The highly computerized plant now awaiting final government approval won't be pumping out vaccine until late next year. But the drugmaker invited Health and Human Services Secretary Mike Leavitt and the media for a rare peek yesterday at a critical facility before its life-saving balm begins flowing.
Leavitt called the plant critical to the health of the country and the world. "We do know that pandemics happen, and that we will see a pandemic, and that we need to be prepared," he said.
The plant looks like a high-tech hospital on perpetual security alert. No merely curious visitors can enter when it's working. Its 200 production workers - all vaccinated for the flu - will be gowned, gloved and masked.
A few workers went through the motions yesterday, entering rooms through special air locks that help keep the virus in and the contaminants out, and pantomiming production steps as a special filtration system purified the air.
Yet, amid the warren of stainless-steel tubes and vats, the plant will still make vaccine the old-fashioned way: with chicken eggs.
They have incubated flu vaccine reliably since 1935. And the plant will need 600,000 eggs a day at full capacity. Sanofi buys what it needs and more from dedicated egg suppliers, to assure an ample supply.
Sanofi senior vice president Wayne Pisano, who oversees vaccine sales, described the process as tried-and-true, and said the emerging cell-culture-based method has not been perfected for making the millions of doses needed.
Leavitt said the federal government was trying to change that by spending $1 billion over the next five years to improve cell-based technology and to increase U.S. vaccine production. The United States has amassed pre-pandemic vaccine for six million people, along with 50 million doses of antiviral medicines. "Obviously, that's not enough," Leavitt said.
While media attention on flu has receded, Leavitt noted that the flu virus was continuing to change and threaten people. An especially dangerous form, called H5N1, has infected 318 people worldwide and killed nearly 200 since 2003. The world has averaged three flu pandemics a century, the last striking in 1968 and 1969. Sooner or later, another one will occur, Leavitt said.
The federal government is continuing to prepare. Last month, Sanofi announced a $77.4 million contract from the government to retrofit a second flu factory at the Swiftwater site. The firm, which will also spend $25 million of its own funds, would be able to make 150 million doses a year by 2010, tripling its current production, when all ongoing upgrades are done.
Sanofi, the world's biggest vaccine-maker, isn't the only company in the game. GlaxoSmithKline P.L.C., which has a U.S. headquarters in Philadelphia, is rehabbing a 90-acre former vaccine plant in Marietta, Lancaster County, to make flu and other vaccines. The firm has received a $274 million federal contract to develop the cell-culture method and to ramp up manufacturing there. Swiss drugmaker Novartis AG is also building a vaccine plant in Holly Springs, N.C. But both projects are years away from production.
Kimberly Elliott, deputy director of Trust for America's Health, a public-health-advocacy group, said the U.S. effort still lags in key areas, such as how to detect the disease quickly and how to handle the large numbers of sick patients in a pandemic. "Most hospitals are already overcrowded," she said. "Hardly any state is doing well on this, including Pennsylvania and New Jersey."
Experts hope that vaccines will provide a lot of protection. And yesterday at the plant, workers were showing how they would be made.
In one room, a mechanical needle will inject virus into the eggs, which will be left to incubate for two or three days.
Workers shine special lights onto the eggs to make sure they are intact. The process is known as "candling" because it was originally done by candlelight.
A mechanical knife then cuts off the top of eggs, and a machine flips 36 at a time, pouring their fluid into a vat. The virus is killed, and then the fluid is run through a centrifuge and purified several times.
"We're still stuck with eggs," noted Paul A. Offit, the chief of the division of infectious diseases at Children's Hospital of Philadelphia and author of Vaccinated: One Man's Quest to Defeat the World's Deadliest Diseases.
"I would like to think," he added, that "the fear of the pandemic will enable us to upgrade our flu technology."
Is the United States ready for an influenza pandemic? Read the White House's assessment
of the current strategy at
Contact staff writer Karl Stark
at 215-854-5363 or firstname.lastname@example.org.