Pressure mounts on EU regulator to approve coronavirus vaccine
The U.K., Canada and even Bahrain beat Brussels in approving the BioNTech/Pfizer coronavirus vaccine. And now, with the news late Friday that the U.S. has followed suit, pressure is mounting on the EU to pull the trigger.
The challenge for the EU: Unlike these other countries, which are green-lighting the jab on an emergency basis, the bloc is waiting for the European Medicines Agency to issue a conditional marketing authorization (CMA) — a one-year full approval. This process involves two independent scientific assessments, along with a consensus among EU countries (in most cases), and an agreement about the liability and responsibilities borne by the drugmakers.
The agency is expected to make a decision by December 29 at the latest. Regulators in the agency’s Amsterdam headquarters and in each EU country are working around the clock, and will do so through the Christmas holiday, to pore over the data on vaccine safety, efficacy and manufacturing quality while the world waits.
Read the full article from Politico here