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Novavax Submits Request to WHO for Emergency Use Listing Expansion of Nuvaxovid COVID-19 Vaccine in Adolescents

Strategic Insights

— 1 min read

Novavax has announced the submission of a request to the World Health Organization (WHO) to expand the Emergency Use Listing (EUL) of its 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) in adolescents aged 12 through 17. This decision is based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial, which demonstrated 80% clinical efficacy overall. The vaccine has been granted authorization in India, the European Union, Australia, and Japan for the same age group, and is actively under review in other markets.

Key Takeaways:

  • Novavax has submitted a request to the WHO to expand the Emergency Use Listing (EUL) of its Nuvaxovid (NVX-CoV2373) COVID-19 vaccine to adolescents aged 12 through 17.
  • The request is based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial, which demonstrated 80% clinical efficacy overall.
  • The vaccine has been granted authorization in India, the European Union, Australia, and Japan for the same age group, and is actively under review in other markets.
  • Preliminary safety data from the trial showed the vaccine to be generally well-tolerated, with serious and severe adverse events being low in number and balanced between vaccine and placebo groups.
  • The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise.
  • Nuvaxovid has been granted authorization for adults aged 18 and older by the WHO in December 2021.

Statistics:

  • 2500 adolescents aged 12 through 17 years have been enrolled in the Phase 3 PREVENT-19 trial across 73 sites in the U.S.
  • The vaccine demonstrated 80% clinical efficacy overall during the trial.
  • 2,247 adolescents aged 12 through 17 years were included in the pediatric expansion of the Phase 3 PREVENT-19 trial.
  • The vaccine has been granted authorization in 4 markets: India, the European Union, Australia, and Japan.
  • The WHO previously granted EUL for Nuvaxovid in adults aged 18 and older in December 2021.

Sources:

  • Novavax
  • World Health Organization
  • U.S. Food and Drug Administration
  • India Ministry of Health and Family Welfare
  • European Medicines Agency
  • Therapeutic Goods Administration (Australia)
  • Japan Ministry of Health, Labour and Welfare

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