Story at a glance
- On Monday, Novavax released positive results from clinical trials.
- Its vaccine candidate showed 90.4 percent efficacy against COVID-19 infection, including 100 percent efficacy against moderate and severe disease.
- By the end of September 2021, the company is slated to produce 100 million doses.
On Monday, drug maker Novavax released new results from its COVID-19 vaccine candidate’s performance in clinical trials — and it’s good news.
Its vaccine was found to be 90.4 percent effective overall in preventing COVID-19 infection. It exhibited a similar 93-percent efficacy against known "Variants of Concern and Variants of Interest." And the vaccine is 100 percent effective in protecting against "moderate and severe disease.”
Novavax officials confirmed that variants that are not labeled "of concern" are more closely related to the original strain, leading researchers to believe the Novavax vaccine candidate is nearly 100 percent effective against the original COVID-19 strain.
"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, Novavax’s president 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."
Its clinical trials featured 29,960 participants within the U.S. and Mexico. Novavax officials said one goal of its study was to recruit a diverse representative population to better gauge vaccine outcomes.
Noted in a report documenting the clinical trials procedures in Mexico, Novavax researchers said that enrollment prioritization was given to Black, Native American and Latino participants. These demographics were more severely affected by COVID-19 infections compared to their white American counterparts.
Researchers aimed for an overall enrollment of at least 15 percent Black Americans, 10 to 20 percent Latino Americans, and roughly 1 to 2 percent Native Americans.
The Novavax vaccine is 91 percent effective in high-risk populations.
Scientists used a placebo-controlled experiment in a randomized study to gauge vaccine effectiveness and safety.
The next step for Novavax is to submit its research and findings to the U.S. Food and Drug Administration for regulatory approval, which officials say it intends to do.
If given the green light, Novavax said it is prepared to produce a capacity of 100 million vaccine doses per month by the end of the third quarter, or roughly toward the end of September.
By the fourth quarter of 2021, it stands to manufacture 150 million doses per month.
"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," said Gregory Glenn, President of Research and Development. "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."