Novavax Files NDA in Japan Following Results of Phase III COVID Vaccine Trial

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The full results of the Phase III trial of NovavaxThe proposed COVID-19 vaccine has demonstrated the drug’s effectiveness in preventing mild, moderate and severe illness.

In New England Journal of Medicine article, COVID-19 vaccine NVX-CoV2373 delivered 100% protection against moderate and severe disease, 93.2% efficacy against widely circulating viral variants and 90.4% efficacy against viruses of any severity. NVX-CoV2372 is a recombinant protein nanoparticle vaccine that works by preventing infection confirmed by the polymerase chain reaction (PCR) with an onset of at least seven days after the second dose.

The PREVENT-19 phase III trial evaluated the efficacy, safety and immunogenicity of NVX-CoV2373 when used with Matrix-M adjuvant in approximately 30,000 participants aged 18 years or older. from 113 sites across Mexico and the United States

Matrix-M is Novavax’s patented saponin adjuvant, which works by stimulating the entry of antigen-presenting cells into the injection site and stimulating the immune response by improving antigen presentation in the injection site. local lymph nodes.

The latest results are consistent with the first results shared in June, which showed 93% efficacy in the predominant variants and variants of interest, 92% efficacy in high-risk participants, and 100% efficacy in other variants that are “not variants of concern.” “. All deaths and hospitalizations recorded during the study period occurred among people in the placebo group.

At the time, the company said it would immediately file for regulatory clearance after the final stages of testing to meet chemistry, manufacturing and control (CMC) requirements. Novavax is expected to achieve a manufacturing capacity of 100 to 150 million doses each month. Full details of the study, titled “Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico“, are available on the NEJM website.

At the time of this writing, Novavax has filed a New Drug Request (NDP) to the Japanese Ministry of Health, Labor and Welfare (MHLW) through its partner Takeda Pharmaceutical Company Limited. In Japan, NVX-CoV2373 will be known as TAK-019 and is the first protein-based COVID-19 vaccine to be considered for NDA in the country.

“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, based on a well-understood vaccine platform, ”said Stanley C. Erck, President and CEO of Novavax, in a statement.

Both Novavax and Takeda aim to begin distributing the vaccine in early 2022. Additional CMC requirements will be submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) during the NDA period.

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