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EMA Starts Rolling Review of Adapted COVID-19 Vaccines

June 21, 2022


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.

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