The Pfizer BioNTech Covid-19 vaccine has received full approval from the US Food and Drug Administration (FDA) in the United States. Pfizer BioNTech is the first covid-19 vaccine to be licensed in the United States.
The Pfizer BioNTech Covid-19 vaccine had initially been given emergency use authorization. Its two doses, three weeks apart, are now fully approved for those aged 16 and older by the FDA.
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.
Full FDA approval for Pfizer
This full FDA approval for the Pfizer BioNTech Covid-19 vaccine 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.
Pfizer CEO Albert Bourla said in a statement the FDA’s approval “affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed.” In Pfizer‘s clinical trial, approximately 12,000 recipients of the vaccine have been followed for at least six months. The vaccine will now also be marketed under the name Comirnaty.
Meanwhile, Thailand’s Public Health Ministry on Friday signed a contract to purchase another 10 million doses of the Pfizer Covid-19 mRNA vaccine, raising the total to 30 million doses for delivery by the end of this year.
The contract was signed by Dr Opas Karnkawinpong, director-general of the Disease Control Department, and Deborah Seifert, executive of Pfizer Thailand and Indochina.
It was witnessed by Deputy Prime Minister and Public Health Minister Anutin Charnvirakul, assistant to the PM’s Office Minister and health minister’s adviser Dr Praphon Tangsrikiarttikul, and health permanent secretary Kiattiphum Wongrajit.