title: Vaccine discontinuation and switching following regulatory interventions in response to rotavirus vaccine contamination with porcine circovirus DNA fragments.
abstract: OBJECTIVE
  The Food and Drug Administration temporarily suspended monovalent rotavirus vaccine (RV1) use following discovery of contamination with porcine circovirus fragments and subsequently announced similar contamination of the pentavalent rotavirus vaccine (RV5) but recommended continued use of the product. We assessed the utilization of these vaccines in relation to the announcements.
  
  
  METHODS
  Using claims submitted to a commercial health insurer for administration of RV1 and RV5, we estimated the number of administrations of the vaccines and the extent of switching between RV1 and RV5. Procedure codes on submitted claims identified vaccine administrations among infants ≤ 1 year old through 16 June 2010. Among infants who received a first dose of vaccine before the corresponding announcement, and whose second dose was anticipated following the announcement, we estimated the number who received no second dose of rotavirus vaccine.
  
  
  RESULTS
  There were 31 178 RV1 initiators and 514 357 RV5 initiators. We observed a 93% reduction in RV1 doses in the month following the recommended suspension of use, coupled with extensive switching to RV5 (90% of subsequent doses) and a reduction in second RV1 doses (from 35.5% incomplete to 40.9%). There was a 15% increase in number of RV5 administrations following announcement of its contamination, with little switching to RV1 but with a possible decrease in completion.
  
  
  CONCLUSIONS
  Recommended suspension of RV1 use led to a substantial decrease in use and extensive switching to RV5. The announcement that RV5 was similarly contaminated, but without a corresponding recommendation to suspend use, had little effect on use.
authors.affiliation: Departments of Health Services, Policy and Practice and Epidemiology; Program in Public Health, The Warren Alpert Medical School of Brown University, Providence, RI, USA. david_dore@brown.edu
authors.forename: David D
authors.initials: DD
authors.lastname: Dore
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Turnbull
authors.forename: John D
authors.initials: JD
authors.lastname: Seeger
mesh_terms: D000818:Animals; D017925:Circovirus / Q000235:genetics / Q000302:isolation & purification*; D004279:DNA, Viral; D004340:Drug Contamination; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage* / Q000592:standards; D013552:Swine; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004279:DNA, Viral; D022243:Rotavirus Vaccines