Pfizer Vaccine Granted Priority Review for Full U.S. Approval

(Bloomberg) -- Pfizer Inc. said its Covid-19 vaccine was granted priority review by U.S. regulators, putting it on track for a potential full approval by early next year.

The drugmaker and its German partner BioNTech SE said in a statement Friday that the Food and Drug Administration plans to decide whether to approve the shot for use in people 16 and older by January 2022.

Shares of Pfizer gained 0.2% at 11:41 a.m. in New York trading, while BioNTech’s U.S. stock climbed 3.7%.

Pfizer’s vaccine has been administered to more Americans than any other shot so far in the U.S. immunization campaign. According to data from the Centers for Disease Control and Prevention, some 85 million people have been fully vaccinated with the two-dose regimen.

A full approval for the Pfizer vaccine could help bolster the flagging U.S. vaccination effort. Some people who have been reluctant to get a shot have said they are unwilling to get an experimental medication. An approval could also make it easier for employers, school districts and others to mandate vaccination.

The two-dose vaccine is currently authorized on an emergency basis for people 12 and over. It was initially authorized for people 16 and up late last year and cleared for use in adolescents this spring.

The companies said in the statement they would apply for full approval in people age 12 to 15 once the required six months of data following second vaccine doses are available.

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