Abstract:The safety of new vaccines under development as well as existing vaccines is a key priority for national and international public health agencies. A number of countries have implemented universal childhood varicella vaccination programmes over the past 30 years. However, strategies differ in terms of the number of doses, type of vaccine(s) recommended, age at vaccination and interval between doses for a twodose schedule. An overview of reviews was undertaken to assess the existing systematic review evidence of… Show more
“…Likewise, Hansen et al., 46 in a study of 14 042 children receiving DTaP‐IPV/Hib vaccines, found no increase in seizures or epilepsy. In addition to DTaP/IPV/Hib, there is no indication that the meningococcal, 47 MMR, 48,49 varicella, 49,50 influenza, 51 pneumococcal vaccine, 52 hepatitis A, 53 hepatitis B, 54 and HPV 55 vaccines cause epilepsy.…”
ObjectiveThe National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program (VICP), a no‐fault alternative to the traditional tort system. Since 1988, the total compensation paid exceeds $5 billion. While epilepsy is one of the leading reasons for filing a claim, there has been no review of the process and validity of the legal outcomes given current medical information. The objectives were to review the evolution of the VICP program in regard to vaccine‐related epilepsy and assess the rationale behind decisions made by the court.MethodsPublicly available cases involving epilepsy claims in the VICP were searched through Westlaw and the United States Court of Federal Claims websites. All published reports were reviewed for petitioner's theories supporting vaccine‐induced epilepsy, respondent's counterarguments, the final decision regarding compensation and the rationale underlying these decisions. The primary goal was to determine which factors went into decisions regarding whether vaccines caused epilepsy.ResultsSince the first epilepsy case in 1989, there have been many changes in the program including the removal of residual seizure disorder as a vaccine‐related injury, publication of the Althen prongs, release of the acellular form of pertussis, and recognition that in genetic conditions the underlying genetic abnormality rather than the immunization causes epilepsy. We identified 532 unique cases with epilepsy: 105 with infantile spasms and 427 with epilepsy without infantile spasms. The petitioners’ experts often espoused outdated, erroneous causation theories that lacked an acceptable medical or scientific foundation and were frequently criticized by the court.SignificanceDespite the lack of epidemiological or mechanistic evidence indicating that childhood vaccines covered by the VICP result in or aggravate epilepsy, these cases continue to be adjudicated. After 35 years of intense litigation, it is time to reconsider whether epilepsy should continue to be a compensable vaccine‐induced injury.
“…Likewise, Hansen et al., 46 in a study of 14 042 children receiving DTaP‐IPV/Hib vaccines, found no increase in seizures or epilepsy. In addition to DTaP/IPV/Hib, there is no indication that the meningococcal, 47 MMR, 48,49 varicella, 49,50 influenza, 51 pneumococcal vaccine, 52 hepatitis A, 53 hepatitis B, 54 and HPV 55 vaccines cause epilepsy.…”
ObjectiveThe National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program (VICP), a no‐fault alternative to the traditional tort system. Since 1988, the total compensation paid exceeds $5 billion. While epilepsy is one of the leading reasons for filing a claim, there has been no review of the process and validity of the legal outcomes given current medical information. The objectives were to review the evolution of the VICP program in regard to vaccine‐related epilepsy and assess the rationale behind decisions made by the court.MethodsPublicly available cases involving epilepsy claims in the VICP were searched through Westlaw and the United States Court of Federal Claims websites. All published reports were reviewed for petitioner's theories supporting vaccine‐induced epilepsy, respondent's counterarguments, the final decision regarding compensation and the rationale underlying these decisions. The primary goal was to determine which factors went into decisions regarding whether vaccines caused epilepsy.ResultsSince the first epilepsy case in 1989, there have been many changes in the program including the removal of residual seizure disorder as a vaccine‐related injury, publication of the Althen prongs, release of the acellular form of pertussis, and recognition that in genetic conditions the underlying genetic abnormality rather than the immunization causes epilepsy. We identified 532 unique cases with epilepsy: 105 with infantile spasms and 427 with epilepsy without infantile spasms. The petitioners’ experts often espoused outdated, erroneous causation theories that lacked an acceptable medical or scientific foundation and were frequently criticized by the court.SignificanceDespite the lack of epidemiological or mechanistic evidence indicating that childhood vaccines covered by the VICP result in or aggravate epilepsy, these cases continue to be adjudicated. After 35 years of intense litigation, it is time to reconsider whether epilepsy should continue to be a compensable vaccine‐induced injury.
“…A single search was conducted to retrieve systematic reviews on the efficacy, effectiveness and safety of alternative varicella vaccination strategies, with the latter outcome reported in a separate paper. 14 A comprehensive electronic search was performed in Embase (Elsevier), Medline (EBSCO), the Cochrane Library and Google Scholar on 2 February 2022, with databases searched since inception. The SYSVAC and PROSPERO registries were also searched to identify relevant reviews and registered protocols for forthcoming systematic reviews.…”
A number of countries have implemented universal childhood varicella vaccination programmes over the past 30 years. However, strategies differ in terms of dosing schedule (one‐ or two‐dose), type of vaccine(s) recommended (monovalent, quadrivalent measles‐mumps‐rubella‐varicella, or both), age at vaccination, and dosing interval for a two‐dose schedule. An overview of reviews was undertaken to assess the existing systematic review evidence of the clinical efficacy/effectiveness of alternative varicella vaccination strategies. A comprehensive search of databases, registries and grey literature was conducted up to 2 February 2022. Two reviewers independently screened, extracted data and assessed the methodological quality of included reviews. A total of 20 reviews were included in the overview; 17 assessed the efficacy/effectiveness of one‐dose strategies and 10 assessed the efficacy/effectiveness of two‐dose strategies. Although the quality of most reviews was deemed ‘critically low’, there was clear and consistent evidence that vaccination is very effective at reducing varicella. While the analysis was restricted due to lack of detail in reporting of the reviews, the evidence suggests that two‐dose strategies are more efficacious/effective than one‐dose strategies in preventing varicella of any severity, but that both strategies have similar high efficacy/effectiveness in preventing moderate or severe varicella. Based on this evidence in this overview of reviews, a key consideration for policymakers on the possible introduction of a childhood varicella vaccination programme and the choice between a one‐ or two‐dose strategy, will be whether the objective of a programme is to prevent varicella of any severity or to prevent moderate to severe varicella.
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