Click for next page ( 28


The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 27
Vaccine Availability: Concerns, Barriers, and Impediments Concerns about the nation's vaccine supply and the factors that affect it are not new. In 1976, the Assistant Secretary for Health convened the National Immunization Work Groups to identify problems associated with immunization programs, including maintaining vaccine supply and continuing innovation.] Three years later, the congres- sional Office of Technology Assessment studied similar issues and no A Review of Selected Federal Vaccine and Immunization Policies.^ To date, no significant actions nave been taken to implement the solutions offered by either group. Many of the problems studied by the Work Groups and OTA have worsened. In this chapter, the committee examines the current situation, including concerns over the present supply, and evaluates some alternatives to existing supply mechanisms. It also identifies specific barriers to vaccine innovation and improvement. 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) used in the United States is now supplied by only one or at most two distributors (Chapter 4~. The situation regarding the supply of the combined diphtheria-tetanus-pertussis (DTP) vaccine is disconcertingly unstable. Two of the three commercial firms marketing DTP at the outset of the study in May 1983 (Lederle Laboratories, Squibb- Connaught, and Wyeth Laboratories), have ceased distribution in 1984. Wyeth Laboratories announced on June 13, 1984, that it intended to discontinue the sale and distribution of pertussis vaccine because of extreme liability exposure, the high cost of litigation, and the difficulty of obtaining adequate insurance at premiums considered acceptable by its managers. Wyeth subsequently agreed to supply 27

OCR for page 27
28 Lederle with vaccine for distribution under the latter's label for an unspecified period.3 In June 1984, Squibb-Connaught Laboratories informed the Centers for Disease Control (CDC) that it would fill only existing contracts, because it was unable to obtain insurance at acceptable premiums to cover its liability risks.4 (Immediately prior to the printing of this report, Connaught Laboratories obtained insurance that allowed it to resume distribution of DTP vaccine.) Spot shortages of vaccine were reported to the American Academy of Pediatrics during the fall of 1984.5 These events demonstrate that the United States is precariously dependent on an extremely small number of companies for the major pediatric vaccines. (Polio, measles, mumps, and rubella vaccines are supplied by only a single manufacturer.) State laboratories in Massachusetts and Michigan produce some vaccines, primarily for intrastate use, but their production facilities are very limited. More recent events provide a good example of the problems associated with reliance on sole suppliers. Hopps noted in 1983, in a background paper for this study, that there had been several instances in which supplies were at least threatened for a limited period of time, but that n there is no single documented instance of a serious major break in the supply of either bacterial or viral vaccines.~6 Unfortunately, this is no longer true. On December 14, 1984, the U.S. Public Health Service Interagency Group to Monitor Vaccine Development, Production and Usage reported via the Centers for Disease Control that a DTP shortage would occur beginning in January 1985.7 Events contributing to this situation included the actions described above by Wyeth and Squibb-Connaught, and the fact that some lots of Lederle DTP did not meet the manufacturer's requirements for release. The shortage originally was anticipated to last through most of 1985.7 The estimated duration of the shortage was the subject of hearings before the subcommittee on Health and the Environment, Committee on Energy and Commerce, House of Representatives, on December 19, 1984. 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

OCR for page 27
29 Japan.l) This series of events highlights the dangers inherent in a sole-supplier situation.* The supply of vaccines can be interrupted by a variety of technical problems, as well as by commercial decisions. Potential problems, described by Hopps,6 include: potency variation stability problems quantitative imbalance of microbial components in polyvalent or combination vaccines variations in the response to inactivation processes excessive undesirable biological activity, e.g., neurovirulence inadvertent contamination (chemical or microbial) 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. The decision by vaccine manufacturers to cease production of a particular product results in the dispersion of these teams and, perhaps, the disassembly of the production facilities. Reversal of this process cannot be achieved cheaply or rapidly--as might be desired in the case of a vaccine needed for military personnel. Hence, the committee believes that there are serious dangers (in addition to possible vaccine supply problems) in permitting the continued decline of the number of vaccine manufacturers. The long-term prospects for an adequate supply of personnel with vaccine-related technological skills are reasonably good, because of the increasing use of biotechnology and bioengineerin9 for other purposes. However, only a healthy industry can attract scientists and technicians of the desired caliber. Stockpiling of Vaccines in 1982, the CDC requested funds to establish a rotating stockpile of vaccines sufficient to meet national needs for 6 months in case of an interruption in supply. The following year, S4.57 million was allotted for this purpose and stockpiling began. In 1984, the CDC requested $20.5 million for stockpiling. The Public Health Service reduced this request to $8 million, and the Office of Management and Budget reduced it further to $4 million. The amount of funds received for stockpiling totaled 84,572,000 for 1983, 84,000,000 for 1984, and *The decision by Connaught to resume distribution of DTP vaccine, announced immediately prior to the printing of this report, led the CDC to recommend reinstatement of regular vaccination schedules.

