- Pfizer and BioNTech have started the regulatory process of seeking full approval for their Covid-19 vaccine for use in people 16 and older in the U.S.
- They are the first companies in the U.S. to file for a full license to market their shots directly to consumers.
- The FDA granted emergency authorization of their Covid vaccine in late December.
Pfizer and partner BioNTech said they have started the process of seeking full approval for their Covid vaccine for use in people 16 and older in the U.S., making the companies the first in the nation to file for full regulatory approval.
The Food and Drug Administration granted emergency authorization of their Covid vaccine in late December. Since then, Pfizer has distributed 170 million doses in the U.S., with the goal of delivering 300 million doses by the end of July.
"We are proud of the tremendous progress we've made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government," Pfizer CEO Albert Bourla said in a statement. "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."
Shares of Pfizer were down nearly 1% in premarket trading Friday, while BioNTech's stock was down more than 1%. Covid vaccine makers' shares tanked after the Biden administration said earlier this week that it would back waiving patent protections for Covid vaccines, citing the global health crisis.
Pfizer will have to demonstrate that it can reliably produce the vaccines to win full clearance. If approved, the companies could market their shots directly to consumers and possibly change the pricing of the doses. It also allows the shot to stay on the market once the pandemic is over and the U.S. is no longer considered in an "emergency."
It usually takes the FDA about a year or longer to determine whether a drug is safe and effective for use in the general public. Due to the once-in-a-century pandemic, which has killed nearly 600,000 people in the United States, the FDA permitted the use of the shots under an Emergency Use Authorization.
The authorization grants conditional approval based on two months of data. It's not the same as a Biologic License Application, which requires six months of data and secures full approval. The companies are seeking approval based on a "rolling submission," which expedites the review process by allowing the FDA to review new data as the company gets it.
"The BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future," Dr. Ugur Sahin, CEO and co-founder of Germany-based BioNTech, said in a statement. "We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data."
Early data collected from 12,000 vaccinated people ages 16 and up in that phase three trial showed its shots were 91.3% effective against getting the disease at up to six months after the second dose and 95.3% effective against severe Covid as defined by the FDA, the companies said April 1. The data also demonstrated "a favorable safety and tolerability profile," they said at the time.
White House chief medical advisor Dr. Anthony Fauci told CNN on April 28 that U.S. regulators would work "as expeditiously as possible" once the companies submit their applications for full approval.
"When you're getting a formal approval you have to have a certain amount of time just observing predominantly the safety, and obviously the safety looks really, really good in well over 140 million people having been vaccinated with at least a single dose," he told CNN. "I hope they do it quickly, because .. people when they hear it's still emergency use, they still have a little concern about how far you can go with it."
The companies are awaiting FDA emergency authorization to use their vaccine in kids ages 12 to 15 and said they intend to apply for a full license once they have six months of data.
They said in late March that the vaccine was found to be 100% effective in a clinical trial of more than 2,000 adolescents. They also said the vaccine elicited a "robust" antibody response in the children, exceeding those in an earlier trial of older teens and young adults. Side effects were generally consistent with those seen in adults, they added.