EMA Hopes to Approve 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.
Cooke said 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 has scheduled a public meeting on COVID-19 vaccines on Dec. 11.