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ACIP: Guidance for Vaccine Recommendations for Pregnant and Breastfeeding Women

The Charter of the Advisory Committee on Immunization Practices (ACIP) states that the ACIP "shall provide advice and guidance to the Secretary, HHS, the Assistant Secretary for Health, and the Director, CDC, regarding the most appropriate selection of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population" of the United States; and "address the principles that govern...special situations or populations that may warrant modification of the routine recommendations." One such special population comprises pregnant and breastfeeding women (P-BFW). Formulation of policy for vaccination of P-BFW is challenging because the evidence base to guide decisions is limited. To date, the ACIP has not provided guidance to its work groups (WGs) on either the process to formulate policy for this population, or the format and language for recommendations. This has resulted in a diversity of recommendations for use of vaccines in P-BFW that vary in clarity and underlying rationale.

To ensure that recommendations on vaccination of P-BFW are developed using a consistent, rigorous process and presented with clarity and uniformity, the ACIP Work Group (WG) on Vaccines during Pregnancy and Breastfeeding was established in 2007 to develop guiding principles for drafting of ACIP recommendations on vaccination of P-BFW. Early in the process ACIP determined that it would not be possible to make general recommendations for P-BFW and that future vaccine-specific recommendations by ACIP would integrate P-BFW recommendations into their statements. In March 2008 the ACIP approved the WG document on Guiding Principles in Development of ACIP Recommendations for Vaccination during Pregnancy and Breastfeeding. This document provides guidance to help standardize both the process of policy formulation and the presentation of the rationale and recommendations for vaccination of P-BFW. Topics in the Guiding Principles include guidance for the background section structure; structure and language of recommendations; clarification of precautions and contraindications in the context of P-BFW; suggestions to aid policy decision-making in the absence of adequate data; and standardization of the gathering of expert opinion. These principles are applied to development of ACIP vaccine statements and routine updates of existing statements in which vaccination of P-BFW is considered.

Guiding Principles in the Development of ACIP Recommendations for Vaccination during Pregnancy and Breastfeeding may be found at

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