A review of China's compensation program for adverse reactions following immunization.

Vaccination is a compelling measure to battle infectious diseases and protect public health. However, because of the constraints on human cognition, it is difficult to ensure that vaccines are safe. Adverse reactions to immunization can cause individual injury. In numerous countries, no-fault programs have been established to compensate individuals for vaccine-related injuries. China also established a vaccine injury compensation system with its own unique characteristics. The Vaccine Administration Law was promulgated in 2019 to establish a compensation system for those who experience adverse reactions following immunization; nevertheless, the compensation system is imperfect. Even when the applicable terms are applied to deal with vaccine-related injuries, some issues remain, such as unreasonable diagnosis and evaluation procedures for adverse reactions, excessively strict standards regarding proof and inconsistent compensation standards across the country. Therefore, to provide effective compensation for vaccine recipients, it is important to clarify the standards of proof and establish a sensible vaccine injury compensation system that includes Corona Virus Disease 2019 vaccine-injury compensation.

Assessing National Public Health Law to Prevent Infectious Disease Outbreaks: Immunization Law as a Basis for Global Health Security.

Immunization plays a crucial role in global health security, preventing public health emergencies of international concern and protecting individuals from infectious disease outbreaks, yet these critical public health benefits are dependent on immunization law. Where public health law has become central to preventing, detecting, and responding to infectious disease, public health law reform is seen as necessary to implement the Global Health Security Agenda (GHSA). This article examines national immunization laws as a basis to implement the GHSA and promote the public's health, analyzing the scope and content of these laws to prevent infectious disease across Sub-Saharan Africa. Undertaking policy surveillance of national immunization laws in 20 Sub-Saharan African countries, this study: (1) developed a legal framework to map the legal attributes relevant to immunization; (2) created an assessment tool to determine the presence of these attributes under national immunization law; and (3) applied this assessment tool to code national legal landscapes. An analysis of these coded laws highlights legal attributes that govern vaccine requirements, supply chains, vaccine administration standards, and medicines quality and manufacturer liability. Based upon this international policy surveillance, it will be crucial to undertake legal epidemiology research across countries, examining the influence of immunization law on vaccination rates and disease outbreaks.

Chile's National Advisory Committee on Immunization (CAVEI): Evidence-based recommendations for public policy decision-making on vaccines and immunization.

A National Immunization Technical Advisory Group (NITAG) provides independent, evidence-based recommendations to the Ministry of Health for immunization programmes and policy formulation. In this article, we describe the structure, functioning and work processes of Chile's NITAG (CAVEI) and assess its functionality, quality of work processes and outputs, and integration of the committee into the Ministry of Health policy process using the Assessment tool for National Immunization Technical Advisory Groups. Among its strengths, CAVEI's administrative and work plasticity allows it to respond in a timely manner to the Ministry of Health's requests and proactively raise subjects for review. Representation of multiple areas of expertise within the committee makes CAVEI a robust and balanced entity for the development of evidence-based comprehensive recommendations. High ranking profile of the Secretariat structure furthers CAVEI's competences in policymaking and serves as a bridge between the committee and international initiatives in the field of immunizations.

Immunisation of migrants in EU/EEA countries: Policies and practices.

In recent years various EU/EEA countries have experienced an influx of migrants from low and middle-income countries. In 2018, the "Vaccine European New Integrated Collaboration Effort (VENICE)" survey group conducted a survey among 30 EU/EEA countries to investigate immunisation policies and practices targeting irregular migrants, refugees and asylum seekers (later called "migrants" in this report). Twenty-nine countries participated in the survey. Twenty-eight countries reported having national policies targeting children/adolescent and adult migrants, however vaccinations offered to adult migrants are limited to specific conditions in seven countries. All the vaccinations included in the National Immunisation Programme (NIP) are offered to children/adolescents in 27/28 countries and to adults in 13/28 countries. In the 15 countries offering only certain vaccinations to adults, priority is given to diphtheria-tetanus, measles-mumps-rubella and polio vaccinations. Information about the vaccines given to child/adolescent migrants is recorded in 22 countries and to adult migrants in 19 countries with a large variation in recording methods found across countries. Individual and aggregated data are reportedly not shared with other centres/institutions in 13 and 15 countries, respectively. Twenty countries reported not collecting data on vaccination uptake among migrants; only three countries have these data at the national level. Procedures to guarantee migrants' access to vaccinations at the community level are available in 13 countries. In conclusion, although diversified, strategies for migrant vaccination are in place in all countries except for one, and the strategies are generally in line with international recommendations. Efforts are needed to strengthen partnerships and implement initiatives across countries of origin, transit and destination to develop and better share documentation in order to guarantee a completion of vaccination series and to avoid unnecessary re-vaccination. Development of migrant-friendly strategies to facilitate migrants' access to vaccination and collection of vaccination uptake data among migrants is needed to meet existing gaps.

