EMA Starts Rolling Review of Adapted COVID-19 Vaccines
The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.
The European Medicines Agency (EMA) has begun a rolling review of the Spikevax vaccine that has been adapted to protect against two variant strains of SARS-CoV-2, the agency announced on June 17, 2022. The review will focus on non-clinical laboratory study data as well as 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 COVID-19 vaccine on June 15, 2022. “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.
Source: EMA
Guidance on Quality Culture Standards
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