Full results from the Phase III trial of Novavax’s proposed COVID-19 vaccine demonstrated the drug’s efficacy in preventing mild, moderate, and severe illness.
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Full results from the Phase III trial of Novavax‘s proposed COVID-19 vaccine demonstrated the drug’s efficacy in preventing mild, moderate, and severe illness.
In the New England Journal of Medicine paper, the COVID-19 vaccine NVX-CoV2373 delivered 100% protection against moderate and severe disease, 93.2% efficacy against widely circulating virus variants and 90.4% efficacy against the virus of any severity. NVX-CoV2372 is a recombinant protein nanoparticle vaccine that works by preventing polymerase chain reaction (PCR)-confirmed infection 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 the Matrix-M adjuvant on some 30,000 participants aged at least 18 years old from 113 sites across Mexico and the U.S.
Matrix-M is Novavax’s patented saponin-based adjuvant, which works by stimulating the entry of antigen-presenting cells into the injection site and boosting immune response by enhancing the antigen presentation in local lymph nodes.
The latest findings are consistent with the initial results shared in June, which showed a 93% efficacy in 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 of the deaths and hospitalizations recorded during the study period happened among those in the placebo group.
Back then, the company said that it would immediately file for regulatory authorizations on completion of the final phases of the trial to meet chemistry, manufacturing, and controls (CMC) requirements. Novavax is posed to hit a manufacturing capacity of 100 million to 150 million doses every month. Full details of the study, titled “Efficacy and Safety of NVX-CoV2373 in Adults in the U.S. and Mexico,” are available on the NEJM website.
As of this writing, Novavax has filed a New Drug Application (NDA) to Japan’s Ministry of Health, Labour 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 considered for an 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, built on a well-understood vaccine platform,” said Stanley C. Erck, president and chief executive officer of Novavax, said in a statement.
Both Novavax and Takeda aim to start 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.
