Extensive vaccination campaigns against COVID-19 have played a significant role in controlling virus spread and preventing severe illness. This study focused on breakthrough infections in vaccinated individuals, raising concerns about vaccine effectiveness against SARS-CoV-2 variant immune escape, with particular attention to lineage distribution among vaccinated and unvaccinated individuals.

A case-control study was conducted from January to April 2023, sequencing 298 samples from participants who tested positive for COVID-19 via rapid diagnostic test (RDT) from 22 health facilities, including vaccinated and unvaccinated cases. Besides clinical and epidemiological data, nasopharyngeal swabs were obtained, and reverse transcription quantitative polymerase chain reaction (RT-qPCR) was conducted to determine Cycle threshold (Ct) values, followed by whole genome sequencing of 298 samples fulfilling sequencing criteria to identify variants of concern and specific virus lineages.

Out of 298 samples sequenced, 281 fulfill quality for analysis with 44.8% (126) had received at least one COVID-19 vaccine dose, while 51.9% (146) were not vaccinated, and 3.2% (9) patients had no vaccination records. The analysis showed that all cases were of the Omicron variant, with the XBB.1.5 lineage being the most prevalent (38.4%), followed by FL.2 (9.3%) and XBB.1.9.1.2 (7.8%). The remaining 44.5% comprised a combination of 22 other lineages. The XBB.1.5 variant accounted for 51 (47.2%) cases among vaccinated individuals with at least one dose and 57 (52.8%) among unvaccinated, showing relatively similar prevalence across both groups. The viral load as indicated by the Ct value varied widely, with a significant appearance in the lower ranges (high viral load), suggesting active viral replication. Notably, 25% of samples exhibited high viral loads (Ct values 13-15), showing the high transmissibility of the XBB.1.5 lineage among both vaccinated and unvaccinated populations.

The findings emphasize the need for continuous genomic surveillance and regular vaccine updates to address emerging SARS-CoV-2 variants, particularly the immune-evasive XBB lineage. The high prevalence of variants like XBB.1.5 in breakthrough infection underscores the importance of adaptive vaccination strategies and next-generation vaccines to maintain efficacy. Ongoing monitoring of variant dynamics is crucial for informed public health responses, strengthening pandemic preparedness and future outbreak prevention.

Messenger RNA (mRNA) has great potential to provide innovative medical solutions in the treatment of heart failure. Although lipid nanoparticles (LNPs) are an established mRNA delivery system, effectively delivering LNPs to the heart remains a significant challenge. Here, we evaluated the efficacy of transcatheter intracoronary (IC) administration compared to intravenous (IV) and intramyocardial (IM) administration in normal and ischemia-reperfusion (I/R) model rabbit hearts using LNPs encapsulating Firefly Luciferase (FLuc) mRNA. In the normal model, IVIS spectrum data showed that FLuc expression was widespread throughout the heart in the IC group and was significantly higher than in the IV group, and comparable to the IM group, where it was highly expressed only at the injection sites. Histological analysis revealed that FLuc-expressing cells were observed in cardiomyocytes, endothelial cells, smooth muscle cells, and fibroblasts. In the I/R model, FLuc expression was also significantly higher in the IC group than the IV group, and comparable to the IM group. Although FLuc expression was strongly observed in the infarct area in all three delivery groups, the IC group demonstrated the most widespread FLuc expression in the remote area. Histological analysis revealed significantly higher FLuc-expressing cells in the remote area in the IC group than in the other groups. IC administration effectively delivered mRNA-LNPs not only to the infarct area (damaged area) but also to the remote area (non-damaged area) in the diseased heart. Moreover, VEGF mRNA-LNP administration via the IC method to I/R model rabbit hearts significantly reduced the infarct area and attenuated the impairment of cardiac function caused by I/R injury compared to the other methods. Considering the invasiveness and clinically limited applications of IM administration, our study suggests that less invasive IC administration is a clinically safe and useful method for mRNA-LNP delivery to a wider range of myocardial tissue in the heart.

When developing public health measures in a pandemic, it is important to examine attitudes and beliefs relating to vaccination uptake. We report the discrimination of a single-item vaccination intention scale and derive cutpoints in terms of sensitivity (true positives) and specificity (true negatives) in relation to subsequent vaccination status.

In a sample of UK adults (n=1119) recruited through an online survey platform, vaccination intention was measured on a 0-10 numerical rating scale (0=very unlikely, 10=very likely) at the beginning of the UK COVID-19 vaccination rollout (January 2021), and self-reported vaccination status was gathered after vaccination had been offered to all adults (October 2021). Discrimination of the scale was measured by the area under the receiver operating characteristic (ROC) curve.

The responders reporting being vaccinated or unvaccinated were 1034 (92.4%) and 85 (7.6%), respectively. The area under the ROC curve was.956 (95% CI.943,.967), indicating a high degree of discrimination. The combined value of sensitivity and specificity was greatest at a cutpoint of 8 on the scale (sensitivity =.821, specificity =.988). If, however, the individual values of sensitivity and specificity are required to be simultaneously optimized, this occurs at point 6 (sensitivity =.886, specificity =.871).

We recommend a 0-10 intention scale as a validated, practical measure of vaccination intention in public health practice, with a cutpoint of 8 on the scale as optimal, unless sensitivity and specificity are to be simultaneously optimized, when 6 is the optimal cutpoint.

While several studies have reported some cases of polymyalgia rheumatica (PMR) following COVID-19 vaccination, studies using large databases are lacking.

To investigate the risk of PMR after COVID-19 vaccination using self-controlled case series (SCCS) analysis METHODS: We used the National Health Insurance Database, linked with the COVID-19 registry between February 2021 and August 2023, to identify adults aged 50 years or older who received at least one dose of COVID-19 vaccine and subsequently diagnosed with PMR within the observation period, defined as 240 days after the first dose of vaccine. The risk window was defined as 28 days after each dose of COVID-19 vaccination, and the control window encompassed the remainder of the observation period. Incidence rate ratios (IRRs) were estimated using conditional Poisson regression with 95% CIs, stratified by dose and vaccine type.

