FDA panel recommends Pfizer’s Covid booster doses for people 65 and older after rejecting third shot

[Right_in_Virginia]

FDA panel recommends Pfizer’s Covid booster doses for people 65 and older after rejecting third shots for general population
CNBC, Sep 17, 2021

An influential Food and Drug Administration advisory committee on Friday rejected a proposal to distribute booster shots of Pfizer’s 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 was down more than 1% in intraday trading after the initial vote. Shares of BioNTech were down more than 4%.

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.

More:
https://www.cnbc.com/2021/09/17/fda-panel-begins-voting-on-pfizers-covid-booster-doses-rejecting-shots-for-general-public.html

[mystery-ak]

Well, that's me..not getting a booster...nope!

[EdinVA]

I am absolutely positive that this decision was based solely on science and biden never pushed... /s

[mountaineer]

AP is reporting this as "a blow" to Biden. If this whole thing weren't political, wouldn't the FDA ruling against a particular drug be "a blow" only to bad, ineffective medicine?

[mountaineer]

Elsewhere, I posted a link to a Detroit TV station's Facebook page, where they asked whether anyone had lost a loved one to Covid after the vaccines became available. They were flooded with accounts of vaccine side effects, from deafness to Covid to heart problems to death.

The 71-year-old wife of a friend is fully vaxxed. Husband had to take her to the hospital recently because she simply felt awful. She was admitted and stayed 9 days without any doctor figuring out what her problem was. Her white blood count soared, so they pumped several different antibiotics into her, without apparent success. They said maybe she should go to an infectious disease hospital, and then discharged her without making any such arrangements. She's weak and can barely walk.

I don't think the booster would help her much, FDA-approved or otherwise.

[mountaineer]

In a vote of 16-2, a key Food and Drug Administration (FDA) panel rejected a plan to approve Pfizer booster shots.

The Associated Press reports that the panel voiced frustration that Pfizer had provided little data on the safety of the extra doses.

President Joe Biden had set a target date of Sept. 20 to begin distributing a third dose of the vaccine. ...

More

Well, you can't expect the impossible, can you?

[Bigun]

https://twitter.com/AlexGiorgio6/status/1438921789552398336

[mystery-ak]

I had Moderna...so far haven't heard much about a booster from them.

The 2nd Moderna shot made me sick for 3 days..I am not going through that again...

[PeteS in CA]

I had Moderna...so far haven't heard much about a booster from them.

The 2nd Moderna shot made me sick for 3 days..I am not going through that again...

Ask and ye shall receive, https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-submission-initial-data-us-fda-its-covid-19 .

The Pfizer "decision" is not surprising. While Pfizer submitted data to the effect that a booster increased recipients' antibodies, I don't think there is data showing that 6-9 months post-vax antibodies are reduced to marginal or ineffective levels and that B- and T-cell changes caused by the vaccine were gone. IOW, need was not demonstrated by data.

This is "a blow" to Biden only in the sense that he tried to lobby/pressure this decision and the panel didn't do his bidding. Moderna's similar, more recent, request for booster authorization is likely to be turned down as well, IMO.