Use of three summary measures of pediatric vaccination for studying the safety of the childhood immunization schedule

Background

Summary measures such as number of vaccine antigens, number of vaccines, and vaccine aluminum exposure by the 2nd birth day are directly related to parents’ concerns that children receive too many vaccines over a brief period. High correlation among summary measures could cause problems in regression models that examine their associations with outcomes.

Monitoring vaccine safety using the vaccine safety Datalink: Assessing capacity to integrate data from Immunization Information systems

BackgroundThe Vaccine Safety Datalink (VSD) uses vaccination data from electronic health records (EHR) at eight integrated health systems to monitor vaccine safety. Accurate capture of data from vaccines administered outside of the health system is critical for vaccine safety research, especially for COVID-19 vaccines, where many are administered in non-traditional settings. However, timely access and inclusion of data from Immunization Information Systems (IIS) into VSD safety assessments is not well understood.MethodsWe surveyed the eight data-contributing VSD sites to assess: 1) status of sending data to IIS; 2) status of receiving data from IIS; and 3) integration of IIS data into the site EHR. Sites reported separately for COVID-19 vaccination to capture any differences in capacity to receive and integrate data on COVID-19 vaccines versus other vaccines.ResultsAll VSD sites send data to and receive data from their state IIS. All eight sites (100%) routinely integrate IIS data for COVID-19 vaccines into VSD research studies. Six sites (75%) also routinely integrate all other vaccination data; two sites integrate data from IIS following a reconciliation process, which can result in delays to integration into VSD datasets.ConclusionsCOVID-19 vaccines are being administered in a variety of non-traditional settings, where IIS are commonly used as centralized reporting systems. All eight VSD sites receive and integrate COVID-19 vaccine data from IIS, which positions the VSD well for conducting quality assessments of vaccine safety. Efforts to improve the timely receipt of all vaccination data will improve capacity to conduct vaccine safety assessments within the VSD.     

2008年美国0～18岁人员推荐免疫程序及变化

为了适应疫苗的发展及疾病预防控制的新需求,美国计划免疫咨询委员会（ACIP）每年都对0～18岁人员免疫程序进行修订。本文介绍2008年美国0～18人员推荐免疫程序及其主要变化,从而为旅行者预防接种提供参考和借鉴。     

Challenges in comparing the safety of different vaccination schedules

As vaccine hesitancy has increased in the United States, various authors have begun proposing alternatives to the Advisory Committee on Immunization Practices’ recommended childhood immunization schedule. Because parents may believe the safety claims made by such authors, evaluations of the safety of alternative vaccination schedules are needed. However, comparing the safety of different vaccination schedules has numerous methodologic challenges. These challenges include defining vaccination history, defining safety, appropriately modeling interactions between vaccines, and appropriately handling age effects. Failure to properly address these challenges can result in biased results.     

Parent resources for early childhood vaccination: An online environmental scan

BackgroundEarly childhood vaccination is one of the most important public health interventions. However, the injections are usually painful. Clinical practice guidelines recommend using pain management strategies for infants during vaccination. Public access to online health information has increased due to the advent of internet. Parents are likely to find thousands of websites, and online video platforms of variable quality. This study aims to identify and critically appraise the quality of online parent-targeted resources concerning early childhood vaccination and determine inclusion of recommended infant pain management strategies.MethodsAn environmental scan of two main internet sources was conducted: (a) Google, (b) Social Media networks. Resources including information relating to infant vaccination and available to Canadians were included. Characteristics of resources were collected. Resource quality was evaluated using the CDC Clear Communication Index. A CDC index score of 90% and above indicates the resource is as an acceptable public communication material. Means and standard deviations were used for normally distributed data; median and interquartile range (IQR) or numbers and proportions were used for data not normally distributed or presented in categorical format.ResultsWe found 55 online resources in website format and 10 resources in video format. Overall, the mean score for the quality of resources was 60% ± 0.19. Most resources were scored as moderate to low quality (33–87%). Only 5% of material scored as acceptable quality. In terms of content, 30 (46%) resources presented information about pain management strategies during vaccination, including breastfeeding (24, 37%), holding (27, 42%), and sweet solutions (22, 34%). The remaining 35 (54%) resources made no clear statement regarding any pain management strategies during vaccination.ConclusionMost publicly accessible online parent-targeted vaccination resources were of poor quality and did not contain information related to the use of recommended pain management strategies during vaccination.     

