Pfizer and BioNTech have already distributed more than 170 million doses of their coronavirus vaccine around the United States under an emergency authorization from the Food and Drug Administration.
The designation would mark another important step for U.S. pharmaceutical giant Pfizer and German biotech firm BioNTech, allowing them to directly market the drug and offer booster shots against coronavirus variants without first seeking a new emergency authorization, Forbes reported.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Albert Bourla, Pfizer’s chairman and chief executive officer, said in a statement shared with The Washington Post. “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 granted an emergency authorization for the Pfizer-BioNTech vaccine on Dec. 11, a designation later also granted to drugs from Moderna and Johnson & Johnson. (The Pfizer-BioNtech vaccine is authorized for individuals age 16 and up; the other two vaccines are authorized for age 18 and up.)
Federal regulators have the power to “authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency,” such as the pandemic, during which more than 579,000 people have died from the coronavirus in the United States.
But that authorization lasts only as long as the public health emergency continues, and limits the producers’ ability to market the drugs. On Friday, Pfizer submitted a host of new clinical and nonclinical data to seek full approval of the vaccine.
The request comes as public health experts expect the FDA to grant a new emergency authorization as soon as next week for 12- to 15-year-olds to receive the Pfizer-BioNTech vaccine.
Pfizer said that once six months of full data was available on that age group, it would also submit a new application for full approval for 12- to 15-year-olds to receive the drug.
“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA [biologics license application] submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” Ugur Sahin, the co-founder and chief executive of BioNTech, said in a statement.