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:
Okay, that’s not what I was asking. Maybe I’m confused.
Didn’t one of the vaccine companies outsource the mass manufacturing/production due to their size?
Why do all these people have names that sound like Die Hard villains?
Check out The BIG cats are getting vaxxed too!
“mysterious metallic metal shards.”
Source?
Those shards were probably chips.
Maybe they’re cashing in their Moderna and Pfizer stock that they “bought.”
Likely right.
Here is one thread.....
Contaminant in Moderna COVID-19 vaccines suspected to be metallic particles: NHK
CNA citing NHK & reuters ^ | 27 Aug 2021
Posted on 8/27/2021, 12:54:43 PM by Mount Athos
A contaminant found in a batch of Moderna's COVID-19 vaccines delivered to Japan is believed to be a metallic particle, Japanese public broadcaster NHK reported, citing sources at the health ministry.
Japan on Thursday (Aug 26) suspended the use of 1.63 million doses shipped to 863 vaccination centres nationwide, more than a week after the domestic distributor, Takeda Pharmaceutical, received reports of contaminants in some vials.
NHK, in a report published late on Thursday, cited ministry sources as saying the particle reacted to magnets and was therefore suspected to be a metal. Moderna has described it as "particulate matter" that did not pose a safety or efficacy issue.
A health ministry official said the composition of the contaminant has not been confirmed. Takeda did not immediately respond to a request for comment by Reuters.
Also see #22.
Remember, it’s all about the science, not the politics. Right? Right.
You mean like it could destroy your immune system and has Graphene poison included?
From your link:
A health ministry official said the composition of the contaminant has not been confirmed.
That is not about the original 1.6 million referenced.
OTOH, from the link in #22:
Japan’s health ministry said some of the incidents may have been due to needles being incorrectly inserted into vials, breaking off bits of the rubber stopper.
The ministry and Takeda Pharmaceutical (4502.T), which distributes the Moderna vaccine in Japan, said there were no safety issues from the Okinawa and Gunma incidents and that there was no need for nationwide suspensions.
Gunma and Okinawa can resume using vials from the lots in question as long as they do not contain foreign materials, the ministry told a briefing late on Monday.
The FDA’ers are the folks that actually do something and are accountable for their output (relative to the CDC). Folks like Fauci and CDC, sit on sidelines a speculate, hypothesize, not surprised they are checking out..................
Sounds terrific!
Take all you want.
🙃
They got The Saline.
Here....here's one more....again...take all of these suspended for caution/contaminated shots that you want.....
Japan's Moderna vaccine contamination woes widen as 1 mln more shots suspended (New: Third suspension)
Reuters ^ | August 29, 2021 | Rocky Swift
Posted on 8/30/2021, 12:57:53 PM by Mount Athos
Moderna Inc's (MRNA.O) COVID-19 vaccine contamination woes in Japan have widened with another million doses being temporarily suspended, after foreign substances were found in more batches and two people died following shots from affected lots.
The suspension of Moderna supplies, affecting more than 2.6 million does in total, comes as Japan battles its worst wave of COVID-19 yet, driven by the contagious Delta variant, with new daily infections exceeding 25,000 this month for the first time amid a slow vaccine rollout.
The latest reports of vaccine contamination came from Gunma prefecture near Tokyo and the southern prefecture of Okinawa, prompting the suspension on Sunday of two more lots in addition to the 1.63 million doses already pulled last week.
A tiny black substance was found in a Moderna vaccine vial in Gunma, an official from the prefecture said, while in Okinawa, black substances were spotted in syringes and a vial, and pink material was found in a different syringe.
The government had said that no safety or efficacy issues had been identified and that the suspension was a precaution. The causes of death are being investigated.
"If the contaminated substances were dangerous enough to cause death for some people, probably many more people would have suffered from some symptoms after the vaccination.
"However, further investigations are definitely needed to evaluate the harm of the particular doses in question."
Japan earlier halted the use of 1.63 million Moderna doses, shipped to 863 vaccination centres nationwide after the domestic distributor, Takeda Pharmaceutical (4502.T), received reports of contaminants in some vials.
Some 500,000 people received shots from those supplies, Taro Kono, the minister in charge of the vaccine push, has said.
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.
“You asked for a source. I pointed to two.”
And neither supported your ‘metal shards’ post.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.