The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety

The Vaccine Safety Datalink (VSD) is a collaborative project between the Centers for Disease Control and Prevention (CDC) and 9 health care organizations. Established in 1990, VSD is a vital resource informing policy makers and the public about the safety of vaccines used in the United States. Large linked databases are used to identify and evaluate adverse events in over 9 million individuals annually. VSD generates rapid, important safety assessments for both routine vaccinations and emergency vaccination campaigns. VSD monitors safety of seasonal influenza vaccines in near-real time, and provided essential information on the safety of influenza A (H1N1) 2009 monovalent vaccine during the recent pandemic. VSD investigators have published important studies demonstrating that childhood vaccines are not associated with autism or other developmental disabilities. VSD prioritizes evaluation of new vaccines; searches for possible unusual health events after vaccination; monitors vaccine safety in pregnant women; and has pioneered development of biostatistical research methods.     

Changes in childhood immunization decisions in the United States: Results from 2012 & 2014 National Parental Surveys

ObjectiveUnderstanding the current status of parents’ vaccine decision making is crucial to inform public policy. We sought to assess changes in vaccine decisions among parents of young children.MethodsWe conducted a web-based national poll of parents of children <7 years in 2012 and 2014. Participants reported vaccine decisions for their youngest child. We calculated survey-weighted population estimates of overall immunizations decisions, and delay/refusal rates for specific vaccines.ResultsIn 2012, 89.2% (95% CI, 87.3–90.8%) reported accepting or planning to accept all recommended non-influenza childhood vaccines, 5.5% (4.5–6.6%) reported intentionally delaying one or more, and 5.4% (4.1–6.9%) reported refusing one or more vaccines. In 2014, the acceptance, delay, and refusal rates were 90.8% (89.3–92.1%), 5.6% (4.6–6.9%), and 3.6% (2.8–4.5%), respectively. Between 2012 and 2014, intentional vaccine refusal decreased slightly among parents of older children (2–6 years) but not younger children (0–1 years). The proportion of parents working to catch up on all vaccines increased while those refusing some but not all vaccines decreased. The South experienced a significant increase in estimated acceptance (90.1–94.1%) and a significant decrease in intentional ongoing refusal (5.0–2.1%). Vaccine delay increased in the Northeast (3.2–8.8%).ConclusionsNationally, acceptance and ongoing intentional delay of recommended non-influenza childhood vaccines were stable. These findings suggest that more effort is warranted to counter persistent vaccine hesitancy, particularly at the local level. Longitudinal monitoring of immunization attitudes is also warranted to evaluate temporal shifts over time and geographically.     

Addressing personal parental values in decisions about childhood vaccination: Measure development

ObjectiveEvidence-based strategies to address vaccine hesitancy are lacking. Personal values are a measurable psychological construct that could be used to deliver personalized messages to influence vaccine hesitancy and behavior. Our objectives were to develop a valid, reliable self-report survey instrument to measure vaccine values based on the Schwartz theory of basic human values, and to test the hypothesis that vaccine values are distinct from vaccine attitudes and are related to vaccine hesitancy and behavior.MethodsParental Vaccine Values (PVV) scale items were generated using formative qualitative research and expert input, yielding 24 items for testing. 295 parents of children aged 14–30 months completed a self-report survey with measures of Schwartz’s global values, the PVV, vaccine attitudes, and vaccine hesitancy. Factor analysis was used to determine vaccine values factor structure. Associations between vaccine values, vaccine attitudes, vaccine hesitancy, and vaccination behavior were assessed using linear and logistic regression models. Late vaccination was assessed from electronic medical records.ResultsA six-factor structure for vaccine values was determined with good fit (RMSEA = 0.07, Bentler’s CFI = 0.91) with subscales for Conformity, Universalism, Tradition, Self-Direction, Security- Disease Prevention, and Security- Vaccine Risk. Vaccine values were moderately associated with Schwartz global values and vaccine attitudes, indicating discriminant validity from these constructs. Multivariable linear regression showed vaccine hesitancy was associated with vaccine values Conformity (partial R² = 0.10) and Universalism (0.04) and vaccine attitudes Vaccine Safety (0.52) and Vaccine Benefit (0.16). Multivariable logistic regression showed that late vaccination was associated with vaccine value Self-direction (OR = 1.80, 95% CI: 1.26–2.65) and vaccine attitude of Vaccine Benefit (OR = 0.44, 95% CI: 0.32–0.60).ConclusionsThe PVV scale had good psychometric properties and appears related to but distinct from Schwartz global values and vaccine attitudes. Vaccine values are associated with vaccine hesitancy and late vaccination and may be useful in tailoring future interventions.     

