Coronavirus: European green light for Novavax's COVID-19 vaccine

PARIS (Reuters) – The European Medicines Agency (EMA) on Monday recommended to grant marketing authorization for the COVID vaccine – 19 from biotech American Novavax, named Nuvaxovid, the fifth vaccine authorized for adults in Europe.

After a thorough evaluation, the Committee for Medicinal Products for Human Use (CMUH) of the AEM concluded during a extraordinary meeting Monday that the data concerning this vaccine “were solid and met European criteria for efficacy, safety and quality,” the Agency noted in a statement.

This validation of Nuvaxovid makes it the fifth vaccine authorized in the European Union, after the two mRNA vaccines (Comirnaty from Pfizer and BioNTech, Spikevax from Moderna

This double-dose vaccine, which does not use messenger RNA (mRNA) technology, is composed of recombinant viral protein particles (copies of parts of the virus’s “Spike” protein obtained by genetic engineering) associated with an adjuvant, which stimulates the immune system.

Novavax said in an email sent to Reuters on Monday shortly before the announcement of this authorization that deliveries of Nuvaxovid to the European Union (EU) would begin in January, in the event of validation.

The American biotech had signed a contract with the European Commission in August for the purchase of 100 million doses of this vaccine, with an option for 100 million additional doses, for the period 2021 – 2023, a conditioned pre-order to an authorization of Nuvaxovid by the AEM.

(Written by Myriam Rivet, with the contribution of Francesco Guarascio in Brussels, edited by Blandine Hénault)