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

Pharmacoepidemiology and Drug Safety

Volumn 21, Issue 4, 2012, Pages 415-419

  Dore, David D ^a,b   Turnbull, Bruce R ^b   Seeger, John D ^b,c,d  

^a BROWN UNIVERSITY   (United States)

^b OPTUM   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

^d HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Health insurance claims data; Pharmacoepidemiology; Risk management; Rotavirus vaccine; Vaccine safety

Indexed keywords

DNA FRAGMENT; MONOVALENT ROTAVIRUS VACCINE; PENTAVALENT ROTAVIRUS VACCINE; ROTAVIRUS VACCINE; UNCLASSIFIED DRUG;

ARTICLE; CHILD; CIRCOVIRUS; CONTROLLED STUDY; DRUG CONTAMINATION; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG UTILIZATION; FEMALE; HEALTH INSURANCE; HUMAN; INFANT; MAJOR CLINICAL STUDY; MALE; PRESCHOOL CHILD; PRIORITY JOURNAL; ROTAVIRUS INFECTION;

ANIMALS; CIRCOVIRUS; DNA, VIRAL; DRUG CONTAMINATION; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; MALE; ROTAVIRUS INFECTIONS; ROTAVIRUS VACCINES; SWINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84859712291     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3217     Document Type: Article

References (19)

1. US Food and Drug Administration. Background on Rotavirus Vaccines. Available at: [22 June 2010].
2. US Food and Drug Administration. Early Communication on Rotarix Vaccine. Available at: [14 May 2010].
3. US Food and Drug Administration. Background on PCV. Available at: [June 2010].
4. Victoria JG, Wang C, Jones MS, et al. Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus. J Virol 2010; 84: 6033-6040.
5. McClenahan SD, Krause PR, Uhlenhaut C. Molecular and infectivity studies of porcine circovirus in vaccines. Vaccine 2011; 29: 4745-4753.
6. US Food and Drug Administration. Update on Recommendations for the Use of Rotavirus Vaccines. Available at: [22 June 2010].
7. Weatherby LB, Nordstrom BL, Fife D, Walker AM. The impact of wording in "Dear doctor letters and in black box labels. Clin Pharmacol Ther 2002; 72: 735-742.
8. Weatherby LB, Walker AM, Fife D, Vervaet P, Klausner M. Contraindicated medications dispensed with cisapride: temporal trends in relation to the sending of 'Dear Doctor' letters. Pharmacoepidemiol Drug Saf 2001; 10: 211-217.
9. Libby AM, Brent DA, Morrato EH, Orton HD, Allen R, Valuck RJ. Decline in Treatment of Pediatric Depression After FDA Advisory on Risk of Suicidality With SSRIs. Am J Psychiatry 2007; 164: 884-891.
10. Morrato EH, Libby AM, Orton HD, et al. Frequency of provider contact after FDA advisory on risk of pediatric suicidality with SSRIs. Am J Psychiatry 2008; 165: 42-50.
11. Centers for Disease Control and Prevention. Prevention of Rotavirus Gastroenteritis Among Infants and Children: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morb Mortal Wkly Rep 2009; 58: 1-25.
12. Andrews E, Dombeck M. The role of scientific evidence of risks and benefits in determining risk management policies for medications. Pharmacoepidemiol Drug Saf 2004; 13: 599-608.
13. Arrighi H, Black S, Shinefield H, DeStefano F. Pharmacoepidemiology of Vaccines. In Pharmacoepidemiology and therapeutic risk management (1st edn), Hartzema AG, Tilson HH, Chan KA (eds). Harvey Whitney Books: Cincinnati, OH, 2008; pp. 855-886.
14. Center for Disease Control and Prevention. Suspension of Rotavirus Vaccine After Reports of Intussusception---United States, 1999. Morb Mortal Wkly Rep 2004; 53; 786-789.
15. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351: 637-641.
16. Eng PM, Seeger JD, Loughlin J, Oh K, Walker AM. Serum potassium monitoring for users of ethinyl estradiol/drospirenone taking medications predisposing to hyperkalemia: physician compliance and survey of knowledge and attitudes. Contraception 2007; 75: 101-107.
17. Loughlin J, Wang FT, El Khoury A, Doherty M, Mast TC, Seeger JD. Adherence to the recommended pentavalent rotavirus vaccine administration schedule in the United States: 2006-2007. Pediatr Infect Dis J 2009; 28: 667-668.
18. Wang FT, Mast TC, Glass RJ, Loughlin J, Seeger JD. Effectiveness of the pentavalent rotavirus vaccine in preventing gastroenteritis in the United States. Pediatrics 2010; 125: e208-e213.
19. Thyagarajan V, Glass R, Rodgers K, et al. Validity of Current Procedural Terminology Codes for Rotavirus Vaccination in Two Commercially-Insured US Populations (Abstract 554). Pharmacoepidemiol Drug Saf 2011; 20: S242. DOI: 10.1002/pds.2206.