Among 44 818 078 COVID-19 vaccine recipients, 376 patients were diagnosed with PMR. The analysis indicated that COVID-19 vaccination was not associated with an increased risk of PMR (IRR, 0.74; 95% CI 0.59 to 0.94). Rather, the risk of PMR was slightly reduced after the first dose (0.52; 0.34 to 0.79), with no significant association with other doses of COVID-19 vaccine (0.83; 0.59 to 1.16 for second dose, 0.77, 0.48 to 1.25 for third dose).

In this nationwide SCCS, there was no association with the increased risk of PMR following COVID-19 vaccination. While these findings support the safety of COVID-19 vaccines, interpretation of the decreased risk of PMR should be cautious.

Background/Objectives: Post-market surveillance of COVID-19 vaccines is vital. This study analyzed EudraVigilance data (Jan 2021-Dec 2023) to detect potential safety signals linking COVID-19 vaccines and specific neurological adverse events (aseptic meningitis, Guillain-Barré syndrome, polyradiculoneuropathies, multiple sclerosis, transverse myelitis, neuromyelitis optica). It also explored the impact of non-healthcare professional reports on disproportionality analysis. Methods: EudraVigilance reports were analyzed to quantify neurological events for 5 COVID-19 vaccines and 47 comparators. Disproportionality was assessed using the Proportional Reporting Ratio (PRR). Spearman's correlation (SCC) was used to examine the impact of non-healthcare professional reports on PRR. Results: An analysis of 4,159,820 COVID-19 vaccine and 114,025 comparator reports showed a reporting decline over time. A higher proportion of adverse drug event reports were submitted by non-healthcare professionals for COVID-19 vaccines compared to control vaccines, a trend observed consistently across 2021 (57.3% vs. 33%, p < 0.001), 2022 (59.4% vs. 36.5%, p = 0.001), and 2023 (42% vs. 24.36%, p = 0.006). In 2023, significant signals (PRR ≥ 2) were found between Jcovden© and polyradiculoneuropathy (PRR 5.4, IC 95% 3.98-7.32), multiple sclerosis (PRR 2.72, IC 95% (1.08-6.87), transverse myelitis (PRR 4.68, IC 95% 1.02-21.35) and neuromyelitis optica (PRR 7.79, IC 95% 3.5-17.37). In addition, both Spikevax© and Comirnaty© showed significant signals with multiple sclerosis (PRR 2.50, IC 95% 1.70-3.68, and PRR 2.33, IC 95% 1.68-3.24) and transverse myelitis (PRR 3.50, IC 95% 1.66-7.50 and PRR 3.58, IC 95% 1.85-6.93). A significant negative correlation between the proportion of reports from non-healthcare professionals and the case/no-case ratio was found (SCC = -0.4683, p = 0.009). Conclusions: While some significant signals emerged in 2023, the combined three-year data showed no vaccine exceeding the PRR threshold of 2. High-quality data and bias mitigation strategies are crucial for accurate PRR estimation in pharmacovigilance and public health.

Vaccination has been instrumental in curbing the transmission of SARS-CoV-2 and mitigating the severity of clinical manifestations associated with COVID-19. Numerous COVID-19 vaccines have been developed to this effect, including BioNTech-Pfizer and Moderna's mRNA vaccines, as well as adenovirus vector-based vaccines such as Oxford-AstraZeneca. However, the emergence of new variants and subvariants of SARS-CoV-2, characterized by enhanced transmissibility and immune evasion, poses significant challenges to the efficacy of current vaccination strategies. In this review, we aim to comprehensively outline the landscape of emerging SARS-CoV-2 variants of concern (VOCs) and sub-lineages that have recently surfaced in the post-pandemic years. We assess the effectiveness of existing vaccines, including their booster doses, against these emerging variants and subvariants, such as BA.2-derived sub-lineages, XBB sub-lineages, and BA.2.86 (Pirola). Furthermore, we discuss the latest advancements in vaccine technology, including multivalent and pan-coronavirus approaches, along with the development of several next-generation coronavirus vaccines, such as exosome-based, virus-like particle (VLP), mucosal, and nanomaterial-based vaccines. Finally, we highlight the key challenges and critical areas for future research to address the evolving threat of SARS-CoV-2 subvariants and to develop strategies for combating the emergence of new viral threats, thereby improving preparedness for future pandemics.

The overlapping global crises of war, pandemic, and inflation have hit the poorest countries the hardest. Political and security risks have risen in nearly all nations, with those lacking resources suffering from significant preparedness gaps. Similar to other developing regions, Ethiopia's Tigray has experienced many of these effects. This study analyzes the only available data to assess COVID-19 incidence and mortality trends and identify the key influencing factors.

A quantitative analysis was performed using the available incidence and mortality data from the Tigray region prior to the war and from Mekelle town for the 11 weeks during the war. This analysis was complemented by qualitative insights obtained conducted through interviews. Vaccination data covering the years 2021-2023 were also available for the Tigray region. Multiple datasets were selected for comparison purposes based on their relevance to the research objectives. Key informant interviews were conducted with members of the regional response team. Narrative analysis and a deductive approach were applied for systematic coding and thematic analysis of the interviews using Atlas.ti. The study was conducted from 1 January 2023 to 10 December 2024.

The region established an Emergency Operation Center with seven pillars to coordinate the overall response efforts. The COVID-19 positivity rate before the war varied between 0.97 and 20%. During the war, when services were briefly resumed for 10 weeks in Mekelle city, 3,802 cases were detected from 13,213 tests conducted, resulting in a positivity rate of 28.8%. During the same period, 85 deaths were reported. Only 45.9% of the eligible population was fully vaccinated, while nearly 29% had received only the first dose of a two-dose vaccine. Despite challenges, key opportunities included government commitment, strong communication between local experts and international institutions, and local resource mobilization. However, the crisis exposed the fragility of the health system, leading to a significant loss of life.

