Novavax Inc NVAX shares are trading lower Thursday following reports that the U.S. Food and Drug Administration's decision on the company's COVID-19 vaccine could be delayed to review manufacturing changes.
According to a CNBC report, citing an agency spokesperson, the FDA needs to review recent adjustments to Novavax's manufacturing process before it can authorize the company's vaccine.
On Tuesday, a committee of independent FDA vaccine advisors voted to recommend Novavax's COVID-19 vaccine for Emergency Use Authorization (EUA). The FDA Vaccines and Related Biological Products Advisory Committee voted 21 to 0, with one abstention to recommend EUA for NVX-CoV2373 in individuals aged 18 years and older.
The FDA considers the recommendations of the independent advisory committee when making decisions on EUA. The Novavax COVID-19 vaccine has been authorized for use in more than 40 countries. It would be the fourth COVID-19 vaccine to receive authorization in the U.S. if approved.
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NVAX Price Action: Novavax shares have traded between $41.10 and $277.79 over a 52-week period.
THe stock was down 5.41% at $47.40 at press time, according to data from Benzinga Pro.
Photo: Jernej Furman from Flickr.
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