Pfizer, BioNTech Seeks Full US Approval For Covid Vaccine

The two pharma companies plan to submit data in support of the application "on a rolling basis over the coming weeks" to the Food and Drug Administration (FDA), they said in a press release.

Pfizer and BioNTech said Friday they were launching an application requesting full US regulatory approval for their game-changing Covid-19 vaccine for individuals 16 years and older. The two pharma companies plan to submit data in support of the application "on a rolling basis over the coming weeks" to the Food and Drug Administration (FDA), they said in a press release. The FDA approved the vaccine in December for emergency use, a designation permitted during public health emergencies. Since then, more than 170 million doses of the vaccine have been delivered in the United States. The companies are now seeking a "Biologics License Application" for permanent regulatory approval, which "requires longer-term follow-up data for acceptance and approval," the companies said.