The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its standalone flu vaccines after a safety concern was found unrelated to the combination shot,

Novavax can move forward with a trial for its combined Covid-19 and influenza vaccine after regulators lifted a clinical hold. The Gaithersburg, Md., vaccine developer said Monday that the U.S. Food and Drug Administration had removed the clinical hold on its investigational new drug application for its combined vaccine and its standalone flu vaccine candidates.

Monday said the Food and Drug Administration or FDA has removed the clinical hold on its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. Novavax shares were up more than 13 percent in pre-market.

Novavax (NVAX) shares surge 12% as FDA lifts clinical hold on COVID-19-Influenza Combination vaccine candidates.