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This is MORNING EDITION from NPR News. I'm Renee Montagne.
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And I'm Steve Inskeep.
If a deadly new strain of flu suddenly emerged, one of the most important lines of defense would be a vaccine. Yesterday, at a meeting of health officials here in Washington, Health and Human Services Secretary Mike Leavitt said one experimental method was especially promising.
Secretary MIKE LEAVITT (Health and Human Services): It will ultimately revolutionize vaccine-making, and it will save millions of lives.
INSKEEP: That method would mass-produce a human flu vaccine using cells from a dog's kidney, but the technology has not been thoroughly tested. Leavitt is not alone in hoping for improvements on a decades-old method of making vaccines, using hens' eggs, and this morning we will report on efforts to develop new and faster methods. The techniques may help in a pandemic and in the regular flu outbreaks that come each season. NPR's Richard Harris has the second of two reports.
RICHARD HARRIS reporting:
Here are some not-very-comforting facts about what would happen if a deadly new strain of flu emerged somewhere on our planet. If history is a guide, the pandemic would last about a year and millions of lives would be at risk. A vaccine against this virus would be our best protection. But Howard Pien, head of the Chiron Corporation, says don't expect a vaccine right away.
Mr. HOWARD PIEN (Chiron Corporation): It will take a considerable period of time, probably four or five months.
HARRIS: A pandemic could already be spread around the world at that point. And even then there wouldn't be enough vaccine to go around unless there's a new way to make vaccines and to have the capacity to make billions of doses in a hurry.
Mr. PIEN: These are big, big issues of the day, and if we have the time, if we have another year or two years or three years, we better not squander the time.
HARRIS: But new ways of making vaccines don't appear overnight. New technologies may carry new risks. So last month the US Food and Drug Administration checked in with two companies that are pushing forward with a new vaccine approach. Harold Shlevin from Solvay Pharmaceuticals says his company's current reliance on millions of chicken eggs for vaccine manufacture makes him nervous.
Mr. HAROLD SHLEVIN (Solvay Pharmaceuticals): If the pandemic strain of flu comes out birds, let's make that assumption, well, part of the issue is many of those strains cannot be grown in chicken eggs because they kill the chicken egg.
HARRIS: It could be tough to find a strain of virus that will grow well in eggs and be the makings of a good vaccine. And he sees an even bigger problem: the possibility there won't be enough chickens during a pandemic.
Mr. SHLEVIN: Various governments have stepped in and they're destroying the whole chicken populations. No chickens, no eggs, no vaccine under today's technology.
HARRIS: So instead his company has developed a new way to produce flu vaccines. This relies on a line of immortal cells, harvested from a cocker spaniel's kidney way back in 1958 and kept alive ever since. This approach is called cell-based technology.
Mr. SHLEVIN: Cell-based technology, you take a little vial of cells out of the freezer, put them in your bioreactor, provide the various nutrients to grow them, inoculate them with the virus, and in principle you can grow an infinite supply of virus, which makes your vaccine.
HARRIS: The bioreactor is essentially a big tank, not too much different from what you'd use to brew beer. So production of flu vaccine is limited only by how many tanks you decide to build, not how many chickens are available to lay eggs for you. Solvay Pharmaceuticals has a head start in this technology. It has built a plant in Holland to produce flu vaccines, and it is approved to sell that vaccine in the Netherlands. But Solvay's competition is not far behind.
Mr. RINO RAPPUOLI (Chief Scientist, Chiron): We will have a manufacturing facility, which is already large-scale, full-scale commercial.
HARRIS: Rino Rappuoli, chief scientist at Chiron, says that plant in Germany has already produced cell-based flu vaccines, and they've been tested for safety on 3,000 people in Europe. This factory won't satisfy demand even within Europe, but he says the company is making exact copies, clones of the equipment, to expand production capacity.
Mr. RAPPUOLI: And we are preparing to clone that facility in the United States if our discussions with the government and things are going in the right direction.
HARRIS: The US government is offering big economic incentives because companies don't have an economic incentive to go it alone. A flu pandemic would require what they call surge capacity--the ability to make a whole lot of extra vaccine in a short period of time.
Mr. RAPPUOLI: So we as manufacturers have always had this problem. We need to respond to public health, social needs, which are very important questions, but for a company it's difficult to be social. I mean, a company has to provide a return for investors, and so that's where the discussions with the government are very important.
HARRIS: Those discussions are just the backdrop for the recent FDA meeting. The issue is whether the next generation of vaccines will be effective and whether they will be safe enough to be given to hundreds of millions of Americans. FDA Advisory Committee member David Markovitz from the University of Michigan says it's a real balancing act: moving quickly in the face of a possible pandemic, but not cutting corners on safety. The new approach got a favorable reception at this non-binding advisory meeting.
Mr. DAVID MARKOVITZ (FDA Advisory Committee Member): I think the overall feeling is that this is the way things are going to go and the question is just how fast. I'm myself convinced enough to think that relatively rapidly would be good. I think other members of the committee might want to go a little more slowly.
HARRIS: Just about everyone agrees on one point. They wish this discussion had taken place years ago. That's because we're looking at at least another three to five years for the plants to be built, vaccines to be approved and manufacturing to be fully up to speed. In the meantime, the federal government's plan is to create a relatively small stockpile of experimental vaccine to protect health-care workers and others at the highest risk. Just up the road in Bethesda, at the National Institutes of Health, Gary Nabel runs one of the nation's premier vaccine labs.
Mr. GARY NABEL (NIH): This is a production suite. It's--we call it a GLP lab.
HARRIS: Air whistles out of this lab, which has been pressurized to reduce contamination. And we step on a sticky floor mat to remove dirt from our shoes.
(Soundbite of peeling noise)
Mr. NABEL: And see, you thought you had clean shoes, but, you know...
HARRIS: The cell-based vaccine would solve one problem: making sure that vaccine production can be scaled up to protect as many people as possible. But it doesn't solve the other problem: getting a vaccine in hand quickly enough to nip a pandemic in the bud.
Mr. NABEL: I think we could do much, much better than we're doing today.
HARRIS: Ideally, he says, we shouldn't need to wait for a new flu virus to emerge. Nabel says why not have a universal flu vaccine, one that doesn't need to be specially tailored to any particular strain of flu, even a pandemic strain?
Mr. NABEL: Universal means we'd just get it once, and we'd have protection against all of the flu strains there are in the world. Or if we're not able to develop a universal flu vaccine, might there be some pattern of immunization that we follow, like we all did for our childhood vaccines, where you'd vaccinate against a certain set of flu viruses in one year, another set the next year, and a third set the last year, and then you're done for life?
HARRIS: This work now has a high priority because of a possible flu pandemic. Nabel wishes the push had started before a potential crisis appeared on the horizon.
Mr. NABEL: We don't know at this point whether the pandemic will come or not. But it's at the very least been a wake-up call to us that we really need to re-examine the problem and see if we're taking the best approaches to dealing with not just pandemic flu but yearly flu as well.
HARRIS: After all, flu kills more than 30,000 Americans a year, Nabel says, and the current vaccine system only protects about a third of the people most at risk. So ideally, he says, all the effort to do something about a possible pandemic flu could pay off with new products and new vaccination routines that will help us all every year. Richard Harris, NPR News.
INSKEEP: You can investigate the flu vaccine methods in this story for yourself by finding a list of pros and cons at our Web site, npr.org.
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