Two FDA officials quit in protest over COVID vaccine reviews

Bill.in.PA · 2021-08-31T22:25:42.760Z

Yes, competence and effective leadership has not been a strong point for Biden.

Israel is seeing record numbers of COVID cases even though its vaccination rate is much higher than that in the US and Israel is already pushing boosters. Vaccinations are not going to make COVID go away no matter what how much wishful thinking comes out of the White House.

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New COVID-19 Cases Worldwide - Johns Hopkins Coronavirus Resource Center (jhu.edu)

A factor that is especially concerning is that the rush to approve boosters comes at the same a time as the White House and drug makers are pushing vaccinations for children under 12 without adequate testing. The risks of COVID to healthy children are extremely low, and the risks associated with the vaccines are undefined. Expect the push for expanded vaccine mandates to follow close behind.

What could go wrong?

CNN – 24 Aug 21

Next up for Covid vaccines: kids under 12 | CNN

The US Food and Drug Administration has given full approval to Pfizer’s coronavirus vaccine for people age 16 and older. Approval for youths ages 12-15 is expected to follow soon.

JayJay · 2021-08-31T22:30:31.637Z

Only 60% of Israel’s population is fully vaccinated, so we need to be careful when we talk about “much more vaccinated than the US”. That’s damning with faint praise.

Lots of unvaccinated Israelis still.

DougBH · 2021-08-31T22:35:24.242Z

Politicians making decisions instead of the scientists. One of the biggest accusations against the way Trump handled Covid. And here we are. Now we have real evidence.

Bill.in.PA · 2021-08-31T22:37:47.379Z

Most of the unvaccinated in Israel are children, and most of the hospitalized cases are among the vaccinated.

As of 15 August, 514 Israelis were hospitalized with severe or critical COVID-19, a 31% increase from just 4 days earlier. Of the 514, 59% were fully vaccinated. Of the vaccinated, 87% were 60 or older. “There are so many breakthrough infections that they dominate and most of the hospitalized patients are actually vaccinated,” says Uri Shalit, a bioinformatician at the Israel Institute of Technology (Technion) who has consulted on COVID-19 for the government. “One of the big stories from Israel [is]: ‘Vaccines work, but not well enough.’”

https://www.science.org/news/2021/08/grim-warning-israel-vaccination-blunts-does-not-defeat-delta

The White House is closing the stable door after the horse has bolted.

SottoVoce · 2021-08-31T22:39:03.029Z

Turnover in a government agency. Shocking. Someone retiring after working for the FDA for 32 years. Shocking. ZeroHedge making a claim based on an anonymous “senior FDA leader.” Shocking. The two people leaving are adults. If they have issues they can state them. They don’t need an anonymous senior FDA leader to talk for them.

Bill.in.PA · 2021-08-31T22:41:39.624Z

Retribution will be sure and swift if they come out publicly against the White House or drug companies. Any career beyond the FDA will be over since the drug companies and the government control all the funding.

SottoVoce · 2021-08-31T22:42:19.696Z

Bill.in.PA:

Retribution will be sure and swift if they come out publicly against the White House or drug companies. Any career beyond the FDA will be over since the drug companies and the government control all the funding.

One is retiring. What retribution would she face?

Bill.in.PA · 2021-08-31T22:45:05.031Z

The decisions need to consider economics and risk management, which may include political considerations.

On the other hand, approving vaccines strictly based political considerations could end in disaster. That appears to be where we are headed.

If Trump had done anything close to this, the media would have been screaming murder with Biden leading the lynch mob.

Camp · 2021-08-31T22:52:43.768Z

It does appear they are winging it with booster shots.

Anything more than one a year sends up a warning flag for me.

