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The Children's Vaccine Initiative: Achieving the Vision (1993)

Chapter: 4 Vaccine Demand and Supply

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Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
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4
Vaccine Demand and Supply

The state of vaccine demand, supply, and innovation on the global level is quite different from that in the United States. Consequently, this chapter examines these trends on a global basis and then explores the domestic conditions of vaccine supply and demand.

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) and the number of vaccines a child receives through adolescence. Eight of the vaccines recommended by the World Health Organization's (WHO's) Expanded Program on Immunization (EPI) should be administered during or shortly after the first year of life (see Appendix G for immunization schedule). According to one estimate, almost 1.5 billion doses of vaccine were used around the world in 1990 (Baudrihaye, 1992) (Table 4-1). Of this amount, North America, Europe, and Japan used just 14 percent of the total, while purchases by the United Nations Children's Fund (UNICEF), the Pan American Health Organization (PAHO), and WHO accounted for approximately 63 percent of the total vaccine used (Baudrihaye, 1992).

Although the number of potential vaccinees in developing countries is

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

TABLE 4-1 Estimated Worldwide Usage of Vaccines, 1990 (in millions of doses)

Vaccine

North America Europe, and Japan

UNICEF PAHO, and WHO

Other

Total

BCG

5

160

20

185

DTP

40

219

50

260

Hepatitis B

15

 

35

50

Influenza

75

 

10

85

Measles and combined

15

131

30

165

Meningococcal

10

20

30

60

Polio (OPV, IPV)

60

450

190

700

Rabies

1

3

4

8

Total

211

983

358

1,552

Percentage of total

14

63

23

100

 

SOURCE: Adapted from N. Baudrihaye, European Federation of Pharmaceutical Industries Association, Brussels, 1992; with additional information provided by Akira Homma, PAHO, 1993; John Gilmartin, UNICEF, 1993; Terrel Hill, UNICEF, 1993.

much larger than that in the industrialized world (almost 80 percent of the 143 million live births occur in the developing world), the amount spent on vaccines in the industrialized world greatly exceeds that spent by UNICEF, PAHO, and WHO. The total worldwide value of human vaccines sold in 1992 has been estimated to be as high as $3 billion (Technology Management Group, 1993), of which only $65 million represented UNICEF purchases (John Gilmartin, UNICEF, personal communication, 1993).

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). For example, the ongoing global campaign to eradicate polio in the Americas has led to increased demand for and, at brief intervals, temporary shortages of polio vaccine (Pan American Health Organization, 1992). In 1992, UNICEF

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

purchased 351 million doses of oral polio vaccine (OPV), which cost $25.6 million including air freight delivery (John Gilmartin, UNICEF, personal communication, 1993; World Health Organization/Children's Vaccine Initiative, 1992b). It is estimated that to duplicate polio eradication efforts elsewhere in the world, the annual purchase of OPV must increase to $87 million (Agency for Cooperation in International Health, 1992).

Vaccine wastage has been identified as another major problem, not only in terms of cost but also in terms of forecasting the demand for vaccine (World Health Organization/Children's Vaccine Initiative, 1992c). Between 1982 and 1992 the demand for EPI vaccines rose 10-fold (Agency for Cooperation in International Health, 1992; UNICEF, 1991b). This kind of growth in demand has forced UNICEF to try to predict the number of doses needed, so that manufacturers will have enough time to increase their production. This has not been an easy task, primarily because the month-to-month variation in demand for a vaccine can vary as much as sevenfold (World Health Organization/Children's Vaccine Initiative, 1992c). Up until 1990, UNICEF's annual forecast of worldwide vaccine demand was fairly accurate. However, in both 1991 and 1992, countries requested substantially less vaccine from UNICEF than estimated (Terrel Hill, UNICEF, personal communication, 1993). The precise reasons for the decreased country demand for UNICEF-supplied vaccine are not fully understood at this time. It is likely, however, that increased local production of vaccines in some countries has led to decreased country-level demand. In addition, improved national census data in many countries may have resulted in a more realistic assessment of vaccine need. Of great concern, however, is that the decreased demand for vaccine may be a result of a slippage in immunization coverage in many countries (Terrel Hill, UNICEF, personal communication, 1993).

Supply

Vaccines are manufactured by both industrialized and developing countries around the world. It is estimated that almost 60 percent of the diphtheria and tetanus toxoids and pertussis vaccine (DTP) currently being used in the world is actually produced in the country that uses it (World Health Organization/Children's Vaccine Initiative, 1992a). 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). Currently, OPV is produced or bulk finished in over 25 nations (of which half are considered to be developing countries). (The quality control requirements for the production of OPV differ from those for the finishing

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

of OPV bulk vaccine. For countries to mount full production of OPV, they must maintain expensive monkey colonies, which are needed for neurovirulence testing and must have considerable staff expertise and training. In contrast, finishing a vaccine that has already been fully tested may reduce the need for such large investments in quality control.) Tetanus toxoid is made in almost 40 countries, DTP is manufactured in approximately 30 countries, and measles and BCG (bacillus Calmette-Guérin) vaccines are produced in approximately 20 countries (Agency for Cooperation in International Health, 1992).

The vaccine supply grid developed by Amie Batson and Peter Evans of the World Health Organization (Figure 4-1) depicts the 130 countries that currently produce vaccines according to per capita gross national product and population size. A number of donor agencies are using the grid to evaluate strategies for helping countries buy vaccines, share vaccine production capabilities, or establish production facilities.

Population expansion, more comprehensive immunization, and greatly increased demands for polio vaccine because of global eradication goals have raised questions about the stability of the global vaccine supply (World Health Organization/Children's Vaccine Initiative, 1992a). According to UNICEF, the demand for OPV peaked in 1990 and declined slightly in 1991 and 1992 (Terrel Hill, UNICEF, personal communication, 1993). The largest single user country, India, is expected to become self-sufficient in OPV production in 1993, thereby reducing demand from UNICEF by at least 50 million doses per year (John Gilmartin, UNICEF, personal communication, 1993). UNICEF's ability to procure adequate levels of vaccine into the future is a concern, given rising vaccine prices and competing priorities for increasingly limited resources (UNICEF, 1991a, 1992a); in addition, some donors, such as the Rotary Foundation, have decreased the amount included in their pledges. Preliminary projections of vaccine requirements through 1995 suggest that there may be significant shortfalls in vaccine supply if UNICEF is unable to secure the procurement of EPI vaccines at very low prices into the future. 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. Among them were the need to strengthen monetary, logistical, and supply mechanisms for integrating new vaccines into EPI and the need to improve substandard manufacturing capabilities in some countries (Agency for Cooperation in International Health, 1991).

