Pfizer expects its COVID-19 vaccine to receive full US approval by early 2022
Pfizer Inc. said its Covid-19 vaccine received priority review by US regulators, putting it on track for possible full approval early next year.
The drugmaker and its German partner BioNTech SE said in a statement on Friday that the Food and Drug Administration (FDA), which has a similar role to ANVISA here in Brazil, plans to decide whether to approve the injection for use in 16-year-olds or more until January 2022.
Pfizer shares were up 0.2% at 11:41 am in New York trading, while BioNTech’s US shares were up 3.7%.
Pfizer’s vaccine has been administered to more Americans than any other vaccine so far in the US immunization campaign. About 85 million people have been fully vaccinated with the two-dose regimen.
A full approval for the Pfizer vaccine could help strengthen the US vaccination effort. Some people who are reluctant to receive an injection say they don’t want to get an experimental drug. An approval can also make it easier for employers, school districts and others to demand vaccinations.
The two-dose vaccine is currently authorized on an emergency basis for people 12 years and older.