Vaccine maker gears up in case of flu pandemic

SWIFTWATER, Pa. — A new flu vaccine plant here is set to begin operations as soon as next year, boosting the supply of vaccine for the annual flu season and providing a much-desired U.S. source of vaccine for use in a flu pandemic.

The new $150 million plant was built by the French company Sanofi Pasteur on its 500-acre campus here in the Pocono Mountains. It joins an older plant, built in the 1970s, that produces the only flu vaccine made entirely in the United States.

"We assume that, in a pandemic, the only vaccine available to Americans is going to be a vaccine made in America," says Bruce Gellin, director of the National Vaccine Program office in the Department of Health and Human Services. "A goal of our pandemic vaccine program is largely to ensure we have sufficient domestic capacity to meet this country's need."

Sanofi's existing plant, which is set to close down for renovations when the new plant goes online, churns out up to 50 million doses a year. The new one, which company officials say will be up and running in late 2008 or early 2009 after licensing by the Food and Drug Administration, will produce 100 million doses of vaccine for annual flu seasons. Total output will jump to 150 million doses once the old plant is back in action, expected by the end of 2010, officials say.

If a pandemic starts, says Sanofi CEO Wayne Pisano, "we can essentially change in a day from seasonal to pandemic vaccine manufacturing, assuming we have the virus."

Pandemics occur when a new variety of flu emerges to which humans have never been exposed. Of concern to health experts is the bird flu virus H5N1, which has caused at least 319 human illnesses and 192 deaths since 2003.

It doesn't spread easily in humans, said HHS Secretary Mike Leavitt, after touring the new vaccine plant last month, but "the potential continues to be strong" that it could mutate in that direction. "We don't know that H5N1 will be the spark of the next pandemic, but we do know pandemics happen."

Goal: Cell-culture production

Sanofi's expansion, which did not involve U.S. funding, represents a step toward readiness for a flu pandemic, Gellin says, but it's only "a piece of it." To further bolster U.S. flu vaccine production, HHS in June awarded $132.5 million to Sanofi Pasteur and MedImmune, maker of the nasal spray vaccine FluMist, to renovate plants for flu vaccine-making using the current technology that relies on fertilized eggs to grow viruses. Developed before World War II, it is time-tested, safe and cost-effective, but is dependent on egg supply and produces varying yields. It's also a slow process, taking about six months from start to finish.