President Biden’s Sept. 20 deadline for rolling out coronavirus booster shots has been marred by pushback from scientists, citing a lack of reliable scientific data, resulting in the recent resignations of two FDA senior officials. For some, the move contradicts his vow to “follow the science” on matters related to COVID policy.
Public health experts are speaking out that keeping pace with the White House’s Sept. 20 timeline put increased pressure on scientists, who are analyzing the evidence, to proceed with the administration’s strategy and timeline, the New York Times reported. The issue was put on full display earlier this week, when two FDA officials – the director of the FDA’s Office of Vaccines Research & Review Marion Gruber, and its deputy director Phil Krause – filed their resignations from the agency.
Gruber and Krause reportedly quit over a disagreement they had with the FDA’s top vaccine official, Peter Marks, and the Biden administration’s push to roll out the vaccine booster shots.
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The incident comes after Biden’s message of following the science was echoed across the nation last year, with Biden’s campaign website stating, “Whatever the state of the COVID pandemic on the day Joe Biden and Kamala Harris take office, their administration will: Listen to science, Ensure public health decisions are informed by public health professionals, Restore trust, transparency, common purpose, and accountability to our government.”
After the election, Biden has continued using the phrase and idea, while also touting the Sept. 20 timeline during various events with the media. Just last Friday, he said “this booster program is going to start here on September the 20th, pending approval of the FDA and then a CDC committee of outside experts.”
Both the FDA commissioner, Dr. Janet Woodcock, and Centers for Disease Control and Prevention director, Dr. Rochelle Walensky, helped draft the rollout for the boosters, but “now those agencies are in a box,” Dr. Steven Joffe, a professor of medical ethics and health policy at the University of Pennsylvania, told the New York Times.
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“We want doctors and scientists and the public to trust in the recommendations and decisions that are made, to be able to point to the F.D.A. and C.D.C. doing their due diligence,” Joffe said.
Woodcock had even reportedly said behind the scenes that it was risky to set such a deadline without more research. And on Thursday, Woodcock and Wallensky both reportedly asked the White House to push back the timeline for at least the Moderna booster.
A U.S. government health source told Fox News this week that members of the CDC feel the White House likely got ahead of itself in setting a Sept. 20 timeline.
Though the controversy over the boosters is getting more traction this week, criticisms of the timeline have been ongoing since August. One vaccine researcher at Johns Hopkins told the STAT, a medical publication, in August, that the push for booster shots so early in the country’s use of the vaccines didn’t appear to be science-based.
“I think there’s this tidal wave building that’s based on anxiety. And I don’t think it’s based on scientific evidence that a booster is needed,” vaccine researcher Anna Durbin told the outlet last month.
“We cannot keep [boosting] and say: ‘We’re going to prevent colds in everybody,’” she added.
Another health official, Jesse Goodman, who was the FDA’s chief scientist under the Obama administration, was also critical of the White House’s booster announcement, according to a different STAT interview this week.
”Normally, what you do is lay out the data first, and then say how the data supports the decision,” Goodman said, explaining the White House did the opposite of the norm.
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“This was a serious mistake in how it was handled,” Goodman added.
White House Press Secretary Jen Psaki has also been questioned if the administration’s timeline was premature, with her telling reporters earlier this week, “This was a recommendation made by our nation’s leading health experts based on mounds and mounds of data.”
Dr. Anthony Fauci also weighed in on the controversy and told STAT that Biden’s coronavirus response has, in fact, relied on data and science.
“Remember, [Biden’s] not there at every single Zoom call, at every single decision,” Fauci said. “But he set the standard, and he made it clear that he wants everyone in this administration, including the medical team, to make sure that science drives the guidelines. That science drives the decisions. That science drives the policy. He has been unequivocal.”
Now, the Pfizer booster is reportedly still on track to meet the Sept. 20 deadline, while Moderna only completed its submission to the FDA on the shots on Friday.
“We always said we would follow the science and this is all part of a process that is now underway. We are awaiting a full review and approval by the FDA and a recommendation by the ACIP,” White House spokesman Chris Meagher told Fox News this week.
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The White House did not immediately respond to Fox News’s request for comment on the administration’s pledge to follow the science amid the pushback.