Vaccine Purchase Research Articles

Analysis of the transition from oral polio vaccine to inactivated polio vaccine for primary immunization in a hospital-based primary care practice.

Analysis of the transition from oral polio vaccine to inactivated polio vaccine for primary immunization in a hospital-based primary care practice.

Creating Markets for New Vaccines. Part II: Design Issues

Several programs have been proposed to improve incentives for research on vaccines for malaria, tuberculosis, and HIV, and to help increase accessibility of vaccines once they are developed. For these programs to spur research, potential vaccine developers must believe that the sponsor will not renege on the commitment once research costs have been sunk. Given appropriate legal language, the key determinant of credibility will be eligibility and pricing rules, rather than whether funds are physically placed in separate accounts. Requiring candidate vaccines to meet basic technical requirements would help ensure that funds were spent only on effective vaccines. Requiring developing countries to contribute co-payments would help ensure that they felt that the vaccines were useful given the conditions in their countries. Purchases under a vaccine purchase program could be the conditions in their countries. Purchases under a vaccine purchase program could be governed by a market exclusivity provision similar to that in the U.S. Orphan Drug Act. A program could start by offering a modest price and increasing it if it proved inadequate to spur research. If donors pledge approximately $250 million per year for each vaccine for ten years, vaccine purchases would cost approximately $10 per year of life saved. No funds would be spent or pledges called unless a vaccine were developed.

Creating Markets for New Vaccines. Part I: Rationale

Malaria, tuberculosis, and the strains of HIV common in Africa kill approximately 5 million people each year. Yet research on vaccines for these diseases remains minimal largely because potential vaccine developers fear that they would not be able to sell enough vaccine at a sufficient price to recoup their research expenditures. Enhancing markets for new vaccines could create incentives for vaccine research and increase accessibility of any vaccines developed. Private firms currently conduct little research on vaccines against malaria, tuberculosis, and the strains of HIV common in Africa. This is not only because these diseases primarily affect poor countries, but also because vaccines are subject to severe market failures. Government- directed research programs may be well-suited for basic research, but for the later, more applied states of research, committing to compensate successful private vaccine developers has important advantages. Under such programs, the public pays only if a successful vaccine is actually developed. This gives pharmaceutical firms and scientists strong incentives to self-select research projects that have a reasonable chance of leading to a vaccine. Committing to purchase vaccines and make them available to poor countries may also be attractive relative to other ways of rewarding vaccine developers.

Pneumococcal Immunization Program: Cost‐Utility Analysis for Quebec

A cost-utility analysis of a pneumococcal immunization program was conducted for Quebec. The goal of this study was to estimate the cost, effectiveness and benefit of an immunization program against pneumococcal infection in Quebec. Two strategies were evaluated using the cu rrent situation of infrequent use of 23-valent polysaccharide vaccine as a reference point. The first strategy the 'private ' program was a vaccine promotion program, with no change in the current distribution system. The second strategy the 'public' program consisted of a promotional program combined with free vaccine distribution through the public health care system. The pneumococcal immunization program targeted practically the same clientele as the influenza program , so that in the two scenarios promotional activities and vaccination were linked . A cost-utility analysis was conducted for four target groups: persons living in residential and extended care centres , persons with certain predisposing chronic conditions (primarily diabetes and heart or lung disease) , persons with human immunodeficiency virus (HIV), and person aged 65 years and over who do not fall into any of the other categories. An additional analysis was conducted for all persons aged 65 years and over, with or without a predisposing chronic condition. Assuming that the same number of individuals would be immunized against influenza and pneumococcus , there would be about 100,000 persons to vaccinate each yea r when the program was in its maintenance phase, and about 375,000 persons targeted for catch-up. In the basic scenario, the vaccine was considered of maximum efficacy in preventing invasive infections with bacteremia but less than half as effective in preventing infections without bacteremia, which are twice as common. Sensitivity analyses were conducted on the assumption that the vaccine was totally ineffective in preventing infections without bacteremia or that it was just as effective for both types of infections. The vaccine efficacy rates were taken from the case control study with the most subjects, and reflected reduced efficacy over the course of time and the fact that 10% of strains are not covered by 23-valent vaccine. For persons with HIV, we used efficacy estimates from a group of American experts. In the basic scenario, the total cost of a private program is about $1 million, two-thirds of which is borne by individuals through vaccine purchases and one-third by the public sector (vaccination). The unit cost is $22.80 per dose. If it was decided to revaccinate individuals at risk after six years, the cost would increase by about $1.7 million to a total of$2.7 million per year for the program. In a public program, all costs, a little less than $800,000, are borne by the public sector. The unit cost is $22.1 O per dose. The difference of approximately one-quarter of a million dol -

