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Health Agencies Update
December 22 2010

Rotavirus Vaccine

JAMA. 2010;304(24):2687. doi:10.1001/jama.2010.1816

The US Centers for Disease Control and Prevention (CDC) continues to recommend vaccination of infants with 2 rotavirus vaccines, Rotarix and RotaTeq, despite emerging reports from large clinical trials in other countries of a small risk of intussusception.

In September, the US Food and Drug Administration announced a change in the label for Rotarix to indicate an increased risk of intussusception among infants during the month after the first dose (http://tinyurl.com/25589oc). The information was based on preliminary data from a postmarketing trial of the vaccine in Mexico, which found an 1.8-fold increased risk of intussusception. On October 28, the CDC's Advisory Committee on Immunization Practices (ACIP) evaluated data from this trial and other postmarketing studies in Latin America and Australia that have suggested an increased risk of intussusception shortly after vaccination with Rotarix or RotaTeq. So far, a study of more than 800 000 doses of RotaTeq in the United States through the Vaccine Safety Datalink (a collaborative effort between the CDC and 8 managed care organizations) has not found an increased risk. The ACIP noted in a statement that if an increased risk of intussusception exists in the United States similar to that seen in the Mexican study, about 1 case of intussusception would occur per 100 000 US infants receiving the vaccine.