Novavax Announces Expanded Conditional Marketing Authorization for COVID-19 Vaccine in European Union

Strategic Insights -

Novavax, a biotechnology company, has announced that the European Commission has approved the expanded conditional marketing authorization (CMA) of their COVID-19 vaccine, Nuvaxovid, in the European Union for adolescents aged 12 through 17. This approval follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use on June 23, 2022. Novavax's President and Chief Executive Officer, Stanley C. Erck, expressed his satisfaction with the authorization, stating that the company is pleased to offer the vaccine to adolescents in the EU. The vaccine's development was based on data from the PREVENT-19 trial, which demonstrated 80% clinical efficacy overall.

Key Takeaways:

  • The European Commission has approved the expanded conditional marketing authorization (CMA) of Nuvaxovid, a COVID-19 vaccine, in the European Union for adolescents aged 12 through 17.
  • The approval is based on data from the PREVENT-19 trial, which included 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S.
  • Nuvaxovid achieved 80% clinical efficacy overall at the time of the trial, 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 serious and severe adverse events being low in number and balanced between vaccine and placebo groups.
  • The most common adverse reactions observed in the trial were injection site tenderness/pain, headache, myalgia, fatigue, and malaise.
  • There was no increase in reactogenicity in younger (12 to 17-year-old) adolescents compared to adults.

Statistics:

  • 2,247 adolescents participated in the PREVENT-19 trial.
  • The trial included 73 sites in the U.S.
  • Nuvaxovid achieved 80% clinical efficacy overall.
  • Serious and severe adverse events were low in number, with 24 serious adverse events reported in the vaccine group and 19 in the placebo group.
  • The most common adverse reactions observed were injection site tenderness/pain (25.7%), headache (21.8%), myalgia (17.3%), fatigue (16.2%), and malaise (14.7%).

Sources:

  • [European Commission]
  • [Novavax, Inc.]