Pediatric Vaccine Safety Monitoring

Marcia L. Buck, PharmD, FCCP, FPPAG


Pediatr Pharm. 2015;21(7) 

In This Article


With the recent release of a 9-valent human papilloma virus (HPV) vaccine and two new meningococcal serogroup B vaccines, the number of vaccines available for use in the pediatric population continues to grow. Establishing the safety profile of new vaccines does not end with premarketing clinical trials. Ongoing assessment is necessary to determine the incidence of adverse events associated with a vaccine, identify rare adverse events not seen during testing, and to rule out those adverse events that may be temporally but not causally related to vaccine administration. Vaccine safety data are available through multiple sources, including post-marketing epidemiologic surveillance studies, case reports in the medical literature, and manufacturer-based adverse effect registries, as well as databases such as the Vaccine Adverse Event Reporting System (VAERS), the National Vaccine Injury Compensation Program (VICP), and the Vaccine Safety Datalink (VSD).