Pfizer and its German partner BioNotech announced on Friday that they had applied for 16 and older US people for their COVID-19 vaccine for full regulatory approval from the Food and Drug Administration.
The companies are the first COVID vaccine manufacturers in the country to apply for full approval, called the Biologics License Application, which will allow Pfizer to market the vaccine directly to consumers.
This would also mean that the sale of the vaccine could continue after the US was in a state of emergency.
Pfizer’s vaccine was the first to receive an emergency authorization from the FDA in mid-December. Since then, according to data from the Centers for Disease Control and Prevention, Pfizer has distributed approximately 170 million doses in the US, and more than 130 million have been administered.
Pfizer CEO Albert Borla said in a statement, “We are proud of the tremendous progress since December in delivering vaccines to millions of Americans with the support of the US government.”
“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 months ahead.”
The FDA required companies to submit at least two months of follow-up safety data from their clinical trials to obtain authorization for a two-shot vaccine on an emergency basis.
Pfizer and Bayonet said that on Friday they have submitted six months of safety data, so the FDA can assess whether it should be fully approved. The companies said that they will also present data about the vaccine manufacturing process.
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