Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that New Zealand's Medsafe has granted provisional approval of NVX-CoV2373, Novavax' COVID-19 vaccine (adjuvanted), for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine will be supplied to New Zealand under the brand name Nuvaxovid™.

"The provisional approval of Nuvaxovid by Medsafe will enable Novavax to deliver the first protein-based COVID-19 vaccine to New Zealand," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank Medsafe for its thorough review and, as the pandemic continues to evolve, we remain committed to supporting New Zealand and the world in the fight against COVID-19."

The provisional approval by Medsafe is based on evaluation of the quality, safety, and efficacy data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19 enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in The New England Journal of Medicine (NEJM); and a trial with almost 15,000 participants in the U.K., the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated efficacy and a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.

Novavax and the New Zealand Government previously announced an advance purchase agreement (APA) for 10.7 million doses of Novavax' COVID-19 vaccine. This provisional approval leverages Novavax' manufacturing partnership with Serum Institute of India (SII), the world's largest vaccine manufacturer by volume, which will supply initial doses to New Zealand. The provisional approval will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.

Novavax received conditional marketing authorization for NVX-CoV2373 in the European Union, emergency use listing (EUL) from the World Health Organization (WHO), and was granted provisional registration by the Therapeutic Goods Administration in Australia, among others. The vaccine is also currently under review by multiple regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA).

For more information on Nuvaxovid, including the approved New Zealand Datasheet and approved Consumer Medicine Information and Important Safety Information, or to request additional information, please visit the following websites:

• Novavax global authorization website
• COVID-19 Vaccine Status of Applications
• Information for Prescribers/Consumers Search  

The brand name Nuvaxovid™ has not yet been authorized for use in the U.S. by the FDA. Novavax' sponsor in Australia and New Zealand is Biocelect Pty. Ltd. 

Provisional Approval of Nuvaxovid^™ in New Zealand
Medsafe has granted provisional approval of Nuvaxovid™ COVID-19 Vaccine (adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. 

Important Safety Information

• Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
• Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid.
• Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
• Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection.
• Nuvaxovid should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
• The efficacy of Nuvaxovid may be lower in immunosuppressed individuals.
• Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
• The effects with Nuvaxovid may temporarily affect the ability to drive or use machines.
• Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients.
• The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

For additional safety information, please visit www.NovavaxCovidVaccine.com for the full New Zealand Datasheet and New Zealand Consumer Medicine Information. Information regarding adverse event reporting instructions can also be found at www.NovavaxCovidVaccine.com.

Information on this vaccine is also available on the New Zealand Medsafe website at www.medsafe.govt.nz.