FDA panel rejects widespread Pfizer booster shots for most

Panel rejects plan to offer booster shots against COVID-19 to most Americans, a blow to President Biden's efforts to increased projection against the delta variant.

By

National News

September 17, 2021 - 3:09 PM

Regina Murdock, a registered nurse with D&H Drugstore, administers a dose of the Pfizer vaccine to a resident on Friday at a clinic at the Neighborhoods by TigerPlace in Columbia, Mo. (TESSA WEINBERG/MISSOURI INDEPENDENT)

WASHINGTON (AP) — An influential federal advisory panel overwhelmingly rejected a plan Friday to offer Pfizer booster shots against COVID-19 to most Americans, dealing a heavy blow to the Biden administration’s effort to shore up people’s protection amid the highly contagious delta variant.

The vote by the committee of outside experts assembled by the Food and Drug Administration was 16-12, with members expressing frustration that Pfizer had provided little data on the safety of extra doses. Many also raised doubts about the value of mass boosters, rather than ones targeted to specific groups.

In an extraordinary move, both FDA leaders and the panel indicated they were likely to take a second vote Friday afternoon on recommending the booster shots for older Americans and other high-risk groups.

That would help salvage part of the Biden administration’s campaign but would still be a huge step back from the sweeping plan proposed by the White House a month ago to offer booster shots of both the Pfizer and Moderna vaccines to nearly all Americans eight months after they get their second dose.

During several hours of vigorous debate Friday, members of the panel questioned the value of offering boosters to nearly everyone.

“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner of Tufts University. “And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses.”

Dr. Amanda Cohn of the Centers for Disease Control and Prevention said: “At this moment it is clear that the unvaccinated are driving transmission in the United States.”

Panel members also complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.

Scientists inside and outside the government have been divided in recent days over the need for boosters and who should get them, and the World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough vaccine for their first.

While research suggests immunity levels in those who have been vaccinated wane over time and boosters can reverse that, the Pfizer vaccine is still highly protective against severe illness and death, even amid the spread of the highly contagious delta variant.

The FDA advisory panel was the first major hurdle that the Biden administration plan faced. The FDA itself has yet to make its own determination but typically follows the recommendations of its expert panel.

In yet another step to the process, a CDC advisory committee that sets policy for U.S. vaccinations campaigns is set meet on Wednesday to debate who, exactly, should get boosters and how many months after their second dose should them receive the extra shot.

The CDC has said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.

Separate FDA and CDC decisions will be needed in order for people who received the Moderna or J&J shots to get boosters.

The FDA panel’s overwhelming rejection came despite full-throated arguments about the need for boosters from both Pfizer and health officials from Israel, which began offering boosters to its citizens in July.

Related