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

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.

Robust Review

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."

The companies' submission was delivered in two batches. On May 7, they shared a package of clinical data including more information on the vaccine's effectiveness and six months of safety data — building on two months of safety data shared in the emergency-use application.

Two weeks later, Pfizer and BioNTech shared information on the vaccine's manufacturing processes and production facilities.

Altogether, the application was 340,000 pages, more than three times the length of the emergency-authorization submission. According to Pfizer, that's significantly longer than the standard application package.

Though the BLA 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 file a BLA for its vaccine in 12-to-15 year-olds before the end of the year. For those under 12, the process will take longer. Neither Moderna nor Johnson & Johnson have yet sought FDA clearance for use of their shots in younger teens 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. Among U.S. residents eligible for immunization against Covid, about 3 in 10 haven't received a single shot.

The FDA decision is likely to have the greatest impact on Americans who have long 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."

Callaghan cautions, however, that more hesitant Americans 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."

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 ultimately open up the government to non-government purchasers — though that critical business shift in supply negotiations won't come until next year.

Pfizer expects 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.