WASHINGTON, D.C. (LifeSiteNews) – Two top U.S. Food and Drug Administration (FDA) officials have chosen to resign in response to ongoing disagreements with the Biden administration’s push to promote COVID-19 booster shots without first obtaining FDA approval.
Their unexpected departure from the agency “is a massive blow to confidence in the agency’s ability to regulate vaccines,” according to EndPoints Senior Editor Zachary Brennan, and raises serious questions about the wisdom of the Biden White House’s rush to give already-vaccinated Americans booster jabs.
Marion Gruber, who has worked at the FDA for more than three decades and now serves as director of the agency’s Office of Vaccines Research and Review, will leave the FDA in October and her deputy director Phil Krause will depart in November.
A former senior FDA official told EndPoints that Gruber and Krause are departing “because they’re frustrated that CDC and their ACIP [Advisory Committee on Immunization Practices] committee are involved in decisions that they think should be up to the FDA.”
The source said that “he’s heard they’re upset with CBER [Center for Biologics Evaluation and Research] director Peter Marks for not insisting that those decisions should be kept inside [the] FDA.”
Despite their role in the approval of the massively rushed, “warp-speed”-developed coronavirus vaccines now on the market in the U.S., the former FDA official suggested Gruber and Krause felt the Biden administration was being too heavy-handed with the FDA.
“What finally did it for them was the White House getting ahead of FDA on booster shots,” claimed the former official.
‘A huge global loss’
The loss of the duo is seen as a blow to the agency.
“Together, Gruber and Krause have been responsible for the oversight and review of COVID-19 vaccines, quietly and calmly steering the agency through the most intense political turbulence and highest stakes scientific challenges it has ever faced,” according to BioCentury, which first broke the news.
Former Biomedical Advanced Research and Development Authority director Rick Bright called their departure “a huge global loss.”
Luciana Borio, MD, Senior Fellow for Global Health at the Council on foreign relations, former National Security Council Director for Medical & Biodefense Preparedness, and former FDA Acting Chief Scientist, called Gruber and Krause “two giants.”
— Luciana Borio, MD (@llborio) August 31, 2021
A 32 year FDA veteran is quitting the agency due to the WH politically strong arming their decision making. If this doesn’t raise red flags among some of you, nothing will. https://t.co/om5VcnpxhC
— Jordan Schachtel @ dossier.substack.com (@JordanSchachtel) August 31, 2021
It’s the ‘Biden booster plan,’ not the FDA’s
It was “the administration’s booster plan; it wasn’t the FDA’s booster plan,” explained Paul Offit, a University of Pennsylvania infectious disease expert who sits on the FDA’s vaccine advisory committee, according to Politico.
“The administration has kind of backed themselves up against the wall a little bit here,” he added.
The FDA “is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary,” Politico added.
The outlet “spoke to 11 current and former health officials and people familiar with the matter who described growing exasperation with the administration’s disjointed process for implementing its booster plan. Those sources said there is little coordination between federal health agencies, even as two top FDA officials try to guide the rollout.”
The Biden Administration announced last month that it is advocating for the additional shot eight months following initial COVID-19 vaccinations.
“The plan is for every adult to get a booster shot eight months after you got your second shot,” Biden said during a mid-August coronavirus briefing.
“We will be ready to start this booster program during the week of September 20,” he declared.
The push for booster shots comes as evidence mounts that the COVID-19 vaccine’s effectiveness decreases over time.
The planned massive roll-out of mRNA vaccine booster shots also comes despite the thousands of deaths and other serious adverse reactions being recorded by individuals who have received the initial jabs.
The World Health Organization rejected calls for COVID-19 booster shots shortly after the Biden administration announced plans to roll out boosters, saying that data “is not conclusive.”
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