Special Issue "Pharmacoepidemiology in Vaccine: Generating the Real-World Data to Promote Vaccine Safety and Uptake"

A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "Vaccines and Society".

Deadline for manuscript submissions: closed (30 May 2021) | Viewed by 40111

Special Issue Editors

Prof. Ju-Young Shin
E-Mail Website
Guest Editor
Department of Clinical and Social Pharmacy, School of Pharmacy, Sungkyunkwan University (SKKU), Suwon 16419, Korea
Interests: pharmacoepidemiology; pharmacovigilance; adverse event following immunization; signal detection
Dr. Ju Hwan Kim
E-Mail Website
Guest Editor
School of Pharmacy, Sungkyunkwan University (SKKU), Suwon 16419, Korea
Interests: pharmacoepidemiology; pharmacovigilance; adverse event following immunization; signal detection

Special Issue Information

Dear Colleagues,

We are currently living in a post-vaccine era where historically known communicable and life-threatening infectious diseases are in under control by an effective immunization strategy. In 2018, approximately 86% of the world’s children received vaccines that would protect them against diphtheria, tetanus, pertussis, polio, and measles, which consequently prevented 2 to 3 million deaths. With the vaccines being recognized as an efficacious, efficient and cost-effective disease prevention strategy, many countries implement nationwide immunization program or campaign to achieve near perfect vaccine coverage rates. Recently, however, vaccine safety came under scrutiny, which is inevitable given the number of individuals receiving vaccines around the world. Given the rarity of adverse events following immunization (AEFIs), they often go undetected due to limited sample size or only affecting a subpopulation with limited representation in the clinical trials. In efforts to address this issue, researchers are utilizing post-marketing surveillance data to generate real-world data to promote vaccine safety. Meanwhile, it is also imperative to grasp a growing anti-vaccine movement that leads to vaccine hesitancy. To confront this resistance to vaccines, a more precise understanding of the factors, both at individual- and community-levels, that affect vaccine hesitancy would be essential for well-being of the global public health.

This special issue titled as “Pharmacoepidemiology in vaccine: Generating the real-world data to promote vaccine safety and uptake” will introduce the readers of the Journal a pharmacoepidemiologic approach to address vaccine safety and hesitancy. Specifically, this issue encompasses the following areas of research:

(1) identifying unsuspected AEFIs by applying novel statistical methods in post-marketing surveillance data;

(2) conducting observational study for casual inference on the safety of vaccine(s);

(3) describing interventions or strategies to combat vaccine hesitancy.

Manuscripts that address any of these research areas are welcome for submission. Manuscripts will follow standard Journal peer-review procedures, and those accepted for publication will appear in this special issue.

Prof. Ju-Young Shin
Dr. Ju Hwan Kim
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Vaccines is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2200 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • pharmacoepidemiology
  • pharmacovigilance
  • adverse event following immunization
  • signal detection

Published Papers (18 papers)

