FDA advisory panel to discuss additional COVID booster shots in April

A Food and Drug Administration (FDA) advisory panel will meet April 6 to discuss COVID-19 vaccine booster doses, the agency announced Monday.

The meeting comes amid a renewed debate about who might need booster shots and the broader goals of the U.S. vaccination campaign. 

There’s clear evidence that the vaccines’ protection against infection wanes after several months across all age groups. Still, many health experts have questioned the effectiveness of repeat booster shots in younger healthy people. 

An initial round of doses, plus a single booster, is enough protection to keep most people out of the hospital. The debate is whether trying to increase antibody levels every few months to protect against any infection, including mild and asymptomatic, is a reasonable goal. 

Both Pfizer and Moderna have filed applications for emergency use authorization of a second booster dose of their vaccines; Pfizer’s request is for older adults ages 65 and older, while Moderna requested authorization for all adults.

However, the FDA said the advisory panel will not be discussing any specific applications, and no vote is planned. The meeting is aimed at addressing the possibility of variant-specific vaccines, as well as the timing and populations for COVID-19 vaccine booster doses in the coming months.

The FDA panel, along with the Centers for Disease Control and Prevention, is widely expected to approve Pfizer’s request, since the 65 and older age group is most vulnerable to severe outcomes from COVID-19, even with vaccinations. 

The April 6 discussion will likely be a window into how advisers feel about the need for boosters in the broader population. 

“Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat,” said Peter Marks, director of the FDA’s vaccine safety division.

“Bringing together our panel of expert scientific external advisors in an open, transparent discussion about booster vaccination is an important step to gain insight, input and expert advice as we begin to formulate the best regulatory strategy to address COVID-19 and virus variants going forward.”