Rotavirus vaccination and intussusception – Science, surveillance, and safety: A review of evidence and recommendations for future research priorities in low and middle income countries

ABSTRACT

As of January 2016, 80 countries have introduced rotavirus vaccines into their national immunization programs. Many have documented significant declines in rotavirus-specific and all-cause diarrheal illnesses following vaccine introduction. Two globally licensed rotavirus vaccines have been associated with a low risk of intussusception in several studies. In July 2014, the Rotavirus Organization of Technical Allies Council convened a meeting of research and advocacy organizations, public health experts, funders, and vaccine manufacturers to discuss post-marketing intussusception surveillance and rotavirus vaccine impact data. Meeting objectives were to evaluate updated data, identify and prioritize research gaps, discuss best practices for intussusception monitoring in lower-income settings and risk communication, and provide insight to country-level stakeholders on best practices for intussusception monitoring and communication. Meeting participants agreed with statements from expert bodies that the benefits of vaccination with currently available rotavirus vaccines outweigh the low risk of vaccination-associated intussusception. However, further research is needed to better understand the relationship of intussusception to wild-type rotavirus and rotavirus vaccines and delineate potential etiologies and mechanisms of intussusception. Additionally, evidence from research and post-licensure evaluations should be presented with evidence of the benefits of vaccination to best inform policymakers deciding on vaccine introduction or vaccination program sustainability.

KEYWORDS:

• infants
• intussusception
• rotavirus
• rotavirus vaccine
• vaccine

Disclosure of potential conflicts of interest

No potential conflicts of interest were disclosed.

Acknowledgments

We would like to thank all meeting participants, particularly the following individuals for their presentations and review of this report: Remon Abu-Elyazeed, Narendra K. Arora, Margaret E. Conner, Maria Elkin, Roger Glass, Michelle Goveia, Harry Greenberg, Jacob John, Hope Johnson, Marc Laforce, Margaret Rennels, Debora Sandiford, Molly Sauer, Mandeep Singh Dhingra, Trina Stout, Rose Weeks, Marietta Vazquez, and Melinda Wharton. Murdoch Childrens Research Institute is supported by a Victorian Government Operational Infrastructure Support Program.

Notes

^a This workshop was organized by the ROTA Council and held on 23-24 July 2014 in Washington, DC. It included invited representatives from the following institutions, organizations, and companies: Baylor University, Houston, TX, USA; Christian Medical College, Vellore, India; INCLEN Trust, New Delhi, India; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Stanford University, Stanford, CA, USA; University of Melbourne, Melbourne, Australia; Yale University, New Haven, CT, USA; the Centers for Disease Control and Prevention, Atlanta, GA, USA; the Bill and Melinda Gates Foundation, Seattle, WA, USA; Gavi, the Vaccine Alliance, Geneva, Switzerland; the National Institutes of Health, Bethesda, MD, USA; PATH, Seattle, WA, and Washington, DC, USA; the Sabin Vaccine Institute, Washington, DC, USA; the World Health Organization, Geneva, Switzerland; GlaxoSmithKline Biologicals, Rixensart, Belgium; Merck Vaccines, West Point, PA, USA; Serum Institute of India, Pune, India; and Shantha Biotechnics, Hyderabad, India.