Ask the Experts: Rotavirus: Vaccine Safety

In the RotaTeq clinical trials in the first week after any dose vaccine recipients had a small but statistically significant increased rate of diarrhea (18.1% in the RotaTeq group, 15.3% in the placebo group) and vomiting (11.6% in the RotaTeq group, 9.9% in the placebo group). During the 42-day period following any dose, statistically significantly greater rates of diarrhea, vomiting, otitis media, nasopharyngitis and bronchospasm occurred in RotaTeq recipients compared with placebo recipients.

In the Rotarix clinical trials, in the first week after vaccination, Grade 3 (i.e., those that prevented normal everyday activities) cough or runny nose occurred at a slightly but statistically higher rate in the Rotarix group (3.6 %) compared with placebo group (3.2%). During the 31-day period after vaccination, these unsolicited adverse events occurred at a statistically higher incidence among vaccine recipients: irritability (11.4% in Rotarix group, 8.7% in placebo group) and flatulence (2.2% in Rotarix group, 1.3% in placebo group).

In clinical trials of both vaccines the occurrence of intussusception was studied very carefully; see the separate question and answer on this topic.

Large pre-licensure clinical trials of both RotaTeq and Rotarix did not find an increased risk for intussusception among vaccine recipients. A large post-licensure study of more than 1.2 million rotavirus vaccine recipients found a very small increased risk of intussusception (1 to 1.5 additional cases of intussusception per 100,000 vaccinated infants) in the 7 to 21 days following the first dose. No increased risk of intussusception was found after the second or third doses. CDC and the Food and Drug Administration (FDA) continue to believe that the benefits of rotavirus vaccination outweigh the risks associated with vaccination and that routine vaccination of infants should continue.

A study conducted by the CDC Vaccine Safety Datalink (VSD) between May 2006 to February 2010 found no increased risk of intussusception following vaccination with RotaTeq. However, the study indicated an increased risk of intussusception following dose 1 and dose 2 of Rotarix. CDC estimates that there is a small increased risk of intussusception, usually within the first week after dose 1 or dose 2 of rotavirus vaccine, resulting in one additional case for every 20,000 to 100,000 U.S. infants who receive the vaccine.