Business
New Zealand's Medsafe Grants Provisional Approval for Novavax' COVID-19 Vaccine
Nuvaxovid™ is the first protein-based COVID-19 vaccine to receive provisional approval for distribution in New Zealand GAITHERSBURG, Md., Feb. 3, 2022
About this update from Novavax, Inc.
[{"type":"text","content":"Nuvaxovid™ is the first protein-based COVID-19 vaccine to receive provisional approval for distribution in New Zealand\n\n\nGAITHERSBURG, Md., Feb. 3, 2022 /PRNewswire/ -- 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™.\n\"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.\"\nThe 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.\nNovavax 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...