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Money, vaccines and lots of soap

by Alex Lash  |  Published May 1, 2009 at 10:26 AM

050409 NWflu.gifWith a new virus circulating around the world, the Obama administration wants to pump $1.5 billion into the flu fight. So what happened to the last round of cash, namely, the $7 billion Pandemic and All-Hazards Preparedness Act of 2006?

No surprise that much of it went to drug companies to stockpile treatments and encourage new, faster ways of making flu vaccine. But the next-generation method, called "cell-culture production," remains a work in progress. If the current swinish strain turns more deadly, we'll have to fight it with vaccines made under the old paradigm, grown in vast numbers of chicken eggs. Under pandemic pressure, the four- to six-month process seems excruciatingly slow.

The Health and Human Services Department has allocated $1.7 billion to big drug firms to grow vaccines in mammalian cells, not chicken eggs. Results have been mixed. Novartis AG is building a cell-culture production facility in North Carolina with as much as $486 million in government funds, but it won't be online until 2012. The U.S. drug unit of Solvay SA was set to receive $300 million for a similar project, but last fall it cut bait.

There are other signs that big firms are wavering. Sanofi Pasteur has an experimental cell-culture plant, but Chris Viehbacher, CEO of parent firm Sanofi-Aventis SA, told The Wall Street Journal last week that cell-based production has proved tricky and was "several years away." A company spokeswoman told The Deal that faster production with cell culture has been "touted a lot" but would only make "a minimal difference" in speed over the current egg-based method, which she emphasized as "tried and true."

While new methods remain elusive, the Pandemic Act money has strengthened weak links in the egg-based process, securing chicken farms against avian flu, ensuring year-round egg supplies, and upgrading the drugmakers' plants. "They've pushed eggs as far as they can go," says Gigi Kwik Gronvall, a biosecurity expert and professor of medicine at the University of Pittsburgh.

Still, the fits and starts in cell-culture production are at odds with the official enthusiasm for it. HHS paints a future in which all manner of flu vaccines, including bioengineered ones and shots that cover all flu strains "will almost inevitably be produced in cell-culture facilities, not in living, embryonated eggs fresh from the farm. The success of the HHS investment in cell-based advanced development has led to the next necessary step toward ensuring availability of influenza vaccine during a pandemic event: the construction of a domestic cell-based manufacturing facility."

If and when it opens, the Novartis plant will be the first in the U.S. Meanwhile, in addition to projects within academia, a score of smaller firms and startups are working on new drugs and technologies, from a universal flu vaccine -- one shot prevents them all -- to growing vaccines in vats of E. coli, a bacterium commonly re-engineered to make biologic drugs.

Most of these efforts are years away from making a difference. Despite the wakeup call of the avian flu emergency four years ago, pandemic startups have attracted less attention than those working on Alzheimer's disease, cancer, and autoimmune diseases.

Blue-chip venture firm Kleiner Perkins Caufield & Byers has a $200 million pandemic and biodefense fund, but most of its investments are later-stage, even public companies. One of its companies, Novavax Inc., used last week's stock bump for all things flu-related to help pay off $17 million of its $22 million debt. The payoff includes 2 million common shares, which until recently were trading under a dollar but shot up as high as $3.88 on April 27.

More typical is Birmingham, Ala., startup Vaxin Inc. Working on a cell culture-based H5N1 avian flu vaccine, as well as a seasonal flu stopper, it has cobbled together $8 million from local VCs, angels, federal grants and alliances with Dutch vaccine powerhouse Crucell NV and Kolmar Korea Co. Ltd., which licensed Vaxin's products for the South Korean market.

Big pharma may find small firms fertile hunting ground for new vaccines and technologies. And once their vaccines pass early tests in human volunteers, the small guys will need help with costly later-stage trials.

For all the hoopla over vaccines, public officials say community response will make or break us in a pandemic.

A small slice of the Pandemic Act funds went to community health officials to develop what-if plans. People on the ground say it has helped immensely. "It's as simple as planning what to do with our kids if schools are closed," says Christian Sandrock, a doctor at University of California, Davis, and a health officer for Yolo County near Sacramento.

Of course, common sense and good hygiene never hurt. Even President Obama at last week's press conference told Americans to stay home when sick and wash their hands frequently.

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Tags: bird flu | Crucell | Kleiner Perkins | Kolmar Korea | Novartis | Novavax | Sanofi-Aventis | Solvay | swine flu | Vaxin
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