Pfizer Inc. and partner BioNTech SE have submitted data to U.S. health regulators needed to clear a Covid-19 booster shot among the general public.
The companies said Monday they sent to the U.S. Food and Drug Administration results from a small, early-stage study showing a third dose of their vaccine generated higher levels of neutralizing antibodies against the original virus and against the Beta and Delta variants than the standard two-dose regimen.
The addition of the third dose also appeared safe in the trial, the companies said.
Given the immune response boost from a third dose, the companies said, a booster shot within six months to a year after the second shot might help maintain protection against symptomatic Covid-19.
Pfizer and BioNTech are also conducting a larger late-stage study evaluating whether a third dose safely provides more protection. The companies said they expect those results shortly and will then submit the data to the FDA.
