Leavitt to Grant Waivers for Bird Flu Vaccine Makers

The government won't wait for bird flu to hit U.S. shores before granting liability protections to vaccine manufacturers and others that make products needed to battle a pandemic.

Health and Human Services Secretary Mike Leavitt said Monday that the administration soon would enter into contracts for bird flu vaccine, rapid tests to detect the virus, and technology that would make available vaccine go farther.

"At some point in that process, we'll need to deal with the issue of liability," he told reporters.

In December, Congress gave Leavitt the authority to grant liability waivers if a public health emergency exists.

Under the waivers, people injured by a vaccine against bird flu would have to prove willful misconduct to bring a claim for damages. Critics have said that such a high threshold would make it almost impossible for people injured by a drug to file a lawsuit.

Leavitt said it's possible that vaccine manufacturers would want the extra protections before conducting clinical trials.

"If you're a vaccine manufacturer, you're likely not going to want to move to that step unless you've got adequate liability protection." he said.

Bird flu has killed at least 88 people in Asia and Turkey since 2003, according to the World Health Organization. An additional two deaths from bird flu have been confirmed in Indonesia. Birds carrying the virus have also been detected in Italy, Greece and Nigeria.

Leavitt said there's no reason to think that H5N1 virus will stop its migration.

"At some point in time, there will be a wild bird that will be discovered (with the virus) in the United States," he said. "That in itself won't be an emergency. That is something we should expect."