The Children's Vaccine Initiative Achieving the Vision (1993) / Chapter Skim
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4 Vaccine Demand and Supply
4 Vaccine Demand and Supply
Pages 66-97
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From page 66... ...
GLOBAL DEMAND AND SUPPLY Demand The potential size of the worldwide pediatric vaccine market is determined by two factors: the annual worldwide birth cohort (approximately 143 million live births per year) (World Bank, 1993)
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From page 67... ...
Regional Demand Assessments of country-level demand for vaccines must take into account the size of the target population, estimated extent of immunization coverage, anticipated vaccine wastage, number of scheduled doses, and any special immunization campaigns or strategies that would lead to a surge in demand. Determination of demand for vaccines is more problematic when special, intensive immunization strategies are considered (World Health Organization/Children's Vaccine Initiative, 1992c)
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From page 68... ...
. The annual production of 500 million doses of EPI vaccines by the People's Republic of China is equivalent to roughly half of all vaccines purchased by UNICEF each year (Agency for Cooperation in International Health, 1992~.
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From page 69... ...
There is also concern that there are now insufficient funds to buy additional EPI vaccines required for such activities as measles control and neonatal tetanus eradication (Agency for Cooperation in International Health, 1991~. At the 1991 International Meeting on Global Vaccine Supply in Kumamoto, Japan, several issues that may affect the future viability of EPI were discussed.
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From page 70... ...
.~s 0 e ._ O C~ _ ~ CJ 0 ~ ~ O ~ C4 _. 0 0 C CL C~ E c, c~ o c~ o 3 ~R _ ~ E o ._ Q o Q o E FIGURE 4-1 Vaccine supply grid of countries that produce vaccines according to per capita gross national product (GNP)
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From page 71... ...
In 1985, UNICEF bought roughly 366 million doses at a cost of approximately $18 million; by 1992, this had increased to 850 million doses at a total cost of some $65 million, including air freight delivery (UNICEF, 1991a, 1992a,b)
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From page 72... ...
Through its procurement system, UNICEF has actively sought to expand the base of suppliers both to ensure a stable vaccine supply and to keep the prices charged for EPI vaccines comparatively low (U.S. Congress, Senate, 1982~.
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From page 73... ...
SmithKline Beecham X X (United Kingdom) Swiss Serum Vaccine Institute X X (Switzerland)
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From page 74... ...
Because these vaccine purchases have a minimal impact on the total vaccine revenues of those companies that sell vaccine to UNICEF and PAHO, some have suggested that dependence on these international vaccine suppliers puts the global vaccine supply in a precarious position (Agency for Cooperation in International Health, 1992; Institute of Medicine, 1986~. Even though a major UNICEF supplier's exit from the vaccine business might have a minor impact on the firm's bottom line, there is concern that it might have a significant negative impact on the supply of high-quality vaccines to the developing world.
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From page 75... ...
Currently, about 20 million doses of DTP and OPV are distributed each year in the United States (National Vaccine Injury Compensation Trust Fund, 1992~. Prior to the measles epidemic of 1989-1991 and the requirement for a second dose of measles vaccine, approximately 10 million doses of measles-mumps-rubella vaccine (MMR)
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From page 76... ...
procurement of vaccines is of considerable concern to the large commercial manufacturers (Douglas, 1992,1993; Saldarini, 1992,1993; Williams, 1993~. They argue that sales to the public sector offset those to the private sector, and increasing public sector procurement will lead to further increases in the prices charged to private-sector clients (Gamier, 1993~.
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From page 77... ...
Measles and mumps virus vaccine live Measles and rubella virus vaccine live Meningococcal polysaccaride vaccine A, C, Y W135 combined Mumps virus vaccine live Pertussis vaccine Pertussis vaccine adsorbed Poliovirus vaccine inactivated Polio vaccine live oral, trivalent Plague vaccine Pneumococcal vaccine' polyvalent Rabies vaccine Rabies vaccine adsorbed Rubella vaccine Rubella and mumps virus vaccine live Smallpox vaccine Continues
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From page 78... ...
Food and Drug Administration requirements for demonstration of vaccine efficacy~, liability concerns, and poor market returns relative to other product areas. In the United States, the few remaining vaccine manufacturers stayed in the vaccine business as much to meet the public health need (there were no other suppliers for OPV and MMR)
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From page 79... ...
It takes considerably more than 6 months to retrofit an existing production facility to make a new vaccine and longer still to construct a facility from the ground up (George Siber, Massachusetts Department of Public Health, personal communication, 1993~. Pricing In the United States, commercial manufacturers list two prices for a vaccine: a contract price, which is negotiated on an annual basis with the CDC, and a catalog price, which sets vaccine prices for private-sector clients, such as hospitals, health maintenance organizations, pharmacies, and physicians.
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From page 80... ...
