Novavax COVID-19 Vaccine Receives Provisional Approval

New Zealand medicines regulator Medsafe has granted provisional approval of the Novavax COVID-19 vaccine, Nuvaxovid, for adults 18 years and over.

“The Medsafe team has worked tirelessly to ensure that COVID-19 vaccine applications are prioritised and urgently reviewed, while still maintaining the same scrutiny that all medicine applications undergo before they can be approved,” says Chris James, Group Manager, Medsafe.

Medsafe has now approved COVID-19 vaccines that use three different technologies.

“Medsafe only approves a vaccine or medicine for use in New Zealand once it is satisfied that it has met acceptable standards for quality, safety and efficacy,” says Mr James.

Medsafe’s provisional approval is one step in a process. Ministers will consider advice from the Ministry of Health about whether to use Nuvaxovid vaccine in New Zealand. Guidance will also be provided by the COVID-19 Vaccine Science and Technical Advisory Group.

Additional information

• The process for approving COVID-19 vaccines - click for description.
• The sponsor of the approval application is Biocelect New Zealand Ltd.
• Other regulators have also approved Nuvaxovid vaccine, including the European Medicines Agency and the Australian Therapeutic Goods Administration.
• An agreement has been made with Novavax to purchase 10.72 million doses of Nuvaxovid COVID-19 vaccine.
• Nuvaxovid is a two-dose protein subunit vaccine.
• Following CV-TAG advice and pending Cabinet’s decision to use, officials are working with Novavax to establish delivery options as early as Q1 2022
• New Zealand may seek to donate some doses of Novavax to support global vaccination efforts (which could include through COVAX), though this decision has not been made yet.

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