U.S. Vaccine Markets: Overview and Four Case Studies by Ernest R. Berndt, Anjli C. Warner, Rena N. Denoncourt

By Ernest R. Berndt, Anjli C. Warner, Rena N. Denoncourt

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While two large epidemiological studies found no evidence that the vaccine caused chronic disease, the injury claims were widely publicized, GlaxoSmithKline spent considerable funds defending their product, and sales of the vaccine declined. S. 13 While product liability is also an issue for nonvaccine biologics and small molecule pharmaceuticals, nonvaccines are generally utilized by ill and nonpediatric populations. Because vaccines are given to millions of healthy children annually, and because rare but serious side effects can reasonably be expected given the widespread utilization, vaccine manufacturers are particularly vulnerable to product liability issues.

13 While product liability is also an issue for nonvaccine biologics and small molecule pharmaceuticals, nonvaccines are generally utilized by ill and nonpediatric populations. Because vaccines are given to millions of healthy children annually, and because rare but serious side effects can reasonably be expected given the widespread utilization, vaccine manufacturers are particularly vulnerable to product liability issues. S. 14 It is useful to distinguish between differentiated (or heterogeneous) and undifferentiated (or homogeneous) medical products.

From there they are distributed to clinics, hospitals, and physicians’ offices, in some cases after repackaging into smaller multidose vials, separate needle-syringe doses, or filled syringes without needles. Second, vaccines may be distributed in PLANNING FOR VACCINE LAUNCH 33 considerably smaller volumes directly from manufacturers to private clinics and physicians’ offices, which purchase and bear the inventory costs of storing them. Finally, vaccines in varying shipment sizes may be distributed from manufacturers to wholesalers, who may undertake secondary packaging before reselling to private physician practices and clinics, the latter again bearing the purchase and inventory costs of acquiring and storing the vaccines.

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