Supporting national immunization technical advisory groups (NITAGs) in resource-constrained settings. New strategies and lessons learned from the Task Force for Global Health's Partnership for influenza vaccine introduction.

National Immunization Technical Advisory Groups (NITAGs) are multidisciplinary national experts who provide independent, evidence-informed vaccine policy recommendations to national health authorities. An essential NITAG function is to ensure that these decisions are grounded in the best available evidence generated through a systematic, transparent process. However, in many low- and middle-income countries (LMICs), experience with this decision making method is limited. The Task Force for Global Health manages the Partnership for Influenza Vaccine Introduction (PIVI) program in collaboration with the Centers for Disease Control and Prevention, Ministries of Health, corporate partners and others. During 2017, PIVI worked with its country partners and the World Health Organization regional and local offices to assess NITAG strengthening needs and to provide technical assistance in 7 LMIC countries (Laos Peoples Democratic Republic, Mongolia, Vietnam, Armenia, Côte d'Ivoire; Moldova and the Republic of Georgia). Our workshops supported general NITAG capacity building and the evidence-based review process using vaccines of interest to the country. For NITAGs reviewing evidence on seasonal influenza, we developed an influenza resource package to support their review and provide country-relevant information in an easy to use format. Of the seven NITAGs trained, six have applied some of the concepts learnt: revision or development of formal transparent, systematic procedures for their operations; preparation of recommendations on seasonal influenza vaccination using quality-assessed data from systematic searches and local data; and have applied the principles learned for making other new vaccine recommendations. Our experience confirms that LMIC NITAGs are considerably under-resourced without adequate technical support or access to global peer-reviewed literature. Ongoing support from NITAG partners must be secured and creative approaches might be needed to help countries achieve the GVAP 2020 target and support development of sustainable vaccine policies and programs.

Elimination of Nonmedical Immunization Exemptions in California and School-Entry Vaccine Status.

BACKGROUND AND OBJECTIVES: California implemented Senate Bill 277 (SB277) in 2016, becoming the first state in nearly 30 years to eliminate nonmedical exemptions from immunization requirements for schoolchildren. Our objectives were to determine (1) the impacts of SB277 on the percentage of kindergarteners entering school not up-to-date on vaccinations and (2) if geographic patterns of vaccine refusal persisted after the implementation of the new law. METHODS: At the state level, we analyzed the magnitude and composition of the population of kindergarteners not up-to-date on vaccinations before and after the implementation of SB277. We assessed correlations between previous geographic patterns of nonmedical exemptions and patterns of the remaining entry mechanisms for kindergarteners not up-to-date after the law's implementation. RESULTS: In the first year after SB277 was implemented, the percentage of kindergartners entering school not up-to-date on vaccinations decreased from 7.15% to 4.42%. The conditional entrance rate fell from 4.43% to 1.91%, accounting for much of this decrease. Other entry mechanisms for students not up-to-date, including medical exemptions and exemptions for independent study or homeschooled students, largely replaced the decrease in the personal belief exemption rate from 2.37% to 0.56%. In the second year, the percentage of kindergartners not up-to-date increased by 0.45%, despite additional reductions in conditional entrants and personal belief exemptions. The correlational analysis revealed that previous geographic patterns of vaccine refusal persisted after the law's implementation. CONCLUSIONS: Although the percentage of incoming kindergarteners up-to-date on vaccinations in California increased after the implementation of SB277, we found evidence for a replacement effect.

Characteristics of immunized and un-immunized students, including non-medical exemptions, in Ontario, Canada: 2016-2017 school year.