OCR for page 27
30 $4,000,000 for 1985.11 It is estimated that several years will be required to build up the 6-month stockpile with this level of funding. Because only single U.S. suppliers existed for oral polio vaccine and for the measles, mumps, and rubella vaccine combined in 1983, it was decided to use all fiscal year 1983 funds for these vaccines--the threat of an interruption in the supply of DTP vaccine with three manufacturers was not considered as great. A solicitation by the CDC for supply of DTP vaccine for stockpiling was issued in April 1984. 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. Stockpiles of inactivated poliomyelitis vaccine (8 weeks) and diphtheria and tetanus toxoids (DT, 11 weeks; Td, 5 weeks) also had been established. No stockpile of pertussis vaccine (marketed only as DTP) had been started. Stockpiling provides a highly desirable protection against the possibility of a temporary, brief interruption in the production of a vaccine, especially one produced by a single supplier. Its capacity to protect against repeated interruptions in supply depends on the magnitude of the stockpile. Recent price increases mean that the cost of establishing 6-month stockpiles will be considerably greater than when originally proposed. Vaccines have a finite shelf life; hence, stockpiles must be rotated (older vaccines are released from the stockpile to purchasers at prevailing prices and are replaced with fresh supplies). The stockpiling approach, as currently envisaged and implemented, does not (and is not intended to) provide protection against the possibility that a single supplier will cease production and distribution of a vaccine. If a manufacturer is already producing a vaccine, increasing output requires approximately 6 to 8 months. The addition of a new vaccine to the product line of an existing manufacturer probably would take even longer, although not as long as construction and staffing of a totally new production facility (2 to 4 years). These time periods are considerably beyond the scope of any existing or projected stockpile, and possibly beyond any stockpiling approach that is financially realistic. The committee is not aware of any contingency plan for dealing with a situation in which no U.S. commercial manufacturer is willing to produce a major childhood vaccine. The committee believes that it is unlikely that foreign manufacturers would be willing to distribute such vaccines in the United States because of the liability situ- ation.4~14 Even if such a source could be found, there are problems inherent in relying on foreign sole-source suppliers.

OCR for page 27
31 Problems With Sole Reliance on Foreign Manufacturers The withdrawal of current U.S. vaccine manufacturers could lead to reliance for supply on foreign manufacturers, if they were willing to distribute their products in the united States. A variety of factors could cause problems in this situation.6 Geographical distance could result in delays in licensing submissions and other communications, and lengthen the chain of supply. Vaccine stability problems could occur if the distribution were particularly slow. Language barriers also could produce problems, especially in the resolution of highly technical issues. Political considerations might arise during a shortage if a foreign manufacturer felt a primary obligation to meet the needs of its home country before exporting vaccine. Differences in regulatory requirements might require manufacturers abroad to add laboratory and regulatory staff, because U.S. standards are often more stringent. This increased cost might be reflected in vaccine prices, although it could be offset by lower foreign labor costs. These factors provide added support for the committee's presumption that a healthy U.S. vaccine industry is a necessity. Reliance on foreign manufacturers as sole-source suppliers is not a desirable situation, although they could provide beneficial competition in a stronger U.S. market. In any case, few foreign firms have shown any desire to distribute vaccine products in this country. The considera- tions that deter their entry have not been examined in detail, but liability issues and low profitability have been cited as major apprehensions.14 Federal Action to Ensure Vaccine Supply The supply of vaccines could be ensured by the federal government. The Office of Technology Assessment addressed this issue, especially with regard to the production of "orphan" vaccines. Supplies could be maintained by direct federal production or by guaranteed contracts with manufacturers, such as those used by the Army to obtain needed vaccines. Employment of these options may become necessary if current sole suppliers find continued "open market" commercial operation no longer viable. 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. These include the range of vaccines that might be produced, whether the facility would compete with commercial manufacturers, and the question of liability for injury from federally produced vaccines. The committee did not consider itself an appropr late forum to resolve these issues, but did review other aspects of potential federal production. For example, a government production bureaucracy in the role of a sole supplier might not be subject to the market pressures that often lead to innovation and the application of new technologies.