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Research

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Article
Caregivers’ Willingness to Vaccinate Their Children against Childhood Diseases and Human Papillomavirus: A Cross-Sectional Study on Vaccine Hesitancy in Malawi
Vaccines 2021, 9(11), 1231; https://doi.org/10.3390/vaccines9111231 - 22 Oct 2021
Cited by 4 | Viewed by 1292
Abstract
Background: Vaccines are among the most effective and cost-efficient public health interventions for promoting child health. However, uptake is considerably affected by vaccine hesitancy. An example is Malawi, with a decline in second vaccine doses and the highest cervical cancer incidence and mortality [...] Read more.
Background: Vaccines are among the most effective and cost-efficient public health interventions for promoting child health. However, uptake is considerably affected by vaccine hesitancy. An example is Malawi, with a decline in second vaccine doses and the highest cervical cancer incidence and mortality rate in Sub-Saharan Africa. Understanding vaccine hesitancy is especially important when new vaccines are introduced. This study explores factors contributing to vaccine hesitancy for routine childhood immunization and the human papillomavirus vaccine in Malawi. Methods: The study used a cross-sectional survey design targeting caregivers of children under five years old and adolescent girls. The sample population was derived using three inclusion criteria: one district with low vaccine uptake (Dowa), one district with high vaccine uptake (Salima), and one district where human papillomavirus vaccine was piloted earlier (Zomba). A convenience sample of one primary and one secondary health facility was selected within each district, and participants were systematically included (n = 600). The measures were based on 5C scale for measuring vaccine hesitancy. Multiple regression analyses were performed to explore vaccination intention predictors. Results: Confidence in vaccine safety was the strongest predictor of routine childhood immunization, followed by constraints due to everyday stress. Caregivers had lower confidence in vaccine safety and efficacy when they believed rumors and misinformation and were unemployed. Confidence was higher for those who had more trust in healthcare workers. Age, gender, religion, education, employment, belief in rumors, and trust in healthcare workers were considered predictors of vaccination intention. A husband’s positive attitude (approval) increased childhood vaccination intention. For human papillomavirus, vaccination intentions were higher for those with lower education, more trust in healthcare workers, lower complacency, and a lower tendency toward calculating the benefits and risks of vaccination. Knowledge of human papillomavirus did not increase vaccination intention, but the need to attain a husband’s approval did. Being a young adult and unemployed increased belief in rumors, while trust in healthcare workers reduced the belief. Conclusions: This study provides good insights into the drivers of vaccine hesitancy across different contexts in Malawi. However, further studies are necessary to understand low risk perception among elderly people and the declining trend in second vaccine doses. Full article
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Article
Quality and Safety of Vaccines Manufacturing: An Online Survey on Attitudes and Perceptions of Italian Internet Users
Vaccines 2021, 9(9), 1015; https://doi.org/10.3390/vaccines9091015 - 13 Sep 2021
Cited by 1 | Viewed by 1063
Abstract
Background: Vaccination is a worldwide public health practice that requires high uptake levels in order to effectively reduce the incidence of vaccine-preventable diseases. The manufacturing of vaccines is a complex process, and little is known about people’s feelings and opinions on that. Our [...] Read more.
Background: Vaccination is a worldwide public health practice that requires high uptake levels in order to effectively reduce the incidence of vaccine-preventable diseases. The manufacturing of vaccines is a complex process, and little is known about people’s feelings and opinions on that. Our study aimed at investigating perceptions and attitudes of the general population towards the vaccine production process before the availability of COVID-19 vaccines. Methods: We designed a 15-question online survey in the Italian language which was spread via Facebook and an Italian website "Vaccinarsintoscana" between January and May 2020. We performed a descriptive analysis and applied statistical tests to assess differences in the given answers according to participants’ sociodemographic characteristics. Results: The collected responses (135 participants) about the perceptions on vaccine production process were largely positive: not being concerned about the vaccine production (70.3%); believing the vials did not contain harmful substances (75.6%) and considering the precautionary withdrawal of some batches as highly effective (83.7%). In contrast, a less positive perception was found for the question about the conflict of interest between manufacturing companies and the control systems (48.9%). Moreover, people’s perceptions towards the vaccine components (i.e., microorganism, adjuvants and opinion on batches withdrawal) also showed a good level of confidence and trust. Conclusions: Our study highlighted a generally positive attitude towards the vaccine production process and showed people’s confidence in the control systems, safety and high standards of quality of the vaccine production process. Full article
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Article
Non-EPI Vaccine Hesitancy among Chinese Adults: A Cross-Sectional Study
Vaccines 2021, 9(7), 772; https://doi.org/10.3390/vaccines9070772 - 10 Jul 2021
Cited by 9 | Viewed by 1768
Abstract
Vaccination against coronavirus disease 2019 (COVID-19) is paramount to curtailing the pandemic. However, the impact of the Non-Expanded Program on Immunization (non-EPI) and COVID-19 vaccine hesitancy on vaccine uptake among Chinese adults remain unclear. This study was an online survey performed in Eastern, [...] Read more.
