FDA Panel to Weigh Covid-19 Booster Shots as Health Officials Debate Need

[mahatmakanejeeves]

Source: The Wall Street Journal.

U.S.

FDA Panel to Weigh Covid-19 Booster Shots as Health Officials Debate Need

Biden administration had hoped to offer extra shots as early as next week

By Jared S. Hopkins and Felicia Schwartz
https://twitter.com/jaredshopkins
[e-mail]
https://twitter.com/felschwartz
Sept. 17, 2021 5:30 am ET

The Biden administration’s push to introduce widespread Covid-19 vaccine boosters faces a test as a Food and Drug Administration advisory panel meets to weigh evidence on the extra shots, a topic that has divided federal health officials.

The outside panel of about 20 scientific advisers is set to review information Friday about the Pfizer Inc. and BioNTech SE vaccine’s declining protection against Covid-19 over time and on how people tolerated additional doses. It will hear presentations from Pfizer, which has asked regulators to clear booster shots for people 16 years and older, and the FDA, which this week said all the shots cleared for use in the U.S. remain effective without boosters. The panel will also consider contrasting scientific data about the extra shots.

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Read more: https://www.wsj.com/articles/fda-panel-to-weigh-covid-19-booster-shots-as-health-officials-debate-need-11631871003

[WHITT]

1. Hmmmm

The panel will also consider contrasting scientific data about the extra shots.

Except one of the "studies" submitted by the two whackos is not a study, but clearly merely an opinion piece, which obviously doesn't contain any "scientific data".

I sure hope this isn't some kind of set-up.

I was encouraged to see the Director of the NIH, Dr. Collins, say he was startled when he looked at the data and saw that both the mRNA vaccines had enough of a drop in effectiveness after six months that they could start to no longer prevent hospitalizations or deaths.

The assholes who oppose boosters want to WAIT UNTIL PEOPLE START DYING before they'll even consider them. ASSHOLES.

[BumRushDaShow]

3. I have been watching it since it started

and CBER head Dr. Peter Marks made a specific note that the members SHOULD BE evaluating the data from the presentations ONLY and SHOULD NOT include topics such as "the global inequity of vaccines" (paraphrased) or similar subjective (opinion) commentary as part of their discussions or decision-making, and if they do, they will be warned.

[WHITT]

5. Not Scientists

They are Marion Gruber and Phil Krause, both who have resigned from the FDA, but they're still there stinkin' up the place, as their resignations aren't effective until next month(?).

They falsely accused the WH of politicalizing the booster issue, when they were the ones acting politically.

[WHITT]

8. But

They were allowed to present an opinion piece as a "scientific" "study", which it is not. Had a vibe the fix was in.

[Steelrolled]

11. Marion Gruber has a PhD in Microbiology and Immunology, graduated Magna Cum Laude.

She has been at the FDA for 32 years.

Phil Krause is an MD from Yale, been been a Deputy Director at FDA for 11 years.

Both have many publications.

[BumRushDaShow]

10. Of the set of people who gave statements

only a couple were. The rest were policy people who were part part of health-monitoring organizations as well as some private citizens.

[BumRushDaShow]

2. Have been watching since it started at 8:30 am EDT

(and I feel sorry for the poor members who had to sign in to this who live in California )

Stream -

[Shanti Shanti Shanti]

6. Dr Gupta just said he doesnt think they will recommend boosters for everyone, just high risk/over 65

They might ALLOW others though, very murky waters, these committees.