Freedom of Information request (FOI 22/1127)
Published 17 January 2024
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4th December 2022
FOI 22/1127
Dear ,
Thank you for your email.
Regarding the authorisation of Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified – PLGB 53632/0012), the following information is on the European Medicines Agency (EMA) website (https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
“Apart from containing mRNA matching different, but closely related, Omicron subvariants, Comirnaty Original/BA.1 and Comirnaty Original/Omicron BA.4-5 have the same composition. Therefore, based on clinical studies showing that Comirnaty Original/Omicron BA.1 triggers an immune response to the original strain and Omicron BA.1, Comirnaty Original/Omicron BA.4-5 is expected to generate an immune response against both the original strain and the subvariants BA.4 and BA.5.
In particular, 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. These data are further supported by non-clinical laboratory data on the ability of Comirnaty Original/Omicron BA.4-5 to trigger an adequate immune response.”
The above medicinal product has not been granted temporary authorisation via Regulation 174, it has been granted a marketing authorisation. Further information, including the Public Assessment Report (PAR) published by the EMA is available via the link above. The UK Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) is available via the below link, a PAR will be published for this product in the next 60 calendar days.
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