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World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine
- Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) listed for emergency use by the WHO - EUL for Nuvaxovid complements listing for
About this update from Novavax, Inc.
[{"type":"text","content":"- Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) listed for emergency use by the WHO\n- EUL for Nuvaxovid complements listing for Novavax vaccine manufactured and marketed by Serum Institute of India as Covovax™ \n- EUL by WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility \n GAITHERSBURG, Md., Dec. 20, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the World Health Organization (WHO) has granted a second Emergency Use Listing (EUL) for NVX-CoV2373, Novavax' recombinant protein nanoparticle COVID-19 vaccine with Matrix-M™ adjuvant, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. Today's EUL pertains to vaccine to be marketed by Novavax as Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) in Europe and other markets. NVX-CoV2373 is also being manufactured and marketed in India and licensed territories by Serum Institute of India Pvt. Ltd. (SII), as Covovax™, which was granted EUL on December 17. Nuvaxovid and Covovax are based on the same Novavax recombinant protein technology and the EULs are based on a common pre-clinical, clinical and chemistry, manufacturing and controls (CMC) package.\nToday's EUL follows the receipt of conditional marketing authorization from the European Commission and prequalifies Nuvaxovid as meeting WHO standards for quality, safety and efficacy. EUL is a prerequisite for exports to numerous countries, including those participating in the COVAX Facility, which was established to enable equitable vaccine allocation and distribution. EUL also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. Novavax and SII have committed a cumulative 1.1 billion doses of the Novavax vaccine to COVAX. \n\"Today's Emergency Use Listing underscores the ongoing need and potential for Novavax to help significantly increase COVID-19 vaccine access across the globe through a protein-based option built on a well-understood platform,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"We thank the World Health Organization for its thorough assessment and look forward to helping ad...