The Food and Drug Administration could authorize Pfizer's updated Covid boosters by the end of August, Pfizer CEO Albert Bourla said during an investor call Tuesday.
The drugmaker asked the FDA in June to authorize an updated version of its Covid booster that is designed to target the XBB.1.5 subvariant, a coronavirus strain that began circulating widely last winter. Moderna made a similar request that same month.
The requests came days after the FDA advised the drugmakers to update the shots to target XBB.1.5 ahead of a fall Covid booster campaign.
XBB.1.5 is no longer the predominant strain, only making up 12.3% of all new Covid cases through the week ending July 22, according to the Centers for Disease Control and Prevention. It's been edged out by XBB.1.16, which accounts for about 15% of all new cases. (Experts said during a June meeting of FDA advisers that they don’t expect that will hurt vaccine effectiveness too much, as the XBB strains aren’t too genetically different from one another.)
Bourla’s prediction on the availability of new boosters comes as Covid hospitalizations are rising in the U.S., though they still remain lower than at any point during the pandemic.
During the call, Bourla said the company expects Covid cases and hospitalizations will continue to pick up heading into the colder months.
“We expect a new Covid wave to start in the U.S. this fall,” Bourla said.
The FDA did not immediately respond to a request for comment on Bourla’s remarks about booster authorization.
It’s unclear if the Covid boosters will be recommended for everyone in the U.S. That decision will be left up to the CDC, which isn’t expected to make a recommendation until after the FDA authorizes the shots.
The FDA is not expected to convene its advisory committee, known as the Vaccines and Related Biological Products Advisory Committee, before making the decision, according to two sources familiar with the agency’s plans.
That committee met in June, voting unanimously in support of updating the shots to target an XBB strain, as well as dropping the original coronavirus strain from the formulation.
The uptake of the booster shots has been low to date. Only 17% of the U.S. population has gotten an updated booster, according to the CDC.