Collins Releases GAO Report Showing Slow Progress in the Nation’s Smallpox Vaccination Program

WASHINGTON — Senator Susan Collins (R-ME), Chairman of the Governmental Affairs Committee, today released a new study by the General Accounting Office (GAO) concluding that the nation’s smallpox vaccination program is far behind schedule in inoculating health care workers due to fear of health risks, liability and cost.

The National Smallpox Vaccination Program, which is administered by the Centers for Disease Control and Prevention (CDC) in collaboration with 62 state, local and territorial jurisdictions, was expected to inoculate as many as 10 million health workers and other emergency response personnel in two stages. The first stage was to inoculate 500,000 health workers within 30 days of the program’s January 24, 2003, startup. However, the GAO found that as of April 4, 2003, 10 weeks after the program began, only 6 percent of the initial 500,000 workers had been inoculated.

Maine had initially targeted 100 public health workers to receive the inoculation during the first phase of the program. To date, 39 workers have received the vaccine.

“Since the smallpox vaccination program is our first large-scale bioterrorism defense program, we need to learn as much as we can from it to aid in the development of future programs,” Collins said. “Unfortunately, the slow progress has made it difficult to determine the actual costs and health risks associated with this program.”

The GAO study, which Collins requested, found that the CDC program is facing major challenges, which may cause the CDC to cut back on its ambitious schedule. Overall, the problem has been caused by the hesitation of state and local public health authorities, hospitals and the health care workers themselves to participate in the program. Their concerns involve the costs of the program, the need for increased protection from liabilities associated with the potential health risks of the smallpox vaccine, and a personal fear of the vaccine’s side effects. There have been isolated cases of deaths caused by heart attacks among smallpox vaccine recipients, although it is unclear that the deaths were related to the vaccinations. According to the GAO study, many potential volunteers and hospitals are also concerned about whether there would be compensation for lost income should they have an adverse reaction to the inoculations.

GAO auditors found that hundreds of hospitals have decided not to participate because they believe that the risks outweigh the benefits of the vaccination program, given that the Administration has characterized the threat of a smallpox attack as being low.

“Congress has taken steps to address concerns that state and local health officials and hospitals have expressed about insufficient resources and the need for increased liability protection,” Collins said. “However, health care workers in Maine and elsewhere continue to be reluctant to voluntarily assume the health risks associated with the vaccine in the absence of a more imminent threat of a smallpox attack. As the CDC adjusts its program, it needs to provide clear guidance and improved communication with its state and local partners to ensure that the health care team it is assembling can effectively respond if such an attack were to occur.”

The 2003 Omnibus Appropriations bill, approved in January, included an additional $1.4 billion to state and local governments and hospitals for their bioterrorism efforts. Maine is expected to receive more than $10.5 million of this funding. In addition, the 2003 Emergency Wartime Supplemental Appropriations bill, signed into law earlier this month, included $100 million for the CDC to assist state and local health authorities with costs already incurred in the smallpox program as well as future costs. An additional $42 million was provided to compensate individuals with injuries resulting from the smallpox vaccine. Congress also passed the Smallpox Emergency Personnel Protect Act, which provides up to $50,000 a year in lost wages to people who are permanently disabled as a result of receiving the vaccine, with no cap on damages. Partially disabled recipients would be eligible for the same amount but with a lifetime cap of $262,100. The law also provides immunity to hospitals and health care workers who administer the vaccine.