Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception

Abstract

Introduction Rotavirus (RV) is the most common cause of acute gastroenteritis in children <5 years of age worldwide, and vaccination reduces the disease burden. Evidence from postmarketing surveillance studies suggested an increased risk of intussusception (IS) in infants post-RV vaccination. An overall positive benefit–risk balance for the human RV vaccine (HRV) Rotarix (GlaxoSmithKline [GSK], Belgium) has been established and recent findings indicate an indirect effect of reduced IS over the long term. Objective The aim of this study was to discuss spontaneous data from the GSK worldwide safety database on IS post- Rotarix administration. Methods The database was reviewed for all spontaneous IS cases from 2004 to 2020. Additionally, an observed versus expected (O/E) analysis was done for adverse events attributed to IS. Data were reviewed as overall worldwide and stratified by region (Europe/USA/Japan) and dose. Results A male predominance of IS patients was observed, consistent with earlier reports. The most frequently reported events in confirmed IS cases (Brighton Collaboration Working Group [BCWG] level 1) with time to onset ≤ 30 days post-vaccination were vomiting (55.8%), haematochezia (47.2%), and crying (21.1%). The observations from the IS spontaneous cases review and results of the O/E analysis are consistent with the known IS safety profile of RV vaccines: a transient increased incidence of IS post-vaccination (primarily in Europe/Japan/worldwide), mostly within 7 days postdose 1. Conclusion Since the outcomes of early IS management are favourable over delayed management, healthcare professionals should inform parents about the importance of seeking immediate medical advice in case of unusual behaviour of the vaccinated infant. GSK continues to monitor the IS risk post- Rotarix administration through routine pharmacovigilance activities. Graphic abstract Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01141-4.

Attitudes and Beliefs towards Rotavirus Vaccination in a Sample of Italian Women: A Cross-Sectional Study

“…In facts, mothers disagreed with natural immunity but more frequently thought that vaccination was more harmful compared to vaccination (mothers: 2 IQR 1–4 vs. non-mothers 2 IQR 1–3). As regards vaccine adverse events, several studies demonstrate the safety of the rotavirus vaccine [ 16 , 17 ], in particular in relation to intestinal intussusception, the most feared complication [ 18 ]. These results were in line with previous literature: Marchetti et al performed a web listening analysis of online discussions about rotavirus [ 19 ].…”