FRIDAY, Jan. 17, 2003 (HealthDayNews) -- A panel of doctors and ethicists is recommending that the U.S. government be forthcoming about a little-known risk of the smallpox vaccine: If you get sick from it, there may be no way to get compensated financially.
People who get vaccinated should be warned about all the possible dangers they might face, even those that aren't medical side effects, said a committee convened by the U.S. Institute of Medicine in a report issued today.
"People should be aware of what costs they should be expected to absorb," said committee member Alta Charo, a professor of law and bioethics at the University of Wisconsin.
After the report was released, the U.S. Centers for Disease Control and Prevention (CDC) said it would include a very brief mention of the lack of compensation in an information sheet about the vaccine.
The panel issued its report as part of an ongoing project to advise the CDC about government plans for a massive smallpox vaccination program. The CDC asked for the report, which was written by a committee made up mostly of professors at medical schools.
The United States abandoned routine immunization against the smallpox virus in 1972, and the World Health Organization declared the infection eradicated in 1980. However, the United States and Russia have preserved samples of the virus, and intelligence experts fear that Iraq and North Korea have supplies of it, too.
While there is no known immediate smallpox threat, President Bush has ordered that vaccinations be provided to 500,000 health-care workers. The first shipments of vaccine will go out to states on Tuesday, with inoculations scheduled to start Jan. 24.
Later, the government plans to offer vaccinations to another 10 million people who work in public safety, such as police officers and firefighters. Finally, the public will get a chance to request vaccinations.
The panels' report emphasizes the uniqueness of the smallpox program, compared to other vaccines that are given routinely.
"This is not a normal public health measure. This is a riskier vaccine than any other vaccine in general use. The risks are very real," said committee chairman Dr. Brian L. Strom, professor and chairman of the department of biostatistics and epidemiology at the University of Pennsylvania School of Medicine.
The smallpox vaccine is effective against the virus, but it can lead to deadly complications in about one in every 1 million people who receive it. Another 10 to 15 people per million suffer serious side effects, such as severe rashes.
Experts estimate that one in three Americans shouldn't get the vaccine because of potential side effects that could be deadly. The vaccine essentially sickens people with a sister virus to smallpox; a successful recovery leads to immunity.
Groups at risk include pregnant women; those with compromised immune systems, like HIV patients, chemotherapy patients and organ transplant recipients; and those who have ever suffered from eczema. And anyone who lives with a member of a risk group shouldn't get vaccinated either, according to the CDC.
The panel also suggested that vaccinations occur outside the workplace, to protect the privacy of employees who don't want to be inoculated.
"That way there's no peer pressure for people to take a vaccine they otherwise wouldn't," Strom said, adding that co-workers won't end up speculating about why someone refused a vaccination.
The panel also recommended that potential recipients visit clinics twice -- once to learn about the vaccine and a second time to actually get vaccinated if they choose. "It gives people time to think about it and digest information and share with family members," Strom said.
The panel said the information must include full details about the vaccine's risks, including the lack of compensation plans in case something goes wrong.
Panel members said they fear that some citizens will wrongly assume that the federal government would reimburse them for medical expenses and lost income if the vaccine makes them sick. In fact, the Homeland Security Act of 2002 allows recipients to file claims only over mishaps due to negligence, such as a wrong dose of the vaccine.
"The way to address [citizens] is through informed consent," Strom said. "We have to be clear to them about what coverage they have and what coverage they don't have."
The panel warned that while worker's compensation and health insurance may pay for some costs, the absence of full compensation may lead many people to turn down the vaccinations.
The CDC is concerned about how to compensate people who are sickened by the vaccine and is exploring how worker's compensation may assist them, said Dr. Julie Gerberding, director of the CDC. She spoke during a teleconference called by the CDC to respond to the committee report.
But she added that "the government has no plans to delay the vaccination program because of concerns about compensation."
More information
For more on the smallpox vaccine, visit Stanford University or the Centers for Disease Control and Prevention.
