Mary Wilson
Well-known member
News 12/09/2022
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 tookinto 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. ...
https://www.ema.europa.eu/en/news/a...ants-original-sars-cov-2-recommended-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.
In its decision to recommend the authorisation of Comirnaty Original/Omicron BA.4-5, the CHMP tookinto 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. ...
https://www.ema.europa.eu/en/news/a...ants-original-sars-cov-2-recommended-approval