Adapted Versions Of Pfizer's Comirnaty & Moderna's Spikevax Recommended For Approval In The EU

(RTTNews) - Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced a 30 µg booster dose of their Omicron BA.1- Bivalent COVID-19 Vaccine, COMIRNATY Original, has been recommended for conditional marketing authorization by the European Medicines Agency's CHMP for individuals 12 years and older.

"Compared to a booster dose of our COVID-19 vaccine, which is currently approved for use in the EU, the bivalent vaccine with mRNA encoding the wild-type and the BA.1 spike proteins provides higher neutralizing antibody titers against the Omicron BA.1 and BA.4/BA.5 sublineages," said Ugur Sahin, CEO and Co-founder of BioNTech.

Separately, Moderna, Inc. (MRNA) announced the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional marketing authorization for Spikevax bivalent Original/Omicron BA.1, the company's next-generation bivalent vaccine candidate that contains mRNA-1273 and a vaccine candidate targeting the Omicron variant of concern. The company noted that the recommendation follows a recent agreement between Moderna and the European Commission to convert contractually agreed doses of Moderna's COVID-19 vaccine to the company's Omicron-targeting bivalent vaccines for supply in 2022.

These vaccines are adapted versions of the original vaccines Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna) to target the Omicron BA.1 subvariant in addition to the original strain of SARS-CoV-2. The CHMP opinions will be sent to the European Commission, which will adopt a final decision.

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