There is mounting concern about the quality of many of the locally produced vaccines used in EPI programs (Hlady et al., 1992; World Health

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

FIGURE 4-1

Vaccine supply grid of countries that produce vaccines according to per capita gross national product (GNP) and population size. SOURCE: Amie Batson and Peter Evans, World Health Organization, 1993.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

Organization, 1992). It has been estimated that more than half of the vaccines produced around the world do not meet accepted WHO standards of quality (Lancet, 1992). Many countries lack functioning national control authorities, and as a result, quality control of locally produced vaccines is emerging as a top-priority concern of EPI and the Children's Vaccine Initiative (CVI).

Procurement

UNICEF is the largest single purchaser of vaccine (in doses) for the developing world. The number of doses of EPI vaccines supplied by UNICEF more than doubled in 5 years (Table 4-2). 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). Polio vaccine and DTP account for the largest number of doses in the UNICEF procurement; this is followed by tetanus toxoid (TT), and BCG and measles vaccine (Table 4-2).

Every 2 years, UNICEF issues a tender for the purchase of vaccines. UNICEF purchases EPI vaccines from all companies that are prequalified to supply vaccine and that submit bids. Companies whose bids are higher than the winning bid are often asked to resubmit an offer. In theory, the lowest bidder receives two-thirds of the UNICEF market, with each successively higher bidder receiving one-third of the remaining market (Peter Evans, Expanded Program on Immunization, World Health Organization, personal communication, 1993). In general, the lowest bidder is unable to

TABLE 4–2 Vaccines Procured by UNICEF, 1985 and 1990

Vaccine

No. of Doses in 1985 (in thousands)

Percent of Total

No. of Doses in 1990 (in thousands)

Percent

BCG

66,296 (4)a

18.11

132,004 (5)

13.65

DTP

89,485 (4)

24.45

183,881 (4)

19.01

DT

20,153 (5)

5.51

13,144 (5)

1.36

Measles

36,215 (5)

9.90

86,313 (7)

8.92

OPV

116,772 (5)

1.90

388,510 (6)

40.17

TT

37,049 (4)

10.12

163,400 (6)

16.89

Totals

365,970 (9)

 

967,254 (11)

 

a Values in parentheses are number of suppliers.

SOURCE: Data supplied by UNICEF, 1993.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

provide UNICEF with two-thirds of the total doses required for any vaccine; therefore, several suppliers provide each vaccine, with preference given to the lowest bidders.

UNICEF has used competitive vaccine bids for many years. From 1985 through 1990, the number of suppliers grew from 9 to 11 (Table 4-2). European vaccine manufacturers supply 90 percent of the vaccines used by UNICEF (this includes Connaught Laboratories, Ltd., [Canada], a subsidiary of Pasteur-Mérieux Sérums et Vaccins) (John Gilmartin, UNICEF, personal communication, 1993). Currently, U.S. vaccine manufacturers are invited to participate in the bidding, but have not made offers since at least 1982. That year, a U.S. vaccine manufacturer was criticized in congressional hearings for selling vaccine to PAHO at prices substantially below those quoted to the U.S. government (U.S. Congress, Senate, 1982). This continues to be a sensitive issue in the United States.

To supply vaccine to UNICEF, a company must request and pay for a WHO-organized evaluation of its manufacturing facilities and the country's national biologics control authority. Several lots of the company's vaccine are then tested at one or more of the WHO's collaborating centers, a process also paid for by the company. Only when the vaccine is determined to meet WHO standards, when the facility is approved, and when the national control authority is determined to be reliable is the company licensed to supply UNICEF with vaccines. UNICEF and WHO do not have the capability to monitor the consistency of vaccine lots produced by manufacturers as is currently done in the United States by the U.S. Food and Drug Administration (see Appendix C).

No manufacturers based in developing countries supplied UNICEF with vaccines in 1990 (Table 4-3). Compared with their international competitors, most vaccine manufacturers in developing countries have several disadvantages. They must frequently import raw materials, often paying substantial import duties on these materials. And because vaccine manufacturing is more capital intensive than labor intensive, the low-cost labor pool in developing countries does not offer any advantages. In fact, some have charged that locally produced vaccines are often more expensive than those procured through UNICEF and PAHO (Baudrihaye, 1992; Vandersmissen, 1992).

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). (In this regard, UNICEF might be reluctant to purchase a ''super" vaccine, such as might result from the CVI, from a single supplier.) UNICEF vaccine prices are a fraction of those commanded elsewhere in the world, including the United States (Table 4-4). Until quite recently, yearly EPI vaccine price increases have barely exceeded inflation. However, in

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

TABLE 4–3 Companies That Supplied EPI Vaccines to UNICEF, 1990

Company

BCG

DTP

TT

Measles

Polio

Connaught Laboratories, Ltd. (Canada)

X

X

X

X

X

Con Pharma (Canada)

 

 

X

X

 

Eisai (Japan)

 

 

 

X

 

Evans-Medical, Ltd. (United Kingdom)

X

 

 

X

 

Behringwerke (Hoechst) (Germany)

X

X

X

 

 

Pasteur Mérieux Sérums et Vaccins (France)

X

X

X

X

X

Inter-Export (Yugoslavia)

 

X

X

 

 

Japan BCG (Japan)

X

 

 

 

 

Sclavo (Italy)

 

 

 

X

X

SmithKline Beecham (United Kingdom)

 

 

 

X

X

Swiss Serum Vaccine Institute (Switzerland)

 

X

X

 

 

 

SOURCE: Data supplied by UNICEF, January 1993.

TABLE 4–4 UNICEF prices for EPI Vaccine, 1992

Vaccine

No. of Doses

Cost($)/Dose

Cost($)/Series

BCG

1

0.065

0.065

DTP

3

0.0575–0.075

0.173–0.225

Measles

1

0.16

0.16

TT

3–5

0.0325–0.05

0.0975–0.25

OPV

3

0.07–0.085

0.210–0.255

Total

11–13

 

0.705–0.955

 

SOURCE: UNICEF Price List, 1992.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

1992, vaccine prices increased 23 percent above the 1990 tender price (Steele, 1992). Vaccine manufacturers have indicated that the low prices quoted to UNICEF for EPI vaccines cannot continue indefinitely because the costs of manufacturing vaccines, research and development, and capital investments are all increasing (Meérieux, 1992; Vandersmissen, 1992).

Although some 90 percent of the vaccine purchased by UNICEF and PAHO are made by several of the largest manufacturers, these purchases amount to less than 10 percent of these company's vaccine revenues (Agency for Cooperation in International Health). Indeed, some companies that supply vaccines to UNICEF do so to utilize their excess capacity, and the prices that they charge generally cover the marginal cost of production (Dupuy and Freidel, 1990; Robbins and Freeman, 1988). 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.

