A Multi-Center, Qualitative Assessment of Pediatrician and Maternal Perspectives on Rotavirus Vaccines and the Detection of Porcine circovirus

BMC Pediatrics

Mary A Staat⁷  Claudia Chesley⁵  Christina Albertin⁴  David Locke⁷  Ana Kobayashi⁶  Eileen J Klein⁶  Kimberly Downing²  Mary Wikswo³  Allison Kennedy⁸  Douglas Opel⁶  Sharon Humiston¹  Daniel C Payne³ 

[1]Children's Mercy Hospitals and Clinics, Kansas City, Missouri, USA

[2]Institute for Policy Research, University of Cincinnati, Cincinnati, Ohio, USA

[3]Epidemiology Branch, Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

[4]Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA

[5]Office of the Director, Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

[6]Department of Pediatrics, University of Washington, Seattle, Washington, USA

[7]Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA

[8]Health Services Research and Evaluation Branch, Immunization Services Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

关键词: focus groups;    communication development;    pediatricians;    adventitious virus;    porcine circovirus (PCV);    Rotarix^®;    RotaTeq™;    rotavirus vaccine;   

Others  :  1172126
DOI  :  10.1186/1471-2431-11-83

 received in 2011-01-20, accepted in 2011-09-26,  发布年份 2011

【 摘 要 】

Background

In 2010, researchers using novel laboratory techniques found that US-licensed rotavirus vaccines contain DNA or DNA fragments from Porcine circovirus (PCV), a virus common among pigs but not believed to cause illness in humans. We sought to understand pediatricians' and mothers' perspectives on this finding.

Methods

We conducted three iterations of focus groups for pediatricians and non-vaccine hesitant mothers in Seattle, WA, Cincinnati, OH, and Rochester, NY. Focus groups explored perceptions of rotavirus disease, rotavirus vaccination, and attitudes about the detection of PCV material in rotavirus vaccines.

Results

Pediatricians understood firsthand the success of rotavirus vaccines in preventing severe acute gastroenteritis among infants and young children. They measured this benefit against the theoretical risk of DNA material from PCV in rotavirus vaccines, determining overall that the PCV finding was of no clinical significance. Particularly influential was the realization that the large, randomized clinical trials that found both vaccines to be highly effective and safe were conducted with DNA material from PCV already in the vaccines.

Most mothers supported the ideal of full disclosure regarding vaccination risks and benefits. However, with a scientific topic of this complexity, simplified information regarding PCV material in rotavirus vaccines seemed frightening and suspicious, and detailed information was frequently overwhelming. Mothers often remarked that if they did not understand a medical or technical topic regarding their child's health, they relied on their pediatrician's guidance.

Many mothers and pediatricians were also concerned that persons who abstain from pork consumption for religious or personal reasons may have unsubstantiated fears of the PCV finding.

Conclusions

Pediatricians considered the detection of DNA material from PCV in rotavirus vaccines a "non-issue" and reported little hesitation in continuing to recommend the vaccines. Mothers desired transparency, but ultimately trusted their pediatrician's recommendation. Both vaccines are currently approved for their intended use, and no risk of human PCV illness has been reported. Communicating this topic to pediatricians and mothers requires sensitivity to a broad range of technical understanding and personal concerns.

