The Covid-19 vaccine made by Pfizer Inc. and BioNTech S.E. was granted a full approval by U.S. regulators, a milestone expected to help bolster the immunization drive amid a renewed surge in infections.
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 will solidify the shot’s status as a blockbuster. Pfizer said last month it expects the vaccine to bring in $33.5 billion in revenue this year, placing it among the biggest-selling drugs of all time.
Pfizer shares rose 2.7%. BioNTech’s American depository receipts jumped 9.5%.
Other vaccines could receive approvals in the 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. The company hasn’t yet completed its submission, a person familiar with the process said. Johnson & Johnson plans to file for a BLA later this year.
New York-based Pfizer and its German partner BioNTech are likely to become a more integral part in reaching hesitant Americans, as the formal approval allows the companies to launch marketing campaigns.
The approval will also open up the shot to non-government purchasers -- though that shift in supply negotiations won’t come until next year.
Pfizer expects the U.S. government to remain the sole distributor of vaccine doses domestically through next April, at the earliest. That means the Biden administration will continue to determine where supply is sent, and those eligible to be vaccinated will continue to receive the regimen and subsequent boosters for free.
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