Sixty-seven NYC hospitals have informed the NYC Department of Health and Mental Hygiene (DOHMH) that they intend to participate in Phase I of the Federal government's pre-event smallpox vaccination program as of DOHMH's deadline for notification of January 13, 2003. As anticipated, on January 24, 2003, U.S. Health and Human Services Secretary Tommy Thompson issued a declaration stating that a potential bioterrorist incident makes it advisable to proceed with the pre-event vaccination program. The declaration is needed in order to trigger the liability protections afforded by the Homeland Security Act discussed below, which are intended to ensure that vaccine is available to protect the public health.

DOHMH plans to begin train-the-trainer sessions for participating hospitals in early February. The NYS Department of Health (DOH) has asked hospitals outside of NYC to inform their local county health departments by January 31, 2003, regarding the number of potential vacinees for Phase I. Regional resource centers outside of NYC will facilitate the vaccination program for hospitals in their regions, assisting with vaccinations, monitoring vaccinees, and responding to any adverse events. Phase I of the pre-event program calls for approximately 450,000 health care and public health workers across the country to be vaccinated for the purpose of developing smallpox response teams, which will consist of 100-200 workers in each hospital. The teams are intended to ensure the availability of workers in each hospital to care for the first one to five smallpox patients who might present to the hospital, and to provide vaccination to the public should mass vaccination be needed in the future. Phase II is intended to vaccinate up to 10 million health care workers and first responders nationwide, and Phase III would involve vaccination of the general public.

GNYHA on Hospital Participation: The Executive Committee of GNYHA's Board of Governors passed a resolution strongly encouraging hospitals to participate in Phase I, given the importance of the program for protecting each hospital's patients, communities, and workforce as well as for national emergency preparedness and response efforts. To assist its members in their decision-making and implementation plans, GNYHA has also held numerous member briefings and training programs, and will continue to work with members, DOHMH, other county health departments, and DOH.

IOM Letter Report: In a letter report dated December 16, 2003, an expert committee empaneled by the Institute of Medicine (IOM) at the request of the Centers for Disease Control and Prevention (CDC) provided advice to the CDC on how best to implement the pre-event vaccination program. While the report does not call for a delay in the implementation of Phase I, it does recommend a number of considerations to be incorporated in Phase I to the extent practicable given the CDC's timetable. At the very least, the report calls for the CDC to consider the recommendations for the purpose of making mid-course adjustments if necessary during Phase I and particularly for the purpose of proceeding with Phase II. The CDC has already incorporated a number of the IOM recommendations in its Phase I plans and will continue to incorporate additional recommendations. The report also recommends that the CDC 1) highlight the unique nature of the program as a public health component of a national bioterrorism preparedness policy; 2) proceed cautiously; 3) use a wide range of methods for proactive communications, training, and education; and 4) designate one scientist as the key spokesperson for the campaign, and ensure sustained contact with the media throughout implementation.

Coverage of Adverse Events: The NYS Department of Health (DOH) has clarified that NYS workers' compensation insurance should cover adverse events associated with administration of the vaccine in accordance with the plan assuming the individual and the situation are otherwise covered by workers' compensation and pursuant to existing coverage limitations. With respect to adverse events that may not be covered by workers' compensation insurance, DOH has also clarified that the costs of medical treatment for vaccine adverse events generally should be covered in accordance with regular policy provisions for those individuals who have comprehensive health insurance. In addition, the Homeland Security Act, which became effective on January 24, 2003, provides that the Federal government will assume liability for adverse events associated with administration of the vaccine, including secondary transmission of the vaccine, under the Federal Tort Claims Act. Because the Federal Tort Claims Act provides remedies for claimants only for negligent actions, some members of Congress and other interested parties have called on the Bush Administration to support the creation of a no-fault smallpox vaccination compensation fund, much like the one that exists for childhood vaccinations. Thus, greater remedies would be available to those who might be injured as a result of receiving the vaccine. Given the potential for side effects, however, the Federal pre-event vaccination plan builds in extensive mechanisms for screening out individuals with possible contraindications and monitoring for adverse events, and encourages hospitals to identify volunteers who were vaccinated in the past to minimize side effects.