Key result
Live, oral human rotavirus vaccine (RV1) showed no increased risk for most outcomes, but convulsion incidence was elevated following Dose 1 compared to concurrent IPV (IRR 2.07; 95% CI 1.27-3.38).
Why the study?
Post-licensure safety monitoring of live, oral human rotavirus vaccine (RV1) was required to compare incidence rates of adverse events versus inactivated poliovirus vaccine (IPV) recipients.
Does the live, oral human rotavirus vaccine (RV1) increase the risk of adverse events such as intussusception, LRTI, Kawasaki disease, convulsion, or mortality compared to IPV in pediatric patients?
Cohort (n=390,659)
Yes
Does the live, oral human rotavirus vaccine (RV1) increase the risk of adverse events such as intussusception, LRTI, Kawasaki disease, convulsion, or mortality compared to IPV in pediatric patients?
The live, oral human rotavirus vaccine (RV1) demonstrates a favorable safety profile with no increased risk of intussusception, LRTI, Kawasaki disease, or mortality, though a potential signal for convulsions after the first dose requires further monitoring.
Reassuring safety for most outcomes supports ongoing RV1 use; convulsion signal after dose 1 is hypothesis-generating and requires confirmation.
As part of a regulatory commitment for post-licensure safety monitoring of live, oral human rotavirus vaccine (RV1), this study compared the incidence rates (IR) of intussusception, acute lower respiratory tract infection (LRTI) hospitalization, Kawasaki disease, convulsion, and mortality in RV1 recipients versus inactivated poliovirus vaccine (IPV) recipients in concurrent (cIPV) and recent historical (hIPV) comparison cohorts. Vaccine recipients were identified in 2 claims databases from August 2008 - June 2013 (RV1 and cIPV) and January 2004 - July 2008 (hIPV). Outcomes were identified in the 0-59 days following the first 2 vaccine doses. Intussusception, Kawasaki disease, and convulsion were confirmed via medical record review. Outcome IRs were estimated. Incidence rate ratios (IRRs) were obtained from Poisson regression models. A post-hoc self-controlled case series (SCCS) analysis compared convulsion IRs in a 0-7 day post-vaccination period to a 15-30 day post-vaccination period. We identified 57,931 RV1, 173,384 cIPV, and 159,344 hIPV recipients. No increased risks for intussusception, LRTI, Kawasaki disease, or mortality were observed. The convulsion IRRs were elevated following RV1 Dose 1 (cIPV: 2.07, 95% confidence interval [CI]: 1.27 - 3.38; hIPV: 2.05, 95% CI: 1.24 - 3.38), a finding which is inconclusive as it was observed in only one of the claims databases. The IRR following RV1 Dose 1 in the SCCS analysis lacked precision (2.40, 95% CI: 0.73 - 7.86). No increased convulsion risk was observed following RV1 Dose 2. Overall, this study supports the favorable safety profile of RV1. Continued monitoring for safety signals through routine surveillance is needed to ensure vaccine safety.
No takes yet. Share an insight, caveat, or question.
Hoffman et al. (2018) conducted a cohort in Post-licensure vaccine safety (n=390,659). Live, oral human rotavirus vaccine (RV1) vs. Inactivated poliovirus vaccine (IPV) recipients (concurrent and historical) was evaluated on Convulsion following Dose 1 (IRR 2.07, 95% CI 1.27 - 3.38). Live, oral human rotavirus vaccine (RV1) showed no increased risk for most outcomes, but convulsion incidence was elevated following Dose 1 compared to concurrent IPV (IRR 2.07; 95% CI 1.27-3.38).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: