European Commission decision on conditional marketing authorization expected imminently
Positive CHMP opinion follows several emergency use authorizations worldwide; committee reviewed totality of scientific evidence, including Phase 3 efficacy and safety data
If authorized, BNT162b2 will be the first COVID-19 vaccine available in the European Union
NEW YORK & MAINZ, Germany (STL.News) Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the conditional marketing authorization (CMA) of the Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older. The purpose of a CMA is to allow for medicinal products to be authorized on a conditional basis for seriously debilitating or life-threatening diseases or for use in emergency situations in response to public health threats recognized either by the World Health Organization or the European Union (EU).
“Today is a particularly personal and emotional day for us at BioNTech. Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic. We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
“We are pleased with the Committee’s strong vote of confidence in our data,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “If the European Commission issues an authorization, we are ready to start delivering this vaccine to government-designated sites all across the EU where cases of disease continue to rise and several countries are managing lockdowns.”
The CHMP advisors based their positive opinion on the scientific evidence supporting the Pfizer-BioNTech COVID-19 Vaccine, including data from a Phase 3 clinical study announced last month and published in The New England Journal of Medicine on December 10, 2020. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on the conditional marketing authorization in the near future. If the EC grants the CMA, the decision will be immediately applicable to all 27 EU member states.
To date, the vaccine has been authorized or approved for emergency use in more than 15 countries. Regulatory reviews are underway in several countries, with more submissions anticipated.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com.