Innovation

There are a number of childhood diseases, including malaria and acute respiratory infections, that claim millions of lives annually and for which effective vaccines are not yet available. Unfortunately, the research and development of new and improved vaccines for exclusively developing-country markets by commercial manufacturers is limited. Most public-sector vaccine institutes in Europe do not have the resources or the mandates required to conduct new vaccine development for developing-country markets. The low prices quoted to UNICEF/PAHO cover the marginal costs of production, but they do not appear to provide sufficient market incentives for international vaccine companies to invest in vaccine research and development.

Furthermore, despite a number of successful programs such as the WHO/UNDP Program for Vaccine Development and the UNDP/World Bank/WHO Special Program for Research and Training in Tropical Diseases, there is no significant international or multinational fund dedicated to the early stages of vaccine development and testing of vaccine for use in the developing world.

New and improved vaccines that are developed and manufactured for

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

industrialized-country markets do "trickle down" eventually (sometimes after many years) to some developing countries. In some cases, vaccines developed by and for the DOD have been introduced into some developing countries on an ad hoc basis by commercial manufacturers. However, the target groups for these vaccines tend to be adults, not infants and children. This is because the DOD's primary responsibility is to protect young-adult soldiers—not infants and children. Commercial manufacturers have been reluctant to invest in the costly clinical trials required to demonstrate further vaccine efficacy in infants and young children probably because the returns are likely to be small compared with those from other investment opportunities. The prices of new vaccines have been beyond the means of most developing countries and such international buyers as UNICEF and PAHO. As a consequence, no new vaccines have been added to the UNICEF procurement scheme since its inception, despite recommendations that hepatitis B vaccine be included in national immunization programs.

DEMAND AND SUPPLY IN THE UNITED STATES

Demand

The pediatric vaccine market in the United States is predictable, limited, and stable. The size of the market is constrained by two factors: the annual birth cohort—approximately 4 million live births per year (World Almanac and Book of Facts, 1992) and the number of vaccines a child receives through adolescence. Thirteen of the eighteen separate vaccinations recommended by the Advisory Committee on Immunization Practices should be administered during or shortly after the first year of life (see Appendix G for immunization schedule). Three of the remaining four vaccines should be given before age 6 years.

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) were distributed each year. In 1990, 19 million doses of MMR were distributed; in 1991, this figure dropped to 16 million (National Vaccine Injury Compensation Trust Fund, 1992).

Over the last decade, the public sector has purchased an increasing share of the vaccines sold in the United States (Table 4-5). Currently, almost half of all vaccines purchased in this country are procured with federal or state funds at contract prices. The current trend toward public-sector

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

TABLE 4–5 Publicly Purchased Doses as a Percentage of Net Doses Distributed in the United States, 1985–1991

Year

DTP

MMR

OPV

1985

15

38

32

1986

29

44

39

1987

45

51

46

1988

33

47

44

1989

35

50

44

1990

40

45

48

1991

43

51

52

1992

 

54

45

NOTE: Data for 1992 DTP sales to the public are not yet available

SOURCE: Division of Immunization. Centers for Disease Control and Prevention, 1993.

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 (Garnier, 1993). Those involved in vaccine manufacturing also contend that if the U.S. government emerges as the sole purchaser of vaccines, company investments in vaccine-related research and development would likely decline (Douglas, 1992; Katz, 1993; Saldarini, 1992; Six, 1992). Others (Edelman, 1993; Shalala, 1993) however, suggest that the effects of any large-scale federal procurement policy on the U.S. vaccine industry are uncertain—policies on pricing, funding for product development, and competitive production of vaccines could entice additional manufacturers to enter this industry (Institute of Medicine, 1986; Shalala, 1993).

Supply

Forty vaccines and toxoids and an additional 10 immune globulins and antitoxins are licensed and available for use in the United States (see the box "Vaccines, Toxoids, Immune Globulins, and Antitoxins Available in the United States, 1993). The current supply of most childhood vaccines is plentiful in the United States. This is not to say, however, that all children who should be immunized are or that potential shortages cannot occur. Nevertheless, the problem of less-than-optimal vaccine coverage in the United States is due more to problems of access and to the failure of the

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

Vaccines, Toxoids, Immune Globulins, And Antitoxins Available in the United States, 1993

Licensed Vaccines and Toxoids

Adenovirus vaccine, live oral, type 4

Adenovirus vaccine, live oral, type 7

Anthrax vaccine, adsorbed

BCG (bacillus Calmette Guérin vaccine)

Cholera vaccine

Diphtheria toxoid

Diphtheria toxoid, adsorbed

Diphtheria and tetanus toxoids, adsorbed (TD)

Diphtheria and tetanus toxoids and pertussis vaccine, adsorbed (DTP)

Diphtheria and tetanus toxoids and pertussis vaccine and Haemophilus influenzae type b

Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP)

Hepatitis B vaccine, plasma derived

Hepatitis B vaccine, recombinant

Haemophilus type b polysaccaride vaccine

Haemophilus b conjugate vaccine (Hib-CV)

Influenza virus vaccine

Japanese encephalitis virus vaccine inactivated

Measles virus vaccine live

Measles, mumps and rubella virus vaccine live (MMR)

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

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

Vaccines, Toxoids, Immune Globulins, And Antitoxins Available in the United States, 1993

Tetanus toxoid

Tetanus toxoid adsorbed

Tetanus-diptheria (Td)

Typhoid vaccine

Typhoid vaccine, live oral Ty21a

Yellow Fever vaccine

Immune globulins and Antitoxins

Botulism antitoxin

Cytomegalovirus immune globulin intravenous

Diphtheria antitoxin

Hepatitis B immune globulin

Immune globulin

Pertussis immune globulin

Rabies immune globulin

Tetanus antitoxin

Tetanus immune globulin

Vaccinia immune globulin

public health and medical communities to fully immunize all U.S. children than to deficiencies in supply (Cutts et al., 1992; Peter, 1992).

Between 1966 and 1977, half of all commercial vaccine manufacturers in the United States stopped producing and distributing vaccines (U.S. Congress, House, 1986). During the late 1970s and early 1980s, the exodus from the vaccine business continued. Eli Lilly, Pfizer, Glaxo, Wellcome, Dow Chemical, and Merrell-National Laboratories were among those companies that discontinued their vaccine operations or sold off their vaccine components altogether (see Appendix H). The reasons for the exodus during these years are many, but include U.S. Food and Drug Administration requirements for demonstration of vaccine efficacy1, 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) as out of corporate commitment to their products.