【 授权许可】

   
2011 Payne et al; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, Dallas MJ, Heyse JF, Goveia MG, Black SB, Shinefield HR, Christie CD, Ylitalo S, Itzler RF, Coia ML, Onorato MT, Adeyi BA, Marshall GS, Gothefors L, Campens D, Karvonen A, Watt JP, O'Brien KL, DiNubile MJ, Clark HF, Boslego JW, Offit PA, Heaton PM: Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006, 354:23-33.
• [2]Vesikari T, Itzler R, Matson DO, Santosham M, Christie CD, Coia M, Cook JR, Koch G, Heaton PM: Efficacy of a pentavalent rotavirus vaccine in reducing rotavirus-associated health care utilization across three regions (11 countries). Int J Infect Dis 2007, 11(Suppl 2):S29-35.
• [3]Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M: Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006, 354:11-22.
• [4]Linhares AC, Velázquez FR, Pérez-Schael I, Sáez-Llorens X, Abate H, Espinoza F, López P, Macías-Parra M, Ortega-Barría E, Rivera-Medina DM, Rivera L, Pavía-Ruz N, Nuñez E, Damaso S, Ruiz-Palacios GM, De Vos B, O'Ryan M, Gillard P, Bouckenooghe A, the Human Rotavirus Vaccine Study Group: Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet 2008, 371:1181-9.
• [5]Block SL, Vesikari T, Goveia MG, Rivers SB, Adeyi BA, Dallas MJ, Bauder J, Boslego JW, Heaton PM: Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics 2007, 119:11-8.
• [6]Belongia E, Irving S, Shui I: Rapid cycle analysis of pentavalent rotavirus (RotaTeq) vaccine safety in the Vaccine Safety Datalink population: preliminary results. Presented at: Advisory Committee on Immunization Practices. Atlanta, GA; 2008.
• [7]Centers for Disease Control and Prevention: Reduction in rotavirus after vaccine introduction -- United States, 2000-2009. MMWR 2009, 58:1146-9.
• [8]Tate JE, Panozzo CA, Payne DC, Patel MM, Cortese MM, Fowlkes AL, Parashar UD: Decline and change in seasonal patterns of rotavirus activity after the introduction of rotavirus vaccine in the United States. Pediatrics 2009, 124:465-71.
• [9]Victoria JG, Wang C, Jones MS, Jaing C, McLoughlin K, Gardner S, Delwart EL: Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus. J Virol 2010, 84:6033-40.
• [10]Li L, Kapoor A, Slikas B, Bamidele OS, Wang C, Shaukat S, Masroor MA, Wilson ML, Ndjango JB, Peeters M, Gross-Camp ND, Muller MN, Hahn BH, Wolfe ND, Triki H, Bartkus J, Zaidi SZ, Delwart E: Multiple, diverse circoviruses infect farm animals and are commonly found in human and chimpanzee feces. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2812408/?tool=pubmed] webciteJ Virol 2010, 84:1674-82.
• [11]Kuehn BM: FDA: Benefits of rotavirus vaccination outweigh potential contamination risk. [http://jama.ama-assn.org/cgi/content/full/304/1/30] webciteJAMA 2010, 304:30-1.
• [12]Friedland L: Rotarix® (Rotavirus Vaccine, Live Oral): GSK's PCV1 Investigation. Presented at: Advisory Committee on Immunization Practices. [http:/ / www.cdc.gov/ vaccines/ recs/ acip/ downloads/ mtg-slides-jun10/ 13-3-rota.pdf] webciteAtlanta, GA; 2010.
• [13]Ranucci C: RotaTeq® (Rotavirus Vaccine, Live Oral, Pentavalent): Update on Porcine Circovirus (PCV). [http:/ / www.cdc.gov/ vaccines/ recs/ acip/ downloads/ mtg-slides-oct10/ 12-6-rota-PCVupdate.pdf] webcitePresented at: Advisory Committee on Immunization Practices Atlanta, GA; 2010.
• [14]Hussain AI, Johnson JA, Da Silva Freire M, Heniene W: Identification and characterization of avian retroviruses in chicken embryo-derived yellow fever vaccines: investigation of transmission to vaccine recipients. J Virol 2007, 77:1105-11.
• [15]Engels E: Cancer risk associated with receipt of vaccines contaminated with simian virus 40: epidemiologic research. Expert Rev Vaccines 2005, 4:197-206.
• [16]Hussain AI, Shanmugam V, Switzer WM, Tsang SX, Fadly A, Thea D, Helfand R, Bellini WJ, Folks TM, Heneine W: Lack of evidence of endogenous avian leukosis virus and endogenous avian retrovirus transmission to measles, mumps, and rubella vaccine recipients. Emerg Infect Dis 2001, 7:66-72.
• [17]Miles MB, Huberman AM: Qualitative data analysis: an expanded sourcebook. 2nd edition. Thousand Oaks: Sage Publications, Strauss; 1994.
• [18]Corbin AJ: Basics of qualitative research: Techniques and procedures for developing grounded theory. 2nd edition. Thousand Oaks, CA: Sage Publications, Inc; 1998.
• [19]U.S. Centers for Disease Control and Prevention website: Vaccines for Children (VFC) Program. [http://www.cdc.gov/vaccines/programs/vfc/default.htm] webcite Accessed November 16, 2010
• [20]The Pink Sheet website: Vaccine Manufacturers Need Plans To Cut Adventitious Agents By October. [http://thepinksheet.elsevierbi.com] webcite Accessed September 7, 2010
• [21]Food and Drug Administration: Product approval information-licensing action, package insert: RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalant), Merck and Co., Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; revised. 2010.
• [22]Food and Drug Administration: Product approval information-licensing action, package insert: Rotarix® (Rotavirus Vaccine, Live, Oral, Monovalant), GlaxoSmithKline Biologicals. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; revised; 2010.
• [23]McClenahan SD, Krause PR, Uhlenhaut C: Molecular and infectivity studies of porcine circovirus in vaccines. Vaccine 2011, 29:4745-53.
• [24]Smith PJ, Kennedy AM, Wooten K, Gust DA, Pickering LK: Association between health care providers' influence on parents who have concerns about vaccine safety and vaccination coverage. Pediatrics 2006, 118:e1287-92.
• [25]Gust DA, Kennedy A, Shui I, Smith PJ, Novak G, Pickering LK: Parent attitudes toward immunizations and healthcare providers: the role of information. Am J Prev Med 2005, 29:105-12.
• [26]Taylor JA, Darden PM, Slora E, Hasemeier CM, Asmussen L, Wasserman R: The influence of provider behavior, parental characteristics, and a public policy initiative on the immunization status of children followed by private pediatricians: a study from Pediatric Research in Office Settings. Pediatrics 1997, 99:209-15.
• [27]Gust DA, Woodruff R, Kennedy AM, Brown C, Sheedy K, Hibbs B: Parental perceptions surrounding risks and benefits of immunization. Semin Pediatr Infect Dis 2003, 14:207-12.
• [28]Taylor JA, Newman RD: Parental attitudes toward varicella vaccination. The Puget Sound Pediatric Research Network. Arch Pediatr Adolesc Med 2000, 154:302-6.
• [29]Sturm LA, Mays RM, Zimet GD: Parental beliefs and decision making about child and adolescent immunization: from polio to sexually transmitted infections. J Dev Behav Pediatr 2005, 26:441-52.