Novavax Announces Approval of Nuvaxovid™ COVID-19 Vaccine for Primary and Booster Immunization in Japan
GAITHERSBURG, Md.: Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, has 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.
Authorization in the U.S.
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.
Important Safety Information
- Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
- Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid.
- Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
- Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
- Nuvaxovid should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
- The efficacy of Nuvaxovid may be lower in immunosuppressed individuals.
- Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
- The effects with Nuvaxovid may temporarily affect the ability to drive or use machines.
- Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients.
- The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.
