Rotavirus vaccine example

In August 1998 the first rotavirus vaccine, RotaShield^®, was licensed in the USA. Pre-licensure literature noted a possible increased risk of intussusception, a potentially life-threatening bowel obstruction that occurs for unknown reasons in about one young child in every 10,000 regardless of vaccination history. The manufacturer noted intussusception as a possible adverse reaction in the package insert and post-licensure surveillance for intussusception was recommended by the United States' vaccine safety surveillance Advisory Committee on Immunization Practices (ACIP).⁵¹

After RotaShield^® was in routine use by the public (approximately one million children vaccinated within the first 9 months following licensure) VAERS began to receive reports of intussusception following administration of the vaccine. Intussusception was confirmed in 98 cases after vaccination with rotavirus vaccine and reported to VAERS, approximately 0.01% of the one million children vaccinated. The passive surveillance system, relying primarily on spontaneous reports from health workers, indicated at least a fourfold increase over the expected number of intussusception cases occurring within a week of receipt of rotavirus vaccine. As a result, additional studies were conducted to better understand the relationship between rotavirus vaccine and intussusception. In light of these studies, the rotavirus vaccine manufacturer voluntarily removed its product from the market less than a year after it had been introduced, and the recommendation for routine use of rotavirus vaccine among infants in the USA was withdrawn.⁵¹

A different Rotavirus vaccine is now being used in the USA, after better understanding and appropriate recommendation for its use.