While the region initially managed to delay the onset of COVID-19 and maintain lower positivity and fatality rates, the war in Tigray led to severe disruption and the eventual collapse of the health system. As a result, the disease was largely neglected and deprioritized, even after the signing of the cessation of hostilities agreement.

Vaccination was the single most effective measure in mitigating the impact of the COVID-19 pandemic. Our study aims to quantify the impact of vaccination programmes during the initial year of vaccination (2021) by estimating the number of case fatalities avoided, using Sweden as a case study.

Using Swedish data on age-specific reported incidence and vaccination uptake, along with vaccine efficacies, age-specific contact patterns and under-reporting from the literature, we fit a Bayesian SEIR epidemic model with time-varying community contact rate for COVID-19 incidence. Age-specific fatality rates from the literature are adjusted proportionally to fit the observed number of case fatalities in the factual analysis, resulting in 5,510 (95% PI: 5,370-5,650) matching the observed number 5,430. The estimated time-varying community contact rate is then used in a counterfactual analysis where the population is unvaccinated, leading to more infections and fatalities. A sensitivity analysis is performed to identify which parameters influence our conclusions.

The counterfactual analysis result in a severe epidemic outbreak during the early autumn of 2021, resulting in about 37,100 (36,700-37,500) number of case fatalities. Consequently, the number of lives saved by the vaccination programme is estimated to be about 31,600 (31,300-32,000), out of which 5,170 are directly saved and 26,400 are indirectly saved, mainly by drastically reducing the severe outbreak in the early autumn of 2021, which would have occurred without vaccination and unchanged community contact rate.

Our mathematical model is used to analyse the impact of COVID-19 vaccination on lives saved in Sweden during 2021, but the same methodology can be applied to other countries. The counterfactual analysis offers insights into an alternative trajectory of the pandemic without vaccination. The results show the direct impact of vaccination on reducing deaths for infected individuals and shed light on the indirect effects of reduced transmission dynamics.

With the emergence of Omicron during the pandemic and the establishment of antibody waning over time, vaccine effectiveness, especially against infection, declined sharply from the original levels seen after the initial rollout. However, studies have demonstrated that they still provided substantial protection vs severe/fatal disease even with Omicron and after waning. Social media has been rife with reports claiming vaccines provided no benefit and some even claiming they made things worse, often driven by simple presentations of raw observational data using erroneous arguments involving epidemiologic fallacies including the base rate fallacy, Simpson's paradox, and the ecological fallacy and ignoring the extensive bias especially from confounding that is an inherent feature of these data. Similar fallacious arguments have been made by some in promoting vaccination policies, as well. Generally, vaccine effectiveness cannot be accurately estimated from raw population summaries but instead require rigorous, careful studies using epidemiologic designs and statistical analysis tools attempting to adjust for key confounders and sources of bias. This article summarizes what aggregated evidence across studies reveals about effectiveness of the mRNA vaccines as the pandemic has evolved, chronologically summarized with emerging variants and highlighting some of the fallacies and flawed arguments feeding social media-based claims that have obscured society's collective understanding.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been widespread since 2020 and will likely continue to cause substantial recurring epidemics. However, understanding the underlying infection burden and dynamics, particularly since late 2021 when the Omicron variant emerged, is challenging. Here, we leverage extensive surveillance data available in New York City (NYC) and a comprehensive model-inference system to reconstruct SARS-CoV-2 dynamics therein through August 2023.

We fit a metapopulation network SEIRSV (Susceptible-Exposed-Infectious-(re)Susceptible-Vaccination) model to age- and neighborhood-specific data of COVID-19 cases, emergency department visits, and deaths in NYC from the pandemic onset in March 2020 to August 2023. We further validate the model-inference estimates using independent SARS-CoV-2 wastewater viral load data.

The validated model-inference estimates indicate a very high infection burden-the number of infections (i.e., including undetected asymptomatic/mild infections) totaled twice the population size ( > 5 times documented case count) during the first 3.5 years. Estimated virus transmissibility increased around 3-fold, whereas estimated infection-fatality risk (IFR) decreased by >10-fold during this period. The detailed estimates also reveal highly complex variant dynamics and immune landscape, and higher infection risk during winter in NYC over the study period.

This study provides highly detailed epidemiological estimates and identifies key transmission dynamics and drivers of SARS-CoV-2 during its first 3.5 years of circulation in a large urban center (i.e., NYC). These transmission dynamics and drivers may be relevant to other populations and inform future planning to help mitigate the public health burden of SARS-CoV-2.

The efficacy of COVID-19 vaccines against the Delta variant has been observed to be high, both against severe disease and infection. The full population level vaccine effectiveness, however, also contains the indirect effects of vaccination, which require analysis of transmission dynamics to uncover. Finland was close to naïve to SARS-CoV-2 infections before the Delta dominant era, and non-pharmaceutical interventions (NPIs) were at an internationally low level. We utilize Finnish register data and a mathematical model for transmission and COVID-19 disease burden to construct a completely unvaccinated control population and estimate the different components of the vaccine effectiveness. The estimated direct effectiveness was 72% against COVID-19 cases and 87-96% against severe disease outcomes, but the estimated indirect effectiveness was even better, 93% against cases and 94-97% against severe disease. The total and overall effectiveness, including both direct and indirect effects of vaccination, were thus excellent. Our results show how well the population was protected by vaccination during the Delta era, especially by the indirect effectiveness, providing protection also to the unvaccinated part of the population. The estimated averted numbers of hospitalizations, ICU admissions, and deaths in Finland during the Delta era under the implemented NPIs were about 100 times the observed numbers.

