As millions get shots, FDA struggles to get safety monitoring system running

FDA says a planned system for tracking adverse reactions to COVID-19 vaccines, dubbed the BEST system, will be unable to analyze safety data for weeks or months. Federal regulators are currently relying on various programs that are less effective because of small sample size, a lack of critical data, or other issues. FDA says BEST is still in its developmental stages. Ashish K. Jha, MD, dean of the Brown University School of Public Health, says regarding COVID-19 vaccines: “It’s critical to track, because it will help build confidence.” The federal government is now primarily relying on a 30-year-old safety monitoring system that FDA shares with CDC, called the Vaccine Adverse Event Reporting System (VAERS). VAERS relies on self-reported cases from patients and health care providers. Regulators also use a new smartphone app that people who get vaccinated can use to voluntarily report problems. In addition, CDC oversees the Vaccine Safety Datalink, a collaboration between the agency and nine health systems that taps vaccine data and the electronic medical records of roughly 12 million patients. Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins University, and a former federal vaccine official, observes: “It’s great for routine stuff, but when it comes to safety surveillance, it’s all about size. The bigger it is, the faster you get an answer. ”