The action allows 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 in the European Union.
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 coronavirus disease 2019 (COVID-19) vaccine BNT162b2 by Pfizer and BioNTech.
According to Pfizer and BioNTech, the action allows for medicinal products to be authorized in the European Union (EU) 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 EU. If authorized, BNT162b2 will be the first COVID-19 vaccine available in the EU, officials for both companies said.
“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, MD, CEO and co-founder of BioNTech, in a prepared statement.
The CHMP advisors based their positive opinion on the scientific evidence supporting BNT162b2, including data from a phase 3 clinical study. 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. According to Pfizer and BioNTech, if the EC grants the CMA, the decision will be immediately applicable to all 27 EU member states.
“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,” said Albert Bourla, chairman and CEO, Pfizer, in a prepared statement.
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 BNT162b2 vaccine against COVID-19, which is caused by SARS-CoV-2 virus, has not been approved or licensed by the FDA, but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) for use in individuals aged 16 years 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.
Although BNT162b2 was the first vaccine against COVID-19 to receive the FDA’s EUA designation, the agency has also granted EUA status to Moderna’s COVID-19 vaccine, mRNA-1273.
Pfizer and BioNTech Receive CHMP Positive Opinion for Their COVID-19 Vaccine [news release]. New York, NY, and Mainz, Germany; December 21, 2020: Pfizer. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-chmp-positive-opinion-their