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Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization in Europe for Valneva's inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for use as primary vaccination in people from 18 to 50 years of age.
The European Commission (EC) will review the CHMP recommendation, and a decision on the marketing authorization application for VLA2001 is expected shortly. If granted, this will be the first COVID-19 vaccine to receive a standard marketing authorization in Europe.
The CHMP concluded by consensus after a thorough evaluation that, "the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality."
