CBER Director Marks Says COVID-19 Boosters May Be Needed

COVID-19 vaccine booster shots may be necessary to sustain waning immunity, said Center for Biologics Evaluation and Research (CBER) Director Peter Marks in remarks at the RAPS Convergence annual conference, which is being held virtually this week because of the pandemic.

Marks said he respectfully disagrees with two outgoing FDA vaccine officials as well as World Health Organization vaccine experts who argued in The Lancet this week that providing widespread boosters isn’t necessary at this time (DID, Sept. 14). The two agency officials who were lead authors of the Lancet piece, Marion Gruber and Phil Krause, argued that it would be better to ensure that unvaccinated people get inoculated while the evidence to support boosters is still being gathered.

“Boosters may turn out to be very important because they may not actually be boosters,” Marks said. “They may be the final dose in a primary series that helps protect us with immunity against COVID-19 that is more durable,” he added, pointing to new data from the U.S. and Israel that shows waning immunity over time, particularly for the now-dominant Delta variant.

Marks is publicly defending the possible authorization of booster shots as the FDA gears up for a meeting of its vaccines advisory committee on Friday to discuss the issue and the Biden administration plans to start distributing the boosters to the general public as soon as Sept. 20 if the FDA and the Centers for Disease Control and Prevention give their go-ahead based on the available data. ― Jason Scott