A recent study published in Annals of Internal Medicine, looking at vaccines approved in the U.S. over a 20-year period, found vaccines to be remarkably safe. The study’s authors analyzed safety-related changes to labels among 57 vaccines approved by the Food and Drug Administration from 1996 through 2015. They found 58 safety-related label changes associated with 25 vaccines, a large proportion of which were identified through existing post-marketing surveillance programs and were of limited clinical significance. The most common safety issue triggering label changes was expansion of restrictions for vaccine use in certain groups (36%) followed by allergies (22%).

The study findings come as the U.S. observes National Immunization Awareness Month. Additional information to help providers and others communicate with patients and families about the importance of vaccination is available through the PIDS Vaccine Education Program. The free program’s second online module focuses on vaccine safety, including the vaccine development process, how recommendations are made, and how safety is monitored. A recently launched fourth module, providing methods and tips for communicating about vaccines, is also available. The program includes the newly updated 2020 Vaccine Handbook App.