Novavax, a biotechnology focused on vaccines for infectious diseases, has received expanded approval for its Covid-19 vaccine candidate Nuvaxovid in Japan.

Also called NVX-CoV2373, the vaccine was previously approved in Japan, for primary and booster immunisation in individuals aged 18 and above.

Japan’s Ministry of Health, Labour and Welfare (MHLW) has now expanded the previous manufacturing and marketing approval to include adolescents aged 12 through 17.

Novavax has teamed up with Japanese pharmaceutical company Takeda to develop, manufacture, and distribute Nuvaxovid in the country.

Novavax president and chief executive officer Stanley C Erck said: “We are pleased to work with Takeda to offer Nuvaxovid™, a protein-based vaccine, to adolescents in Japan.

“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.”

In a separate development, Novavax received expanded approval from Australia’s Therapeutic Goods Agency (TGA) for provisional registration of Nuvaxovid.

Nuvaxovid was previously approved in Australia, both as a primary series and booster dose, for active immunisation in people aged 18 years of age and above.

With the expanded approval, the company’s Covid-19 vaccine is allowed for active immunisation in adolescents aged 12 through 17.

Novavax president and chief executive officer Stanley C Erck said: “Today’s provisional registration of Nuvaxovid for adolescents is timely with Australia’s current winter surge of Covid-19 and the return to schools.

“We are committed to reducing the burden of Covid-19 and believe that our vaccine, developed using an innovative approach to traditional technology, may help increase the adolescent vaccination rate.”

The expanded approval in Japan and Australia was supported by positive safety, immunogenicity, and efficacy data from the ongoing Phase 3 PREVENT-19 trial.

The Phase 3 trial enrolled 2,247 adolescents, aged 12 through 17 years, across 73 sites in the US.

In the study, Nuvaxovid achieved the primary effectiveness endpoint and showed an overall clinical efficacy of 80%, while the Delta variant was predominantly circulating in the US.

The vaccine has been authorised in this population, in the European Union (EU), India, Japan and Australia, and is being actively reviewed in various other markets, said Novavax.