The Covid-19 vaccine made by Pfizer Inc. and BioNTech SE has been granted full approval by U.S. regulators. It is believed that this move is a milestone expected to help bolster and encourage the immunization drive as the country records a surge in infections fueled by the delta variant.
In a statement by the Food and Drug Administration, the Federal agency said that it had cleared the shot for the prevention of the disease caused by the novel coronavirus in people 16 years old and older and it will be marketed under the Comirnaty.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA).
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.
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 have received two shots.
The vaccine continues to be available to people age 12 to 15 under an emergency use authorization, the FDA said.
The approval is expected 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 $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 10:14 a.m. in New York trading today, Monday, August 23rd, 2021, while BioNTech shares jumped 8.8%. Pfizer expects to file a BLA for its vaccine in those aged 12-to-15 before the end of the year. For those under 12, the process will take even longer.
Other vaccines could receive approvals in the coming months. In June, Moderna Inc. said it had initiated a rolling submission of its Biologics License Application for its vaccine in people 18 and older. Neither Moderna Inc. nor Johnson & Johnson have yet approached U.S. regulators with a Biologics License Application for any age group.