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Novavax NVAX announced that patient enrollment has begun in phase I/II study to evaluate a combination of its COVID-19 vaccine candidate NVX-CoV2373 and seasonal influenza vaccine candidate, NanoFlu.
The phase I/II study will evaluate the safety and immunogenicity of both NVX-CoV2373 and NanoFlu in a single formulation along with Novavax's patented saponin-based Matrix-M adjuvant to boost immune response.
While separately both the vaccines have already demonstrated encouraging results in phase III clinical studies, Novavax announced positive data from a preclinical study evaluating the combination vaccine in May 2021. Data from the preclinical study demonstrated that the combined COVID-19 and seasonal influenza vaccines achieved positive immune responses against both the indications.
Shares of Novavax have rallied 139.3% so far this year in comparison with the industry’s 1.2% growth.
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Novavax’s NVX-CoV2373 and NanoFly are both currently in late-stage development. In June, the company announced data from the phase III PREVENT-19 study, which evaluated NVX-CoV2373 in the United States and Mexico. The study met its primary endpoint by demonstrating an overall vaccine efficacy of 90.4%. The vaccine also provided 100% protection against moderate and severe disease - a key secondary endpoint.
The company also announced positive top-line data from a pivotal phase III study, which demonstrated both the efficacy and safety of NanoFlu in March 2020. The study met all the primary goals and achieved statistical significance in key secondary endpoints.
We remind investors that Novavax has not filed regulatory applications with the FDA for either of the vaccines. The company plans to apply to the FDA for emergency use authorization for NVX-CoV2373 in fourth-quarter 2021.
If approved, NVX-CoV2373 will face stiff competition from COVID vaccines developed by AstraZeneca AZN, Moderna MRNA and Pfizer PFE/BioNTech, which are already in the market. Pfizer’s COVID vaccine became the first to receive full approval in the United States in August 2021. Meanwhile, Moderna has also filed regulatory applications seeking full approval for its COVID vaccine in the United States.
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Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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