Novavax on Monday announced that its Covid vaccine — NVX-CoV2373 —demonstrated 100% protection against moderate and severe disease with 90.4% efficacy overall in the phase-3 trial.
- 93% efficacy against predominantly circulating Variants of Concern and Variants of Interest
- 91% efficacy in high-risk populations
- 100% efficacy against variants “not considered Variants of Concern/Interest”
- All COVID-19 hospitalizations/death occurred in the placebo group
- Company to host investor conference call today at 8:30 am ET
“NVX-CoV2373, recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial,” Novavax said in a press statement on June 14.
It said the study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.
Novavax CEO and President Stanley C. Erck said that Novavax was 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,” he said.
The company said that it “intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.”
“Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 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” it said.
“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.
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