Study Analyzes the Safety of DTaP Vaccine as Reported to National Data System

A study that reviewed U.S. reports of adverse events involving DTaP vaccine over a 19-year period found no new or unexpected safety issues. The study, “Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis(DTaP) Vaccines,” will be published in the July 2018 issue of Pediatrics (online June 4). Researchers analyzed reports made to the U.S. Vaccine Adverse Event Reporting System (VAERS), from Jan. 1, 1991, through Dec. 31, 2016. Researchers analyzed 50,157 reports involving DTaP vaccines, which protect against diphtheria, tetanus and pertussis, and are given as a 5-dose series to children at ages 2 months; 4 months; 6 months; between 15 and 18 months; and between ages 4 and 6. Of the total adverse reports, 11.2 percent (5,627) were coded as serious. In nearly 88 percent of all cases, DTaP vaccines were reported as being administered concurrently with one or more other vaccines. The most frequent adverse effects, described as non-serious, were reddening, swelling or warmth of the skin at the injection site. The authors found disproportionate reporting for some non-serious vaccination errors and suggest better education of vaccine providers on specific indications for each of the DTaP vaccines.

Editor’s Note: A related commentary, “Safer pertussis vaccines for children: Trading efficacy forsafety,” will be published in the same Pediatrics issue and online June 4.

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The American Academy of Pediatrics is an organization of 66,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults. For more information, visit www.aap.org and follow us on Twitter @AmerAcadPeds