Pfizer and BioNTech asked for full Food and Drug Administration approval of their Covid vaccine on Friday, leading BioNTech stock to pop.
The vaccine is already authorized for emergency use in people ages 16 and older. But if approved, the vaccine could stay on the market after the pandemic ends. The companies could also market directly to consumers and change the price.
"Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the (application) submission is an important cornerstone of achieving long-term herd immunity and containing Covid-19 in the future," BioNTech Chief Executive Ugur Sahin said in a written statement.
In morning trading on today's stock market, BioNTech stock jumped 5.6% near 177.40. Pfizer stock rose 0.9% near 39.60.
BioNTech Stock Pops On FDA Submission
Pfizer and BioNTech gained emergency authorization for their Covid vaccine in December. At that time, the FDA said it would require at least six months of follow-up data in vaccinated volunteers before considering a full approval.
The data submitted Friday to the FDA include the most recent analysis from Phase 3 testing. The companies' observed the vaccine's safety and effectiveness for up to six months after the second dose, Pfizer and BioNTech said in a news release.
"We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months," Pfizer Chief Executive Albert Bourla said in a written statement.
Next, the FDA must decide whether the accept or reject the application. Then, the agency will set a date to review it. That could also stoke BioNTech stock.
Vaccine Shares Recover
The news Friday was a breath of fresh air for BioNTech stock.
Earlier this week, shares were under pressure after President Joe Biden and his administration voiced support for waiving patent rights for Covid vaccines. The goal is to help other countries make their own vaccines. BioNTech stock lost nearly 20% this week, as of Thursday's close.
On Thursday, though, German Chancellor Angela Merkel opposed waiving patent protection for vaccines. That helped BioNTech, which is based in Mainz, Germany, pare much deeper losses. At one point, BioNTech stock was off by 15%.
Comments