Agency will be reviewing laboratory study and CMC data on the bivalent jab that targets two strains of the SARS-CoV-2 virus
The European Medicines Agency (EMA) has begun a rolling review of the Spikevax (Moderna) vaccine that has been adapted to protect against two variant strains of SARS-CoV-2.
The review will focus on non-clinical laboratory study data, along with chemistry, manufacturing, and controls (CMC) data relating to the manufacturing of the vaccine. A rolling review allows the agency to begin assessing available data before marketing approval of the vaccine. The agency will review additional data from the sponsor company as it is received.
EMA also began a rolling review of an adapted Comirnaty (Pfizer-BioNTech) COVID-19 vaccine last week. “The details about the adapted vaccine, for example, whether it will specifically target one or more SARS-CoV-2 variants or subvariants, are not yet defined. However, EMA’s review will initially focus on CMC data for the component targeting Omicron subvariants,” the agency stated in a press release.