Monitoring vaccine safety using the Vaccine Safety Datalink: utilizing immunization registries for pandemic influenza

Mass vaccination campaigns during which new vaccines may be administered to many millions of people in a short period of time call for timely and accurate post-licensure surveillance to monitor vaccine safety. To address the need for timely H1N1 influenza vaccine safety information during the 2009-2010 H1N1 influenza pandemic, the Vaccine Safety Datalink (VSD) project assessed the feasibility and potential mechanisms for utilizing data from state and local immunization registries to capture vaccinations that would not otherwise be captured by the data systems of the participating VSD managed care organizations (MCOs). Three of the eight VSD sites were able to capture H1N1 immunization data electronically from the state and local registries, and one site was able to capture the immunizations through a paper-based system; however, the remaining four sites encountered various obstacles that prevented capture of such data. Additional work will be required at these sites to overcome the barriers, which included privacy and confidentiality laws, time constraints brought on by the pandemic, as well as data quality concerns.     

贵州省少数民族地区计划免疫IEC传播策略分析

目的 通过评价儿童计划免疫信息、教育与传播（IEC）策略在贵州省黔东南州的试点实施情况及效果，探讨IEC综合策略的可行性、有效性和适宜性，为在贵州全省推广实施提供依据。方法 采用社区干预试验研究方法，分别以贵州省黔东南州实施和对照县的儿童母亲作为研究对象，在实施县进行为期8个月的干预活动。干预后，问卷调查实施县291名、对照县279名儿童母亲，同时访谈实施县村干部、乡村医生及7岁以下儿童家长。结果 干预县被调查儿童母亲有关IEC关键信息知识、态度和行为意向得分显著高于对照县。干预县儿童母亲获知计划免疫知识主要来自IEC策略的传播主体和媒介，与对照县有明显差异。从工作开展情况看，宣传画的张贴最到位，此外带插页接种证的发放率较高；被访谈村干部和乡村医生对IEC策略持认同态度。结论 IEC策略是适合当地计划免疫工作的健康传播策略，在当地推广具有可行性，但应根据当地情况适当调整。     

Assessing vaccine safety during a pandemic: Recent experience and lessons learned for the future

During the roll out of vaccines during a pandemic, questions regarding vaccine safety often arise. This was surely true during the SARS-CoV-2 pandemic. Different tools and capabilities exist during the pre-authorization phase and post introduction each with its strengths and limitations. Here we review the various tools and their strengths and limitations and discuss what functioned well in high income settings and the limitations that unequal vaccine safety pharmacovigilance capacity imposed upon middle and low income countries.     

高风险人群流感疫苗接种现况和免疫策略分析

流感是由流感病毒引起的一种呼吸道传染性疾病,严重疾病负担常见于高风险人群。接种流感疫苗是预防流感及其并发症的有效方法,尤其是对高风险人群。虽然已有部分国家将流感疫苗纳入国家免疫规划,但全球范围内高风险人群流感疫苗接种率仍然较低。目前,流感疫苗在我国仍属于自愿自费接种的非免疫规划疫苗,且全国各地流感疫苗免疫策略差异化明显,接种率与发达国家仍有差距。进一步优化我国流感疫苗全人群免疫策略,加强流感疫苗全人群免疫策略的宣传,降低我国流感的疾病负担,是目前迫切需要解决的问题。     

Inclusion of intersectionality in studies of immunization uptake in Canada: A scoping review

IntroductionIntersectionality refers to the interconnectedness of various social locations creating unique experiences for individuals and groups, in the context of systems of privilege and oppression. As part of immunization coverage research, intersectionality allows healthcare professionals and policymakers to become aware of the constellation of characteristics contributing to low vaccine uptake. The objective of this study was to examine the application of intersectionality theory or concepts, and the appropriate use of sex and gender terminology, in Canadian immunization coverage research.Materials and methodsThe eligibility criteria for this scoping review included English or French language studies on immunization coverage among Canadians of all ages. Six research databases were searched without date restrictions. We searched provincial and federal websites, as well as the Proquest Dissertations and Theses Global database for grey literature.ResultsOf 4725 studies identified in the search, 78 were included in the review. Of these, 20 studies included intersectionality concepts, specifically intersections of individual-level characteristics influencing vaccine uptake. However, no studies explicitly used an intersectionality framework to guide their research. Of the 19 studies that mentioned “gender”, 18 had misused this term, conflating it with “sex”.ConclusionsBased on our findings, there is an evident lack of intersectionality framework utilization in immunization coverage research in Canada, as well as misuse of the terms “gender” and “sex”. Rather than only focusing on discrete characteristics, research should explore the interaction between numerous characteristics to better understand the barriers to immunization uptake in Canada.     