Although 18 companies and two states are licensed to manufacture selected vaccines for the U.S. market, only a handful of companies supply pediatric vaccines. The supply of two of the vaccines, MMR and OPV, is dependent on sole-source suppliers (U.S. Department of Health and Human Services, 1991). Reliance on such a small number of companies for the production of U.S. pediatric vaccines has not been without problems

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

(Institute of Medicine, 1985; U.S. Congress, House, 1986). A series of unfortunate events in 1984 and early 1985 led to a shortage of DTP in the United States: two private-sector manufacturers withdrew from the market because of liability concerns (among other reasons), and a third manufacturer experienced some production problems. State manufacturers of DTP could not meet the demand, and the Centers for Disease Control and Prevention (CDC) had to issue a revised immunization schedule that urged physicians to delay giving some DTP booster shots until more vaccine became available (U.S. Congress, House, 1986). The fragility of the nation's vaccine supply had been demonstrated.

In 1983, Congress appropriated funds to the CDC to ensure that a 6-month stockpile of critical vaccines be maintained at all times as a solution to a temporary shortage of vaccine. Although a 6-month stockpile would compensate for short-term interruptions in supply, it is unlikely that U.S. immunization efforts could be sustained if a sole producer of a vaccine were to halt the production and distribution of a needed product. 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. As can be seen in Table 4-6, the catalog price for each

TABLE 4-6 Cost and Price (including Excise Tax) of the Basic Series of Childhood Vaccines in the United States, as of March 31, 1993

Vaccine

Price ($)

No. of Doses

Cost ($)

Contact

Catalog

Public Sector

Private Sector

DTaP

11.01

16.33

2

22.02

32.66

DTP

5.99

10.04

3

17.97

30.12

Hib-CV

5.37

15.13

4

21.48

60.52

MMR

15.33

25.29

2

30.66

50.58

OPV

2.16

10.43

4

8.64

41.72

Hepatitis B

6.91

10.71

3

20.73

32.12

Total

 

 

18

121.50

247.72

 

SOURCE: Division of Immunization, Centers for Disease Control and Prevention, 1993.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

childhood vaccine is higher than the contract price. The total public-sector cost of the required pediatric vaccines in 1993 is $122, while the cost to private-sector clients is more than double that ($248). Although there are differences in the terms and conditions of vaccine sales to the public and private sectors (companies bear the cost of distributing catalog-priced vaccines and buy back unused doses), sales to the private sector are said to offset those to the public sector. As the percentage of doses procured by the public sector has increased over time, vaccine prices in the private sector have risen substantially.

Excluding the cost of vaccine, the charges associated with administering the complete series of pediatric vaccines may run from as little as $25 at a public health clinic to more than $200 at a private physician's office (Freeman et al., 1993). Thus, the total amount, including vaccine, needed to fully immunize a child in the United States ranges from almost 147 in the public sector to more than $448 in the private sector.

In 1988, in an effort to compensate for adverse events from government-mandated vaccines as well as to offset vaccine manufacturers' liability concerns, an excise tax was added to the price of each of the government-mandated childhood vaccines. 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 vaccine-related 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. A provision to extend the National Vaccine Injury Compensation Program was included as part of a larger congressional bill, which was subsequently vetoed for reasons unrelated to the compensation program. Because there was no further congressional action to extend the collection of excise taxes, the Secretary of the Treasury, in accordance with the law, revoked the excise tax in January 1993. This situation has caused some confusion, but is expected to be resolved shortly by Congress. (See Appendix B for a discussion of the National Vaccine Injury Compensation Program.)

The list price for each of the major government-mandated childhood vaccines in both the public and private sectors has increased substantially since 1977 (see Table 4-7). Tables 4-8 and 4-9 show federal contract and private catalog prices, respectively, in constant dollars for OPV, DTP, and MMR for the period 1977-1992. For comparison, the last three columns in Tables 4-8 and 4-9 present the indices used to track changes in the prices of various goods. The first, the Consumer Price Index (CPI), reflects the price rise of a general "basket" of consumer goods; the second, the Pharmaceutical Producer Price Index (PPPI), reflects price changes in ethical pharmaceuticals. Prices in both indices are standardized to the base year of 1983.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

TABLE 4-7 Vaccine Prices (in dollars) in the United States from 1977–February 1993

Year

DTP

OPV

MMR

Hib-CV

 

CP

FC

CP

FC

CP

FC

CP

FC

1977

0.19

0.15a

1.00

0.30

6.01

2.42

NA

NA

1978

0.22

0.15a

1.15

0.31

6.16

2.35

NA

NA

1979

0.25

0.15a

1.27

0.33

6.81

2.62

NA

NA

1980

0.30

0.15a

1.60

0.35

7.24

2.71

NA

NA

1981

0.33

0.15a

2.10

0.40

9.32

3.12

NA

NA

1982

0.37

0.15a

2.75

0.48

10.44

4.02

NA

NA

1983

0.45

0.42a

3.56

0.58

11.30

4.70

NA

NA

1984

0.99

0.65a

4.60

0.73

12.08

5.40

NA

NA

1985

2.80

2.21

6.15

0.80

13.53

6.85

NA

NA

1986

11.40

3.01

8.67

1.56

15.15

8.47

NA

NA

1987

8.92

7.69

8.07

1.36

17.88

10.67

NA

NA

1988

11.03

8.46b

8.07

1.36

24.11

16.18

13.75

11.00

1989

10.65

7.96

9.45

1.92

24.11

16.18

13.75

6.00

1990

10.65

6.91

9.74

1.92

24.07

14.71

14.55

5.20

1991

9.97

6.25

9.91

2.09

25.29

15.33

14.55

5.16c

1992

9.97

6.25

9.91

2.09

25.29

15.30

14.55

5.16c

1993

10.04

5.99

10.43

2.16

25.29

15.33

15.13

5.37

NOTE: CP, Catalog Price; FC, Federal contract Price; NA, vaccine not licensed. 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.

a No federal contract. The price represents the average price charged to the states.

b Federal contract price was $9.62 for a portion of 1988.

c Merck federal contract price was $8.25 for use among Native American populations.

SOURCE: Division of Immunization, Centers for Disease Control and Prevention, 1993.

It is worth noting that through the early 1980s, the prices of OPV and DTP were quite low, an indication, the committee believes, that manufacturers were treating vaccines much like generic products that cost little to produce, that had high-volume sales, and that had low profit margins. Vaccines appear to have been priced to cover their marginal costs of production. Indeed, companies marketed DTP at roughly $0.15 a dose and OPV at $0.30 a dose to the federal government into the early 1980s.

