Global Vaccine Research Articles

Global and Regional Burden of Vaccine-Associated Erythema Multiforme and Their Related Vaccines, 1967–2023: An In-Depth Analysis of the World Health Organization Pharmacovigilance Database

Objective: Vaccine-associated erythema multiforme (EM) remains under-researched, impacting global vaccine safety evaluations. This study examines the global and regional burden of EM and its association with specific vaccines to optimize vaccination strategies. Subject and Methods: We analyzed data from the WHO pharmacovigilance database on vaccine-associated EM from 1967 to 2023 (n = 131,255,418 reports). Reporting frequencies, reported odds ratios (RORs), and information components (IC) were calculated for 16 vaccines across 170 countries. Results: We identified 6,355 cases (males, n = 3,182 [50.07%]) of vaccine-associated EM from a total of 46,378 reports of all-cause EM. While vaccine-associated EM has been consistently reported, there has been a notable increase in reported incidence particularly in 2010 and 2020. Measles, mumps, and rubella vaccines had the highest association with vaccine-associated EM reports (ROR: 8.75 [95% confidence interval, 8.11–9.44]; IC, 3.10 [IC0.25, 2.97]), followed by hepatitis B (8.54 [7.66–9.51]; 3.06 [2.88]), hepatitis A (8.11 [7.01–9.39]; 2.98 [2.74]), typhoid (6.50 [4.75–8.90]; 2.60 [2.07]), encephalitis (5.86 [4.35–7.91]; 2.47 [1.96]), diphtheria, tetanus toxoids, pertussis, polio, and Hemophilus influenza type b (5.70 [5.42–5.99]; 2.46 [2.38]), pneumococcal (5.56 [5.11–6.06]; 2.45 [2.31]), rotavirus (4.96 [4.21–5.84]; 2.29 [2.01]), varicella-zoster (4.44 [3.99–4.95]; 2.13 [1.95]). Vaccine-associated EM reports were more strongly correlated with younger age groups and males. The overall fatality rate of vaccine-associated EM was 0.04%. Conclusions: The rise in vaccine-associated EM across multiple vaccines, especially in younger populations, highlights the need for closer monitoring and more informed vaccination practices to mitigate adverse reactions.

A-270 Evaluation of a multiplex panel to determine antibody profile to monkeypox virus in vaccinated, exposed, and naïve individuals

Abstract Background Monkeypox Virus (MPXV) is a double-stranded DNA virus of the Orthopoxvirus genus that causes Mpox disease with symptoms such as swollen lymph nodes, chills, exhaustion, and blisters that appear on the face, inside the mouth, hands, feet etc. The genus orthopoxvirus (OPXV) has four species, namely, MPXV, smallpox-causing variola major virus (VARV), variola minor virus, and cowpox virus (CPXV), that cause disease in humans. In 1980, the World Health Assembly declared that smallpox had been eradicated due to a successful global vaccination program. This vaccine also provided cross-protection against other OPXV. Historically, the pox disease was rarely seen outside West and Central Africa. The first case of Mpox was identified in 1970 in a 9-year-old boy from the Democratic Republic of Congo (DRC), two years after the smallpox vaccination was discontinued. Since then, it has been reported in 11 African countries. In 2003, the first Mpox outbreak outside of Africa was in the USA and was linked to contact with infected pet prairie dogs. The recent 2022-2023 Mpox outbreak has generated renewed interest in the scientific community to understand the level of OPXV-specific immunity in the various geographic regions, among different age groups, and especially in the risk groups and its impact on future outbreaks by using integrated serosurveillance. To meet the need of the hour, we developed a novel multiplex assay for the detection of human IgG antibodies using Luminex® xMAP® technology for the detection of the human IgG profiles. Methods We have evaluated 11 different recombinant antigens from VARV, Vaccinia virus (VACV), and MPXV in a multiplex assay for detecting human IgG antibodies to OPXV using Luminex® xMAP® technology. We have covalently coupled magnetic fluorescent microspheres to three recombinant proteins from VARV, three from VACV, and five from MPXV to interrogate IgG responses. This 15-plex assay also includes four internal controls that assure the assay and reagent performance. In this preliminary evaluation, we have tested 84 de-identified serum and plasma from healthy subjects. We evaluated 24 serum samples of MPXV-exposed individuals procured commercially. We performed principal component analysis to determine which of these 11 antigens contributed the maximum differential and a result analysis algorithm was developed to predict these individuals' positive and negative antibody outcomes. Results The healthy subjects that were assumed to have been vaccinated showed positive response to A35R of MPXV; A36R of VARV, A33R of VACV, the homologous proteins in the three species and were distinct from unvaccinated younger individuals. There was some reactivity with B6R of MPXV protein. In MPXV-exposed subjects, we observed strong positive antibody responses to A35R of MPXV, A36R of VARV, A33R of VACV, and B6R of MPXV proteins in 19 out of 24 individuals. Fifteen individuals showed a moderate positive response to the A27L protein of VACV, and 8 out of 24 showed a weak positive response to the A29 protein of MPXV. Conclusions This panel is a useful tool to understand the level of OPXV-specific immunity by measuring IgG profiles for successful serosurveillance programs for public health.