Addressing the challenges to immunization practice with an economic algorithm for vaccine selection

The biotechnology revolution is producing a growing bounty of new vaccines which pose difficult choices in selecting among many products. Some major public and private purchasers of vaccine may offer individual physicians and clinics their choice in assembling vaccine inventories. Others might purchase only a limited stock of products that would satisfactorily immunize a typical child. In either case, current vaccine selection decisions are based principally on purchase price alone without systematic consideration of other factors of fiscal consequence. As a potential tool for decision making, we developed an economic algorithm for vaccine selection that would minimize the overall costs of disease control through immunization by considering: (1) purchase price, (2) number of doses needed, (3) preparation time, (4) route of administration, (5) cold storage needs, (6) shelf life, (7) earliest age of full immunity, (8) adverse events frequency, and (9) efficacy of protection. To demonstrate the algorithm, variables (1) to (4) above were incorporated into a pilot binary-integer linear programming model that satisfied the recommended immunization schedule for diphtheria, tetanus, pertussis, Haemophilus influenzae b, and hepatitis B, using eleven vaccines ( DTaP, DTaP-Hib, Hib, HepB and Hib-HepB ) from four manufacturers. Five (or six) opportunities to vaccinate were modeled at (1), 2, 4, 6, 12–18, and 60 months of life, assuming US$40 per clinic visit, $15 per injection, and $0.50 per minute of nurse preparation time. Vaccine costs were varied using actual March and September 1997 US Federal vaccine prices, as well as estimates for unpriced new vaccines. Over 16000 distinct vaccine stocking lists by vaccine type and brand were possible. Including a 1-month visit, the lowest-cost ‘solution’ of the algorithm was $529.41 per child in the March cost-assumption case, and $490.32 in the September one (both included four doses of DTaP-Hib , three HepB , and one DTaP ). Without a 1-month visit, the lowest-cost solution in the March case cost $486.67 (four DTaP , two Hib-HepB , one DTaP-Hib , and one HepB ), while the September case cost $450.32 (four DTaP-Hib , three and one DTaP ). Ensuring at least one product was selected from each of the four manufacturers increased costs about $13.00, and the needed injections rose from eight to nine. The most economical selection of vaccines to use cannot be intuitively predicted, as permutations are large and solutions are sensitive to minor changes in costs and constraints. A transparent, objective selection method that weighs the economic value of distinguishing features among competing vaccines might offer the ‘best value’ to vaccine purchasers, while also creating strong market incentives for continuing innovation and competition in the vaccine industry.

Are state immunization programs effective? Implications for the children's immunization initiative

Several states operate universal vaccine purchase (UVP) programs aimed at ensuring adequate immunization of children. Some of these programs have been in operation for many decades. Recently, there has been a great deal of interest in implementing a federal UVP program. It is not clear, however, that such programs can significantly increase immunization levels; many nonfinancial barriers to full immunization exist and would have to be addressed. This paper uses cross-sectional data at the state level to estimate the effect of state UVP programs on the immunization levels of preschool children. The results indicate that states with UVP programs do not have significantly higher immunization rates than do other states. Therefore, it is not likely that a federal UVP program would significantly affect immunization rates.

Use of public immunization services after initiation of a universal vaccine purchase program.

