USA – FDA to use real-world data to decide on updating vaccines

U.S. officials plan to use data gathered from people who have already been vaccinated against COVID-19 as well as data from ongoing clinical trials to determine when and whether current vaccines need to be updated to address viral variants.

Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, said in a hearing on Wednesday that his agency has already started getting data on vaccine safety from surveillance systems.

Those systems have been set up to gather reports of vaccine side effects from individuals and physicians and are managed in partnership with the FDA and the U.S. Centers for Disease Control and Prevention…