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

Abstract

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.

Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement

“…. should be modified to indicate that pregnant women are not a vulnerable population for the purposes of ethical review" (13). This recommendation and concurrent policy action led to a change in the U.S. Code of Federal Regulations which had previously classified pregnant women as being inherently vulnerable to coercion (14).…”

“…First, a report of the U.S. National Vaccine Advisory Committee's Working Group on Maternal Immunization recommended that “Relevant regulations, statutes, and policies…should be modified to indicate that pregnant women are not a vulnerable population for the purposes of ethical review” ( 13 ). This recommendation and concurrent policy action led to a change in the U.S. Code of Federal Regulations which had previously classified pregnant women as being inherently vulnerable to coercion ( 14 ).…”

Review of the status and challenges associated with increasing influenza vaccination coverage among pregnant women in China

“…104 As an example, although influenza vaccination of pregnant women has been recommended for decades in the United States, it was only relatively recently that government authorities identified remaining legal and programmatic hurdles to vaccinating pregnant women that should be addressed to instill confidence in providers to vaccinate pregnant women. 105 The National Vaccine Advisory Committee stated that, "although [US] CDC already recommends the use of vaccines during pregnancy, certain ethical, policy, educational, and research barriers need to be addressed to improve uptake of currently recommended vaccines and promote the development of additional maternal immunizations." 105 It is likely that China will need to do the same.…”

“…105 The National Vaccine Advisory Committee stated that, "although [US] CDC already recommends the use of vaccines during pregnancy, certain ethical, policy, educational, and research barriers need to be addressed to improve uptake of currently recommended vaccines and promote the development of additional maternal immunizations." 105 It is likely that China will need to do the same.…”

Current Challenges and Achievements in Maternal Immunization Research

“…Other advances relate to the change in classification of pregnant women from being considered a “vulnerable” population for research, to no longer being considered “vulnerable.” This challenge for maternal immunization was addressed by the National Vaccine Advisory Committee to the Department of Health and Human Services, who also recommended the prioritization of maternal immunization as a public health strategy, and the investment in the development of vaccines for pregnant women ( 31 ). Globally, the 2017 updated International Guidelines for Health-Related Research Involving Humans of the Council for International Organizations of Medical Sciences, in collaboration with the WHO, also conclude that women must be included in health-related research, unless a good scientific reason justifies their exclusion, and that women should provide informed consent for themselves ( 32 ).…”