Just before Thanksgiving, officials of the international drug company Novartis will be joined by a gaggle of local, state and federal officials in a business park on the edge of Holly Springs, N.C.
There they'll cut ribbons and give speeches to mark the official opening of the first flu vaccine manufacturing plant in the United States that won't rely on virus grown in chicken eggs to produce serum. The facility could ship its first vaccine in another two or three years.
With a federal investment of $487 billion toward the plant and other start-up and development costs, the Holly Springs project represents the largest outlay of more than $1 billion in grants and contracts the government has awarded in recent years to encourage new, faster techniques for making flu vaccine.
Yet none of those innovations have had any impact on struggling efforts to supply enough vaccine to inoculate up to half the country's population considered at high risk from the H1N1 swine flu.
"We need to have better vaccine production methods, but they're not ready yet,'' said Dr. Thomas Frieden, director of the federal Centers for Disease Control and Prevention in a briefing for reporters this week. "We hope that in future years -- certainly not this year, and probably not next, but in the not too distant future -- we might have newer methods that would be able to provide vaccine at a more rapid pace.''
Dr. Marie-Paul Kieny, director of the World Health Organization's Initiative for Vaccine Research, in a media call said, "We will be seeing in the coming years some new technologies coming on the market that will make the surge capacity to produce more vaccine when needed, better than what we have currently."
Egg-based vaccines are still the state-of-the art method both in the U.S. and much of the world, although a few European firms have been making regular seasonal flu vaccines grown in cultures of canine kidney cells for several years. And Novartis's plant in Marburg, Germany - essentially a twin of the one in Holly Springs - has won approval from German authorities to market its cell-based swine flu vaccine, called Celtura.
Using mammalian cells to grow flu virus rather than eggs removes several difficulties. First, it cuts out a step that involves splicing the target flu virus with another that grows well in eggs to produce what amounts to vaccine seed, and requires several weeks.
And even with a good seed stock and a dedicated supply of hundreds of millions of eggs, the yield of flu virus from each egg can fall short of expectations - as has been the case in swine flu vaccine production this year. That is a big reason that 120 million doses first promised by the end of October turned out to be more like 20 million.
Yield from the animal cells tends to be more consistent, experts say, and production can be expanded much faster than with eggs. But even cell-cultured vaccine can take four or five months to get ready to ship.
Some experts see more promise in methods that use other types of cell, or that produce proteins or fragments of DNA to generate immunity rather than whole virus that has been weakened or killed.
In June the Department of Health and Human Services gave Protein Sciences Corp. of Meriden, Conn., a $35 million contract, which could extend to $147 million, to develop a technique to grow flu virus proteins in insect cells. The company says it could make up to 100,000 doses a week of a swine flu vaccine. But officials expect it could take five years to bring such a vaccine to market.
U.S. health officials are caught between a sizeable portion of the population demanding quick access to vaccine and what polls suggest are about half the population that either doesn't think a swine flu shot is necessary or that have concerns over safety, despite assurances that the manufacturing method is tried and true.
Despite some discussion about possible emergency approval of new vaccines or drugs in the face of pandemic earlier this year, public opinion and the relatively mild toll taken by H1N1 thus far have discouraged such steps. "We're not cutting any corners,'' CDC's Frieden said.
E-mail reporter Lee Bowman at bowmanl(at)shns.com.
(Distributed by Scripps Howard News Service, http://www.scrippsnews.com)
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