Moderna: Spikevax vaccine approved by EMA

(CercleFinance.com) - The Committee for Human Medicinal Products (CHMP) of the EMA has recommended to convert the conditional marketing authorisation of the COVID-19 Spikevax vaccine (Moderna's vaccine) into a standard marketing authorisation.


The marketing authorisation no longer needs to be renewed annually.

Spikevax vaccine, like Pfizer's Comirnaty vaccine, had received a conditional marketing authorisation at the time of its authorisation. This authorisation required companies to submit results of ongoing clinical trials and to provide additional data.

These trials and additional studies, including observational studies, provided reassuring data on key aspects such as the efficacy of the vaccines in preventing severe COVID-19.


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