OCR for page 27
32 The committee recognizes that existing state production labora- tories have excellent safety and production records, but believes that federal production on the scale required to meet national needs might not prove a totally satisfactory solution. Thus, the committee believes that, at present, solutions to the problem of ensuring vaccine supply should employ the facilities and expertise already existing in the private sector. 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. BARRIERS AND IMPEDIMENTS TO VACCINE INNOVATION One of the goals of this study was to define the barriers and impediments to vaccine innovation, including vaccine improvement. The issues discussed below were identified in the course of the committee's work as the primary factors in the debate on what, if anything, needs to be done to ensure the desirable level of vaccine innovation. For the lay public, the successes achieved by immunization may appear to diminish the need for ongoing vaccine innovation. Many existing vaccines are not optimal, however, and should be replaced by safer, more effective preparations. Also, vaccines are not available for many diseases of importance in the United States, including varicella-zoster, cytomegalovirus~ hepatitis A, Herpes simplex, rotavirus, gonorrhea, and others. 5 The list is even longer for countries in the tropics where parasitic diseases are an additional major problem. Identification of Need and Establishing Priorities Federal resources for basic research on infectious diseases and for vaccine development are limited. Hence, some rational method is needed to identify priorities for these health-related investments. A disease must be defined as clinically important relative to others to warrant the efforts required to understand the etiologic agentts), host responses to the agents, and the pathobiology in human beings. The Institute of Medicine report New Vaccine Development: Establishing Priorities provides a quantifiable approach for comparing the health impact of diseases and for setting priorities among vaccine development projects.15 Establishing the Technical Feasibility of Vaccine Development Modern vaccine development requires a firm scientific foundation. Among the factors that must be understood are the nature of the

OCR for page 27
33 etiologic agent, including the number of serotypes and the identity of important immunogenic antigens; the nature of the host response to the antigents); the clinical manifestations of the disease; and the epidemiology of the disease. Impediments at this crucial stage begin with the inability to recognize and isolate an etiologic agentts). For example, Legionnaires' disease was not recognized as a definable entity until 1976, although in retrospect evidence of infection and disease had existed since the mid-1940s. Serum hepatitis" was described as early as 1833,16 but it was not clearly distinguished from infectious hepatitis until the 1940s.l7 The discovery of Australia antigen (now designated as hepatitis B surface antigen) in 1965 and its subsequent association with serum hepatitis were essential elements in the development and use of a hepatitis B vaccine.18-20 The identification of a retrovirus as the probable etiologic agent of acquired immune deficiency syndrome (AIDS) removes one barrier to the development of a vaccine for that disease. For some pathogens, the knowledge may be lacking to say which antigens should be incorporated into a vaccine to provide the desired immunity (gonorrhea is a current example). Delays in acquiring the necessary information may be exacerbated by constraints on funding for basic research and training, especially in disease pathogenesis. Vaccine Improvement Lack of basic knowledge also may impose barriers to the improvement of vaccines. As noted in Chapter 2, some vaccines that were developed empirically have contributed to drastic reductions in their target diseases, especially after standardization of the vaccine preparation. Pertussis vaccine is an example. In these cases, an understandable tendency exists to divert resources to the control of other pressing disease problems. 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. (The capacity of the public sector to undertake vaccine development is limited, primarily by financial considerations, but also by other resource limitations, e.g., lack of expertise and facilities for production.) The potential disincentives or impediments at the development stage are primarily economic and are examined more fully elsewhere in this report. They include: complexity of development, production, and quality control; lengthy vaccine production processes may adversely affect inventory and cash flow