The binomial nature of immunization session size distributions and the implications for vaccine wastage

In this paper we demonstrate that immunization session size distributions are governed by binomial statistics and determined by just two readily available programmatic parameters, the birth cohort of the catchment area and the session frequency. Given this new knowledge, the unavoidable component of an immunization facility’s opened vial wastage rate can be determined algebraically for each vial size and discard time. This has significant positive programmatic implications for immunization session planning, vaccine needs forecasting, vaccine wastage monitoring, and vaccine product specification and choice. Further operational research is required to field test the different applications of the model and to inform the development of tools and guidance.     

不同毒株脊髓灰质炎灭活疫苗开展序贯免疫程序接种的安全性观察

目的 评价使用不同毒株脊髓灰质炎灭活疫苗（IPV）开展序贯免疫程序在大规模人群中使用的安全性。方法 于2017年3月至2018年5月,采用随机、平行对照设计,以Sabin株脊髓灰质炎灭活疫苗（sIPV）、野毒株脊髓灰质炎灭活疫苗（wIPV）和Ⅰ+Ⅲ型脊髓灰质炎减毒活疫苗（bOPV）作为研究疫苗,在上海市选择1 917例2月龄婴儿为研究对象,分为4组：①sIPV+sIPV+bOPV;②sIPV+wIPV+bOPV;③wIPV+sIPV+bOPV;④wIPV+wIPV+bOPV,采用主动观察的方法观察其在2、3、4月龄接种后的不良反应。结果 4组完成3剂基础免疫接种后总的不良事件发生率为16.79%（946/5 633）,各组均未报告严重不良事件,全身和局部反应均以轻度反应为主。常见局部反应为注射部位疼痛、红和硬结等;全身反应为异常哭闹、嗜睡、腹泻和食欲下降等。接种后30 d内,局部反应率为1.65%（93/5 633）,其中轻度、中度和重度反应率分别为1.26%（71/5 633）、0.21%（12/5 633）和0.20%（11/5 633）;全身反应率为15.14%（853/5 633）,其中轻度、中度和重度反应率分别为11.33%（638/5 633）、3.18%（179/5 633）和0.64%（36/5 633）。各组间重度反应率差异无统计学意义（χ²=4.17,P=0.24）。结论 本研究中未观察到使用不同毒株脊髓灰质炎灭活疫苗开展序贯免疫程序接种相关的严重不良事件,多数为轻度的不良反应,所有反应均痊愈。同时或交替使用sIPV和wIPV开展序贯免疫程序对于适龄儿童均具有良好的预防接种安全性。     

Comparison of the implementation of human papillomavirus and hepatitis B vaccination programs in the United States: Implications for future vaccines

Vaccines for two viruses which cause cancer, human papillomavirus (HPV) and hepatitis B virus (HBV), are recommended for all children in the United States. Numerous parallels exist between the two vaccines in addition to their roles in cancer prevention, including transmission through sexual contact, multiple doses needed for series completion, and vaccine administration in adolescence for HPV and in the initial phase of the HBV vaccination program. All of these factors were viewed as potential barriers to achieving high rates of coverage, yet the ultimate success of the HBV vaccination program led to predictions that similarly high rates of coverage could be achieved for the HPV vaccine. However, currently, only the recommendation for HBV vaccination is supported by mandates for school entry in most states. Uptake of the HPV vaccine has lagged far behind U.S. goals for public health promotion. The aim of this paper is to examine factors which may account for the divergent pathways of the two vaccines. Four main factors are identified: logistical challenges of vaccine administration, attitudes of parents and healthcare providers, safety concerns, and cost. For each factor examined, recommendations are offered to confront similar barriers likely to arise for future vaccines. The authors conclude that gender-neutral state mandates coupled with school-located vaccination programs, stronger gender-neutral messaging from pharmaceutical companies and healthcare providers, and younger age of vaccine administration, if approved, present the most promising approaches to improving uptake of the HPV vaccine, and similar vaccines down the road.     