Molecular epidemiology and vaccine compatibility analysis of seasonal influenza A viruses in the context of COVID-19 epidemic in Wuhan, China.

The COVID-19 pandemic had a significant impact on the global influenza vaccination and the epidemics of seasonal influenza. To further explore the molecular epidemiology of influenza viruses and assess vaccine effectiveness, we collected influenza cases in Wuhan during the 2022-2023 influenza season. Among 1312 clinical samples, 312 samples tested positive for influenza viruses using reverse transcription polymerase chain reaction. These positive samples included 146A/H1N1 subtypes (46.8%), 164A/H3N2 subtypes (52.6%) and 2 influenza B virus types (0.6%). Based on the whole genome sequence information of hemagglutinin (HA) and neuraminidase (NA) from 27A/H1N1 influenza virus strains and 26A/H3N2 influenza virus strains obtained in this study, a phylogenetic analysis was conducted. The analysis revealed that all A/H1N1 strains belonged to the evolutionary branch 6B.1A.5a.2a, and they exhibited specific substitutions at positions K71Q, Q206E, E241A, and R276K. Similarly, all A/H3N2 strains were classified into the 3C.2a1b.2a.1a subclade and displayed amino acid substitutions at positions S172H, N175Y, I176T, K187N, and S214P. Notably, the A/H3N2 strains also acquired a new potential glycosylation site at position N174. Using an epitope model, the predicted vaccine effectiveness was assessed for the A/H1N1 and A/H3N2 strains. The predicted vaccine effectiveness against the Wuhan influenza epidemic strain was over 85% for the A/H1N1 vaccine strain. However, the effectiveness against the A/H3N2 vaccine strain was only 48.7%. To further verify the protection of influenza vaccine against circulating influenza viruses in the region, we conducted in vivo and in vitro animal studies. The results of in vitro neutralization experiment showed that rabbit serum antibodies inoculated with quadrivalent isolated influenza vaccine had neutralization ability against all 24 isolated influenza viruses. In vivo experiments showed that vaccinated mice had fewer lung lesions when infected with the influenza strain circulating in Wuhan, suggesting that vaccination can effectively reduce the occurrence of severe lung damage. These findings emphasize the importance of accurately predicting seasonal influenza strains for effective influenza prevention and control, especially during the co-circulation of SARS-CoV-2 and influenza viruses. This study provides valuable information on the seasonal influenza virus in Wuhan during the COVID-19 pandemic and serves as a basis for vaccine prediction and updates.

N-protein vaccine is effective against COVID-19: Phase 3, randomized, double-blind, placebo-controlled clinical trial

Despite the success of first-generation COVID-19 vaccines targeting the spike (S) protein, emerging SARS-CoV-2 variants have led to immune escape, reducing the efficacy of these vaccines. Additionally, some individuals are unable to mount an effective immune response to S protein-based vaccines. This has created a need for alternative vaccine strategies that are less susceptible to mutations and capable of providing broad and durable protection. This study aimed to evaluate the efficacy and safety of a novel COVID-19 vaccine based on the full-length recombinant nucleocapsid (N) protein of SARS-CoV-2. We conducted a prospective, multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial (NCT05726084) in Russia. Participants (n=5229) were adults aged 18 years and older, with a BMI of 18.5-30kg/m², and without significant clinical abnormalities. They were randomized in a 2:1 ratio to receive a single intramuscular dose of either the N protein-based vaccine (50µg) or placebo. Randomization was done through block randomization, and masking was ensured by providing visually identical formulations of vaccine and placebo. The primary outcome was the incidence of symptomatic COVID-19 confirmed by PCR more than 15 days after vaccination within a 180-day observation period, analyzed on an intention-to-treat basis. Between May 18, 2023, and August 9, 2023, 5229 participants were randomized, with 3486 receiving the vaccine and 1743 receiving the placebo. Eight cases of PCR-confirmed symptomatic COVID-19 occurred in the vaccine group (0.23%) compared to 27 cases in the placebo group (1.55%), yielding a vaccine efficacy of 85.2% (95% CI: 67.4-93.3; p<0.0001). Adverse events were mostly mild and included local injection site reactions. There were no vaccine-related serious adverse events. The N protein-based COVID-19 vaccine demonstrated significant efficacy and a favorable safety profile, suggesting it could be a valuable addition to the global vaccination effort, particularly in addressing immune escape variants and offering an alternative for those unable to respond to S protein-based vaccines. These results support the continued development and potential deployment of N protein-based vaccines in the ongoing fight against COVID-19.

