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Rotavirus Vaccination & Risk of Adverse Events

Paediatr Perinat Epidemiol; ePub 2018 Jul 26; Layton, et al

Vaccination with rotavirus vaccine (RV) was not consistent with increased risk of intussusception or adverse events in US infants, expect potentially for a small increased risk of otitis media, a recent study found. The study evaluated the short-term risk of adverse events associated with RV in infants, overall and by vaccine formulation (3-dose pentavalent; RV5; 2-dose monovalent, RV1). Researchers identified US newborns with commercial insurance during 2006-2014 receiving a diphtheria-tetanus-pertussis vaccine (DTaP) dose and assessed if RV was administered concurrently. Infants were followed for 30 days after each dose for diagnoses of intussusception, other gastrointestinal events, seizures, Kawasaki disease, thrombocytopenia, otitis media, all-cause emergency department visits, and all-cause hospitalizations. They found:

  • 1,031,431 first DTaP doses, 821,833 second doses, and 615,293 third doses were identified; 79.2% had a concurrent RV, 94.1% of which were RV5.
  • Compared to infants who received DTaP alone, those who received RV+DTaP did not experience consistently increased risk of intussusception (HR, 1.13) or any other outcome expect for otitis media after dose 2 (HR, 1.11).
  • The increased otitis media risk was not as pronounced in RV5 when compared to RV1 (HR, 0.92).

Citation:

Layton JB, Butler AM, Panozzo CA, Brookhart MA. Rotavirus vaccination and short-term risk of adverse events in US infants. [Published online ahead of print July 26, 2018]. Paediatr Perinat Epidemiol. doi:10.1111/ppe.12496.

Commentary:

There was a previous rotavirus vaccine, Rotashield, that was withdrawn in 1999 secondary to concerns with its association with intussusception. With the new rotavirus vaccine, there are very specific time intervals for administration. The hope is that in giving the first dose before 15 weeks and the last dose no later than 32 weeks that it will avoid the time period of lymph tissue growth that could lead to intussusception. This study reinforces that decrease of risk with current practices. — John Russell, MD