Not enough safety data.
QUICK FACTS:
- Two of the U.S. Food and Drug Administration’s most senior vaccine leaders are exiting from their positions, according to Endpoints News.
- Doctors Marion Gruber and Phil Krause resigned after the Biden administration sidelined the FDA from major decision-making about Covid-19 vaccines.
- The two could not support the White House’s expedited rollout of booster shots because the FDA has not determined whether booster shots are safe or effective.
- Neither believed there was enough data to justify offering booster shots yet, notes The New York Times.
- One former FDAer also said he’s heard they’re upset with Center for Biologics Evaluation and Research (CBER) director Peter Marks for not insisting that those decisions should be kept inside FDA, notes Endpoints.
- Dr. Gruber will leave in October, Dr. Krause in November.
ABOUT GRUBER & KRAUSE:
- Dr. Gruber is director of FDA’s Office of Vaccines Research & Review (OVRR) and 32-year veteran of the agency.
- Dr. Krause is OVRR deputy director and has been at FDA for more than a decade.
- FDA former acting chief scientist Luciana Borio on Twitter referred to doctors Gruber and Krause as “two giants” of the industry. “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service,” Luciana said.
- “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,” said Former BARDA director Rick Bright. “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.”
WHAT EXPERTS ARE SAYING:
- Associate professor of health policy at the Yale School of Public Health Jason L. Schwartz said, “This process has been the reverse of what we would normally expect in vaccine policy,” with the administration announcing plans based on a certain outcome before regulators can complete their review. “That has made it even more complicated and confusing for the public.”
BACKGROUND:
- The Japanese Ministry of Health, Labor and Welfare announced on Aug 26 that it had found “Black substances…in syringes and a vial, with pink substances found in another syringe” within a lot of Moderna Inc.’s experimental mRNA vaccine, Reuters reports. 1.6 million vials were rejected.
Jon Fleetwood is Managing Editor for American Faith and author of “An American Revival: Why American Christianity Is Failing & How to Fix It.“
