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The evidence shows that COVID-19 vaccines can reduce the risks of poor pregnancy outcomes. Yet, reluctance to vaccinate remains high in pregnant populations. In this paper, we take a precision health and patient-centered approach to vaccine hesitancy. We adopted the society-to-cells vaccine hesitancy framework to identify society, community, family, individual, and physiologic factors contributing to COVID-19 vaccine hesitancy in pregnancy. Nurses are particularly well-suited to impact the factors associated with vaccine hesitancy. Because of their proximity to the patient, nurses are positioned to provide individualized, timely health information, and clinical guidelines to assist patients with decision-making related to vaccinations. Recommendations are provided to bolster nurses' engagement in precision health and patient-centered models of care to mitigate COVID-19 vaccine hesitancy in pregnancy., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

The Coronavirus Disease 2019 (COVID-19) pandemic has now persisted globally for four years, resulting in a staggering death toll of over 4 million individuals. The COVID-19 vaccine has emerged as a highly effective tool in controlling the spread of this virus. However, as the number of individuals receiving COVID-19. In this context, the investigation of adverse reactions related to COVID-19 vaccines holds paramount importance in relevant research. The purpose is to evaluate the current research status regarding adverse reactions associated with COVID-19 vaccines, offering insights for future research. A total of 3,746 articles were included in this analysis, and there has been a notable upward trajectory in the volume of published articles. The CiteSpace v6.1.R6, VOSviewer, SCImago Graphica, and Excel 2019 were employed to analyze and visualize the results. The institutions, countries, journals, authors, co-cited references, and keywords of these articles were analyzed. Furthermore, this study delves into the characteristics of articles on adverse reactions associated with COVID-19 vaccines. It was observed that the number of studies on COVID-19 vaccines has increased year by year since 2019 and witnessed a surge in output in 2021. The vast majority of studies have affirmed the overall safety of COVID-19 vaccines, with adverse reactions tending to be more concentrated in specific diseases. These findings provide valuable ideas for future research in this field and suggest the importance of strengthening international cooperation on adverse reactions to COVID-19 vaccines.

In over a year, the COVID-19 pandemic caused 2.69 million deaths and 122 million infections. Social isolation and distancing measures have been the only prevention available for months. Scientific research has done a great deal of work, developing in a few months safe and effective vaccines against COVID-19. In the European Union, nowadays, four vaccines have been authorized for use: Pfizer-BioNTech, Moderna, ChAdOx1 (AstraZeneca/Oxford), Janssen (Johnson & Johnson), and three others are currently under rolling review.Vaccine allocation policy is crucial to optimize the advantage of treatment preferring people with the highest risk of contagion. These days the priority in the vaccination program is of particular importance since it has become clear that the number of vaccines is not sufficient for the entire Italian population in the short term. Cardiovascular diseases are frequently associated with severe COVID-19 infections, leading to the worst prognosis. The elderly population suffering from cardiovascular diseases is, therefore, to be considered a particularly vulnerable population. However, age cannot be considered the only discriminating factor because in the young-adult population suffering from severe forms of heart disease, the prognosis, if affected by COVID-19, is particularly ominous and these patients should have priority access to the vaccination program. The aim of this position paper is to establish a consensus on a priority in the vaccination of COVID-19 among subjects suffering from different cardiovascular diseases.

Background: Anaphylaxis, which is rare, has been reported after COVID-19 vaccination, but its management is not standardized., Method: Members of the European Network for Drug Allergy and the European Academy of Allergy and Clinical Immunology interested in drug allergy participated in an online questionnaire on pre-vaccination screening and management of allergic reactions to COVID-19 vaccines, and literature was analysed., Results: No death due to anaphylaxis to COVID-19 vaccines has been confirmed in scientific literature. Potential allergens, polyethylene glycol (PEG), polysorbate and tromethamine are excipients. The authors propose allergy evaluation of persons with the following histories: 1-anaphylaxis to injectable drug or vaccine containing PEG or derivatives; 2-anaphylaxis to oral/topical PEG containing products; 3-recurrent anaphylaxis of unknown cause; 4-suspected or confirmed allergy to any mRNA vaccine; and 5-confirmed allergy to PEG or derivatives. We recommend a prick-to-prick skin test with the left-over solution in the suspected vaccine vial to avoid waste. Prick test panel should include PEG 4000 or 3500, PEG 2000 and polysorbate 80. The value of in vitro test is arguable., Conclusions: These recommendations will lead to a better knowledge of the management and mechanisms involved in anaphylaxis to COVID-19 vaccines and enable more people with history of allergy to be vaccinated., (© 2022 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.)

Background and Purpose: Health risks associated with SARS-CoV-2 infection are undisputed. Moreover, the capability of vaccination to prevent symptomatic, severe, and fatal COVID-19 is recognized. There is also early evidence that vaccination can reduce the chance for long COVID-19. Nonetheless, the willingness to get vaccinated and receive booster shots remains subpar among people with neurologic disorders. Vaccine scepticism not only jeopardizes collective efforts to end the COVID-19 pandemic but puts individual lives at risk, as some chronic neurologic diseases are associated with a higher risk for an unfavorable COVID-19 course., Methods: In this position paper, the NeuroCOVID-19 Task Force of the European Academy of Neurology (EAN) summarizes the current knowledge on the prognosis of COVID-19 among patients with neurologic disease, elucidates potential barriers to vaccination coverage, and formulates strategies to overcome vaccination hesitancy. A survey among the Task Force members on the phenomenon of vaccination hesitancy among people with neurologic disease supports the lines of argumentation., Results: The study revealed that people with multiple sclerosis and other nervous system autoimmune disorders are most skeptical of SARS-CoV-2 vaccination. The prevailing concerns included the chance of worsening the pre-existing neurological condition, vaccination-related adverse events, and drug interaction., Conclusions: The EAN NeuroCOVID-19 Task Force reinforces the key role of neurologists as advocates of COVID-19 vaccination. Neurologists need to argue in the interest of their patients about the overwhelming individual and global benefits of COVID-19 vaccination. Moreover, they need to keep on eye on this vulnerable patient group, its concerns, and the emergence of potential safety signals., (© 2022 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.)

