Pfizer said Friday it will request an emergency-use authorization from the Food and Drug Administration for its coronavirus vaccine candidate.
The drugmaker, which is working with German partner BioNTech on the project, is the first to seek authorization for a coronavirus vaccine in the U.S.
“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” Pfizer CEO Albert Bourla said in a statement.
In recent days, Pfizer reported its vaccine candidate had 95% effectiveness overall, spurring the corporate partners to seek government approval for their drug.
The vaccine candidate, known as BNT 162b2, could be available for high-risk people in the U.S. by mid-December, CNN reported.