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Pfizer Inc. has said its Covid-19 vaccine has received priority review by U.S. regulators, putting it on track for possible full approval by early next year.
The drug maker and its German partner BioNTech SE stated in a statement Friday that the Food and Drug Administration plans to decide whether or not to approve the vaccine for use in people 16 years of age and older by January 2022.
Pfizer shares gained 0.2% as of 11:41 am in New York trading, while US BioNTech shares climbed 3.7%.
Pfizer’s vaccine has been given to more Americans than any other vaccine so far in the US vaccination campaign. According to According to data from the Centers for Disease Control and Prevention, some 85 million people have been fully vaccinated with the two-dose regimen.
Full approval of Pfizer vaccine could help bolster declining US vaccination efforts. Some people who were hesitant to get the vaccine said they didn’t want to be given an investigational drug. An approval could also make it easier for employers, school districts and others to demand immunizations.
The bidose vaccine is currently authorized as an emergency for people 12 years of age and over. It was initially cleared for people 16 and over late last year and cleared for use in teens this spring.
The companies said in the statement they would seek full approval for people ages 12 to 15 once the required six months of data following second doses of the vaccine are available.
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