Novavax to Seek Regulatory Approval After COVID-19 Vaccine Displays 90% Efficacy in US Trial

by Rajaneesh K. Gopinath
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June 14th, 2021 – Earlier today, Novavax announced that its COVID-19 vaccine, NVX-CoV2373 met the primary endpoint in the Phase 3, PREVENT-19 trial conducted in the US and Mexico.

Results from the 29,960 participant study demonstrated that the recombinant nanoparticle protein-based vaccine registered an overall efficacy of 90.4% and conferred 100% protection against moderate and severe disease. Earlier, in a Phase 3 trial conducted in the UK, the vaccine had demonstrated a 96.4% efficacy against mild, moderate, and severe disease caused by the original COVID-19 strain.

“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, President and CEO of Novavax.

“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.”


Fourth Vaccine Option

With these positive results, the Maryland-based company plans to submit an application for FDA’s emergency approval in the third quarter of this year. If approved, the company would be heading towards its goal of producing 100 million and 150 million doses per month in the third and fourth quarters of 2021, respectively.

Additionally, the approval would give the US a fourth vaccine option behind Pfizer/BioNTech, Moderna, and J&J’s vaccines. Since the US government has already procured enough doses from the three manufacturers to vaccinate its population, the FDA might urge Novavax to apply for full approval.

Just days earlier, the FDA rejected the EUA of Covaxin, India’s indigenous COVID-19 vaccine manufactured by Bharat Biotech. Instead, the agency asked Ocugen, Bharat Biotech’s US partner, to pursue full approval.

Nevertheless, with the increasing COVID-19 cases caused by variants, NVX-CoV2373 could very well prove to be a booster shot to the public. Novavax mentioned that the efficacy endpoints of the PREVENT-19 trial were accrued from January 25 through April 30, 2021, when COVID-19 cases in the US were dominated by the Alpha (B.1.1.7) variant, first identified in the UK. Other strains, including Variants of Interest (VoI) and Variants of Concern (VoC), were also on the rise.

“PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Our vaccine will be a critical part of the solution to COVID-19, and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government.”

Besides, Novavax’s vaccine could also help meet the increasing demand for COVID-19 jabs in other countries. “Many of our first doses will go to … low- and middle-income countries, and that was the goal to begin with,” Stanley Erck told The Associated Press.

Related Article: COVID-19: Rise in UK Cases Trigger Global Concerns Over “Highly Infectious” Delta Variant


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