OCR for page 27
34 cost of research and development in relation to anticipated sales (Chapter 4) perception that vaccines historically have received less effective patent protection than drugs apprehension over the liability situation (Chapter 6) Factors Influencing the Market for Vaccines Factors that influence anticipated vaccine sales or profitability are described below (precise information on the profitability of vaccines is regarded as proprietary information and was not available to the committee): The basic requirement that a vaccine deliver long-lasting or lifelong immunity is at odds with the prospect of multiple/repeated sales. This reflects the fact that vaccines represent a higher levee of technology than drugs, but makes them less attractive as commercial products. If a vaccine eradicates a disease, as in the case of smallpox, the market no longer exists. Also, the success of a vaccine in reducing the apparent threat of a disease, e.g., pertussis, tetanus, or measles, reduces the perceived need for it. Export sales are usually small (compared with drug sales).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). A large proportion of the doses of many pediatric vaccines (about 40 to 50 percent) are purchased by federal or state governments at reduced prices.4 The effect of these purchases on profits is uncertain. Experience has shown that the achievable market for a vaccine may be considerably less than would be expected on the basis of its potential economic and health benefits because of misperceptions among health care providers and the public. VACCINE UTILI ZATION The decision to develop and manufacture new vaccines undoubtedly is affected by the pharmaceutical firms' estimates of subsequent utilization. As noted above, the actual market size for a particular vaccine (especially for adult vaccines) often is substantially smaller than the population whose health it could protect or for whom it would be cost-effective.22~25 Various features of the care delivery system, and of clients and health professionals, contribute to vaccine underutilization.* - *The following sections were prepared originally for the report of the Committee on Issues and Priorities for New Vaccine Development, Institute of Medicineel5

OCR for page 27
35 System Factors Characteristics of the medical care system and payment practices influence patterns of vaccine use and market size. In general, the system slights preventive technologies, such as vaccines, and overemphasizes diagnostic and therapeutic technologies. Medical education and the attitudes of medical professionals encourage the use of sophisticated technologies for acute care. With the exception of pediatricians, medical specialists generally are not attuned to prevention and do little to encourage the use of preventive technologies by patients. Lack of information also may contribute to lower use of vaccines. The system does not emphasize provision of information to clients or to health professionals about the risks of certain diseases or the benefits and risks of vaccines. Underutilization of vaccines for communicable diseases is especially likely because benefits to society as a whole (through reduced transmission) often exceed the benefits to individuals. 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 vaccina- tion). The Medicare program covers only pneumococcal vaccine and hepatitis vaccine for patients with end-stage renal disease, despite several bills that have been introduced in Congress over the years to cover other vaccines, such as influenza. Medicare does cover vaccines used for treatment, however, including tetanus toxoid administered in the course of treating an injury. Client Factors Utilization is determined, in part, by characteristics of the target population, including its access to health care providers and the ease with which its members can be identified by the health care ~ system (in turn, dependent on size, composition, age, and socio- economic status of the target population). Also important are target population attitudes toward the vaccine, particularly those related to perceptions of the likelihood of contracting the disease, its severity if contracted, and the vaccine's efficacy and safety. Many investigations examining lay attitudes toward vaccines and the relationship between these attitudes and utilization have employed a Health Belief Model (HBM), depicted in Figure 3.1. This model is based on the hypothesis that willingness to undertake a recommended preventive health measure depends on (1) the individual's subjective state of readiness to take action, which is determined both by perceptions of the likelihood of susceptibility to the particular illness and perceptions of the probable severity of the consequences (organic and social) of contracting the disease; (2) the individual's evaluation of the feasibility and efficacy of the advocated health

OCR for page 27
36 behavior (i.e., an estimate of the action's potential benefits in reducing susceptibility, severity, or both), weighed against perceptions of physical, psychological, financial, and other barriers involved in the proposed action; and (3) the occurrence of one or more cues to action to stimulate conscious or semiconscious feelings about O7 the disease threat or about the recommended action.~' Cues to action may be either internal (e.g., symptoms) or external {e.g., mass media or interpersonal communications). Although it is assumed that diverse demographic and sociopsychological variables may, in any given instance, influence an individual's health-related attitudes and beliefs, those variables are not thought to be direct causes of health action. The literature provides considerable empirical support for the usefulness of the HBM in accounting for an individual's health-related decisions.29 Table 3.1 summarizes findings from studies that have examined one or more of the HBM elements as determinants of vaccine-acceptance behavior. These findings indicate that factors included in the HBM play a significant role in decisions about vaccination. They suggest that efforts to maximize public participa- tion in immunization programs should begin with a survey of the intended vaccine recipients to obtain information about their HBM-related perceptions. If a problem is noted, those promoting the vaccine can develop and implement a campaign that addresses and modifies the perceptions most likely to act as obstacles. In some cases, lay perception of a vaccine's safety may be the most important obstacle to its acceptance (e.g., concern about the occurrence of Guillain-Barre syndrome interfered with the influenza vaccination programs after the swine flu episode). In other instances, the difficulty may be a low perception of the severity of the disease. This has occurred with measles and influenza. There is also evidence supporting the important role played by the provider's recommendation.3 Provider Factors The question of whether or not a provider will "accept" a new vaccine fits logically within the framework provided by literature on the adoption and diffusion of medical innovations in the health profession.32 Researchers in this area generally have posited that three classes of variables are important: (1) characteristics of the adopters (in this case, both the providers and their patients); (2) characteristics of the innovation (the vaccine); and (3) charac- teristics of the "setting. 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. Compared with their colleagues, opinion leaders tend to be younger, to hold more advanced degrees, to be more active in national health and medical organizations, to be

OCR for page 27
37 INDIVIDUAL PERCEPTIONS Perceived Susceptibility to D; sea.e 'X' Perceived Seriousness (severity) of Di'.a.e'X' MODIFYING FACTORS LIKELIHOOD OF ACTION . Demograpl~ic variables hoe sex, race, Perceived benefits of ethniciq, ic) 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. Reprinted, with permission, from Becker, M.H., Haefner, D.P., Kasl, J.P., Kirscht, J.P., Maiman, L.A., and Rosenstock, I.M. 1977. Selected psychosocial models and correlates of individual health- related behaviors, Medical Care (supplement), 15~51:27-46. more interested in publishing in scientific journals, to be more likely to read and be influenced by research reports in scientific journals (they rate them as their primary source of reliable information), and to be more aware of the latest advances in their areas of specialization. These opinion leaders influence their colleagues, who use them as a primary source of credible information and advice--this process then continues as a cascade of influence. These findings suggest that if one wishes to increase the likelihood or rate of acceptance of a new vaccine by health care providers, efforts at persuasion should be concentrated on those physicians and other providers who exercise the relevant opinion leadership. Scarce influence resources should not be spread evenly across all providers.33 Innovations themselves possess characteristics that have been shown to influence their potential for adoption by providers.34 These include: relative advantage--the degree to which the innovation is perceived as being better than the idea it supersedes _ (Is the new vaccine superior to what was previously available to prevent or treat the disease in terms of efficacy, safety, costs, ease of administra- tion, and other factors?)

