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 8000 participants greater than 18 years of age and unsolicited safety data from approximately 38000 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.>