Pfizer/BioNTech seek full approval of COVID-19 vaccine in U.S.
Topics: PFIZER BIONTECH U.S.
The companies said they initiated the process of Biologics License Application (BLA) to give their shots to those aged 16 and older with full authorization.
The vaccine is currently available in the US under an emergency use authorization granted by the FDA on Dec. 11 and 170 million doses have been delivered across the country so far.
If the FDA gives a green light after the long review process, the vaccine would be the first fully approved jab in the US.
"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," said Albert Bourla, chairman and CEO of Pfizer.
"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," Bourla added.
BioNTech CEO Ugur Sahin called the BLA submission "an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future."
"We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data," Sahin said. ■