David Swinbanks1 has succinctly outlined the political, fiscal, commercial and technical challenges faced by the Seoul-based International Vaccine Institute (IVI). Pending completion of the building of its laboratories, IVI is planning epidemiological studies of the burden of vaccine-preventable diseases, an assessment of vaccine requirements and clinical trials and field studies.
IVI must also concern itself with problems in the field for vaccines, therapeutics and diagnostics in Asia. There are alarming reports of large-scale theft and resale on the black market of expired and potentially toxic vaccines in Myanmar (formerly Burma). Nearly 10,000 doses of unrefrigerated vaccines were on sale in 1995. The vaccines were many months past the printed expiry date, had lost their potency and were toxic when injected into laboratory animals2. Moreover, the use of expired drugs is an established practice in many countries, such as Sierra Leone, that have no organized system for monitoring reaction to drugs3. Following the use of pre-tested blood for HIV with expired or improperly stored antibody screen reagents, the risk of HIV transmission in Zambia was at least six times as great as expected4.
Such events would be the rule rather than the exception in the event of global warming because of climate change or the effects of El Niño. IVI should start field studies immediately to monitor different permutations of temperature, humidity, atmospheric pressure and air velocity in remote parts of Asia. These parameters should be monitored with appliances such as electronic loggers. Monitoring of vaccine storage temperature by such loggers in Adelaide, South Australia, showed inadvertent vaccine exposure to sub-zero temperatures as well as to temperatures of more than 22 °C (ref. 5).
The data compiled by IVI would be of immense value both to the institute itself and to its partners in the venture. For instance, the World Health Organization would be able to modify the established criteria for stability of vaccines, prophylactic and therapeutic, to ensure intact potency even in black-market sales of products past their use-by date. The manufacturers, in the West and elsewhere, could select products stabilized against the adverse environment described by IVI. Last but not least, the risk of an iatrogenic HIV spread during blood transfusion would be minimized through the availability of sturdy antibody assay kits. The frequent field exposure of IVI personnel before their premises are ready could significantly reduce the hostility of national/international manufacturers and funding agencies.
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Costen, E. C. J.et al. Transfusion 37, 930–934 (1997).
Wawryk, A., Mavromatis, C. & Gold, M. Br. Med. J. 315, 518 (1997).