Persistent rotavirus vaccine shedding in a new case of severe combined immunodeficiency: A reason to screen
Cincinnati Children's Hospital Medical Center, OhioThe Journal of allergy and clinical immunology (Impact Factor: 11.48). 01/2010; 125(1):270-1. DOI: 10.1016/j.jaci.2009.10.029
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ABSTRACT: HintergrundRotaviren sind weltweit die häufigste Ursache von schweren Durchfallserkrankungen im Kindesalter. Sowohl in den Industrie- als auch in den Entwicklungsländern sind Rotavirusinfektionen mit einer hohen Morbidität verbunden. ErgebnisseZwei orale Rotaviruslebendimpfstoffe (Rotateq®, Rotarix®), die in Europa zugelassen sind, haben ihre Wirksamkeit und Sicherheit vorher bei vielen Tausenden von Kindern weltweit erwiesen. Die Einführung der Rotavirusimpfung in den allgemeinen Impfkalender hat in mehreren Ländern (Österreich, USA etc.) bereits nach 1–2Jahren zu einer drastischen Reduktion der Rotaviruserkrankungen und Hospitalisationen wegen Rotavirusgastroenteritis geführt. Vorbild in Deutschland sind hier die Bundesländer Sachsen, Mecklenburg-Vorpommern, Brandenburg und Thüringen. SchlussfolgerungEs ist zu hoffen, dass in baldiger Zukunft die Rotavirusimpfung durch die STIKO (Ständige Impfkommission) in allen Bundesländern empfohlen wird und dann auch die Frage der Kostenübernahme durch die Krankenkassen geklärt ist. BackgroundRotavirus (RV) is the leading cause of severe gastroenteritis in infants and young children. The morbidity of RV infections is high in developing as well as in developed countries. ResultsTwo live attenuated RV vaccines, (Rotateq®, Rotarix®), which have both been approved in European countries, have shown excellent protective efficacy against severe RV gastroenteritis in trials conducted mainly in Latin America, Europe, and the USA. The introduction of RV vaccine into national immunization programs (Austria, USA, and others) has led to a marked decrease of severe RV gastroenteritis and of hospitalization rates due to RV gastroenteritis within 1–2 years. In Germany, the federal states of Saxony, Mecklenburg-West Pomerania, Brandenburgum and Thuringia have introduced RV vaccination into the immunization program in recent years. ConclusionWe hope that the STIKO will now recommend the RV vaccine for all infants in all federal states of Germany. As a consequence, all health insurance funds have to pay the costs of the RV vaccine. SchlüsselwörterAkute Rotavirusgastroenteritis-Rotavirusimpfung-Wirksamkeit-Nationale Impfprogramme KeywordsAcute rotavirus gastroenteritis-Rotavirus vaccines-Efficacy-Immunization program
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ABSTRACT: Rotavirus vaccines are the only live vaccines recommended for infants in the US. Postmarketing reports have described severe gastroenteritis with vaccine viral shedding in infants who received rotavirus vaccine and were later diagnosed with SCID. The US Food and Drug Administration recently approved labeling changes for RotaTeq and Rotarix contraindicating administration to individuals with a history of SCID. We queried VAERS to characterize reports of SCID after rotavirus vaccination. VAERS inclusion criteria included current US-licensed rotavirus vaccines, report dates from February 3, 2006 to January 15, 2010, and queries for the MedDRA preferred term "combined immunodeficiency" as well as any text containing the terms, "SCID" or "combined immunodeficiency." We identified nine reports of SCID and rotavirus vaccination in infants between 3 and 9 months of age. All but one case presented with diarrhea among other symptoms. All infants were hospitalized and had workups leading to the SCID diagnosis. Stool rotavirus testing was positive in all cases and the virus was identified as the vaccine strain in six cases. Prolonged viral shedding was documented in five cases. No deaths were reported. The aforementioned labeling changes were warranted given the risk posed by live rotavirus vaccine to individuals with SCID, as illustrated by these VAERS cases. Although congenital, SCID was not diagnosed in these infants until after rotavirus vaccination. Earlier identification of SCID (e.g., from expanded newborn screening or heightened clinical vigilance) could prevent inadvertent live rotavirus vaccine administration and also potentially result in earlier life-saving stem cell transplants.
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