BACKGROUND: Our objectives were: (1) to quantify and describe un-immunized students in Ontario, Canada and assess the extent to which these students have exemptions; and (2) to quantify and describe students with non-medical exemptions (NMEs), including what proportion have up-to-date immunizations. METHODS: We examined Ontario students 7 to 17 years-of-age in the 2016-2017 school year using information within a centralized immunization repository. We identified and described students with different immunization/exemption classifications by age, sex, school type, geography and area-level material deprivation using descriptive and multivariable logistic regression analyses. Finally, we assessed the immunization status of students with NMEs, by antigen. RESULTS: We found that students could be recorded as un-immunized with or without an NME, or be immunized with an NME. From a cohort of 1.65 million students, 2.9% of students had zero vaccine doses recorded, and of these 68% had no exemption of any kind. A total of 2.4% of students had an NME. Of these, 39% were un-immunized and 61% had received ≥1 vaccine. Among all students with NMEs, 19-48% had up-to-date immunizations, varying by antigen. Factors associated with increased odds of having a NME and being un-immunized included: attendance at private and 'other' schools, rural residence, and geography. Older age and greater area-level deprivation were associated with a reduced odds. CONCLUSIONS: Our assessment revealed that Ontario students with NMEs cannot be assumed to be un-immunized and at risk for all vaccine-preventable diseases. Conversely, not all un-immunized students had NMEs suggesting that future studies of un-immunized children in Ontario must consider additional factors beyond NME status alone. Other jurisdictions that use NME data to inform research and surveillance of vaccine hesitancy and risks for VPD outbreaks may wish to undertake a similar assessment to determine how well student NMEs correlate with student immunization status.

Catching up with catch-up: a policy analysis of immunisation for refugees and asylum seekers in Victoria.

This study examines catch-up immunisation for people of refugee-like background in Victoria, exploring effective models of service delivery to complete catch-up vaccinations. The analysis is based on: (i) review of the medical literature, Commonwealth and Victorian government immunisation policy and immunisation patient information; (ii) review of vaccination coverage and service delivery data; and (iii) stakeholder interviews completed in 2014 with 45 people from 34 agencies, including 9 local government areas in Victoria. Although refugees and asylum seekers all need catch-up vaccinations on arrival, they face significant barriers to completing immunisation in Australia. Analysis suggests missed opportunities by service providers and perceptions that catch-up vaccination is time-consuming, difficult and resource-intensive. Service delivery is fragmented across primary care and local government, and pathways depend on age, location and healthcare access. There are strengths, but also limitations in all current service delivery models. Gaps in vaccine funding for refugee-like populations have now been addressed through Commonwealth initiatives, however migration is still not well considered in immunisation policy, and existing systems for notification payments do not capture catch-up vaccination for these groups. Providers identify areas for improvement in professional development and support, patient information, patient-held records and immunisation surveillance data.

Conflicts of interest and the (in)dependence of experts advising government on immunization policies.

There has been increasing attention to financial conflicts of interest (COI) in public health research and policy making, with concerns that some decisions are not in the public interest. One notable problematic area is expert advisory committee (EAC). While COI management has focused on disclosure, it could go further and assess experts' degree of (in)dependence with commercial interests. We analyzed COI disclosures of members of Québec's immunization EAC (in Canada) using (In)DepScale, a tool we developed for assessing experts' level of (in)dependence. We found great variability of independence with industry and that companies with the highest vaccine sales were predominantly associated with disclosed COIs. We argue that EACs can use the (In)DepScale to better assess and disclose the COIs that affect their experts. Going forward our scale could help manage risk and select members who are less conflicted to foster a culture of transparency and trust in advisors and policy-makers.

Preferences for health economics presentations among vaccine policymakers and researchers.

PURPOSE: Measure the preferences of decision makers and researchers associated with the Advisory Committee on Immunization Practices (ACIP) regarding the recommended format for presenting health economics studies to the ACIP. METHODS: We conducted key informant interviews and an online survey of current ACIP work group members, and current and previous ACIP voting members, liaison representatives, and ex-officio members to understand preferences for health economics presentations. These preferences included the presentation of results and sensitivity analyses, the role of health economics studies in decision making, and strategies to improve guidelines for presenting health economics studies. Best-worst scaling was used to measure the relative value of seven attributes of health economics presentations in vaccine decision making. RESULTS: The best-worst scaling survey had a response rate of 51% (n = 93). Results showed that summary results were the most important attribute for decision making (mean importance score: 0.69) and intermediate outcomes and disaggregated results were least important (mean importance score: -0.71). Respondents without previous health economics experience assigned sensitivity analysis lower importance and relationship of the results to other studies higher importance than the experienced group (sensitivity analysis scores: -0.15 vs. 0.15 respectively; relationship of the results: 0.13 vs. -0.12 respectively). Key informant interviews identified areas for improvement to include additional information on the quality of the analysis and increased role for liaisons familiar with health economics. CONCLUSION: Additional specificity in health economics presentations could allow for more effective presentations of evidence for vaccine decision making.

