Avian Flu Declaration May Spur Firms to Develop Vaccines...

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Avian Flu Declaration May Spur Firms to Develop Vaccines...

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Avian Flu Declaration May Spur Firms to Develop Vaccines Without Fearing Liability

By Matthew E. Berger, CQ Staff

http://public.cq.com/docs/hs/hsnews110- ... 42447.html

The federal government has declared a potential pandemic emergency, prompting liability protection for avian influenza vaccine manufacturers.

Health and Human Services Secretary Michael O. Leavitt made the declaration, which became public Thursday, as required under the Public Readiness and Emergency Preparedness (PREP) Act. The declaration says there is “credible risk that the spread of avian influenza viruses and resulting disease could in the future constitute a public health emergency.”

The notice is expected to help persuade manufacturers of pandemic vaccines and countermeasures to contract with the government, without fear of liability if their drugs are misused or have unknown effects.

Analysts said it also puts the government on record about the likelihood of a pandemic.

“The big news is that you now have a very strong pronouncement by [the Department of Health and Human Services] that the threat of the avian flu pandemic is significant,” said John Clerici, a biodefense consultant.

The PREP Act passed in December as part of the Defense Department’s fiscal 2007 spending bill (PL 109-148). It was designed to give the government the ability to plan ahead of time for a pandemic by stockpiling drugs, while alleviating the fears of drug manufacturers wary of sending drugs to the Strategic National Stockpile before they were fully approved.

“It speeds up drug development because any company that was worried about liability doesn’t need to be,” Clerici said.

An HHS spokesman said the secretary made the declaration as soon as possible after receiving congressional authority because the government has already entered into contracts with several pharmaceutical companies.

Leavitt’s announcement became public on the same day the government began rolling out pandemic mitigation plans for local communities across the country.

“We have the opportunity to become the first generation in human history to plan for a pandemic,” Leavitt said at a press conference at the headquarters of the Centers for Disease Control and Prevention in Atlanta.

The plan recommends basic mitigation strategies that could be instituted based on a five-point scale of the severity of the pandemic. Techniques range from closing schools and voluntary quarantines to cancelling public gatherings and telecommuting to work. The goal is to separate people from each other as much as possible.

Pandemic severity would be determined by death rate. A category 1 pandemic would be akin to the seasonal flu while events like the pandemic of 1918 would be a category 5.

An outbreak in the first category would anticipate fewer than 90,000 deaths, or 30 people out of every 100,000 Americans. A category 3 outbreak would kill at least 450,000 people and the most extreme category could kill more than 1.8 million people.

CDC Director Julie L. Gerberding said the mitigation techniques would be necessary for the time before a vaccine can be developed, expected to be at least six months after the pandemic strain is identified.

“Our goal is to make sure we can do everything we can to save lives,” she said, adding the techniques could help slow down the spread of the disease and “buy some time.”

Leavitt also introduced English and Spanish-language public service announcements to get people to visit pandemicflu.gov for education on the flu.

Matthew E. Berger can be reached at mberger@cq.com.

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