Vaccine Supply and Innovation (1985) / Chapter Skim
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3 Vaccine Availability: Concerns, Barriers, and Impediments
3 Vaccine Availability: Concerns, Barriers, and Impediments
Pages 27-44
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From page 27... ...
The decision to pursue vaccine development usually depends, in part, on assessments of the potential market; the final portion of this chapter explores the determinants of vaccine utilization. CONCERNS ABOUT THE CURRENT S ITUATION Supply Each of the major pediatric vaccines (or vaccine combinations)
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From page 28... ...
Testimony at these hearings from Squibb-Connaught indicated that they had continued manufacturing vaccine and would be willing to distribute it if some federal protection were provided from liability risks.8 In response to the anticipated shortage, the Interagency Group to Monitor Vaccine Development, Production and Usage recommended that all health care providers postpone administration of the DTP vaccine doses usually given at 18 months and 4 to 6 years (the fourth and fifth doses) until adequate supplies of vaccine became available.7 The suspected mode of transmission of pertussis suggests that unvaccinated or partially immunized infants, particularly those who have older siblings, are at greatest risk of complications from pertussis.9 The CDC stressed its expectation that the recommendation to modify vaccine schedules would protect these infants.4 (Reductions in immunization levels substantially greater than that expected in this country were associated with increases in the incidences of pertussis cases and deaths in the United Kingdom and
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From page 29... ...
Vaccine manufacturing requires major investment in a sophisticated production plant and the establishment of teams with multidisciplinary expertise in the large-scale production of biological products. Thus, firms that have experience in vaccine production represent a unique combination of resources that would be extremely difficult to duplicate.
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From page 30... ...
Squibb-Connaught, Inc., was the only supplier to respond to this solicitation. On June 15, 1984, Squibb-Connaught, Inc., wrote to the CDC requesting that its offer on the contract solicitation be placed on hold pending clarification of its insurance coverage; later that month, the company withdrew all offers on solicitations from the CDC and state and local health departments.4 In December 1984, stockpiles of major childhood vaccines were estimated to be 15 weeks for oral poliomyelitis vaccine and 12 weeks for measles, mumps, and rubella vaccine combined.
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From page 31... ...
The willingness of manufacturers to supply vaccines for public use under guaranteed contracts probably would depend on prior agreements on liability responsibilities. The possibility of federal vaccine production raises a number of policy questions.
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From page 32... ...
It suggests that a national vaccine commission, proposed in Chapter 7, be charged with developing contingency plans and making recommendations, on a case-by-case basis, for ensuring vaccine availability. These plans should include the possibility of direct federal involvement in vaccine supply if commercial manufacturers continue to withdraw from marketing.
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From page 33... ...
Unfortunately, when the need for an improved vaccine is recognized, the knowledge base may be inadequate because basic research on the pathogenesis of the disease and the mode of action of the vaccine has not been afforded a high priority. Economic Disincentives to Innovation and Production Pharmaceutical manufacturers may be unwilling to undertake development of a vaccine even if the need and potential technical feasibility have been established.
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From page 34... ...
.2 United States manufacturers are often at a disadvantage competing in foreign markets because U.S. regulatory requirements are more stringent and many foreign governments actively promote or underwrite vaccine production (Appendix G)
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From page 35... ...
Insurance coverage and payment practices reflect and reinforce these patterns of technology use. Health insurance routinely covers diagnostic and therapeutic procedures for acute care, and new methods based on expensive, sophisticated technologies.26 In contrast, few insurance policies cover preventive procedures (including vaccination)
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From page 36... ...
into which the innovation is introduced (e.g., the norms and values of a population or population subgroup or the norms and policies of a health care delivery organization) .33 Investigations show that the diffusion of many new medical technologies depends on their successful adoption by "opinion leaders" in the relevant medical community.
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From page 37... ...
preventive action Sociopeychological variables (personalily, ~minus social class, peer and reference group Perceived barriers to P - ~~ "~] preventive action ' 1 ' 1 Perc - Bed Threat of Di~ase 'X' ~ 1 , Cues to Action Moss media campaigns Advice from other' Iteminder postcard from physician or dentist Illness of family member or friend Newspaper or magazine article Lil`elihood of Jolting Recommended Preventive Health Action FIGURE 3.1 Variables and relationships in the health belief model.
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From page 39... ...
the extent to which contracting the disease will disrupt the patient's life.35 In other words, it is possible to describe a "health belief model" for physicians with dimensions parallel to those for the patient (although the physician's perceptions may be quite different from those of the patient)
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From page 40... ...
These plans should include the possibility of direct federal involvement in vaccine supply, if commercial manufacturers find continued Open market" operation no longer viable. Barriers and Impediments to Vaccine Innovation Modern vaccine development requires a firm scientific foundation, based on an understanding of the pathogen and the host thuman)
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From page 41... ...
Specific economic deterrents to vaccine innovation and production include: · the complexity of development, production, and quality control · the cost of research and development in relation to anticipated sales · a perception that vaccines historically have received less effective patent protection than drugs · apprehension over the liability situation In addition, the need for a vaccine to deliver lifelong or long-lasting immunity is at odds with the prospect of multiple or repeat sales, and the prospects for export sales are poor. Finally, the achievable market may not reflect the true public health benefits of a vaccine because certain features of the health care delivery system and of clients and health care providers contribute to vaccine underutilization.
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From page 42... ...
1983. Unpublished paper prepared for the Committee on Public-Private Sector Relations in Vaccine Innovation, Institute of Medicine, National Academy of Sciences, Washington, D.C.
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From page 43... ...
1979. Participation of senior citizens in the swine flu inoculation program: an analysis of health belief model variables in preventive health behavior.
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From page 44... ...
1972. Differential education concerning therapeutics and resultant physician prescribing patterns.
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