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Simultaneous administration of diphtheria-tetanus-pertussis-polio and hepatitis B vaccines in a simplified immunization program: immune response to diphtheria toxoid, tetanus toxoid, pertussis, and hepatitis B surface antigen.

We studied the interactions of hepatitis B vaccine with other vaccines used in the World Health Organization expanded programs of immunization. Three groups of Senegalese children were vaccinated with hepatitis B vaccine (HB) alone, diphtheria-tetanus-pertussis (DTP)-polio vaccine alone, or a combination of hepatitis B vaccine and DTP-polio vaccines simultaneously. The immune responses to HBsAg, tetanus toxoid, diphtheria toxoid, and pertussis were measured after one and two vaccinations at 6-month intervals. The immune responses to the combination of HB vaccine and DTP-polio vaccines were similar to the immune responses observed after administration of each vaccine alone. In addition, no adverse reactions were noted. These experimental trials also demonstrated that with a DTP-polio vaccine containing 30Lf of tetanus and diphtheria toxoids, two doses given at 6-month intervals are sufficient to provide a satisfactory immune response. In the case of pertussis and HB vaccines; however, a third dose is necessary.

Antibodies, Bacterial

The failure of the 1976 swine influenza immunization program.

The program to immunize 210 million Americans against swine flu failed. It set back the Federal government's relations with state health agencies, private physicians, pharmaceutical manufacturers, and the insurance industry. It increased mistrust of immunization programs and of government health programs in general.The well-intentioned plan had far-reaching consequences because its scope and the speed with which it was implemented were overreactions to the threat. Its size magnified every one of its faults, legal, medical and political. Organizational and scientific capacity were less than expected. Local health agencies could not administer the program with the inadequate funds from HEW and pharmaceutical companies could not produce a safe, effective children's vaccine.Because of the urgency given the program, Congress neglected the opposition of consumer advocates and state health officials, and did not spend time trying to include immunization against childhood disease in the swine flu program.The failure illustrates the dangers of hasty decisions, of considering only direct medical costs and benefits and not social and political effects on health policy, of launching a public health program whose scientific basis is weak and whose administrative requirements are untested.

Humans

Evaluation and control of vaccines for the National Influenza Immunization Program.

The National Influenza Immunization Program of 1976 offered an ideal opportunity to test the capability of the system in the United States for production and distribution of maximal amounts of inactivated influenza virus vaccine of carefully regulated quality. The four licensed manufacturers were able to produce and distribute greater than 10 million doses of vaccine per week over a 14-week period. Assays showed that the quality of these vaccines was comparable to or exceeded that of vaccines produced in recent years under less stressful circumstances. Because of the extensive clinical trials conducted as part of the program, it was possible to make an unprecedented evaluation of the significance of various laboratory tests of vaccines in relation to their pertinence in prediction of immunogenicity and reactivity for humans. This experience demonstrated the superiority of immunodiffusion methods as compared with the standard chick cell-agglutination method for assay of vaccine potency. Qualitative differences in immunogenicity between whole-virus and disrupted-virus vaccines were recognized that are not measured by in vitro potency tests. The results also indicated that influenza viral components are responsible for most febrile reactions to the vaccine.

Evaluation Studies as Topic

Door-to-door canvassing for immunization program acceleration in Mozambique: achievements and costs.

The Expanded Program on Immunization has made remarkable progress in raising coverage in developing countries. Countries have been urged to accelerate their programs, especially in urban areas. In Mozambique, as part of program acceleration, volunteers from grassroots organizations conducted door-to-door canvassing for the Program. Concurrently, the availability of immunization was increased in health centers and in outreach visits. By 1987, over 90 percent coverage for all vaccines was achieved in the capital, Maputo; two other cities doubled their immunization coverage to over 50 percent fully immunized children, and rural areas of the pilot province achieved 60 percent coverage. Immunization costs were estimated in one city as $6.9 (U.S. dollars) per fully vaccinated child. Door-to-door canvassing accounted for more than 40 percent of personnel costs, and may have diverted attention from the quality of service in the health centers. In this article we outline the achievements and costs of door-to-door canvassing and discuss other strategies to raise coverage. The analysis of the need to balance the mobilization of demand with the capacity to respond is relevant to other countries in their efforts to develop sustainable immunization services.

Cost-Benefit Analysis

Proposed calfhood immunization program for the commercial dairy herd.

Immunization programs never will usurp the central role of sound management practices and good nutrition in the disease prevention program of the commercial dairy operation. However, certain immunizations against diseases such as brucellosis, leptospirosis, and clostridial infections should be routine. Other diseases such as infectious bovine rhinotracheitis, bovine virus diarrhea, parainfluenza-3, colibacillosis, and pasteurellosis should be considered if it can be determined that the herd is infected chronically. The present knowledge of other disease conditions, vaccine effectiveness and safety makes the use of vaccines for other diseases of questionable value.