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in pregnancy is associated with a higher risk for severe morbidity and mortality when compared with infection in non-pregnant women of childbearing age. An increasing number of countries recommend immunization against SARS-CoV-2 in pregnant women. Recent studies provide preliminary and supportive evidence on safety, immunogenicity and effectiveness of coronavirus disease 2019 (COVID-19) vaccines in pregnant women; however, important knowledge gaps remain which warrant further studies. This collaborative consensus paper provides a review of the current literature on COVID-19 vaccines in pregnant women, identifies knowledge gaps and outlines priorities for future research to optimize protection against SARS-CoV-2 in the pregnant women and their infants., Competing Interests: SE: Research support from GSK, Sanofi and Vifor. Speaker’s fees from GSK, Pfizer, Novartis, Sanofi Pasteur and MSD in the past three years. BA is supported by Michael Smith Health Research BC. MO’R: Received research funding for Phase III Covid-19 vaccine trial from Janssen; Received research funding for Phase II Pneumococcal conjugate vaccine trial from Pfizer. VD-B: no conflict of interest to declare. SM: Institution received funding on COVID-19 from BMGF, South African Medical Research Council and Novavax. Also, participating in clinical trials of Pfizer/Biontech and JJ Covid-19 vaccines in pregnant women. MS is a member of the data safety and monitoring board for Janssen and CEPI and received research grants and/or consultancy fees from Astra Zeneca, Janssen, Pfizer, Sanofi, Seqirus, Takeda, MSD and GSK. KF is a member of the Australian Technical Advisory Group on Immunisation noting that this paper represents her own personal view; received honoraria as a member of the vaccine advisory boards for Seqiris and Sanofi Pasteur in the last 5 years. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Abu-Raya, Madhi, Omer, Amirthalingam, Giles, Flanagan, Zimmermann, O’Ryan, Safadi, Papaevangelou, Maertens, Wanlapakorn, Diaz-Brito, Tommelein and Esposito.)

According to a recent World Health Organization estimate, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, which originated in China in 2019, has spread globally, infecting nearly 100 million people worldwide by January 2021. Patients with chronic liver diseases (CLD), particularly cirrhosis, hepatobiliary malignancies, candidates for liver transplantation, and immunosuppressed individuals after liver transplantation appear to be at increased risk of infections in general, which in turn translates into increased mortality. This is also the case for SARS-CoV-2 infection, where patients with cirrhosis, in particular, are at high risk of a severe COVID-19 course. Therefore, vaccination against various pathogens including SARS-CoV-2, administered as early as possible in patients with CLD, is an important protective measure. However, due to impaired immune responses in these patients, the immediate and long-term protective response through immunisation may be incomplete. The current SARS-CoV-2 pandemic has led to the exceptionally fast development of several vaccine candidates. A small number of these SARS-CoV-2 vaccine candidates have already undergone phase III, placebo-controlled, clinical trials in healthy individuals with proof of short-term safety, immunogenicity and efficacy. However, although regulatory agencies in the US and Europe have already approved some of these vaccines for clinical use, information on immunogenicity, duration of protection and long-term safety in patients with CLD, cirrhosis, hepatobiliary cancer and liver transplant recipients has yet to be generated. This review summarises the data on vaccine safety, immunogenicity, and efficacy in this patient population in general and discusses the implications of this knowledge on the introduction of the new SARS-CoV-2 vaccines., Competing Interests: Conflict of interest MC reports personal fees from Abbvie, personal fees from Gilead Sciences, personal fees from Merck Sharp & Dohme (MSD), personal fees from GlaxoSmithKline (GSK), personal fees from Janssen-Cilag, personal fees from Spring Bank Pharmaceuticals, personal fees from Novartis, from Swedish Orphan Biovitrum (SOBI), personal fees from Falk Foundation, grants and personal fees from Roche, outside the submitted work. PAG reports personal fees from Merck, Sharp & Dohme, personal fees from Biotest, personal fees from Angelini, personal fees from Nordic Pharma, personal fees from Vertex, personal fees from Gilead, personal fees from Astellas, outside the submitted work. MB, CSE and DS have nothing to disclose., (Copyright © 2021 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

This study aims to analyze whether good government management of the COVID-19 pandemic can increase the likelihood of vaccine uptake among poor people in Africa. The analysis is based on a sample of 18,010 people living in 34 African countries, drawn from data collected by Afrobarometer (Merged Round 8 data (34 countries), database, 2022). The econometric results, obtained using a bivariate probit regression, show that poverty significantly reduces the odds of accepting the said COVID-19 vaccine. However, acceptance of the vaccine increases among poor individuals when there is (i) trust in the government's published statistics on COVID-19, (ii) control of corruption by the government in managing the pandemic, (iii) individual confidence in the government's ability to ensure the safety of the COVID-19 vaccine, and (iv) belief that the Covid 19 vaccine will be more effective than religious prayer in the fight against this pandemic., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background and Aim: The coronavirus disease 2019 (COVID-19) virus pandemic is still ravaging the world with its ongoing resurgence and continuous mutation, suggesting the need for continuous research on safe and effective novel vaccines. Presently several types of vaccines have been developed and emerged in the global market to control COVID-19 virus. Consequently, the knowledge and information on COVID-19 have been expanding at a high level. Researchers need to gain relevant knowledge regarding the different vaccines; however scattered information makes this process time-consuming and laborious. The present study aimed to evaluate the characteristics and trends in global COVID-19 vaccine high-cited literature using bibliometric and visualizations methods and offer some directions and suggestions for future research. Methodology: Studies published between December 2019 and 22 Nov 2022 on COVID-19 vaccines were retrieved from the Scopus database. From the 16026 studies retrieved, 406 were identified as high-cited papers (HCPs) having received 100 or more citations. From the 406 HCPs, information about publications outputs, countries, institutions, journals, keywords, and citation counts was identified. Data analysis and visualization were conducted using Microsoft Excel, VOSViewer and Bibliometrix R software. Results: The 406 global HCPs on COVID-19 vaccines research were identified in Scopus database since Dec 2019 till 30 Nov 2022 using a search strategy, which received 123614 citations, averaging 304.17 citations per publication (CPP). An external funding was received by 53.20% (216 publications), which were cited 76107 times (with an average of 352.35 CPP). The 7086 authors from 694 organizations affiliated to 76 countries and publishing in 121 journals were involved in global COVID-19 vaccine research. The most productive countries were USA (n=213), U.K (n=91), China (n=36) and Germany (n=35). The most impactful countries in terms of citations per paper (CPP) and relative citation index (RCI) were South Africa (794.68 and 2.61), Germany (507.11 and 1.67), U.K. (396.59 and 1.30) and Spain (367.5 and 1.121). The most productive organizations were University of Oxford, U.K., Imperial College London, U.K. (n=25 each), Center for Disease Control & Prevention (CDC), USA and Tel Aviv University (n=19 each) and the most impactful organizations were University of Cambridge, U.K (783.4 and 2.57), Emory University, USA (780.1 and 2.56), John Hopkins Bloomberg School of Public Health, USA (702.67 and 2.31) and National Institute of Allergy & Infectious Diseases. USA (676.41 and 2.22). The most productive authors were A.J. Pollard (n=16) and T. Lambe (n=14) (of University of Oxford), O. Tureci and P.R. Dormitzer (n=12 each) (of BioNTechSE, Germany) and the most impactful were D. Cooper (1239.22 and 4.07), K.J. Janseu (1228.11 and 4.03) (BioNTechSE, Germany, K.A. Swanson (987.0 and 3.24) (University of Oxford, U.K.) and P.R. Dormitzer (983 and 3.23) (BioNTechSE, Germany). The most productive journals were New England Journal of Medicine (n=53), The Lancet (n=28), Nature (n=22) and JAMA (N=17). The most impactful journals (as per citations per paper) were New England Journal of Medicine (613.15), Lancet (496.39), Human Vaccines and Immunotherapeutics (369.67) and Nature (360.64). Among population age groups, the major focus was on adults (51.48%) and Middle Aged (39.16%). Among publication types, the major focus was Clinical Studies (26.85%), Epidemiology (22.66%) and Genetics (21.92%). The most significant keywords by frequency of appearances were "COVID-19" (n=388), "COVID-19 Vaccines" (n=357), "Vaccination" (n=221), "Prevention & Control" (n=181) and "Vaccine Immunogenicity" (n=133). Conclusion: The HCPs in COVID-19 vaccine research was done mainly by the authors and institutions of high-income countries (HIC) and was published in high-impact medical journals. Our research has identified the leading countries, institutions, journals, hotspots and development trend in the field that could provide the foundation for further investigations. The bibliometric analysis will help the clinicians to rapidly identify the potential collaborative partners, identify significant studies, and research topics within their domains of COVID-19 vaccines. [ABSTRACT FROM AUTHOR]

