USA – The Food and Drug Administration (FDA) has granted full approval to Pfizer’s COVID-19 vaccine for individuals 16 years and older, and will now be marketed as Comirnaty.
The approval is expected to set off more vaccine mandates by employers and organizations across the USA. It comes amid lingering vaccine hesitancy among many Americans.
Even so, out of more than 170 million people in the United States fully vaccinated against Covid-19, more than 92 million have received the Pfizer/BioNTech vaccine.
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.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Commissioner Janet Woodcock said in a statement.
COVID-19 vaccines developed by Pfizer, Moderna and Johnson & Johnson have all previously been granted emergency use authorization (EUA) after meeting the FDA’s safety and efficacy requirements.
Since December 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 2021.
The FDA initially gave Pfizer temporary authorization – a clearance given if the agency determines the benefits of a product outweigh potential risks during a public health emergency.
This full approval is essentially permanent. The licensing process requires companies to provide the FDA with information on how and where the product is made, as well as other clinical testing data.
Critics had been calling on the FDA to speed up this approval process as the nation struggled with dropping vaccination rates earlier this year. The spread of the contagious Delta variant has already given some hard-hit regions a bump in vaccination rates in recent weeks.
While the agency took steps to increase staff and resources, it had previously said it would take six months to get the required data.
The approval ultimately came less than four months after Pfizer-BioNTech filed for licensing in early May – the fastest vaccine approval in the FDA’s more than 100-year history.