May 7 (UPI) — Pfizer and BioNTech announced Friday that they have asked federal regulators for full approval of its COVID-19 vaccine, authorization that would allow them to market the shot directly to Americans.
The companies said they initiated the approval process with the Food and Drug Administration.
The vaccine has been distributed in the United States since December under emergency use authorization, but not full FDA approval.
“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the [approval] submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” BioNTech CEO Dr. Ugur Sahin said in a statement.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans,” Pfizer CEO Albert Bourla said.
“We look forward to working with the FDA … with the goal of securing full regulatory approval of the vaccine in the coming months.”
Recent clinical trials and real-world data have shown that Pfizer’s vaccine is about 95% effective at preventing infection, severe illness and hospitalization.
The company said earlier this week it was seeking full FDA approval. It’s also waiting for FDA authorization for the vaccine in adolescents between 12 and 15.