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RotaFlash: GACVS review of intussusception data provides reassurance that the benefits of rotavirus vaccines still outweigh risks

17 March 2014

WHO recommendation for universal rotavirus vaccination remains unchanged

The World Health Organization’s (WHO) Global Advisory Committee on Vaccine Safety (GACVS) recently reviewed new intussusception data to update its assessment of the risk of intussusception related to RotaTeq®, and Rotarix®. GACVS provides independent, scientifically rigorous advice to WHO on global and regional vaccine safety issues that could potentially impact national immunization programs. Intussusception, a serious and potentially life-threatening condition that occurs when the intestine becomes blocked, is most common in infants between two and nine months of age. Because intussusception has been associated with rotavirus vaccines in the past, post-marketing surveillance of rotavirus vaccines has included monitoring for intussusception.

GACVS last reviewed the safety profile of rotavirus vaccines in December 2011 and found that both vaccines were safe but had a possible increased risk of intussusception after the first dose of vaccine in some populations. GACVS’s December 2013 safety profile review, which was published February 14, 2014 in the WHO World Epidemiological Record, concluded:

  • Data from both Australia and the United States confirms there is a small risk of intussusception following administration of both licensed rotavirus vaccines, in particular during the first seven days following a first dose, but overall the risk remains small compared to the benefits of preventing the impact of severe diarrhea (hospitalizations and deaths).
  • Estimates of the risk of intussusception due to rotavirus vaccines vary across studies.
  • It is important that rotavirus vaccine introductions across the world are accompanied by active intussusception surveillance together with rotavirus disease surveillance so that the benefits and risks can be determined for each population, as there may be variations in the rates of intussusception.

GACVS’s conclusions are similar to the conclusions reached by the US Advisory Committee on Immunization Practices (ACIP), which met on June 20, 2013 to review preliminary data from Australia and the United States. Read PATH’s RotaFlash on the ACIP review here.

US data shows low risk of intussusception

In January 2014, two of the United States intussusception studies were published in the New England Journal of Medicine, "Intussusception Risk after Rotavirus Vaccination in US Infants" and "Risk of Intussusception after Monovalent Rotavirus Vaccination." Preliminary data from the studies were included in the GACVS and ACIP reviews. The studies reported data from the CDC’s Vaccine Safety Datalink (VSD) and the FDA’s Post-Licensure Rapid Immunization Safety Monitoring (PRISM) systems, respectively:

The VSD study showed a significant association of Rotarix® with intussusception (an excess of 5.3 cases of intussusception per 100,000 infants after two doses) but no significant increase in the risk of intussusception after vaccination with RotaTeq®.

The PRISM study did not have enough participants to be able to detect risk after vaccination with Rotarix® but did identify a significant association of RotaTeq® with intussusception (an excess of 1.5 cases of intussusception per 100,000 infants given their first dose during a 21-day risk window).

The studies support the conclusion that there is a small but real risk of intussusception after receipt of either currently licensed rotavirus vaccine, Rotarix® or RotaTeq®. It appears to happen in approximately 1 to 5 cases per 100,000 babies who get vaccinated. This is in addition to the approximate 2,000 cases of intussusception that are not related to vaccination that occur in infants each year in the US.

In an editorial that accompanied the published studies, "Rotavirus Vaccines – Balancing Intussusception Risks and Health Benefits," Dr. Roger Glass, Director of the Fogarty International Center and Associate Director for International Research, NIH, and Dr. Umesh Parashar, Leader of Enteric Viruses Epidemiology Team, Division of Viral Diseases, CDC noted that many questions related to intussusception remain to be resolved, including whether the findings from the United States and other middle- and high-income and countries will extend to low-income countries where currently licensed rotavirus vaccines have been found to be less efficacious. They conclude, however, that “despite lower efficacy in low-income countries, the public health benefits of rotavirus vaccines in these settings, where the vast majority of deaths from rotavirus occur, are likely to be substantial and outweigh a small risk of intussusception.”

PATH collaborates on rotavirus vaccine activities with the CDC, WHO, UNICEF, vaccine manufacturers, and countries around the world. RotaFlash is funded by the GAVI Alliance.

For information on rotavirus disease and vaccines and to access the RotaFlash archives, please visit the website. For information on diarrheal disease, please visit DefeatDD’s website. For information on the GAVI Alliance’s support for rotavirus vaccine introduction, please click here.
Please click RotaFlash for the full e-newsletter available online.

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