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Executive Summary

OSHA CONSIDERING MANDATORY HEPATITIS B VACCINATIONS for all hospital personnel as part of a more comprehensive rule to control the exposure of health care workers to infectious diseases. The regulation being considered by the Occupational Safety and Health Administration (OSHA) would cover necessary equipment and handling techniques to prevent the infection of the estimated 5 mil. U.S. health care workers. While OSHA now regulates worker exposure to a multitude of chemicals and conditions, the new rule would mark the agency's first effort to control exposure to biological agents. A draft the infectious disease exposure rule is currently under review by the Office of Management & Budget. The OSHA rule could be published as early as April, according to the agency. The hepatitis B part of the proposal faces several difficulties, however, including the high cost of vaccination and the large number of workers who would need to be immunized. In addition, OSHA says that any vaccination program might have to be expanded to include nonmedical personnel such as police and fire fighters, who could be exposed to the disease while on duty. Also of concern are the legal issues associated with such a mass vaccination program. The regulation could be a boon for Merck, which markets two hepatitis B vaccines, Recombivax HB and Heptavax B. SmithKline has had a PLA pending at FDA since 1987 for its recombinant hepatitis B vaccine, Engerix-B.

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