The onset of the COVID-19 pandemic revealed significant gaps in the United States' pandemic and public health emergency response system. In this position paper, the American College of Physicians (ACP) offers several policy recommendations for enhancing federal, state, and local preparedness for future pandemics and public health emergencies. The onset of the COVID-19 pandemic revealed significant gaps in the United States' pandemic and public health emergency response system. At the federal level, government responses were undercut by a lack of centralized coordination, inadequately defined responsibilities, and an under-resourced national stockpile. Contradictory and unclear guidance throughout the early months of the pandemic, along with inconsistent funding to public health agencies, also created notable variance in state and local responses. The lack of a coordinated response added pressure to an already overwhelmed health care system, which was forced to resort to rationing care and personal protective equipment, creating moral distress and trauma for health care workers and their patients. Despite these severe shortcomings, the COVID-19 pandemic also highlighted successful policies and approaches, such as Operation Warp Speed, which led to the fastest development and distribution of a vaccine in history. In this position paper, the American College of Physicians (ACP) offers several policy recommendations for enhancing federal, state, and local preparedness for future pandemic and public health emergencies. This policy paper builds on various statements produced by ACP throughout the COVID-19 pandemic, including on the ethical distribution of vaccinations and resources, conditions to resume economic and social activity, and efforts to protect the health and well-being of medical professionals, among others. [ABSTRACT FROM AUTHOR]

Conspiracy beliefs have spread during the Covid-19 pandemic. It is important to understand them because of their potential to undermine trust in societal institutions and willingness to get vaccined. In the present research (N = 538), we assessed the links between conspiracy beliefs, trust in institutions (e.g., government, WHO), and attitudes towards the Covid-19 vaccination across the USA, Brazil and the UK. A moderated mediation analysis revealed the crucial role of political leaders in linking conspiracy beliefs with vaccination attitudes. Trust in the president was positively associated with conspiracy beliefs in Brazil because of its conspiracist president at the time (Bolsonaro), which in turn was negatively associated with vaccination attitudes. In contrast, trust in political leaders at the time in the UK (Johnson) and the USA (Biden) was negatively associated with conspiracy beliefs. In conclusion, our findings contribute to understanding the underlying mechanisms that link conspiracy beliefs with trust and vaccination attitudes., (© 2024 The Author(s). International Journal of Psychology published by John Wiley & Sons Ltd on behalf of International Union of Psychological Science.)

Objective: To provide pooled analyses on the association between COVID-19 vaccine and the incidence of idiopathic sudden sensorineural hearing loss (ISSNHL)., Data Sources: "Medline" via "PubMed", "EMBASE", and "Google scholar"., Review Methods: Data sources were inspected from January 2020 to January 2024 using search terms relevant to vaccines for COVID-19. Included were papers with reported numbers of vaccinated populations and incidence if ISSNHL in those populations. Quality assessment was performed with the Newcastle-Ottawa Quality Assessment Scale Criteria., Results: Three publications encompassing more than 191.8 million patients and at least 283 million vaccine doses were included in the quantitative data synthesis. The pooled reported incidence (95%confidence interval) of ISSNHL among COVID-19 vaccine recipients was 1.2588 per 100,000 (0.1385-3.4836). This incidence is significantly lower than the incidence of 5-27 and 60 per 100,000/year reported in the United States and in the European Union, respectively (P < 0.0001)., Conclusion: There is no evidence to indicate that the COVID-19 vaccine is associated with the incidence of ISSNHL., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

The concept of mRNA-based vaccines emerged more than three decades ago. Groundbreaking discoveries and technological advancements over the past 20 years have resolved the major roadblocks that initially delayed application of this new vaccine modality. The rapid development of nucleoside-modified COVID-19 mRNA vaccines demonstrated that this immunization platform is easy to develop, has an acceptable safety profile and can be produced at a large scale. The flexibility and ease of antigen design have enabled mRNA vaccines to enter development for a wide range of viruses as well as for various bacteria and parasites. However, gaps in our knowledge limit the development of next-generation mRNA vaccines with increased potency and safety. A deeper understanding of the mechanisms of action of mRNA vaccines, application of novel technologies enabling rational antigen design, and innovative vaccine delivery strategies and vaccination regimens will likely yield potent novel vaccines against a wide range of pathogens., (© 2024. Springer Nature Limited.)

Background: COVID-19 vaccine hesitancy is a major barrier to vaccine uptake, and the achievement of herd immunity is required to reduce morbidity and mortality and protect the most vulnerable populations. In Nigeria, COVID-19 vaccine hesitancy has been high, and uptake remains very low. Healthcare workers (HCWs) in Nigeria can help support public health efforts to increase vaccine uptake., Aim: This study evaluates Nigerian HCWs' acceptance and intent to recommend the COVID-19 vaccine., Subjects and Methods: Cross-sectional survey among 1,852 HCWs in primary, secondary, and tertiary care settings across Nigeria. Respondents included doctors, nurses, pharmacy workers, and clinical laboratory professionals who have direct clinical contact with patients in various healthcare settings. A 33-item questionnaire was used in the study, with two of the questions focused on the COVID-19 vaccine. The responses to the two questions were analyzed using Chi-square (c2) tests and independent t-tests to determine the acceptance of the vaccine., Results: The majority of respondents were younger than 34 years (n = 1,227; 69.2%) and primarily worked in hospitals (n = 1,278; 72.0%). Among the respondents, 79.2% (n = 1,467) endorsed the COVID-19 vaccine as a critical tool in reducing the impact of the disease, and 76.2% (n = 1,412) will accept and recommend the vaccine to their patients. The younger HCWs were more likely to endorse and recommend the vaccine to their patients., Conclusion: There is a moderately high COVID-19 vaccine acceptance rate among HCWs surveyed in our study. The confidence of HCWs in its use and their willingness to recommend it to their patients can provide a potentially useful element in increasing acceptance by the larger population in Nigeria., (Copyright © 2024 Copyright: © 2024 Nigerian Journal of Clinical Practice.)

