FDA To Release New Vaccine Approval Framework Amid Questions Over COVID-19 Shots

The Washington Post (5/15, Roubein) reports FDA Commissioner Marty Makary “said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines.” Makary said Thursday during a conference of the Food and Drug Law Institute, “We want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry how is this going to be received.” HHS recently said “that all new vaccines will be required to undergo placebo testing.” Earlier this year, the Trump Administration “sought for drug manufacturer Novavax to commit to conducting a new clinical trial on its coronavirus vaccine after it gets approved.” Makary’s comments come a week ahead of the FDA’s Advisory Committee on Immunization Practices meeting “to make recommendations on selecting the formula vaccine makers should use to update their shots to target the strain of the virus currently circulating in the country.”