Novavax announced on Monday that its COVID-19 vaccine was found to be over 90% effective overall, and offered 100% protection against moderate and severe disease in a Phase 3 clinical trial. The company said it intends to file for FDA authorization in the third quarter.
"Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines," Stanley C. Erck, Novavax’s president and CEO said in a statement. "These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection. 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."
The Phase 3 PREVENT-19 trial had enrolled nearly 30,000 participants ages 18 and older in the U.S. and Mexico. Data reflected 63 COVID-19 cases reported among the placebo group and 14 in the vaccine group. All cases identified in the vaccine group were classified as mild, while 10 cases in the placebo group were moderate and four were severe.
The vaccine also demonstrated over 93% efficacy against variants of concern and variants of interest that were detected through sequencing of confirmed cases in the trial.
"PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile," Gregory M. Glenn, M.D., president of research and development, said in the news release. "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."
The study noted that no single adverse event term was reported by more than 1% of participants and that the most common local symptoms reported after dose one and dose two was injection site pain described as generally mild to moderate in severity and lasting less than three days. Fatigue, headache and muscle pain were also reported as lasting less than two days.
A trial involving adolescents ages 12-17 is ongoing.
The company said that following approval, it 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."