Novavax Announces Approval of Nuvaxovidtm COVID-19 Vaccine for Primary and Booster Immunization in Japan

• Nuvaxovid is the first protein-based COVID-19 vaccine approved for use in adults aged 18 and older in Japan
• Approval is first in the world for NVX-CoV2373 that includes both primary and booster vaccination

GAITHERSBURG, Md., April 19, 2022 /CNW/ -- 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 Nuvaxovidtm 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-Mtm 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.

For additional safety information, including the full Summary of Product Characteristics with Package Leaflet, please visit www.NovavaxCovidVaccine.com.

About TAK-019 Clinical Trial

This placebo-controlled Phase 1/2 study in Japan evaluated the safety and immunogenicity of two vaccinations of TAK-019 given 21 days apart. The first of 200 subjects aged 20 years and older was dosed in Japan on February 24, 2021, and each participant was assigned to receive a placebo or a 0.5 ml dose of TAK-019 at both vaccinations. Participants Subjects were followed for 12 months after the second dose of investigational product.

About the NVX-CoV2373 Phase 3 trials

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.

PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000 participants aged 18 years and older, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM).

A trial conducted in the U.K. with 14,039 participants aged 18 years and older was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.

About Matrix-Mtm Adjuvant

Novavax' patented saponin-based Matrix-Mtm adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company's COVID-19 vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu, its quadrivalent influenza investigational vaccine candidate. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-Mtm adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on LinkedIn.

Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373 and NanoFlu, its COVID-seasonal influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, additional worldwide authorizations of NVX-CoV2373, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety and intended utilization of NVX-CoV2373, and the expected distribution of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

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SOURCE Novavax, Inc.