Pfizer and BioNTech sought authorization for a COVID-19 booster shot.

Pfizer and BioNTech sought authorization for a COVID-19 booster shot. Credit: AFP via Getty Images/JUSTIN TALLIS

WASHINGTON — Top federal health officials have warned the White House that the Biden administration's plan to begin offering booster shots to most Americans later this month may have to be limited initially, with third shots made available only to people who had received the Pfizer-BioNTech vaccine, according to people familiar with the matter.

Janet Woodcock, acting commissioner of the Food and Drug Administration, and Rochelle Walensky, director of the Centers for Disease Control and Prevention, told White House coronavirus coordinator Jeff Zients on Thursday that their agencies may not be able to approve a more expansive coronavirus booster plan that they, along with other top doctors across the administration, endorsed last month.

Woodcock and Walensky told Zients they may be able to approve and recommend booster shots only for people who received the Pfizer-BioNTech vaccine. The people familiar with the discussion spoke on the condition of the anonymity because they were not authorized to speak publicly.

The New York Times first reported the warnings.

Last month, President Joe Biden announced his administration would begin offering booster shots for all Americans beginning the week of Sept. 20 pending approval from the FDA. Americans were told they should plan to get a third shot eight months after they received their second dose of Pfizer-BioNTech or Moderna vaccine. Biden said people who received the Johnson & Johnson vaccine would probably need a booster shot as well, but officials would need more time to analyze data.

Now, Woodcock and Walensky, who have faced criticism for endorsing a plan before FDA approval, have warned that their agencies may need more time to make a determination about recommending boosters for people who received the Moderna vaccine. The FDA has only partial data on Moderna and Johnson & Johnson boosters.

"We always said we would follow the science and this is all part of a process that is now underway," Chris Meagher, a White House spokesman, said in a statement. "We are awaiting a full review and approval by the FDA and a recommendation by the [CDC's Advisory Committee on Immunization Practices]. When that approval and recommendation are made, we will be ready to implement the plan our nation's top doctors developed so that we are staying ahead of this virus."

The FDA declined to comment.

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