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JUNE 15, 2000


Good morning. I am Dr. Dixie Snider, Associate Director for Science at the Centers for Disease Control and Prevention (CDC). As Executive Secretary for CDCís Advisory Committee on Immunization Practices (ACIP), I am pleased to be here to discuss the policies and procedures of the Committee and its role in developing recommendations for vaccine use.

The ACIP provides advice and guidance to the Secretary, Department of Health and Human Services (HHS), the Assistant Secretary for Health, and the CDC Director on the most effective means to prevent vaccine-preventable diseases. The ACIP develops written recommendations, subject to the approval of the CDC Director, for the routine administration of vaccines for the pediatric and adult populations, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines. In addition, as provided by statute, the ACIP designates vaccines for administration in the Vaccines for Children Program (VFC). The ACIP makes such recommendations taking into account available information about a vaccine and placing that information in the larger context of the various health care delivery systems in the U.S., the current disease epidemiology, implementation issues, ethical and legal constraints, and other factors. The overall goal of the ACIP is to provide advice that assists CDC, HHS and the Nation in reducing new cases of vaccine preventable diseases and increasing the safe usage of vaccines and related biological products that provide active and passive immunoprophylaxis.

The ACIP consists of twelve regular voting members, selected by the Secretary, HHS, from authorities who are knowledgeable in the field of immunization practices, have multi-disciplinary expertise in public health, and have expertise in the use of vaccines and immunologic agents in both clinical and preventive medicine. It is crucial that these varied areas of expertise are represented by the Committee membership. One of the purposes of an advisory committee is to provide additional scientific expertise to add to the body of special knowledge and information, beyond what may be selected for presentation at committee meetings. Experts are more likely to be familiar with the published scientific literature with its strengths and weaknesses than non-experts. In addition, experts are more likely to know cutting-edge research information, including unpublished information, that may not be available to non-experts. If this expertise were not available, members would be limited to decision-making based solely on selected information presented at ACIP meetings. In addition to required technical expertise, consideration for ACIP membership is given to representation from diverse geographic areas, both genders, racial and ethnic groups, and the disabled.

In addition to the regular voting members, the ACIP has ex-officio members from other Federal agencies involved with vaccine issues, and non-voting liaison representatives from professional societies and organizations responsible for the development and execution of immunization programs for children and adults. The participation of these ex-officio members and liaison representatives provides a better understanding of the position and views of their sponsoring organizations resulting in better informed decisions.

ACIP regularly scheduled meetings are held three times a year, with meeting dates announced 6-12 months in advance. Notices of each meeting, along with agenda items that may be discussed, are published in the Federal Register in accordance with the requirements of the Federal Advisory Committee Act (FACA). Notices of these meetings are issued at least 15 days in advance of the meeting, to allow adequate time for all interested parties to make arrangements to attend. ACIP meetings are open to the public, who are welcome to attend and present their views. Public comments are solicited during the ACIP meetings and are included in the decision making process prior to voting on recommendations.

To ensure a thorough review of available information, the ACIP often appoints working groups to assist in the development of drafts of recommendations. Working groups generally consist of ACIP members and CDC staff and may include ex-officio members, liaison representatives and other consultants with immunization expertise. Working groups present these drafts for deliberation by the full Committee at regularly scheduled meetings of the ACIP. Only the full committee of the ACIP may issue ACIP recommendations, after a vote approving those recommendations is taken. A vote may be taken when a quorum of at least seven eligible ACIP members are present. Eligible voters are those members who do not have a conflict of interest. If there are not seven eligible voting members present, the Executive Secretary of the Committee can appoint the ex officio members as voting members, as provided in the Charter for this Committee.

Federal advisory committees inherently have members who may have potential financial conflicts of interest because, as Iíve mentioned, the members are chosen for service based on their expertise in the areas in which advice is sought by the government. Experts in the vaccine field frequently have affiliations with, or may be engaged in research conducted by, academic institutions or other institutions which may receive funding from vaccine manufacturers. Physicians in private practice who are considered experts often do consultancies, work for managed care organizations involved in clinical trials, and/or accept honoraria for lectures given at scientific meetings sponsored by manufacturers. This professional experience which contributes toward the development of their immunization expertise also may result in potential conflicts of interest. Congress has recognized the need for service on federal advisory committees by these experts and has provided for waivers of the conflict of interest prohibitions under 18 U.S.C. ß 208 when the need for the individualís services outweighs the potential for a conflict of interest created by the financial interest involved. CDC is sensitive to any perception regarding potential conflicts of interest of members serving on the ACIP and is committed to taking steps to ensure not only that there is technical compliance with the provisions of 18 U.S.C. ß 208, but that the spirit of those provisions is also fulfilled.

