FDA in Rebellion Over White House's Rushed 'Booster' Plans

Two top resignations at FDA.

Political science — when the scientists are told to say what the politicians want them to say.https://t.co/xacRLHQjvo

— Thomas Massie (@RepThomasMassie) September 1, 2021

Biden's top-down booster plan sparks anger at FDA

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.

By SARAH OWERMOHLE

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.

On Tuesday, two top FDA vaccine regulators resigned — a decision that one former official said was rooted in anger over the agency's lack of autonomy in the booster planning so far. A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA's top vaccine official Peter Marks. 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.

[...] 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. "The administration has kind of backed themselves up against the wall a little bit here."

[...] 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.

The tension within the administration plus open skepticism from outside experts has fueled finger-pointing and divisions among health agencies. Career scientists in particular have been confused and surprised by the process, multiple people involved in the talks said.

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.

But others familiar with the administration's thinking said that Biden and his top health aides, including Zients and chief medical adviser Anthony Fauci, had to lay the groundwork for booster shots so the public would be ready for what they saw as the unavoidable reality of additional vaccinations.

"If the White House didn't lead, what would happen?" said a person familiar with the discussions behind the scenes.

Yet, the confusion over the plan continues to build. While Pfizer completed its initial booster application on Aug. 27, it is unclear when Moderna and Johnson & Johnson might join its ranks, or when FDA will approve Pfizer's submission. Pfizer also has data coming in mid-October tracking booster doses administered between 4.8 and eight months after the original regimen.

Biden's five-month remark was "an innocent question" by the president after hearing from Bennett that Israel has forged ahead on broad booster dosing, a person familiar with the discussion said. In reality, the timeframe for additional doses comes down to the FDA and the companies submitting data — and likely will turn out to be a range of several months for getting a third dose rather than a specific window, they added.

Biden health officials are still confident that they will "have enough information and enough data" by Sept. 20 to make that call, the person familiar said. Several pointed to Israel's booster data and a "clear" benefit to additional doses, as one health official said.

"It's unprecedented," that the Biden administration would announce a specific booster rollout date before regulators had weighed in, said one Trump official. [...]

While the [CDC] has released five studies in recent weeks — some showing fading immunity among health care workers and more breakthroughs than previously recorded — other Biden officials say they are waiting anxiously for a collection of state data that many expect will provide more definitive evidence that breakthrough infections are much higher than previously thought.

BREAKING: White House chief of staff Mark Meadows has pressed FDA chief Stephen Hahn to grant an emergency use authorization for Pfizer’s coronavirus vaccine by the end of Friday, or face possible dismissal. https://t.co/mODWIick0K

— The Associated Press (@AP) December 11, 2020