EU Launches Rolling Review of Pfizer’s Updated COVID-19 Vaccine

The EU’s European Medicines Agency (EMA) has begun a rolling review of an updated version of the Pfizer-BioNTech COVID-19 vaccine that is intended to provide better protection against variants of the SARS-CoV-2 virus.

The initial review includes chemistry, manufacturing and control (CMC) data for the variant-adapted vaccine for Omicron subvariants of the virus. It is not yet clear which other variants will be targeted.

A rolling review allows the EMA to assess data as it becomes available, until there is enough for a complete application.

The companies also plan to begin submitting data supporting a variant-adapted vaccine to the FDA in the coming weeks.