6 December 2022 - EMA’s Emergency Task Force considers that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 sub-variants of SARS-CoV-2 may be used for primary (initial) vaccination. These vaccines are currently only authorised as boosters.
In reaching this conclusion, the Emergency Task Force reviewed laboratory (non-clinical) studies and data on the immune response following natural infection with Omicron BA.4-5 in unvaccinated people who had not been previously infected with SARS-CoV-2.