Background: Because previous studies on adolescent COVID-19 attitudes focused on intent to get vaccinated, this study examined attitudinal factors and racial/ethnic differences associated with vaccine uptake., Methods: In a cross-sectional survey of a metropolitan high school district, students were asked about their COVID-19 attitudes, information sources, and whether they had been vaccinated. Logistic regression predicted vaccination status and adjusted odds ratios (aOR) controlled for race/ethnicity., Results: Being unvaccinated was associated with themes of distrust with concerns about vaccine newness (aOR: 0.10; 95% confidence intervals [CI]: 0.06-0.15), side effects (aOR: 0.22; 95% CI: 0.15-0.33), efficacy (aOR: 0.25; 95% CI: 0.17-0.38), distrust of vaccines (aOR: 0.16; 95% CI: 0.09-0.27), government oversight (aOR: 0.19; 95% CI: 0.13-0.30), and politicization (aOR: 0.60; 95% CI: 0.41-0.88). Vaccine uptake was influenced by official information sources, school closures, and vaccine availability. The majority of vaccinated and unvaccinated students trusted primary care professionals as a source for COVID-19 information, but their influence varied across race/ethnic groups., Conclusions: Trust and distrust were the main themes of vaccinated and unvaccinated students, respectively. Incorporating trusted information sources (primary care professionals) in information dissemination efforts may improve vaccine uptake., (© 2023, American School Health Association.)

Social workers, especially in the Global North/developed countries such as the United States of America, Australia, Canada, and the United Kingdom, have been actively involved in implementing social programs to improve the psychosocial, health, and wellbeing of older adults during the COVID-19 pandemic. However, this is not the case in the Global South/developing countries like Nigeria, Ghana, etc. This concept paper aims to describe the current state of Nigerian social workers' role in developing and implementing social programs for older adults during the COVID-19 pandemic and to identify action plans for further strengthening their involvement. We systematically reviewed the literature to identify Nigerian social workers' role in developing and implementing social programs for older adults during COVID-19. Our review reflected that social workers are rarely involved in developing and implementing social programs; when involved, their involvement is on a consultation basis, which limits their active involvement in multidisciplinary team of COVID-19 prevention and vaccination ad hoc committees in Nigeria. [ABSTRACT FROM AUTHOR]

Annual vaccination is widely recommended for influenza and SARS-CoV-2. In this essay, we analyse and question the prevailing policymaking approach to these respiratory virus vaccines, especially in the United States. Every year, licensed influenza vaccines are reformulated to include specific strains expected to dominate in the season ahead. Updated vaccines are rapidly manufactured and approved without further regulatory requirement of clinical data. Novel vaccines (i.e. new products) typically undergo clinical trials, though generally powered for clinically unimportant outcomes (e.g. lab-confirmed infections, regardless of symptomatology or antibody levels). Eventually, the current and future efficacy of influenza and COVID-19 vaccines against hospitalization or death carries considerable uncertainty. The emergence of highly transmissible SARS-CoV-2 variants and waning vaccine-induced immunity led to plummeting vaccine effectiveness, at least against symptomatic infection, and booster doses have since been widely recommended. No further randomized trials were performed for clinically important outcomes for licensed updated boosters. In both cases, annual vaccine effectiveness estimates are generated by observational research, but observational studies are particularly susceptible to confounding and bias. Well-conducted experimental studies, particularly randomized trials, are necessary to address persistent uncertainties about influenza and COVID-19 vaccines. We propose a new research framework which would render results relevant to the current or future respiratory viral seasons. We demonstrate that experimental studies are feasible by adopting a more pragmatic approach and provide strategies on how to do so. When it comes to implementing policies that seriously impact people's lives, require substantial public resources and/or rely on widespread public acceptance, high evidence standards are desirable., (© 2024 The Author(s). European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.)

Purpose: To assess the validity of privacy-preserving synthetic data by comparing results from synthetic versus original EHR data analysis., Methods: A published retrospective cohort study on real-world effectiveness of COVID-19 vaccines by Maccabi Healthcare Services in Israel was replicated using synthetic data generated from the same source, and the results were compared between synthetic versus original datasets. The endpoints included COVID-19 infection, symptomatic COVID-19 infection and hospitalization due to infection and were also assessed in several demographic and clinical subgroups. In comparing synthetic versus original data estimates, several metrices were utilized: standardized mean differences (SMD), decision agreement, estimate agreement, confidence interval overlap, and Wald test. Synthetic data were generated five times to assess the stability of results., Results: The distribution of demographic and clinical characteristics demonstrated very small difference (< 0.01 SMD). In the comparison of vaccine effectiveness assessed in relative risk reduction between synthetic versus original data, there was a 100% decision agreement, 100% estimate agreement, and a high level of confidence interval overlap (88.7%-99.7%) in all five replicates across all subgroups. Similar findings were achieved in the assessment of vaccine effectiveness against symptomatic COVID-19 Infection. In the comparison of hazard ratios for COVID 19-related hospitalization and odds ratio for symptomatic COVID-19 Infection, the Wald tests suggested no significant difference between respective effect estimates in all five replicates for all patient subgroups but there were disagreements in estimate and decision metrices in some subgroups and replicates., Conclusions: Overall, comparison of synthetic versus original real-world data demonstrated good validity and reliability. Transparency on the process to generate high fidelity synthetic data and assurances of patient privacy are warranted., (© 2024 John Wiley & Sons Ltd.)

Introduction: The impact of mRNA-based coronavirus disease-2019 (COVID-19) vaccines on atrial arrhythmias (AA) and ventricular arrhythmias incidence is unknown., Methods: BIOTRONIK Home Monitoring data and Medicare Claims data were utilized to identify individuals implanted with a cardiac implantable electronic device (CIED) between 2010 and 2020 who received one or more doses of COVID-19 vaccine in 2021. The burden of AA (%) in the 3 months postvaccination was compared to those noted in the preceding 3 months using the Wilcoxon signed rank test. Sub-analyses comparing the effects of the influenza vaccine against the COVID-19 vaccine were also evaluated for individuals who received the influenza vaccine in 2020. A 1:1 propensity score match comparison between COVID-19 vaccine and non-vaccinated patients was also performed., Results: First and second doses of the COVID-19 vaccine were administered to 7757 and 6579 individuals with a CIED (age 76.2 ± 9.0 years, 49% males), respectively. While a small but statistically significant increase in the burden of AA was noted in the 3 months postvaccination compared to the preceding 3 months after the first dose of the COVID-19 vaccine (0.43 ± 9.04%, p = .028) a similar rise in AA was found following the influenza vaccine and for matched patients who did not receive the COVID-19 vaccine. No significant difference in device therapies was seen pre- and postvaccination., Conclusions: Though we report a small but significant increase in the number of CIED-detected AAs following vaccination for COVID-19 over a 3-month window, we believe these results correlate more with time and the progressive nature of AF rather than the vaccine itself. While these data should not dissuade from the use of these vaccines, increased vigilance and prompt treatment of AF is required for high-risk groups, specifically males over 70 years of age, following vaccination., (© 2024 Wiley Periodicals LLC.)

Vaccines protect against many infectious diseases, including some that can directly or indirectly cause nervous system damage. Serious neurological consequences of immunization are typically extremely rare, although they have the potential to jeopardize vaccination programmes, as demonstrated most recently during the COVID-19 pandemic. Neurologists have an important role in identifying safety signals at population and individual patient levels, as well as providing advice on the benefit-risk profile of vaccination in cohorts of patients with diverse neurological conditions. This article reviews the links between vaccination and neurological disease and considers how emerging signals can be evaluated and their mechanistic basis identified. We review examples of neurotropic infections with live attenuated vaccines, as well as neuroimmunological and neurovascular sequelae of other types of vaccines. We emphasize that such risks are typically dwarfed by neurological complications associated with natural infection and discuss how the risks can be further mitigated. The COVID-19 pandemic has highlighted the need to rapidly identify and minimize neurological risks of vaccination, and we review the structures that need to be developed to protect public health against these risks in the future., (© 2024. Springer Nature Limited.)

Background: To counteract the coronavirus disease 2019 (COVID-19) pandemic, several severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) vaccines have been licensed since December 2020. Shortly after the start of the vaccination campaigns, occasional allergic reactions related to vaccines were described, thus, leading to concerns in many patients with a history of allergies. The aim of this work was to evaluate which anamnestic events represented a reason for an allergology work-up before COVID-19 vaccination. Furthermore, the results of the allergology diagnostics are described., Methods: We performed a retrospective data analysis of all patients who presented at the Center for Dermatology, Allergology and Dermatosurgery of the Helios University Hospital Wuppertal during the years 2021 and 2022 for allergology work-up prior to COVID-19 vaccination. Demographic data, allergological history, reason for the consultation in the clinic and results of allergology diagnostic tests including reactions after vaccination were included., Results: A total of 93 patients presented for allergology work-up with COVID-19 vaccines. In about half of the cases, the reasons for the presentation to the clinic were doubts and concerns about allergic reactions and side effects. In all, 26.9% (25/93) of the presented patients had not previously received a COVID-19 vaccine yet and 23.7% (22/93) of patients developed non-allergic reactions after prior COVID-19 vaccine (e.g., headache, chills, fever, malaise). Of the patients, 46.2% (43/93) were successfully vaccinated in the clinic due to a complex allergological history, while the remaining 53.8% (50/93) were subjected to outpatient vaccination in the vaccination practice. Only one patient with known chronic spontaneous urticaria developed a mild angioedema of the lips a few hours after vaccination; however, we do not consider this episode an allergic reaction to the vaccine due to the time delay., Conclusion: Allergic reactions after COVID-19 vaccines are rare, but many patients with a positive medical history of allergies are concerned about allergic reactions after COVID-19 vaccination. Thus, public work by practicing allergologists is important during vaccination campaigns to meet the concerns and fears of the population, especially of patients with allergies in their medical history., (© 2023. The Author(s).)

Background: Vaccination of the population is required to combat the COVID-19 pandemic. Allergy testing could reduce anxiety towards COVID-19 vaccination and thereby may increase vaccination rate, however, its effectiveness remains unclear., Methods: One hundred and thirty prospective real-life patients in need of but not daring to get vaccinated asked for allergy workup for COVID-19 vaccine hypersensitivity in 2021/2022. Characterization of patients, identification of anxieties, decrease of patient's anxiety levels, overall vaccination rate and adverse reactions after vaccination were assessed., Results: Tested patients were characterized by being female (91.5%) and having a high rate of previous allergies (e.g. to food 55.4%, drugs 54.6%, or previous vaccinations 50%) and dermatological disease (29.2%) but not always had medical contraindications for COVID-19 vaccination. Sixty one patients (49.6%) were highly concerned (4-6, Likert scale 0-6) about vaccination and 47 (37.6%) expressed resolving thoughts about vaccinaion anaphylaxis (3-6, Likert scale 0-6). However only 35 patients (28.5%) were scared of getting COVID-19 within 2 months (4-6, Likert scale 0-6) and only 11 (9%) patients had high expectations of getting COVID-19 (4-6, Likert scale 0-6). Allergy testing significantly (p < 0.01 to p < 0.05 respectively) reduced the median anxiety of allergic symptoms following vaccination: dyspnoea (4.2-3.1), to faint (3.7-2.7), long-term consequences (3.6-2.2), pruritus (3.4-2.6), skin rash (3.3-2.6) and death (3.2-2.6). After allergy testing, most patients (108/122, 88.5%) let themselves be vaccinated within 60 days. Revaccinated patients with previous symptoms experienced a reduction of symptoms (p < 0.05) upon revaccination., Conclusions: Patients not daring to get vaccinated have more anxiety towards vaccination than to acquire COVID-19. For those, allergy testing excludes vaccine allergy, and is a tool to increase vaccination willingness and thereby helps to combat vaccination hesitancy., (© 2023 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Fibrodysplasia ossificans progressiva (FOP) is a rare genetic disorder associated with increased immune activity and severe, progressive heterotopic ossification. We previously described a cohort of 32 patients with FOP who were either exposed to SARS-CoV-2 or received a COVID-19 vaccine1 and showed that these patients did not develop heterotopic ossification after COVID-19 vaccination. Here, we present additional clinical data from new subjects and additional long-term follow-up from the first cohort. We enrolled 15 new subjects between August 24th, 2021 and May 17th, 2022 and collected additional self-reported outcomes. The larger cohort with 47 individuals encompassing 49 events showed that patients with FOP exhibited no additional change in FOP disease activity or flare activity resulting from COVID-19 infection or after receipt of a SARS-CoV-2 vaccine. Thus, although any vaccination carries a risk of inducing heterotopic ossification in patients with FOP, our results show that patients with FOP who choose to receive a COVID-19 vaccination may be able to tolerate the procedure without a high risk of heterotopic ossification when following the published guidelines. [ABSTRACT FROM AUTHOR]

