Sanofi Pasteur to open new flu vaccine plant

Who says there is hardly any money to be made in producing vaccines? Not Sanofi Pasteur, that’s for sure. A new flu vaccine plant in Swiftwater, Pennsylvania, 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 $150 million plant was built by the French company Sanofi Pasteur on its 500-acre campus in the Pocono Mountains. It joins an older plant, built in the 1970s, which 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 (HHS). “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, produces up to 50 million doses a year. The new one, which the company says will be ready in late 2008 or early 2009 after licensing by the Food and Drug Administration (FDA), 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, which is expected by the end of 2010, officials say. If a pandemic strikes, Sanofi CEO Wayne Pisano says, “we can essentially change in a day from seasonal to pandemic vaccine manufacturing, assuming we have the virus.”

Sanofi’s expansion, which did not involve federal funding, represents a step toward readiness for a flu pandemic, Gellin says, but it is only “a piece of it.” To bolster U.S. flu vaccine production further, HHS awarded $132.5 million in June to Sanofi Pasteur and Gaithersburg, Maryland-basedMedImmune, 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 the Second World War, it is time-tested, safe and cost-effective, but it is dependent on egg supply and produces varying yields. It is also a slow process: It takes about six months from start to finish. To assure a more reliable supply, HHS has awarded $1 billion to six vaccine makers to speed development of cell-culture production, which will allow large amounts of flu virus to be grown in giant steel vats rather than in chicken eggs.

USA Today’s Anita Manning writes that cell culture, which is used to make vaccines against polio and rabies and others, “allows you to ramp up and have surge capacity quickly,” Gellin says, but it is not cost-effective except at large volumes. “To have a company switch over just because it’s stainless steel instead of chickens, companies are never going to do that,” he says. “Our interest was surge capacity for a pandemic, so we needed to come up with an incentive to drive a company to do something they wouldn’t have done on their own.”

Investors should note that the government also is investing in research into next-generation vaccine-making technologies designed to speed production, and in adjuvants, which boost the immune response to vaccines, stretching out the supply. This is important, Gellin notes, because the sole licensed vaccine against H5N1 is effective only at high doses given in two shots. “Everything we do for pandemic preparation has other public health value,” he says. U.S. vaccine plants and a trained workforce offer the ability to make a pandemic vaccine while assuring a plentiful supply to prevent seasonal flu, which kills an estimated 36,000 people each year.