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No Adverse Events Found in DTaP Vaccine Study
Pediatrics; ePub 2018 Jun 4; Moro, Perez-Vilar, et al
No new or unexpected adverse events were detected in a recent study designed to assess the safety of currently licensed diphtheria-tetanus-acellular pertussis (DTaP) vaccines in the US by using data from the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. The observed disproportionate reporting for some non-serious vaccination errors calls for better education of vaccine providers on the specific indications for each of the DTaP vaccines. Researchers searched VAERS for US reports of DTaP vaccinations occurring from January 1, 1991, through December 31, 2016, and received by March 17, 2017. They reviewed available medical records for all death reports and a random sample of reports classified as non-death serious. They found:
- VAERS received 50,157 reports after DTaP vaccination; 43,984 (87.7%) of them reported concomitant administration of other vaccines, and 5,627 (11.2%) were serious.
- Median age at vaccination was 19 months (interquartile range 35 months).
- The most frequently reported events were injection site erythema (12,695; 25.3%), pyrexia (9,913; 19.8%), injection site swelling (7,542; 15.0%), erythema (5,599; 11.2%), and injection site warmth (4,793; 9.6%).
Moro PL, Perez-Vilar S, Lewis P, Brant-Genevier M, Kamiya H, Cano M. Safety surveillance of diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccines. [Published online ahead of print June 4, 2018]. Pediatrics. doi:10.1542/peds.2017-4171.
VAERS is a passive surveillance system for side effects of vaccines. Created in 1990 and co-administered by the CDC and FDA, it collects spontaneous reports of side effects of vaccines from providers and other sources. The findings in this 19-year sophisticated analysis of DTaP vaccines is reassuring. Most side effects were local (injection site redness, swelling, and warmth) and no new associations were found. However, while VAERS is a useful tool in monitoring vaccine side effects, the value is limited to correlation and not causation.—Sarah Rawstron, MB, BS, FAAP, FIDSA; Pediatric Residency Program Director, The Brooklyn Hospital Center, NY; Clinical Associate Professor, Icahn School of Medicine, Mount Sinai, NY.