Moderna submits vaccine booster data to EMA

Friday, 03. September 2021 22:04

Moderna announced on Friday it has submitted data to the European Medicines Agency (EMA) for the approval of its COVID-19 vaccine booster shots.

"We are pleased to submit for a conditional marketing approval with the EMA for our booster candidate at the 50 µg dose level. The amended Phase 2 study and additional analyses shows that a 50 µg booster dose of our COVID-19 vaccine induces robust antibody responses against the Delta variant," the pharmaceutical company stated.

Earlier, media reported the United States Food and Drug Administration (FDA) is assessing Moderna's request to lower the dose for the booster from 100 µg, which is the dose level of the first two shots people received.

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Breaking the News / NP