Vaccines: All things considered

Vaccines remain the primary means for preventing disease and reducing health care costs of treatment and lost work time due to sickness. Despite our greater understanding of immunology and the technological advances that have been made, we are in jeopardy of losing the acceleration of vaccine development that has occurred since Jenner's discovery in 1775 due to the incredible expense, small profit margin, great risk against success, and even greater risk for litigation. The presentations at this meeting presented the warning with optimistic suggestions for improvement. New technology, new approaches to production, and greater cooperation between the FDA and vaccine developers will enhance vaccine development. The vaccine industry can help themselves by careful analysis of potential markets prior to development, by working closely with the legal and production people early in the development process, by carefully designing vaccine trials to ensure applicability to the regulations of multiple countries, by dialogue with the FDA early in the development process, and by having a plan for dealing with change. The federal government can help in many ways: initiate tort reform to help remove/lessen the manufacturer's liability; develop new incentives for early stage investment in vaccine development by providing tax advantages, such as lower capital gains rates, or by allowing the sale/transfer of research and development tax credits; reduce the regulatory burden on vaccine development without compromising safety by categorizing vaccines within orphan drug status for clinical trials and by greater utilization of surrogate indicators of efficacy, especially in phase I trials; change patent rules to promote mandatory patent pooling and extend the life of a patent for time lost in the regulatory process to increase the incentives and the return on the investment. Government can facilitate vaccine development by enriching the funding of vaccine research and development. Although Project Bioshield has been given a considerable budget, its funds are distributed to a very limited number of companies and for very limited and defined projects. As a result, the benefit to the advancement of the vaccine field is also limited. NIH remains the primary funding source for most vaccine projects, both academic and industrial. Review of the CRISP (Computer Retrieval of Information on Scientific Projects) database of NIH projects for the past 5 years indicated that vaccine projects represent approximately 3% of NIH projects compared to the approximately 17.5% for drug or pharmaceutical projects. Interestingly, the number of NIH intramural vaccine projects suggests that they have a higher priority within the NIH campus than is applied to extramural projects. In addition to the many approaches that NIH is currently taking to enhance vaccine development, more development could be reached by increasing the number (including Small Business Innovation Research [SBIR]/Small Business Technology Transfer [STTR]) of study sections that review immunology/vaccine projects, increasing the representation of reviewers on the study sections who come from vaccine segments of industry, and by increasing and expanding the number of requests for applications specific for vaccines. In addition, greater recognition can be paid by funding sources and the FDA towards vaccines that elicit protections other than antibody and therapies for noninfectious diseases, such as autoimmunity, allergy, and cancer, and therapies for diseases, such as Alzheimer's dementia, obesity, smoking, drug abuse, and hypertension. Many developments have been made within the vaccine industry, but interestingly, there are relatively few new technologies that have entered the vaccine market. There are many other diseases that can be targeted for vaccine prevention or treatment, but funding, risk, and limited profit/return reduce their initiation. The development of vaccines in the 21st and even the 22nd century is going to require a team effort from all the different constituencies that were represented at the Vaccines: All Things Considered meeting and presented in this minireview. The fourth annual meeting will be held in November 2006 in Washington, D.C. (http://gtcbio.com/confpage.asp-?cid=28).