Pfizer & BioNTech Photograph:( AFP )
USFDA had approved the vaccines in December for emergency use
Pharma giants Pfizer and BioNTech said on Friday that they were seeking approval for use of their vaccines for individuals aged 16 and above. The companies are planning to submi data to support application "on a rolling basis over the coming weeks" to US Food and Drug Administration (FDA), they said in a press release.
USFDA approved the vaccines in December for emergency use.
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."
Both the companies have also submitted data in order to obtain emergency use approval for the vaccine to be used for individuals 12 to 15 years. Pfizer said earlier in the week that it expects imminent US approval for this application.
(With inputs from agencies)