Two Key Senior FDA Officials Resign Over Vaccine Decisions
In what one major news source is calling a “major blow to vaccine efforts,” two senior U.S. Food and Drug Administration officials have suddenly turned in their resignations.
Thirty-two-year FDA veteran Marion Gruber is leaving her position as director of FDA’s Office of Vaccines Research & Review (OVVR) in October, and her deputy, Dr. Philip Krause, who has worked in the OVVR for 10 years, is leaving in November. According to The Defender,1 Gruber and Krause:
“… reportedly said they don’t believe there is data to support the Biden administration’s push to offer COVID booster shots later this month …
However, a former senior FDA leader told Endpoints News, Gruber and Krause are departing because they’re frustrated the Centers for Disease Control and Prevention (CDC) and its advisory panel — the Advisory Committee on Immunizations and Practices (ACIP) — are involved in decisions they think should be up to the FDA.
The source said he heard Gruber and Krause were upset with [FDA’s Center for Biologics Evaluation and Research, CBER, director Dr. Peter] Marks for not insisting those decisions be kept inside the FDA, and with the White House for getting ahead of FDA on booster shots.”
“The news, first reported by BioCentury, is a massive blow to confidence in the agency’s ability to regulate vaccines,” Endpoints News said.2 Former director of Biomedical Advanced Research and Development Authority (BARDA) Rick Bright called the resignations a “huge global loss.”
Boosters Planned Despite Inadequate Data
August 12, 2021, health officials authorized a third booster shot for people with weakened immune systems who had initially received the Pfizer or Moderna injections. Since then, at least 955,000 COVID-19 boosters have been administered, though it’s unclear whether all of these were technically authorized. Dr. Jesse Goodman, a former chief scientist with the FDA, told STAT News:3
“Normally, what you do is lay out the data first, and then say how the data supports the decision. When the White House made its announcement on booster shots, it did essentially the opposite. This was a serious mistake in how it was handled.”
ACIP member Helen Keipp Talbot, associate professor of medicine at Vanderbilt University, worries that health care providers may be putting themselves at risk by immunizing patients outside FDA and CDC recommendations, based on premature White House pronouncements alone.4,5
The rollout of booster shots for adults who got their second dose at least six months ago is expected to begin September 20, 2021. According to CNN,6 this rollout may be limited to Pfizer’s injection to start. Moderna’s boosters may be delayed by another few weeks due to inadequate data.
In its September 3, 2021, report, CNN claimed federal health officials warned White House staff that we still don’t have enough data to recommend boosters for all adults.7
The administration pushed forward anyway — a decision that appears to have prompted or played a role in Gruber’s and Krause’s resignations. FDA officials had also urged the Biden administration not to put a specific date on the rollout of boosters. They didn’t follow that recommendation either. Children’s Health Defense chairman Robert F. Kennedy, Jr., commented:8
“With 50% of its overall budget and 75% of its drug-testing budget coming from industry, the FDA long ago won its notoriety as the most corrupt and pliable of all federal agencies. Now, the White House has torn away its last shred of integrity by ordering top regulators to put politics before science.”
How Many Shots Will Be Required?
According to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, the recommended “full regimen” for the Pfizer and Moderna shots will likely end up being three doses. During a White House COVID-19 response team briefing, he stated:9
“… I would not at all be surprised that the adequate full regimen for vaccination will likely be three doses. It is entirely understandable why the results … reported from the Israeli boost is so dramatic.
And we all hope, and I believe we have good reason to believe, that that only will not be a strong response, but that it will actually be durable, and if it is durable, then you’re going t
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