EMA’s human medicines committee (CHMP) has recommended authorising an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2.

This recommendation will further extend the arsenal of available vaccines to protect people against COVID-19 as the pandemic continues and new waves of infections are anticipated in the cold season.
Comirnaty Original/Omicron BA.4-5 is for use in people aged 12 years and above who have received at least a primary course of vaccination against COVID-19. This vaccine is an adapted version of the mRNA COVID-19 vaccine Comirnaty (Pfizer/BioNTech).

Vaccines are adapted to better match the circulating variants of SARS-CoV-2 and are expected to provide broader protection against different variants. Prompt assessment of the available data on these adapted vaccines will enable their timely deployment in the autumn vaccination campaigns.

In its decision to recommend the authorisation of Comirnaty Original/Omicron BA.4-5, the CHMP took into account all the available data on Comirnaty and its adapted vaccines, including the recently authorised adapted vaccine Comirnaty Original/Omicron BA.1 as well as investigational vaccines against other variants of concern.

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 CHMP’s opinion for Comirnaty Original/Omicron BA.4-5 is also based on data on its quality and manufacturing process, which confirmed that it meets the EU standards for quality. In addition, immunogenicity data (the ability of the vaccine to trigger an immune response) from laboratory (non-clinical) studies provided supportive evidence that Comirnaty Original/Omicron BA.4-5 triggers adequate immunity against the strains it targets.

Based on all these data, the CHMP concluded that Comirnaty Original/Omicron BA.4-5 is expected to be more effective than Comirnaty at triggering an immune response against the BA.4 and BA.5 subvariants. 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.

Published on: 13 September 2022