EMA Recommends Adapted Spikevax Vaccine

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The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

The European Medicines Agency announced on Oct. 19, 2022 that its Committee for Medicinal Products for Human Use (CHMP) has recommended the authorization of the adapted Spikevax COVID-19 vaccine. The new vaccine targets the Omicron subvariants BA.4 and BA.5 and the original strain of SARS-CoV-2. The recommendation is for use in adults and children 12 years and older who have already received a primary vaccination course against COVID-19.

CHMP took into account available data on the Spikevax vaccine and the authorized Spikevax bivalent Original/Omicron BA.1. According to EMA, both adapted vaccines have the same composition. The decision by CHMP was also based on the quality and manufacturing process that meets quality standards in the European Union. Non-clinical laboratory data also showed that the adapted vaccine triggered an adequate immune response.

“Based on all these data and the similar composition of the adapted vaccines, the CHMP concluded that Spikevax bivalent Original/Omicron BA.4-5 is expected to be more effective than the originally authorized vaccine at triggering an immune response against the BA.4 and BA.5 subvariants. The vaccine’s safety profile is expected to be comparable to that of Spikevax bivalent Original/Omicron BA.1 and the originally authorized Spikevax, for which a large amount of data is available,” the agency stated in a press release.


The opinion now goes to the European Commission for final adoption.

Source: EMA