Pfizer Submits Early Data on Boosters’ Protection to FDA (2)

Pfizer Inc. and BioNTech SE submitted early-stage data to U.S. regulators showing that a third dose of their Covid-19 vaccine led to higher levels of protective antibodies when given eight to nine months after the initial regimen.

The companies expect results from a larger final-stage trial evaluating the effects of the third booster dose shortly, according to a statement Monday, which will be submitted to the U.S. Food and Drug Administration, the European Medicines Agency and other regulatory authorities.

Last month, Pfizer said it would approach U.S. regulators for emergency-use authorization of a third booster dose of its vaccine, ...