***Govt ready to use measure to lure flu vaccine makers***

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http://tinyurl.com/dytrh Govt ready to use measure to lure flu vaccine makers Mon Feb 13, 2006 7:18 PM ET By Maggie Fox, Health and Science Correspondent WASHINGTON (Reuters) - Health and Human Services Secretary Mike Leavitt said on Monday he is ready to make use of a special measure to grant vaccine makers immunity from liability from lawsuits over pandemic flu vaccines. Leavitt was given this power in controversial last-minute legislation passed by Congress in December as part of the U.S. defense budget. The measure is aimed at encouraging vaccine makers to get back

into the American market. Leavitt said he is particularly keen to persuade manufacturers to open vaccine factories on U.S. soil, so there would be no problem with supplies in case of an influenza pandemic. Manufacturers have said they are put off by fears that they could be forced to spend hundreds of millions of dollars fighting off lawsuits from people who are harmed, or who claim to be harmed, by vaccines. The new legislation allows the health secretary to lift this liability in case of a pandemic. Leavitt is negotiating with manufacturers who want to contract with the U.S. government to make vaccines and would invoke the special powers when needed to keep negotiations moving, he said. "I am going to do it as soon as it is necessary to assure continued progress," he told reporters. "When we get to that point ... I will use the power. Until then, I won't." Some Democrats had objected to the language slipped into the defense budget bill,

arguing that people who were genuinely hurt by vaccines needed some compensation mechanism. Manufacturers have pressed for a program that resembles that in place for childhood vaccines. The Vaccine Injury Compensation Program allows parents to petition for compensation from a fund set up by the federal government and manufacturers that bypasses the question of liability. Just four companies currently produce flu vaccine for the American market and only one makes it on U.S. soil. There are regular shortages of vaccine and experts are worried about what would happen if there were a flu pandemic. Vaccine makers and health experts all agree it would take months to get started on a vaccine against H5N1 avian influenza and warn that there is insufficient manufacturing capacity to make enough doses to cope with a bird flu pandemic. Experts also agree that in the event of a pandemic, most countries would

keep any vaccine made on their territory -- leaving very little for the United States. "Our objective is to create the capacity to manufacture 300 million doses of (pandemic) flu vaccine in six months," Leavitt said. To do that, vaccine makers would have to be assured of a steady market. "That capacity has to remain warm. Someone has to be using those facilities to make vaccine of some sort," Leavitt added. "It is not unreasonable for us to be looking at 180 to 200 million doses annually." The most influenza vaccine ever produced for the U.S. market is half that amount.

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