The University of Pittsburgh Medical Center, which already is laying the groundwork for vaccine research, is now contemplating the creation of a its own vaccine production plant, possibly on the site of an old steel mill.
The idea is preliminary, and a feasibility study for the vaccine plant has not yet been undertaken. Although UPMC President Jeffrey Romoff suggested in a recent interview that the plant could be built in Homestead, no site has been selected, and the health system has not determined what a full manufacturing initiative would cost.
The vaccine initiative, which would tap into the public-health need for vaccine development, fits with a broader theme of commercializing research that UPMC is pushing in everything from information technology to cancer care.
"The concept of this is to do this here on one of the old steel sites that needs to be developed," Romoff said in an interview. "We're talking about everything associated, and one component would be a vaccine production plant.
"Another component would be enhancing the science; another component would be contracts related to biosecurity; and another component would be cancer research." Romoff said.
UPMC is not be alone in its vaccine aspirations. Florida A&M University officials announced in December a plan to spend $40 million to create a research institute and production plant in Tallahassee.
But it still would be highly unusual for an academic medical center to start making vaccines on a large scale, said Dr. Tony Fauci, the top official on infectious diseases at the National Institutes of Health.
NIH has a "pilot plant" on its campus outside Washington, D.C., that enables researchers to take a vaccine through the first two phases of trials required by the Food and Drug Administration. But the final phase of testing requires the sort of large-scale manufacturing like that of commercial drug companies, Fauci said.
"If they do a full-blown, industry-sized plant, that would be very unusual for an academic center -- possibly unprecedented," Fauci said.
It also would be surprising, Fauci noted, because many drug companies have retreated from vaccine production in order to invest in more lucrative avenues of pharmaceutical research.
The production plant would be related to the University of Pittsburgh's Center for Vaccine Research, part of which will be housed at Pitt's new Biomedical Research Tower 3 in Oakland. The building will house a Regional Biocontainment Laboratory that was funded in 2003 with an $18 million grant from the NIH, in part to do vaccine research.
Pitt's vaccine-research center will focus on "neglected diseases." such as malaria, drug-resistant tuberculosis and hemorrhagic fever viruses, said Dr. Arthur Levine, senior vice chancellor for health sciences and dean of the Pitt medical school. Pharmaceutical companies are less interested in developing these vaccines because they don't believe they can make money selling them in the poor regions of the world, where the diseases often thrive, Levine said.
But private philanthropies such as the Bill and Melinda Gates Foundation do have an interest in funding these projects, according to Levine, and the federal government might buy vaccines that protect against agents of bioterrorism. The government might also fund vaccines against avian influenza, which looms as a potential public health nightmare if the virus jumps into humans.
Levine agreed that building a production plant would be an unusual move for an academic medical center, but he said UPMC is unique in its profitability. Just last week, UPMC reported $125 million in profits for the first six months of its current fiscal year, a 24 percent improvement over the same period in 2003.
A production plant that makes vaccines to prevent infectious disease could also make therapeutic vaccines, Levine said, such as those being developed for some cancers.
"I think there's a rational basis for this," Levine said. "What remains to be seen is whether the money can be raised for such a facility in Pittsburgh."
At Florida A&M, officials want to create a commercial flu vaccine plant that would help prevent shortages in vaccine supply, such as when the United States lost half its supply in October 2004 due to manufacturing problems in England. Chiron Corp., the U.S. company that wasn't allowed to market its vaccine, accounted for roughly half of the 100 million flu shots that were to be available for the current flu season.
A budget request filed in January by Florida A&M officials says the effort could create 2,000 jobs in the Tallahassee area.
UPMC also is looking for ways to generate income aside from patient care, Levine noted. The health system, for example, is also negotiating with vendors such as IBM and Hewlett-Packard on an agreement to commercialize any successes in deploying medical information technology, Romoff said.
Levine said it would likely take a year for UPMC to both complete its feasibility study and talk with state and federal officials about their level of support.
"What's interesting is that the idea has emerged and that there's legitimacy to the idea," Levine said. "But it's also very complicated, very challenging and requires many things to fall into place."
The notes of caution were emphasized by industry experts.
Dr. Thomas Vernon, a former vice president in the vaccine division at Merck & Co., said newcomers often underestimate the vast array of professionals needed to sustain a vaccine operation.
Those costs are in addition to the considerable capital investment required to run a plant that complies with federal regulations, Vernon said.
The costs linked to regulation are higher for making vaccines than other drugs, said Mark Pauly, an economist at the University of Pennsylvania who served on a federal Institute of Medicine committee that reported in 2003 on solutions to vaccine supply problems. Companies typically cover those costs by spreading them over many vaccine products, he said.
Cancer vaccines and a vaccine to fight avian influenza represent niche markets that could be profitable, Pauly agreed, although he noted that for political reasons, flu vaccine manufacturers are never allowed to fully profit from their products during shortages.
He questioned the advantage UPMC might have on these projects compared with established vaccine companies.
"Viewed as a business proposition, I'd advise them to expand the flower shop instead," Pauly said.