WASHINGTON: Pfizer has recently received full approval from the US Food and Drug Administration (FDA) for its two-dose Covid-19 vaccine. It became the first licensed vaccine in the US.
Its two shots, three weeks apart, have been fully approved for those aged 16 and older. Initially, it has authorisation for emergency use.
The approval would set off more vaccine mandates by employers and organisations across the country.
The vaccine arrived amid lingering vaccine hesitancy among many Americans.
The FDA said its review for approval included data from approximately 44,000 people. The vaccine, which would now be marketed as Comirnaty, was 91% effective in preventing Covid disease.
It still has authorisation for emergency use for children aged 12 to 15.
This full approval is essentially permanent. Companies have to provide the FDA with information on how and where the product is made and other clinical testing data in the licensing process.
Earlier, experts called the FDA to speed up this approval process as the nation struggled with dropping vaccination rates earlier this year. The spread of the Delta variant has already increased the vaccination rates in recent weeks.