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BY ED SILVERMAN

NEWJERSEYNEWSROOM.COM

Could the solution to the next pandemic be found in a plain vanilla laboratory amid a cluster of warehouses in central New Jersey?

Alan Shaw certainly hopes so. That’s because the jovial, plain-spoken scientist heads VaxInnate, a tiny, privately held company that is one of several small biotechs that has received a rush of attention after the swine flu epidemic suddenly emerged and caused a brief global panic.

Unlike a few of the very largest drug makers, which make vaccines using a decades-old approach, VaxInnate uses a process that may prove faster and cheaper. The biggest names in flu vaccines – Novartis, Sanofi-Aventis and GlaxoSmithKline, among others – typically grow a virus in eggs and then harvest it, before turning the creation into a vaccine. But this can take at least a few months, if not longer.

By contrast, the little biotech is using a different approach – growing viruses in cells. As a result, Shaw maintains that a new vaccine for H1N1 flu could be developed in just six weeks. From there, he foresees churning out roughly 400 million doses in less than one month, exceeding the entire annual output of the current line-up of flu vaccine manufacturers.

“What we’re making right now is an experimental vaccine,” says Shaw, who started VaxInnate in 2002 after working at Merck, where he was executive director of virus and cell biology, and was responsible for overseeing such well-known vaccines for combating chickenpox and shingles. He also had a hand in the early development of Gardasil, which fights the humanpapilloma virus that can lead to cervical cancer.

In recent years, the biotech has been racing still other small players to produce the world’s first ‘universal’ flu shot, which would immunize people from all types of flu - a deadly pandemic to annual strains that can also kill. This would be a game changer in the vaccine industry, because annual shots would no longer be required. And when the swine flu outbreak occurred last month, VaxInnate was among a handful of biotechs that was able to switch gears, ever so slightly and transfer its technique to researching the H1N1 strain specifically. It took about two weeks.

“We began making a swine flu vaccine on Friday, April 24. We heard about the Mexican situation at lunch,” Shaw says. “We got into the (Global Initiative on Sharing Avian Influenza) database that night; pulled the relevant sequences the next morning; ordered the synthetic DNA on Monday; received the DNA on the next day, (along with the virus from the Centers for Disease Control), and on Friday the 8th of May, we had the new synthetic DNA sequence locked into our expression vector. Fermentation started on Monday the 11th. We anticipate having clean, pure vaccine protein ready to go into animals (this month).

“If we were a licensed (vaccine) manufacturer, our vaccine could be ready for use in a couple of months from now. We’d be able to supply the global need in two months from the time we started, say August. Right now, a vaccine is made in chicken eggs. The fluids are sucked out and the virus is killed with formaldehyde, and then you break it open with a mild detergent, clean it up a little and that’s it. It’s pretty crude stuff, but it works. However, it takes a long time. So if you’re one of the major manufacturers and start in February, it won’t be finished until November.”

The system he refers to is particularly deceptive. Rather than throwing vaccine soup into an industrial vat the size of a small car, Shaw describes how the vaccine is concocted in an apparatus that isn’t much bigger than an oversized pitcher of Fourth of July lemonade. The contents, however, hardly appear appetizing – the liquid sloshing around inside is best described as gunk that is the color of dirty peanut butter.

The kind of output Shaw envisions would greatly supplement existing stockpiles. The World Health Organization currently estimates the combined capacity of the big vaccine makers is about one billion to two billion doses of flu vaccine this year, which is insufficient to cover the planet if a pandemic occurs. To spur production, drug makers can add adjuvants, or immune stimulants, which cut needed doses and would allow more vaccine to be produced. But the U.S. Department of Health and Human Services is trying to jumpstart output by providing $1.3 billion to drug makers to develop vaccines based on cell cultures.

VaxInnate, however, is not yet licensed by the U.S. Food and Drug Administration, because the company needs about two and a half years of clinical trials to obtain authorization as a supplier of vaccines for emergency use. And whether its efforts will actually reach the public anytime soon remains uncertain at best. Despite continued reports of ongoing outbreaks and deaths due to swine flu, a true global pandemic may not occur for several months, if past patterns are any guide.

On the other hand, the FDA may be willing to consider the options offered by companies such as VaxInnate if a genuine pandemic shows signs of emerging later this year. The greater the risk, the more likely it is that regulators may be forced to consider a fast-track approach for approving nascent companies using a cell-based cultures to make vaccines. As of mid-May, the CDC was reporting 5,123 cases in the U.S., including 15 in New Jersey, and five deaths nationwide. “The point here,” says Shaw, “is that this is fastest system one can imagine for making a vaccine.”