WASHINGTON (AP) — An influential federal advisory panel has soundly rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans.
The vote Friday, 16-2, was a blow to the Biden administration’s effort to shore up people’s protection against the virus amid the highly contagious delta variant.
Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on safety of extra doses.
And they complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.
THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.
WASHINGTON (AP) — The Biden administration’s embattled plan to dispense COVID-19 booster shots to most Americans faced its first major hurdle Friday as a government advisory panel vigorously debated whether to endorse extra doses of the Pfizer vaccine.
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.
The panel, made up of outside experts who advise the Food and Drug Administration, weighed a less than clear-cut case: 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 experts were scheduled to vote on one basic question: Does the evidence show that a Pfizer booster would be safe and effective for people 16 and older? In the event of a yes vote, the FDA is expected to quickly approve boosters for Pfizer's shot.
But that is just one step in the process. The more thorny question of who should get the shots and when will be debated on Wednesday by advisers to the Centers for Disease Control and Prevention. The CDC generally adopts the recommendations of the group, which sets policy for U.S. vaccination campaigns.
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.
At Friday's meeting, the FDA panelists heard 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.
Sharon Alroy-Preis of Israel’s Ministry of Health said the booster dose improves protection tenfold against infection in people 60 and older.
“It’s like a fresh vaccine,” bringing protection back to original levels and helping Israel “dampen severe cases in the fourth wave,” she said.
And representatives for Pfizer argued that it is important to shore up immunity before protection against severe disease starts to erode. A company study of 44,000 people showed effectiveness against symptomatic COVID-19 was 96% two months after the second dose, but had dropped to 84% by around six months.
Both Pfizer and the Israeli representatives faced pushback from panelists. Several expressed skepticism about the relevance of Israel’s experience to the U.S. Also complicating the committee’s decision: No one yet knows the antibody level below which infection is likely and boosters are needed.
“That would be a great way for us to monitor if we really needed booster shots,” said Dr. James Hildreth, president of Meharry Medical College.
FDA vaccine reviewer Dr. Philip Krause raised a host of questions about the reliability of one of the key studies Pfizer said showed that immunity is waning.
Another concern was whether third doses would exacerbate serious side effects.