The Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine received expanded manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for primary immunization to prevent COVID-19 in adolescents aged 12 through 17. Novavax has partnered with Takeda to develop, manufacture, and distribute Nuvaxovid in Japan.
"We are pleased to work with Takeda to offer Nuvaxovid™, a protein-based vaccine, to adolescents in Japan," said Stanley C. Erck, President, and Chief Executive Officer, Novavax. "As COVID-19 continues to surge in the country, this approval offers another option to help protect the health of the people of Japan and help bolster the vaccination rate."
The expanded approval was based on data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, and effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the trial, 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 trial showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No new safety signal was observed through the placebo-controlled portion of the study.
Novavax licensed and transferred its manufacturing technologies and is supplying the Matrix-M™ adjuvant to enable Takeda to manufacture the vaccine at its Hikari facility.
In the 12 through 17-year-old population, Nuvaxovid has been granted conditional authorization in the European Union, emergency use authorization in India, and provisional registration in Australia, and is actively under review in other markets.
The MHLW previously approved Nuvaxovid for individuals aged 18 and older in April 2022.
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