Pfizer and BioNTech said they will ask the feds for emergency approval of their experimental coronavirus vaccine on Friday, a key step that could make the shot available next month.
The Manhattan-based drugmaker and the German biotech firm will be the first to seek a so-called emergency use authorization in the US for their COVID-19 inoculation, which was 95 percent effective and posed no serious safety concerns in a major clinical trial.
The vaccine could be distributed to “high-risk populations” in the US by mid- to late December if the Food and Drug Administration approves the request, the companies said in a news release.
“Filing in the US 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.
The application boosts US