by Rav Arora, Unreported Truths:
No one can accuse Dr. Philip Krause of being an anti-vaxxer. But he hated the way Joe Biden rushed through Covid boosters in summer 2021 so much that he quit the FDA. Now he tells his story.
NOTE: Rav Arora is an up-and-coming independent journalist. He co-founded The Illusion of Consensus Substack and podcast with Dr. Jay Bhattacharya and now runs it himself. He’s just interviewed Dr. Philip Krause, who worked as the No. 2 in the vaccine division of the Food and Drug Administration before quitting in 2021. He asked me if I’d wanted to run the interview. As you know, I usually stick to my own stuff, but this seemed worth offering. Enjoy.
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On Mon., Aug. 30, 2021, Dr. Philip Krause tended his resignation as deputy director of the FDA’s Office of Vaccines Research and Review — abruptly leaving the agency where he had worked nearly his entire adult life. His decision came amid an escalating political and scientific fight over the mRNA Covid vaccines that still reverberates.
Now in his first long-form interview, Krause explains what really happened in 2021 and how external political pressure from the Biden Administration ruined the FDA’s regulatory and scientific independence.
Sidelined for Standing by Science
In summer 2021, Krause and his boss, Dr. Marion Gruber, were overseeing the full licensure of the Pfizer COVID-19 vaccine—a step that would move the product from what was called emergency use authorization (EUA) to full approval, and pave the way for vaccine mandates across schools, businesses, and the military.
But something alarming happened behind closed doors.
The FDA’s top officials asked Krause and Gruber to expedite the review process at an unreasonable speed, despite the need for a thorough safety review, including risks like myocarditis. They refused – and the agency retaliated.
“When we refused to commit to a rushed timeline, we were abruptly removed from the process,” Krause sad. “It became clear that I couldn’t be effective in my job anymore based on the way in which decisions were being made…The decisions were being influenced by factors that came from the outside, that were something other than the traditional objective review of the facts that the FDA is bound to conduct.”
The licensure process was then taken over by Dr. Peter Marks, Gruber’s boss. Marks, who oversaw not just the vaccine unit but several other FDA divisions, had pressed for rapid testing and approval of mRNA vaccines from the start and actually coined the name “Operation Warp Speed.” With the approval of the White House and top FDA officials, Marks would now be responsible for evaluating vaccines from a program he had helped create.
No surprise, on August 23, 2021, the FDA fully licensed Pfizer’s mRNA vaccine, now called Comirnaty.1
“As predicted by Drs. Woodcock and Marks, vaccine mandates followed immediately afterwards and were announced the same day for DoD and for New York State,” Krause stated in House testimony last June.
The Booster Debacle: White House Overrules FDA Experts
The pressure didn’t stop there.
On August 18, 2021, the White House announced plans to offer COVID-19 booster shots to all fully vaccinated adults, with distribution set to begin the week of September 20, 2021. Health officials justified the decision based on concerns over waning immunity and the spread of the Delta variant.
There was only problem. The FDA had not yet finished reviewing booster dose safety and efficacy.
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