Pfizer, BioNTech submit CMA to EMA for COVID-19 vaccine

By The Science Advisory Board staff writers

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.

Pfizer, BioNTech to submit EUA request
Pfizer and BioNTech will submit a request on November 20 to the U.S. Food and Drug Administration for emergency use authorization (EUA) of their messenger...
FDA to review Pfizer, BioNTech's vaccine EUA on December 10
The Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration (FDA) has set a date of December 10 to discuss...
Pfizer, BioNTech just days away from applying for EUA for COVID-19 vaccine
Pfizer and BioNTech have passed another milestone in their effort to deliver a vaccine for the SARS-CoV-2 virus. The companies on November 18 reported...
Pfizer, BioNTech finalize supply deal with EU for COVID-19 vaccine
Pfizer and BioNTech, developers of BNT162b2, a messenger RNA-based SARS-CoV-2 vaccine candidate, have reached an agreement with the European Commission...
Pfizer, BioNTech tout positive results for COVID-19 vaccine
Pfizer and BioNTech have released results from a phase III clinical trial evaluating their messenger RNA-based vaccine candidate, BNT162b2, demonstrating...

Copyright © 2020

Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter