Skip to Main Content
Skip Nav Destination

Study confirms safety of DTaP :

June 4, 2018

New research from federal authorities confirms the safety of diphtheria, tetanus and acellular pertussis (DTaP) vaccines.

The Academy and Centers for Disease Control and Prevention (CDC) recommend children receive five doses of DTaP starting at 2 months of age.

DTaP vaccines won federal approval in 1991 and eventually replaced a whole cell pertussis-containing vaccine that had been linked to severe local reactions and febrile seizures, according to the study “Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines” (Moro PL, et al. Pediatrics. June 4, 2018,

Researchers from the CDC and the Food and Drug Administration used data from the Vaccine Adverse Event Reporting System to look at safety from the 1991 licensure of the vaccine through 2016.

During that time, there were 50,157 reports, of which about 88% occurred in people getting other vaccines at the same time. Authors noted the data could not prove a vaccination caused the adverse reactions reported.

The most common issues reported were injection site erythema (25%), pyrexia (20%) and injection site swelling (15%), consistent with pre-licensure studies.

About 11% of the reports were classified as serious events/deaths and most commonly reported pyrexia, vomiting or irritability. Seizures/convulsions, which had been a concern when using the previous vaccine, were fourth on the list, making up about 17% of serious reports.

Deaths, which made up 1.7% of the total reports, largely were attributed to sudden infant death syndrome (SIDS), but the authors noted the “large body of evidence showing that vaccination is not causally associated with SIDS.”

“It would not be uncommon to observe a coincidental close temporal relationship between vaccination and SIDS as this condition peaks at a time when children receive a relatively large number of recommended vaccinations,” authors wrote.

They noted that overall, they “did not identify any new or unexpected safety issue” and would continue to monitor the vaccine.

For a related commentary, visit

Close Modal

or Create an Account

Close Modal
Close Modal