Pfizer (PFE) - Get Report and its partner, BioNTech (BNTX) - Get Report, said on Friday that they had submitted a biologics license application to the U.S. Food and Drug Administration to gain full clearance for their COVID-19 vaccine...
The companies since December have been using the vaccine under emergency-use authorization in the U.S. while conducting other clinical trials.
In their application, Pfizer, the New York health-care group, and BioNTech, the Mainz, Germany, biotech, are asking the FDA to clear the vaccine for use in Americans 16 and older.
“Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for priority review,” the companies said in a statement.
The move follows Pfizer’s earnings report on Tuesday. The company said its revenue rose 21% from a year earlier to $14.6 billion, topping analysts' consensus estimate of $13.63 billion.
The approval process is likely to take months, media reports say.
Meanwhile, the companies are pushing forward with their current emergency-use authorization status to get people vaccinated and to continue trials.
Over 134 million doses of the vaccine have been administered in the U.S. as of Thursday, the Centers for Disease Control and Prevention said.
The companies have also recently submitted an EUA request to use the vaccine for individuals aged 12 to 15, and they plan to add the age group to the biologics license application after six months of data are available, media reports say.
At last check Pfizer shares were trading little changed at $39.15. BioNTech American depositary receipts were trading 6.2% higher at $178.46.