Postmarketing Surveillance of Intussusception Following Mass Introduction of the Attenuated Human Rotavirus Vaccine in Mexico

Velázquez, F. Raúl; Colindres, Rómulo E.; Grajales, Concepción; Hernández, M. Teresa; Mercadillo, María Guadalupe; Torres, Fiorella; Cervantes-Apolinar, MariaYolanda; DeAntonio, Rodrigo; Ortega-Barrı́a, Eduardo; Blum, Maxim; Breuer, Thomas; Verstraeten, Thomas

doi:10.1097/inf.0b013e318253add3

Cited by 109 publications

(79 citation statements)

References 30 publications

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“…Title and abstract screening resulted in the identification of 16 potentially relevant publications. Ten of these 16 studies met the inclusion criteria for the meta-analysis (Table 1) (18,(26)(27)(28)(29)(30)(31)(32)(33)(34). The publications not included in the full text screening are listed as references e2-e7.…”

Section: Resultsmentioning

confidence: 99%

Risk of Intussusception After Rotavirus Vaccination

Koch¹,

Harder²,

Kries³

et al. 2017

Deutsches Ärzteblatt International

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SUMMARYBackground: In 2013, the German Standing Committee on Vaccination (Stän-dige Impfkommission, STIKO) recommended rotavirus (RV) vaccination for all infants while stating that this mildly increased the risk of intussusception, a potentially life-threatening event. Since this recommendation was issued, multiple observational studies on this topic designed as self-controlled case series (SCCS) have been published. The SCCS design is particularly suitable for the study of rare adverse effects of medications.

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Section: Resultsmentioning

confidence: 99%

Risk of Intussusception After Rotavirus Vaccination

Koch¹,

Harder²,

Kries³

et al. 2017

Deutsches Ärzteblatt International

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“…One study estimated Rotarix increased risk by 3.7 additional cases per 100 000 person years in Mexico. 87 The other Latin American study estimated risk as 1 case per 51 000 vaccinations in Mexico and 1 case per 68 000 vaccinations in Brazil. 88 In sum, there is moderate strength evidence that vaccination against rotavirus is associated with intussusception, but the occurrence is extremely rare, and risk factors have not been investigated.…”

Section: Rotavirus Vaccines: Rotateq and Rotarixmentioning

confidence: 99%

“…We identified 5 postlicensure studies on intussusception risk [86][87][88][89][90] ; an earlier brand of rotavirus vaccine (Rotashield) was withdrawn from the market in 1999 due to concerns about risk for this condition. A high-quality epidemiologic study (N = 296 023) conducted in Australia 86 found RotaTeq associated with intussusception in children 1 to 21 days after the first of 3 required doses but found no association with Rotarix.…”

Section: Rotavirus Vaccines: Rotateq and Rotarixmentioning

confidence: 99%

Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review

et al. 2014

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BACKGROUND: Concerns about vaccine safety have led some parents to decline recommended vaccination of their children, leading to the resurgence of diseases. Reassurance of vaccine safety remains critical for population health. This study systematically reviewed the literature on the safety of routine vaccines recommended for children in the United States. METHODS: Data sources included PubMed, Advisory Committee on Immunization Practices statements, package inserts, existing reviews, manufacturer information packets, and the 2011 Institute of Medicine consensus report on vaccine safety. We augmented the Institute of Medicine report with more recent studies and increased the scope to include more vaccines. Only studies that used active surveillance and had a control mechanism were included. Formulations not used in the United States were excluded. Adverse events and patient and vaccine characteristics were abstracted. Adverse event collection and reporting was evaluated by using the McHarm scale. We were unable to pool results. Strength of evidence was rated as high, moderate, low, or insufficient. RESULTS: Of 20 478 titles identified, 67 were included. Strength of evidence was high for measles/mumps/rubella (MMR) vaccine and febrile seizures; the varicella vaccine was associated with complications in immunodeficient individuals. There is strong evidence that MMR vaccine is not associated with autism. There is moderate evidence that rotavirus vaccines are associated with intussusception. Limitations of the study include that the majority of studies did not investigate or identify risk factors for AEs; and the severity of AEs was inconsistently reported. CONCLUSIONS: We found evidence that some vaccines are associated with serious AEs; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide.

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“…In a recent Mexican PMS study, a temporal increase in the risk of IS within 7 d of receiving the first dose of Rotarix™ was observed. 17 This translated to an estimated 3.7 (95.5% CI: 1.2-7.3) cases of IS per 100 000 person-years which could be attributed to Rotarix™ vaccination. 17 These observations were also consistent with another study conducted in Australia, where the relative risk of IS in infants during the first 7 d after the first dose of Rotarix™ was 3.41 (95% CI: 0.70-9.96).…”

Section: Discussionmentioning

confidence: 99%

“…17 This translated to an estimated 3.7 (95.5% CI: 1.2-7.3) cases of IS per 100 000 person-years which could be attributed to Rotarix™ vaccination. 17 These observations were also consistent with another study conducted in Australia, where the relative risk of IS in infants during the first 7 d after the first dose of Rotarix™ was 3.41 (95% CI: 0.70-9.96). 18 Another case-control study in Mexican and Brazilian infants reported an increased risk of intussusception during the first 7 d after receiving the first dose in Mexico (odds ratio = 5.8 [95% CI: 2.6-13.0]) and during the first 7 d after receiving the second dose in Brazil (odds ratio = 1.9 [95% CI: 1.1-3.4]).…”

Section: Discussionmentioning

confidence: 99%

Reactogenicity and safety of the human rotavirus vaccine,Rotarix™ in The Philippines, Sri Lanka, and India: A post-marketing surveillance study

Bravo

Chitraka

Liu

et al. 2014

Human Vaccines & Immunotherapeutics

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Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix ™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix ™ were administered according to the local prescribing information (PI). The occurrence of at least Grade “2”/”3” solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade “2”/”3” solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix ™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India.

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Postmarketing Surveillance of Intussusception Following Mass Introduction of the Attenuated Human Rotavirus Vaccine in Mexico

Cited by 109 publications

References 30 publications

Risk of Intussusception After Rotavirus Vaccination

Risk of Intussusception After Rotavirus Vaccination

Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review

Reactogenicity and safety of the human rotavirus vaccine,Rotarix™ in The Philippines, Sri Lanka, and India: A post-marketing surveillance study

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