Pfizer and its German partner BioNTech announced Friday that they’ve applied for full regulatory approval from the Food and Drug Administration for their COVID-19 vaccine for people 16 and older in the US.
The companies are the first COVID vaccine makers in the nation to apply for full approval, called a biologics license application, which would allow Pfizer to market the vaccine directly to consumers.
It would also mean that the vaccine can continue to be sold after the US is no longer in an official state of emergency.
Pfizer’s vaccine was the first to receive an emergency authorization from the FDA in mid-December. Since then, Pfizer has distributed nearly 170 million doses in the US, and more than 130 million have been administered, according to data 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 said in a statement.
“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 companies to submit at least two months of follow-up safety data from its clinical trials in order to receive authorization of the two-shot vaccine on an emergency basis.
Pfizer and BioNTech said Friday they have now submitted six months of safety data so the FDA can assess whether it should be fully approved. The companies said they will also submit data on the manufacturing process of the vaccine.