Recently, an article by Seneff et al. entitled "Innate immunosuppression by SARS-CoV-2 mRNA vaccinations: The role of G-quadruplexes, exosomes, and MicroRNAs" was published in Food and Chemical Toxicology (FCT). Here, we describe why this article, which contains unsubstantiated claims and misunderstandings such as "billions of lives are potentially at risk" with COVID-19 mRNA vaccines, is problematic and should be retracted. We report here our request to the editor of FCT to have our rebuttal published, unfortunately rejected after three rounds of reviewing. Fighting the spread of false information requires enormous effort while receiving little or no credit for this necessary work, which often even ends up being threatened. This need for more scientific integrity is at the heart of our advocacy, and we call for large support, especially from editors and publishers, to fight more effectively against deadly disinformation. [ABSTRACT FROM AUTHOR]

Objective: Vaccine hesitancy is a global concern and a significant threat to COVID-19 vaccination programs. This study aimed to explore vaccine hesitancy from the perspective of the Indonesian community related to policies and cultural beliefs., Design: A descriptive qualitative approach was utilized in this study., Sample: Twenty participants were recruited from various settings to ensure the representation of experiences in different contexts in Indonesia., Measurement: Audio-recorded, semi-structured, individual, in-depth interviews were carried out. Content analysis was performed to identify the main key themes., Results: Twenty participants were recruited from various regions of Java Island, Indonesia. The participants revealed hesitancy about the COVID-19 vaccine, including the themes of mistrust, controversy, and the culture and beliefs of the community., Conclusions: This study highlights COVID-19 vaccine hesitancy in Indonesia, which may have implications for the community's perceptions and beliefs regarding the uptake of the COVID-19 vaccine. The trust issue remains a major challenge to convincing the community to accept the vaccine at the grassroots level. Targeted education and communication strategies are essential in addressing trust issues surrounding COVID-19 vaccines among critical stakeholders and religious leaders in Indonesia. Public health nursing plays a crucial role in fostering community acceptance and ensuring the success of vaccination programs., (© 2024 Wiley Periodicals LLC.)

The immune response of patients with chronic liver disease tends to be lower after receiving their second coronavirus disease 2019 (COVID-19) vaccine dose, but the effect of a third vaccine dose on their immune response is currently unknown. We recruited 722 patients without previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection from three hospitals. The patients received homologous (MMM) and heterologous (AZAZBNT, AZAZM) boosters, where AZ, BNT, and M denoted the AZD1222, BNT162b2, and mRNA-1273 vaccines, respectively. Serum IgG spike antibody levels were measured at a mean 1.5 ± 0.7 (visit 1) and 5.0 ± 0.5 (visit 2) months after the third vaccine booster. A threshold of 4160 AU/mL was considered significant antibody activity. In both visits, the patients who received the MMM booster had higher anti-S-IgG levels than those who received the AZAZBNT and AZAZM boosters. Patients with active hepatocellular carcinoma (HCC) had lower anti-S-IgG levels than the control group (761.6 vs. 1498.2 BAU/mL; p = 0.019) at visit 1. The anti-S-IgG levels decreased significantly at visit 2. The patients with significant antibody activity had a lower rate of liver cirrhosis with decompensation (0.7% decompensation vs. 8.0% non-decompensation and 91.3% non-liver cirrhosis, p = 0.015), and active HCC (1.5% active HCC vs. 3.7% non-active HCC and 94.7% non-HCC, p < 0.001). Receiving the MMM booster regimen (OR = 10.67, 95% CI 5.20-21.91, p < 0.001) increased the odds of having significant antibody activity compared with the AZAZBNT booster regimen. Patients with active HCC had a reduced immune response to the third COVID-19 vaccine booster. These findings underscore the importance of booster vaccinations, especially in immunocompromised patients, with superior efficacy observed with the homologous mRNA-1273 regimen., (© 2024 The Authors. The Kaohsiung Journal of Medical Sciences published by John Wiley & Sons Australia, Ltd on behalf of Kaohsiung Medical University.)

My Turn is software used to manage several Covid-19 mass vaccination campaigns in California. The objective of this article is to describe the use of My Turn at two points of dispensing in California and comment on process improvements to reduce manual tasks of six identified processes of vaccination–registration, scheduling, administration, documentation, follow-up, and digital vaccine record–and paper. We reviewed publicly available documents of My Turn and patients vaccinated at George R. Moscone Convention Center in San Francisco and Oakland Coliseum Community Vaccination Clinic. For publicly available documents of My Turn, we examined videos of My Turn on YouTube, and documentation from EZIZ, the website for the California Vaccines for Children Program. For patients, we examined publicly available vaccination record cards on Instagram and Google. At the George R. Moscone Convention Center, 329,608 vaccines doses were given. At the Oakland Coliseum Community Vaccination Clinic, more than 500,000 vaccine doses were administered. The use of My Turn can be used to reduce manual tasks and paper for mass vaccinating patients against Covid-19. [ABSTRACT FROM AUTHOR]

Hypersensitivity reactions to drugs are increasing worldwide. They display a large degree of variability in the immunological mechanisms involved, which impacts both disease severity and the optimal diagnostic procedure. Therefore, drug hypersensitivity diagnosis relies on both in vitro and in vivo assessments, although most of the methods are not well standardized. Moreover, several biomarkers can be used as valuable parameters for precision medicine that provide information on the endotypes, diagnosis, prognosis, and prediction of drug hypersensitivity development, as well on the identification of therapeutic targets and treatment efficacy monitoring. Furthermore, in the last 2 years, the SARS-CoV-2 (severe acute respiratory syndrome-coronavirus) pandemic has had an important impact on health system, leading us to update approaches on how to manage hypersensitivity reactions to drugs used for its treatment and on COVID-19 (Coronavirus disease) vaccines used for its prevention. This article reviews recent advances in these 3 areas regarding drug hypersensitivity: in vitro tools for drug hypersensitivity diagnosis, recently identified biomarkers that could guide clinical decision making and management of hypersensitivity reactions to drugs and vaccines used for COVID-19., (© 2022 European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.)