SARS-CoV-2 disease (COVID-19) has had an enormous health and economic impact globally. Although primarily a respiratory illness, multi-organ involvement is common in COVID-19, with evidence of vascular-mediated damage in the heart, liver, kidneys and brain in a substantial proportion of patients following moderate-to-severe infection. The pathophysiology and long-term clinical implications of multi-organ injury remain to be fully elucidated. Age, gender, ethnicity, frailty and deprivation are key determinants of infection severity, and both morbidity and mortality appear higher in patients with underlying comorbidities such as ischaemic heart disease, hypertension and diabetes. Our aim is to gain mechanistic insights into the pathophysiology of multiorgan dysfunction in people with COVID-19 and maximise the impact of national COVID-19 studies with a comparison group of COVID-negative controls.

COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19 (COSMIC) is a prospective, multicentre UK study which will recruit 200 subjects without clinical evidence of prior COVID-19 and perform extensive phenotyping with multiorgan imaging, biobank serum storage, functional assessment and patient reported outcome measures, providing a robust control population to facilitate current work and serve as an invaluable bioresource for future observational studies.

Approved by the National Research Ethics Service Committee East Midlands (REC reference 19/EM/0295). Results will be disseminated via peer-reviewed journals and scientific meetings.

COSMIC is registered as an extension of C-MORE (Capturing Multi-ORgan Effects of COVID-19) on ClinicalTrials.gov (NCT04510025).

In this paper, we draw on qualitative methods from the medical humanities and quantitative approaches from corpus linguistics to assess the different mappings of pandemic risks by Twitter (X) users employing the #Covid19nz hashtag. We look specifically at their responses to government measures around vaccines between August and November 2021. Risk, we reveal, was a major discursive thread in tweets during this period, but within our tweets, it was the vaccine rather than the virus around which hazard perception and response were grouped. We find that the discursive stance of those opposed to the vaccine evoked entangled medical and political hazards, untrustworthy experts, obscure information, restrictions on sovereignty, threats to children, and uncertain future dangers, all of which positioned them within what Ulrich Beck termed the world risk society. We also found that these narratives of risk manifested in specific Twitter styles, which employed a consistently larger number of hashtags. The lack of conjunctions between the hashtags, we argue, encouraged a disordered reading of doubt and precaution, as the hashtags presented triggering phrases whose interconnections were hinted at rather than specified. By contrast, those who tweeted in support of government measures were rhetorically led by solutions rather than risks, with one exception: their perception of those who were vaccine opposed. We use scholarship on risk and precautionary logic to map out the contrasting positions in tweets addressing Aotearoa New Zealand's pandemic experience during the closing months of 2021.

The COVIVAX study assessed the association between COVID-19 vaccination and the risk of common neurological disorders in a multicenter case-control design. Vaccination exposure was compared between individuals with a first diagnosis of a neurological disorder (cases) and age- and sex-matched controls. A total of 624 participants were enrolled, and after random 1:1 matching 265 cases and 265 matched controls (total 530 participants) were included in the analyses. The most frequent neurological diagnosis in cases were stroke (60.4%), multiple sclerosis (11.3%) and seizures (6.4%). The proportion of vaccinated participants was 72.1% among cases and 79.6% among controls. A protective role of vaccination on the risk of developing a new neurological disorder was detected in the unadjusted analysis (OR 0.50; 95% CI 0.29-0.86; p = 0.0114). After adjustment for confounders, the number of vaccination doses received was associated with a reduced risk of developing new neurological disorders for participants aged over 60 years ( p = 0.0472; OR 0.14, 95% CI 0.03-0.68), with pre-existing comorbidities (p = 0.0122; OR 0.04, 95% CI 0.01-0.99) and for stroke (p = 0.0232; OR 0.04, 95% CI 0.02-0.97). The COVIVAX study provided no warning sign regarding an increase in the risk of developing new neurological disorders following COVID-19 vaccination of any type or doses. A potentially protective effect of multiple doses of COVID-19 vaccines against the risk of stroke in people aged over 60 needs to be confirmed by further studies.

The integration of real-world evidence (RWE) from real-world data (RWD) in clinical research is crucial for bridging the gap between clinical trial results and real-world outcomes. Analyzing routinely collected data to generate clinical evidence faces methodological concerns like confounding and bias, similar to prospectively documented observational studies. This study focuses on additional limitations frequently reported in the literature, providing an overview of the challenges and biases inherent to analyzing routine clinical care data, including health claims data (hereafter: routine data).

We conducted a literature search on routine data studies in four high-impact journals based on the Journal Citation Reports (JCR) category "Medicine, General & Internal" as of 2022 and three oncology journals, covering articles published from January 2018 to October 2023. Articles were screened and categorized into three scenarios based on their potential to provide meaningful RWE: (1) Burden of Disease, (2) Safety and Risk Group Analysis, and (3) Treatment Comparison. Limitations of this type of data cited in the discussion sections were extracted and classified according to different bias types: main bias categories in non-randomized studies (information bias, reporting bias, selection bias, confounding) and additional routine data-specific challenges (i.e., operationalization, coding, follow-up, missing data, validation, and data quality). These classifications were then ranked by relevance in a focus group meeting of methodological experts. The search was pre-specified and registered in PROSPERO (CRD42023477616).

In October 2023, 227 articles were identified, 69 were assessed for eligibility, and 39 were included in the review: 11 on the burden of disease, 17 on safety and risk group analysis, and 11 on treatment comparison. Besides typical biases in observational studies, we identified additional challenges specific to RWE frequently mentioned in the discussion sections. The focus group had varied opinions on the limitations of Safety and Risk Group Analysis and Treatment Comparison but agreed on the essential limitations for the Burden of Disease category.

This review provides a comprehensive overview of potential limitations and biases in analyzing routine data reported in recent high-impact journals. We highlighted key challenges that have high potential to impact analysis results, emphasizing the need for thorough consideration and discussion for meaningful inferences.

