Key steps forward for maternal immunization: Policy making in action

• Published in: Vaccine Vol. 36; no. 12; pp. 1521 - 1523
• Main Authors: Beigi, R.H., Omer, S.B., Thompson, K.M.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 14.03.2018; Elsevier Limited
• Subjects: Compensation; Consent; Ethics; FDA approval; Federal regulation; Female; Health Policy; Humans; Immunization; Immunization - legislation & jurisprudence; Immunization - methods; Liability; Maternal Health Services - legislation & jurisprudence; Maternal immunization; Policy; Policy Making; Pregnancy; Public health; Risk reduction; Task forces; United States; Vaccination - legislation & jurisprudence; Vaccination - methods; Vaccines; Womens health; United States > US; Policy; Pregnancy; Maternal immunization
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2018.02.041

Institutional Review Board (IRB) guidance on interpretation of minimal risk; Code of Federal Regulations language surrounding research in pregnancy; Collaboration with bioethics experts, regulatory agencies, and the scientific community to optimize the design of studies to minimize the risk of interventions for research in pregnancy; and Relevant regulations, statutes, and policies that should be modified to indicate that pregnant women are not a vulnerable population for the purposes of ethical review” [4]. [...]the report recommended “The ASH should advocate to the Secretary of Health and Human Services (HHS) to resolve the uncertainties around coverage under the Vaccine Injury Compensation Program (VICP) for vaccines administered to pregnant women that are not recommended for use in children by the CDC, and for liability protections for live-born infants born to mothers vaccinated during pregnancy” [4]. Related, the law says that with respect to criteria for excluding pregnant or lactating women from research the Secretary should consider any appropriate criteria to be used by IRBs and individuals reviewing grants for excluding pregnant or lactating women as a study population requiring additional protections from participating in human subject research (section 2041 (c) of P.L. 114-255).5 Eligibility for compensation and liability protection under the VICP The Childhood Vaccine Injury Act of 1986, as amended (Vaccine Act) (42 U.S.C. §§ 300aa-1 to 300aa-34) created the VICP to provide compensation to people (regardless of age) found to have been injured by, or died as a result of, the administration of certain covered vaccines. [...]the NVAC report [4] noted a contrast between the VICP and the Countermeasures Injury Compensation Program (CICP).