CHMP Recommends Authorisation of Comirnaty Variant (BioNTech/Pfizer) Adapted to Omicron BA.4/BA.5 As Booster Vaccination for Children Aged 5 to 11 Years
On 10 November 2022, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) voted in favour of authorising one of the variants of the Comirnaty vaccine that has been adapted to the Omicron variants BA.4/BA.5 as a booster vaccination for children aged 5 to 11 years. The EU Commission followed the recommendation and granted a marketing authorisation.
The booster vaccine Comirnaty Original/Omicron BA.4-5 contains both messenger RNA (mRNA) with the blueprint of the spike protein of the original SARS-CoV-2 (Wuhan) and mRNA with the spike protein blueprint of the Omicron variants BA.4 or BA.5. The two variants have an identical spike protein.
One of the Comirnaty vaccine variants adapted to the Omicron variants BA.4/BA.5 was already authorised for persons aged 12 years and over (Comirnaty Original/Omicron BA.4-5). The version of Comirnaty containing the spike protein blueprint of the original SARS-CoV-2 virus (Wuhan) was also already authorised for children aged 5 to 11 years in an age-adapted dosage (10 µg).