Q+A: Understanding Vaccine Post-Approval Safety Systems

In the U.S., long-standing vaccine safety systems are in place to ensure that vaccine safety is closely monitored at every step, even after a vaccine is approved. These systems include multi-stage clinical trials, ongoing safety studies, regulatory review while a vaccine is being developed, and continuous safety monitoring once a vaccine becomes publicly available. Post-approval monitoring ensures that the vaccine’s benefits continue to outweigh any risks and back up demonstrated safety that was seen during clinical trials.