Novavax partner gets Japenese nod for Nuvaxovid

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.

NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.