Beginning in the early 1980s and continuing to the present, vaccine prices have risen substantially. Over the 15-year period from 1977 to 1991, the cumulative increases (in 1993 dollars and excluding the excise tax) in the contract and catalog prices for DTP were $1.55 (1,033 percent increase) and $5.22 (2,847 percent increase) respectively. The cumulative increase in the price of OPV from 1977 through 1992 was $8.62, or 500 percent for the contract price of vaccine, and $1.50, or 862 percent, for the catalog price of

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

vaccine. From 1977 through 1992, the contract price for MMR increased by $8.47, or 350 percent, wheras the catalog price rose by $14.84, or 247 percent. During this same period, the CPI rose 122 percent and the PPPI jumped 232 percent.

The rate of price increases in the market for DTP, MMR, and OPV has outstripped the rise in prices for the economy as a whole and for ethical pharmaceuticals. Those companies that remained in the vaccine business after the exodus in the 1970s appear now to be treating vaccines much like other pharmaceutical products with a corresponding investment in new facilities and in research and development and with an anticipation of returns.

Vaccine Innovation

The pharmaceutical industry has often been described as a high-risk, high-profit enterprise that is dependent upon the development and marketing of novel products (di Masi et al., 1991; Grabowski and Vernon, 1990; Lasagna, 1992; Office of Technology Assessment, 1991). Most established pharmaceutical firms have viewed the vaccine business as unpromising, characterized by undifferentiated product lines, a high risk of product liability, a few large high-volume, low-price purchasers, and poor patent protection (DeBrock, 1983; Institute of Medicine, 1985, 1986; Nicholas Mellors, Merlin, personal communication, 1993; Vandersmissen, 1992). The exodus of companies from the vaccine business in the 1960s through 1970s (see Appendix H), the relatively low expenditures on research and development into the 1980s (Table 4-10), and the small proportion (less than 5 percent) of vaccine Product License Applications (PLAs) as a total of all PLAs filed at the Center for Biologics and Evaluation Research from 1987 to 1991 would appear at the outset to confirm this assessment.

The pharmaceutical industry devotes a relatively small share of its research and development expenditures to biologics, a category that includes vaccines (Table 4-10). This is hardly surprising since vaccine sales account for less than 5 percent of most diversified companies' total sales (Agency for Cooperation in International Health, 1991; American Cyanamid, 1991; Institute of Medicine, 1992; Merck & Co., Inc., 1991b). Although spending in real terms (as reported to the Pharmaceutical Manufacturers Association) on pharmaceutical and biologics R&D has increased over time, the pattern of investment in biologics R&D has, until very recently, been one of decline. Spending on biologics research fell from 4 percent of the total in 1973 to a little more than 2 percent in 1983. By 1988, spending on biologics R&D had returned to the 1973 level (in relative terms), and it has increased every

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

TABLE 4-8 Federal Contract Prices for Vaccines in ''Current" Dollars

Year

Price of OPV ($)

PI

Price of MMR ($)

PI

Price of DTP ($)

Price Indices

 

 

 

 

 

 

CPI

PPPI

1977

0.30

51

2.42

51

0.15

61

59

1978

0.31

54

2.35

50

0.15

65

62

1979

0.33

57

2.62

56

0.15

73

67

1980

0.35

61

2.71

58

0.15

82

73

1981

0.40

68

3.12

66

0.15

91

81

1982

0.48

82

4.02

86

0.15

97

90

1983

0.58

100

4.70

100

0.42

100

100

1984

0.73

125

5.40

115

0.65

104

109

1985

0.80

138

6.85

146

2.21

108

119

1986

1.56

268

8.47

180

3.01

110

130

1987

1.36

234

10.67

227

7.69

114

141

1988

1.07

184

11.74

250

3.90

118

152

1989

1.63

280

11.74

250

3.40

124

166

1990

1.63

280

10.27

219

2.35

131

181

1991

1.71

294

10.89

232

1.70

136

196

1992

1.80

310

10.89

232

1.70

140

208

NOTE: Prices are indexed at a base year of 1983. PI, price index. Prices exclude the excise taxes for the Vaccine Injury Compensation Program that were in effect from 1988 to January 1993.

SOURCE: Bureau of Labor Statistics, U.S. Department of Labor, Centers for Disease Control.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

TABLE 4-9 Private Catalog Prices for Vaccines in "Current" Dollars

Year

Price of OPV ($)

PI

Price of MMR ($)

PI

Price of DTP ($)

Price Indices

 

 

 

 

 

 

CPI

PPPI

1977

1.00

28

6.01

53

0.19

61

59

1978

1.15

32

6.16

55

0.22

65

62

1979

1.27

36

6.81

60

0.25

73

67

1980

1.60

45

7.24

64

0.30

82

73

1981

2.10

59

9.32

82

0.33

91

81

1982

2.75

77

10.44

92

0.37

97

90

1983

3.56

100

11.30

100

0.45

100

100

1984

4.60

129

12.08

107

0.99

104

109

1985

6.15

173

13.53

120

2.80

108

119

1986

8.67

244

15.15

134

11.40

110

130

1987

8.07

227

17.88

158

8.92

114

141

1988

7.78

219

19.67

174

6.47

118

152

1989

9.16

257

19.67

174

6.09

124

166

1990

9.45

265

19.63

174

6.09

131

181

1991

9.16

257

20.85

185

5.41

136

196

1992

9.62

270

20.85

185

5.41

140

208

NOTE: Prices are indexed at a base year of 1983. PI, price index. Prices exclude the excise taxes for the Vaccine Injury Compensation Program thai were in effect from 1988 to January 1993.

SOURCE: Bureau of Labor Statistics, U.S. Department of Labor; Centers for Disease Control.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

year since then. Of more relevance, however, is spending on vaccine R&D as a percentage of total vaccine sales. This percentage decreased substantially from 1976 to 1982 (Table 4-10). Although recent data on vaccine R&D as a percentage of vaccine sales are unreported and unavailable, it is likely that investment in R&D has increased to 12–15 percent of sales, which is similar to that for the overall pharmaceutical industry (Business Week, 1992; Financial Times, 1993).