Healthcare Workers (HCWs) are at ongoing risk of SARS-CoV-2 infection, potentially contributing to its transmission. This study assessed full vaccination and vaccination timeliness impact on SARS-CoV-2 infections among HCWs in Italy's Marche Region, using Healthcare Utilization Databases. We evaluated vaccination coverage and its associated factors. The cohort comprised 21,118 HCWs aged 18-70 from the region's five Local Health Authorities (LHA), enrolled between February 2020 - May 2021. Factors associated with full vaccination were assessed using multiple logistic regression. The impact of vaccination status, time to vaccination, occupational role, age, gender, and health status on infection risk was analysed with a multiple Cox regression model, adjusting for vaccination coverage velocity, swabbing probability, and monthly intensive care unit admissions rate in each LHA. Of the cohort, 81.2% were fully vaccinated. Factors associated with full vaccination included age, role, LHA, prior infection, and health status. Vaccination reduced infection risk by 77% (95% CI: 70-82). Infection risk was higher among healthcare assistants, nurses/physiotherapists/technicians compared to physicians, among male HCWs, and it decreased as vaccination timeliness increased. Vaccination timeliness is crucial for reducing SARS-CoV-2 infection risk among HCWs, regardless of their characteristics. This underscores the importance of efficiently organizing vaccination administration across different territories and for all HCW categories.

On March 11, 2020, the World Health Organization declared Coronavirus disease 2019 (COVID-19) as a pandemic. The spread of the Delta variant of coronavirus started in June 2021 and accounted for the fifth peak of COVID-19 in Iran in July 2021. According to reports from other countries, vaccination protects against severe diseases caused by COVID-19, including the Delta variant. Studies have also shown that vaccination provides strong protection against SARS-CoV-2 infection, COVID-19-related hospitalization, and mortality. This retrospective cohort study was designed based on the medical care monitoring center database of Sayyad Shirazi Hospital.

COVID-19 confirmed patients' data were extracted for this study from June 22, 2021, to September 22, 2021 including demographic characteristics, signs and symptoms, ICU admission, need for aggressive oxygen therapy, including intubation, mortality, and vaccination status.

A total of 2962 patients were enrolled. Being vaccinated was associated with a 4.14-fold increase in survival (adjusted OR = 4.14; 95% CI: 2.22-7.69; p < 0.01), and individuals in a younger age group demonstrated a 5.58-fold higher likelihood of surviving (adjusted OR = 5.58; 95% CI: 4.25-8.14; p < 0.01). The risk of severe COVID-19 was significantly lower in vaccinated individuals, showing a 3.12-fold decrease in risk (adjusted OR = 3.12; 95% CI: 2.06-4.72; p < 0.01), and in younger age groups, the risk exhibited a 3.28-fold decrease (adjusted OR = 3.28; 95% CI: 2.66-4.04; p < 0.01).

The present results suggest that receiving at least one dose of COVID-19 vaccine had a significant relationship with decreased COVID-19 severity and mortality in vaccinated patients compared to unvaccinated patients.

Vaccination is the most important preventive measure to protect people from coronavirus disease 2019 (COVID-19). Governments worldwide have prioritized their vaccination policy against COVID-19. However, there is a lack of relevant research on Taiwanese attitudes and considerations toward COVID-19 vaccination. This study aimed to investigate the cognition, preventive behaviors, and attitudes toward COVID-19 vaccines that influence people's willingness to get vaccinated in Taiwan.

From October 1 to 31, 2021, a computer-assisted telephone interview system was used to randomly select Taiwanese people to investigate their COVID-19 preventive behaviors, knowledge, and willingness to be vaccinated.

We included 2000 participants of whom 96.45% showed vaccination willingness. The overall mean age and knowledge scores were 48.6 years and 5.78, respectively. All of the participants chose to wear masks, and 80% chose to be vaccinated to prevent COVID-19. Compared with the non-willing vaccination participants, those with younger ages, higher incomes, and higher knowledge scores regarding masks and vaccination were more likely to be vaccinated. Furthermore, apprehensions about vaccine side effects and negative news about COVID-19 vaccines were the major reasons for vaccination hesitancy.

To improve people's willingness to get vaccinated, the government should strive to deliver correct knowledge and refute inappropriate negative information about COVID-19 vaccination. Moreover, recommendation by physicians was an important factor for older individuals to decide on receiving the COVID-19 vaccine, and policies could be implemented from this aspect.

With an ever growing and expanding body of literature on the newly developed vaccines against the COVID-19, there is an urgent need for a comprehensive analysis of the current state of research on vaccine effectiveness (VE). This study conducted a comprehensive bibliometric analysis to critically examine the productivity and impact of retrieved publications on COVID-19 VE and to predict the future directions of research in the field.

The global literature on COVID-19 VE from 2021 to 2024 was extracted from the VIEW-hub website. Using bibliometric analysis tools, specifically Microsoft Excel, the R package "bibliometrix, biblioshiny" and VOSviewer, we analyzed publications for trends in productivity, citations, and global collaboration. Key metrics assessed include publication and citation trends, influential authors, collaborative networks, and thematic evolution, offering a comprehensive view of the research landscape on COVID-19 VE.

A total of 490 publications were authored by 5031 authors from 934 institutions and 78 countries and published in 119 journals. Most retrieved publications were original articles (99.6 %). The United States was the most productive country with 205 publications (41.8 %). Global research collaborations were mainly within developed countries. Analysis of the thematic evolution of the field illustrated changing research focus over three distinct time clusters. Throughout 2021, studies were focused on outlining infection prevention and control measures, as well as examining the efficacy of novel mRNA vaccines. In 2022, the linchpin of research was shifted towards dissecting the epidemiological correlates of the pandemic in light of the widespread use of vaccines. The final cluster showed special emphasis on the new variants of COVID-19 and the long-term outcomes of vaccines.

Our study identified geopolitical disparities and weak engagement from developing countries in the ongoing efforts regarding COVID-19 VE. This study can inform researchers, policymakers, and funding agencies as they assess ongoing research and future directions in COVID-19 VE.

