Joe Biden has said he would “follow the science” on coronavirus policy, but two Food and Drug Administration (FDA) officials have just resigned in protest against what they claim is political pressure to push coronavirus booster shots.
According to Politico, the two top FDA vaccine regulators – Marion Gruber and Philip Krause – resigned from the agency over what they see as “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.”
Prior to his inauguration earlier this year, President Biden unveiled his team of scientific advisers and used the opportunity to take a swipe at the Trump administration by promising to help restore America’s faith in “science and discovery.”
“This is the most exciting announcement I’ve gotten to make,” Biden said at the time. “This is a team that is going to help restore your faith in America’s place in the frontier of science and discovery.”
“Science is discovery. It’s not fiction,” Biden added. “It’s also about hope.”
Likewise, during his inauguration, President Biden said that he will allow his administration to be “guided by the best science.”
“The Federal Government must be guided by the best science and be protected by processes that ensure the integrity of Federal decision-making,” Biden said at the time. “It is, therefore, the policy of my Administration to listen to the science.”
When addressed about potentially implementing a mask mandate, Biden again repeated the mantra that his team will “follow the science.”
According to officials in the FDA, the Biden administration’s approach to “the science” has been more political than a frontier of hope and discovery. In fact, as many as 11 current and former FDA officials told Politico that they have grown frustrated with the administration’s “disjointed process” regarding the booster shots.
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.”
In August, the HHS released a joint statement with medical health officials announcing the release of coronavirus booster shots by September 20, but senior health officials told Politico that “political appointees within the White House largely steered” the statement instead of the FDA and other medical professionals.
“The tension within the administration plus open skepticism from outside experts has fueled finger-pointing and divisions among health agencies,” according to Politico. “Career scientists, in particular, have been confused and surprised by the process, multiple people involved in the talks said.”
FDA officials were also confused over the fact that Biden abruptly shifted from suggesting that boosters be recommended 8 months after the first shots to 5 months after the first shots. His suggestion allegedly came “after a meeting with Israeli Prime Minister Naftali Bennett.”
Despite the resignations, acting FDA Commissioner Janet Woodcock sent a memo on Tuesday expressing support for the current process, saying that “issues are complex.”
“The issues are complex and the days are long, but please know the work you all have done to date and will continue to do in the days, weeks and months ahead, will hopefully one day allow us to fully put Covid-19 behind us and better prepare us for future challenges,” Woodcock wrote.