Pfizer-BioNTech Covid Vaccine Wins Landmark U.S. Approval

Pfizer-BioNTech Covid Vaccine Wins Landmark U.S. Approval

13:37 - 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 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 is the first for a Covid vaccine in the U.S., and it arrives at a crucial time, as the country is ensnared in a wave of illness sparked by the highly transmissible delta variant. The Biden administration has made increasing vaccinations a priority in its efforts to tamp down the latest outbreak, and hopes the approval will increase confidence in the shot among people who say they are wary of its rapid-fire development.

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. Following the announcement, the Pentagon said it would move forward to make vaccinations mandatory for U.S. military personnel worldwide, a Defense Department spokesman said.

The two-dose regimen was initially made available in the U.S. through an emergency authorization in December. 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 designation is temporary, and only lasts for the duration of the pandemic.

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% at 11:56 a.m. in New York trading on Monday. BioNTech’s American depository receipts jumped 9.5%.

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. 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.

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