Rotavirus vaccination and short-term risk of adverse events in US infants

J Bradley Layton1,2, Anne M Butler3,4, Catherine A Panozzo5

  • 1Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Research Triangle Park, North Carolina.

Insights

Rotavirus vaccination (RV) in infants showed no increased risk for intussusception or other serious adverse events. A slight increase in otitis media risk was observed, particularly with the RV1 formulation.

Area of Science:

  • Pediatric Vaccinology
  • Public Health
  • Epidemiology

Background:

  • Rotavirus vaccines (RV) are crucial for preventing severe rotavirus gastroenteritis in infants.
  • Understanding the short-term safety profile of RV, including different formulations, is essential for public health recommendations.

Purpose of the Study:

  • To evaluate the short-term risk of adverse events following rotavirus vaccination in infants.
  • To compare adverse event risks between pentavalent (RV5) and monovalent (RV1) rotavirus vaccine formulations.

Main Methods:

  • A cohort study of US newborns (2006-2014) receiving diphtheria-tetanus-pertussis vaccine (DTaP) was conducted.
  • Infants were monitored for 30 days post-vaccination for intussusception, gastrointestinal events, seizures, Kawasaki disease, thrombocytopenia, otitis media, and hospitalizations.
  • Cox proportional hazards models were used to compare risks between DTaP+RV and DTaP alone, and between RV5 and RV1.

Main Results:

  • Over 1 million DTaP doses were analyzed, with 79.2% receiving concurrent RV (94.1% RV5).
  • Absolute risks of serious outcomes were very low.
  • No consistent increased risk of intussusception or other adverse events was found with RV+DTaP compared to DTaP alone, except for a small increase in otitis media after dose 2.
  • The increased otitis media risk was less pronounced with RV5 compared to RV1.

Conclusions:

  • Rotavirus vaccination is not associated with an increased risk of intussusception or other major adverse events.
  • A potential small increase in otitis media risk may be associated with rotavirus vaccination, particularly the RV1 formulation.
  • These findings support the overall safety of rotavirus vaccines in infants.
Abstract

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