Background: Urticaria following the COVID-19 vaccine was rarely reported and had a short self-limited resolution. However, there has been relatively little literature published on CSU induced by COVID-19 vaccines., Purpose: We describe a case series of patients who experienced CSU after SARS-CoV-2 vaccination., Methods: A retrospective case series of 10 patients referred to the Department of Clinical Pharmacology of the University of Monastir (January 2021-January 2022) and included for evaluation of urticaria after COVID-19 vaccination., Results: The median age was 31 years and patients were mostly female. Atopy was presented in 3 patients and urticaria was accompanied by angioedema in 6 patients. The median time interval between vaccination and the onset of urticaria was 28.5 h. The offended dose was the first one in 8 patients. The resolution of the eruption was observed at least 2 months later, despite the regular use of a full dose of antihistamine in nine patients. Polynuclear leucocytosis was identified in 5 patients. Anti-TPOAb was positive in one patient after receiving the BNT162b2 vaccine. Total serum IgE was elevated in 4 patients. Skin tests for the suspected vaccine as well as the vaccine excipient were negative., Conclusion: We add to the medical literature ten new cases of chronic spontaneous urticarial reactions following COVID-19 vaccines uncontrolled with high-dose first-generation H1 antihistamines., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Systemic allergic reactions to vaccines are very rare. In this study we assessed the management and outcome of suspected SARS-CoV-2 vaccine hypersensitivity., Methods: Totally, 334 individuals underwent an allergy work up regarding SARS-CoV-2 vaccination (group A: 115 individuals suspected to be at increased risk for vaccine-related reactions before vaccination and group B: 219 patients with reactions after COVID vaccination). The large majority of the SPT/IDT with the vaccines were negative; however, we identified in 14.1% (n = 47) a possible sensitization to the SARS-CoV-2 vaccine and/or its ingredients defined as one positive skin test. Of the 219 individuals (group B) who experienced symptoms suspicious for a hypersensitivity reaction after vaccination, 214 were reported after the first vaccination with a mRNA vaccine (157 mRNA (Comirnaty®, 38 Spikevax®) and 18 with a vector vaccine (Vaxzevria®), 5 cases were after the second vaccination., Results: The symptom profile in group B was as follows: skin symptoms occurred in 115 cases (n = 59 angioedema, n = 50 generalized urticaria and n = 23 erythema/flush. Seventy individuals had cardiovascular, 53 respiratory and 17 gastrointestinal symptoms. Of the overall 334 individuals, 78 patients tolerated (re)-vaccination (out of skin test positive/negative 7/19 from group A and 17/35 from group B)., Conclusion: Proven IgE-mediated hypersensitivity to SARS-CoV-2 vaccines is extremely rare and not increased in comparison with reported hypersensitivity to other vaccines. The value of skin tests is unclear and nonspecific reactions, in particular when intradermal testing is applied, should be considered., (© 2022 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.)

Following the outbreak of COVID-19, scientists rushed to develop vaccines to protect individuals and ferry the world out of the pandemic. Unfortunately, vaccine hesitancy is a major threat to the success of vaccination campaigns. Research on previous pandemics highlighted the centrality of perceived risk and confidence as core determinants of vaccine acceptance. Research on COVID-19 is less conclusive, and frequently it relies on one-country, cross-sectional data, thus making it hard to generalize results across contexts and observe these relationships over time. To bridge these gaps, in this article, we analyzed the association between perceived risk, confidence, and vaccine acceptance cross-sectionally at individual and country levels. Then, we longitudinally explored whether a within-country variation in perceived risk and confidence was correlated with a variation in vaccine acceptance. We used data from a large-scale survey of individuals in 23 countries and 19 time-points between June 2020 and March 2021 and comparative longitudinal multilevel models to estimate the associations at different levels of analysis simultaneously. Results show the existence of cross-sectional relationships at the individual and country levels but no significant associations within countries over time. This article contributes to our understanding of the roles of risk perception and confidence in COVID-19 vaccines' acceptance by underlining that these relationships might differ at diverse levels of analysis. To foster vaccine uptake, it might be important to address individual concerns and persisting contextual characteristics, but increasing levels of perceived risk and confidence might not be a sufficient strategy to increase vaccine acceptance rates., (© 2023 Society for Risk Analysis.)

Background: The relationship between behavioral problems and asthma is bidirectional; while the presence of a chronic disease such as asthma might predispose the person to stress, anxiety, and other behavioral issues, behavioral problems might in turn cause uncontrolled asthma through nonadherence to asthma management strategies. In Lebanon, behavioral problems and uncontrolled asthma could be of significant concern for adolescents. Consequently, we found it necessary to evaluate association between behavioral problems and uncontrolled asthma in a sample of Lebanese adolescents., Methods: Data for this cross-sectional study were collected using the snowball sampling technique in July 2023. The questionnaire was developed with Google Forms and distributed to participants via social media platforms and messaging applications. The Asthma Control Test (ACT) was used to check for uncontrolled asthma, and the Youth Self-Report (YSR) scale was used to assess behavioral problems. It yields nine subscales (anxious-depressed, withdrawn-depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, aggressive behavior, and other problems) and a total score., Results: When taking each behavior score as an independent variable, older age was associated with lower ACT scores (more controlled asthma); F(15, 186) = 3.66, P = 0.014, and 95% Confidence Interval (CI) [-0.85, -0.10]. Living in a rural area, compared to urban was associated with higher ACT scores, P = 0.018, and 95% Confidence Interval (CI) [0.28, 2.94]. The intake of the COVID-19 vaccine, P = 0.003 and 95% CI [0.73, 3.55]; waterpipe smoking, P = 0.017 and 95% CI [0.38, 3.85]; and having more somatic complaints, P = 0.005 and 95% CI [0.04, 0.25], also were significantly associated with higher ACT scores (more uncontrolled asthma). When taking the total behavior score as an independent variable, higher YSR scores were associated with higher ACT scores (more uncontrolled asthma), F(10, 191) = 4.30, P = 0.038, and 95% CI [0.003, 0.10]., Conclusion: Our findings support the inclusion of mental health treatments for better asthma control and point to a link between behavioral issues and uncontrolled asthma. In a developing nation without a clear established strategy for asthma prevention, the findings of this study could help develop potentially beneficial public health treatments., Competing Interests: The authors have nothing to disclose.