OCR for page 27
38 a a C~ .,' o ~n a) Q .~1 o ~ , _I a m .,, v .,' 0 o ~ 0 0 ~ a) u' 0 0 .,, U] a) o ~n .,, U) ~ o 0 ~ v v .d .,' Q :' ~U E~ O U] ,. m U] .,' a .,, U. .,, ._, n ,1 v ~n U) ~ 0 . - 0 V V V a: ~Q o .,, U] H + `: + + + + V U] + ~+ + + + + + n + + + + ~e + + + + + + + ~+ + + U] U] ~ 0 .,4 . - {Q U2 .,1 N - ~ ~ V ~ ~N V (V V S: ~ U O ~1 -1 ,' . - ~ _1 .- ~\ ~_ ~ O - ~ - -, ~,1 ,t ~1 O ~1 3 3 3 H 3 ~0 u] u] H CO ~a v - a, . ~ ~3 a) ~ 0 U] - - a V ~ ~o' O - ~ ^ ~ ~U] S O ~C O ~ ~1 a' ~ a, c~ U] ~ ~s~ ~o ~ a ~(13 < ~,l i- ~- ns a ~ a ~0 a a' ~ ~ ~ 0 U] ~ - ~ - ~ ~O Q o 0 ~Q. S a; ~O ~: o U] a) zo ~q a a) a, .,' a) ~n S~ a) Q U] a,. S o ~n V V O ~n ~ ~n ~n ~ U] O ~ oZ e E ~O O ~ V ,1 .~1 .,' U]

OCR for page 27
39 compatibility--the degree to which the innovation "fits in" with existing values, procedures, past experiences, etc. (Does the vaccine require new techniques of administration, new personnel, or interactions with groups of clients not familiar with vaccination processes?) complexity--the degree to which the innovation is seen as relatively difficult to understand and use (IS the new vaccine's mode of operation, mode of administration, or follow-up schedule simple or complex?) suitability for pilot studies--the degree to which the innovation can be implemented and assessed on a limited basis (Does the new vaccine require large commitments of resources?) observability--the degree to which the results of adopting the innovation are visible to others (How much time must elapse before the provider is able to estimate the benefits and adverse effects associated with prescription of the new vaccine in a group of patients?) risk--the degree to which adopting the innovation poses danger to the adopter (Can the new vaccine cause serious injury to some recipients? Is the provider who prescribes the vaccine earlier than his peers likely to be admired or scorned? Will the provider be protected against possible litigation?) Riddiough et al.35 list several factors that may influence physicians' vaccine-prescribing behavior and that seem to fit within one or more of the innovation characteristics described above: attitudes and knowledge about the targeted disease attitudes and knowledge about the safety and efficacy of vaccines perceptions about a patient's need for vaccination consideration of revenue generated by administering vaccines consideration of the potential liability for vaccine-related injury They suggest that concern about possible adverse reactions and concomitant legal action are the greatest obstacles to physician acceptance. They add that: [I]n assessing a patient's need for a particular vaccine, physicians may consider (a) the likelihood of the patient's being exposed to a given disease-producing organism; (b) the patient's vulnerability to the disease after being exposed to the organism; and (c) 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). When attempting to influence the adoption and diffusion of a new vaccine, it is extremely important to obtain information from the

OCR for page 27
40 potential adopters about how they rate the innovation.34 If these ratings indicate that one or more of the vaccine's characteristics present obstacles, at least two courses of action are possible: (1) attempt to persuade the potential adopters that their perceptions about those characteristics are wrong or (2) attempt to alter the real or perceived characteristics of the vaccine to overcome the adopters' objections.33 Provider prescribing behavior is influenced by the setting in which the behavior takes place (e.g., the structure of the health care delivery organization, or group versus solo practice).36 Some communities or population subgroups hold beliefs, attitudes, and norms that oppose vaccination in general or that oppose a particular vaccine. Any campaign to introduce a new vaccine should be based on a prior assessment of the relevant setting, taking into account important sources of opposition. CONCLUSIONS The committee's assessment of the current vaccine situation leads to the following conclusions. There is cause for grave concern over the nation's vaccine supply. Many factors contribute to this concern: most major pediatric vaccines and many other vaccines are available only from sole suppliers; the manufacture of vaccines can be interrupted by a variety of technical problems; stockpiling cannot be expected to guard against the withdrawal of a sole manufacturer; there are no contingency plans to prepare for such a possibility; and sole reliance on foreign manufacturers does not offer a practicable solution. The supply of vaccines could be ensured if the federal government were willing to become the manufacturer of last resort or to enter into guaranteed contracts with manufacturers for needed vaccines. The possibility of federal vaccine production raises many complex policy questions, including the question of liability for injury from such vaccines. The committee believes that, at present, solutions to the problem of ensuring vaccine supply should employ the facilities, resources, and expertise already existing in the commercial vaccine industry. It recommends, however, that a national vaccine commission, proposed in Chapter 7, should develop contingency plans and 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 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) response to it. Limitations of funding for basic research and training,

