Novavax, Inc. announced the first doses of Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) have begun shipping to European Union (EU) member states. Nuvaxovid, also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine authorized for use in Europe.
Local test and release procedures were completed and Nuvaxovid doses are shipping from Novavax' Netherlands distribution center to EU member states beginning this week. The first wave of shipments includes several countries, such as Germany, France and Austria. Shipments to additional EU member states are expected to quickly follow.
"Today's announcement paves the way for vaccination with Nuvaxovid to begin in Europe within the coming days. The Novavax COVID-19 vaccine provides a differentiated option to bolster vaccination rates across Europe," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Nuvaxovid has demonstrated efficacy, a reassuring safety and tolerability profile, and is built on a well-understood protein-based vaccine platform used for other vaccines for decades."
The European Commission (EC) granted conditional marketing authorization (CMA) for Nuvaxovid for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The authorization followed the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation to authorize the vaccine and is applicable in all 27 EU member states. Novavax expects to submit its regulatory filing for a pediatric indication in adolescents aged 12 through 17-years to global regulatory authorities, including EMA, during the first quarter of 2022.
Novavax and the EC have an advance purchase agreement for up to 100 million doses of Nuvaxovid with the option for an additional 100 million doses (up to 200 million doses total). Through the second quarter, Novavax has received a commitment for orders from the EC totaling 69 million doses. The initial doses were manufactured by Novavax' partner, the Serum Institute of India, the world's largest vaccine manufacturer by volume. Information about dose administration will be available through each member state.
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