Rotavirus immunization: Global coverage and local barriers for implementation

BackgroundRotavirus (RV) is a major agent of gastroenteritis and an important cause of child death worldwide. Immunization (RVI) has been available since 2006, and the Federation of International Societies of Gastroenterology Hepatology and Nutrition (FISPGHAN) identified RVI as a top priority for the control of diarrheal illness. A FISPGHAN working group on acute diarrhea aimed at estimating the current RVI coverage worldwide and identifying barriers to implementation at local level.MethodsA survey was distributed to national experts in infectious diseases and health-care authorities (March 2015–April 2016), collecting information on local recommendations, costs and perception of barriers for implementation.ResultsForty-nine of the 79 contacted countries (62% response rate) provided a complete analyzable data. RVI was recommended in 27/49 countries (55%). Although five countries have recommended RVI since 2006, a large number (16, 33%) included RVI in a National Immunization Schedule between 2012 and 2014. The costs of vaccination are covered by the government (39%), by the GAVI Alliance (10%) or public and private insurance (8%) in some countries. However, in most cases, immunization is paid by families (43%).Elevated cost of vaccine (49%) is the main barrier for implementation of RVI. High costs of vaccination (rs = −0.39, p = 0.02) and coverage of expenses by families (rs = 0.5, p = 0.002) significantly correlate with a lower immunization rate. Limited perception of RV illness severity by the families (47%), public-health authorities (37%) or physicians (24%) and the timing of administration (16%) are further major barriers to large- scale RVI programs.ConclusionsAfter 10 years since its introduction, the implementation of RVI is still unacceptably low and should remain a major target for global public health. Barriers to implementation vary according to setting. Nevertheless, public health authorities should promote education for caregivers and health-care providers and interact with local health authorities in order to implement RVI.     

Effective interventions to increase routine childhood immunization coverage in low socioeconomic status communities in developed countries: A systematic review and critical appraisal of peer-reviewed literature

ObjectivesChildhood immunization coverage rates are known to be disproportionate according to population’s socioeconomic status (SES). This systematic review examined and appraised quality of interventions deemed effective to increase routine childhood immunization uptake in low SES populations in developed countries.MethodsA literature search was conducted using Medline, Embase, CINAHL, EBMR, PsycInfo, PubMed, and Health STAR. We systematically searched and critically appraised articles published between January 1990 and December 2019 using the Effective Public Health Practice Project Quality Assessment tool. This systematic review provides a synthesis of the available evidence for childhood immunization interventions deemed effective for low SES parents or families of children ≤ 5 years of age.SynthesisThe search yielded 3317 records, of which 2975 studies met the inclusion criteria. From the 100 relevant studies, a total of 40 were included. The majority of effective and strongly rated studies synthesized consisted of multi-component interventions. Such interventions addressed access, community-based mobilization, outreach, appointment reminders, education, clinical tracking and incentives, and were language and health literacy appropriate to support low SES parents. Improving access to low SES parents was deemed effective in the vast majority of strongly rated studies. Incorrect contact information of low SES parents due to increased social mobility (i.e. household moves) rendered reminders ineffective, and therefore, updating contact information should be pursued proactively by front-line healthcare providers. In addition, plain language communication with low SES parents regarding immunization was deemed effective in improving immunization uptake.ConclusionComprehensive multi-component interventions including improved access, appointment reminders, education and precision health communication are effective for addressing health inequities in immunization coverage amongst marginalized populations. Most low SES parents still believe that the benefits of immunization outweigh the risks.     

Parental perceptions,attitudes and acceptance of childhood immunization in Saudi Arabia: A cross sectional study

ObjectivesThe widespread availability and use of vaccines have tremendously reduced morbidity, mortality and health care costs associated with infectious diseases. However, parental beliefs about vaccination are one of the major factors in achieving high vaccination rates. Thus, this study aims to assess the perceptions and attitudes regarding routine childhood immunization among Saudi parents.MethodsA cross sectional study with a pre-tested 18-item questionnaire was conducted using 467 randomly selected parents from the Hail region of Saudi Arabia in the period between February 1st, 2016, and February 1st, 2017. The validated questionnaire consisted of three sections that collected information on participants’ demographics, parents’ awareness of vaccine benefits, and parents’ practices regarding the immunization of their children.ResultsFemale and male parents comprised 54.5% (255) and 45.5% (212) of the sample, respectively, and the response and completion rates were 97%. The majority of the respondents had received a formal education (94.1%, 439), were gainfully employed (62.9%, 294) and had a regular monthly income (73.3%). The majority of the respondents were aware of childhood vaccinations (78.9%), completed vaccinations mandated for children up to 5 years (86.2%), encouraged other parents to do so (89.9%), and had easy access to vaccines (90.5%). Sixty to ninety percent of the respondents were knowledgeable regarding the health benefits of vaccinations in children, even though 18.4% of their children had experienced vaccination-related minor adverse effects during or after vaccination of which 23.2% required doctor's visits. Health care professionals were the most frequent source of parents’ vaccine-related information (65.2%), and vaccination reminder services provided by the Ministry of Health (MOH) via mobile phones were cited by 57.5% of respondents.ConclusionsConfidence in and acceptance of childhood vaccinations, perceptions of vaccine-related health benefits and ease of access to immunizations appeared to be quite good among Saudi parents.