A rotavirus vaccine for prevention of severe diarrhoea of infants and young children: development, utilization and withdrawal.
Level 5 - mechanism / opinion, no new human data
Narrative review and historical commentary on vaccine development and post-licensure surveillance
PubMed 11444025 · doi:10.1002/0470846534.ch10
What was done
This paper reviews the development, regulatory approval, and withdrawal of the quadrivalent live attenuated rhesus rotavirus vaccine (RRV-TV, RotaShield) targeting serotypes G1 through G4. It outlines the transition from prelicensure Phase III clinical trials to nationwide recommendation and post-licensure adverse event monitoring by the CDC.
What was found
The abstract reports no specific numerical efficacy or incidence figures. It notes that after approximately 1.5 million doses were administered in the United States, surveillance identified an association with intussusception. In October 1999, recommendations were withdrawn after findings confirmed intussusception occurred with significantly increased frequency in the first 1-2 weeks after vaccination, particularly following the first dose.
Why it matters
It documents a key historical case in vaccine pharmacovigilance, showing how post-licensure surveillance detected a rare, severe adverse event that altered immunization policy and led to product withdrawal.
Limits
The abstract is a narrative review without primary trial data, explicit sample sizes for the Phase III trials, or quantitative risk estimates and confidence intervals for intussusception.
Cited by
- supports A rotavirus vaccine was removed from the market because it caused intussusception.