AMSTERDAM – As Canadians, Britons and Americans begin getting immunized with a German-developed vaccine against coronavirus, pressure is building on the European Medicines Agency to approve the shot made by Pfizer Inc. and the German company BioNTech. German officials have been especially vocal that they want it approved before Christmas. Here's a look at the EMA approval process:
WHAT IS THE EUROPEAN MEDICINES AGENCY?
The EMA is Europe’s medicines regulatory agency and approves new treatments and vaccines for all 27 countries across the European Union. It is roughly comparable to the U.S. Food and Drug Administration. The agency is headquartered in Amsterdam and it has nearly 900 employees.
WHY IS THE EMA TAKING SO LONG TO APPROVE A VACCINE?
Britain, Canada and the U.S. granted approval for the Pfizer-BioNTech vaccine to be used under emergency use provisions earlier this month, meaning the shot is an unlicensed product whose temporary use is justified by the urgency of a pandemic that has already killed over 1.6 million people.
But the EMA's approval process for coronavirus vaccines is largely similar to the standard licensing procedure that would be granted to any new vaccine, only on an accelerated schedule. The companies will still need to submit follow-up data to the EU regulator and the approval will need to be renewed after one year.