Getting to Market: The Scientific and Legal Climate for Developing an AIDS Vaccine

Expectations of a vaccine to prevent acquired immunodeficiency syndrome (AIDS) are rising. Not only are the prospects for an effective immunogen improving, but immunization appears to hold the greatest promise for halting the spread of infection and disease.\u27 Identification of the causal agent-the retrovirus called HTLV-III, LAV, or generically, HIV (human immunodeficiency virus)-has provided the direction and limited the options for containing the disease. Prevention is, of course, critical where the disease must be presumed to be fatal in all cases. Although there is no clear evidence that any single exposure to HIV will result in infection or disease, prudence dictates that all exposures be considered potentially infectious and, ultimately, disease-producing until more is known. Public education or, more specifically, behavior modification, intended to reduce or eliminate unsafe sexual contact and the sharing of syringes and needles by users of illicit intravenous (IV) drugs, is perhaps the only effective means of prevention that currently exists. 3 Public education, however, has rarely been sufficiently persuasive to eliminate the transmission of infectious disease, and faces distinct resistance when applied to matters of sexual conduct and illegal drug use. 4 Therefore, while education is necessary, it may not be sufficient to reduce the risk of exposure to HIV to the level required for damping out the spread of infection.5 Yet vaccine development faces obstacles as significant as those confronting a successful program of public education. The scientific and technical hurdles are themselves formidable. But while the scientific task is becoming clearer, legal and ethical concerns are beginning to loom larger. Among the questions that have yet to be answered is whether producers of any AIDS vaccine will be or should be held liable for the probably inevitable adverse reactions to the vaccine. If so, will the threat of liability dissuade commercial producers from seeking to develop or distribute a vaccine? If not, will the public be confident that the vaccine is safe enough to use? Are Food and Drug Administration (FDA) requirements for testing and licensing sufficient to ensure a safe and effective vaccine? Should they be relaxed to speed a promising vaccine to market or should they be rigorously enforced to keep a potentially dangerous one out of circulation? Answering these questions requires a clear understanding of the scientific, legal, ethical, and public policy issues at stake and, most importantly, their interdependence This article attempts to clarify such issues and to indicate how they may affect both private and public decisions to produce, distribute, and accept a vaccine