Vaccination against coronavirus disease 2019 (COVID-19) is paramount to curtailing the pandemic. However, the impact of the Non-Expanded Program on Immunization (non-EPI) and COVID-19 vaccine hesitancy on vaccine uptake among Chinese adults remain unclear. This study was an online survey performed in Eastern, Central, and Western China between February 2021 and March 2021 using proportional sampling (n = 7381). Adults aged ≥ 18 years were included, especially younger people (aged < 65). Vaccine hesitancy was assessed using the 3C model and relative scales; logistic regression was used to explore the factors affecting vaccination uptake; structural equation modeling was used to evaluate the correlations between variables. Overall, 67.6% and 24.7% of adults reported vaccine hesitancy toward the non-EPI and COVID-19 vaccines, respectively. Participants (66.3%) reported taking the vaccine mainly based on recommendations from medical staff. Vaccine-hesitant participants (60.5%) reported a fear of side effects as the deciding factor in vaccine rejection. Vaccine hesitancy interacted negatively with confidence (β = −0.349, p < 0.001) and convenience (β = −0.232, p < 0.001), and positively with complacence (β = 0.838, p < 0.001). Nonmedical personnel, adults who had previously received the influenza vaccine, and older people had lower vaccine hesitancy than their counterparts. Most Chinese adults have non-EPI but not COVID-19 vaccine hesitancy. Vaccine safety remains a concern. Full article
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Article
Association between Influenza Vaccination and the Risk of Bell’s Palsy in the Korean Elderly
Vaccines 2021, 9(7), 746; https://doi.org/10.3390/vaccines9070746 - 06 Jul 2021
Cited by 2 | Viewed by 1087
Abstract
Previous studies have shown controversial results on the risk of Bell’s palsy after influenza vaccination. Since the antigenic components of influenza vaccine can vary from season to season, continuous safety monitoring is required. The aim of the present study was to determine whether [...] Read more.
Previous studies have shown controversial results on the risk of Bell’s palsy after influenza vaccination. Since the antigenic components of influenza vaccine can vary from season to season, continuous safety monitoring is required. The aim of the present study was to determine whether there was an increased risk of Bell’s palsy in the elderly after influenza vaccination between the 2015/2016 and 2017/2018 flu seasons. This study included the elderly who received influenza vaccinations for three flu seasons using a large-linked database of vaccination registration data from the Korea Disease Control and Prevention Agency and the National Health Insurance Service claims data. We used a self-controlled risk interval design with a risk interval of 1 to 42 days and a control interval of 57 to 98 days postvaccination and calculated the incidence rate ratio. To ensure the robustness of the results, sensitivity analyses were also carried out with different risk and control intervals. Of 4,653,440 elderly people who received the influenza vaccine, there was no statistically significant increase in the risk of Bell’s palsy (IRR: 0.99, 95% CI: 0.92–1.07). Similar results were found in analysis results for each season and the results of the sensitivity analyses excluding the 2017/2018 season. In conclusion, we found no evidence of an increased risk of Bell’s palsy after influenza vaccination. The results of our study provide reassurance about the safety of the influenza vaccine NIP program. However, it is necessary to continuously monitor the risk of Bell’s palsy during future flu seasons. Full article
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Article
Differential Demographic and Clinical Characteristics between MMR Vaccinated and Unvaccinated Children in South Korea: A Nationwide Study
Vaccines 2021, 9(6), 653; https://doi.org/10.3390/vaccines9060653 - 15 Jun 2021
Viewed by 1143
Abstract
In the context of recent measles outbreaks, substantial factors associated with measles-mumps-rubella (MMR) unvaccination need to be clarified. This study aimed to identify differential demographic and clinical characteristics between MMR vaccinated and unvaccinated groups. We used a large-linked database to identify children born [...] Read more.
In the context of recent measles outbreaks, substantial factors associated with measles-mumps-rubella (MMR) unvaccination need to be clarified. This study aimed to identify differential demographic and clinical characteristics between MMR vaccinated and unvaccinated groups. We used a large-linked database to identify children born between 2008 and 2016 by combining data from the Korea Immunization Registry Information System and National Health Information database. The MMR vaccination status was ascertained up to the age of 2 to define MMR vaccinated and unvaccinated groups. We conducted a multivariate logistic regression to estimate odds ratios (ORs) with 95% confidence intervals (CIs) to identify factors associated with MMR unvaccination. Of 3,973,253 children, 75,674 (1.9%) did not receive the MMR vaccine. Compared with the MMR vaccinated group, the underutilization of healthcare resources was more notable in the MMR unvaccinated group (number of outpatient visits (5.73 ± 12.1 vs. 25.8 ± 17.06); days hospitalized (1.69 ± 14.5 vs. 2.32 ± 6.90)). Children were less likely to receive the MMR vaccine if they were born with congenital anomaly (OR 2.12; 95% CI 1.90–2.36), were never admitted to an intensive care unit (1.88; 1.78–1.98), or never visited an emergency room (3.57; 3.53–3.72). There were substantial factors associated with MMR unvaccination, underscoring a need to optimize targeted interventions tailored to the subset of children in South Korea. Full article
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Article
Lack of Trust, Conspiracy Beliefs, and Social Media Use Predict COVID-19 Vaccine Hesitancy
Vaccines 2021, 9(6), 593; https://doi.org/10.3390/vaccines9060593 - 03 Jun 2021
Cited by 86 | Viewed by 13346
Abstract
As COVID-19 vaccines are rolled out across the world, there are growing concerns about the roles that trust, belief in conspiracy theories, and spread of misinformation through social media play in impacting vaccine hesitancy. We use a nationally representative survey of 1476 adults [...] Read more.
