Novavax asks the FDA to authorize its COVID-19 vaccine candidate


Shares of Novavax Inc. NVAX, +13.00% rallied 10.0% in trading on Monday after the company said it filed for authorization of its experimental COVID-19 shot in the U.S. Novavax’s COVID-19 vaccine candidate is protein-based, meaning it’s a different type of vaccine than the mRNA shots developed by BioNTech SE BNTX, +6.08% /Pfizer Inc. PFE, -3.02% and Moderna Inc. MRNA, +6.18% or the Johnson & Johnson JNJ, +0.29% viral vector vaccine. Novavax said it is seeking authorization for its two-dose vaccine in adults, based on two clinical studies. One Phase 3 trial assessing the vaccine in about 15,000 adults in the U.K. reported an 89.7% efficacy rate against infection with the virus, according to research published in the New England Journal of Medicine in September. A second trial that enrolled about 30,000 adults in the U.S. and Mexico found that shots produced an efficacy rate of 92.6% against any variants of concern or interest. That study was also published in the New England Journal of Medicine, in December. Some of the vaccine’s side effects include headache, pain at the injection site, and fatigue. The vaccine requires two shots, spaced 21 days apart. Novavax’s stock has tumbled 59.2% over the past year, while the broader S&P 500 SPX, +1.89% is up 17.0%.

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