WASHINGTON – COVID-19 vaccine maker Pfizer Inc will meet with federal health officials as soon as Monday to discuss the need for a booster dose of the coronavirus vaccine as it prepares to seek authorization, the company said on Sunday.
The meeting comes days after the drugmaker and its partner BioNTech SE announced plans to seek U.S. and European regulatory approval for a third dose of their COVID-19 shot amid the spread of variants and data they said showed heightened risk of infection six months after initial inoculation.
That push prompted a quick response from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, saying Americans do not need a booster right now.
On Monday, Pfizer is scheduled to meet with representatives of the FDA, a company spokesperson said. The meeting was first reported by the Washington Post.
Representatives for the U.S. Department of Health and Human Services did not immediately respond to a request for comment.