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Tue Nov 16, 2021, 05:38 PM

The F.D.A. plans to authorize Pfizer-BioNTech boosters as soon as Thursday.

Source: New York Times

WASHINGTON — The Food and Drug Administration is aiming to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for all adults as early as Thursday, a move that would expand the number of Americans eligible for additional shots by tens of millions, according to people familiar with the agency’s plans. The Centers for Disease Control and Prevention’s independent committee of vaccine experts has scheduled a meeting for Friday to discuss data on the booster dose’s efficacy and safety.

If both the F.D.A. and the C.D.C. sign off this week, they will have acted strikingly quickly — a little more than a week after Pfizer asked for authorization of boosters for everyone 18 and older. Under that scenario, any adult who received a second dose of the vaccine at least six months earlier would be officially eligible to get a booster as soon as this weekend. The F.D.A. is expected to rule without consulting its own expert panel, which has met frequently during the pandemic to review vaccine data and make a recommendation ahead of a regulatory decision.

Moderna is expected to soon submit its own request for the F.D.A. to broaden eligibility for its booster. But for now, every adult could get the Pfizer booster, according to people familiar with the planning.The broad booster authorization has been viewed as something of a fait accompli for weeks. Some state and local officials have begun rolling out similar policies ahead of F.D.A. action — responding to persistent virus case counts and the eagerness of many Americans to seek additional protection ahead of holiday gatherings. New York City health officials on Monday encouraged all adults who want boosters to seek them out. Arkansas, California, Colorado and New Mexico have already moved to expand access.

Many Americans, regardless of where they live, have taken the matter into their own hands and sought out extra doses even if they do not officially qualify yet.The F.D.A. in September downsized Pfizer-BioNTech’s request to fully approve booster doses for all adults, instead signing off on a more limited population, including those 65 and older, as well as adults with underlying medical conditions or those at risk because of their jobs. At least 30 to 40 percent of vaccinated adults are still excluded from booster eligibility, according to some estimates.

Read more: https://www.nytimes.com/2021/11/16/us/politics/fda-pfizer-booster-shots-adults.html





(got my Moderna booster yesterday along with a flu shot)

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Reply The F.D.A. plans to authorize Pfizer-BioNTech boosters as soon as Thursday. (Original post)
BumRushDaShow Nov 16 OP
Tomconroy Nov 16 #1
BumRushDaShow Nov 16 #2
BigmanPigman Nov 16 #3

Response to BumRushDaShow (Original post)


Response to Tomconroy (Reply #1)

Tue Nov 16, 2021, 06:08 PM

2. I don't think there will be a supply problem

particularly since Moderna's booster, for example, is a (technically) "true" booster (versus a "3rd dose" used as a "booster" like Pfizer's) and is a 1/2 dose (so right there you can double the number of doses available from a vial if used as a booster).

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Response to BumRushDaShow (Original post)

Tue Nov 16, 2021, 07:39 PM

3. Yippee...I can get mine on Nov 22 (6 months since last vax).

"...Monday encouraged all adults who want boosters to seek them out. Arkansas, California, Colorado and New Mexico have already moved to expand access". Now my sister will be able to get one too and the whole family will have them by Thanksgiving.

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