The impact of pharmacy-based immunization services on the likelihood of immunization in the United States.

OBJECTIVES: A major policy to increase immunization rates against infectious diseases in the United States has included pharmacy-based immunization services. We aimed to determine the impact of pharmacy-based immunization services on the likelihood of adult influenza and pneumococcal immunization. DESIGN: National individual-level immunization data were merged with pharmacy-level data on the availability of immunization services for 8466 pharmacies from a national pharmacy chain. County-level variation in availability of vaccines from 2006 to 2010 was used to characterize exposure to immunization services. We used a longitudinal logistic regression model to estimate the impact of pharmacy-based immunization services on the outcomes of interest. SETTING AND PARTICIPANTS: We conducted the main analysis in the U.S. adult population. We conducted subgroup analyses of high-risk populations, including people 65 years of age or older. OUTCOME MEASURES: Odds of being immunized for influenza or pneumococcal disease after exposure to the service compared with before the service while controlling for existing trends in immunization rate growth and other confounders. RESULTS: Each additional year of exposure to pharmacy-based immunization services was associated with a 1.023 (CI 1.012-1.034) greater odds of reporting an influenza immunization and a 1.016 (CI 1.006-1.027) greater odds of reporting a pneumococcal immunization. Five years after national implementation, we estimate that 6.2 million additional influenza immunizations and 3.5 million additional pneumococcal immunizations are attributable to pharmacy-delivered immunization services each year. Subgroup analyses further indicate that the policy increased the odds of immunization for both diseases over time among adults 65 years of age or older (influenza odds ratio [OR] 1.025, CI 1.013-1.038; and pneumococcal OR 1.026, CI 1.010-1.042). CONCLUSION: Pharmacy-based immunization services increased the likelihood of immunization for influenza and pneumococcal diseases, resulting in millions of additional immunizations in the United States.

Measles and rubella eradication.

This article discusses concepts of eradication, some issues relating to vertical and horizontal public health programs, some current issues relating to measles and rubella, and what we need to do about them. It concludes that measles and rubella/CRS can and should be eradicated. A target date should be established in 2020 (or before). Eradication can only be accomplished in the context of strengthening ongoing immunization services and strengthening surveillance so it can guide activities. Additional resources will be required to achieve the goal.

FDA licensure of and ACIP recommendations for vaccines.

Many healthcare providers are not familiar with the Food and Drug Administration (FDA) vaccine licensure process, the Advisory Committee on Immunization Practices (ACIP) vaccine recommendation process, and how FDA vaccine licensure and ACIP recommendations are related. Vaccines for use in the United States military and civilian populations are licensed by the FDA by several potential pathways but use of licensed vaccines in the civilian population should be based on recommendations made by the ACIP. In performing these distinct activities, FDA and ACIP function under different mandates. In this article, we discuss whether the FDA licensure pathways used to approve a vaccine impacts ACIP recommendation categories for vaccines licensed from 2006 to 2016.

Immunization Strategies Targeting Newly Arrived Migrants in Non-EU Countries of the Mediterranean Basin and Black Sea.

Background: The World Health Organization recommends that host countries ensure appropriate vaccinations to refugees, asylum seekers and migrants. However, information on vaccination strategies targeting migrants in host countries is limited. Methods: In 2015-2016 we carried out a survey among national experts from governmental bodies of 15 non-EU countries of the Mediterranean and Black Sea in order to document and share national vaccination strategies targeting newly arrived migrants. Results: Four countries reported having regulations/procedures supporting the immunization of migrants at national level, one at sub-national level and three only targeting specific population groups. Eight countries offer migrant children all the vaccinations included in their national immunization schedule; three provide only selected vaccinations, mainly measles and polio vaccines. Ten and eight countries also offer selected vaccinations to adolescents and adults respectively. Eight countries provide vaccinations at the community level; seven give priority vaccines in holding centres or at entry sites. Data on administered vaccines are recorded in immunization registries in nine countries. Conclusions: Although differing among countries, indications for immunizing migrants are in place in most of them. However, we cannot infer from our findings whether those strategies are currently functioning and whether barriers to their implementation are being faced. Further studies focusing on these aspects are needed to develop concrete and targeted recommendations for action. Since migrants are moving across countries, development of on-line registries and cooperation between countries could allow keeping track of administered vaccines in order to appropriately plan immunization series and avoid unnecessary vaccinations.