Novavax: FDA removes clinical hold on Covid-19/flu combo trial

Novavax (NVAX) announced that the U.S. FDA has removed the clinical hold on Novavax’s Investigational New Drug application for its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. The FDA has cleared the company to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues. Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible. “We thank the FDA for their partnership and thorough review of the additional information provided as part of our response package,” said Robert Walker, MD, Chief Medical Officer, Novavax. “The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine. We plan to start our Phase 3 trial as soon as possible.”