The EU’s drug regulator will hold an extraordinary meeting to decide whether to approve the Pfizer/BioNTech coronavirus vaccine by December 29 at the “latest,” according to the agency’s new chief, Emer Cooke.
The announcement, made Wednesday at an informal meeting of Europe’s health ministers, comes on the heels of the U.K. announcement Wednesday morning that it’s authorizing the vaccine, making it the first Western country to approve a shot against the coronavirus.
Cooke, who took over the helm of the European Medicines Agency last month, said that she “noted” the decision made by U.K. authorities to approve the vaccine.
Cooke will also hold a meeting “tentatively” scheduled for January 12 to decide whether to approve a similar messenger RNA-based vaccine developed by Moderna, she said.
The vaccine assessments will be made on the strength of the science, Cooke assured ministers, and they’ll be granted marketing authorization only when the evidence showing they’re safe and effective greatly outweighs any risks.
Should the decision to green-light the Pfizer/BioNTech vaccine across the EU come at the end of the month, it would give the U.K. a significant head start in starting its vaccination campaign.
German Health Minister Jens Spahn, who chaired the conference representing the presidency of the Council of the EU, urged those present to not waste time.
Spahn warned about the “perception†that regulators in the U.K., U.S. and EU will approve a vaccine on different timelines — the last of which most likely will be the EMA.
“We need to be as quick as we can,†he said.