As COVID-19 vaccines are rolled out across the world, there are growing concerns about the roles that trust, belief in conspiracy theories, and spread of misinformation through social media play in impacting vaccine hesitancy. We use a nationally representative survey of 1476 adults in the UK between 12 and 18 December 2020, along with 5 focus groups conducted during the same period. Trust is a core predictor, with distrust in vaccines in general and mistrust in government raising vaccine hesitancy. Trust in health institutions and experts and perceived personal threat are vital, with focus groups revealing that COVID-19 vaccine hesitancy is driven by a misunderstanding of herd immunity as providing protection, fear of rapid vaccine development and side effects, and beliefs that the virus is man-made and used for population control. In particular, those who obtain information from relatively unregulated social media sources—such as YouTube—that have recommendations tailored by watch history, and who hold general conspiratorial beliefs, are less willing to be vaccinated. Since an increasing number of individuals use social media for gathering health information, interventions require action from governments, health officials, and social media companies. More attention needs to be devoted to helping people understand their own risks, unpacking complex concepts, and filling knowledge voids. Full article
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Article
Vaccine Production Process: How Much Does the General Population Know about This Topic? A Web-Based Survey
Vaccines 2021, 9(6), 564; https://doi.org/10.3390/vaccines9060564 - 29 May 2021
Cited by 3 | Viewed by 2002
Abstract
Background: Vaccine hesitancy has been recognized as a major global health threat by the World Health Organization. Many studies have investigated vaccine safety as a determinant for vaccine hesitancy; however, not much attention has been paid to vaccine production and quality control during [...] Read more.
Background: Vaccine hesitancy has been recognized as a major global health threat by the World Health Organization. Many studies have investigated vaccine safety as a determinant for vaccine hesitancy; however, not much attention has been paid to vaccine production and quality control during the vaccine production process or whether knowledge about this topic may influence vaccine confidence. The aim of this study was to characterize the common knowledge about the vaccine production process. Methods: A freely accessible online questionnaire was developed on Google Modules and disseminated through social networks. A descriptive analysis of the collected answers was performed, and the chi-square test was used to assess significant differences for the sociodemographic characteristics of the study population (age, gender, work or education and training in the healthcare setting, minor offspring). A binary logistic regression model was performed considering these socio-demographic categories as independent variables. Results: The number of collected questionnaire was 135. Most of the participants (127/135, 94.1%) were aware that quality control measures are carried out during manufacturing, although some knowledge gaps emerged in specific aspects of the vaccine production process, without statistically significant differences between age groups. Working in the healthcare setting or being educated in healthcare may be considered predictors for a better understanding that more than 50% of the production time is spent on quality control (AOR = 3.43; 95% CI: 1.84–8.14, p = 0.01) and that considering quality control performed during the vaccine production process is adequate for avoiding contamination (AOR = 7.90; 95% CI: 0.97–64.34; p = 0.05). Conclusions: This study allowed for a characterization of common knowledge about the vaccine production process. It highlighted the need to implement specific strategies to spread correct information about the vaccine production process. This study may contribute to increased confidence and trust in vaccines and vaccination among the general population. Full article
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Article
Strategies for Vaccine Prioritization and Mass Dispensing
Vaccines 2021, 9(5), 506; https://doi.org/10.3390/vaccines9050506 - 14 May 2021
Cited by 7 | Viewed by 1335
Abstract
We propose a system that helps decision makers during a pandemic find, in real time, the mass vaccination strategies that best utilize limited medical resources to achieve fast containments and population protection. Our general-purpose framework integrates into a single computational platform a multi-purpose [...] Read more.
We propose a system that helps decision makers during a pandemic find, in real time, the mass vaccination strategies that best utilize limited medical resources to achieve fast containments and population protection. Our general-purpose framework integrates into a single computational platform a multi-purpose compartmental disease propagation model, a human behavior network, a resource logistics model, and a stochastic queueing model for vaccination operations. We apply the modeling framework to the current COVID-19 pandemic and derive an optimal trigger for switching from a prioritized vaccination strategy to a non-prioritized strategy so as to minimize the overall attack rate and mortality rate. When vaccine supply is limited, such a mixed vaccination strategy is broadly effective. Our analysis suggests that delays in vaccine supply and inefficiencies in vaccination delivery can substantially impede the containment effort. Employing an optimal mixed strategy can significantly reduce the attack and mortality rates. The more infectious the virus, the earlier it helps to open the vaccine to the public. As vaccine efficacy decreases, the attack and mortality rates rapidly increase by multiples; this highlights the importance of early vaccination to reduce spreading as quickly as possible to lower the chances for further mutations to evolve and to reduce the excessive healthcare burden. To maximize the protective effect of available vaccines, of equal importance are determining the optimal mixed strategy and implementing effective on-the-ground dispensing. The optimal mixed strategy is quite robust against variations in model parameters and can be implemented readily in practice. Studies with our holistic modeling framework strongly support the urgent need for early vaccination in combating the COVID-19 pandemic. Our framework permits rapid custom modeling in practice. Additionally, it is generalizable for different types of infectious disease outbreaks, whereby a user may determine for a given type the effects of different interventions including the optimal switch trigger. Full article
