The drug maker has started the biologics license application process.
Pfizer has initiated the biologics license application for approval of their COVID-19 vaccine.
According to a news release, since the vaccine became the first to receive emergency use authorization from the Food and Drug Administration (FDA) in December, 170 million doses have been delivered across the country. The biologics license application is the next step in the FDA review process.
“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, chairman and CEO of Pfizer, says in the release. “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 company has submitted nonclinical and clinical data to support licensure of the vaccine for use in patients 16 years and older, the required manufacturing and facility data will be submitted in the coming weeks, according to the release.
Pfizer is also applied to the FDA seeking to expand the current emergency use authorization to include administering the vaccine to patients between 12 and 15 years old. A supplemental biologics licensing application will be submitted to support approval for this age group once the required data is collected, the release says.
In April, Bourla said that a third dose six to 12 months after the initial two doses of the vaccine and annual vaccinations thereafter is a likely scenario due to the emerging variants of the disease.