On Friday, Pfizer and BioNTech announced the initiation of the full FDA approval application process for its COVID-19 vaccine, saying data to support what’s called a Biologics License Application would be submitted on a rolling basis in the coming weeks.
“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 at Pfizer, said in a press 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 process kicked off with the submission of data on the vaccine for use in people 16 years of age and older, including the most recent analyses from the Phase 3 clinical trial, which showed high efficacy up to six months after the second dose. Manufacturing and facility data will be submitted soon to complete the BLA application process.
Previously, the Pfizer vaccine was among those given an emergency use authorization (EUA) by the FDA. An EUA is given if it’s determined that there is a “public health emergency,” i.e. COVID-19, that has a “significant potential” to affect national security and/or the health of citizens. The EUA allows for vaccines or other medical products to be used in an emergency-inspired capacity.
In December 2020, the Pfizer/BioNTech vaccine became the first COVID-19 vaccine to receive EUA approval from the FDA. The EUA status is expected to be expanded soon to include those between the ages of 12 and 15.