In its decision, the ETF reviewed non-clinical studies and data on the immune response following natural infection with Omicron BA.4/BA.5 in unvaccinated people who had not been previously infected with SARS-CoV-2.
The data suggested that primary vaccination with adapted bivalent vaccines, which are currently only authorised as boosters, should induce a broad immune response in those who have not yet been exposed to, or vaccinated against, SARS-CoV-2.