The total number of Investigational New Drug (IND) applications submitted to the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration (FDA) has increased dramatically, from 66 in 1980 to just under 558 in 1992 (Zoon and Beatrice, 1993). Almost half of the IND applications filed since the mid-1980s are for biologic products produced by using biotechnology (Figure 4-2). Although almost four times as many IND applications were submitted for therapeutics than for vaccines in 1992 (Figure 4-3), there has been a notable increase in the number of vaccine IND applications filed in the last several years. From 1983 through 1989, an average of 32 vaccine IND applications were filed each year. In 1990, 67 vaccine IND applications were filed; in 1992, 81 were filed (Zoon and Beatrice, 1993). Thus, it appears that the relatively low number of PLAs filed during the late 1980s and early 1990s reflects both the lengthy development timeline of vaccines and the time-consuming FDA licensure process. Many more vaccine-related PLAs can be expected in the future.

There are other signs that vaccines are becoming more important relative to other operations of pharmaceutical companies. For example, Merck & Co., Inc., created the Merck Vaccine Division in 1991, and Lederle-Praxis Biologicals was made a full business unit of American Cyanamid in 1992. Corporate-level reorganization has also translated into major capital investments for some companies. Indeed, Merck & Co., Inc., is investing $150 million in the construction of a biotechnology facility for vaccines in Pennsylvania (Douglas, 1993).

Established pharmaceutical firms with vaccine interests are also actively pursuing promising technologies developed by various biotechnology companies by either licensing the technology or simply buying the company outright (Sugawara, 1992). In 1989, Lederle Laboratories, a unit of the American Cyanamid Corporation, acquired Praxis Biologics, a biotechnology company that had developed a conjugate Haemophilus influenzae type b conjugate vaccine (Hib-CV). Merck & Co., Inc., has entered into a variety of strategic alliances with a variety of companies, including MedImmune, Inc., a biotechnology firm involved in vaccine development (MedImmune, 1991; Merck & Co., Inc., 1991a). By the end of 1992, there were over 75

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

TABLE 4-10 R&D Expenditures and Sales of All U.S. Pharmaceuticals and of the Biologics Component

Year

R&D Expenditures

Sales

Total R&D/Total Sales (percent)

Biologics R&D/Biologics Sales (percent)

 

Pharmaceuticals (millions of $)

Biologics (millions of $)

Biologics Component (percent)

Pharmaceuticals (millions of $)

Biologics (millions of $)

Biologics Component (percent)

 

 

1973

644

25.7

4.0

5,122

138.3

2.7

12.57

18.58

1974

726

32.7

4.5

5,657

152.7

2.7

12.83

21.41

1975

829

24.9

3.0

6,412

160.3

2.5

12.92

15.53

1976

903

28.0

3.1

7,117

121.0

1.7

12.69

23.14

1977

984

30.5

3.1

7,705

169.5

2.2

12.77

17.99

1978

1,089

34.9

3.2

8,424

235.9

2.8

12.93

14.79

1979

1,243

31.0

2.5

9,240

240.2

2.6

13.45

12.91

1980

1,455

45.1

3.1

11,091

244.0

2.2

13.12

18.48

1981

1,765

42.3

2.4

13,000

468.0

3.6

13.58

9.04

1982

2,158

49.6

2.3

15,394

538.8

3.5

14.02

9.21

1983

2,538

53.3

2.1

16,565

 

 

15.32

 

1984

2,843

 

 

 

 

 

 

 

1985

3,234

84.1

2.6

21,205

 

 

15.25

 

1986

3,721

85.6

2.3

24,032

 

 

15.48

 

1987

4,342

121.6

2.8

27,019

 

 

16.07

 

1988

5,051

207.1

4.1

29,692

 

 

17.01

 

1989

5,824

273.7

4.7

33,469

 

 

17.40

 

1990

6,446

 

 

 

 

 

 

 

1991

7,276

 

 

 

 

 

 

 

NOTE: All data are for members of the Pharmaceutical Manufacturers Association. R&D expenditures are for company-financed R&D for ethical pharmaceuticals and biologics for human use. Biologics include bacterial and viral vaccines, antigens, antitoxins, toxoids, and allogenic extracts as well as sera, plasma, and other blood derivatives for human use.

a Sales of biologics are unavailable for 1983 to present.

SOURCE: PMA Survey of Members, Annual Survey Report; Timothy Brogan, personal communication, Pharmaceutical Manufacturers Association, 1992.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

FIGURE 4-2

CBER biotech INDs received, compared to total. SOURCE: Application Review and Policy, Therapeutics Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration.

FIGURE 4-3

CBER INDs received, by category. SOURCE: Application Review and Policy, Therapeutics Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

biotechnology companies worldwide (most of them in the United States) conducting vaccine-related R&D (Oryx Press, 1992).

There is also considerable international activity in the area of vaccine innovation. A number of U.S. companies are entering into cross-licensing arrangements with European and Japanese partners, and European companies are acquiring firms that have access to the U.S. market. In 1989, Institut Mérieux acquired Connaught Laboratories, Inc., and Merck and Company entered into a product development and licensing agreement with Pasteur Mérieux Sérums et Vaccins in 1993. Chiron, a U.S. biotechnology firm, joined with Ciba-Geigy, an established Swiss-based pharmaceutical firm, to purchase the financially troubled Sclavo, an Italian manufacturer of vaccines in 1990 (Chiron Corporation, 1991). A number of biotechnology companies involved in vaccine-related R&D have entered into strategic alliances with Japanese companies (National Research Council, 1992).

A review of the vaccines licensed for use in the United States since 1986 shows that approximately half are new (Table 4-11). This is markedly different from the situation just 10 years ago. A majority of the vaccines licensed in the 1970s were improvements of old vaccines (Institute of Medicine, 1985). A recently licensed vaccine against typhoid resembles a product, 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. An indication of the level of vaccine innovation is the sheer number of vaccines in various stages of development in the United States (Table 4-12). As can be seen, however, few of the vaccines currently being developed by established vaccine manufacturers are for exclusive use in the developing world, simply because such vaccines are perceived to be without sufficient returns on investment. As noted earlier, some vaccines developed by or for the DOD have been introduced into some developing countries on an ad hoc basis by commercial manufacturers. A few small biotechnology firms are working on vaccines of potential benefit to the developing world. As discussed in Chapter 3 and later in this report, few of these companies have the capacity to take a vaccine through to licensure and full-scale manufacture. Most of the development-stage companies working on vaccines of relevance to the developing world do so as part of cooperative research and development agreements (CRADAs) with the U.S. Department of Defense, and to a lesser extent, with the National Institute of Allergy and Infectious Diseases. At this time, the Walter Reed Army Institute of Research has almost 40 CRADAs with private-sector firms, the vast majority

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

of which are development-stage biotechnology companies based in the United States (LTC Willis. A. Reid, Chief, Office of Research and Technology Applications, Walter Reed Army Institute of Research, personal communication, 1993).

