FDA panel rejects plan for wide access to Covid vaccine booster shots, but approves them for older Americans

The Food and Drug Administration turned down the plan in a 16-2 vote on Friday

An advisory panel to the US Food and Drug Administration has rejected a Biden administration proposal to offer booster Pfizer Covid shots to most Americans, but approved their use for elderly or at-risk patients.

In a vote of 16 to two on Friday, the panel of outside experts decided against the plan for widespread boosters, citing insufficient data on the safety or necessity of the third shots. However, in a second vote, the experts voted unanimously in favor of administering the boosters to Americans aged 65 or over, and to those at high risk of severe disease.

The FDA itself has not yet officially rejected the first proposal, but it typically follows the advice of the panel.

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

Over the course of an hours-long discussion, the panelists lamented that Pfizer had not provided enough data, and that Israel’s experience with the boosters would not necessarily be replicated in the United States.

The decision comes as a setback for the Biden administration, which had vigorously promoted the idea of booster shots as a new tool for combating the pandemic.

“A booster promises to give Americans their highest level of protection yet,” the White House says on its website. “Three-shot vaccines are common (Hepatitis B, Tetanus) and offer some of the most durable and robust protection… The Administration is preparing for boosters to start as early as the week of September 20th, subject to authorization or approval by the FDA and a recommendation from ACIP.”

But not all Americans have waited for the FDA to make its decision. According to the Centers for Disease Control and Prevention, 2.04 million people have already received a booster shot of a Covid vaccine.

This article was amended on 30 September 2021. The article originally said the vote was defeated by 16 votes to 12, but that was incorrect. The vote was 16-2.