FDA awards Bexsero vaccine Breakthrough Therapy designation
Anna MazarakisBexsero, the meningitis B vaccine created by Novartis that was offered to all undergraduate students over the course of the past four months, has received Breakthrough Therapy designation in the United States from the Food and Drug Administration. The drug received the new designation on Monday, which will allow for an expedited review, after an announcement last week that the company was filing an application for FDA review in hopes of obtaining a license. According to a press release on Novartis’ website, the Breakthrough Therapy designation “is intended to expedite the development and review of new medicines that treat serious or life-threatening conditions.” The FDA declined to comment and Novartis declined to be interviewed for this article. The Centers for Disease Control and Prevention, which sponsored the emergency use authorization of the vaccine at the University, has not shared any of the data collected from the vaccine clinics with the FDA, CDC spokesperson Jason McDonald said. “What [the] CDC did during the vaccination clinics at Princeton was monitor for adverse events,” McDonald said.