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Article
The Impact of an Inactivated Hepatitis A Vaccine with One Dose in Brazil: A Retrospective Time-Series
Vaccines 2021, 9(4), 407; https://doi.org/10.3390/vaccines9040407 - 20 Apr 2021
Cited by 2 | Viewed by 1142
Abstract
Background: In 2014, a recommended one-dose of inactivated hepatitis A vaccine was included in the Brazilian National Immunization Program targeting children 12–24 months. This decision addressed the low to intermediate endemicity status of hepatitis A across Brazil and the high rate of infection [...] Read more.
Background: In 2014, a recommended one-dose of inactivated hepatitis A vaccine was included in the Brazilian National Immunization Program targeting children 12–24 months. This decision addressed the low to intermediate endemicity status of hepatitis A across Brazil and the high rate of infection in children and adolescents between 5 and 19 years old. The aim of the study was to conduct a time-series analysis on hepatitis A incidence across age groups and to assess the hepatitis A distribution throughout Brazilian geographic regions. Methods: An interrupted time-series analysis was performed to assess hepatitis A incidence rates before (2010–2013) and after (2015–2018) hepatitis A vaccine program implementation. The time-series analysis was stratified by age groups while a secondary analysis examined geographic distribution of hepatitis A cases. Results: Overall incidence of hepatitis A decreased from 3.19/100.000 in the pre-vaccine period to 0.87/100.000 (p = 0.022) post-vaccine introduction. Incidence rate reduction was higher among children aged 1-4 years old, with an annual reduction of 67.6% in the post-vaccination period against a 7.7% annual reduction in the pre-vaccination period (p < 0.001). Between 2015 and 2018, the vaccination program prevented 14,468 hepatitis A cases. Conclusion: Our study highlighted the positive impact of a recommended one-dose inactivated hepatitis A vaccine for 1–4-years-old in controlling hepatitis A at national level. Full article
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Article
Vaccine Hesitancy: COVID-19 and Influenza Vaccine Willingness among Parents in Wuxi, China—A Cross-Sectional Study
Vaccines 2021, 9(4), 342; https://doi.org/10.3390/vaccines9040342 - 01 Apr 2021
Cited by 36 | Viewed by 2907
Abstract
Objectives: We aimed to (1) assess parental hesitancy about category A (Expanded Program on Immunization (EPI)) and B (non-EPI) vaccines, (2) assess parental willingness for COVID-19 and influenza vaccinations, and (3) explore the association of vaccination hesitancy of parents and healthcare workers (HCWs). [...] Read more.
Objectives: We aimed to (1) assess parental hesitancy about category A (Expanded Program on Immunization (EPI)) and B (non-EPI) vaccines, (2) assess parental willingness for COVID-19 and influenza vaccinations, and (3) explore the association of vaccination hesitancy of parents and healthcare workers (HCWs). Methods: The study was performed in Wuxi, eastern China between 21 September 2020 and 17 October 2020. Parents of children aged <18 years and HCWs were recruited from the selected immunization clinics. Vaccine hesitancy was assessed using the Strategic Advisory Group of Experts (SAGE) vaccine hesitancy survey (VHS) by summing the total score for 10 items (maximum 50 points). Results: A total of 3009 parents and 86 HCWs were included in the analysis. The category A VHS scores were significantly higher than the category B VHS scores (p = 0.000). Overall, 59.3% and 52.4% of parents reported willingness to avail COVID-19 and influenza vaccination for their children, respectively; 51.2% of the HCWs wanted to be vaccinated against COVID-19. Parental category B VHS scores were associated with HCW category B VHS scores (r = 0.928, p = 0.008). Conclusions: In China, parents are more hesitant about category B vaccines than category A vaccines. More than 40% of parents showed hesitancy and a refusal to use COVID-19 and influenza vaccines. Full article
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Article
Improving Pneumococcal Vaccination Rates among Rural Older Adults through Academic Detailing: Medicine, Nursing and Pharmacy Partnership
Vaccines 2021, 9(4), 317; https://doi.org/10.3390/vaccines9040317 - 31 Mar 2021
Cited by 1 | Viewed by 1066
Abstract
Academic detailing is an educational approach involving provision of evidence-based information by healthcare providers for healthcare providers with the goal of improving clinical decision-making. An interprofessional academic detailing initiative was developed to encourage rural providers to utilize guidelines when deciding which patients to [...] Read more.
Academic detailing is an educational approach involving provision of evidence-based information by healthcare providers for healthcare providers with the goal of improving clinical decision-making. An interprofessional academic detailing initiative was developed to encourage rural providers to utilize guidelines when deciding which patients to vaccinate against pneumonia. This study utilized a quasi-experimental, single-group, pre-post observational design with physicians, nurses, and staff at two rural medical clinics. The 12-month academic detailing intervention included a needs assessment, workflow assessment of practice-based health information technology, vaccination training for providers and staff, and creation of exam-room posters encouraging patients to discuss vaccination with their provider. Six visits were made to deliver education, discuss needs, select priorities, and develop action plans from recommendations. Data were collected from each site for three years prior to the intervention year and for one year following the intervention. The annual rate of patients vaccinated increased during the five-year study. The cumulative proportion of the sample population that received vaccination also increased over time. Interprofessional academic detailing was well received and increased pneumococcal vaccination rates among rural-dwelling older adults. Given the alarming disparities in health outcomes for rural patients, educational outreach is needed to improve healthcare access and outcomes. Full article
