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GENERAL

Vaccine manufacture began in humble academic laboratories such as that of Louis Pasteur in the Rue d’Ulm in Paris1 or on the cow farms in which vaccinia was produced.2 The results of vaccine application hardly needs emphasis, and numerous data testify to the impact of vaccination with regard to disease incidence, mortality, and economics.3–8 However, by the beginning of the twentieth century, it was obvious that a large number of doses was needed and that standardization was necessary. At first this was accomplished in government laboratories but soon the scale of effort exceeded the personnel and facilities, and also the possibility of profit became evident, so that manufacture passed to pharmaceutical laboratories. These were concentrated in Europe and the United States. After the Second World War, when the number of routine vaccines increased, lawsuits against vaccine manufacturers began to increase sharply. The result was the withdrawal of some manufacturers from the vaccine field, and the contraction of the industry to four major players: GlaxoSmithKline, Merck, Pfizer, and Sanofi.

The development of the Vaccine Compensation System in 1986 rescued vaccine manufacturing, in that the United States government paid those who claimed damage from vaccination, often without proof of an association. This allowed commercial manufacturers immunity from most lawsuits, and brought new players into the field. Thus, organizations that have succeeded or are seeking to develop vaccines for the American market now include Janssen, Takeda, Astellas, and Dynavax, among others. In addition, the growing economies in other countries allowed for the growth of many companies that were producing vaccines for domestic markets, but which had aspirations for selling in foreign markets. These include notably, Serum Institute of India, Bharat, Biological E, Butantan, Indonesia, Sinovac, Chengdu, and Commonwealth Serum Laboratories. Thus, the vaccine industry is once again strong and fertile.

However, problems remain. The cost of vaccine development to the point of registration, has mounted considerably. There have been variable estimates, but half a billion dollars for development of a new vaccine appears to be a reasonable one.9 Nevertheless, the cost of the Sanofi developed vaccine against dengue exceeded 1 billion dollars, and it appears that Dengvaxia will not give return on investment because of unanticipated safety problems.10 The length of time for vaccine development from the end of preclinical research to licensure has also become elongated, 11 years being about average. In addition, most projects end in failure.11

These difficulties have been inhibitory to vaccine development in two ways. First, it inhibits companies from investing in vaccines with small markets or markets predominantly in developing countries. Second, the research and development costs are not afforded by most companies in the developing world, although that is beginning to change for the better. A consequence of the difficulties has been the birth of the Coalition for Epidemic Preparedness (CEPI), an organization funded by multiple countries and charitable organizations specifically to ...

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