26 August 2022 - Submission follows application for Omicron BA.1 adapted bivalent vaccine submitted in July.

Pfizer and BioNTech today announced they have completed a submission to the EMA for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. 

This application for a variation of the conditional marketing authorisation follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities to work towards introducing Omicron adapted bivalent vaccines.

Read Pfizer press release