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.