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Article
Change Point Analysis for Detecting Vaccine Safety Signals
Vaccines 2021, 9(3), 206; https://doi.org/10.3390/vaccines9030206 - 02 Mar 2021
Cited by 4 | Viewed by 1041
Abstract
It is important to detect signals of abrupt changes in adverse event reporting in order to notice public safety concerns and take prompt action, especially for vaccines under national immunization programs. In this study, we assessed the applicability of change point analysis (CPA) [...] Read more.
It is important to detect signals of abrupt changes in adverse event reporting in order to notice public safety concerns and take prompt action, especially for vaccines under national immunization programs. In this study, we assessed the applicability of change point analysis (CPA) for signal detection in vaccine safety surveillance. The performances of three CPA methods, namely Bayesian change point analysis, Taylor’s change point analysis (Taylor-CPA), and environmental time series change point detection (EnvCpt), were assessed via simulated data with assumptions for the baseline number of events and degrees of change. The analysis was validated using the Korea Adverse Event Reporting System (KAERS) database. In the simulation study, the Taylor-CPA method exhibited better results for the detection of a change point (accuracy of 96% to 100%, sensitivity of 7% to 100%, specificity of 98% to 100%, positive predictive value of 25% to 85%, negative predictive value of 96% to 100%, and balanced accuracy of 53% to 100%) than the other two CPA methods. When the CPA methods were applied to reports of syncope or dizziness following human papillomavirus (HPV) immunization in the KAERS database, Taylor-CPA and EnvCpt detected a change point (Q2/2013), which was consistent with actual public safety concerns. CPA can be applied as an efficient tool for the early detection of vaccine safety signals. Full article
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Article
Vaccine-Related Errors in Reconstitution in South Korea: A National Physicians’ and Nurses’ Survey
Vaccines 2021, 9(2), 117; https://doi.org/10.3390/vaccines9020117 - 02 Feb 2021
Cited by 1 | Viewed by 1386
Abstract
Vaccine-related errors (VREs) result from mistakes in vaccine preparation, handling, storage, or administration. We aimed to assess physicians’ and nurses’ experiences of VREs in South Korea, focusing on reconstitution issues, and to understand the barriers to and facilitators of preventing them. This was [...] Read more.
Vaccine-related errors (VREs) result from mistakes in vaccine preparation, handling, storage, or administration. We aimed to assess physicians’ and nurses’ experiences of VREs in South Korea, focusing on reconstitution issues, and to understand the barriers to and facilitators of preventing them. This was a cross-sectional study using an internet-based survey to examine experiences of reconstitution-related errors, and experience or preference with regard to ready-to-use vaccines (RTU) by physicians and nurses. A total of 700 participants, including 250 physicians and 450 nurses, responded to the questionnaire. In total, 76.4% and 41.5% of the physicians and nurses, respectively, reported an error related to reconstituted vaccines. All errors had been reported as experienced by between 4.9% and 52.0% of physicians or nurses. The errors were reported to occur in more than one in 100 vaccinations for inadequate shaking of vaccines by 28.0% of physicians and 6.9% of nurses, incomplete aspiration of reconstitution vials by 28.0% of physicians and 6.4% of nurses, and spillage or leakage during reconstitution by 20.8% of physicians and 6.9% of nurses. A total of 94.8% of physicians had experience with RTU vaccines, and all preferred RTU formulations. In conclusion, this study highlights the high frequency and types of reconstitution-related errors in South Korea. RTU vaccines could help reduce the time needed for preparation and reduce the risk of errors in South Korea. Full article
Article
Vaccination during the First Diagnosis of Multiple Myeloma: A Cohort Study of the French National Health Insurance Database
Vaccines 2020, 8(4), 722; https://doi.org/10.3390/vaccines8040722 - 02 Dec 2020
Cited by 2 | Viewed by 1045
Abstract
Purpose: Infections are frequent and often result in serious complications in patients with multiple myeloma (MM). Prophylactic vaccination is recommended for influenza virus, Streptococcus pneumoniae (SP), and Hemophilus influenzaeb (Hib). The aims of this study were to measure the vaccination [...] Read more.
Purpose: Infections are frequent and often result in serious complications in patients with multiple myeloma (MM). Prophylactic vaccination is recommended for influenza virus, Streptococcus pneumoniae (SP), and Hemophilus influenzaeb (Hib). The aims of this study were to measure the vaccination rates within 24 months after the diagnosis of multiple myeloma and to identify factors associated with vaccine use. Methods: MM patients were selected through the French national health insurance database from 1 January 2010 to 31 December 2015. Patients with a previous history of MM were excluded. Results: Vaccination rates against influenza, SP, and Hib among 22,831 newly diagnosed MM patients were, respectively, 28.5%, 10.3%, and 1.4%. Only 0.7% received all three vaccines. Factors associated with vaccination were young age, male gender, an absence of comorbidity, a history of higher medication and vaccine consumption, Herpes simplex virus (HSV), Varicella zoster virus (VZV), and the use of pneumocystis prophylaxis. Conclusion: The low rates of vaccination indicate the need to improve physician and MM patient adherence and education regarding vaccination. Full article
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Review