Patients on dialysis (PoD) are at high risk of severe morbidity and mortality from COVID-19. Characterizing long-term vaccine immune responses in these patients will help optimize vaccine schedule for PoD. This study aimed to determine whether long-term humoral and B and T cell-responses post 3rd and 4th dose of the BNT162b2 vaccine differed between PoD and controls. Non-infected PoD and controls vaccinated with BNT162b2 were recruited in Ziv Medical Center, Israel, between 2021 and 2022. Specimens were collected 1-2 months pre 3rd dose; 1-3 months post 3rd dose; 4-5 months post 3rd dose and 3-5 months post the 4th dose. Anti-SARS-CoV-2 spike (spike) specific antibodies, spike specific memory B cells, and spike specific CD154+ T cells as well as cytokines producing CD4+/CD8+ T cells were measured using standardized assays and compared between PoD and controls at each time point using Mann Whitney and Fisher's exact tests. We recruited 22 PoD and 20 controls. Antibody levels in PoD were lower compared to controls pre 3rd dose but not post 3rd and 4th doses. Frequencies of spike specific memory B cell populations were similar between PoD and controls overall. Frequencies of spike specific T cells, including those producing IFNγ and TNFα, were not lower in PoD. B and T cell mediated immune response in PoD following a 3rd and a 4th dose of the BNT162b2 vaccine was not inferior to controls up to 5 months post vaccination. Our results suggest that standard BNT162b2 vaccination is suitable for this group.

Coronavirus disease 2019 (COVID-19) was extraordinarily harmful, with high rates of infection and hospitalization. This study aimed to evaluate the impact of COVID-19 vaccination status and other factors on hospitalization and disease severity, using data from Nagasaki Prefecture, Japan. Confirmed cases of COVID-19 infection with vaccination status were included and the differences in characteristics between different vaccination statuses, hospitalization or not, and patients with varying levels of disease severity were analyzed. Furthermore, logistic regression was used to calculate odds ratio (ORs) and 95% confidence intervals (CI) to evaluate the association of various factors with hospitalization and disease severity. From March 14, 2020 to August 31, 2022, 23,139 patients were unvaccinated 13,668 vaccinated the primary program with one or two doses, and 4,575 completed the booster. Vaccination reduced the risk of hospitalization with an odd ratio of 0.759 (95% CI: 0.654-0.881) and the protective effect of completed booster vaccination was more pronounced (OR: 0.261, 95% CI: 0.207-0.328). Similarly, vaccination significantly reduced the risk of disease severity (vaccinated primary program: OR: 0.191, 95% CI: 0.160-0.228; completed booster vaccination: OR: 0.129, 95% CI: 0.099-0.169). Overall, unvaccinated, male, elderly, immunocompromised, obese, and patients with other severe illness factors were all risk factors for COVID-19-related hospitalization and disease severity. Vaccination was associated with a decreased risk of hospitalization and disease severity, and highlighted the benefits of completing booster.

Patients with ongoing or planned anticancer treatment at 19 Italian Radiation Oncology centers were included in the study retrospectively from 3 February 2020 to 31 December 2020 and prospectively from 1 January 2021 to 31 May 2021. Anonymized data were processed through a specific website and database. Antineoplastic treatment characteristics and timing and outcomes of COVID-19 and its impact on radiotherapy or systemic therapy were described.

The retrieved cohort included 41,039 patients that received treatment or were planned for therapy in the study period. Overall, 123 patients had a confirmed COVID-19 diagnosis during antineoplastic treatment (group A) and 99 patients before treatment start (group B). The incidence of COVID-19 across the whole cohort in the index period was 0.54% (groups A + B) and 0.30% considering only group A. A total of 60 patients developed severe COVID-19, and a total of 45 patients died as a consequence of the infection (incidence of 0.15% and 0.11%, respectively). Nonetheless, mortality among COVID-19 patients was high, with an attributable death rate after confirmed infection of 20.27%. Among the 123 patients in group A, 37.4% required temporary treatment suspension, 32.5% definitive suspension and 37 patients continued treatment while positive. As for the 99 patients in group B, 53.5% experienced temporary delay, 20.2% experienced definitive treatment suspension and 26.3% had no delay.

Most of the patients with a COVID-19 diagnosis in our cohort recovered and completed their treatment; nonetheless, the attributable death rate after confirmed infection was 20.27%, and mortality was high among cancer patients with severe COVID-19 presentation. The global incidence of death due to COVID-19 or severe COVID-19 was low and decreased over time. Radiation oncology activity could be safely continued during the COVID-19 pandemic with the adoption of adequate preventive measures.

The immune escape capacities of XBB variants necessitate the authorization of vaccines with these antigens. In this study, we produce three recombinant trimeric proteins from the RBD sequences of Delta, BA.5, and XBB.1.5, formulating a trivalent vaccine (Tri-Vac) with an MF59-like adjuvant at a 1:1:4 ratio. Tri-Vac demonstrates immunogenicity in female NIH mice, inducing cross-neutralization against various SARS-CoV-2 variants, including pre-Omicron and Omicron BA.2.75, BA.5, and XBB lineages. It elicits measurable antigen-specific T cell responses, germinal center B cell responses, and T follicular helper responses, effectively protecting against live Omicron XBB.1.16 challenges. Protective immunity is maintained long-term, with sustained neutralizing antibodies and T cell responses, as well as memory B cells and long-lived plasma cells observed by day 210 post-immunization. Tri-Vac also serves as a candidate booster for enhancing immunity after three doses of inactivated virus or mRNA vaccines. A phase 1 investigator-initiated trial was initiated to assess safety and immunogenicity in humans, focusing on the primary endpoint of adverse reactions within 7 days and key secondary endpoints including the geometric mean titers (GMTs) of serum neutralizing antibodies within 30 days and 6 months post-vaccination, as well as adverse events within 30 days and serious adverse events within 6 months post-vaccination. Preliminary data indicate Tri-Vac has good safety and immunogenicity, improving neutralization against multiple variants, including JN.1, in previously vaccinated individuals, highlighting its clinical potential for protecting against SARS-CoV-2 variants. The registration number of this clinical trial is ChiCTR2200067245.

