Novavax says its COVID-19 vaccine demonstrates 90% efficacy, 100% protection against moderate, severe disease

Biotech firm Novavax on Monday announced that its COVID-19 vaccine is 93 per cent efficacy against predominantly circulating variants of concern and variants of interest.

"COVID19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial," Novavax tweeted.

While releasing its Phase 3 trial details, the company said that Novavax NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100 per cent protection against moderate and severe disease, 90.4 per cent efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial.

The Biotech firm plans to file for authorisation with the Food and Drug Administration in the third quarter of 2021.

"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 Chief Executive Officer, 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," Erck added.

NVX-CoV2373 showed success among "high-risk" populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0% (95% CI: 83.6, 95.0), with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group, the company said in its release

The company has assured to manufacture 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.

"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," Glenn said.