Friday, September 3, 2021

U.S. FDA officials resign over Biden booster plans

Anger, frustration at FDA over Biden’s booster plan; two top regulators resign | Ars Technica - Beth Mole:

September 1, 2021 - "Two top vaccine regulators have resigned from the Food and Drug Administration, revealing anger, frustration, and turmoil at the federal agency as it faces intensifying pressure to authorize COVID-19 vaccine booster shots and doses for children under the age of 12. The two regulators leaving are Marion Gruber, director of the FDA’s Office of Vaccines Research and Review (OVRR), and OVRR Deputy Director Phil Krause. Gruber has been with the FDA for more than 30 years, and Krause has been at the agency for more than a decade.

"Their resignations, first reported by pharmaceutical trade publication BioCentury, were apparently sparked by frustration that the Biden administration had overstepped the FDA in announcing plans to offer COVID-19 booster shots beginning on September 20. The pair also clashed with higher-up Peter Marks, who reportedly went along with the administration's plans. Marks is the director of the FDA's Center for Biologics Evaluation and Research (CBER), which includes the OVRR. Marks announced the two resignations in a letter sent to FDA staff ... published in full by biopharmaceutical outlet Endpoints News.

"As news spread of the high-profile resignations, current and former FDA regulators were quick to reveal growing tensions coming from some in the agency who see the Biden administration's booster plan as premature, unnecessary, and out of step with regulators' opinions. Politico, which spoke with 11 former and current health officials, described the situation at the FDA as a 'potential mutiny' among agency staff and outside vaccine experts."

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Biden's top-down booster plan sparks anger at FDA - Politico - Sarah Owermohle:

August 31, 2012 - "The Biden administration’s decisions over when to administer coronavirus vaccine boosters are triggering turmoil within the Food and Drug Administration, frustrating regulators and sparking fear that political pressures will once again override the agency’s expertise. FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters' benefits before the administration’s Sept. 20 deadline for rolling them out to most adults. 

"Many outside experts, and some within the agency, see uncomfortable similarities between the Biden team's top-down booster plan and former President Donald Trump's attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments.... Now the agency 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....

"Acting FDA Commissioner Janet Woodcock sent a memo Tuesday evening to vaccine regulators, reiterating her support as frustration over the process spreads within their ranks.... The tensions between FDA's regulators and top Biden administration officials — including Woodcock, who has publicly endorsed the booster plan — come as the agency begins to tackle its most difficult decisions yet on Covid-19 shots. Many center around making them available to children under 12, whose bodies react differently to the virus and vaccines to prevent it. FDA will have to decide whether the rising number of cases in kids warrants making shots available to them on an emergency basis, before the lengthier approval process, which is more likely to detect any rare side effects. But for now, much of the discord within the agency centers on the administration's decision to push ahead with boosters before FDA's top scientists had a chance to weigh in.

"It was 'the administration's booster plan; it wasn't the FDA's booster plan,' said Paul Offit, a University of Pennsylvania infectious disease expert who sits on FDA’s vaccine advisory committee.... Another senior health official with direct knowledge of the situation said that political appointees within the White House largely steered the mid-August booster announcement.

"Biden added to the confusion and controversy last weekend when he suggested that boosters could be administered just five months after the initial regimen, rather than the eight his administration had just proposed. Those remarks, coming after a meeting with Israeli Prime Minister Naftali Bennett, fueled worries that an administration that had pledged to 'follow the science' was letting politics dictate outcomes."

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