Novavax says received formal PMC request from FDA related to COVID vaccine

Novavax (NVAX) issued the following update on the FDA BLA for the company’s COVID-19 vaccine: “We believe that our Biologics License Application is approvable based on conversations with the U.S. Food and Drug Administration, as of our Prescription Drug User Fee Act – PDUFA – date of April 1 and through today. We have recently received formal communication from the FDA in the form of an information request for a postmarketing commitment to generate additional clinical data. We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible.”