To explore the reasons why North Carolina families continue to use public immunization services 2 years after implementation of a universal vaccine purchase program, a state program intended to eliminate financial barriers to immunization in private physicians' offices. In-person interviews were conducted in 11 local public health departments in North Carolina. Consecutive sample of 64 adults accompanying children aged 2 years or younger presenting for immunization services. (1) Reasons for seeking immunization at the health department and (2) history of immunization from private physicians. Two thirds of children obtained immunizations at the health department because of cost, including two thirds of children enrolled in Medicaid. Only 33% of children received well-child care from a private physician; for more than half of this group, the parents cited cost as the reason for using the health department, even though their physician was participating in the state universal purchase program. Of the 8 parents who told their child's private physician that they could not afford immunizations, none was told that the vaccine administration fee would be waived. Even though North Carolina's universal vaccine purchase program had been in effect for more than 2 years, a substantial number of children still received care from a private physician but used the health department for immunizations because of cost. These results indicate a need to explore additional strategies to preserve children's "medical homes."

Differential Effects of a State Universal Purchase Program on Children's Immunization Rates According to Insurance Status ♦ 632

Background: To eliminate financial barriers to immunization, North Carolina implemented a universal vaccine purchase program, in which the state purchases vaccine serum for all children and distributes it free to all participating providers. Providers may charge an established administration fee only. Objective: This study examined the impact of the UP program on immunization rates for children with different types of insurance. Methods: From a random birth-certificate sample of 4,000 children born in 1994 and 1995, parents were interviewed to obtain children's sites of medical care and insurance history. Chart abstraction was performed in all sites of preventive care; details of insurance coverage were verified with insurance companies, employers, and the Division of Medical Assistance. Results: Parent interviews were completed for 71% of eligible children; chart abstraction and insurance data were obtained for 97% of those with parent interviews. In month-by-month comparisons, children born in 1995 had immunization rates 4%-10% higher than their 1994 counterparts. By 24 months of age, 84% of the 1995 cohort had completed the primary immunization series, compared with 79% of the 1994 cohort (p<0.001). In all insurance subgroups (i.e., fully insured for well-child care, partially insured for well-child care, insured but with no well-child benefits, enrolled in Medicaid exclusively or in combination with private insurance, or having some periods of being uninsured), 1995 immunization rates were higher than 1994 rates. The biggest increases in immunization rates from 1994 to 1995 occurred for children who were privately insured with no well-child coverage, children who had periods of being uninsured, and children enrolled in Medicaid exclusively or with private insurance. More children in the 1995 cohort received all immunizations in the private sector. Conclusion: The North Carolina universal purchase program appears to have had a significant, positive impact on immunization rates, especially for children with inadequate insurance for well-child care. However, insurance status still influences the ability of children to receive immunizations on schedule.

ECONOMIC IMPACT OF A NEW UNIVERSAL PURCHASE VACCINE PROGRAM ON FAMILIES' EXPENSES FOR PREVENTIVE CARE † 539

Background: Universal purchase (UP), the state purchase of vaccines for all children regardless of income or insurance status, is one strategy to lower families' health care expenses. North Carolina implemented a UP program in 1994.

Poliomyelitis eradication and its impact on primary health care in the Philippines.

Since 1992, the Philippines has conducted four national immunization days (NIDs) for polio eradication. Surveillance for acute flaccid paralysis (AFP) began in 1992. Through good routine immunization, the incidence of paralytic polio had decreased to low levels in the Philippines even before the NIDs were initiated. With continuously improving AFP and virologic surveillance, wild poliovirus has not been isolated since May 1993. NIDs had a direct positive effect on child health through supplementary immunization with oral poliovirus vaccine, measles vaccine, and tetanus toxoid, as well as through the distribution of vitamin A. Following the successful NIDs, the government budget for vaccine purchases increased significantly. Also, the NID strategy was used as a model for several other priority prevention programs of the Department of Health. Through the development of AFP surveillance, polio eradication also helped to improve surveillance for other Expanded Programme on Immunization diseases.

