Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that its partner, Takeda,  received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare for its Nuvaxovid™ Intramuscular Injection (Nuvaxovid), Novavax' novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. Nuvaxovid (NVX-CoV2373 outside Japan and TAK-019 in Japan) is the first protein-based vaccine to be authorized for use in Japan.

Stanley C. Erck, President and Chief Executive Officer, Novavax said: "Together with Takeda, we are pleased to be able to offer the first protein-based COVID-19 vaccine to adults aged 18 and over in Japan. This approval is significant because it includes both primary and booster vaccination. Our partnership with Takeda demonstrates our ongoing commitment to offer another option as public health officials consider the need for boosters and annual revaccination."

The approval is based on Takeda's New Drug Application submission which included positive interim results from a Phase 1/2 study conducted by Takeda in Japan and several studies conducted by Novavax, including two pivotal Phase 3 clinical trials in the U.K. and U.S. and Mexico and Phase 1/2 studies in Australia and the U.S. Additional safety and efficacy data were submitted for booster immunization review, which included a Phase 2 study conducted by Novavax in South Africa for a single vaccination given six months after primary immunization.

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. Takeda, the Marketing Authorization Holder for Nuvaxovid in Japan, will begin distribution of doses purchased by the Government of Japan as soon as possible.