Although the Coronavirus disease 2019 (COVID-19) pandemic has ended, there are still many important lessons we can learn, as the pandemic profoundly affected every area of laboratory practice. During the pandemic, extensive changes to laboratory staffing had to be implemented, as many healthcare institutions required regular screening of all healthcare staff. Several studies examined the effectiveness of different screening regimens and concluded that repeated testing, even with lower sensitivity tests, could rival the performance of gold-standard RT-PCR testing in the detection of new cases. Many assay evaluations were performed both in the earlier and later periods of the pandemic. They included both nucleocapsid/spike antibodies and automated antigen assays. Early in the pandemic, it was generally agreed that the initial nucleocapsid antibody assays had poor sensitivity when used before 14 days of disease onset, with total or IgG antibodies being preferred over the use of IgM. Spike antibody assays gradually replaced nucleocapsid antibody assays, as most people were vaccinated. Spike antibodies tracked the rise in antibodies after vaccination with mRNA vaccines and became invaluable in the assessment of vaccine response. Studies demonstrated robust antibody secretion with each vaccine dose and could last for several months post-vaccination. When antigen testing was introduced, they became effective tools to identify affected patients when used serially or in an orthogonal fashion with RT-PCR testing. Despite the numerous findings during the pandemic period, research in COVID-19 has slowed. To this day it is difficult to identify a true neutralizing antibody test for the virus. An appropriate antibody level that would confer protective immunity against the plethora of new variants remains elusive. We hope that a summary of events during the pandemic could provide important insights to consider in planning for the next viral pandemic.

Background/Objectives: Healthcare professionals (HCPs) hold significant influence over public attitudes toward vaccinations. Studies suggest that HCPs are hesitant towards the coronavirus disease 2019 (COVID-19) vaccines. This hesitancy could lead to lower vaccination rates in the community. Therefore, this scoping review aimed to assess the extent of hesitancy towards COVID-19 booster doses among HCPs and identify the associated factors. Methods: A comprehensive search was conducted in the PubMed and Scopus databases from April to August 2024, using keywords related to COVID-19, vaccine hesitancy, HCPs, and booster vaccination. Studies that had been peer-reviewed, published in English after 2022, and focused on the hesitancy of the COVID-19 booster dose hesitancy among HCPs were included. Out of the 6703 studies screened, 24 studies were included. Results: Most of the HCPs have received their initial series of COVID-19 vaccinations. However, there is a lower rate of uptake for booster doses, with hesitancy rates ranging from 12% to 66.5%. Hesitancy rates varied significantly across continents, with Asia, Africa, and Europe ranging from 19.7% to 66.5%, 27% to 46.1%, 14% to 60.2%, respectively. Hesitancy was reported to be influenced by various factors, including concerns about vaccine safety, necessity, and effectiveness of these vaccines. In addition, the hesitancy regarding booster doses was also found to be influenced by factors like age, gender, profession, and previous COVID-19. Physicians, nurses, and pharmacists exhibited vaccine hesitancy rates ranging from 12.8% to 43.7%, 26% to 37%, and 26% to 34.6%, respectively. Conclusions: Our review underscores the hesitancy among HCPs towards receiving booster doses across countries around the world and explores the underlying factors. These findings provide valuable insights for the design of future pandemic vaccination programs.

Despite the widespread administration of coronavirus disease 2019 (COVID-19) vaccines, the impact on patients with asymptomatic to mild illness remains unclear. Here, we aimed to assess the efficacy of various vaccine doses and types on the duration of isolation duration and discharge rates, the viral shedding duration, and negative rates in asymptomatic to mild COVID-19 patients.

We included adult patients at the Fangcang isolation centres in Pazhou or Yongning between November and December 2022. We analysed data on basic demographics, admission details, laboratory indicators and vaccination information.

A total of 6560 infected patients were included (3584 from Pazhou and 2976 from Yongning). Of these, 90.6% received inactivated vaccines, 3.66% received recombinant SARS-CoV-2 spike protein subunit vaccines and 0.91% received adenovirus vaccines. Among the 6173 vaccinated individuals, 71.9% received a booster dose. By day 9, the isolation rate reached 50% among vaccinated patients. On day 7.5, the positive rate among vaccinated individuals reached 50%.

Full vaccination was effective, with heterologous vaccines showing greater efficacy than inactivated vaccines alone. However, there was no significant difference in the vaccine protective effect 12 months after vaccination.

Elderly infected with COVID-19 has high mortality risk, and the protection from COVID-19 vaccine is limited by vaccine hesitancy. The information of vaccine hesitancy in elderly is incomplete and fragmented. In this study, we attempt to examine the level of vaccine hesitancy in elderly and the related factors in global perspectives.

A systematic review was conducted to include observational studies of COVID-19 vaccine hesitancy in elderly from January 2020 to September 2021. Search strategies covering COVID-19 vaccine, vaccine hesitancy and elderly in four databases of PUBMED, MEDLINE, EMBASE and COCHRANE LIBRARY were adopted. Studies reporting COVID-19 vaccine hesitancy prevalence in elderly were included. A meta-analysis of the vaccine hesitancy prevalence was performed. The primary outcome is the vaccine hesitancy prevalence in elderly population globally. The secondary outcomes are the factors of COVID-19 vaccine hesitancy among elderly.

