Vaccine Makers Receive Immunity From the U.S.

JANE ZHANG / Wall Street Journal 2feb2007

WASHINGTON — The Bush administration triggered a provision of a 2005 law that gives companies protection from product-liability lawsuits for vaccines or drugs they produce in connection with the avian-flu strain.

The law, enacted 13 months ago, gives the Secretary of Health and Human Services the power to grant immunity to vaccine makers in the event of a risk to public health. In a directive dated last week, HHS invoked that clause, "based on a credible risk that an avian influenza virus spreads and evolves into a strain capable of causing a pandemic of human influenza."

Bill Hall, an HHS spokesman, said that the agency's declaration "allows us to remove the remaining barrier to building up our domestic capacity to manufacturers of vaccines in a flu pandemic." He denied that the move reflected heightened concern about the avian flu. Rather, he said, "It was a precautionary step."

The HHS action comes at a time when fresh cases of avian flu are cropping up in Asia, Russia, Nigeria and parts of Europe, and some in Congress are expressing renewed concern about the threat. Recently, Democratic Sen. Tom Harkin of Iowa held a hearing to question senior administration officials on what they are doing to prepare for a possible pandemic in the U.S.

Some saw the HHS action as a reflection of increased concern. "This is probably the loudest pronouncement by the federal government to date that the threat of an avian flu pandemic is real," says John Clerici, a partner at McKenna Long & Aldridge in Washington, D.C., a law firm whose clients have included vaccine makers.

The U.S. has long been concerned about a shortage of vaccines, both for seasonal influenza and to combat the H5N1 bird-flu strain and other potentially lethal strains. As part of a plan to encourage development of experimental vaccines and other countermeasures against public health and bioterrorism threats, Congress passed in late 2005 a bill that provided liability protection to those vaccine makers. The measure, signed by President Bush in December 2005, was roundly criticized by trial lawyers and other critics as a giveaway to drug companies. Sen. Edward Kennedy (D., Mass.) demanded a generous compensation scheme for victims of potential side effects of the vaccines. But as part of the defense appropriations bill, the measure had no funds provided.

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