An ambitious smallpox vaccination program should be put on hold before it is expanded to a large pool of emergency responders, the influential Institute of Medicine said Tuesday.
Right now, the program is still in its so-called phase one, principally dedicated to nurses and doctors. Phase two, which states are expected to roll out this summer, includes first responders, such as firefighters, police officers and other emergency personnel.
In its ongoing review of the national smallpox vaccination program, the Institute of Medicine, a branch of the National Academy of Sciences that advises the government on health care policy, said the pause is necessary to consider changes to the strategy.
The Bush administration launched the program in January. It was the first time in 30 years that the vaccine was administered in the United States. The World Health Organization officially declared the disease eradicated in 1980. But fear of a bioterrorism attack led administration officials to revive the vaccination program.
The strategy calls for voluntary armies of smallpox response teams in every state. These would consist of nurses, doctors and emergency responders inoculated against the disease. They could sweep into areas of an outbreak and administer the vaccine.
As many as 450,000 health care workers have been identified as potential participants in the first phase of the program. Another 10 million workers could be included in the second phase. To date, 36,000 health care workers have been vaccinated. Administration officials had wanted to have roughly 50,000 health care workers vaccinated by now.
Between January and early May, more than 40 cases of side effects among vaccinated workers, including inflamed hearts, were reported to the Centers for Disease Control and Prevention. Three people have died. It is unclear if there is a direct link to the vaccine. The IOM wants the CDC to get a better handle on the medical complications before offering the vaccine to a broader universe of health care workers.
In addition, the IOM, in a May 23 letter to CDC Director Julie Gerberding, said it is "imperative" that national and state public health officials determine the number of people they need vaccinated. Health and Human Services officials have consistently said that they do not have a set target. Rather, they are leaving it up to the states to come up with their own goals.
"We are not pausing the program," Jerome Hauer, head of public health preparedness at the Health and Human Services Department said during an interview Friday. "The IOM has its opinions. We certainly understand that. It doesn't mean that we follow them. [Secretary Tommy Thompson] has a host of experts and there is no pause … if health departments want to vaccinate police and firemen, they are free to do that."
The IOM recognizes that a pause comes with some risks.
"A pause implies slower vaccination of the number of responders a jurisdiction may require for preparedness, a loss of momentum, and perhaps vulnerability in the event of a potential smallpox event," the group's letter said. "However, given that the smallpox threat level, as it is publicly described, has not changed, the committee continues to believe that the benefits of the pause likely outweigh the risks. The committee is aware that some jurisdictions have already begun offering the vaccine to a wider population of potential vaccinees, but reaffirms the need for a pause."
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