2020-12-01 05:24:50 PFE Pfizer
BioNTech
12/01/20 12/0105:24 12/01/2005:24 | Pfizer, BioNTech submit CMA application to EMA for COVID-19 vaccine candidatePfizer (PFE) and BioNTech (BNTX) have submitted a formal application for conditional marketing authorization, or CMA, to the European Medicines Agency, or EMA, for their mRNA vaccine candidate, BNT162b2, against COVID-19. This submission completes the rolling review process initiated on October 6, with nonclinical data and partial chemistry, manufacturing and controls, or CMC, data, followed by emerging clinical data submitted by Pfizer and BioNTech. If EMA concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID-19, it will recommend granting a CMA that could potentially enable use of BNT162b2 in Europe before the end of 2020. The submitted clinical data demonstrated a vaccine efficacy rate of 95% in the companies' Phase 3 clinical study in participants without prior SARS-CoV-2 infection, in each case measured from seven days after the second dose. Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%. The first primary objective analysis was based on 170 confirmed cases of COVID-19. In the trial, BNT162b2 also showed an overall favorable tolerability with no safety concerns reported by the Data Monitoring Committee to date. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. Pfizer
BioNTech
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