Animals

Tetanus and diphtheria antitoxin levels following a hospital-based adult immunization program.

A hospital-based program to immunize adults against tetanus unless specific contraindications to immunization are present has been in effect at Parkland Memorial Hospital since 1959. Adsorbed tetanus toxoid was used from 1959 to 1970, and was replaced at that time by adult type adsorbed combined tetanus/diphtheria toxoid. In the present survey, the titers of diphtheria and tetanus antitoxins were determined in sera from 97 adults admitted to the Medical Service. Titers of diphtheria antitoxin less than 0.0125 units per ml were found in only seven patients and less than 0.0125 units per ml of tetanus antitoxin in only 17 patients. This high prevalence of immunity especially to tetanus appears to reflect our practice of routine immunization of adults. Although the recommended frequency of tetanus boosters has recently been reduced for adults who have completed a full primary immunization series, susceptibility to diphtheria or tetanus or both is not uncommon among adults in the US. Unless contraindications are present, we therefore urge routine immunization of all adults seeking medical care and of all hospital personnel as a means of diminishing the risk of diphtheria and tetanus in those adult populations with a significant incidence of susceptibility to these diseases.

Adolescent

Immunization programs and human immunodeficiency virus.

The emergence of human immunodeficiency virus (HIV) in epidemic form has implications for immunization programs. Infection with HIV, which is capable of infecting cells of the immune system and which can remain latent for many years, results in profound and progressive immunosuppression. As a consequence, vaccines may not elicit a protective response from HIV-infected individuals. Stimulation of the immune system may also be a cofactor for the progression of infection to AIDS, since stimulated lymphocytes are needed for the replication of HIV. HIV-positive individuals may also react differently to vaccines than do uninfected persons. The standard vaccines in use today are extremely safe. The possibility that the excellent safety profile of vaccines may be altered in HIV-positive patients must be considered. Since this virus can be transmitted through exposure to blood and blood products, mass immunization programs must take steps to minimize the possibility of accidental transmission of infection during a mass vaccination program. Finally, the problems and prospect for the testing and use of vaccines to prevent HIV are discussed.

Acquired Immunodeficiency Syndrome

The national immunization program of The Netherlands.

After a brief explanation of the immunization policy in the Netherlands, the national immunization program is described, with special attention given to coupling of the municipal population records with a computerized database of individual immunization records at the provincial level. The Dutch program achieves coverage rates greater than 90% for all routine immunizations. Participation in the program is free of charge to every child living in the country up to the age of 13 years, but there is no obligation or requirement to be immunized. Financing of the program is also discussed.

Adolescent

Crash of the immunization program: consequences of a totalitarian approach.

India's Universal Immunization Program, which was to cover a population of more than 90 million pregnant mothers and 83 million infants living in more than 575,000 villages during 1986-90, has failed dismally. The coverage has been less than one-fifth of the requirement in more than half of the population. The situation in most third world countries, which have even weaker political clout and weaker health service infrastructures, is even more catastrophic. From a purely public health standpoint, the disaster was inevitable. No efforts were made even to define the problem of the six immunizable diseases; there was no question of understanding their natural history; the efficacy of the vaccines used was not well-known; the cold chain, which is meant to retain the potency of the vaccines at the time of inoculation, frequently broke down; there was confusion about the dosage; and even where the program is most successful, ecological conditions will erode much of the benefits from immunization. That such a technocentric program was imposed on the peoples of the third world by their governments was bad enough; even more frightening is that these countries were persuaded to follow the line developed in affluent countries by influential agencies such as UNICEF, WHO, the World Bank, the Rockefeller Foundation, and Rotary International. This is an awe-inspiring manifestation of the power of the affluent countries to impose their will on the weak and helpless peoples of the world. It is a bitter irony that UNICEF and WHO, which sponsored the famous global conference at Alma-Ata, should have lent their weight to a program that is the very antithesis of the Declaration. To embark on such a venture, the exponents had to ignore weighty scientific evidence that raised serious doubts about the program. They had to stoop to suppression of information, disinformation, and distortion of information. What is even worse, efforts will be made to erase this experience from memory, and similar efforts will again be made to launch such ill-conceived programs in the name of the welfare of the oppressed peoples of the world. Scholars who have concern for the oppressed must remain vigilant.

Female

Influenza immunization program in long term care facilities.

Infection control, nursing and occupational health at St Mary's Hospital and Marian Villa Home for the Aged collaborated to develop, present and evaluate a successful influenza immunization program for patients, residents and staff. The methods used may be applied to any health care facility for a major immunization program. The success of the program can be attributed to the enthusiastic efforts of all three departments and a dedicated task force.

Aged

Managing public health risks: the swine flu immunization program revisited.

