The Covid-19 vaccine made by Pfizer and BioNTech was granted a full approval by US regulators, a milestone expected to help bolster the immunisation drive.
The Food and Drug Administration said in a statement on Monday that it had cleared the shot for the prevention of the disease caused by the novel coronavirus in people 16 and older. It will be marketed under the Comirnaty brandname. The approval is the first for a Covid vaccine.
The two-dose regimen was initially made available in the US through an emergency authorisation late last year. It has since become the most widely used of three available vaccines against the disease caused by the coronavirus, according to data from the Centres for Disease Control and Prevention, with more than 92 million people having received two shots.
The approval is likely to boost confidence in the shot among people who say they are wary of its rapid-fire development, and could open the door to more vaccination requirements among employers and businesses.
It is also likely to solidify the shot’s status as a blockbuster for its makers. Pfizer said last month it expects the vaccine to bring in US$33.5-billion in revenue this year, a total that would place it among the biggest-selling drugs of all time. In the second quarter, the vaccine booked $7.8-billion in sales.
Pfizer shares rose 3.7% at 10.14am in New York trading on Monday. BioNTech shares jumped 8.8%.
Other vaccines could receive approvals in coming months. In June, Moderna said it had initiated a rolling submission of its Biologics Licence Application for its vaccine in people 18 and older.
Pfizer and BioNTech approached the FDA in May with a so-called Biologics Licence Application or BLA, prompting even greater scrutiny of the two-shot regimen.
“The FDA’s review of a BLA is among the most comprehensive in the world,” the agency said in an e-mail earlier this month. “We conduct our own analyses of the information in the BLA to make sure the vaccines are safe and effective and meet our standards for approval.”
The companies’ submission was delivered in two batches. On 7 May, they shared a package of clinical data including more information on the vaccine’s effectiveness and six months of safety data — building on two months of safety data shared in the emergency-use application.
Two weeks later, Pfizer and BioNTech shared information on the vaccine’s manufacturing processes and production facilities.
Altogether, the application was 340 000 pages, more than three times the length of the emergency authorisation submission. According to Pfizer, that’s significantly longer than the standard application package.
Though the BLA review process typically takes eight months, US regulators said they turned to “sprint teams” to evaluate “a tremendous amount of data”. The review was ultimately concluded in less than half the time. — Reported by Riley Griffin, (c) 2021 Bloomberg LP