A Cautionary Tale  pg. 6

Crowe explains, “We believe that at the time of birth babies are in transition from an environment in which they are not exposed to foreign antigens to one where they immediately need to start making antibody responses. It may be that the answer to how to induce better immune responses in children is to give vaccines more frequently very early in life, so that we catch children at a time point when their immunologic development is moving along. The whole public health infrastructure would have to be reoriented for vaccines that have to be given more than once during the first month of life. We’re currently not set up to do that.”

As researchers work to create a vaccine against HIV/AIDS, infrastructure issues become even more problematic. Comprehensive studies show that in developing countries such a vaccine would have to be targeted towards 12- to 15-year-old children, who are not yet sexually active. To date, there is no effective AIDS vaccine, and the pressure is mounting to find one. Says Wright, “Perhaps the new antiretroviral drugs can slow an epidemic, but I don’t think anyone will make a projection that HIV will go away without a vaccine component. The cost of AIDS in the countries of Africa where 10 to 15 percent of the young adults have HIV is of great interest to the U.S. government.” He cites the potential for social disruption and political instability if such a large number of the most productive members of a country’s work force becomes sick. “It is appropriate to take those costs into account as we introduce new vaccines,” he says.

In fact, cost and liability, rather than scientific know-how, have become the greatest barriers to vaccine production. Even minor side effects and reactions from new vaccines are likely to result in lawsuits, a liability that vaccine manufacturers are unwilling to bear. The government will have to pick up the tab. Says Webster, “There used to be five manufacturers of flu vaccine in the United States. Now there is only one company manufacturing the standard injectable, and one making the nasal mist vaccine. I would like to send a message to our nation’s legislators: If you want to have a vaccine in the face of a pandemic, then you’d better consider the liability issues now.”

Vaccines, Edwards explains, are not like other drugs. A drug to prevent ulcer disease, for example, will be taken by millions of people over the course of years, whereas people may take a particular vaccine only once in a lifetime. “So the market share for vaccine is totally different than the market share for a pharmaceutical,” she says. “The incentive to make new, sexy vaccines that could use incredible technology is not what it is for pharmaceuticals. Coupled to that, a lot of vaccines are given to children—and children don’t vote.”

In addition, Americans are used to purchasing their vaccines at bargain basement prices, since the government purchases half the vaccines available in this country. Edwards says, “If you work for a pharmaceutical company, you have to ask why you should be investing resources in a vaccine you give once a year to part of the population, and sell it to half those people for cost.”

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