In this Comment, the Massachusetts Commissioner of Public Health views the federal government's 1976-77 Swine Flu Immunization Program, which was sharply criticized by Dr. Cyril Wecht in a recent Article in this journal, as a classic example of a public policy decision made under conditions of stress and uncertainty. Once the responsible government officials had made a public commitment to immunize the entire populace of the United States, he contends, they found it very difficult to reformulate the program in response to changing information concerning its relative costs and benefits. Dr Fielding offers suggestions for avoiding in the future some of the problems that surrounded the Swine Flu Program and for preventing further erosion of public confidence in essential preventive medicine programs.

Decision Making

The swine flu immunization program: scientific venture or political folly?

The author of this Article, an internationally recognized coroner perhaps best known among laymen for his incisive and tenacious criticism of the Warren Commission report on the Kennedy assassination, turns his attention to the federal government's 1976--1977 Swine Flu Immunization Program. Dr. Wecht contends that although this program may have been viewed by its key proponents as having great public health importance, or perhaps even political value, its creation and continuation nevertheless were scientifically unjustified. Furthermore, he contends, the federal government failed to inform the public adequately of important facts about the program's origins and progress, and it mismanaged the program in several important respects. Among the topics he discusses are swine flu's epidemiological history (including the 1976 Fort Dix outbreak that propelled swine flu into the national consciousness); the key elements leading to the government's decision to immunize; the government's failure to reevaluate the program seriously as problems arose; the shortcomings of the federal swine flu statute; the inadequacy of the government's investigation of the deaths of three persons in Pittsburgh within a few hours after being vaccinated (a matter that was of immediate concern to the author in his role as Coroner of Allegheny County, Pennsylvania); the long-delayed termination of the program following the emergence of a possible statistical link between the immunizations and an increase in the incidence of the Guillain-Barré Syndrome; the financial and human costs of the program; and the need for calmer, more objective decision making in future situations where immunization of the general populace is being considered.

Centers for Disease Control and Prevention, U.S.

Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976--1977.

Because of an increase in the number of reports of Guillian-Barre syndrome (GBS) following A/New Jersey influenza vaccination, the National Influenza Immunization Program was suspended December 16, 1976 and nationwide surveillance for GBS was begun. This surveillance uncovered a total of 1098 patients with onset of GBS from October 1, 1976, to January 31, 1977, from all 50 states, District of Columbia, and Puerto Rico. A total of 532 patients had recently received an A/New Jersey influenza vaccination prior to their onset of GBS (vaccinated cases), and 15 patients received a vaccination after their onset of GBS. Five hundred forty-three patients had not been recently vaccinated with A/New Jersey influenza vaccine and the vaccination status for 8 was unknown. Epidemiologic evidence indicated that many cases of GBS were related to vaccination. When compared to the unvaccinated population, the vaccinated population had a significantly elevated attack rate in every adult age group. The estimated attributable risk of vaccine-related GBS in the adult population was just under one case per 100,000 vaccinations. The period of increased risk was concentrated primarily within the 5-week period after vaccination, although it lasted for approximately 9 or 10 weeks.

Adolescent

Evidence for reinstatement of infants 12 to 14 months of age into routine measles immunization programs.

The hemagglutination inhibition (HI) serologic responses of 851 measles-susceptible infants and children to the live, further-attenuated measles virus vaccine were evaluated over a ten-year period. The response by age at 23-day intervals was determined. Infants inoculated at 12 through 14 months of age demonstrated seroconversion rates by HI assay comparable to those in infants and children inoculated at 15 months of age or older. This finding does not support the recent recommendation that routine active immunization with measles vaccine should be postponed until 15 months of age. We emphasize the possible consequence of electively leaving infants 12 throught 14 months of age vulnerable to measles because of the current endemicity of this disease in the United States. We also present evidence for the reinstatement of infants 12 through 14 months of age into routine measles immunization programs and for the need to further evaluate the causes for vaccine failure in vaccines after the loss of maternal antibody.

Antibody Formation

The epidemiology of measles in a partially vaccinated population in an African city: implications for immunization programs.

A large outbreak of measles was reported in Pointe-Noire, Congo, between October 1984 and March 1985. An investigation was conducted to determine the epidemiology of measles in this community in which, in 1985, 54% of the children 12-23 months of age had documented evidence of vaccination against measles. The investigation included hospital and clinic record reviews and a community survey. Measles has been continuously transmitted in Pointe-Noire since at least 1979, with seasonal epidemics. In early 1984, the expected epidemic did not occur, and at least 1,000 measles hospital admissions and 100 measles deaths were prevented. Between October 1984 and March 1985, 1,942 measles cases were hospitalized, of which 306 (15.8%) died. During the epidemic, the proportion of nonpreventable cases (cases occurring before nine months of age) was 17%, reflecting the change in age distribution of measles cases in childhood since the immunization program started in Pointe-Noire in 1982. From the community survey, it was estimated that 13% of all children under age five years acquired measles in Pointe-Noire in 1985. Vaccine efficacy was calculated from community and hospital samples to be between 78% and 87%. Our findings suggest that increasing vaccination coverage levels to well above 50% is necessary to substantially reduce measles morbidity and mortality in African cities.

Child