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Background Assessments of vaccine efficacy and safety capture only the minimum information needed for regulatory approval, rather than the full public health value of vaccines. Vaccine efficacy provides a measure of proportionate disease reduction, is usually limited to etiologically confirmed disease, and focuses on the direct protection of the vaccinated individual. Herein, we propose a broader scope of methods, measures and outcomes to evaluate the effectiveness and public health impact to be considered for evidence-informed policymaking in both pre- and post-licensure stages. Discussion Pre-licensure: Regulatory concerns dictate an individually randomised clinical trial. However, some circumstances (such as the West African Ebola epidemic) may require novel designs that could be considered valid for licensure by regulatory agencies. In addition, protocol-defined analytic plans for these studies should include clinical as well as etiologically confirmed endpoints (e.g. all cause hospitalisations, pneumonias, acute gastroenteritis and others as appropriate to the vaccine target), and should include vaccine-preventable disease incidence and ‘number needed to vaccinate’ as outcomes. Post-licensure: There is a central role for phase IV cluster randomised clinical trials that allows for estimation of population-level vaccine impact, including indirect, total and overall effects. Dynamic models should be prioritised over static models as the constant force of infection assumed in static models will usually underestimate the effectiveness and cost-effectiveness of the immunisation programme by underestimating indirect effects. The economic impact of vaccinations should incorporate health and non-health benefits of vaccination in both the vaccinated and unvaccinated populations, thus allowing for estimation of the net social value of vaccination. Conclusions The full benefits of vaccination reach beyond direct prevention of etiologically confirmed disease and often extend across the life course of a vaccinated person, prevent outcomes in the wider community, stabilise health systems, promote health equity, and benefit local and national economies. The degree to which vaccinations provide broad public health benefits is stronger than for other preventive and curative interventions.

For many individuals from developing countries, infection with Mycobacterium tuberculosis is almost inevitable. In recent years, there has been an increase in the number of immigrants and refugees from some of these countries, and thus the proportion of these individuals among newly diagnosed cases of tuberculosis has increased. The identification of these patients and the proper management of their cases are important public health priorities. Dr. Nancy Binkin and her colleagues review the data on the epidemiology of tuberculosis in immigrants and refugees and describe the available screening and evaluation programs overseas and in this country. They also highlight the importance of maintaining and expanding health care services in this country that are appropriate and welcoming to foreign-born persons. They clearly demonstrate that the control of tuberculosis in the United States will require a coordinated effort that transcends its borders. —Wafaa El-Sadr Division of Infectious Diseases, Harlem Hospital Center, New York, New York Chair, IDSA Tuberculosis Committee The number of reported cases of tuberculosis (TB) in foreign-born persons in the United States during 1995 was 8,042, 36% of the national total. The overseas screening of immigrants and refugee visa applicants, which relies on a chest radiograph and smear microscopy, is designed to identify future U.S. residents who have active TB or who are at high risk for TB. In this commentary, we summarize current policies and review retrospective evaluations of the screening system currently in place. The system appears to detect most persons who have active TB at the time of screening. However, active TB is actually diagnosed in <15% of persons who are identified by screening as having suspected TB and who are evaluated in the United States. To improve the system, more sensitive and specific techniques as well as improved means of data transmission to state and local health departments are needed.

To assess the impact of the National Immunization Days (NIDs) on measles vaccine coverage in Burkina Faso in 1998. During the week after the campaign, in which measles vaccine was offered to children aged 9-59 months in six cities regardless of vaccination history, a cluster survey was conducted in Ouagadougou and Bobo Dioulasso, the country's two largest cities. Interviewers visited the parents of 1267 children aged up to 59 months and examined vaccination cards. We analysed the data using cluster sample methodology for the 1041 children who were aged 9-59 months. A total of 604 (57%) children had received routine measles vaccination prior to the campaign, and 823 (79%) were vaccinated during the NIDs. Among those who had previously had a routine vaccination, 484 (81%) were revaccinated during the NIDs. Among those not previously vaccinated, 339 (78%) received one dose during the NIDs. After the campaign, 943 (91%) children had received at least one dose of measles vaccine. Better socioeconomic status was associated with a higher chance of having been vaccinated routinely, but it was not associated with NID coverage. The mass campaign enabled a substantial increase in measles vaccine coverage to be made because it reached a high proportion of children who were difficult to reach through routine methods.

