BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19

Shots:

• The companies have submitted CMA to the EMA for BNT162b2, against COVID-19. The submission completes the rolling review process initiated on Oct 6, 2020
• The submitted data showed a 95% efficacy rate, efficacy was consistent across age, gender, race, and ethnicity demographics, with an observed efficacy in adults aged ≥65yrs. of >94%, favorable tolerability with no safety concerns
• In addition to submission to EMA, FDA & MHRA, the companies have also initiated additional rolling submissions across the globe including in Australia, Canada, and Japan, and plan to submit applications to other regulatory agencies globally

Click here ­to­ read full press release/ article | Ref: Globe Newswire | Image: Stat