3
Research Background
Safety and cost issues
Unlike other medications, the end users of which are mostly in poor health, vaccines are
generally adopted by public agencies to inoculate a mass of healthy people to prevent an
epidemic. This causes a fundamental difference between general pharmaceutical innovation
and vaccine innovation. In other words, as vaccines given to a healthy public, the extreme
safety requirements and relatively high cost to reach those requirements are major issues in
vaccine innovation (Rappuoli et al., 2002).
It has been estimated that an average of 15 years is required to move from the
development of a new drug in the laboratory to completion of the three trial phases
(Robbins-Roth, 2000, pp. 117). While new technology in the post-genomic era might shorten
the time required for laboratory work, innovation of a new vaccine might involve up to five
phases, including two post-licensing phases for review of the safety (Nalin, 2002).
These disadvantageous factors, as well as the inequality of living standards between
industrialized and less developed countries, are considered obstacles to vaccine innovation,
and they should be removed by intervention by the public sector to increase the incentive for
innovation (Kremer, 2001).
The facts described above are, however, the status quo of vaccine innovation without
historical and social considerations. The structure of the current pharmaceutical industry,
which is dominated by a few ‘big pharmas,’ was gradually formed over decades, in
coincidence with the progressive pace of the biotechnology and new biological revolutions.
The pattern of vaccine research and production is expected to change with this rhythm
(Galambos & Sewell, 1995). The cost and safety concerns could be the results of a century of
vaccine development that was strongly influenced by the evolution of related scientific
knowledge and social institutions.
Knowledge insufficiency
On the other hand, the role of a vaccine in society is controversial because, due to
limitations in scientific and technological knowledge, the vaccines cannot promise one
hundred percent efficacy (Wilson & Marcuse, 2001). Even today, acquiring the knowledge
required to develop a new vaccine is still a major challenge to scientists, with the AIDS
Convention