FDA retirements reignite debate over Biden booster plan

FDA retirements reignite debate over Biden booster plan
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The retirement of two top federal vaccine regulators has intensified the spotlight on the Biden administration's plan for booster shots of COVID-19 vaccines, reigniting the debate about its commitment to following the science.

Former health officials and outside experts have questioned the need for booster doses, stating they were concerned that when the Biden administration announced that boosters could be available to all adults on Sept. 20, political leaders were getting ahead of the typical process.

Those concerns were amplified this week when the Food and Drug Administration (FDA) confirmed the retirements of two top agency vaccine regulators. Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, is scheduled to depart the FDA at the end of October. Phil Krause, the office's deputy director, will retire in November.

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Neither FDA official has spoken publicly about their reasons for leaving, but there has been speculation that Gruber and Krause grew frustrated with an increasing lack of autonomy and encroachment by other agencies, particularly around booster shots.

"There's a deep bench in that group, but I think this evidences some frustration that's coursing through the agency particularly with CDC and the way CDC's been encroaching on FDA's regulatory affairs," Scott Gottlieb, the FDA commissioner under former President TrumpDonald TrumpGraham says he hopes that Trump runs again Trump says Stacey Abrams 'might be better than existing governor' Kemp Executive privilege fight poses hurdles for Trump MORE, said on CNBC Wednesday.

The Biden administration rolled out a plan last month to make booster shots widely available to the public on Sept. 20, but the start date was announced before any of the relevant agencies had examined the evidence.

Standard practice is for the FDA and Centers for Disease Control and Prevention's (CDC) outside advisory group to recommend what vaccines Americans should get and when.

A third dose of the Pfizer and Moderna vaccines has already been approved by both the FDA and CDC for the immunocompromised. 

In addition, Pfizer-BioNTech applied to the FDA for the approval of widespread use of booster doses last month. Moderna started its submission process on Wednesday. 

Jesse Goodman, who was FDA's chief scientist during the Obama administration, said he doesn't think the Biden administration handled the booster announcement well — but he also doesn't see it as political interference.

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"I don't think this was an ill-will power grab by the White House. I do see it as a concerning lapse in understanding the importance of what your scientists have to contribute to the decisionmaking process," Goodman said.

"I think some of the senior level people saw the data about breakthrough infections, saw Israel's decision [to administer boosters], and got highly concerned," Goodman added. "But part of the reason we have the process there is to make sure the evidence is really carefully looked at. And I think [officials are] wanting to lean forward with a public health response, they just got it sequenced wrong."

A joint announcement by the heads of every health agency cited evidence showing that the mRNA vaccines developed by Pfizer-BioNTech and Moderna are no longer as efficient against COVID-19.

Officials said that data “could” signal a decline in protection against serious disease, and it was important to be prepared with boosters. The recommendation will only happen, they said, if both CDC and FDA sign off.

White House coronavirus response coordinator Jeff ZientsJeff ZientsGOP senators say Biden COVID-19 strategy has 'exacerbated vaccine hesitancy' The Hill's Morning Report - Presented by Alibaba - Government shutdown fears increase as leaders dig in Travel industry hopes for rebound with loosened COVID-19 restrictions MORE reiterated the FDA was the "gold standard" during a Tuesday press briefing, adding that the administration was committed to following the data.

"That decision was made by and announced by the nation's leading public health officials," Zients said, adding that the announcement was made "to stay ahead of the virus and to be transparent on latest data."

But that commitment to the data could be tested if agency scientists don't agree on the timing or method.

"I do think that the White House will not have as smooth a path through the FDA as they think on boosters," said Lawrence Gostin, a professor of global health law at Georgetown University Law.

"The scientific community is clearly not in lockstep behind them. President BidenJoe BidenHaiti prime minister warns inequality will cause migration to continue Pelosi: House must pass 3 major pieces of spending legislation this week Erdoğan says Turkey plans to buy another Russian defense system MORE got ahead of his public health agencies," Gostin said.

The FDA on Wednesday scheduled a meeting of its outside vaccine advisory panel for Sept. 17 to discuss the data from Pfizer-BioNTech. The meeting, which will take place just days before the Sept. 20 deadline, is ostensibly the first step in the process about whether to recommend booster doses.

It's likely the discussion will not be limited to the particulars of Pfizer's application, and will examine thorny issues including the debate about boosters among health experts. 

“A transparent, thorough and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines," Peter Marks, the FDA's top vaccine official, said in a statement. 

CDC's independent vaccine advisory panel this week questioned the level of evidence provided, and indicated offering boosters to all adults by Sept. 20 may be premature.

The panel will convene again and vote later this month, but it wasn't clear that the administration's desire to provide boosters for everyone would pass muster. 

The initial announcement from the president created confusion, panel members said, because it gave the impression booster doses were authorized, when they haven't been.

Compounding the problem is that the FDA and CDC have authorized a third dose for people who are immunocompromised. More than 1 million third doses have been administered to date, according to CDC data, but it doesn't distinguish between the immunocompromised or unauthorized boosters.

Panel member Helen Talbot, an infectious disease specialist at Vanderbilt University, said she has heard from "many, many" hospitals across the South that have already begun administering third doses to health workers. 

“This highlights, critically, the need for any vaccine recommendations to go through the normal avenues and not come out from outside,” Talbot said. “It is very frightening to me that health care providers, trying to do the best job that they can, are taking guidance from HHS and the White House, and now have put themselves at risk.”