Novavax COVID vaccine Nuvaxovid gets provisional nod in New Zealand for adolescents aged 12 through 17

"We are pleased to offer a protein-based COVID-19 vaccine choice as a primary series to New Zealanders aged 12 and older and as a booster for adults 18 and older," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Providing Nuvaxovid now for adolescents may help increase vaccination rates amidst rising cases of COVID-19."

Nuvaxovid (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19

The provisional approval was based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the pediatric expansion, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.

Preliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated.

In the 12 through 17 year-old population, the Novavax COVID-19 vaccine has been granted authorization in India, the European Union, Australia, Japan, and Thailand, and is actively under review in other markets.

New Zealand previously granted provisional approval for Nuvaxovid in adults aged 18 and older in February 2022 and for use as a booster in July 2022. Novavax' sponsor in Australia and New Zealand is Biocelect Pty. Ltd.