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U.S. Response: Experts Disagree Over Who Should Make Anti-Weapon Vaccines Pharmaceutical companies and other experts disagree over whether the United States should operate a federal plant to produce vaccines against biological weapons agents, Technology Review reported this month (see GSN, Nov. 8, 2001). The National Academy of Sciences has said that the private sector has few incentives to produce such vaccines, according to the Review. “The anthrax terrorism event clearly exposed the weaknesses we have in the research, development and production of vaccines that are important for fighting terrorism,” said Kenneth Shine, president of the National Academy of Sciences’ Institute of Medicine. The Institute of Medicine first developed the idea of creating a National Vaccine Authority 10 years ago, and the plan was supported by two additional advisory panels that examined counterterrorism measures and the military’s ability to produce vaccines, according to the Review. According to recommendations, the authority would operate a U.S.-owned vaccine production plant and oversee new vaccine research that might have little commercial viability, Shine said. For example, researchers could examine new ways to combine vaccines into a single product. “It’s not about replacing the private sector,” Shine said. “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.” The authority would not be a large bureaucracy, but a government-industry partnership similar to a World War II-era program to produce penicillin for allied soldiers, Shine said. The authority could be run as a joint effort between the Defense and Health and Human Services departments, he added. Retired U.S. Army Maj.-Gen, Phillip Russell, a vaccine expert recently recruited by the Bush administration, however, has said a government vaccine program should be independently operated. “What it really needs 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,” Russell said. The pharmaceutical companies that produce vaccines oppose the idea of a National Vaccine Authority, according to the Review. Merck Vaccines President Adel Mahmoud said the authority plan is too large to succeed. Many people do not understand how difficult it is to produce vaccines, he said. It was not the fact that vaccines are unprofitable, but a general complacency about infectious diseases that led to vaccine shortages, said Michael Friedman of the Pharmaceutical Research and Manufactures of America, an industry-lobbying group. Since the Sept. 11 and anthrax attacks, however, the situation has now changed, he added. “Now that we are facing a real bioterrorist threat ... public and private resources will be mobilized,” said Friedman, a former Food and Drug Administration commissioner. Instead of building a vaccine plant, the government should invest funds in infectious diseases research and encourage academic researchers to work with the pharmaceutical industry, said William Haseltine, chief executive officer of Human Genome Sciences (see GSN, May 2). “You don’t ask DOD to build fighter planes; why should it make vaccines?” Haseltine said. “We need to rebuild and provide funding; the new scientists will come.” Industry Support Other pharmaceutical industry executives, however, support the idea of the government becoming involved in vaccine production, the Review reported. “I am one of the rare people in industry who thinks it would be a good idea” for the government to build a vaccine production plant, said Thomas Monath, vice president of research at the pharmaceutical company Acambis. It would be better for the government to have complete control of a vaccine production plant and have it overseen by outside experts, rather than attempt to partner with smaller private firms, which could lead to added delays and costs, said Franklin Top, executive vice president at the biotechnology firm MedImmune. “Once the big contracts are in place, you’re stuck with them,” Top said. “These behemoths have a life of their own” (Technology Review, May 2002).
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