Evaluation of the results of a survey of dairy producers on dairy herd biosecurity and vaccination against bovine viral diarrhea

Summary A survey on biosecurity and vaccination practices was sent to 632 dairy producers in Pennsylvania to determine the proportion of the approximately 12,500 dairy herds in Pennsylvania that might be at risk for outbreaks of vaccine-preventable diseases. Most producers relied on their veterinarian for vaccination information and vaccine purchases, but administered the vaccine to the cattle themselves. Many producers did not vaccinate all susceptible groups of cattle in their herd. Also, many producers did not administer a booster vaccination after administration of an initial killed-virus vaccine, as recommended by vaccine manufacturers. As a result, although 309 of 376 (82.2%) dairy producers indicated that they routinely vaccinated their herds, only 73 of 266 (27.4%) herds were considered adequately vaccinated. Veterinarians were as likely to administer vaccines to cattle in adequately vaccinated herds as to cattle in inadequately vaccinated herds. Adequately vaccinated herds were more likely to be larger herds (&gt; 121 cattle) than smaller herds. Analysis of survey results indicated that veterinarians are not taking full advantage of their pivotal role in dairy herd vaccination programs.

Paralytic poliomyelitis: seasoned strategies, disappearing disease

With more than 2 years having elapsed since the last case of paralytic poliomyelitis occurred in the Western Hemisphere, significant progress has been made towards the global eradication of wild polioviruses. Poliomyelitis is disappearing from Europe, North Africa, Southern Africa, the Middle East, China, and the Pacific. Reported poliomyelitis cases declined to 15 587 cases in 1992. Current eradication strategies recommended by the World Health Organization include national mass campaigns administering oral poliovaccine to all children under 5 years of age, enhanced surveillance to detect cases of acute flaccid paralysis, creating a network of laboratories for viral diagnosis, and targeted immunisation to areas and populations where poliovirus transmission is likely to persist. The major obstacles to eradication include inadequate political support for eradication and insufficient funding, especially for the purchase of vaccine. With additional support for the international eradication effort, epidemics of poliomyelitis will cease in developing countries, and industrialised countries will be able to save the large sums spent each year on poliovaccine and rehabilitation.

Putting prevention research at risk: implementation of the Vaccines for children programme

The United States Department of Health and Human Services is in the process of implementing the recently created Vaccines for Children programme (VFC) that provides for expanded government purchase of childhood vaccines at capped prices. Vaccine companies have traditionally sold their vaccines to the government at discounted prices and to private providers at higher prices, and policymakers have encouraged this ad hoc cost-shifting system. Greatly increased government purchase of vaccines at artificially low capped prices will not have a significant impact on immunization rates, and, because vaccine manufacturers depend on private sector sales to finance research and development, such purchase will delay or curtail efforts to bring new vaccines to the market.

Risk of vertebral fracture in women with rheumatoid arthritis.

project. We thank Merieux UK and SmithKline Beecham for funding purchase of the monitor marks; the staff of St Patrick's for their help; the doctors and staff of the participating practices for their cooperation; and Mr S Potter, chief pharmacist at Queen Elizabeth Hospital, for giving background information. 1 Lugosi L, Battersby A. Transport and storage of vaccines in Hungary: the first cold chain monitor study in Europe. Bull World Health Organ 1990;68:431-9. 2 Hunter S. Storage of vaccines in general practice. BMJ 1989;299:661-2. 3 Thakker Y, Woods S. Storage of vaccines in the community: weak link in the cold chain? BAfJ 1992;304:756-8. 4 Malone-Lee MC. Purchase and supply of vaccines for the childhood immuniston programme. London: NHS Management Executive, 1992. (EL(92)26.)

The Influenza Vaccination Demonstration Project: An Expanded Policy Goal

In 1980, the Public Health Service established an objective of immunizing 60% of high-risk persons with influenza vaccine annually by the year 1990. As no more than 32% of high-risk persons currently receive influenza vaccine each year, the Health Care Financing Administration (HCFA) has undertaken an influenza vaccination demonstration project for Medicare enrollees. Federally purchased vaccine is being distributed to physicians, health departments, hospitals, nursing homes and health maintenance organizations (HMOs). If the project is cost-effective, Congress has authorized HCFA reimbursement for influenza vaccination. Changing reimbursement policy alone, however, is unlikely to substantially improve influenza vaccine delivery; HCFA reimbursement for pneumococcal immunization since 1981 has not increased the use of pneumococcal vaccine. In contrast, federal purchase and distribution of vaccines to state and local health departments has helped maintain the remarkable success of childhood immunization programs. In addition, in Canada, provincial health departments purchase more than 80% of all influenza vaccine distributed, and from 1980 through 1988, per capita vaccine distribution increased 140%. These experiences suggest the need for an expanded policy goal for the influenza vaccination demonstration project that includes federal purchase and distribution of influenza vaccine. This approach, together with a change in reimbursement policy, offers greater promise for achieving our nation's objective for influenza vaccination.

