Global Vaccine Safety

Statement on RotaTeq® vaccine and intussusception

15 February 2007

WHO and the Global Advisory Committee on Vaccine Safety (GACVS)1 have taken note of the United States Food and Drug Administration (FDA) Public Health Notification to health-care providers and consumers about reports of intussusception following the use of RotaTeq® vaccine (Rotavirus, Live, Oral, Pentavalent vaccine manufactured by Merck and Co., Inc.) in the United States of America. The reported cases were detected through routine monitoring of RotaTeq® vaccine by the United States Vaccine Adverse Event Reporting System (VAERS). It should be noted that the number of intussusception cases reported to date after RotaTeq® administration does not exceed the number of cases expected based on background rates in the United States infant population, and therefore does not suggest an increased risk of intussusception with RotaTeq®. However, continued monitoring is warranted.

GACVS has previously concluded that clinical trial data and preliminary data from adverse event reports in the post-marketing phase, from the United States of America and elsewhere, did not show an increased risk for intussusception following RotaTeq®; the current information from the United States of America does not change the previous GACVS conclusions. The Committee is in agreement with the steps taken by the FDA and the United States Centers for Disease Control and Prevention (CDC) to remind health-care providers and consumers to maintain a high level of attention to the diagnosis and reporting of intussusception in order to appropriately investigate their potential association with rotavirus vaccination. WHO and the GACVS will continue to review the data for cases of intussusception reported in the United States of America by the CDC and FDA as well as reports from other countries which have introduced rotavirus vaccine.

1The GACVS is an expert scientific advisory body established by WHO to provide reliable and independent scientific assessment of vaccine safety issues in order to respond promptly, efficiently and with scientific rigour to such issues. Membership includes experts from around the world in the fields of epidemiology, paediatrics, internal medicine, pharmacology and toxicology, infectious diseases, public health, immunology and autoimmunity, drug regulation, and safety.