EMA’s CHMP Recommends Pfizer and BioNTech’s Adapted Comirnaty Vaccine

September 14, 2022

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing Pfizer and BioNTech’s adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2.

The recommendation for the adapted Comirnaty Original/Omicron BA.4-5 vaccine is for use in people aged 12 years and older who have received at least a primary course of vaccination against COVID-19.

When making the recommendation, the CHMP says it took into account all of the available data surrounding Comirnaty and its adapted vaccines, including the authorized adapted vaccine Comirnaty Original/Omicron BA.1, but also investigational vaccines against other variants of concern.

However, clinical studies with Comirnaty Original/Omicron BA.4-5 are ongoing and the CHMP will receive emerging clinical data as they are being generated, according to the EMA.

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