Two rotavirus vaccines, Rotarix and RotaTeq, are in widespread use globally for the prevention of rotavirus gastroenteritis in young infants. WHO recommends the inclusion of rotavirus vaccine in all country immunization programs. Their use has resulted in reductions of infant diarrheal deaths, hospitalizations and incidence of rotavirus gastroenteritis.1 2 Thus even in countries where mortality rates for rotavirus gastroenteritis are low, there is a substantial health benefit associated with vaccination. 3 4
An increased risk of intussusception has been found in multiple countries for both vaccines following the first and second dose of the vaccine series (2 doses with Rotarix and 3 doses with RotaTeq), especially within the first 7 days after vaccination. However, the benefits of prevention of rotavirus gastroenteritis have continued to be judged to outweigh risks associated with vaccination, including the risk of intussusception.
In France, a preliminary review of adverse event data also suggested an overall risk of intussusception following rotavirus vaccination. This risk was in the same range as that observed elsewhere. However, French health authorities reported that since rotavirus vaccines had been introduced, they identified two deaths temporally related to intussusception. One was an infant who died at home without receiving medical care 7 days following the first dose of rotavirus vaccine. The other infant death followed a third dose of vaccine. So far, the third dose has not been associated with an increased risk in published studies. As the third dose is usually administered at an age of highest incidence of intussusception, this association is more likely to be a coincidental event.
Death from intussusception following rotavirus vaccine underscores the importance of close monitoring of infants and prompt medical care for signs and symptoms of intussusception any time. This is irrespective of the vaccine product administered. If recognized and treated early, intussusception generally has a good outcome and is rarely fatal. Risks of adverse immunization outcomes due to intussusception can be reduced by early evaluation and treatment of children with symptoms consistent with intussusception.
Based on its reviews over the past several years, including the risk of intussusception, GACVS continues to affirm that the safety profile of current rotavirus vaccines is acceptable, with the benefits of vaccination greatly exceeding risks. The benefits of rotavirus vaccination are particularly important in resource-poor countries where rotavirus disease remains an important cause of mortality among young children.
1 Patel M, Parashar UD, Santosharm M, Richardson V. The rotavirus experience in Mexico: discovery to control. Clin Infect Dis 2013 Feb 15;56(4):548-51
2 Linhares AC, Justino MCA. Rotavirus vaccination in Brazil: effectiveness and health impact seven years post-introduction. Expert Rev Vaccines 2014;13(1):43-57.
3 Rha B, Tate JE, Payne DC, Cortese MM, Lopman BA, Curns AT, Parashar UD. Effectiveness and impact of rotavirus vaccines in the United States – 2006-2012. Expert Rev Vaccines 2014:13(3):365-376.
4 Clark A, Jit M, Andrews N, Atchison C, Edmunds WJ, Sanderson C. Evaluating the potential risks and benefits of infant rotavirus vaccination in England. Vaccine 2014 Jun 17;32(29):3604-10. doi: 10.1016/j.vaccine.2014.04.082. Epub 2014 May 9.