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Review
What Is the State-of-the-Art in Clinical Trials on Vaccine Hesitancy 2015–2020?
Vaccines 2021, 9(4), 348; https://doi.org/10.3390/vaccines9040348 - 05 Apr 2021
Cited by 5 | Viewed by 1906
Abstract
Background: Vaccine hesitancy is related to a delay in acceptance or refusal of vaccination. Aim: to perform a systematic review of clinical trials on vaccine hesitancy (2015–2020). Methods: a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria (PRISMA). [...] Read more.
Background: Vaccine hesitancy is related to a delay in acceptance or refusal of vaccination. Aim: to perform a systematic review of clinical trials on vaccine hesitancy (2015–2020). Methods: a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria (PRISMA). Five databases were screened—PubMed, Cochrane Library, DOAJ, SciELO and b-on—which comprise multiple resources. Keywords: “Vaccine hesitancy” and (“randomized controlled trial” or “clinical trial”). Inclusion criteria: trials about “vaccine hesitancy” enrolling patients and/or health professionals (2015–2020). Exclusion criteria: studies about other topics, repeated and qualitative studies, reviews and papers written in languages other than English, Portuguese, French or Spanish. Results: a total of 35 trials out of 90 were selected (19 PubMed, 14 Cochrane Library, 0 DOAJ, 0 SciELO and 2 b-on). Selected trials were classified into five topics: children/pediatric (n = 5); online or electronic information (n = 5); vaccination against a specific disease (n = 15) (e.g., influenza or COVID-2019); miscellaneous (n = 4); and educational strategies (n = 6). Conclusion: the provision of online or electronic information (e.g., through virtual reality, social websites of experts, or apps), communication-based interventions and training of health professionals, residents or subjects seemed to improve vaccine hesitancy. Full article
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Review
Measuring the Benefits of Mass Vaccination Programs in the United States
Vaccines 2020, 8(4), 561; https://doi.org/10.3390/vaccines8040561 - 29 Sep 2020
Cited by 2 | Viewed by 2705
Abstract
Since the late 1940s, mass vaccination programs in the USA have contributed to the significantly reduced morbidity and mortality of infectious diseases. To assist the evaluation of the benefits of mass vaccination programs, the number of individuals who would have suffered death or [...] Read more.
Since the late 1940s, mass vaccination programs in the USA have contributed to the significantly reduced morbidity and mortality of infectious diseases. To assist the evaluation of the benefits of mass vaccination programs, the number of individuals who would have suffered death or permanent disability in the USA in 2014, had mass vaccination never been implemented, was estimated for measles, mumps, rubella, tetanus, diphtheria, pertussis, polio, Haemophilus influenzae type b (Hib), hepatitis B, varicella, and human papillomavirus (HPV). The estimates accounted for mortality and morbidity trends observed for these infections prior to mass vaccination and the impact of advances in standard of living and health care. The estimates also considered populations with and without known factors leading to an elevated risk of permanent injury from infection. Mass vaccination prevented an estimated 20 million infections and 12,000 deaths and permanent disabilities in 2014, including 10,800 deaths and permanent disabilities in persons at elevated risk. Though 9000 of the estimated prevented deaths were from liver cirrhosis and cancer, mass vaccination programs have not, at this point, shown empirical impacts on the prevalence of those conditions. Future studies can refine these estimates, assess the impact of adjusting estimation assumptions, and consider additional risk factors that lead to heightened risk of permanent harm from infection. Full article

