The two-dose vaccine has been shown to be 100% effective in preventing moderate to severe disease and 93% effective against some variants of concern.
The biotechnology firm said on June 14 that its COVID-19 vaccine is 90.4% safe and effective.
These data were obtained during the third phase of a clinical trial involving nearly 30,000 participants from the United States and Mexico.
The two-dose vaccine has been shown to be 100% effective in preventing moderate to severe disease and 93% effective against some variants, Novavax said. The company said it plans to apply to the Food and Drug Administration in the third quarter of this year.
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The late-stage trial “confirms that NVX-CoV2373 offers an encouraging tolerability and safety profile,” said Dr. Gregory Glenn, president of research and development at Novavax, in a press 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.”
The study assessed 77 confirmed COVID infections among 29,960 study participants. Novavax noted that the placebo group observed 63 cases of coronavirus against 14 cases in the group receiving two doses of the vaccine. This led to an estimate of the effectiveness of the vaccine at 90.4%.
According to the company, the vaccine is well tolerated. The most common side effects were fatigue, headache, muscle pain, and pain at the injection site, which usually lasted no more than two to three days.
All COVID hospitalizations during the trial occurred in the placebo group, the company said.
Novavax said the vaccine was effective against some variant, including the Alpha variant, first discovered in the UK. About 65% of the cases included were “variants of concern,” the company said.
It was previously reported that seven people in Japan develop heart complications after the second dose of the Pfizer vaccine.
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