In September 2015, Pediatrics published the work of Alison Kawai, ScD, SM and Grace Lee, MD, MPH of the Center for Healthcare Research in Pediatrics at DPM in the “Online First” section of the website. The objective of the study was to examine whether there was an increased risk of febrile seizures (FS) after 2010–2011 trivalent inactivated influenza vaccine (TIV), or concomitant 13-valent pneumococcal conjugate vaccine (PCV13), in a U.S. population of children aged 6 months to 5 years.
During the 2010-2011 influenza season, two complementary systems detected potentially increased risks of FS: the Vaccine Adverse Event Reporting System, co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA); and the Vaccine Safety Datalink (VSD), an active surveillance system led by the CDC and 8 medical care organizations. The study population of 1.9 million children was derived from the Post-Licensure Rapid Immunization Safety Monitoring Program (PRISM), a component of the FDA-sponsored Mini-Sentinel Pilot Initiative.
The investigators found no statistically significant associations between TIV and risk of FS in their unadjusted or adjusted models. Adjusted for age and seasonality, PCV13 was significantly associated with FS, but not when further adjusting for concomitant TIV and diphtheria tetanus acellular pertussis (DTaP) containing vaccines. Same-day TIV and PCV13 vaccination was not associated with excess risk of FS when compared with separate-day vaccination. Read more about the study here.