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COVID-19

Novavax's Nuvaxovid COVID-19 Vaccine Approved as Booster in European Union

Strategic Insights

— 2 min read

The European Commission has granted an expanded conditional marketing authorization (CMA) for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) as a homologous and heterologous booster for active immunization against COVID-19 in adults aged 18 and older. This approval follows a recommendation made by the European Medicines Agency's Committee for Medicinal Products for Human Use on September 1, 2022. Nuvaxovid, a protein-based vaccine, has already been authorized in Japan, Australia, and New Zealand as a booster in adults aged 18 and older and is under review in other markets. The vaccine has also been approved in the EU as a primary series and booster, making it the first protein-based vaccine to offer both primary series and booster options in the region.

Key Takeaways:

  • Novavax's Nuvaxovid COVID-19 vaccine has been approved as a homologous and heterologous booster for active immunization against COVID-19 in adults aged 18 and older in the European Union (EU).
  • The vaccine was granted an expanded conditional marketing authorization (CMA) by the European Commission following a recommendation made by the European Medicines Agency's Committee for Medicinal Products for Human Use on September 1, 2022.
  • Nuvaxovid has already been authorized in Japan, Australia, and New Zealand as a booster in adults aged 18 and older and is under review in other markets.
  • The vaccine has been approved as a primary series and booster in the EU, making it the first protein-based vaccine to offer both primary series and booster options in the region.
  • The approval was based on data from Novavax' Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial.
  • Nuvaxovid showed increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials when used as a booster dose.
  • The vaccine also induced a robust antibody response when used as a heterologous third booster dose in the COV-BOOST trial.
  • Local and systemic reactions were generally short-lived, with a median duration of approximately two days, and the incidence of Grade 3 or higher events remained relatively low.

Statistics:

  • Novavax' Phase 2 trial involved testing the vaccine in Australia and South Africa (Novavax, Inc.)
  • The UK-sponsored COV-BOOST trial involved 3,738 participants who received the vaccine as a third dose after two doses of an approved COVID-19 vaccine (Lawrence, et al., 2022)
  • The vaccine showed increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials when used as a booster dose (Novavax, Inc.)
  • The vaccine induced a robust antibody response when used as a heterologous third booster dose in the COV-BOOST trial (Lawrence, et al., 2022)
  • Local and systemic reactions were generally short-lived, with a median duration of approximately two days (Novavax, Inc.)
  • The incidence of Grade 3 or higher events remained relatively low (Novavax, Inc.)

Sources:

  • Novavax, Inc. (2022). Novavax Announces Expanded Conditional Marketing Authorization for Nuvaxovid in the European Union as a Homologous and Heterologous Booster.
  • Lawrence, J. H., et al. (2022). Efficacy and safety of NVX-CoV2373, an adjuvanted SARS-CoV-2 vaccine. The Lancet. Vol. 399, Issue 10319, pp. 1349-1359. doi: 10.1016/S0140-6736(22)00229-5

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