December 1, 2020 -- Pfizer and BioNTech submitted an application on November 30 for conditional marketing authorization (CMA) to the European Medicines Agency (EMA) for their messenger RNA vaccine candidate, BNT162b2.
The submission completes the rolling review process initiated on October 6, which included nonclinical data and partial chemistry, manufacturing, and controls data, and emerging clinical data submitted by the companies. If the EMA determines that the benefits of the vaccine candidate outweigh its risks in protecting against COVID-19, it will recommend granting the CMA enabling the use of BNT162b2 in Europe before the end of 2020.
The vaccine candidate will be assessed according to the EMA's normal standards for quality, safety, and efficacy. In submitted clinical data, the vaccine achieved an efficacy rate of 95%.
In addition to submissions to the EMA, the U.S. Food and Drug Administration, and the U.K. Medicines and Healthcare Products Regulatory Agency, the companies have initiated rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other global regulatory agencies.
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