COMMENTARY

Rotavirus Vaccine and Intussusception: The Latest Data

Frank DeStefano, MD, MPH

Disclosures

October 14, 2013

Editorial Collaboration

Medscape &

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Rotavirus vaccines have greatly reduced the burden of rotavirus disease among infants in the United States. CDC recommends that all infants in the United States receive rotavirus vaccine.

Hello. I am Dr. Frank DeStefano, Director of the Immunization Safety Office at CDC. I am speaking with you as part of the CDC Expert Commentary Series on Medscape.

During the June 2013 meeting of the US Advisory Committee on Immunization Practices (ACIP), CDC scientists presented recent vaccine safety monitoring data for the 2 rotavirus vaccines licensed in the United States: Rotarix® and RotaTeq®. Findings from these postmarketing studies show that there is a small risk for intussusception from these vaccines.

As you know, intussusception is a potentially life-threatening condition in which one segment of the intestine slides into an adjacent segment. This can lead to bowel perforation, infection and, ultimately, the death of bowel tissue.

Intussusception is the most common cause of acute bowel obstruction in infants. Before the introduction of the rotavirus vaccines, there were about 2000 cases annually of intussusception in infants in the United States. In the great majority of cases, the cause is not known.

The data presented to ACIP were collected through 3 vaccine safety monitoring systems conducted by CDC, the US Food and Drug Administration (FDA), and partners, including:

The Vaccine Safety Datalink (VSD);

The Post-licensure Rapid Immunization Safety Monitoring (PRISM); and

The Vaccine Adverse Event Reporting System (VAERS).

The 2 main US studies, which were based on VSD and PRISM data, evaluated postlicensure risk following the use of rotavirus vaccines. The results from the VSD study showed an increased risk for intussusception during the week following the first and second doses of Rotarix. The VSD study did not find an increased risk for intussusception among infants vaccinated with RotaTeq.

The results from the PRISM study showed an increased risk for intussusception following the first dose of RotaTeq, primarily during the first week after vaccination. No increased risk was detected following the second and third doses. The PRISM study could not assess the risk for intussusception after Rotarix vaccination, because fewer doses of Rotarix were used in the PRISM population.

Studies in other countries have also found increased risk for intussusception associated with the 2 vaccines, but the results have been variable. Overall, for rotavirus vaccines, the risk in the United States and elsewhere ranges from about 1 in 20,000 to 1 in 100,000.

The bottom line remains the same: The benefits of either rotavirus vaccine continue to outweigh the risks associated with vaccination, including the small excess risk for intussusception. In the United States, rotavirus vaccines have reduced rotavirus hospitalizations by 85%-90%. Thanks to vaccination, since 2008, between 40,000 and 50,000 hospitalizations for rotavirus disease have been prevented -- each year -- in US children under 5 years of age. CDC continues to recommend that all US infants receive rotavirus vaccination.

Providers should be ready to talk with parents about the benefits of rotavirus vaccine, as well as the small risk for intussusception associated with the vaccines. Parents need to know the signs and symptoms of intussusception. They also need to know that they should seek prompt care if they are concerned that their child may be ill.

In an otherwise healthy infant, the first sign is usually severe crying, caused by abdominal pain. The crying may be brief and sporadic, because the pain associated with intussusception often comes and goes. Other symptoms include vomiting, blood in the stool, and appearing weak or very irritable.

These signs would usually appear during the first week after the infant has received the first or second dose of rotavirus vaccine, but parents should be aware to look for signs at any time following vaccination.

The concerns of information-seeking parents are teachable moments -- for everyone. Parents who are interested in more information about rotavirus disease and vaccine are invited to visit CDC's rotavirus Website. Also, helpful information for parents is available on CDC's rotavirus vaccines Website. Here they can find a helpful rotavirus fact sheet as well as the Rotavirus Vaccine Information Statement.

CDC, the FDA, and our partners continue to closely monitor the impact of the rotavirus vaccines on disease burden and for any possible adverse events from the vaccine such as intussusception. Recently, the FDA required that the RotaTeq vaccine package insert be changed to reflect the findings from the PRISM data. This change was then communicated broadly. Also, the ACIP will continue to conduct systematic evaluations of the data collected through the vaccine safety monitoring systems. As new information becomes available, CDC remains committed to providing the most updated information and education materials for healthcare providers and parents.

For more information on CDC's vaccine safety monitoring activities, please see the resource links listed on this page. Thank you for watching.

Web Resources

CDC: Rotavirus

CDC: Rotavirus Multimedia

Rotavirus Fact Sheet for Parents

Rotavirus Clinical Information

Rotavirus en Español

FDA Safety Communication

FDA Mini-Sentinel: Intussusception Risk After Rotavirus Vaccination in U.S. Infants

Frank DeStefano, MD, MPH, is Director of the Immunization Safety Office of the Centers for Disease Control and Prevention (CDC). He is a graduate of Cornell University and the University of Pittsburgh School of Medicine. He received training in public health and preventive medicine in the Epidemic Intelligence Service and preventive medicine residency at CDC. He obtained a master of public health degree at Johns Hopkins University School of Hygiene and Public Health. He has had extensive epidemiologic research experience at CDC, the National Institutes of Health, and at nongovernmental research organizations. His areas of research have included immunizations, autism and other developmental disabilities, reproductive health, veterans' health, diabetes, cardiovascular diseases, and other chronic diseases. Dr. DeStefano is an author on over 150 publications in leading scientific and medical journals. For the past 16 years, Dr. DeStefano has had a focus on vaccine safety.

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