Acute flaccid paralysis (AFP) surveillance data from India were analysed to examine sensitivity of poliovirus isolation from stool specimens and the added sensitivity obtained from collection of a second stool specimen. Analysis was restricted to Indian AFP cases, 1998–2000, with two adequate stool specimens. The proportion of cases confirmed with wild poliovirus isolation by the second specimen only was calculated, regardless of specimen quality. Overall specimen sensitivity (1998–2000) was 81% using the first specimen, 78% using the second, and 96% using both. Sensitivity increased from 1998 to 2000, with slightly higher sensitivity each year for the first specimen. The second specimen increased sensitivity by 15% overall and contributed more when the first specimen was collected late or was in poor condition. As wild poliovirus disappears, increased sensitivity provided by a second stool specimen may reduce the risk of missing circulating virus.

Major vaccine safety controversies have arisen in several countries beginning in the last decades of 20th century. Such periodic vaccine safety controversies are unlikely to go away in the near future as more national immunization programs mature with near elimination of target vaccine-preventable diseases that result in relative greater prominence of adverse events following immunizations, both true reactions and temporally coincidental events. There are several ways in which vaccine safety capacity can be improved to potentially mitigate the impact of future vaccine safety controversies. This paper aims to take a “lifecycle” approach, examining some potential pre- and post-licensure opportunities to improve vaccine safety, in both developed (specifically U.S. and Europe) and low- and middle-income countries.

•There is improved global vaccine safety surveillance and investigative capacity.•As a result, rare but severe vaccine reactions are documented, including in resource limited settings.•Several countries with mature immunization systems have developed no-fault compensation programmes.•In recent years a few low- and middle-income countries have established such compensation programmes. Improvements in vaccine safety surveillance and investigative capacity lead to identification of rare reactions attributable to vaccination. As a result, the issue of fair compensation for those who experience vaccine injuries is gaining growing attention. Although vaccine injury compensation programmes (VICP) have been developed in a few countries for more than 50 years, no global policy guidance to guide vaccine injury compensation in all countries wishing to adopt such compensation schemes is currently available. To update the landscape analysis of no-fault compensation programmes and characterize VICP implementing countries, we conducted a survey of all 194 Member States from the World Health Organization and received feedback from 151. This analysis describes the economic and vaccine safety surveillance characteristics of Member States implementing VICPs. This analysis describes the characteristics of 25 Member States implementing a compensation programmes. Characteristics examined include economic, vaccination and safety surveillance indicators. Twenty of the 25 Member States (80%) with compensation programmes are categorized as high-income countries, 20/25 (80%) met the Global Vaccine Action Plan (GVAP) safety indicator of reporting at least ten annual reports of adverse events following immunization per 100,000 population, 21/25 (84%) met the GVAP coverage indicator by achieving greater than 90% third dose of Diphtheria, Tetanus and Pertussis vaccine (DTP3) and 17/25 (68%) assessed vaccine hesitancy in 2017. All Member States with VICP have a national immunization technical advisory group. This study identified growing interest in the implementation of no-fault compensation programs beyond high-income countries. Global policies guiding compensation should be developed for countries regardless of the maturity of their immunization programmes. As a result of improved vaccine safety surveillance, World Health Organization (WHO) Member States are facing situations where known untoward serious vaccine reactions are documented, including in low- and middle-income settings. This has led to increased interest for the development of national no-fault compensation policies for vaccine injuries. As of 2010, compensation schemes for vaccine related injuries had been identified and characterized in 19 out of 194 WHO member states. All these programmes were in the industrialized world with none in low- and middle-income countries. Previous reviews have described the characteristics of the existing programmes based on the six common elements identified by Evans in 1999 with less emphasis on characteristics from countries implementing these no-fault compensation programmes. This manuscript aimed to identify predictors of countries implementing no-fault compensation programmes for vaccine injuries and update the inventory of existing programmes as part of a more comprehensive global landscape evaluation of existing programmes. This information will be useful for country self-evaluation and future compensation policy formulation as discussion to develop policies guiding the implementation of vaccine injury compensation continues to gain growing attention.

