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efforts underway on bird flu vaccine for humans Boston Globe 1 hour ago


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Efforts underway on bird flu vaccine for humans
White House pressing for greater production
By Diedtra Henderson, Globe Staff | October 8, 2005

WASHINGTON -- While the White House yesterday pressed domestic vaccine manufacturers to bolster the nation's ability to fend off an avian influenza pandemic, a vaccine to prevent humans from being infected with a strain of bird flu now circulating in Asia is already being produced and an experimental bird flu vaccine will soon be tested in humans.

Sanofi Pasteur Inc., the American subsidiary of a French drug maker, Sanofi-Aventis, has been producing bird flu vaccine at its plant in Swiftwater, Pa., since early September through a $100 million contract with the federal government.

Meanwhile, GlaxoSmithKline has refined the way it makes vaccine to increase production value from its plant in Dresden, Germany. Glaxo's move has the potential to increase plant capacity sixfold, a company executive said, transforming a production run that would make enough vaccine for 5 million people into one that could treat as many as 30 million. But first, clinical trials in humans must confirm the vaccine's safety and effectiveness.

''In the next few months, we aim to start this. We need approval from regulatory authorities," Dr. Bruce Innis, Glaxo's vice president of clinical research for virus vaccines, said of the early-stage human clinical trials. ''We're anxious to get into a posture of readiness as soon as possible. On the other hand, we don't want to place anyone at risk. So you have to find the right balance."

A Bush administration report on how the United States might deal with a possible outbreak of pandemic flu shows that the nation is severely unprepared for what could become the worst disaster in its history, The New York Times reported today.

The plan prescribes detailed quarantine and travel restrictions but concedes that an epidemic starting in Asia could reach the United States in weeks, overwhelming hospitals, causing potential rioting at vaccination clinics, and creating power and food shortages.

In the worst-case outcome, the report said, more than 1.9 million people in the United States would die and 8.5 million would be hospitalized. The costs of the disaster would exceed $450 billion.

Yesterday's meeting with vaccine manufacturers at the White House came amid a bipartisan push to increase production capacity so that the nation is better prepared for the possible public health crisis than it was for Hurricane Katrina.

The Senate has already added $4 billion to ensure that the nation's flu vaccine stocks include a remedy for a strain of flu that so far has killed 65 in Asia.

There is also an added urgency to the preparations: A recent reconstruction of the flu virus that killed 30 million to 50 million in 1918 showed it was a bird flu that spread easily from person to person. The bird flu currently coursing through poultry flocks in Asia has a higher mortality rate than the 1918 flu strain.

Andrew Parmentier, a senior policy analyst at Friedman, Billings, Ramsey, said the post-Katrina political atmosphere has elevated avian flu preparedness above congressional qualms over budget deficits.

Parmentier expects the Bush administration to offer tax credits to bolster vaccine manufacturing and storage facilities, as well as a shield from product liability lawsuits and financial incentives to entice back companies that stopped manufacturing vaccines.

Whether the extra spending for vaccines and antivirals amounts to a few billion dollars or tens of billions, a few companies are poised to benefit, including familiar names such as GlaxoSmithKline, Hoffmann-La Roche Inc., Sanofi Pasteur, and a possible newcomer, BioCryst Pharmaceuticals Inc.

Roche has amassed orders for its antiviral drug Tamiflu from 40 countries, including 14.6 million doses ordered by Britain, said Terence J. Hurley, a company spokesman.

The United States has ordered enough doses to treat 2 million people, he said. ''We have met all US orders to date and have capacity for additional orders but have not yet received them," Hurley said.

Peramivir, a failed influenza drug resurrected through reformulation by BioCryst, is effective against some strains of avian flu in mice.

Reni Benjamin, a senior biotechnology analyst at Rodman & Renshaw, said relaxed rules that speed approval of drugs aimed for the nation's stockpile could benefit the firm, based in Birmingham, Ala.

While spending billions of dollars more to add antivirals and vaccines to the nation's stockpile provides ''the most immediate bang for the buck," a flu specialist said, the infusion of federal dollars should also fund research.

''What you really want to see is sustained funding to minimize this threat, not just respond because today it's a hot-button issue," said Dr. Gregory Poland, director of the vaccine research group at the Mayo Clinic.

On Sept. 29, the Senate unanimously approved a $3.9 billion amendment to a Defense Department appropriations bill, including more than $3 billion to purchase enough antiviral medication to protect at least 50 percent of the US population.