- Novavax shares climbed as much as 9% on Monday following the biotech firm's upbeat data about its potential COVID-19 vaccine.
- The study of nearly 30,000 people in the US and Mexico produced an overall efficacy rate of 90.4%.
- The company is aiming to file for FDA approval in the third quarter of this year.
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Novavax shares climbed as much as 9% on Monday after the company said a late-stage study of its experimental COVID-19 vaccine showed efficacy of more than 90% in nearly 30,000 people. The results move the company closer to seeking authorization for its use in the US.
The company said it plans on filing for regulatory approval of NVX-CoV2373 with the Food and Drug Administration in the third quarter and upon receiving clearance it would remain on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter. It also foresees hitting manufacturing capacity of 150 million doses per month by the end of the fourth quarter.
Novavax traded 2% higher as of 9:55 a.m. in New York, and has now gained more than 90% year-to-date.
Novavax's phase 3 study of 29,960 participants in 119 sites in the US and Mexico overall efficacy of 90.4% after observing 77 COVID-19 cases among the participants, with 63 in the placebo group and 14 in the vaccine group. It said the potential vaccine demonstrated 100% protection against moderate and severe disease.
The vaccine is administered in two doses and preliminary safety data from the Prevent-19 study showed the potential product to be generally well-tolerated.
"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, M.D., president of Research and Development at Novavax, in a statement.
The company said further analyses of the trial are ongoing and that data will be submitted to peer-review journals for publication. It also said the placebo-controlled portion of its study of 2,248 adolescents ranging from 12 years to less than 18 years of age continues.
In May, the company's shares slid to the $121 range after Novavax said it was delaying seeking approval for its COVID-19 vaccine from three regulators, including the Food and Drug Administration, because of manufacturing issues.