CHMP Gives Positive Opinion for Pfizer-BioNTech Vaccine

December 21, 2020
BioPharm International Editors

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

The first COVID-19 vaccine for the European market moved closer to approval on Dec. 21, 2020 when the European Medicines Agency’s (EMA’s) human medicines committee (CHMP) recommended the granting of a conditional marketing authorization for the Pfizer-BioNTech COVID-19 vaccine (named Comirnaty in the European Union) for people from 16 years of age.

The European Commission (EC) is expected to review the CHMP recommendation and make a final decision on the conditional marketing authorization in the near future, Pfizer reported in a press statement. If granted, the conditional marketing authorization will apply to all 27 EU member states.

The United Kingdom granted an emergency use authorization on Dec. 2, 2020. The vaccine is currently being administered in the United States under FDA Emergency Use Authorization.

“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said Emer Cooke, executive director of EMA in a press statement. “We have achieved this milestone thanks to the dedication of scientists, doctors, developers, and trial volunteers as well as many experts from all EU Member States.

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here. We will continue to collect and analyze data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the 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, CEO and co-founder of BioNTech in a Pfizer press statement.

“We are pleased with the Committee’s strong vote of confidence in our data,” said Albert Bourla, chairman and chief executive officer, Pfizer in a press statement. “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."

Clinical trial results showed a 95% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine and a 95% efficacy in the participants at risk of severe COVID-19, EMA reported in a press statement.

Comirnaty is given as two injections, 21 days apart. Common side effects were usually mild or moderate and got better within a few days after vaccination. They included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills, and fever.

Sources: EMA and Pfizer