Postmarketing evaluation of the safety and effectiveness of varicella vaccine

Black, Steven; Shinefield, Henry R.; Ray, Paula; Lewis, Edwin; Hansen, John; Schwalbe, J.; Coplan, Paul; Sharrar, Robert G.; Guess, Harry A.

doi:10.1097/00006454-199912000-00003

Cited by 90 publications

(37 citation statements)

References 8 publications

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“…The IOM committee found evidence "convincingly supports" causal relationships in children between varicella virus vaccine and the following: disseminated Oka strain varicella zoster virus (Oka VZV) without other organ involvement; disseminated Oka VZV with subsequent infection resulting in pneumonia, 91 meningitis, or hepatitis in individuals with demonstrated immunodeficiencies; vaccine strain viral reactivation without other organ involvement; vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis 92 ; and anaphylaxis. 91 We identified 1 study that investigated possible relationships among Hib, PCV, MMR, DTaP, TIV, hepatitis A, varicella, and meningococcal vaccines and immune thrombocytopenic purpura in children enrolled in 5 US health maintenance organizations.…”

Section: Varicellamentioning

confidence: 99%

“…91 We identified 1 study that investigated possible relationships among Hib, PCV, MMR, DTaP, TIV, hepatitis A, varicella, and meningococcal vaccines and immune thrombocytopenic purpura in children enrolled in 5 US health maintenance organizations. 18 Purpura was not associated with any of the vaccines in children aged 2 to 6 years but was associated with vaccination against varicella in children aged 11 to 17 years (incidence rate ratio R 12.14, 95% CI 1.10-133.96; findings related to other vaccines are reported in their respective sections).…”

Section: Varicellamentioning

confidence: 99%

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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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Section: Varicellamentioning

confidence: 99%

Section: Varicellamentioning

confidence: 99%

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

et al. 2014

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“…[1][2][3][4] The occurrence of unplanned readmission among high-cost patients, such as the elderly and those with chronic disease, is a significant concern as prospective payment systems are implemented for medical rehabilitation and postacute care. [5][6][7][8][9][10][11] We examined the relation between length of stay (LOS) and hospital readmission in a large sample of patients who received inpatient medical rehabilitation from 1994 through 1998. Our goal was to provide basic descriptive information regarding trends between LOS and readmission across different rehabilitation impairment groups.…”

Section: Introductionmentioning

confidence: 99%

“…2,4,5 The varicella vaccine is safe and highly efficacious, with estimates of postlicensure efficacy among children ranging from 83% to 100%. 2,[6][7][8] Physicians' initial acceptance of the vaccine was not uniform. The 1997 National Immunization Survey showed that 26% of US children aged 19 to 35 months had received varicella vaccine.…”

mentioning

confidence: 99%

Attitudes and practices regarding varicella vaccination among physicians in Minnesota: implications for public health and provider education

et al. 2000

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OBJECTIVES: This study sought to determine physicians' attitudes and practices regarding varicella vaccine. METHODS: A sample of Minnesota family physicians and pediatricians was surveyed in January 1997. RESULTS: Of 255 physicians surveyed, 108 (42%) reported routinely offering varicella vaccine. Physicians who perceived their professional organization's recommendations as "very important" were more likely to routinely offer varicella vaccine. Physicians who preferred natural disease over vaccination and those concerned about waning immunity were less likely to routinely offer vaccine. CONCLUSIONS: Recommendations of professional organizations have encouraged varicella vaccine use and may further enhance future use. Differences in pediatricians' and family physicians' attitudes and practices regarding this vaccine suggest that education of providers by specialty may be needed to increase acceptance of newly licensed vaccines.

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“…The rate of adverse reactions with active surveillance of chickenpox vaccine has been reported to be about 10 times higher than that in our program (12,13), likely reflecting under-reporting in our passive system. It is likely that many reports of chickenpox lesions after receiving vaccine were caused by wild virus rather than the vaccine strain (14).…”

Section: Discussionmentioning

confidence: 60%

Canada′s First Universal Varicella Immunization Program: Lessons from Prince Edward Island

Sweet

Gallant

Morris

et al. 2003

Canadian Journal of Infectious Diseases and Medical Microbiolog

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A live attenuated varicella vaccine was licensed in Canada in December 1998. The first universal varicella immunization program in Canada was initiated in Prince Edward Island in 2000. Students in grades one to six without a history of varicella were offered the vaccine, administered by Public Health Nurses, in school clinics during February and March 2000. The acceptance rate ranged from 29.1% of all grade one students to 9.8% of all grade six students; overall, 18.8% of students received the vaccine. A universal program for children 12 months of age was introduced on April 1, 2000 and catch-up clinics for those between 12 months of age and those in grade one were introduced in June 2000. Repeated media announcements and the cooperation of staff in schools and daycare facilities assisted in informing parents about the availability of the vaccine. Vaccine- associated adverse events have been uncommon and the vaccine has been well accepted.

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Postmarketing evaluation of the safety and effectiveness of varicella vaccine

Abstract: In this study population of 89753 children and adults, the varicella vaccine (Oka strain, Merck) appeared to have a favorable safety profile. In addition rates of varicella-like rash and of breakthrough cases were both low and consistent with the rates observed in prelicensure studies.

Cited by 90 publications

References 8 publications

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

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

Attitudes and practices regarding varicella vaccination among physicians in Minnesota: implications for public health and provider education

Canada′s First Universal Varicella Immunization Program: Lessons from Prince Edward Island

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