Background: There are few publications regarding manifestations of vestibular disorders (VDs) following BNT162b2 mRNA COVID-19 vaccination., Purpose: We describe cases of VD potentially related to BNT162b2 vaccination and calculate its reporting rate, in order to enlarge knowledge about this adverse effect., Methods: A retrospective analysis of cases of VD following BNT162b2 vaccination reported to the pharmacovigilance centre of Georges-Pompidou European Hospital (France), in 2021 was performed. In order to identify these cases from the pharmacovigilance database containing all our registered cases, we used the Standardised MedDRA Query (SMQ) 'vestibular disorders'. Then we analysed cases with vestibular symptoms, based on the association of typical manifestations. The reporting rate was calculated based on the number of VD cases and the number of vaccinated patients., Results: Among 6608 cases reported to our centre related to COVID-19 vaccines during 2021, 34 VDs associated with BNT162b2 administration were included. They were mainly reported in females (79%), 62% occurred after the first dose and 32% were serious. Symptoms had completely resolved in 13 cases (38%). Vertigo was the most common symptom followed by balance disorders. Three patients received second dose without reappearance of VD. The final diagnosis was reported in 10 patients (six cases of vestibular neuritis, two cases of central VD, two cases of benign paroxysmal positional vertigo). The regional reporting rate was 26 [95% CI: 17-34] cases of VD per 1 million persons vaccinated., Conclusion: Although the relationship between vaccination and VD cannot be established, clinicians should be aware of this rare adverse effect., (© 2023 Société Française de Pharmacologie et de Thérapeutique Published by John Wiley & Sons Ltd.)

The initial period of vaccination shows strong heterogeneity between countries' vaccinations rollout, both in the terms of the start of the vaccination process and in the dynamics of the number of people that are vaccinated. A predominant thesis for this observation is that a key determinant of the swift and extensive vaccine rollout is state capacity. Here, we utilize two measures that quantify different aspects of the state capacity: (i) the external capacity (measured through the soft power of the country) and (ii) the internal capacity (measured via the country's government effectiveness) and provide an empirical test for their relationship with the coronavirus vaccination outcome in the initial period (up to 31st March 2021). By using data on 128 countries and a two-step Heckman approach, we find that the soft power is a robust determinant of whether a country has started with the vaccination process. In addition, the government effectiveness is a key factor that determines vaccine roll-out. Altogether, our findings are in line with the hypothesis that state capacity determines the observed heterogeneity between countries in the initial period of COVID-19 vaccines rollout. As such, they are a stark reminder for the need for transparent and fair global response regarding fair and equitable availability of vaccines to every country., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

COVID-19 pandemic has raised concerns for a number of strategical social interactions. From quarantines and social distancing to vaccination and geopolitics, the cooperation or even the coordination of efforts has been challenging, as governments, economic sector, institutions, and individuals, often have conflicting interests. Game theory, which is a mathematical tool extensively used in order to determine the outcomes of strategical interactions, has been applied to a number of issues arising from the pandemic. In this paper, 60 publications are analyzed to identify the key contributions of game theory to addressing COVID-19. First, 10 keywords-topic are chosen and each publication is examined to consider if it deals with these topics. Then R package "igraph" and cluster Louvain are used in order to group the papers to 3 clusters. The results indicate that there is a temporal variation in the topics examined. In the beginning the main concern has been coupling the modelling of the transmission of the virus with social distancing responses from the public and quarantining policy. Then the economic implications of the pandemic drew the attention and finally the application of the vaccination campaigns and the cooperation of the individuals with vaccination guidelines. The paper targets on bridging the gap between game theorists and epidemiologists, illustrating how modelling agents interactions can improve responses. The clusters created can help researchers identify groups of problems that can be addressed jointly, using similar approaches. The analysis indicates that game theory can reveal social aspects that can improve the responses to future emergencies. [ABSTRACT FROM AUTHOR]

Background: COVID-19 vaccines have been recommended to people with multiple sclerosis (pwMS) and, to ensure durable immunity, a third booster dose has been administered in several countries. Data about potential risks associated with the third booster dose in pwMS, such as vaccine-triggered disease exacerbations, are still scarce., Objective: To investigate whether the administration of a third booster dose of mRNA COVID-19 vaccines was associated with an increased risk of short-term disease reactivation in a large cohort of pwMS., Methods: We retrospectively selected 1265 pwMS who received a third booster dose of an mRNA COVID-19 vaccine. Demographic and clinical data were collected, including the presence, number and characteristics of relapses in the 60 days prior to and after the third booster dose., Results: In the selected cohort, the relapse rate in the two months after administration of the third booster dose of mRNA COVID-19 vaccines did not increase when compared with the prior two months. Indeed, the percentage of pwMS experiencing relapses in the 60 days following the administration of the third booster dose was 2.1%, similar to the percentage recorded in 60 days prior to vaccination, which was 1.9%., Conclusions: The third booster dose of mRNA COVID-19 vaccines appeared to be safe for pwMS., (© 2023. The Author(s).)

In addition to proteins, discussed in the Chapter "Advances in Vaccine Adjuvants: Nanomaterials and Small Molecules", there are a wide range of alternatives to small molecule active ingredients. Cells, extracellular vesicles, and nucleic acids in particular have attracted increasing research attention in recent years. There are now a number of products on the market based on these emerging technologies, the most famous of which are the mRNA-based vaccines against SARS-COV-2. These advanced therapeutic moieties are challenging to formulate however, and there remain significant challenges for their more widespread use. In this chapter, we consider the potential and bottlenecks for developing further medical products based on these systems. Cells, extracellular vesicles, and nucleic acids will be discussed in terms of their mechanism of action, the key requirements for translation, and how advanced formulation approaches can aid their future development. These points will be presented with selected examples from the literature, and with a focus on the formulations which have made the transition to clinical trials and clinical products., (© 2023. The Author(s), under exclusive license to Springer Nature Switzerland AG.)

The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

We implemented a clustered randomized controlled trial with 6,963 residents in six rural Ghana districts to estimate the causal impact of financial incentives on coronavirus disease 2019 (COVID-19) vaccination uptake. Villages randomly received one of four video treatment arms: a placebo, a standard health message, a high cash incentive (60 Ghana cedis) and a low cash incentive (20 Ghana cedis). For the first co-primary outcome-COVID-19 vaccination intentions-non-vaccinated participants assigned to the cash incentive treatments had an average rate of 81% (1,733 of 2,168) compared to 71% (1,895 of 2,669) for those in the placebo treatment arm. For the other co-primary outcome of self-reported vaccinations 2 months after the initial intervention, the average rate for participants in the cash treatment was 3.5% higher than for participants in the placebo treatment (95% confidence interval (CI): 0.001, 6.9; P = 0.045): 40% (602 of 1,486) versus 36.3% (672 of 1,850). We also verified vaccination status of participants: in the cash treatment arm, 36.6% (355 of 1,058) of verified participants had at least one dose of the COVID-19 vaccine compared to 30.3% (439 of 1,544) for those in the placebo-a difference of 6.3% (95% CI: 2.4, 10.2; P = 0.001). For the intention and the vaccination outcomes, the low cash incentive (20 Ghana cedis) had a larger positive effect on COVID-19 vaccine uptake than the high cash incentive (60 Ghana cedis). Trial identifier: AEARCTR-0008775 ., (© 2023. The Author(s).)