Associated Press/Evan Vucci
- The heads of the FDA and CDC are pushing back on the White House's plan for COVID-19 booster shots.
- The top health officials say they need more time to review data on extra doses, The New York Times reported Friday.
- It's the latest setback to the Biden administration's booster plan, which has also prompted resignations at the FDA.
- See more stories on Insider's business page.
The Biden administration's booster-shot plan is facing another setback.
Top health officials have told the White House they need more time and data to potentially authorize extra doses, The New York Times reported Friday.
The heads of the Food and Drug Administration and Centers for Disease Control and Prevention told the White House they may only be able to recommend boosters for some recipients of the Pfizer-BioNTech vaccine in the next few weeks, according to the report.
On August 18, top US health officials – including the FDA and CDC heads – issued an unusual joint statement saying they plan to start offering boosters on September 20 for people who are eight months removed from their second dose of either the Pfizer or Moderna vaccines. Officials added that people who got the single-dose Johnson & Johnson vaccine would also probably be offered a booster.
That announcement and timeline leaped ahead of the typical FDA and CDC review process. The top two leaders of the FDA's Office of Vaccines Research and Review recently announced their resignations from the agency, reportedly in part due to the White House's booster-plan announcement.
The Times reported that FDA interim head Janet Woodcock and CDC director Rochelle Walensky met Thursday with Jeffrey Zients, the White House's pandemic coordinator, asking to scale back the booster plan.
It raises doubts that the regulatory process will align with the Biden administration's announced timeline on boosters.
The FDA plans to convene its group of independent advisors to review booster data on September 17, just three days before the White House's planned start date for rolling out boosters. Not all virologists believe boosters are yet needed, as recent data suggest the shots still are highly effective at preventing hospitalization and death, even if protection has partially waned in stopping less severe breakthrough cases.
The White House, CDC, and FDA did not immediately respond to requests for comment from Insider.
A White House spokesman told The Times that the administration is waiting for a "full review and approval" by the FDA for the booster shots as well as a recommendation from the CDC.
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