Why was RotaShield® was taken off U.S. market in 1999?

RotaShield® vaccine was the first vaccine to prevent rotavirus gastroenteritis approved for use in the United States in August 1998. Its removal from the market is a good case study for how the Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) quickly worked together and took action based on increased reports of incidents to the Vaccine Adverse Event Reporting System (VAERS) and removed the vaccine from use.

In the U.S., some infants developed intussusception–a rare type of bowel obstruction–soon after RotaShield® was licensed in August 1998. At first, it was not clear if the vaccine or some other factor was causing the bowel obstructions. The CDC quickly recommended that use of the vaccine be suspended and immediately started two emergency investigations to find out if receiving RotaShield® vaccine was causing some of the cases of intussusception. Based on the results of the investigation, CDC estimated that RotaShield® vaccine increased the risk for intussusception by one or two cases of intussusception among each 10,000 infants vaccinated. When the results of these investigations became available, the ACIP withdrew its recommendation to vaccinate infants with RotaShield® vaccine, and the manufacturer voluntarily withdrew RotaShield® from the market in October 1999.

More information about this case is available on the CDC website.

CDC: Rotavirus Vaccine (RotaShield®) and Intussusception


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