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

Abstract

BackgroundIn 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.MethodsWe 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.ResultsPediatricians 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.ConclusionsPediatricians 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.

Rotavirus immunization: Global coverage and local barriers for implementation

“…The Strategic Advisory Group of Experts on immunization in 2010 reported to the World Health Organization that porcine circovirus type-1 is not known to cause disease in humans and is often found in food products, confirming the safety of Rotarix™ [5,24]. However, according to our data, in an Islamic-prevalent country the potential assumption of pig derivate seems to overweigh safety reasons and this significantly impacts on regional health authorities, religious leaders and families’ beliefs.…”

“…In addition, we observed that, after approval of the two RV vaccines and early endorsement by some countries in 2006, most countries recommended RVI very recently between 2012 and 2014. This two-peak distribution might be affected by the emergence of data on potential side effects, including the risk of intestinal intussusception (2008–2012) [23] and the presence of porcine circovirus in Rotarix™ (2009–2010) [24].…”

Detection of PCV-2 DNA in stool samples from infants vaccinated with RotaTeq®

“…Though extensive clinical data supports the safety of both vaccines, 10,23 there is still concern among expectant mothers or parents with children eligible for vaccination. 23 The shedding of rotavirus vaccine strains in RotaTeq ® and Rotarix ® vaccinees has been documented 18,24 hence the question remained whether or not these vaccinees were also excreting PCV.…”

Comparative genomic analysis of genogroup 1 (Wa-like) rotaviruses circulating in the USA, 2006–2009

“…In industrialized countries, RVA associated mortality is minimal yet the financial cost of treatment associated with disease burden is enormous (Payne et al, 2011). The RVA genome is composed of 11 double-stranded RNA (dsRNA) segments which code for 11or 12 proteins in total, six structural proteins VP1-VP4, VP6 and VP7, and five or six nonstructural proteins NSP1-NSP5/6 (Estes and Kapikian, 2007).…”