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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
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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
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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.
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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.
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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.
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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
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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
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· 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
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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
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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
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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?)
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· 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
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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,
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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
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Representative terms from entire chapter:
vaccine supply
