Vaccine discontinuation and switching following regulatory interventions in response to rotavirus vaccine contamination with porcine circovirus DNA fragments

Pharmacoepidemiol Drug Saf. 2012 Apr;21(4):415-9. doi: 10.1002/pds.3217. Epub 2012 Jan 30.


Purpose: 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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Circovirus / genetics
  • Circovirus / isolation & purification*
  • DNA, Viral
  • Drug Contamination*
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Rotavirus Infections / prevention & control*
  • Rotavirus Vaccines / administration & dosage*
  • Rotavirus Vaccines / standards
  • Swine
  • United States
  • United States Food and Drug Administration


  • DNA, Viral
  • Rotavirus Vaccines