What You Need to Know
- The approval is the first for a COVID vaccine, and it arrives at a crucial time in the trajectory of the pandemic
- Other vaccines could receive approvals in coming months.
- Pfizer expects to file a Biologics License Application for its vaccine in 12-to-15 year-olds before the end of the year.
The Covid-19 vaccine made by Pfizer Inc. and BioNTech SE was granted a full approval by U.S. regulators, a milestone expected to help bolster the immunization drive amid a surge in infections fueled by the delta variant.
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 name Comirnaty.
The approval is the first for a Covid vaccine, and it arrives at a crucial time in the trajectory of the pandemic, as the U.S. is ensnared in a wave of illness sparked by the highly transmissible delta mutation. The Biden administration has made increasing vaccinations a priority in its efforts to tamp down the latest outbreak.
Many large employers, colleges and universities and state and local governments are expected to put vaccine requirements in place in the wake of the approval. The FDA’s move is also likely to boost confidence in the shot among people who say they are wary of its rapid-fire development.
The two-dose regimen was initially made available in the U.S. through an emergency authorization late last year. It has since become the most widely used of three available vaccines, according to data from the Centers for Disease Control and Prevention, with more than 92 million people having received two shots.
The vaccine continues to be available to people age 12 to 15, as does a third-dose for certain people with compromised immune systems, under an emergency-use authorization.
The approval will solidify the shot’s status as a blockbuster for its makers.
Pfizer said last month it expects the vaccine to bring in $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 3.5% at 11:08 a.m. in New York trading on Monday. BioNTech’s American depository receipts jumped 10%.
Other vaccines could receive approvals in coming months.
In June, Moderna Inc. said it had initiated a rolling submission of its so-called Biologics License Application, or BLA, for its vaccine in people 18 and older. Johnson & Johnson plans to file for a BLA later in 2021.
Pfizer and BioNTech approached the FDA with a BLA in May, launching a formal review process 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 email 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.”