Novavax Files NDA for Approval of COVID-19 Vaccine in Japan

Biotechnology company Novavax, Inc. (NASDAQ: NVAX) revealed on Wednesday that its partner Takeda Pharmaceutical Company Limited has submitted a New Drug Application (NDA) to the Ministry of Health, Labour, and Welfare (MHLW) in Japan for its COVID-19 vaccine.

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Following the news, shares of the company had risen more than 3% in the pre-market trading session at the time of writing.

Novavax’s recombinant nanoparticle COVID-19 vaccine with Matrix-M adjuvant, named TAK-019 in Japan and NVX-CoV2373 outside Japan, is the first-of-its-kind protein-based COVID-19 vaccine to be submitted under an NDA in Japan.

The companies hope to manufacture TAK-019 at Takeda’s units in Japan, with the support of the MHLW. Notably, distribution is likely to begin in early 2022, pending regulatory approval.

Details of the Application

The NDA submission is supported by data from the interim analysis of Takeda’s ongoing Phase 1/2 immunogenicity and safety clinical trial of NVX-CoV2373 in Japan. The data demonstrated that the vaccine has a well-tolerated profile, with a strong immune response.

Positive safety and efficacy data from Novavax’s two pivotal Phase 3 trials also supported the application. Notably, the PREVENT-19 trial included 30,000 participants in the U.S. and Mexico, while the other trial included 15,000 participants in the U.K.

CEO Comments

Novavax CEO Stanley C. Erck commented, “Today’s submission marks further progress in our quest to ensure broad global access to our protein-based COVID-19 vaccine. Our partnership with Takeda reflects our shared commitment to tireless collaboration to deliver a COVID-19 vaccine, built on a well-understood vaccine platform.”

Prior Approvals

Novavax and Serum Institute of India Pvt. Ltd. (SII) has recently received Emergency Use Authorization (EUA) for the vaccine in Indonesia and the Philippines, and filed for the same in India, along with Emergency Use Listing (EUL) with the World Health Organization (WHO).

Additionally, Novavax has completed rolling submissions for the authorization of the Novavax vaccine with regulatory agencies in the United Kingdom, European Union, Canada, Singapore, New Zealand, Australia, United Arab Emirates, and with the WHO. Furthermore, submission of the complete package to the U.S. Food and Drug Administration (FDA) is expected by the end of the year.

Wall Street’s Take

On December 7, B.Riley Financial analyst Mayank Mamtani reiterated a Buy rating on the stock based on his belief that the company will experience a durable COVID vaccine market and the need for vaccine boosters at least annually.

The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on 2 Buys and 1 Hold. The average Novavax price target of $222 implies 23.68% upside potential. Shares have gained 48.5% over the past year.

Bloggers Weigh In

TipRanks data shows that financial blogger opinions are 70% Bullish on NVAX, compared to a sector average of 69%.