NEW YORK: 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), reports AFP.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.
The information will include data on the vaccine efficacy and safety profile up to six months after the second dose in a phase-three clinical trial.
"We are proud of the tremendous progress we've made since December in delivering vaccines to millions of Americans, in collaboration with the US government," said Pfizer Chief Executive Albert Bourla.
"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."