Newly unearthed documents offer additional insight into the departure of multiple key vaccine officials from the Food and Drug Administration (FDA) last year.
Dr. Phil Krause, who resigned from his position as deputy director of the FDA’s vaccine review office last year, expressed frustration with the Centers for Disease Control (CDC) and Department of Health and Human Services (HHS) in emails obtained via a Freedom of Information Act (FOIA) request by Judicial Watch. Krause, along with director of the FDA’s vaccine review office, Dr. Marion Gruber, resigned due to reported disagreements with a push to authorize COVID-19 boosters for the general population.
This FDA FOIA release is heavily redacted but paints a clear-ish picture of why FDA officials Krause & Gruber resigned last year. They wanted to require clinical studies before approving the booster, but the CDC wanted the booster approved without a trial.https://t.co/kOivfj2NsL
— Jay Bhattacharya (@DrJBhattacharya) October 25, 2022
“From my brief discussion with Peter [presumably, CBER Director Peter Marks] this morning, after some calls with CDC and HHS last night, the problem is that the [redacted]. Take a deep breath before reading this next paragraph,” Krause wrote in an unearthed email. “On that call, the CDC evidently stated that they will assemble all the data they are aware of on third dosing in this setting, and send it to us in the hope that we will (very soon) authorize the third dose for immunocompromised as part of the EUA.”
“Peter told me that CBER IOD [presumably CBER Immediate Office of the Director] will triage this—I told him I need to be cc:ed on any of these communications so we don’t get blindsided, but that we also need to protect the review team.” (RELATED: The FDA’s Own Experts Have No Idea Why It Approved Another COVID Booster Dose)
Last year, Krause co-authored an op-ed in The Washington Post criticizing the Biden administration for “sidelining” scientists in its rush to authorize and distribute booster vaccines. He then wrote in February that booster mandates weren’t justified, and would be “overkill at best” considering how many people already had natural immunity through prior infection.
More recently, FDA advisors have expressed frustration that the CDC and Biden administration are rapidly moving forward with booster authorization and recommendation. Dr. Paul Offit, an advisor on the FDA’s expert vaccine committee, told the Daily Caller he and his peers are at a loss for why the FDA is so determined to bypass normal procedures for the COVID-19 vaccines.