The Institute of Medicine’s Shine thinks there is a reasonable way out of this bind. His idea is based on a plan he and others introduced nine years ago. In 1993, the Institute of Medicine issued a report that spelled out how the United States could best support a broad effort to increase the number of children receiving basic immunization. The report advocated creating a National Vaccine Authority that would “advance the development, production and procurement of new and improved vaccines of limited commercial potential but of global public-health need.” Despite making a big media splash for a time, the proposal never made much headway.Since September 11, the Institute of Medicine has aggressively shopped the idea around once again. The new version calls for a total overhaul of the vaccine enterprise, and a National Vaccine Authority that would meet both civilian and military needs. The authority would oversee a government-owned manufacturing plant that would not only make vaccines for rare diseases and bioweapons but also fill in the supply gaps for more common diseases. In addition to manufacturing vaccines, Shine says, the authority would sponsor research into new vaccine ideas that hold little commercial interest. Combining three vaccines into one product, for example, makes the vaccines easier to administer-but offers no obvious benefit to manufacturers, particularly if the three vaccines are made by different companies.
“It’s not about replacing the private sector,” says Shine. “It’s based on the notion that there is a spectrum of vaccine needs that cannot and will not be met by the private sector.” Shine still believes, however, that industry has a role to play. He envisions the proposed manufacturing system as a private-public partnership, not a huge government bureaucracy. During World War II, just such a partnership, led by a U.S. Department of Agriculture lab, had tremendous success in quickly producing massive amounts of penicillin for Allied troops and, by the war’s end, the public at large.
Shine’s conclusions are remarkably similar to those reached independently by a panel that reviewed the military’s own vaccine acquisition program. The military’s reliance on a network of contracts with private manufacturers “is insufficient and will fail,” the panel wrote in its December 2000 report. The panel instead recommended that the government build its own vaccine production plant and hire a contractor to operate it, calculating that a $3.2 billion research-and-development program could reliably produce eight vaccines. The U.S. surgeon general subsequently endorsed the idea and suggested that it could benefit civilians, too.
In fact, for several decades, the Department of Defense actually had such a facility-a vaccine plant in Swiftwater, PA. While it was owned and operated by the La Jolla, CA-based Salk Institute for Biological Studies, the plant was dedicated exclusively to manufacturing vaccines to defend army troops against possible biological weapons. “It was a well-organized laboratory with good staff completely at the discretion of the army,” recalls Alexis Shelokov, who headed the facility from 1981 to 1991. The Swiftwater-made vaccines, says Shelokov, cost the government “practically nothing per dose.” And Swiftwater’s managers steadily upgraded the facilities to keep pace with the state of the art.
In the mid-1990s, in a move that dumbfounded many observers, the Department of Defense decided to dump the Swiftwater plant in favor of its current contract-based vaccine program. But now the military’s skyrocketing demand for anthrax and smallpox vaccines is making the program’s shortcomings all the more apparent-and the recommendations of both the military review panel and the Institute of Medicine for a government-owned vaccine plant are receiving new attention.
The Institute of Medicine did not suggest which agency should ultimately run a national vaccine program but hinted that a collaboration between the Defense Department and Health and Human Services might work. Retired U.S. Army major general Philip Russell, a vaccine expert recently recruited by the Bush administration to work on biological defense, has a different idea altogether. “What it really needs,” Russell said, “is a NASA-like organization that is independent and meets the needs of both agencies and is not encumbered by either bureaucracy, but can just accomplish its mission.”