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Marching toward a better flu vaccine

The 60-year-old formula in use today isn't keeping pace. New methods could soon put an end to shortages and create more effective protection.

December 15, 2003|Melissa Healy | Times Staff Writer

This is a story about eggs, time and the flu. And how advances in the craft of vaccine-making might break a lot fewer eggs and help more of us dodge the flu.

With the nation already in the throes of flu season, a growing number of Americans are hunting around for an elusive dose of flu vaccine. Others are simply wondering why the medical establishment has such a spotty record of protecting us from this yearly scourge.

For now, they can blame the eggs, but it won't always be that way.

Today chicken eggs are at the heart of a lengthy, brittle process of producing each year's vaccine, a process that has changed little since the first flu vaccine was introduced in the 1940s.

It takes months -- as many as eight, by one authoritative count -- to collect millions of these delicate incubators from the nation's coops and barnyards, and then use them to grow the tiny viruses that make up the next season's vaccine. So when the flu season arrives and the virus is not exactly what health officials predicted last March, or when more people want or need to get the vaccine than originally expected, it's too late to change the recipe or mix up a new batch.

It's time to start collecting eggs for next year's vaccine.

On the horizon, however, are new vaccine design and production techniques that could get around the many problems that chicken eggs pose. Two techniques in particular, reverse genetics and mammalian tissue culture, promise to accelerate the vaccine-making process.

Banishing or diminishing the role of the egg could allow pharmaceutical companies to turn out flu vaccine much more quickly. With less production lead time, the vaccine-makers could keep up with fast-changing flu viruses and even faster-changing public demand for flu vaccine.

The U.S. Department of Health and Human Services has asked Congress for $100 million this year to help develop and test these new techniques and to begin working out some of the complex legal issues their adoption would raise. That money is a down payment on U.S. plans to build what Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, last week called a "surge capacity" for flu vaccine.

If that sounds like war, it is no accident. Building "surge capacity" is key to preparing for a scenario that state and federal health officials have called "nature's terrorist attack" -- pandemic influenza. In the world of virus-watchers, such a worldwide influenza epidemic is "the big one," and most consider it an inevitability in the next decade or two. It could come in waves lasting as long as three years, killing millions.

Typically, pandemics involve an influenza virus that has never been seen, or that hasn't been seen in years, so that immunity among the broad population is low -- and illness and death are rampant. The notorious Spanish flu pandemic of 1918 is thought to have killed at least 20 million worldwide. More recent pandemics occurred in 1957 and 1968, when the Asian flu and Hong Kong flu killed 70,000 and 34,000 in the United States alone.

The surprise factor of the pandemic flu virus makes shortening the vaccine-making process so important. This would not be last year's virus with a few adjustments. Rather, it would be a bolt from the blue bearing down on an unprotected population. International health officials may not have eight months to see it coming. And so they cannot afford a cumbersome and lengthy production process to pump out a vaccine, because tens of thousands could die while vaccine-makers gather eggs.

In laying plans for pandemic preparedness, health officials feel a very real urgency: they are spurred by last year's SARS outbreak and a pandemic scare that flared in Hong Kong in 1997, but was contained when health officials there ordered the slaughter of all chickens, the bird population that harbored the threatening virus.

Neither event turned out to be "the big one" and SARS, while caused by a previously unknown virus, wasn't flu at all. And this year's flu, while nasty, almost certainly won't be catastrophic either. But these cases have lighted a fire under U.S. public health officials, who hope they can put a vaccine "surge capacity" well in place by the time it hits.

"We need to do what we can now, before we face a pandemic. We need to diversify the manufacturing technology," says Dr. Bruce Gellin, director of the national vaccine program in the Department of Health and Human Services. "The egg-based vaccine has been quite successful for some time. But in the spirit of increasing the chances that things will go right, a different production technology may give you some advantages."

One new approach called reverse genetics essentially shortcuts the process by which a flu virus is created for large-scale replication in a given vaccine.

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