Sep 17, 2021 - Health

FDA advisory panel recommends Pfizer boosters for those 65 and older

A healthcare worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at the Key Biscayne Community Center in Key Biscayne, Florida, U.S., on Tuesday, Aug. 24, 2021.

A healthcare worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at the Key Biscayne Community Center on Aug. 24, 2021. Photo: Eva Marie Uzcategui/Bloomberg via Getty Images

A key Food and Drug Administration advisory panel on Friday overwhelmingly voted against recommending Pfizer vaccine booster shots for younger Americans, but unanimously recommended approving the third shots for individuals 65 and older, as well as those at high-risk of severe COVID-19.

Why it matters: While the votes are non-binding, and the FDA must still make a final decision, Friday's move pours cold water on the Biden administration's plan to begin administering boosters to most individuals who received the Pfizer vaccine later this month.

Driving the news: Friday's votes followed an intense day of discussion by the independent experts on the panel. Many questioned whether the available data justified recommending boosters for the general population.

  • “It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” Michael Kurilla, an infectious disease specialist at the National Center for Advancing Translational Sciences, said during the meeting.

The big picture: The White House's booster plan has been the subject of much debate since it was unveiled in August, with some frustrated that the administration announced the plan before boosters went through the regulatory process.

  • Top government health officials earlier this month urged the White House to scale back its booster plan, saying regulators need more time to collect and review necessary data for a third dose.
  • The White House has already paused plans to offer boosters for individuals who received the Moderna vaccine, saying it will wait for more data.
  • The World Health Organization, meanwhile, has called on countries to forgo booster shots through at least the end of the year.

Pfizer said the data presented during Friday's meeting "underscore our belief that boosters will be a critical tool in the ongoing effort to control the spread of this virus."

  • “We thank the committee for their thoughtful review of the data and will work with the FDA following today’s meeting to address the committee’s questions, as we continue to believe in the benefits of a booster dose for a broader population," said Kathrin Jansen, senior vice president and head of Vaccine Research & Development at Pfizer.

What to watch: A CDC advisory committee will meet to discuss boosters next week, "after which the CDC will make their final recommendation," Surgeon General Vivek Murthy said at a briefing on Friday.

Editor's note: This story has been updated with Pfizer's statement.

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