Consistent with these provisions of law, limited waivers may be issued to individual ACIP members who have potential conflicts of interest so that the government may benefit from the scientific and public health expertise of each member. Under these waivers, each member with a potential or actual financial conflict of interest may be granted a limited waiver to allow participation in all committee discussions, with the conditions that (a) the member publicly discloses relevant interests at the beginning of each ACIP meeting and (b) the member abstains on votes involving entities with which the member has a current direct financial interest, when that vote could potentially result in a significant financial impact on the entities.

All ACIP members are required to disclose financial interests they have had within the past 12 months, as well as the financial interests of their spouse and minor children. This information is collected using the Office of Government Ethics (OGE) 450 Confidential Financial Disclosure Form. Financial interests which are reported include: 1) stock-ownership; 2) honoraria; 3) employment; 4) general partnership interests; 5) contracts; and, 6) receipt of grant funds. Consistent with OGE guidance, the OGE 450 forms of ACIP members are reviewed for vaccine-related interests by CDCís Committee Management Office, the ACIPís Executive Secretary and Administrative Assistant, and CDCís Office of General Counsel. In addition, membersí curricula vitae are reviewed to determine whether additions need to be made to the OGE 450 forms. Members revise/update their OGE 450 forms on an annual basis.

As noted, in addition to disclosing financial interests by submitting a Confidential Financial Disclosure Report, members are required to publicly disclose all relevant financial interests at the beginning of each ACIP meeting. This public disclosure, which is fairly unique to ACIP, ensures that the agency, their fellow members, and the public are aware of each memberís interests which can be weighed in the deliberations of the committee.

ACIP maintains the highest scientific standards in developing recommendations for the use of vaccines. Their process includes (1) a review of the labeling/package inserts for each vaccine; (2) a thorough review of the scientific literature (both published and unpublished, when available) on the safety, efficacy, acceptability, and effectiveness of the immunizing agent, with consideration of the relevance, quality, and quantity of published and unpublished data; (3) an assessment of cost effectiveness; (4) a review of the morbidity and mortality associated with the disease in the population in general and in specific risk groups; (5) a review of the recommendations of other groups; and (6) a consideration of the feasibility of vaccine use in existing child and adult immunization programs. Feasibility issues include (but are not limited to) acceptability to the community, parents, and patients; vaccine distribution and storage; access to vaccine and vaccine administration; impact on the various health care delivery systems; population distribution effects; and social, legal and ethical concerns.

ACIP recommendations are extremely useful to CDC and others engaged in developing vaccine use recommendations and policies. Once the ACIP recommendations are submitted to CDC, they are reviewed and a determination is made whether or not to accept them. When approved by CDC, the ACIP recommendations are published in the Morbidity and Mortality Weekly Report Recommendations and Reports series, and occasionally reprinted in other publications.

CDC is continuously reviewing its policies related to its advisory committees to achieve the highest level of scientific integrity in obtaining external expertise. We welcome any suggestions to improve this process which will also provide this necessary expertise which is so essential to an advisory committee.

In closing, Iíd like to note how immunization recommendations such as those developed by the ACIP have benefitted this nation. Immunization is recognized as one of the greatest public health achievements of the 20th century, based on its impact on preventing death, illness, and disability. Immunizations have resulted in the eradication of smallpox; elimination of poliomyelitis in the Americas; and control of measles, rubella, tetanus, diphtheria, Haemophilus influenzae type b, and other infectious diseases in the U.S. and other parts of the world. Vaccine-preventable diseases are at an all time low in the U.S. Still, there are challenges which face us. CDC is committed to meeting those challenges to improve the health of children and the nation as a whole.

Iíll be happy to respond to any questions you may have.

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