How the Delayed Distribution: BACKGROUND
The 2000 and 2001 Vaccine Delays
The magnitude of the 2000 and 2001 vaccine distribution delays is best illustrated by comparing the volume of vaccine delivered by manufacturers by the end of October in those years with the amount of vaccine delivered by the same time point in 1999 (Figure 1). In 1999, four manufacturers distributed a combined total of approximately 75.8 million doses of vaccine (99% of the year’s total) by the end of October. By contrast, in 2000 and 2001, three manufacturers distributed a combined total of approximately 26.6 million (38% of the year’s total) and 43 million (55% of the year’s total) doses of vaccine, respectively, by the end of October. The volume of vaccine delivered by the end of October is an important benchmark because October and early November, traditionally, have been the months of peak influenza vaccine demand in the U.S.The basis for the delays differed somewhat by year. In 2000, some manufacturers experienced difficulties growing and processing the influenza A (H3N2) vaccine strain. Such difficulties are not unusual, especially early in the production and processing of new vaccine strains. Different manufacturers employ different manufacturing techniques, which can affect how well a specific influenza virus strain grows or processes for a particular manufacturer. As a result, some manufacturers might experience difficulties growing or processing a particular strain in a certain year, while other manufacturers do not experience similar difficulties. In any case, manufacturers commonly “tweak” or make minor adjustments (within a range of established and validated parameters) to their vaccine production processes to optimize the yield of vaccine strains.
In 2000, however, two of the four manufacturers also experienced regulatory issues related to the FDA’s current Good Manufacturing Practices (GMP). The combination of growth and processing problems related to one strain and unrelated current GMP issues resulted in an unprecedented distribution delay of approximately six weeks.
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Figure 1. Cumulative Monthlylnfluenza Vaccine Distribution, U.S., for 1999, 2000, and 2001
During the summer of 2000, responses to the delay were complicated by continued uncertainty over the potential magnitude of the delay and the question of whether a significant absolute shortage would occur. Uncertainties about these issues made it difficult, in turn, to widely communicate precise information about the delays. One of the steps taken by Centers for Disease Control and Prevention (CDC) in the late summer, as insurance against the possibility of a significant shortage, was to contract with Aventis Pasteur for the production of an additional nine million vaccine doses, beyond the company’s planned production. These doses first became available to providers in early December, but by that month, the national demand for vaccine had waned substantially; eventually 7.5 million of these vaccine doses remained unused.
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Also in 2000, Parkdale Pharmaceuticals, Inc. decided to permanently stop production of influenza vaccine, leaving Aventis Pasteur, Evans Vaccines, Ltd., and Wyeth Lederle Laboratories as the remaining companies selling influenza vaccine in the U.S. The time needed by these manufacturers to expand their vaccine production and to make up for the loss of Parkdale Pharmaceuticals, as well as continued current GMP issues experienced by one of the three manufacturers, led to a second, albeit less severe, influenza vaccine distribution delay in 2001.
A major consequence of the 2000 delay, and to a lesser extent the 2001 delay, was a situation in which some providers received limited or no supplies of vaccine while other providers were able to procure full allotments during periods of high vaccine demand. In some instances, vaccine was delivered to community- or work-site-based clinics and large store chains before delivery of vaccine to physician offices, hospitals, and nursing homes. The prices of vaccine to some providers also increased. A group of physicians surveyed by the General Accounting Office indicated that the average price paid by them for vaccine ordered in June was $2.90 (range: $1.90-$6.35), which rose to an average of $6.98 (range: $2.50-$12.80) per dose in October and November. The uneven distribution of vaccine, coupled with price increases and increasing provider concerns about inadequate reimbursement for influenza vaccination activities, provoked strong reactions and expressions of concern by many physicians and others. cialis soft tablets
The uneven distribution patterns largely reflected the differing rates at which companies were able to produce and distribute vaccine to secondary distributors or to end-users of vaccine, as well as the free market nature of the influenza vaccine distribution system. This distribution situation stands in contrast to that for pediatric vaccines, for which the federal government has a substantial role. For example, CDC establishes contracts for the purchase of substancial amounts of vaccine on behalf of state and territorial health departments through the Vaccines for Children Program. No governmental or single private entity has a similiar central coordinating role in the distribution of influenza vaccine to providers.
