Pfizer and BioNTech SE submit emergency use authorisation request to the FDA for their vaccine , BNT 162b2 , for COVID-19 .

Pfizer Inc.and BioNTech SE announced they will submit a request to the FDA for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT 162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020. PDUFA date is reported as 18 December 2020. The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ phase iii 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. the first primary objective analysis was based on 170 confirmed cases of covid-19. this submission also is supported by solicited safety data from a randomized subset of approximately 8,000 participants greater than 18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. the submission also includes solicited safety data on approximately 100 children 12-15 years of age. approximately 42% of global participants and 30% of u.s. participants in the phase iii study have racially and ethnically diverse backgrounds, and 41% of global and 45% of u.s. participants are 56-85 years of age. to date, the data monitoring committee (dmc) for the study has not reported any serious safety concerns related to the vaccine.>