster for people 16 and older after a tense daylong public discussion that put divisions in the agency and the administration on public display. Officials from the Centers for Disease Control and Prevention and the National Institutes of Health joined infectious disease experts and doctors in voting against additional shots for such a broad swath of the population.
the rest here :
F.D.A. Advisory Panel Recommends Pfizer Boosters for Older People and Others at High Risk (Published 2021)
The committee said there was insufficient evidence to recommend third shots for all adult recipients of the vaccine, as Pfizer had requested.
