Withdrawal of rotavirus vaccine recommendation.
Level 4 - case-series / case-control
Passive surveillance report and case series from VAERS
What was done
The Centers for Disease Control and Prevention (CDC) reviewed post-licensure adverse event reports from the Vaccine Adverse Event Reporting System (VAERS) regarding cases of intussusception in infants administered the rhesus rotavirus vaccine-tetravalent (RRV-TV; RotaShield).
What was found
A total of 15 cases of intussusception were identified in infants who received the rotavirus vaccine. In response to these reports, the CDC recommended in July 1999 that providers and parents postpone vaccination at least until November 1999, and the manufacturer voluntarily halted vaccine distribution in consultation with the FDA.
Why it matters
This report marks the public health alert and initial withdrawal of the first licensed rotavirus vaccine following early post-marketing safety signals of bowel obstruction.
Limits
Data derive exclusively from passive surveillance via VAERS, which is subject to underreporting, reporting bias, and cannot establish causation. The abstract reports no denominator, control group, incidence rate, or statistical measure of association.
Cited by
- supports A rotavirus vaccine was removed from the market because it caused intussusception.