Until recently, the taxes-$4.56 per dose of DTP, $4.44 per dose of MMR, and $0.29 per dose of OPV-were paid into a special trust fund that was used to pay the claims of those with vaccinerelated injuries. The law establishing the National Vaccine Injury Compensation Program mandated that the excise taxes be collected until 1992, at which point the program was to be reassessed.
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From page 81... ...
From 1988 to 1992, prices include federal excise tax for the Vaccine Injury Compensation Program. Excise taxes are set at $4.56 per dose of DTP, $4.44 per dose of MMR, and $0.29 per dose of OPV.
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From page 82... ...
. Although spending in real terms (as reported to the Pharmaceutical Manufacturers Association)
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From page 84... ...
84 ~ c: en o I: it: · c~ ·O c)
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From page 85... ...
In 1989, Lederle Laboratories, a unit of the American Cyanamid Corporation, acquired Praxis Biologics, a biotechnology company that had developed a conjugate Haemophilus infl~`enzoe type b conjugate vaccine (Hib-CV)
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From page 86... ...
86 lo: o · o4 o - o · As o so: ed cn · :, .
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From page 87... ...
VACCINE DEMAND AND SUPPLY 600 _ 500 400 300 200 100 INDs Received 1 ., .........
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From page 88... ...
in some respects, that might be used in the CVI, but it was developed in part by and for the DOD. The current vaccine development process in the United States, from basic research through to the production, distribution, and marketing of vaccine products, although poorly integrated, does lead to the development and production of new vaccines for the domestic market, primarily because vaccine manufacturers perceive there to be adequate returns on their investment.
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From page 89... ...
By all accounts, the worldwide vaccine industry appears to be entering a new era of activity and innovation. In the United States, commercial vaccine manufacturers and biotechnology firms are pursuing the development of innovative vaccine products targeted to the industrialized-world market.
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From page 90... ...
Lederle-Praxis Biologicals Diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed (DTaP) Connaught Laboratories, Inc.
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From page 91... ...
92.5 12/1989 New vaccine Swiss Serum & Vaccine Institute Berne New introduction of old vaccine New vaccine Enhanced poliovirus vaccine Independent introduction Independent introduction Independent introduction SOURCES: New Drug Approvals in 1991, Pharmaceutical Manufacturers Association, January 1992; New Drug Approvals in 1990, Pharmaceutical Manufacturers Association, January 1991; New Drug Approvals in 1989, Pharmaceutical Manufacturers Association, January 1990; Biotechnology Medicines, Pharmaceutical Manufacturers Association, 1990; Douglas Reynolds, Connaught Laboratories, Swiftwater, Pennsylvania, October 1992; Carolyn Hardegree, Center for Biologics Evaluation and Research, U
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From page 92... ...
Connaught Laboratories, Inc./Pasteur Merieux Serums et Vaccins ActHIB + DTaP; Diptheria and tetanus toxoids and acellular pertussis vaccine, adsorbed, reconstituting Haemophilus influence type b conjugate vaccine (tetanus protein conjugate) Connaught Laboratories, Inc./Pasteur Merieux Serums et Vaccins Phase I Phase I/II Phase I Phase III (infant efficacy study)
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From page 93... ...
Diphtheria and tetanus toxoids and pertussis vaccine, hepatitis B and Haemophilus infFuenzoe type b conjugate vaeeine Michigan Department of Public Health/ SmithKline Beeeham Diphtheria and tetanus toxoids and acellular pertussis vaccine and hepatitis B vaccine and Haemophilus influence type b conjugate vaccine Michigan Department of Public Health/ SmithKline Beeeham Diptheria and tetanus toxoids and pertussis vaeeine, adsorbed, and poliovirus vaeeine, inactivated Connaught Laboratories, Ine./Pasteur Merieux Serums et Vaeeins AetHIB Haemophilus influence type b conjugate vaeeine (tetanus protein conjugate) Connaught Laboratories, Ine./Pasteur Merieux Serums et Vaeeins lIaernophilus influence type b conjugate vaccine Massachusetts Department of Public Health Haemophilus influenzas type b conjugate vaeeine, hepatitis B vaccine Merek & Co., Ine.
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From page 94... ...
Pneumocoeeal conjugate vaccine (streptococcal conjugate vaccine, diphtheria toxoid and tetanus protein conjugates for otitis media and pneumonia) Connaught Laboratories, Inc./Pasteur Merieux Serums et Vaceins Pneumoeoceal conjugate vaccine, streptoeoecal pneumonia vaccine, enhanced Lederle-Praxis Biologieals Pneumoeoecal conjugate vaccine Merek & Co., Inc.
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From page 95... ...
1991. Report of the International Meeting on Global Vaccine Supply, May 23-26, Kumamoto, Japan.
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From page 96... ...
1983. Vaccine Supply and Inn~lion.
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From page 97... ...
February. Washington, D.C.: Pharmaceutical Manufacturers Association.
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