U.S. urged to reveal risks of smallpox vaccine

Associated Press

WASHINGTON -- The Bush administration should tell health workers being offered the smallpox vaccine that it carries real risks and they are likely to receive only minimal compensation if they are injured, scientific experts said today.

"The committee suggests explicitly stating that the benefit of the vaccination program is to increase the nation's public health preparedness, but that the benefit of vaccination to any one individual might be very low," the panel reported to the Centers for Disease Control and Prevention.

The panel, convened by the Institute of Medicine, also urged the White House to analyze the first round of inoculations -- set to begin next week -- before offering the vaccine to millions of other health care workers and emergency responders.

The last case of smallpox in the United States was more than 50 years ago. Routine vaccinations here ceased in 1972, but experts fear the disease could return in an act of bioterror.

Still, the risk of such an attack is unknown, the Institute of Medicine noted, while the risks of the vaccine are well documented. Based on historical information, as many as 40 people out of every million being vaccinated for the first time will face life-threatening reactions, and one or two will die.

President Bush's plan calls for quickly vaccinating nearly a half million people working in hospital emergency rooms and on special smallpox response teams. The panel emphasized that information about risks and benefits must be clearly communicated to them.

The experts also recommended that people be told that they may not receive any compensation if they are injured by the vaccine.

Congress acted to protect people and institutions delivering the vaccine from most lawsuits that could be filed by those injured by the inoculation, leaving such patients with little recourse. Under the policy, injured people may have access to state workers' compensation programs, but those programs are not likely to cover all medical expenses and time lost from work.

An existing compensation fund helps people injured by other vaccines, but it does not cover smallpox. So far, the administration has not proposed any similar fund for smallpox.

The panel advised the Bush administration to look for "bold and creative" solutions to provide compensation to people who are injured.

Without a way to reimburse people for their lost work time and medical expenses, the panel said, "some, perhaps many" people may decline to get vaccinated, thus "undermining the effectiveness" of the program.

The report also recommends that federal officials move slowly from the program's first phase, set to begin next week. In the second phase, the vaccine would be offered to some 10 million people, including other health care workers and emergency responders such as police and firefighters.

Today's report recommended that the CDC evaluate the rate of serious reactions, the effectiveness of its educational material and the variation in vaccination policies from round one before moving to the second group of vaccines.

The CDC also should name a "single voice" to communicate with the public -- someone with a strong scientific background and widely recognized credibility, the panel said.

"To safeguard the separation between political and public health communications, the key spokesperson should not be a politician," the report said.

During the 2001 anthrax attacks, the administration was roundly criticized for inaccurate information given by politicians, particularly in the early days of the crisis.

Today's report comes a day after a pair of large health care unions argued that a delay in the program is needed to address many of the same issues spotlighted by the Institute of Medicine. The White House responded Thursday that the program would move forward as planned.