Special guest piece: A former FDA vaccine regulator speaks out about the Covid jabs
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.
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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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(Tony Fauci, plus sign language Tony Facui!)
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This preemptive declaration made one thing clear: political leaders were deciding public health policies before scientific experts could even analyze the data.
Krause immediately recognized the scientific and ethical dangers of this approach.
“The acting commissioner of the FDA and the White House had already announced boosters would be available by September—before we had even reviewed the data.”
When the FDA’s independent vaccine advisory committee met to review booster shot data on September 17, 2021, it rejected the idea of boosters for the general population, recommending them only for the elderly and immunocompromised. But FDA leadership and the Centers for Disease Control overruled the committee and expanded booster recommendations anyway.
By then, Krause had quit.
A Broken System: How the FDA Became a Political Tool
Krause’s called his resignation a case study in how the FDA has lost its independence.
He warned that the agency’s leadership has too much power to overrule its frontline scientists. “What we’ve seen more and more at the FDA is we've had senior leaders who've overruled review teams and said, ‘I disagree with the review team on scientific grounds.’ And to me, that's a very dangerous reason to overrule the review team.” Politics can corrupt even decisions that are nominally scientific, he said.
Instead of acting as a neutral regulator, the FDA became an enforcer of preordained political decisions—sacrificing scientific integrity along the way.
“If a politician wants to make a difficult decision, then maybe they should just make it themselves and own it—rather than ask a public health agency director to say or do something politically motivated.”
Krause argues that transparency is the key to restoring trust—ensuring that scientific review processes remain open, public, and resistant to political influence.
"If the basis for the FDA decision has to be transparent, has to be published, has to be made available... then the motivation to apply pressure to these people in order to get favorable FDA decisions may decline."
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Rav Arora is an independent journalist covering Big Pharma, health agencies, and holistic mental health treatments. You can follow his Substack for coverage of Dr. Bhattacharya’s hearing next week to become director of the National Institutes of Health and the full podcast release with Dr. Krause.
Or, as one wag on Twitter called it, Come Here Naughty. Yes, Alex was that wag.
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This was not just politics, it was money. Billions of dollars were made marketing these vaccines to a coerced public.
Scientists on the government payroll are always beholden to them. Government scientific inquiry is a contradiction in terms just as free scientific inquiry is redundant as in Atlas.