SixFoot · 2021-08-31T23:14:26.228Z

Rats are jumping ship. lol

Ben_Natuf · 2021-08-31T23:16:54.108Z

timesofisrael.com

Among older Israelis, serious COVID rate six times as high if unvaccinated

As government desperately tries to galvanize 1.1 million who are spurning vaccine, data shows that severe cases also far higher among younger people if they aren't inoculated

you may want to update

fallenturtle · 2021-08-31T23:43:24.557Z

Bill.in.PA:

“A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA . The former FDAer also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA. What finally did it for them was the White House getting ahead of FDA on booster shots.”

ZeroHedge

Should political considerations from the White House override FDA review of safety and effectiveness of COVID vaccines?

Joe Biden already answered this question, and I agree with him, but apparently his concerns only applied with Donald Trump was in the White House:

“One thing is certain. We can’t allow politics to interfere with the vaccines in anyway . . .” --Joe Biden

See video starting at 1:10
https://www.youtube.com/watch?v=1aqhWQcBYso

Why post Zerohedge and not the Bloomberg and Endpoints articles? It’s like if the sky were falling and you posted Chicken Little’s blog instead of an announcement from NASA or Astronomy Magazine.

fallenturtle · 2021-08-31T23:46:42.955Z

I like watching as the headlines change:
Biocentury: Top FDA vaccine regulators Gruber, Krause, stepping down
Bloomberg: Two FDA Vaccine Officials to Leave After Covid Clearances
Endpoints News: BREAKING: In a major blow to vaccine efforts, senior FDA leaders stepping down
Zerohedge: Two Senior FDA Officials Stepping Down Over Reported Disagreements With White House Over Booster Shots
Thread Title: Two FDA officials quit in protest over COVID vaccine reviews

fallenturtle · 2021-08-31T23:50:21.526Z

Bill.in.PA:

The decisions need to consider economics and risk management, which may include political considerations.

On the other hand, approving vaccines strictly based political considerations could end in disaster. That appears to be where we are headed.

how do you know they aren’t considering economics and risk management?

JayJay · 2021-09-01T00:01:08.433Z

Ben_Natuf:

https://www.timesofisrael.com/among-older-israelis-serious-covid-rate-six-times-higher-if-unvaccinated/

you may want to update

You do realize your article is a bigger problem for the OPers arguments than for any I have made.

Konssurvative1 · 2021-09-01T00:11:42.555Z

Politicians should never be making medical or Health Care decisions. Look how bad they ■■■■■■ up with Obama Care.

Bill.in.PA · 2021-09-01T00:30:09.939Z

If they come forward with criticism of the vaccine or the drug companies, expect that they will have zero opportunity for any further employment in their field. It would be a bit like a tobacco exec admitting that smoking causes cancer back in the 1950s.

If they a very vocal there is also the risk that Antifa will show up at their home and launch abuse and harassment while police watch and do nothing.

Dissidents must be punished.

Bill.in.PA · 2021-09-01T00:33:16.939Z

The links to Bloomberg and Endpoints are in the Zerohedge article if people want to read them.

Zerohedge does not have the paywalls found in many other sources.

SottoVoce · 2021-09-01T00:40:20.769Z

Bill.in.PA:

If they come forward with criticism of the vaccine or the drug companies, expect that they will have zero opportunity for any further employment in their field. It would be a bit like a tobacco exec admitting that smoking causes cancer back in the 1950s.

If they a very vocal there is also the risk that Antifa will show up at their home and launch abuse and harassment while police watch and do nothing.

Dissidents must be punished.

Uh sure. Or it’s just one person retiring and a another person deciding to move on for whatever reason.

A secret anonymous former FDA leader combined with Antifa and the fear of retribution forcing them to hide their real motivations! That is a lot more fun! Ungrounded speculation is exciting!

fallenturtle · 2021-09-01T00:41:59.205Z

Bill.in.PA:

The links to Bloomberg and Endpoints are in the Zerohedge article if people want to read them.

Zerohedge does not have the paywalls found in many other sources.

The Bloomberg and Endpoints articles aren’t behind pay walls. But I suppose this way has the potential to help Zerohedge’s advertisers and Zerohedge’s analytics. Joke’s on us as we unintentionally help yellow journalism.