Novavax on Monday announced positive results of Phase 3 of its coronavirus vaccine trial, reporting 90.4 percent efficacy overall against the Chinese coronavirus, 93 percent efficacy against what it described as “predominantly circulating Variants of Concern and Variants of Interest,” and 100 percent protection against “moderate and severe disease,” according to the company.
The vaccine, described as a protein-based coronavirus 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,” according to the results of a trial touted by the company.
The study involved 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.”
“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 [Chinese coronavirus] vaccines,” Stanley C. Erck, President and Chief Executive Officer, said in a statement, adding that the results “reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection.”
Per the press release:
The company 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.
“PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile,” Gregory M. Glenn, M.D., President of Research and Development, Novavax, said in a statement.
“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,” he continued, expressing hope that their vaccine would serve as a “critical part of the solution to COVID-19.”
The news comes as the Biden administration continues to push for Americans to get vaccinated, hoping to reach 70 percent by July 4th.
According to the U.S. Centers for Disease Control and Prevention’s (CDC) June 14 data, 174,234,573 people in the United States have received at least one dose of a coronavirus vaccine, representing 52.5 percent of the U.S. population. Nearly 145 million are now considered “fully” vaccinated, representing 43.7 percent of the country’s population. The vast majority of those fully vaccinated opted for the non-traditional mRNA vaccines via Pfizer or Moderna.
The CDC is holding an emergency meeting June 18 to discuss rare cases of heart inflammation disorders among young people after receiving the mRNA vaccines.
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