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Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine

  • First EUL granted by WHO for a protein-based COVID-19 vaccine
  • EUL vaccine manufactured and marketed by SII as COVOVAX
  • WHO EUL for Nuvaxovid currently under assessment; will be completed following European Medicines Agency (EMA) review

GAITHERSBURG, Md. and PUNE, India, Dec. 17, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announced that the World Health Organization (WHO) has granted Emergency Use Listing (EUL) for NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant, for active immunization of individuals 18 years of age and older for the prevention of coronavirus disease 2019 caused by SARS-CoV-2. Today's EUL pertains to vaccine manufactured and marketed by SII as COVOVAX, a novel recombinant, adjuvanted SARS-CoV-2 rS Vaccine, in India and licensed territories. An additional EUL filing is under review by the WHO for vaccine to be marketed by Novavax under the brand name Nuvaxovid. 

The EUL prequalifies Novavax' COVID-19 vaccine as meeting the established 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 allocate and distribute vaccines equitably to participating countries and economies.

"Today's decision from the World Health Organization is vital to ensuring global access to a protein-based COVID-19 vaccine for hundreds of millions of people around the world," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank the World Health Organization for its thorough assessment. We believe this vaccine will help overcome barriers to vaccine access in many regions of the world by leveraging the traditional refrigeration used in existing vaccine supply channels, while also offering an option based on a familiar and well-understood technology."

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Nachrichtenquelle: PR Newswire (engl.)
17.12.2021, 16:50  |  253   |   |   

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Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine First EUL granted by WHO for a protein-based COVID-19 vaccine EUL vaccine manufactured and marketed by SII as COVOVAX WHO EUL for Nuvaxovid currently under assessment; will be completed following European Medicines Agency (EMA) review GAITHERSBURG, …

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