Pfizer and BioNTech announced Friday that they are seeking full approval for its landmark COVID-19 vaccine from the U.S. Food and Drug Administration for Americans age 16 and older.
The full approval process will likely take several months.
The two-dose mRNA vaccine was the first to receive Emergency Use Authorization from the FDA in December 2020. As of Thursday, the U.S. has administered over 134 million doses of the Pfizer-BioNTech vaccine, more than any other COVID-19 inoculation, and over 55 million people have been fully vaccinated with it.
"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," 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."
“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” BioNTech CEO Dr. Ugur Sahin added. “We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”
The companies submitted a Biologics License Application (BLA) with the FDA to get the ball rolling on full approval. The FDA will require the companies to submit all clinical and pre-clinical trial data, as well as demonstrate that they can produce the vaccine on a consistent basis.
As the company seeks full approval, it is also asking the regulatory agency to expand its existing EUA to vaccinate 12-15-year-olds, a decision which is expected to come early next week.
Pfizer and BioNTech asked for what is known as Priority Review, which could expedite the typically 10-month process to a reduced 6 months.
The FDA's approval could help reduce vaccine hesitancy, as well as prompt companies, schools and other agencies to require the vaccine, which many organizations were reticent to do while the vaccine was under emergency authorization.
This is a developing story. Check back later for further updates.