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Brief Report
Low Adherence to Pneumococcal Vaccination in Lung Cancer Patients in a Tertiary Care University Hospital in Southern Germany
Vaccines 2022, 10(2), 311; https://doi.org/10.3390/vaccines10020311 - 16 Feb 2022
Cited by 2 | Viewed by 931
Abstract
Introduction: The aim of this study was to investigate the adherence to vaccinations, especially pneumococcal vaccinations, in lung cancer patients. Methods: the study was performed at the University Hospital Regensburg, Germany. All patients with a regular appointment scheduled between 1 December 2020 and [...] Read more.
Introduction: The aim of this study was to investigate the adherence to vaccinations, especially pneumococcal vaccinations, in lung cancer patients. Methods: the study was performed at the University Hospital Regensburg, Germany. All patients with a regular appointment scheduled between 1 December 2020 and 29 April 2021 and who provided informed consent were included. Available medical records, vaccination certificates, and a questionnaire were analyzed. Results: we included 136 lung cancer patients (NSCLC n = 113, 83.1%, SCLC n = 23, 16.9%). A correct pneumococcal vaccination according to national recommendations was performed in 9.4% (12/127) of the patients. A correct vaccination was performed for tetanus in 50.4% (66/131), diphtheria in 34.4% (44/128), poliomyelitis in 25.8% (33/128), tick-borne encephalitis in 40.7% (24/59), hepatitis A in 45.5% (7/11), hepatitis B in 38.5% (5/13), shingles in 3.0% (3/101), measles in 50.0% (3/6), pertussis in 47.7% (62/130), influenza in 54.4% (74/136), and meningococcal meningitis in 0% (0/2) of the patients. Conclusion: adherence to pneumococcal vaccinations, as well as to other vaccinations, is low in lung cancer patients. Full article
Brief Report
Serum Anti-HPV Antibody Titer as a Marker of Vaccine Effectiveness in Males with Genital Infection
Vaccines 2020, 8(4), 743; https://doi.org/10.3390/vaccines8040743 - 07 Dec 2020
Cited by 2 | Viewed by 1294
Abstract
Introduction: Persistent human papillomavirus (HPV) semen infection is increasingly associated with male infertility. Adjuvant HPV vaccination is suggested to reduce the time to clearance and the disease relapse in males with persistent HPV semen infection. However, only a sub-population of patients show a [...] Read more.
Introduction: Persistent human papillomavirus (HPV) semen infection is increasingly associated with male infertility. Adjuvant HPV vaccination is suggested to reduce the time to clearance and the disease relapse in males with persistent HPV semen infection. However, only a sub-population of patients show a clinical benefit from adjuvant vaccination. Here, we aimed to address the effectiveness rate of HPV adjuvant vaccination in males with genital tract infection and the possible prognostic markers of healing. Methods: Clinical records from 379 patients with persistent seminal HPV detection, all receiving HPV adjuvant vaccination, were considered. Clinical data, including genital HPV-DNA assessment by INNO-LiPA genotyping, semen HPV-DNA analysis by FISH analysis and serum antibody titer, were collected at basal (T0) and after 6 months (T1) since the vaccination cycle ended. Results: Clearance of genital HPV-DNA was recorded in 326 (86%) patients. Serum HPV-antibody titer at T1 was the most important prognostic factor associated with HPV-DNA clearance. A serum antibody titer equal to or greater than the threshold value 1:125, obtained by ROC curve analysis, was prognostic of healing. Conclusions: Anti-HPV antibody represents a suitable marker of adequate immune response to HPV vaccination in patients with genital infection. Full article
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