Pfizer and its German associate BioNTech introduced Friday that they’ve utilized for full regulatory approval from the Food and Drug Administration for their COVID-19 vaccine for individuals 16 and older within the US.
The corporations are the primary COVID vaccine makers within the nation to use for full approval, referred to as a biologics license application, which might permit Pfizer to market the vaccine on to shoppers.
It would additionally imply that the vaccine can proceed to be offered after the US is not in an official state of emergency.
Pfizer’s vaccine was the primary to obtain an emergency authorization from the FDA in mid-December. Since then, Pfizer has distributed almost 170 million doses within the US, and greater than 130 million have been administered, in keeping with information from the Centers for Disease Control and Prevention.
“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,” Pfizer CEO Albert Bourla stated in a press release.
“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.”
The FDA required the businesses to submit a minimum of two months of follow-up security information from its scientific trials as a way to obtain authorization of the two-shot vaccine on an emergency foundation.
Pfizer and BioNTech stated Friday they’ve now submitted six months of security information so the FDA can assess whether or not it needs to be absolutely accepted. The corporations stated they will even submit information on the manufacturing means of the vaccine.