Large-scale immunization programmes now extend to all parts of the world, including least developed countries, where they reach unprecedented numbers of people. The number of vaccine doses administered worldwide continues to increase as new vaccines are developed and made available, and more people have access to immunization services. Development of immunization programmes in low- and middle-income countries (LMIC) has increased immunization coverage, which in turn has led to a reduction in vaccine-preventable diseases. However, as vaccine use has increased in LMICs, so has public attention to vaccine safety issues, as happened previously in high-income countries. The Decade of Vaccines aims to increase coordination within the vaccine community worldwide. The Global Vaccine Action Plan includes a vaccine safety strategy, the Global Vaccine Safety Blueprint. Capacity development at country level is the main guiding principle of the Global Vaccine Safety Initiative. The initiative is aligned with other related WHO capacity-building efforts, including the strengthening of immunization programmes and national regulatory authorities.

Tetanus cases that occurred in Switzerland between 1980 and 1989 have been reviewed with the help of three data surveillance systems: a) morbidity data from the Federal Office of Public Health (FOPH), b) mortality data from the Swiss Federal Statistical Office (SFSO), and c) data from the Association of Swiss Hospitals and Clinics (VESKA), completed by a written enquiry to clinics which did not (or only partly) participate in the VESKA system during the study period. For every case, a questionnaire was sent to the clinic to verify the diagnosis and to obtain additional information on the circumstances of occurrence. Ninety-one cases were identified. This corresponds to a yearly incidence of 1.93 per million population between 1980-84 and 0.88 for the 1985-89 period (p < 0.01). Eighty-one percent of the cases were older than 50 years of age and women were significantly more frequently affected than men. None of the cases identified had a documented primary immunization series. Data available at the FOPH and SFSO level have been compared to data obtained through the VESKA system using the Chandra Sekhar and Deming method. It is estimated that 134 tetanus cases (95% CI: 91-197) have occurred in Switzerland between 1980 and 1989, together with 28 deaths (95% CI: 27-31). Based on these estimates, FOPH appears to detect only 6-13% of tetanus cases occurring in Switzerland. By contrast, SFSO had fairly consistent data for 81-100% of tetanus associated deaths. The low rate of tetanus reported by physicians necessitates a sustained effort to increase the understanding of epidemiological surveillance by Swiss practitioners.

Objective: To examine the characteristics of foreign-born people with tuberculosis (TB) in Southern Florida, their contribution to the total number of TB cases, and available data on their HIV status as well as to determine the number of cases detected by the overseas medical screening of immigrants and refugees. Methods: The authors reviewed TB cases reported by Broward, Dade, and Palm Beach counties in 1995. Case records were matched against the CDC Division of Quarantine database of immigrants and refugees suspected to have TB at the time of visa application overseas. Results: Nearly half (49%) of TB cases in the three counties were among people born outside the United States--34% in Broward County, 58% in Dade County, and 40% in Palm Beach County. A high percentage (26%) were co-infected with HIV. Of those with known date of arrival, 68% had been in the United States for five or more years. Only three cases had been identified by overseas immigrant screening. Conclusions: A low percentage of TB cases in foreign-born people were identified through the overseas screening system. Controlling TB in South Florida will require efforts targeted toward high risk populations, including people with HIV infection.