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Novavax Submits Request for WHO Emergency Use Listing Expansion

Strategic Insights

— 1 min read

Novavax, Inc. has announced the submission of a request to the World Health Organization (WHO) to expand the Emergency Use Listing (EUL) of their COVID-19 vaccine, Nuvaxovid(TM) (NVX-CoV2373), for active immunization to prevent coronavirus disease 2019 (COVID-19) in adolescents aged 12 through 17. This decision is based on data from a pediatric expansion of the Phase 3 PREVENT-19 trial, which demonstrated 80% clinical efficacy in adolescents. The trial, conducted across 73 sites in the U.S., involved 2,247 adolescents aged 12 through 17 years, and showed that the vaccine was generally well-tolerated with low instances of serious and severe adverse events.

Key Takeaways:

  • Novavax has submitted a request to the WHO to expand the Emergency Use Listing (EUL) of Nuvaxovid(TM) (NVX-CoV2373) COVID-19 vaccine for adolescents aged 12 through 17, making it the first protein-based COVID-19 vaccine available to this age group by the WHO.
  • The decision is based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial, which involved 2,247 adolescents across 73 sites in the U.S.
  • The trial demonstrated 80% clinical efficacy in adolescents, with the vaccine achieving its primary effectiveness endpoint, when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.
  • Preliminary safety data from the trial showed the vaccine to be generally well-tolerated, with low instances of serious and severe adverse events.
  • 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.
  • The vaccine's submission to the WHO for EUL expansion is a significant step towards making Nuvaxovid available to adolescents globally.

Statistics:

  • 2,247 adolescents aged 12 through 17 participated in the pediatric expansion of the Phase 3 PREVENT-19 trial.
  • 73 sites in the U.S. were involved in the trial.
  • 80% clinical efficacy was demonstrated in adolescents aged 12 through 17.
  • Low instances of serious and severe adverse events were reported.

Sources:

  • Novavax, Inc.

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