EMA Issues New Guidance on Variant COVID-19 Vaccines

The European Medicines Agency (EMA) has outlined in a new guidance how vaccine developers can seek revised authorizations for currently authorized COVID-19 vaccines to address threats from new variants of the SARS-CoV-2 virus.

Sponsors should begin communications with the agency approximately three months before filing a new submission, the EMA advised.

The guidance, which also applies to coronaviruses other than SAR-CoV-2, explains how sponsors can seek approval for vaccines that target mutated coronavirus strains. Separate product information needs to be submitted for each variant vaccine, the EMA said.