US pharmaceutical giant Pfizer and German BioNTech applied Monday to the European Medicines Agency (EMA) for conditional approval of their COVID-19 vaccine in the European Union after clinical trials showed that the vaccine is 95% effective. and without significant side effects.
The joint statement said today that the vaccine could be available by the end of the year if approved in the EU. They also announced that Emma had confirmed the acceptance of their application on Monday. CEO of Pfizer Albert Bourla They welcomed the adoption of the proposal as another important milestone in joint efforts with BioNTech to mitigate the health crisis.
According to Emi, a motion for conditional approval of the COVID-19 vaccine by the US pharmaceutical company Moderna is also expected on Monday.
Moderna, BioNTech, and Pfizer have already applied to the US Federal Food and Drug Administration (FDA) for approval for their covid-19 vaccines to be used in the United States.
The European Commission confirmed on Twitter that EMA has received requests for conditional marketing authorization for coronavirus vaccines from both Pfeizer and Moderna. “Over the next few weeks, EMA would like to conduct independent scientific reviews of the quality, safety and efficacy of each vaccine”, they even tweeted.
However, Ema announced today that it will hold an emergency meeting on December 29 at the latest to decide whether to authorize vaccines, provided, of course, that the data presented are robust enough to draw conclusions about the quality, safety and efficacy of the vaccine.