Regulation lays out compensation for illnesses from smallpox shots

With little fanfare, the Bush administration on Friday issued the final regulation that lays out how healthcare workers who become ill because of smallpox vaccinations can receive financial compensation.

Although the regulation itself has changed little from the interim rules that have been in force since December 2003, the underlying program appears to be a solution to a problem that does not exist. No healthcare worker has reported an illness related to the vaccine for more than two years, according to Lola Russell, spokeswoman for the U.S. Centers for Disease Control and Prevention (CDC).

“There’s no concern [because] the numbers haven’t changed since the end of 2003,” she said.

Mike Leavitt, secretary of the Department of Health and Human Services (HHS), said in a written statement, “By offering compensation to first responders and others injured by the vaccine, the program protects those pledged to protect us in the event of a smallpox outbreak.”

But the main reason that new adverse events have not cropped up is that almost no medical personnel have been vaccinated since then.

“They’ve had very limited vaccinations,” Russell said.

Congress created the Smallpox Vaccine Injury Compensation Program in 2003 as the final piece of a campaign to inoculate medical personnel and first responders against the deadly and highly contagious smallpox disease. The Health Resources and Services Administration oversees the compensation program.

Smallpox no longer exists in nature after a global campaign to eradicate it more than 20 years go, but it is considered a likely bioterrorism agent.

In December 2002, President Bush unveiled an ambitious plan that, he said, would create a response force of up to 10 million people who would be protected against the disease in the event of a smallpox attack.

But the program, run by the CDC, never took off. Instead of the hundreds of thousands of frontline healthcare workers whom the administration expected to be vaccinated, fewer than 40,000 received the vaccine. Nearly all of those people were inoculated in the first few months of the program.

The vaccine can cause serious and even fatal side effects, some of which doctors do not fully understand and cannot always predict. Before the eradication campaign that wound down in the 1980s, nearly all Americans received smallpox inoculations. Based on that experience, the CDC says 1,000 people out of every million people vaccinated suffered serious side effects.

When the administration’s vaccination program rolled out in 2003, reports of vaccine-related illnesses began to trickle out and scare healthcare workers away from the program, said Georges Benjamin, executive director of the American Public Health Association.

“People did a risk-assessment,” he said.

Ironically, Congress and the administration belatedly agreed to create the compensation program to quiet an uproar among healthcare workers and labor unions.

Because the vaccine can lead to serious illnesses — and a few medical personnel died in the early days of the immunization campaign — healthcare workers, along with congressional Democrats, insisted that the compensation program be a part of the rollout of the smallpox program.

The administration initially resisted but relented and agreed to develop a compensation scheme along with Congress. In the meantime, interest among healthcare workers in receiving the vaccine apparently diminished and the existence of a compensation plan did not quell their skepticism.

“When HHS moved, it didn’t move fast enough. Quite frankly, it was too little, too late,” said Benjamin.