FDA grants full approval to Pfizer-BioNTech coronavirus vaccine
- The FDA approved the two-dose vaccine for use in people over the age of 16.
- More than 204 million people in the United States have received the vaccine since it was given emergency authorization.
- Public health officials hope it will convince more unvaccinated Americans that Pfizer’s shot is safe and effective.
The United States Food and Drug Administration (FDA) on Monday granted full approval to the Pfizer Inc/BioNTech SE COVID-19 vaccine that earned emergency-use authorization in December, making it the first to secure such regulator’s validation as health authorities struggle to win over vaccine sceptics.
The vaccine had initially been given emergency use authorization. Its two jabs, three weeks apart, are now fully approved for those aged 16 and older.
The approval is expected to set off more vaccine mandates by employers and organisations across the country.
It comes amid lingering vaccine hesitancy among many Americans.
In a statement, the FDA said its review for approval included data from approximately 44,000 people. The vaccine, which will now be marketed as Comirnaty, was found to be 91% effective in preventing Covid disease.
Acting FDA commissioner Janet Woodcock said that the public “can be very confident” the vaccine meets high safety, effectiveness and manufacturing quality standards.
“While millions of people have already safely received COVID-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated,” said Janet Woodcock, the US Food and Drug Administration’s acting commissioner.
The FDA’s approval is based on updated data from the company’s clinical trial.
“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Albert Bourla, CEO of Pfizer, said in a statement.
The Pfizer-BioNTech vaccine will now be marketed under the name Comirnaty, the FDA said.
Some US cities including New York and San Francisco have already imposed rules requiring vaccination to dine at restaurants or work in government offices, among other activities.