Active immunizations for adults.

Lack of effective antiviral drugs has led to dependence on vaccines for control of many viral diseases. These diseases are primarily diseases, so immunization activities have largely been directed toward children. Notable exceptions to this emphasis on children are influenza immunizations. Even with effective viral vaccines, significant efforts to im­ munize children, and generous financial support to purchase vaccines, it is becoming evident that a portion of the adult population remains susceptible to one or more of these common diseases. These adults are victims of one or more of the following circumstances: (a) the widespread use of vaccines creates a herd immunity that reduces the usual exposure to these viruses; (b) not all persons are immunized in childhood; or (c) some persons receive ineffective or mishandled vaccines (vaccine failure). The bottom line is that an increasing proportion of adults could greatly benefit from childhood vaccinations. The situation is somewhat complicated by the relative lack of knowledge of these vaccines among nonpediatricians, as well as indications that these vaccines are less antigenic (1) and at times more reactive (2) in adults. Adults are the primary target for influenza and rabies vaccines, although children frequently receive the latter. Influenza immunization creates con­ fusion, frustration, and/or fright because of the many influenza strains that have been isolated, the phenomena of antigen drift and shift, the unpredicta­ bility of influenza outbreaks, the varying manufacturing processes, the cre­ ation of priority categories to receive the vaccines, frequent reactions, and the unexplained relation between Swine influenza vaccine and the Guil­ lain-Barre syndrome. Decisions on administration of rabies vaccination may be delayed and the vaccine may cause serious side effects. Several viral vaccines are required only by the traveler, and at times are unavailable at the family practitioner's or internist's office. Finally, in the

Present Status of and Trends in Tuberculosis and Brucellosis in Cattle

Tuberculosis and brucellosis have been greatly reduced in the cattle population. The reduction has led to complacency in the eradication effort. In each of these cooperative State-Federal Eradication Programs there have been modifications of program procedures as husbandry practices changed. Surveillance at slaughter is currently the basis for location of herds affected with either of these diseases. A lesion resembling a tubercle found by the meat inspector on postmortem examination starts a tracing procedure leading to a tuberculin test of the herd from which the lesioned animal originated. A blood sample for brucellosis is also collected from adult cattle at slaughter and sent to the laboratory. Any reactors likewise are traced and herds tested. Effectiveness of the surveillance is dependent on accurate identification of slaughter animals. This has improved, but needs further improvement. Dairy herds benefit from additional surveillance through the milk ring test which has proven to be very effective when conducted three or four times each year on bulk milk samples collected at dairy plants. Use of Brucella abortus strain 19 vaccine decreased with reduction of Federal funds supporting vaccine purchase and administration. Vaccination is currently being encouraged especially for cattle moving into the more heavily infected areas in the South. New immunizing agents and diagnostic procedures are being studied for brucellosis. The comparative cervical test is being widely used to eliminate problems relating to sensitivity to mycobacteria other than those causing tuberculosis in cattle.

Adenovirus vaccines in military recruit populations: a cost-benefit analysis.

In 1966, the Army instituted an Adenovirus Surveillance Program to monitor acute respiratory disease (ARD) in recruit populations and the efficacy of adenovirus (ADV) vaccines in reducing ARD associated with ADV types 4 and 7. Between 1966 and 1971, the total cost of the surveillance program, including vaccine development, purchases, and administration, was estimated to be $4.83 million. In 1970 and 1971, when types 4 and 7 ADV vaccines were first used together for immunization of recruits entering basic training, it was estimated that these vaccines prevented 26,979 hospitalizations due to ARD. Direct and indirect costs associated with the hospitalization of one trainee with ARD amount to $279 (in 1971 dollar values). Thus the dollar estimate of benefits derived from use of these vaccines was 26,979 times $279, or $7.53 million. Based on these data, benefits derived from immunization ($7.53 million) outweigh the costs associated with immunization ($4.83 million), yielding a favorable benefit-cost ratio of 1.56.