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. The development and manufacture of vaccines for exclusively developing-world markets are not attractive investments for either commercial vaccine manufacturers or biotechnology firms because they are unlikely to offer adequate returns on investments under current market arrangements.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

TABLE 4-11 Vaccines Licensed for Use in the United States Since 1986

Vaccine and Company

Review Time (months)

FDA Approval

Characteristics

BCG live

18.1

05/1990

New approval of an old vaccine for limited indication (treatment of carcinoma-in-situ of the urinary bladder

Connaught Laboratories, Inc.

 

 

 

BCG vaccine

29.5

08/1990

New approval of old vaccine (also indicated for the treatment of carcinoma-in-situ of the urinary bladder

Organon Teknika Corporation

 

 

 

Diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed (DTaP)

51.5

12/1991

New acellular pertussis component; shared manufacture with Takeda Chemical Industries, Ltd.

Lederle-Praxis Biologicals

 

 

 

Diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed (DTaP)

27.1

08/1992

New acellular component; shared manufacture with Biken (Research Foundation of Osaka University)

Connaught Laboratories, Inc.

 

 

 

Diphtheria and tetanus toxoids and pertussis vaccine, adsorbed and Haemophilus influenzae type b conjugate

14.9

03/1993

New vaccine

Lederle-Praxis Biologicals

 

 

 

Haemophilus influenzae type b meningococcal outer membrane conjugate vaccine

24.9

12/1989

New vaccine (18–60 months)

Merck & Co., Inc.

 

 

 

Haemophilus influenzae type b meningococcal outer membrane conjugate vaccine

4.1

12/1990

Infant indication

Merck & Co., Inc.

 

 

 

Haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjugate)

27.8

03/1993

New vaccine

Pasteur Mérieux Sérums et Vaccins

 

 

 

Haemophilus influenzae type b and diphtheria CRM 197 protein conjugate vaccine

22.5

12/1988

New vaccine (18–60 months)

Praxis Biologics, Inc.

 

 

 

Haemophilus influenzae type b conjugate vaccine

6.9

10/1990

Infant indication

Praxis Biologics, Inc.

 

 

 

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

Vaccine and Company

Review Time (months)

FDA Approval

Characteristics

Haemophilus influenzae type b conjugate (diphtheria toxoid conjugate)

55.4

12/1987

New vaccine (18–60 months)

Connaught Laboratories, Inc.

 

 

 

Hepatitis B vaccine, recombinant

18.0

07/1986

New vaccine

Merck & Co., Inc.

 

 

 

Hepatitis B vaccine, recombinant

20.8

08/1989

Independent introduction

SmithKline Beecham

 

 

 

Influenza virus vaccine

17.3

08/1988

New introduction of old vaccine

Evans Medical, Ltd.

 

 

 

Japanese encephalitis virus, inactivated

30.8

12/1992

New vaccine

Research Foundation of Osaka University

Connaught Laboratories, Inc.

 

 

 

Poliovirus vaccine, inactivated

16.1

11/1987

Enhanced poliovirus vaccine

Connaught Laboratories, Inc.

 

 

 

Poliovirus vaccine, inactivated

93.3

12/1990

Independent introduction

Pasteur Mérieux Sérums et Vaccins

 

 

 

Rabies vaccine, adsorbed

93.3

03/1988

Independent introduction

Michigan Department of Public Health

 

 

 

Rabies vaccine

42.4

12/1991

Independent introduction

Connaught Laboratories, Inc.

 

 

 

Typhoid vaccine, live oral (Ty21a)

92.5

12/1989

New vaccine

Swiss Serum & Vaccine Institute, Berne

 

 

 

 

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.S. Food and Drug Administration.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

TABLE 4.12 Selected Vaccines in Development

Product and Company U.S.

Development Status

Adenohepatitis B virus vaccine

Phase I

Wyeth-Ayerst

 

Acellular pertussis vaccine

Phase I/II

Massachusetts Department of Public Health

 

Acellular pertussis component

Phase I

Michigan Department of Public Health

 

Diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed

Phase III (infant efficacy study)

Lederle-Praxis Biologicals

 

Diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed

Phase III

North American Vaccine

 

Diphtheria and tetanus toxoids and accellular pertussis vaccine, adsorbed and inactivated polio vaccine

Phase III

North American Vaccine

 

TetrammuneTM Diphtheria and tetanus toxoids and pertussis vaccine, adsorbed, and Haemophilus influenzae type b vaccine

PLA submitted (recommended for approval by FDA advisory committee, ages 2 months up to 7th birthday)

Lederle-Praxis Biologicals

 

Diptheria and tetanus toxoids and acellular pertussis vaccine, adsorbed, and Haemophilus influenzae type b conjugate vaccine

Phase II (for booster dose at 15–18 months of age or when both vaccines recommended to be given simultaneously)

Lederle-Praxis Biologicals

 

PropediaTM Diphtheria and tetanus toxoids and pertussis vaccine, adsorbed and Haemophilus influenzae type b vaccine (diphtheria toxoid conjugate)

PLA submitted (for 15–60 months of age as final booster dose in Hib series or as n single dose primary immunization at 15–60 months of age)

Connaught Laboratories, Inc.

 

Act HIBTM + DTP; Diptheria and tetanus toxoids Act HIB and pertussis vaccine, adsorbed, reconstituting Haemophilus influenzae type b conjugate vaccine (tetanus protein conjugate)

Submitted as part of PLA for alone (for 2–60 months of age)

Connaught Laboratories, Inc./Pasteur Mérieux Sérums et Vaccins

 

Act HIBTM + DTaP; Diptheria and tetanus toxoids and acellular pertussis vaccine, adsorbed, reconstituting Haemophilus influenzae type b conjugate vaccine (tetanus protein conjugate)

Phase II for 15–60 months of age

Connaught Laboratories, Inc./Pasteur Mérieux Sérums et Vaccins

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

Product and Company

Development Status

Diphtheria and tetanus toxoids and pertussis vaccine, Haemophilus influenzae type b, hepatitis B vaccine

Phase I (by summer of 1993)

Merck & Co., Inc./Connaught Laboratories, Inc.

 

Diphtheria and tetanus toxoids and pertussis vaccine, Haemophilus influenzae type b, hepatitis B vaccine and inactivated polio vaccine

Phase I (by summer of 1993)

Merck & Co., Inc./Connaught Laboratories, Inc.

