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Panel questions HHS on low smallpox vaccinations

By Emily Heil
Congress Daily

Public health officials faced questions from the Senate Health, Education, Labor and Pensions Committee Thursday about why fewer health care workers than expected have received smallpox vaccinations, after Congress passed legislation intended to boost vaccine use in preparation for a possible bioterrorism attack.

During a hearing on bioterrorism readiness efforts, lawmakers also said they were close to reaching an agreement on legislation enacting President Bush's "Bioshield" plan to encourage commercial development of countermeasures to biological threats.

Congress passed the "Smallpox Emergency Protection Personnel Act" in April to compensate healthcare workers harmed by side effects of the vaccine, which has been linked to heart problems and other complications. The administration had hoped to vaccinate between 400,000 and 500,000 emergency and health care workers who might respond to a smallpox outbreak.

Democrats argued when the legislation was passed that it should be more generous in order to ensure broader participation in the vaccination effort. As of last Friday, only 38,000 civilian public health workers had been vaccinated.

"The vaccination program is off course and behind schedule," said HELP ranking member Edward Kennedy, D-Mass. Kennedy pinned the blame for the delay on the failure of the Health and Human Services Department to release a table of vaccine-related injuries that are eligible for compensation, as required by the legislation.

HELP Chairman Judd Gregg, R-H.H., said he was concerned about the delay and about the slow pace of vaccinations. "Clearly, we haven't gotten the vaccine out as aggressively as we should," Gregg said.

In a letter to HHS Secretary Tommy Thompson, Kennedy and Sen. Christopher Dodd, D-Conn., pressed the agency to complete work on the table. "We are increasingly concerned by the delay," they wrote. "Too many first responders aware of the possibility of side effects are refusing to participate in this very high priority vaccination program."

Julie Gerberding, director of the Centers for Disease Control and Prevention, said HHS was close to completing the table, which she said was slowed by both legal and scientific issues, including a newly discovered complication involving heart attacks.

Gerberding said relatively low vaccination rates also were due to the incorrect perception that a smallpox attack is less likely than it was in the wake of the 2001 terrorist attacks. With war in Afghanistan and Iraq over, people do not think smallpox is an imminent threat, she told the committee.

"We are still operating under the assumption that the smallpox threat is real," she said. "We have to be prepared as a nation for the possibility of a smallpox attack."

Kennedy said he and Gregg were working to break the impasse that has prevented the Bioshield bill from reaching the Senate floor. The bill passed the committee, but has been stymied because of concerns about its funding source. Appropriatiors, including Senate Appropriations ranking member Robert Byrd, D-W.Va., do not want the program to have mandatory funding.

Food and Drug Commissioner Mark McClellan said passage of Bioshield legislation would help speed up research and approval of vaccines. "Enactment of Project Bioshield is a priority for the administration," he said.