Safe administration of rotavirus vaccine in a cohort of infants exposed to immunosuppressive drugs during gestation
Maria Isabel Saraiva DinelliAmélia Miyashiro Nunes dos SantosLily Yin WeckxMaria Isabel de Moraes‐Pinto
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In utero exposure to immunosuppressive drugs might be a contraindication to rotavirus vaccine, but that may vary according to the immunosuppressive regimen. We evaluated 24 infants born to kidney transplanted mothers exposed to 3 immunosuppressants during pregnancy (prednisone, azathioprine, and tacrolimus or cyclosporine) and 31 control infants not exposed to these medications. No differences in adverse events were detected after rotavirus vaccination at 2 and 4 months.Keywords:
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The Food and Drug Administration (FDA) has approved revised prescribing information and patient labeling from GlaxoSmithKline Biologicals for the monovalent rotavirus vaccine (RV1, marketed as Rotarix) and revised prescribing information and patient labeling from Merck & Co. for the pentavalent rotavirus vaccine (RV5, marketed as RotaTeq) to include history of intussusception as a contraindication. FDA approved the revisions for RV1 in February 2011 and for RV5 in July 2011. In its rotavirus vaccination recommendations, CDC is updating the contraindications for rotavirus vaccine (RV1 and RV5) to include history of intussusception. Previously, CDC had considered history of intussusception a precaution but not a contraindication.
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Rotavirus is the leading cause of acute gastroenteritis (AGE) among children worldwide. Prior to rotavirus vaccine introduction, over one third of AGE hospitalizations in Africa were due to rotavirus. We describe the impact of rotavirus vaccines using data from the African Rotavirus Surveillance Network (ARSN).For descriptive analysis, we included all sites reporting to ARSN for any length of time between 2008 and 2018. For vaccine impact analysis, continuous surveillance throughout the year was required to minimize potential bias due to enrollment of partial seasons and sites had to report a minimum of 100 AGE cases per year. We report the proportion of rotavirus AGE cases by year relative to vaccine introduction, and the relative reduction in the proportion of rotavirus AGE cases reported following vaccine introduction.From 2008 to 2018, 97 366 prospectively enrolled hospitalized children <5 years of age met the case definition for AGE, and 34.1% tested positive for rotavirus. Among countries that had introduced rotavirus vaccine, the proportion of hospitalized AGE cases positive for rotavirus declined from 39.2% in the prevaccine period to 25.3% in the postvaccine period, a 35.5% (95% confidence interval [CI]: 33.7-37.3) decline. No declines were observed among countries that had not introduced the vaccine over the 11-year period.Rotavirus vaccine introduction led to large and consistent declines in the proportion of hospitalized AGE cases that are positive for rotavirus. To maximize the public health benefit of these vaccines, efforts to introduce rotavirus vaccines in the remaining countries in the region and to improve coverage should continue.
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Oral rotavirus vaccines, including bovine rotavirus strains RIT 4237 and RIT 4256, rhesus rotavirus (RRV) vaccine, rhesus-human rotavirus vaccine reassortants (D 'd7 RRV, DS-l x RRV, and tetravalent RRV), and human nursery rotavirus strain M37, have been evaluated in 5353 Finnish infants for safety, immunogenicity, and efficacy against rotavirus gastroenteritis. Bovine rotavirus vaccines were nonreactogenic in infants, whereas RRV-based and M37 vaccines were occasionally associated with febrile reactions 2–5 days after vaccination. All vaccines showed dose-dependent immunogenicity. Vaccine efficacy correlated with overall immunogenicity but not with the vaccine virusG serotype. For each vaccine, protective efficacywas better against severe rotavirus disease than against any rotavirus-associated gastroenteritis. Maximal protective efficacy against any rotavirus gastroenteritis in subjects with demonstrable vaccine immunogenicity was -75%. To achieve similar protection in all vaccinees, efforts should be focused on enhancing the immunogenicity of oral rotavirus vaccines.
