Republicans ask FDA for details on any White House pressure on boosters

Republicans ask FDA for details on any White House pressure on boosters
© Greg Nash

House Republicans are requesting the Food and Drug Administration (FDA) provide information on any potential White House pressure to approve COVID-19 booster vaccines for the general population. 

House Minority Whip Steve ScaliseStephen (Steve) Joseph ScaliseFifth House Republican comes out in support of bipartisan infrastructure bill Democratic leaders racing toward Monday infrastructure vote House GOP to whip against bipartisan infrastructure bill MORE (R-La.) and Rep. James ComerJames (Jamie) R. ComerOvernight Defense & National Security: US-Australian sub deal causes rift with France Oversight Republicans seek testimony from Afghanistan watchdog Republican requesting data, notes, emails in intelligence report on COVID-19 origins MORE (R-Ky.), ranking member on the House Oversight and Reform Committee, sent a letter Tuesday to the FDA requesting documents on Biden administration communications about booster shots amid concerns of “potential political interference.”

In the letter, lawmakers accused Biden of announcing its plan to allow mRNA vaccine recipients to get boosters beginning on Sept. 20 “without evidence and data.”

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President BidenJoe BidenFighter jet escorts aircraft that entered restricted airspace during UN gathering Julian Castro knocks Biden administration over refugee policy FBI investigating alleged assault on Fort Bliss soldier at Afghan refugee camp MORE, instead of following the science, is attempting to distract from his numerous crises by playing politics and moving out ahead of the FDA and the Centers for Disease Control (CDC) when it comes to the science on coronavirus vaccine booster shots,” the letter to acting FDA Commissioner Janet Woodcock reads.

“Top scientists and researchers were stunned by this decision—particularly because the CDC and the FDA had not yet conducted their independent review of the data,” Scalise and Comer wrote. 

The Republicans’ request comes a day after two departing FDA officials, Marion Gruber and Phil Krause, wrote in a paper published in The Lancet that current evidence does not show boosters for the general population are necessary.

"Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high," Gruber and Krause wrote in the paper published on Monday, which that was cited in the letter to the FDA.

These scientists have not revealed why they decided to leave their positions, but the announcement of their exodus came as the FDA defended the administration’s booster strategy. 

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The Hill has reached out to the FDA for comment. 

For their probe, the Republicans set a Sept. 28 deadline for receiving all documents and communications, including those between the FDA and the White House on booster shots, studies into booster shots for mRNA vaccine recipients and Biden’s announcement on booster availability. 

The request also involves documents and communications related to the departure of Gruber and Krause, as well as  “any effort by political appointees or White House personnel to review, revise, edit, delay, or prohibit publication of information related to booster shots” and any employment action “taken or considered ... related to the science” of booster shots. 

Experts have had mixed reactions to the administration’s approach to booster vaccines, with some criticizing officials for moving too quickly and without enough data.

Federal health officials have said publicly that pursuing booster shots will allow the U.S. population to stay ahead of the virus amid concerns that effectiveness could decrease over time. 

But Gruber and Krause in The Lancet paper argued that the two-shot vaccine regimen remains effective against severe disease, despite an apparent slight reduction against symptomatic infection caused by the delta strain.

An FDA advisory group is scheduled to discuss the matter in a Friday meeting.