FDA lifts clinical hold on Novavax' combo COVID-19 flu jab study

The US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug (IND) application for the COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates, US vaccines developer Novavax (Nasdaq: NVAX) revealed yesterday.

The FDA has cleared the company to begin enrolling the planned Phase III trial following the determination that Novavax satisfactorily addressed all clinical hold issues. Novavax said it 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 Dr Robert Walker, 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 III trial as soon as possible,” he added.