Europe – Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval

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…