Pfizer and BioNTech are asking drug regulators in the United States for full approval for their COVID-19 vaccines.
The two companies announced on May 7 that they initiated a rolling submission for a biologics license application by submitting nonclinical and clinical data, including the most recent analyses from a phase three clinical trial, to the Food and Drug Administration (FDA) in the coming weeks.
They plan to submit more data in the coming weeks to complete the application.
“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,” Albert Bourla, Pfizer’s chairman and CEO, 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.”
“The BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” added Ugur Sahin, CEO and co-founder of BioNTech.
The companies asked for priority review. If that request is approved, a decision would come within 6 months instead of the typical 10-month time frame.
The FDA didn’t immediately respond to an inquiry.
Dr. Ashish Jha, dean of the Brown University of Public Health, called the initiation a major development.
“Here is why. Obviously, on some level, day-to-day vaccinations will continue, and in that way it’s not a huge deal, but it’s a signal that we have so much safety data now on millions and tens of millions of people that we can get the full authorization, the full approval. It will also give confidence to a lot of people who have been on the fence, businesses that want to mandate it for workers coming back. So I do think it’ll end up being a big deal,” he said during an appearance on ABC.
Both shots use messenger RNA technology, a brand new way of developing vaccines.
Moderna plans on starting the biologics license application later this month.
The FDA greenlit the Pfizer shot on Dec. 11, 2020, less than one month after the company and its partner BioNTech asked for emergency authorization.
Regulators said they found that data from an ongoing trial analyzing the vaccine showed that the known and potential benefits of the shot outweighed the known and potential risks. The authorization was for people aged 16 or older.
Since then, over 134 million doses of the vaccine have been administered in the United States. It’s the most used COVID-19 vaccine in the country.
Also on May 7, Pfizer and BioNTech asked regulators to allow children between the ages of 12 and 15 to get the shot. Once enough data is acquired, the companies plan to request full approval for that age group.
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