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Azathioprine [AZA] and mercaptopurine [MP] are recommended for maintenance of steroid-free remission in children with Crohn`s disease [CD]. Azathioprine-induced pancreatitis, an idiosyncratic and major side effect, has been considered as an absolute contraindication for the use of a second thiopurine in IBD patients. We describe two children with CD in whom MP were successfully trialled after a confirmed azathioprine-induced pancreatitis, being well tolerated in both cases. Two boys [13 and 10 years old] started exclusive enteral nutrition after diagnosis of moderate (Pediatric Crohn′s Disease Activity Index [wPCDAI] = 45) and mild [wPCDAI = 35] CD. Both developed an acute mild to moderate pancreatitis after 2 and 3 weeks, respectively, of AZA treatment but recovered fully in hospital after AZA withdrawal. They started on MP treatment without any adverse effect. They were tested for the presence of polymorphisms 238G>C, 460G>A, and 719A>G in the TPMT gene and 94C>A and 21>C in the ITPase. Both patients were wild-type for all tested polymorphisms. Azathioprine-induced acute pancreatitis should not be considered as an absolute contraindication for the use of MP. Further investigation is required to create a better understanding of the mechanism underlying the adverse events and to allow more possibilities for personalised therapy.
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The introduction of the rotavirus vaccine, Rotarix, into the Fiji National Immunisation Program in 2012 has reduced the burden of rotavirus disease and hospitalisations in children less than 5 years of age. The aim of this study was to describe the pattern of rotavirus genotype diversity from 2005 to 2018; to investigate changes following the introduction of the rotavirus vaccine in Fiji. Faecal samples from children less than 5 years with acute diarrhoea between 2005 to 2018 were analysed at the WHO Rotavirus Regional Reference Laboratory at the Murdoch Children’s Research Institute, Melbourne, Australia, and positive samples were serotyped by EIA (2005–2006) or genotyped by heminested RT-PCR (2007 onwards). We observed a transient increase in the zoonotic strain equine-like G3P[8] in the initial period following vaccine introduction. G1P[8] and G2P[4], dominant genotypes prior to vaccine introduction, have not been detected since 2015 and 2014, respectively. A decrease in rotavirus genotypes G2P[8], G3P[6], G8P[8] and G9P[8] was also observed following vaccine introduction. Monitoring the rotavirus genotypes that cause diarrhoeal disease in children in Fiji is important to ensure that the rotavirus vaccine will continue to be protective and to enable early detection of new vaccine escape strains if this occurs.
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We read with interest the paper by Kennedy et al. describing patients with inflammatory bowel disease (IBD) who had been intolerant of azathioprine and had subsequently been trialled with mercaptopurine.1 It was an interesting article, but it did not highlight some recent data that indicate that the development of azathioprine-induced pancreatitis is not necessarily a strict contraindication to subsequent use of mercaptopurine. Thiopurine-induced pancreatitis occurs in up to 5% of patients and is an idiosyncratic drug reaction. In our study published earlier this year, we described 64 patients with IBD over 10 years of whom 23 were intolerant to azathioprine, seven of whom developed acute pancreatitis. In all seven patients, the pancreatitis was mild and resolved within a few days of withdrawal of azathioprine. Three of these seven patients with azathioprine-related pancreatitis then went on to tolerate mercaptopurine.2 Ledder et al. also recently described a case series of four paediatric patients with IBD who developed azathioprine-induced pancreatitis. The subsequent trial of mercaptopurine was tolerated in all four patients, leading to the conclusion that the results called into question that azathioprine-induced pancreatitis is an absolute contraindication to the use of mercaptopurine and is most relevant in those with an aggressive phenotype where long-term immunosuppression is required.3 Azathioprine-induced pancreatitis should not be considered a strict contraindication to the subsequent use of mercaptopurine in patients with IBD. Introduction of mercaptopurine following azathioprine-induced pancreatitis in a controlled setting should be considered. Declaration of personal and funding interests: None.
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