Posted on 08/31/2021 1:24:51 PM PDT by rxsid
BREAKING: In a major blow to vaccine efforts, senior FDA leaders stepping down
Two of the FDA’s most senior vaccine leaders are exiting from their positions, raising fresh questions about the Biden administration and the way that it’s sidelined the FDA.
Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, will leave at the end of October, and OVRR deputy director Phil Krause, who’s been at FDA for more than a decade, will leave in November. The news, first reported by BioCentury, is a massive blow to confidence in the agency’s ability to regulate vaccines.
The bombshell announcement comes at a particularly crucial moment, as boosters and children’s shots are being weighed by the regulator. The departures also come as the administration has recently jumped ahead of the FDA’s reviews of booster shots, announcing that they might be available by the week of Sept. 20.
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.
FDA’s former acting chief scientist Luciana Borio added on Twitter, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”
“These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Former BARDA director Rick Bright wrote, weighing in on the news. “Dr. Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”
In a letter from Marks to staff, he explained:
https://www.nippon.com/en/news/yjj2021082601094/
Tokyo, Aug. 26 (Jiji Press)—Foreign materials found in some unused vials of U.S. biotechnology company Moderna Inc.’s COVID-19 vaccine in Japan may have been pieces of metal, sources at the Japanese health ministry said Thursday.
The ministry believes that the foreign objects may have been mixed in with the vaccine vials during the manufacturing process.
I’m not.
You got a complaint, sis?
Take it up with Al Rueters and the Japanese news agency.
Then, get some new reading glasses. And, learn how to research rather than asking others to do it, for you.
And, finally, take your precious, suspended, contaminated vials and kindly buzz off.
it’s not impossible
In a major blow to vaccine efforts, senior FDA leaders stepping down
“leaders”
They call long-term government employees that.
Thanks.
Not worth the trouble, trust me!
I thought I read where they are leaving to take jobs with big pharma
Specify whom. There are numerous Gators on here... :)
You’re the GOOD Gator. :)
Thank you.
Why leave easy jobs probably making $300K per year?
They can make more from the drug companies who owe them.
"The cat is up on the roof."
Add to this, Japanese have a new phrase モデルナアーム or Moderna Arm...a weeks long saucer sized blotch where they were vaccinated.
Also, Japanese are demanding ALL shots be stopped until an official analysis is made as to what these shots are. I’m sure Moderna has a NDA up the wazoo about this but they did name Takeda Pharma as their distributor and once you’ve lost trust with the Japanese, you never get it back.
I wouldn’t be surprised if they do stop all vaccination and release an extensive report.
Yes, that was Moderna. They have a contract with a company in Madrid called Rovi, which is where the contaminated vials were shipped from.
SOMEONE NEEDS TO FOIA all their emails and records now.
“...due to needles being incorrectly inserted into vials, breaking off bits of the rubber stopper.”
I really needed a good laugh today. Thanks.
Thank you.
Good post, Chode.
A government that can rationalize a mandate to force citizens to submit to an invasive medical procedure can rationalize anything. It can force you to do anything.
And it can do anything TO you. And will.
p
they can run but they can’t hide....
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