BREAKING: In a major blow to vaccine efforts, senior FDA leaders stepping down

[Mito]

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 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...

endpts.com

”Together, Gruber and Krause have been responsible for the oversight and review of COVID-19 vaccines, quietly and calmly steering the agency through the most intense political turbulence and highest stakes scientific challenges it has ever faced."

Departure of top FDA vaccine regulators a ‘huge loss,’ CBER Director Marks says

Resignation announcements Tuesday from FDA’s two most senior regulators responsible for oversight of vaccines, Marion Gruber and Phil Krause, surpri...

www.biocentury.com

 

[tankasnowgod]

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.”

I wonder if there will be a slew of articles coming out in the next few months about how Marion Gruber and Phil Krause are actually just crazy Anti-Vaxxers?

I said earlier in the year that I didn't think the FDA wanted to get more involved in the whole COVID 19 vaccination thing than they already were. While I was certainly wrong to ascribe this idea to the agency, I think departures such as these shows there was probably a lot of controversy behind the scenes, even for people whose careers were rooted in mainstream medicine and science.

 

[yerrag]

It must be hard for them to be part of the mass murder of innocent people who trusted them blindly.

It takes a heavy toll. They started their career probably thinking they could leave the world a better place. Little did they know they would slowly transmogrify into creatures they themselves would disown.

 

[haidut]

It must be hard for them to be part of the mass murder of innocent people who trusted them blindly.

It takes a heavy toll

I don't think they care the slightest bit about others. I met my fair share of HHS/CDC/FDA officials during my days as IT consultant at federal agencies. Without a single exception, every one of them, labor category GS-14 or above, was a psychopath. I think these are leaving as they smell the vaccine fiasco is about to unravel and the agency will probably throw them under the bus (as it has done many times in the past) when criminal proceedings start.

 

[haidut]

I wonder if there will be a slew of articles coming out in the next few months about how Marion Gruber and Phil Krause are actually just crazy Anti-Vaxxers?

Actually more like these two will be arrested and charged with knowingly approving a deadly vaccine when the vaccine side effects become too big to ignore and courts start looking into it. This way they can say "hey look, we tried to blow the whistle but FDA political leadership suppressed us, so the only other thing we could was resign so that we are no longer part of this lethal scam". It does not guarantee they won't become scapegoats but at least gives them some leverage/credibility during a trial. Of course, if it gets to the point of criminal proceedings many of those "courageous" dissidents will probably commit "suicide"...juts like those Capitol Police cops.

 

[yerrag]

I don't think their care the slightest bit about others. I met my fair share of HHS/CDC/FDA officials during my days as IT consultant at federal agencies. Without a single exception, every one of them, labor category GS-14 or above, was a psychopath. I think these are leaving as they smell the vaccine fiasco is about to unravel and the agency will probably throw them under the bus (as it has done many times in the past) when criminal proceedings start.

Most likely.

But they weren't born evil.

Society has this mechanism to corrupt people into making them monsters.

Over generations spanning millenia, those who die for principles keep dying, and weakling survive.

Two millenia after Christ, the martyr and hero pool has been exhausted. It also doesn't help that our material reward system pay robot minds higher than critical minds.

I have a classmate who was a McKinsey consultant and now does big mega corporate acquisition deals in Hongkong. He was once bright, but the corporate grind had made him rich but dumb. He is Pfizer vaxxed and thinks it's the best thing since sliced bread. He can't engage in debate and can only provide links from mainstream media about what he considers factual which we deride as propaganda.

That's what those corporate elite minds are. Each are role players with a defined task. Marketers market lies. Commandos assassinate threats to these lies. All are mercenaries for their way to the good life. For them, there is no higher meaning to life.

 

[Mito]

“Reports that Food and Drug Administration officials plan to step down over the White House’s COVID-19booster shot guidance have created a "mess" for the Biden administration, according to Dr. Mark Siegel.

In a statement on Tuesday, the FDA said that Marion Gruber, director of the agency’s Office of Vaccines Research and Review, and her deputy director, Phil Krause, will leave in October and November, respectively.

Siegel told "America’s Newsroom" that the seeming clash between the FDA and the White House has created "a mess for the administration."

“There’s a lot of confusion, there’s a lot of finger pointing … this is a mess for the administration right now," Siegel said.

Siegel acknowledged that studies out of Israel indicate a significant reduction to the spread of the virus, but that the "confusion" between the White House and health officials have complicated matters.

"It’s a combination of things where the messaging is coming out of the White House and not of the FDA, and also out of the NIH with Tony Fauci and Dr. Francis Collins has said, ‘Hey, we might have the vaccines for the 5 to 11 year olds in a couple of months’ … well, FDA hasn’t reviewed the data yet," Siegel explained. "And with the boosters, the president himself said, ‘We’re going to get boosters in a month,’ and the FDA says, ‘Wait, we haven’t reviewed the data yet.’”

Siegel claimed that acting Commissioner Janet Woodcock is also under fire, especially with her position not yet fully confirmed.

Earlier this month, President Biden said the plan was for every adult to get a booster shot eight months after getting the second shot.

The White House’s decision comes amid the surge of the highly transmissible delta variant of COVID-19, which studies have shown to double the risk of hospitalization for unvaccinated individuals.

However, the FDA did not provide guidance to Biden on the issue of booster shots, with the Centers for Disease Control (CDC) and the Advisory Committee on Immunization Practices (ACIP) reportedly spearheading decisions.

FDA resignations over White House booster shot guidance a 'mess for administration'

Reports that Food and Drug Administration officials plan to step down over the White House’s COVID-19 booster shot guidance have created a “mess” for the Biden administration, according to Dr. Mark Siegel.

www.foxbusiness.com

 

[BRBsavinWorld]

I don't think they care the slightest bit about others. I met my fair share of HHS/CDC/FDA officials during my days as IT consultant at federal agencies. Without a single exception, every one of them, labor category GS-14 or above, was a psychopath. I think these are leaving as they smell the vaccine fiasco is about to unravel and the agency will probably throw them under the bus (as it has done many times in the past) when criminal proceedings start.

Dang! Can you tell psychopath stories?