The two-dose vaccine is 90.4% effective overall, The Associated Press reported, which is similar to the efficacy rates for the Pfizer and Moderna COVID-19 vaccines.
“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines,” Stanley Erck, the president and CEO of Novavax, said in a statement.
“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine … to a world that is still in great need of vaccines,” he said.
The clinical trial enrolled 29,960 participants across 119 locations in the U.S. and Mexico to evaluate the vaccine’s efficacy and safety, as well as the kind of immune response it brings. Two-thirds of people in the study received two doses of the vaccine, spaced 21 days apart.
There were 77 COVID-19 cases among the participants, with 14 in the vaccine group, all of whom had only mild symptoms. Among the 63 cases in the placebo group, 10 were moderate COVID-19, while four had severe COVID-19.
Novavax’s vaccine provided 100% protection against moderate and severe COVID-19, as well as 93% efficacy against major variants of concern and 91% efficacy in high-risk groups such as adults over age 65, the company said
The side effects were mostly mild, with pain at the site of the shot, fatigue, headache, and muscle pain being the most common. There were no reports of unusual blood clots or heart problems, Erck told the AP.
Novavax intends to file for authorizations from the FDA and European agencies in September and plans to produce 100 million doses per month by that time, according to the news release. More analyses will be submitted to peer-reviewed journals for publication. The company is also beginning to test the vaccine in ages 12-18.
The vaccine, which can be stored in regular refrigerators and is easy to transport, is expected to play a major role in vaccine supply worldwide, the AP reported. More than half of the U.S. population has received at least one vaccine dose, but less than 1% of people in developing countries have gotten a vaccine. Novavax has committed to supply the U.S. with 110 million doses during the next year and 1.1 billion doses to developing countries.
“Many of our first doses will go to … low- and middle-income countries, and that was the goal to begin with,” Erck told the AP.
“I think there’s room for many more vaccines because we’re going to be dealing with this virus for years, if not decades,” Paul Offit, MD, a professor at the University of Pennsylvania and a member of the FDA’s vaccine advisory panel, told the newspaper.