Pfizer and BioNTech are submitting emergency use authorization request for their Covid-19 vaccine to the US FDA
On Friday, Pfizer and BioNTech are submitting an emergency use authorization request for their Covid-19 vaccine to the US Food and Drug Administration. While it's unclear how long the process will take, the US government is expected to approve the vaccine until mid-December.
"The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose," Pfizer said in a statement posted on its website.