OCR for page 27
41 especially in disease pathogenesis, may contribute to delays in acquiring the necessary knowledge to develop new vaccines or improve . existing ones. 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. The widespread, timely adoption and diffusion of new technologies depends on their successful adoption by "opinion leaders" in the relevant medical community. This suggests that spreading scarce resources across all providers to increase awareness of new approaches (such as the use of new vaccines) may not be as successful as concentrating on those who exercise opinion leadership. Considerable empirical evidence supports the usefulness of the Health belief model" in accounting for individuals' health-related decisions. Efforts to maximize public participation in immunization programs should begin with a survey of intended vaccine recipients to obtain information on their perceptions of the disease and the vaccine. Those promoting the vaccine can then develop and implement a campaign that addresses and modifies the Misperceptions most likely to act as obstacles. REFERENCES AND NOTES National Immunization Work Group. 1977. Report and Recommenda- tions of the National Immunization Work Group. McLean, Va.: J.R.B. Associates. 2. United States Congress, Office of Technology Assessment. 1979. A Review of Selected Federal Vaccine and Immunization Policies. Washington, D.C.: U.S. Government Printing Office. Shaw, D. 1984. Testimony for Wyeth Laboratories on H.R. 5810 before the Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, December 19, 1984, Washington, D.C. Mason, J. 1984. Testimony on H.R. 5810 before the Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, December 19, 1984, Washington, D.C.

OCR for page 27
42 5. Smith, M. 1984. Testimony on H.R. 5810 before the Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, December 19, 1984, Washington, D.C. 6. Hopps, H. 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. 7. Centers for Disease Control. 1984. Diphtheria-tetanus-pertussis vaccine shortage--United States. Morbid. Mortal. Weekly Rept. 33:695-696. 8. Williams, D. 1984. Testimony for Connaught Laboratories, Inc. on H.R. 5810 before the Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, December 19, 1984, Washington, D.C. 9. Centers for Disease Control. 1984. PertuSSis transmission. Morbid. Mortal. Weekly Rept. 33:2-5. 10. Fulginiti, V.A. 1984. Editorial. Pertussis disease, vaccine and controversy. JAMA 251:251. 11. Pickelsimer, C.F. 1984. Personal communication, Office of Financial Management, Centers for Disease Control, Atlanta, Ga. Teske, R. 1984. Personal communication, Division of Immunization, Centers for Disease Control, Atlanta, Ga. 13. Johnson, R.B. 1984. Testimony for Lederle Laboratories on H.R. 5810 before the Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, December 19, 1984, Washington, D.C. 14. Beale, A.J. 198S. Modern approaches to the development of vaccines: perspective of a traditional manufacturer. Pp. 377-381 in Vaccines 85. b'`olecular and Chemical Basis of Resistance to Parasitic, Bacterial, and Viral Diseases, R.A. Lerner, R.M. Chanock, and F. Brown, eds. Cold Spring Harbor, N.Y.: Cold Spring Harbor Laboratory. Institute of Medicine. 1985. New Vaccine Development: Establishing Priorities, Volume 1. Diseases of Importance in the United States. Washington, D.C.: National Academy Press. 16. Lurmann, A. 1855. Eine icterus epidemic. Berl. Rlin. Wochenschr. 22:20. Paul, J., Havens, W.P., Sabin, A.B., and Philip, C.B. 1945. Transmission experiments in serum jaundice and infectious hepatitis. JAMA 128:911-915. 18. Blumberg, B.S., Alter, H.J., Visnich, S. 196S. A "new" antigen in leukemia sera. JAMA 191:541-546. 19. Krugman, S., Giles, J.P., and Hammon, J. 1967. Infectious hepa~itis: evidence for two distinctive clinical, epidemiological and immunological types of infection. J. AMA 200:365-373. 20. Prince, A.M. 1968. An antigen detected in blood during the incubation period of serum hepatitis. Proc. Natl. Acad. Sci. USA 60:814-821. 21. Pharmaceutical Manufacturers Association. 1984. statistical Fact Book. Washington, D.C.: Pharmaceutical Manufacturers Association. 22. U.S. Congress, Office of Technology Assessment. 1979. A Review of Selected Federal Vaccine and Inununization Policies. Washington, D.C.: U.S. Government Printing Office.

