Abstract
In 1991, a goal of improved thermostability of oral poliovirus vaccine (OPV) was set, and the Product Development Group was established under the Children's Vaccine Initiative to achieve this goal. Several initial research strategies were unsuccessful. The substitution of deuterium oxide for water in the final blending stage of vaccine production resulted in a significantly more stable product at temperatures of > or = 37 degrees C. A large body of clinical data shows the safety of deuterium at the dosage that would be given with this vaccine. However, reservations about the public acceptability of the vaccine, combined with the progress achieved in polio eradication with the current vaccine and the availability of vaccine vial monitors to indicate time and temperature exposure of every vial of OPV, have resulted in a recommendation that vaccine development cease. This product development activity has been instructive for the process of introduction of new vaccines.
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