World Health Organization Updates Emergency Use Listing for Novavax Nuvaxovid COVID-19 Vaccine as a Primary Series in Adolescents and as a Booster in Adults

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[{"type":"text","content":"GAITHERSBURG, Md., Nov. 29, 2022 /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 issued an updated Emergency Use Listing (EUL) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a primary series of two doses in adolescents aged 12 through 17 and as a booster in adults aged 18 and older.\n\"Today's updated Emergency Use Listing from the WHO allows us to offer our protein-based vaccine as a primary series to adolescents and as a booster for adults around the world,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"WHO member countries now have a vaccine option for these indications developed using an innovative approach to traditional technology that can also be stored in standard refrigeration, making it easy to transport.\"\nPrimary Series in AdolescentsThe updated EUL for Nuvaxovid as a primary series in adolescents aged 12 through 17 was based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,232 adolescents aged 12 through 17 years across 75 sites in the U.S., to evaluate the safety and effectiveness of Nuvaxovid. In the pediatric expansion, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.\nPreliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to 30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccinati...

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