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Vaccines

Novavax Nuvaxovid™ COVID-19 Vaccine Receives Expanded Provisional Approval in New Zealand

Strategic Insights

— 2 min read

Novavax's Nuvaxovid™ COVID-19 vaccine has been granted expanded provisional approval by New Zealand's Medsafe for use as a first or second booster dose in adults aged 18 and older. This approval makes Nuvaxovid the first and only protein-based COVID-19 vaccine available in New Zealand. The decision is based on data from various clinical trials, including Phase 2 trials in Australia and South Africa, as well as the UK-sponsored COV-BOOST trial. The vaccine has shown to induce a significant antibody response and is considered a strong option for those aged 18 and older, particularly during the winter months.

Key Takeaways:

  • Novavax Nuvaxovid™ COVID-19 vaccine has been granted expanded provisional approval in New Zealand for use as a first or second booster dose in adults aged 18 and older.
  • The approval makes Nuvaxovid the first and only protein-based COVID-19 vaccine available in New Zealand.
  • The decision is based on data from Phase 2 trials in Australia and South Africa, as well as the UK-sponsored COV-BOOST trial.
  • The vaccine showed a significant antibody response in the COV-BOOST trial when used as a heterologous third booster dose.
  • Local and systemic reactions had a median duration of approximately two days after the booster dose.
  • Incidence of Grade 3 or higher events remained relatively low after the booster dose.
  • Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently and were balanced between vaccine and placebo groups.
  • Nuvaxovid is provisionally registered in Australia and approved in Japan, and is actively under review in other markets.
  • Novavax's sponsor in Australia and New Zealand is Biocelect Pty. Ltd.
  • European Medicines Agency (EMA) and the US Centers for Disease Control and Prevention (CDC) have granted emergency use authorization for Nuvaxovid.
  • The vaccine is part of the Novavax-sponsored Phase 2 trials, where a single booster dose was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid.

Statistics:

  • 2,600 people participated in the Phase 2 trial in Australia.
  • The trial showed that the third dose of Nuvaxovid produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials.
  • 34,000 participants were enrolled in the COV-BOOST trial.
  • The trial showed that Nuvaxovid induced a significant antibody response when used as a heterologous third booster dose.
  • 98.8% of participants in the COV-BOOST trial showed an immune response after the booster dose.
  • The median duration of local and systemic reactions after the booster dose was approximately two days.
  • The incidence of Grade 3 or higher events remained relatively low after the booster dose.

Sources:

  • Novavax press release, August 17, 2022.
  • Medsafe COVID-19 Vaccine Status of Applications.
  • Medsafe Information for Prescribers/Consumers.
  • Novavax global authorization website.
  • COV-BOOST trial results.

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