EMA approved, išlo to rýchlo vzhľadom na podobnosť sa vakcínou upravenou na BA.1. https://www.ema.europa.eu/en/news/adapted-vaccine-targeting-ba4-ba5-omicron-variants-original-sars-cov-2-recommended-approval

"The CHMP based its opinion in particular on the clinical data available with Comirnaty Original/Omicron BA.1. Apart from containing mRNA matching different, but closely related, Omicron subvariants, Comirnaty Original/Omicron BA.4-5 and Comirnaty Original/Omicron BA.1 have the same composition. Clinical studies with Comirnaty Original/Omicron BA.1 showed that the vaccine was more effective at triggering an immune response against the BA.1 subvariant than Comirnaty, and was as effective as Comirnaty against the original strain. Side effects were comparable to those seen with Comirnaty. This was further supported by data from investigational vaccines targeting other variants which have also shown similar safety profiles and predictable immune responses against the strains they target. (...)

(...) The vaccine’s safety profile is expected to be comparable to that of Comirnaty Original/Omicron BA.1, and of Comirnaty itself for which a large amount of data is available.

Clinical studies with Comirnaty Original/Omicron BA.4-5 are ongoing and the CHMP will receive emerging clinical data as they are being generated.

The CHMP opinion on Comirnaty Original/Omicron BA.4-5 will now be sent to the European Commission, which will adopt a final decision. (...)"