OCR for page 27
43 23. U.S. Congress, Office of Technology Assessment. 1981. Cost Effectiveness of Influenza Vaccination. Washington, D.C.: U.S. Government Printing Office. 24. U.S. Congress, Office of Technology Assessment. 1984. update of Federal Activities Regarding the Use of Pneumococcal Vaccine. Washington, D.C.: U.S. Government Printing Office. 25. Willems, J.S., and Sanders, C.R. 1981. Cost-effectiveness and cost-benefit analyses of vaccines. J. Infect. Dis. 144:486-493. 26. Schroeder, S., and Showstack, J. 1979. Financial incentives to perform medical procedures and laboratory tests: illustrative models of office practice. Med. Care 16:289-298. 27. Becker, M.H., ed. 1974. The Health Belief Model and Personal Health Behavior. Thorofare, N.J.: Charles B. Slack. 28. Becker, M.H., and Maiman, L.A. 1980. Strategies for enhancing patient compliance. J. Community Health 6:113-135. 29. Janz, N.K., and Becker, M.H. 1984. The health belief model: A decade later. Health Educ. Quarterly 11:1-47. 30. Cummings, K.M., Jette, A.M., Brock, B.M., and Haefner, D.P. 1979. Psychosocial determinants of immunization behavior in a swine influenza campaign. Med. Care 17:639-649. 31. Rosenstock, I.M., Derryberry, M., and Car riger, B.K. 1959. Why people fail to seek poliomyelitis vaccination. Public Health Rep. 74:98-103. Leventhal, H., Rosenstock, I.M., Hochbaum, G.M., and Carriger, B.K. 1960. Epidemic impact on the general population in two cities. Pp. 53-77 in The Impact of Asian Influenza on Community Life: A Study in Five Cities. Washington, D.C.: U.S. Government Printing Office. DREW, PHS, Pub. No. 766. Becker , M.H., Nathanson, C.A., Drachman, R.H., and Kirscht, J.P. 1977. Mothers' health beliefs and children's clinic visits: a prospective study. J. Community Health 3:125-135. opinion Research Corporation. 1978. Public attitudes toward immunization: August 1977 through February 1978. A study for the Centers for Disease Control, Atlanta, Georgia. Princeton, N.J.: Opinion Research Corporation. Aho, W.R. 1979. Participation of senior citizens in the swine flu inoculation program: an analysis of health belief model variables in preventive health behavior. J. Gerontol. 34:201-208. Rundall, T.G., and Wheeler, J.R.C. 1979. Factors associated with utilization of the swine flu vaccination program among senior citizens in Tompkins County. Med. Care 17:191-200. Cummings et al., see note 30. Larson, E.B., Bergman, J., Heidrich, F., Alvin, B.L., and Schneeweiss, R. 1982. Do postcard reminders improve influenza vaccination compliance? A prospective trial of different postcard "cues. Med. Care 20:639-648. 32. Greer, A.L. 1977. Advances in the study of diffusion of innovation in health care organizations. Milbank Memorial Fund Quarterly: Health and Society 505-532. 33. Becker, M.H. 1970. Factors affecting diffusion of innovations among health professionals. Am. J. Public Health 60:294-304. 34. Becker, M.H. 1970. Sociometric location and innovativeness: Reformulation and extension of the diffusion model. Am. Social. Rev. 35:267-282.

OCR for page 27
44 35. Riddiough, M.A., Willems, J.S., Sanders, C.R., and Remp, K. 1981 Factors affecting the use of vaccines: considerations for immunization program planners. Public Health Rept. 96:528-535. 36. Becker, M.H., Stolley, P.D., Lasagna, L., McEvilla, J.D., and Sloane, L.M. 1972. Differential education concerning therapeutics and resultant physician prescribing patterns. J. Med. EdUC. 47:118-127.