RotaShield, for rotavirus infection, was a vaccine withdrawn for safety and was recalled less than a year after marketing approval, based on safety signals identified from VAERS reports.
Even in that case the adverse condition was caused within weeks of vaccination but it took a while to determine it was caused by the vaccine due to the rarity of the adverse effect (15 cases) as well as the fact that it occurred in infants.
Withdrawal of Rotavirus Vaccine Recommendation
In July 1999, CDC recommended that health-care providers and parents postpone use of the rhesus rotavirus vaccine-tetravalent (RRV-TV) (RotaShield[Registered]*, Wyeth Laboratories, Inc., Marietta, Pennsylvania), for infants, at least until November 1999. This action was based on reports to the Vaccine Adverse Event Reporting System of intussusception (a type of bowel obstruction that occurs when the bowel folds in on itself) among
15 infants who received rotavirus vaccine. Also at that time, the manufacturer, in consultation with the Food and Drug Administration, voluntarily ceased further distribution of the vaccine.
On October 22, 1999, the Advisory Committee on Immunization Practices (ACIP), after a review of scientific data from several sources,
concluded that intussusception occurs with significantly increased frequency in the first 1-2 weeks after vaccination with RRV-TV, particularly following the first dose. Therefore, ACIP no longer recommends vaccination of infants in the United States with RRV-TV and withdraws its recommendation that RRV-TV be administered at 2, 4, and 6 months of age.
Children who received rotavirus vaccine before July and remain well are not now at increased risk for intussusception.