Takeda's first COVID-19 vaccine approved in Japan for primary and booster immunization

April 23, 2022 / eMedClub News / -- On April 19, 2022, Takeda announced that it has obtained a license from the Japanese Ministry of Health, Labour and Welfare (MHLW) to manufacture and market Nuvaxovid
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Nuvaxovid is a novel recombinant protein-based COVID-19 vaccine for primary and booster immunizations in people 18 years of age and older
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Nuvaxovid (called NVX-CoV2373 outside Japan and TAK-019 inside Japan) is the first protein vaccine approved for use in Japan
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NVX-CoV2373 was developed by Novavax and was first approved for marketing in the EU in December 2021
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In August 2020, Takeda introduced its development, production and commercialization rights in Japan
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According to the press release, Takeda expects to produce more than 250 million doses of the COVID-19 vaccine annually
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The vaccine is an antigen derived from the new coronavirus spike protein and is used in conjunction with Matrix-M adjuvant (saponin-based adjuvant) to enhance the immune response and the production of neutralizing antibodies in the human body
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NVX-CoV2373 has a total of two doses, with a 21-day interval between vaccinations.
It can be stored in an environment of 2-8 degrees Celsius, which is easier to store and transport, and is beneficial to low- and middle-income countries
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About Matrix-M™ Adjuvant Novavax's patented saponin Matrix-M™ adjuvant has shown potent and well-tolerated effects by stimulating antigen-presenting cells to enter the injection site and enhancing antigen presentation in regional lymph nodes, enhancing immune responses
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About the TAK-019 Clinical Trial This placebo-controlled Phase 1/2 study in Japan evaluated the safety and immunogenicity of two TAK-019 vaccinations administered 21 days apart
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On February 24, 2021, the first of 200 subjects aged 20 and older was dosed in Japan, each assigned to receive either placebo or 0.
5 ml doses of TAK- 019
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Subjects were followed for 12 months after the second dose of investigational product
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About NVX-CoV2373 Phase 3 Trials NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials
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PREVENT-19, a trial conducted in the United States and Mexico, enrolled nearly 30,000 participants aged 18 years and older, with an overall efficacy rate of 90.
4%
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It was designed as a 2:1 randomized, placebo-controlled, observer-blind study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373
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The primary endpoint of PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 and after the second dose at baseline in seronegative (for SARS-CoV-2) adult subjects Onset for at least 7 days
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Statistical success criteria included a lower limit of 95% CI > 30%
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The secondary endpoint was prevention of PCR-confirmed, symptomatic moderate or severe COVID-19
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Volunteers who had not previously been infected with SARS-CoV-2 were assessed at least seven days after the second study vaccination
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In both studies, it was generally well tolerated and elicited a strong antibody response after the second dose
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The full results of the trial were published in the New England Journal of Medicine (NEJM)
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A trial conducted in the United Kingdom, with 14,039 subjects aged 18 years and over, was designed as a randomized, placebo-controlled, observer-blinded study with an overall efficacy of 89.
7%
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The primary endpoint is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 and seronegative (for SARS-CoV-2) adult subjects at baseline for at least 7 days after the second study vaccination day sickness
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The full results of the trial are published in NEJM
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About Novavax Novavax, Inc.
is a biotechnology company that contributes to the improvement of global health by discovering, developing and commercializing innovative vaccines to prevent serious infectious diseases
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The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to meet pressing global health needs
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The company's COVID-19 vaccine, NVX-CoV2373, has received conditional authorization from multiple regulatory agencies around the world, including the European Commission and the World Health Organization
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The vaccine is also under scrutiny from multiple regulatory agencies around the world
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In addition to the COVID-19 vaccine, Novavax is currently evaluating a COVID seasonal influenza combination vaccine, which combines NVX-CoV2373 and NanoFlu, its quadrivalent influenza research candidate, in a Phase 1/2 clinical trial
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These vaccine candidates incorporate Novavax's proprietary saponin-based Matrix-M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies
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Novavax said it expects to start a larger Phase 2 trial by the end of this year, and a vaccine could be ready to roll out by the end of 2023
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References: 1.
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