From RT.com….
Pharma giants Pfizer and BioNTech have applied for full FDA approval for their Covid vaccine, becoming the first to do so in the US as drug firms say regular booster shots may be needed to ward off “concerning” virus variants.
The two companies filed their application to the FDA on Friday, requesting full authorization for use of their vaccine in people aged 16 and older.
“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,” Pfizer CEO Albert Bourla said in a press release.
While the FDA approved the two-dose Pfizer shot on an emergency basis in December, full authorization would mean the vaccine could be administered even after health officials say the Covid-19 crisis is over.
The companies said they plan to send their vaccine data “on a rolling basis,” also requesting the FDA fast-track the review process, hoping for a decision within six months rather than the standard 10. In addition to their trial data, they are also required to submit information on their manufacturing process and facilities.
