Maryland-based Novavax said Monday that its COVID-19 vaccine is 90.4% effective overall in a Phase 3 study conducted in the United States and Mexico, including 93% against predominant variants.
The company said the study of 29,960 participants, which is ongoing, showed the vaccine is 91% against high-risk populations, such as the elderly and those with compromised immune systems.
"Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines," company CEO Stanley C. Erck said in a statement.
"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."
Novavax said it plans to file for regulatory authorizations in the third quarter once its final phases of process qualification needed to meet chemistry, manufacturing and controls requirements are completed.
Once approved, Novavax said it can produce 100 million doses of the vaccine per month and 150 million doses per month by the end of the year.
"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," Dr. Gregory M. Glenn, president ofNovavax's research and development said in a statement.
"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.
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