Baxter hopes to sell its vaccine, PrefluCel, in Europe in 2006 and in the United States in 2008.
Protein Sciences, a privately held company with 39 employees, said its vaccine, FluBlok, is on track for approval by the Food and Drug Administration in 2007. The company recently began advanced human testing of FluBlok, which is produced from cloned flu strains that are grown in caterpillar cells.
Protein Sciences Corp. grows vaccine in cells extracted from caterpillar ovaries
(Courtesy Of Protein Sciences Corp.)
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The company says testing has shown that the vaccine is safe and that it may have fewer side effects than traditional flu shots and work better in the elderly. But the company acknowledged it has had trouble raising money, at least until the recent flurry of interest from investors.
Other companies experimenting with cell culture vaccines aren't nearly as far along. Vaxin Inc., a company with two dozen employees in Birmingham, Ala., is in preliminary human testing, as is ID Biomedical Corp. in Canada and the two major flu shot providers for the United States, Chiron Corp. and Aventis Pasteur.
Aventis and Vaxin are using cells developed by Crucell NV, a Dutch company. The cells derive from a single cell harvested from an 18-week-old fetus aborted in 1985, raising questions about how Americans would greet such a vaccine, given the debate over fetal stem cell research. Crucell chief executive Ronald Brus said the cell was harvested many years ago with permission from the woman who donated it. No more fetuses would be needed to sustain production, he said.
In any case, some experts and industry leaders caution that new technologies won't change the flu vaccine marketplace anytime soon, and perhaps not ever. Perfecting the technology is at least several years away. It won't make vaccine production cheaper. And it likely won't make production significantly faster. "It's more hype than reality," said Anthony F. Holler, chief executive of ID Biomedical, which sells millions of flu shots in Canada but also is dabbling in development of cell culture vaccines.
Producing the flu vaccine the way it's done now is very much a matter of time and patience. After acquiring millions of specially purified chicken eggs, companies need about six months to create and distribute the vaccines. The process takes too long to be of much help if an unexpected strain erupts or if, as happened this year, something goes awry with the current season's batch.
While Adams of Protein Sciences said his company's technology might allow it to manufacture several million doses in eight to 10 weeks, officials at the other companies developing cell culture vaccines said their production process, including checks for quality control, would take about five months, shaving perhaps a month off the traditional method.
"Cell culture has the potential to save a few weeks," said Michel De Wilde, executive vice president for research and development at Aventis. "You have to start up your fermenters. It still takes a lot of time, but maybe a little less time."
Cell culture vaccines may hold safety advantages. Unlike those produced in chicken eggs, some cell culture vaccines are not processed with chemicals that can cause rare side effects, and people with egg allergies won't have dangerous reactions to them. Also, cell cultures could produce vaccines for the deadly avian flu, which might kill the chicken embryo needed to develop vaccine in an egg.
Q. What is the flu? 
