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
Ref: Globe Newswire | Image: Stat
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