EMA Hopeful It Can Authorize a COVID-19 Vaccine by Christmas

The new head of the European Medicines Agency (EMA), Emer Cooke, said she is “hopeful” that the agency will grant a conditional marketing authorization for a COVID-19 vaccine by Christmas.

A conditional authorization would be equivalent to Emergency Use Authorization from the FDA and would require the vaccine’s sponsor to submit additional data to receive a full approval.

The agency is conducting “rolling reviews” of vaccine candidates from Moderna, Pfizer/BioNTech and AstraZeneca that consider the latest data from ongoing clinical trials.

Messenger RNA-based vaccines — such as those from Moderna and Pfizer/BioNTech — which instruct the body to make disease-fighting antibodies, require special analysis, Cooke said, adding that the agency must review clinical, animal and manufacturing studies to make sure “what the public ultimately get can be reproduced and can be trusted.”

The EMA will hold a public meeting on vaccines on Dec. 11, during which “anyone can voice concerns or ask questions,” she said.

Cooke previously served as the World Health Organization’s director of regulation for medicines before replacing Guido Rasi as EMA executive director earlier this month. ― Jason Scott