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Help sought for future victims of smallpox vaccine

By Julie Appleby, USA TODAY

With the start of an effort to vaccinate health care workers against smallpox just days away, pressure is mounting to establish a compensation fund for those injured by the vaccine.

• The influential Institute of Medicine issued a report Friday that called for, among other things, a compensation fund. The institute, which advises lawmakers and policymakers on scientific matters, said workers who volunteer to receive the vaccine should be told of the "availability, or lack thereof, of compensation for adverse reactions."
• Eight Democrats in Congress wrote to President Bush on Friday to urge him to heed the institute's recommendations.
• Two large health care unions called on Bush on Thursday to halt the vaccination effort until a medical-screening program for volunteers is established and a compensation fund set up.

Many states expect to begin the first phase of the program, aiming to vaccinate roughly 440,000 hospital and public health workers, as soon as Friday. That's the day federal liability protections kick in. Those protections, included in legislation that established the Department of Homeland Security, guarantee that hospitals, clinics and vaccine-makers cannot be sued for injuries from the vaccine.

The criticism could hamper efforts to make the voluntary vaccination program as widespread as possible. Already, concerns about the risks have prompted a number of hospitals to say they would not recommend that their workers volunteer for the vaccine.

Based on previous experience with smallpox vaccination, which was halted in the USA in 1972 when it appeared the disease had been wiped out here, it is estimated that at least 15 out of every 1 million people being vaccinated for the first time will face life-threatening complications; one or two will die.

The Bush administration has said a compensation fund might not be necessary. Workers' compensation and health insurance policies are expected to cover many of the costs associated with the effort. But some worker's compensation companies say costs might not be fully covered. Some workplaces, for example, might say the vaccination program is voluntary — not a required part of the job — and therefore not covered.

"If employees volunteer to take it, they should ask their employer, 'Am I covered?' " says P.J. Crowley, vice president of the Insurance Information Institute, a group sponsored by the property and casualty insurance industry.

Bill Pierce, a spokesman for the Department of Health and Human Services, says patients injured by the vaccine could sue the government under the Federal Tort Claims Act. But most such cases would be difficult to win because the patient would have to prove negligence. Pierce said the administration is awaiting action from Congress on any further compensation effort.

Several proposals are being circulated in Congress.

Rep. Henry Waxman, D- Calif., says he will introduce legislation to set up a compensation program similar to one in place to cover costs incurred by patients harmed by childhood vaccines.

Proponents of a new fund say it would not be easy to add smallpox to the current vaccine compensation program because it is geared toward children, who generally are not awarded damages for lost wages. Advocates of the current vaccine trust fund also say opening it up to smallpox claims would siphon money away from children.

The cost of a smallpox fund has not been established. But, based on the similar childhood fund and recent payments to victims of the Sept. 11 attacks, it is estimated that the fund would pay an average of $1 million per death or serious injury. Out of the first phase of 440,000 workers vaccinated, one death and eight or more serious injuries could be expected. The second phase of Bush's program would offer the vaccination to up to 10 million health and rescue workers, including police and emergency medical technicians. The vaccine also may be made available to the public in 2004.

The childhood vaccination compensation fund is paid for through an excise tax on vaccines. Because the government has purchased the smallpox vaccine and is dispensing it free, government funds are the likely source for any smallpox compensation effort.