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www.fdanews.com/articles/90744-u-s-grants-liability-protection-to-pandemic-vaccine-manufacturers

U.S. GRANTS LIABILITY PROTECTION TO PANDEMIC VACCINE MANUFACTURERS

February 5, 2007

Manufacturers of vaccines used to prevent potential avian pandemics will receive immunity from product liability claims, the U.S. HHS announced recently.

The agency said it would grant protection from such claims for parties involved in the preparation of reference strains and the manufacturing, testing, development and distribution of vaccines. The agency was granted this authority through the Public Health Service Act, which was established by the Public Readiness and Emergency Preparedness Act of 2005.

Alleviating potential liability is necessary to "ensure that the countermeasures are available and can be administered in the event an avian influenza virus spreads and evolves into a strain capable of causing a pandemic of human influenza," the notice said.

HHS decided to grant such a protection because of a "credible risk" of such an outbreak.

Experts are concerned that avian flu will mutate into a form that can be passed from human to human.

The declaration is effective from Dec. 1, 2006, until Feb. 28, 2010.

The notice is available at a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-1635.pdf.