On Jun. 15, 2022, Pfizer and BioNTech announced the European Medicines Agency (EMA) had initiated a rolling review for a variant-adapted version of the companies’ COVID-19 vaccine. This rolling review was initially based on chemistry, manufacturing, and controls (CMC) data shared with EMA earlier this month. As clinical data become available, including immunogenicity against Omicron and its subvariants, it will be added to the rolling submission.

The companies also plan to begin the submission of data supporting a potential variant-adapted vaccine to the U.S. Food and Drug Administration (FDA) in the coming weeks.

Pfizer and BioNTech are evaluating several variant-adapted vaccines. The composition of the variant-adapted vaccine will be discussed with global regulatory bodies to determine a vaccine booster approach for the Fall 2022 season.