Liability and maternal immunization: in utero injury claims in the VICP

Jacobs, Anna

doi:10.1016/j.ajog.2012.06.076

Cited by 10 publications

(5 citation statements)

References 2 publications

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“…Potential liability issues are a consideration for a vaccine strategy targeted at women with childbearing potential. Of note, the issue of whether in utero injuries are compensable under the Vaccine Injury Compensation Act has not been resolved 36 .…”

Section: Use Of a CMV Vaccine In Different Target Populations To Prevmentioning

confidence: 99%

Priorities for CMV vaccine development

Krause

Bialek

Boppana

et al. 2013

Vaccine

126

104

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A multidisciplinary meeting addressed priorities related to development of vaccines against cytomegalovirus (CMV), the cause of congenital CMV (cCMV) disease and of serious disease in the immunocompromised. Participants discussed optimal uses of a CMV vaccine, aspects of clinical study design, and the value of additional research. A universal childhood CMV vaccine could potentially rapidly reduce cCMV disease, as infected children are sources of viral transmission to seronegative and seropositive mothers. A vaccine administered to adolescents or adult women could also reduce cCMV disease by making them immune prior to pregnancy. Clinical trials of CMV vaccines in women should evaluate protection against cCMV infection, an essential precursor of cCMV disease, which is a more practical and acceptable endpoint for assessing vaccine effects on maternal-fetal transmission. Clinical trials of vaccines to evaluate prevention of CMV disease in stem cell transplant recipients could use CMV viremia at a level triggering preemptive antiviral therapy as an endpoint, because widespread use of preemptive and prophylactic antivirals has rendered CMV-induced disease too rare to be a practical endpoint for clinical trials. In solid organ transplant patients, CMV-associated disease is sufficiently common for use as a primary endpoint. Additional research to advance CMV vaccine development should include identifying factors that predict fetal loss due to CMV, determining age-specific incidence and transmission rates, defining the mechanism and relative contributions of maternal reactivation and re-infection to cCMV disease, developing assays that can distinguish between reactivation and re-infection in seropositive vaccinees, further defining predictors of sequelae from cCMV infection, and identifying clinically relevant immune response parameters to CMV (including developing validated assays that could assess CMV antibody avidity) that could lead to the establishment of immune correlates of protection.

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Section: Use Of a CMV Vaccine In Different Target Populations To Prevmentioning

confidence: 99%

Priorities for CMV vaccine development

Krause

Bialek

Boppana

et al. 2013

Vaccine

126

104

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“…Because these vaccines are covered under the VICP, the manufacturers and administrators of such vaccines generally are afforded the Vaccine Act's liability protections. 57 Although these 2 vaccines are currently covered under the provisions of the VICP, maternal immunizations in general still have several coverage gaps that endanger the manufacturer's liability protection. Although influenza and Tdap vaccines are covered under the VICP, new categories of vaccines that would potentially be indicated only for use during pregnancy and not routinely recommended for use in children would not be covered under this program if they were not also recommended for use in children.…”

Section: Nvac Recommendationsmentioning

confidence: 99%

Overcoming Barriers and Identifying Opportunities for Developing Maternal Immunizations: Recommendations From the National Vaccine Advisory Committee

2017

Public Health Rep

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Recognizing the importance and impact of maternal immunizations on public health, the Assistant Secretary for Health of the US Department of Health and Human Services charged the National Vaccine Advisory Committee (NVAC) in June 2012 with reviewing the state of maternal immunizations and existing best practices to identify programmatic gaps and/or barriers to the implementation of current recommendations regarding maternal immunization. The NVAC established the Maternal Immunization Working Group in August 2012 to conduct these assessments and to provide recommendations for overcoming identified barriers. The report that follows reflects the work of the group charged with identifying barriers to and opportunities for developing vaccines for pregnant women and making recommendations to overcome these barriers. The NVAC working group initially focused its efforts on 4 areas: (1) ethical issues, (2) policy issues, (3) preclinical and clinical research issues, and (4) provider education and support issues.

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“…Some special masters and judges of the U.S. Court of Federal Claims have rendered decisions concluding that Congress intended "receipt" to mean only direct injection, thereby precluding compensation for in utero injuries, whereas others have concluded that Congress intended "receipt" to have a broader meaning that includes in utero receipt. 202 However, none of these decisions are binding, because only the U.S. Court of Appeals for the Federal Circuit (or the U.S. Supreme Court) sets binding precedent over the VICP. To date, the U.S. Court of Appeals for the Federal Circuit has not addressed the issue of compensability of in utero injuries, so the question has not been resolved.…”

Section: Vaccine Liability Under the Vaccine Injury Compensation Programmentioning

confidence: 99%

“…Uncertainties surrounding maternal immunizations and vaccine liability under the VICP create barriers that limit obstetrical care providers' willingness to administer immunizations during pregnancy. To be considered for compensation, a petitioner must demonstrate by a preponderance of the evidence that the injury (or death) was caused or significantly aggravated by the vaccine and that the vaccine received was listed in the Vaccine Injury Table. 202 A presumption of causation is provided if an injury meets all of the requirements for an injury listed in the Vaccine Injury Table. Vaccines included in the Vaccine Injury Table are all those that have been recommended by CDC for routine use in children, for which an excise tax has been imposed, and that the Secretary of HHS has added to the VICP. The VICP trust fund provides funds to the VICP through the excise tax that is imposed on these vaccines.…”

Section: Vaccine Liability Under the Vaccine Injury Compensation Programmentioning

confidence: 99%

The National Vaccine Advisory Committee: Reducing Patient and Provider Barriers to Maternal Immunizations

Orenstein¹,

Gellin²,

Viswanath³

et al. 2015

Public Health Rep

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Recommendation 5: recognize and address current vaccine liability law barriers to optimize investigations and uptake of recommended and future vaccines during pregnancy 5.1. The ASH should support efforts by HRSA to address the issue of including in utero injuries allegedly incurred following maternal immunization within the Vaccine Injury Compensation Program (VICP). The ASH should support resolution of the issue regarding infants born with alleged in utero injuries in favor of allowing such claims to be pursued under the VICP and in favor of providing settled liability protections to vaccine manufacturers and administrators.

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Liability and maternal immunization: in utero injury claims in the VICP

Cited by 10 publications

References 2 publications

Priorities for CMV vaccine development

Priorities for CMV vaccine development

Overcoming Barriers and Identifying Opportunities for Developing Maternal Immunizations: Recommendations From the National Vaccine Advisory Committee

The National Vaccine Advisory Committee: Reducing Patient and Provider Barriers to Maternal Immunizations

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