Initial 479 articles were included for screening, with 54 studies included for meta-analysis of COVID-19 vaccine hesitancy in elderly and 6 studies included for qualitative analysis of factors for vaccine hesitancy. The overall prevalence of vaccine hesitancy was 27.7 % (95 % C.I: 23.8-31.6 %). The prevalence was significantly higher in Asia than in Europe (35.3 % VS 17.9 %, p < 0.05). The vaccine hesitancy was significantly higher before the launch of the vaccine than after (30.3 % VS 18.7 %, p < 0.05). Important factors of vaccine hesitancy in elderly identified were low income, low education, perception of COVID-19 being more contagious, more vaccine side effects and lower vaccine efficacy.

COVID-19 vaccine hesitancy is an important problem in elderly, with geographical variation. Tailored policy and strategies targeting the hesitancy factors were required to promote COVID-19 vaccine to elderly.

There is limited research on real-world effectiveness of BBIBP-CorV Sinopharm COVID-19 vaccine. This study evaluated real-world effectiveness of Sinopharm vaccine in Sri Lanka by assessing absolute vaccine efficacy.

A retrospective test-negative case-control study was conducted at ten large government hospitals across the country.

Consecutive adults aged ≥18 years attending outpatient departments who tested reverse-transcription-PCR positive for SARS-CoV-2 during the study period were recruited.

An interviewer-administered questionnaire was administered, and outcome of COVID-19 infection was assessed in cases.

Of 1829 recruited, 914 (49.9%) were male, and mean age was 45.2 (SD 15.3) years; 1634 (89.3%) were vaccinated with two doses of BBIBP-CorV Sinopharm vaccine, while 195 (10.1%) were vaccine-naïve. Compared with the vaccinated, unvaccinated persons were older but otherwise similar in their demographic and medical profiles. Unvaccinated were more likely to have fever, shortness of breath and vomiting as symptoms and were more likely to seek treatment. Significantly more vaccinated individuals received treatment at home. After admission, the unvaccinated were more likely to receive oxygen. Significantly more unvaccinated persons died of COVID-19 compared with the vaccinated. Sinopharm vaccine was 78.2% (94% CI 69.0% to 85.0%) effective at preventing COVID-19 infection, 88.7% (81.6%-93.2%) effective at preventing severe infection and 85.6% (69.6%-93.6%) effective at preventing death.

BBIBP-CorV Sinopharm vaccine is effective at mitigating severity of illness and reducing the likelihood of hospitalisation, severe illness and death, in those who received primary vaccination, compared with the unvaccinated.

The COVID-19 pandemic has underscored the pivotal role of vaccines in mitigating the devastating impact of the virus. In Thailand, the vaccination campaign against SARS-CoV-2 began on 28 February 2021, initially prioritizing healthcare professionals before expanding into a nationwide effort on 7 June 2021. This study employs a mathematical model of COVID-19 transmission with vaccination to analyze the impact of Thailand's COVID-19 vaccination program from 1 March 2021 to 31 December 2022. We specifically assess the potential loss of lives and occurrence of severe infections across various age groups in a hypothetical scenario where vaccines were not administered. By fitting our model with officially reported COVID-19 death data, our analysis reveals that vaccination efforts prevented a total of 300,234 deaths (95% confidence interval: 295,938-304,349) and averted 1.60 million severe COVID-19 infections (95% confidence interval: 1.54-1.65 million). Notably, the elderly population over 80 years old benefited the most from vaccination, with an estimated 84,518 lives saved, constituting 4.28% of this age group. Furthermore, individuals aged between 70 and 74 years experienced the highest reduction in severe infections, with vaccination potentially preventing 8.35% of this age bracket from developing severe COVID-19.

The mucosal immune response plays a crucial role in the prevention of respiratory viruses. Given the risk of recurrent SARS-CoV-2 infections in the population, the rapid development of next-generation intranasal COVID-19 vaccines with high safety and efficacy is paramount. In the current study, we developed a protein-based intranasal vaccine comprising the XBB.1.5 receptor binding domain (RBD)-derived trimeric recombinant protein (RBDXBB.1.5-HR) and an MF59-like oil-in-water adjuvant. Intranasal administration of RBDXBB.1.5-HR vaccine elicited robust and sustained humoral immune responses in mice and rats, resulting in high levels of neutralizing antibodies against XBB-lineage subvariants, with protection lasting for at least six months. The intranasal RBDXBB.1.5-HR vaccine generated potent mucosal immune responses, characterized by the inductions of tissue-resident T (TRM) cells, local cellular immunity, germinal center, and memory B cell responses in the respiratory tract. The combination of intramuscular and intranasal delivery of the RBDXBB.1.5-HR vaccine demonstrated exceptional systemic and mucosal protective immunity. Furthermore, intranasal delivery of RBDXBB.1.5-HR vaccine as a heterologous booster shot showed more effective boosting effects after mRNA administration compared to homologous vaccination, as evidenced by the induction of superior systemic and extra mucosal immune response. Importantly, the intranasal RBDXBB.1.5-HR vaccine conferred efficient protection against the challenge with authentic EG.5.1 viruses in vivo. These findings identify the intranasal RBDXBB.1.5-HR vaccine as a potential mucosal vaccine candidate for the prevention of SARS-CoV-2 infection.

The biological progression of aging encompasses complex physiological processes. As individuals grow older, their physiological functions gradually decline, including compromised immune responses, leading to immunosenescence. Immunosenescence significantly elevates disease susceptibility and severity in older populations while concurrently compromising vaccine-induced immune responses. This comprehensive review aims to elucidate the implications of immunosenescence for vaccine-induced immunity and facilitate the development of optimized vaccination strategies for geriatric populations, with specific focus on COVID-19, influenza, pneumococcal, herpes zoster, and respiratory syncytial virus (RSV) vaccines. This review further elucidates the relationship between immunosenescence and vaccine-induced immunity. This review presents a systematic evaluation of intervention strategies designed to enhance vaccine responses in older populations, encompassing adjuvant utilization, antigen doses, vaccination frequency modification, inflammatory response modulation, and lifestyle interventions, including physical activity and nutritional modifications. These strategies are explored for their potential to improve current vaccine efficacy and inform the development of next-generation vaccines for geriatric populations.