In some cases where data are lacking or inadequate, the opinion of ACIP members or other experts are used to make recommendations. Information about new ACIP recommendations that is published in official letters or in the official immunization reference book usually does not describe in detail the methods used in developing recommendations, but does describe the evidence used to inform these recommendations, such as the results of clinical trials, case–control studies, case series, expert opinion, or cost-effectiveness analyses. After formulation
by the Working Group, the draft recommendations are subjected to further extensive review by ACIP members, staff of the DDC, and members of the Working Group. Working Group or ACIP members may identify a need for additional data, corrections in the data, or modifications in the interpretation of the data, and members may critique find more and challenge the opinions of experts. Selleckchem Crizotinib The Working Group then compiles all of these comments and views in an iterative process and presents options for action to the ACIP for final consideration. While the government is not obligated to implement recommendations made by the ACIP, to date it has never rejected any ACIP recommendation. However, sometimes the recommendation cannot be implemented immediately, due to operational or programmatic considerations. For example,
the ACIP agreed in 1999 that the EPI use the combination DPT-hepatitis GBA3 B vaccine in place of separate DPT and hepatitis B vaccines. However, due to concerns about the programmatic feasibility of this change, including the high vaccine price and supply issues, since there was only one manufacturer producing the combination
vaccine at that time, the DDC requested that the implementation of the new recommendation be delayed. The switch to the combination vaccine was subsequently implemented nation-wide in 2007, after the vaccine price had been reduced and more manufacturers had entered their DPT-hepatitis B vaccine onto the market. The minutes of each ACIP meeting are distributed to all Committee members, who are allowed to suggest revisions before the minutes are finalized. These minutes are reviewed again at the next ACIP meeting. The meeting minutes are not posted for the public, but individuals and organizations can request them in writing, if they clearly state the specific reasons for their request. Most requests are from researchers conducting research on related topics, but such requests are rare. If a new vaccine is recommended for introduction, the Department of Disease Control will then prepare a proposal and budget for approval by the MoPH and then by the NHSO, which oversees the national health insurance plan. As shown in Fig. 2, the budget for introduction of the new vaccine must be approved by the Cabinet and finally by the Parliament.