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Policymakers Look to Create Fund for Those Harmed by Smallpox Vaccine

Health Care Policy Report

The Bush administration and members of Congress Jan. 24 signalled support for creating a fund to compensate those who suffer side effects from smallpox vaccinations.

Meanwhile, the first smallpox vaccinations under President Bush's plan to protect against biological attack began in Connecticut Jan. 24. Under Bush's plan, state health departments will urge vaccinations for about 439,000 health care workers who would be designated to staff volunteer smallpox response teams. After these initial teams are vaccinated, the administration plans to offer the vaccine to 10 million emergency responders, including fire and police personnel and other health workers. A mandatory vaccination program already is under way for certain military personnel.

For every 1 million people receiving the smallpox vaccine, one to two deaths can be expected and an additional 14-52 life-threatening events can be expected, according to estimates from federal health officials.

"There is a possibility that there will be some sort of fund set up," Department of Health and Human Services Secretary Tommy G. Thompson told reporters after speaking to the U.S. Conference of Mayors Jan. 24.

Thompson said administration officials had been talking to leadership on Capitol Hill about creating a compensation fund.

Top Republican leaders in the Senate on health care policy have agreed to work together on legislation establishing such a fund, according to a GOP leadership aide.

Senate Democrats Favor Compensation Fund

A group of 22 Senate Democrats wrote to President Bush Jan. 22, saying that those who volunteer to be vaccinated and suffer side effects deserve to be compensated.
"We are writing to express our dismay at your Administration's proposal to vaccinate millions of Americans against smallpox without assuring that persons injured by the vaccine will receive medical care and fair compensation," the senators wrote. Sen. Edward M. Kennedy (D-Mass.), the ranking Democrat on the Senate Health, Education, Labor, and Pensions Committee, was the leading signatory to the letter.

Senate Majority Leader Bill Frist (R-Tenn.), Kennedy, and HELP Committee Chairman Judd Gregg (R-N.H.) agreed during a Jan. 23 colloquy on the Senate floor to collaborate with one another on the issue, according to Nick Smith, spokesman for Frist.

"Senator Frist believes there needs to be appropriate compensation" and wants to work on it with Gregg and Kennedy, Smith told BNA Jan. 25.

Frist said in a December 2002 speech that policymakers should weigh creating such a fund. He noted that, in 1986, the government created a Vaccine Injury Compensation Program, but that program only compensates the families of children suffering from vaccine side effects.

Must Prove Negligence

The homeland security law allows damages to be paid to those suffering side effects from the smallpox vaccine. However, the law requires that the injured person or his or her family prove negligence in administering the vaccine or the making of the vaccine in order to obtain compensation.

The first smallpox vaccinations for health care workers had to wait until Jan. 24 when liability safeguards for those administering the vaccine and vaccine makers kicked in under the recently enacted Homeland Security Act of 2002 (Pub. L. No. 107-296).

In his December speech, Frist said he supported the liability safeguards in the homeland security law for those administering and making the smallpox vaccine. However, Frist said that the provisions do nothing to assuage health professionals' concerns about administering future vaccines protecting against other dangerous agents like anthrax.

Frist urged legislation that "more globally" provides liability safeguards for those administering vaccines to protect Americans against dangerous biological agents, so that Congress will not need to act in an ad hoc manner every time the issue arises.