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Pfizer-BioNTech Covid Vaccine Wins Landmark U.S. Approval (3)

Aug. 23, 2021, 4:37 PM

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.

Read More: Biden Calls on Companies to Require Workers to Vaccinate

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.

LISTEN: Bloomberg’s Riley Griffin discusses Pfizer’s FDA approval with Ed Baxter on Bloomberg Radio.

Robust Review

Pfizer and BioNTech’s approval application was delivered in two batches. On May 7, they shared more information on the vaccine’s effectiveness and six months of safety data, building on data that was included in the emergency-use application.

Two weeks later, the companies shared information on manufacturing processes and production facilities. The full submission was completed in mid-July.

Altogether, the application was 340,000 pages, more than three times the length of the emergency-authorization submission.

Though the review process typically takes eight months, U.S. 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.

Pfizer expects to seek full approval for its vaccine in 12-to-15 year-olds before the end of the year. For children under 12, the process will take longer. Neither Moderna nor Johnson & Johnson have yet sought a full FDA clearance for use of their shots in younger children or adolescents.

‘Pandemic of the Unvaccinated’

President Joe Biden and top U.S. health officials hope the full approval will build confidence in the shot among unvaccinated Americans. About 3 in 10 U.S. residents eligible for immunization haven’t received a shot.

Peter Marks, the head of the FDA division that reviewed the approval application, said the immunization campaign has been plagued by falsehoods, including that shots contain microchips or cause infertility.

“Let me be clear, these claims are simply not true,” Marks said in a Monday briefing. “Getting a Covid-19 vaccine can save your life.”

The FDA decision is likely to have the greatest impact on people who have suggested they are taking a “wait and see” approach, said Timothy Callaghan, who studies rural health at Texas A&M University.

“This approval, paired with the spread of the delta variant, could spur many in that group to vaccinate,” he said. However, Callaghan cautioned that more hesitant Americans, many of whom hold fast to misinformation, will remain unmoved.

Ezekiel Emanuel, a medical ethicist at the University of Pennsylvania and former adviser to the Biden transition team, puts it differently. “The last excuse would be removed,” he said, “we have more than enough data.”

Opening the Market

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.

Acting Director of the FDA Janet Woodcock said the agency still needs to evaluate additional data before clearing a third-dose booster for people who are not immunocompromised.

“We do not encourage off-label use,” Woodcock said at the briefing. “Ordinarily our clinicians can do this, but this is a circumstance where the vaccine is being distributed under a provider agreement with the CDC and so providers agree to conform to certain conditions.”

(Updates with more details throughout)

--With assistance from Josh Wingrove, Fiona Rutherford and Daniel Flatley.

To contact the reporter on this story:
Riley Griffin in New York at

To contact the editor responsible for this story:
Timothy Annett at

© 2021 Bloomberg L.P. All rights reserved. Used with permission.