 

Diphtheria and tetanus toxoids and pertussis vaccine, hepatitis B and Haemophilus influenzae type b conjugate vaccine

Pre-clinical studies completed; preparing IND submissions

Michigan Department of Public Health/ SmithKline Beecham

 

Diphtheria and tetanus toxoids and acellular pertussis vaccine and hepatitis B vaccine and Haemophilus influenzae type b conjugate vaccine

Pre-clinical studies completed; preparing IND submissions

Michigan Department of Public Health/ SmithKline Beecham

 

Diptheria and tetanus toxoids and pertussis vaccine, adsorbed, and poliovirus vaccine, inactivated

PLA submitted

Connaught Laboratory, Inc./Pasteur Mérieux Sérums et Vaccins

 

Act HIBTMHaemophilus influenzae type b conjugate vaccine (tetanus protein conjugate)

PLA submitted

Connaught Laboratories, Inc./Pasteur Mérieus Sérums et Vaccins

 

Haemophilus influenzae type b conjugate vaccine

Phase III

Massachusetts Department of Public Health

 

Haemophilus influenzae type b conjugate vaccine, hepatitis B vaccine

Phase Ill

Merck & Co., Inc.

 

VAQTATM hepatitis A vaccine

Phase III

Merck & Co., Inc.

 

Hepatitis B vaccine

Phase II

Connaught Laboratories. Inc.

 

Hepatitis B vaccine

Phase III

Amgen/Johnson & Johnson

 

Herpes vaccine

Phase I (adults)

Lederle-Praxis Biologicals

 

PrymeTM lyme disease vaccine (recombinant OspA lipoprotein for Lyme borreliosis)

Phase I

Connaught Laboratories, Inc.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

Product and Company

Development Status

Lyme disease vaccine (recombinant OspA lipoprotein for Lyme borreliosis)

Phase I (by summer of 1993)

SmithKline Beecham

 

M-M-R®II measles, mumps, rubella, and varicella

Phase III

Merck & Co., Inc.

 

Measles, mumps, rubella virus vaccine, live

Project currently inactive

Connaught Laboratories, Inc./Pasteur Mérieux Sérums et Vaccins

 

Meningococcal group B vaccine (outer membrane protein)

Phase III for 2 years of age and older

Connaught Laboratories, Inc.

 

Pneumococcal conjugate vaccine (streptococcal conjugate vaccine, diphtheria toxoid and tetanus protein conjugates for otitis media and pneumonia)

Phase I

Connaught Laboratories, Inc./Pasteur Mérieux Sérums el Vaccins

 

Pneumococcal conjugate vaccine, streptococcal pneumonia vaccine, enhanced

Phase I/II

Lederle-Praxis Biologicals

 

Pneumococcal conjugate vaccine

Phase II

Merck & Co., Inc.

 

Respiratory syncytial virus vaccine

Phase I/II

Lederle-Praxis Biologicals

 

Rhesus rotavirus vaccine

Phase III

Wyeth-Ayerst

 

Rhesus rotavirus vaccine

Phase II

Merck & Co., Inc.

 

Sabin IPV inactivated Sabin polio vaccine

Phase III (age 2 months and up)

Lederle-Praxis Biologicals

 

Salmonella, live attenuated

Phase I

Lederle-Praxis Biologicals

 

Streptococcal group B vaccine

Phase I

North American Vaccine

 

Varivax® varicella vaccine

PLA submitted

Merck & Co., Inc.

 

 

SOURCES: Pharmaceutical Manufacturers Association. 1990. New Medicines in Development for Children. Washington, D.C.; Pharmaceutical Manufacturers Association. 1990. Biotechnology Medicines. Washington, D.C.; Douglas Reynolds, Connaught Laboratories, Inc., October 1992; Glenna Crooks and Ronald B. Ellis, Merck & Co., Inc., May 1993; Jane Scott, Lederle-Praxis Biologicals, February 1993; George Siber, Massachusetts Biologic Laboratories, June 1993; Robert Meyers, Michigan Department of Public Health, May 1993; Dan Soland, SmithKline Beecham, June 1993.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

NOTE

1.  

When the Division of Biologics (DBS) became a part of the Food and Drug Administration in 1972, the Commissioner of Food and Drugs appointed vaccine advisory panels to evaluate the safety and effectiveness of biological products licensed prior to 1972 (USC § 601.22, 21 CFR Ch.l). Several vaccines were found not to be safe and/or effective or in many other cases the manufacturers did not submit the required information for evaluation of their vaccines, but requested the FDA to revoke the licenses without prejudice.

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American Cyanamid. 1991. Form 10-K. Washington, D.C: Securities and Exchange Commission.


Baudrihaye N. 1992. European vaccine manufacturers: Present status and future trench. Vaccine 10:893–5.

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DeBrock, LM. 1983. The domestic vaccine industry: The economic framework. Paper presented at the Institute of Medicine Conference on Barriers to Vaccine Innovation, November 28–29, Washington, D.C.

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Douglas GR. 1992. Testimony before the Senate Subcommittee on Appropriations. Childhood vaccine research and development Issues. April 8. Washington, D.C.

Dupuy JM Freidel L. 1990. Lag between discovery and producing of new vaccines for the developing world. Lancet 336:733–734.


Edelman, MW. 1993. Testimony of the Children's Defense Fund. Senate Labor and Human Resources Committee and the House Subcommittee on Health and Environment. April 21. Washington, D.C.


Financial Times. 1993. Pharmaceuticals: Research and Development. April 22. Pp. 1–6.

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Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

Hlady GW, Bennett JV, Samadi AR, Begum J, Hafez A, Tarafdar AI, Boring JR. 1992. Neonatal tetanus in rural Bangladesh: Risk factors and toxoid efficacy. American Journal of Public Health 82:1365–1369.

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Katz S. 1993. Could the Childhood Vaccine Act Be Bad? Letter to the Editor. Pediatrics 91:160.


Lancet. 1992. Noticeboard. Vaccines quality control deficient. Lancet 340:1282.

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Steele I. 1992. Vaccine price rise jeopardizes UCI. First Call for Children. A UNICEF Quarterly no.4:1–2.

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×

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UNICEF. 1992b. Data regarding volume and price of purchased vaccines. Vaccine Supply Division. New York, New York.

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Zoon KC Beatrice MG. 1993. New directions for FDA's Center for Biologics Evaluation and Research (CBER). New Drug Approvals in 1992. February. Washington, D.C.: Pharmaceutical Manufacturers Association.

Suggested Citation:"4 Vaccine Demand and Supply." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
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The Children's Vaccine Initiative is an international endeavor to ensure that children throughout the world are immunized. This book notes that one of the best opportunities to address the growing problem of immunization in the United States and to improve the health of children in developing countries lies in marshaling the vaccine development and production efforts in the United States and abroad. The book contains information on the nature and status of vaccine development and production efforts in the United States and abroad, and it recommends ways to enhance participation in the International Children's Vaccine Initiative.

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