Lead Author: Yih, et al.
Original date of publication: 02/06/2014
Link: https://www.nejm.org/doi/full/10.1056/NEJMoa1303164
Summary Context
This study admits the increased rate of dangerous adverse events after rotavirus vaccination (the previous rotavirus shot was recalled in 1999), specifically bowel intussusception. This event happened at a rate of 1.5 cases per 100,000 kids vaccinated. It is a life-threatening side effect that usually requires surgery and can result in death.
Comments
This paper in the prestigious New England Journal analyzed the rate of bowel intussusception in children who took the rotavirus vaccine, and found it was associated with a significantly increased risk of the event after the first dose, 9 times more likely. The second dose study was underpowered (not enough data to draw a strong conclusion)
Abstract or Results, Key Passages
“RV5 was associated with approximately 1.5 (95% CI, 0.2 to 3.2) excess cases of intussusception per 100,000 recipients of the first dose. The secondary analysis of RV1 suggested a potential risk, although the study of RV1 was underpowered. “
Keywords: adverse eventsFDA studyIntussusceptionrotarixrotavirusrotavirus vaccine
Full Author List: W. Katherine Yih, Tracy A. Lieu, Martin Kulldorff, David Martin, Cheryl N. McMahill-Walraven, Richard Platt, Nandini Selvam, Ph.D., , Mano Selvan, Grace M. Lee, and Michael Nguyen
