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Publication of Vaccine Information Pamphlets

On October 15, 1991, the U.S. Department of Health and Human Services (HHS) published in the Federal Register (56 FR 51798) the vaccine information materials mandated under Section 2126 of the Public Health Service Act (42 U.S.C. section 300aa-26). The National Childhood Vaccine Injury Act (Public Law 99-660) required the Secretary of HHS to develop vaccine information materials for distribution by health-care providers to each adult or to the legal representative of each child receiving any of the following vaccines: diphtheria, tetanus, pertussis, measles, mumps, rubella, and poliomyelitis vaccines. The vaccine information materials are written as three pamphlets and cover the following vaccines: one for diphtheria, tetanus, and pertussis (DTP); the second for measles, mumps, and rubella (MMR); and the third for poliomyelitis.

The purpose of the vaccine information materials is to ensure that sufficient writ ten information about the risks for the diseases and the risks for and benefits of the vaccines is provided to enable informed choices before vaccination. These materials include information on the disease each vaccine is designed to prevent; manifestations of reactions to the vaccine; precautionary measures that should be taken to reduce the risk for any major adverse reactions to the vaccine; contraindications to, and basis for delay of, administration of the vaccine; an identification of certain groups who may be at substantially higher risk than the general population for major adverse reactions to the vaccine; notice of the availability of the National Vaccine Injury Compensation Program; and federal recommendations concerning a complete schedule of childhood vaccines.

Drafts of these vaccine information materials were published in the Federal Register on March 3, 1989 (54 FR 9180). Publication of these final vaccine information materials by HHS follows public comment and extensive consultation with health-care providers, parent organizations, and the Advisory Commission on Childhood Vaccines.

Effective April 15, 1992, each health-care provider who administers one of the specified vaccines must provide copies of the relevant information material to each adult or to the legal representative of each child receiving any of these vaccines. Health-care providers who administer privately purchased vaccines may elect to develop their own information materials, provided these materials meet the detailed requirements of the law. Whether using the HHS-developed vaccine information materials or other materials meeting the requirements of the law, the health-care provider must provide the relevant material before administration of the vaccine.

By arrangement with CDC, each state's immunization project will provide single camera-ready copies of each of the vaccine information pamphlets to each health-care provider who administers any of the applicable vaccines.

Additional information is available from the Training Coordinator, Division of Immunization, National Center for Prevention Services, CDC; telephone (404) 639-2590 (FTS 236-2590).

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