Withdrawal of the tetravalent rhesus-human reassortant rotavirus vaccine from our arsenal of vaccines to prevent childhood diseases was a major disappointment. However, the experience demonstrated that the mechanisms established to monitor vaccine safety in the United States functioned effectively. This article reviews how the association with intussusception was discovered and evaluated, and speculates about lessons learned and how to use them.

Prelicensure clinical evaluation of the rhesus-human reassortant vaccine was a process that lasted >15 years, cost hundreds of millions of dollars, involved multiple governmental agencies, industry, and dozens of clinical investigators. It was given to >10 000 infants in 27 clinical trials conducted in 9 different countries. After this large and lengthy experience the vaccine was submitted to the Food and Drug Administration (FDA) for consideration for licensure. Concurrently, a Rotavirus Working Group of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention...

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