The Vaccine Godmother: Dr. Gagandeep Kang's Pioneering Journey in Global Health and Vaccine Development.

Dr. Gagandeep Kang is a distinguished Indian microbiologist and virologist known for her pioneering work in the study of gastrointestinal diseases, diarrheal infections, and vaccine development. This article highlights her career, beginning with her medical education at Christian Medical College (CMC) Vellore, where she embarked on her groundbreaking research in enteric diseases, particularly rotavirus, a major cause of child mortality globally. Over the course of her distinguished career, she has led groundbreaking research on rotavirus, contributing to the development of two WHO-approved vaccines tailored for Indian communities: Rotavac (Bharat Biotech, Hyderabad, India) and Rotasiil (Serum Institute of India, Pune, India). Beyond her research, Dr. Kang has held significant advisory roles on national and global platforms, including WHO's Global Advisory Committee on Vaccine Safety and the Coalition for Epidemic Preparedness Innovations (CEPI). She has authored over 300 scientific publications and coauthored the bestselling book "Till We Win,"which details India's fight against the COVID-19 pandemic. Her exceptional contributions have earned her numerous accolades, including the Infosys Prize in Life Sciences, the Fellowship of the Royal Society, and the Canada Gairdner Global Health Award. Dr. Kang's career exemplifies her dedication to advancing public health, vaccine development, and global health initiatives, making her a trailblazer in the field of microbiology and virology.

Comparison of post-COVID-19 pulmonary complications in individuals vaccinated with BioNTech or Sinovac

Aims: Although several research have been undertaken to investigate the impact of the vaccination on long Coronavirus Disease 2019 (COVID-19) syndrome or post-acute sequelae, there is a lack of published evidence on the long-term effects of vaccines on lung-sequelae-related disease. Considering the limited global COVID-19 vaccine distribution, it is essential to establish the impact of vaccination in reducing pulmonary complications. Turkey has been offering COVID-19 vaccines from two platforms, including BNT162b2 (Pfizer-BioNTech, mRNA vaccine) and CoronaVac (Sinovac, inactivated vaccine). This study aimed to evaluate the efficacy of BioNTech and Sinovac vaccines in reducing post-COVID-19 pulmonary complications in individuals. Methods: A total of 94 patients COVID-19 pneumonia patients who were categorized based on the quantity of BioNTech or Sinovac vaccines they received before their first COVID-19 infection were included. The inclusion criteria consisted of a confirmed diagnosis of COVID-19 pneumonia through polymerase chain reaction testing, availability of the mentioned before and follow-up computed tomography scans, and administration of at least one dose of vaccine. Results: The number of complications in patients fully vaccinated with Sinovac and who experienced post-COVID lung complications was significantly greater than in those vaccinated with BioNTech. The C-reactive protein and D-Dimer measurements of individuals who experienced complications in the Sinovac vaccinated group were significantly elevated on the index date. Conclusion: The quantity of lung sequelae after COVID and laboratory parameters indicating this result were found to be higher in inactivated virus vaccines than in mRNA vaccines. This suggests that the protection of inactivated vaccines may be insufficient in severe cases.

Dynamics of multi-level programme integration in a strategic programme: The case of the COVID-19 vaccination campaign in France

Our human societies are facing major challenges (climate change, pandemics) to which the scientific field of project management is trying to provide answers. Work on the projectification and programmification of society confirms that projects and programmes are privileged organisational forms that contribute to the transformation of socio-technical systems responsible for the main functions of our economies. The aim of this article is to analyse the interaction dynamics of programme integration in project systems and operational systems within the COVID-19 vaccination campaign in France, which enabled the rapid and effective transition to a global vaccine supply chain capable of immunising 80 % of the French population. Our results present a model of multi-level programme integration dynamics resulting from two systems integration mechanisms: macro-micro systems integration and meso-micro systems integration. These results show that the lifecycles of project systems and operational systems were intertwined during the vaccination campaign, combining systems integration and operational integration through a dynamic of destabilisation and adaptation. This entanglement enabled major functional changes in the French vaccination chain. Our approach is original in that it sheds light on the relationships that exist at the boundary between projects and operations, which are organised as socio-technical systems. The challenges posed by the need to transform such systems open promising research prospects for the management of strategic programmes with a societal impact.

Estimates of Potential Demand for Measles and Rubella Microarray Patches.

Global measles vaccine coverage has stagnated at approximately 85% for over a decade. By simplifying vaccine logistics and administration, the measles and rubella microarray patch (MR-MAP) may improve coverage. Clinical trials have demonstrated similar safety and immunogenicity in 9-month-old infants for MR-MAPs compared with syringe-and-needle vaccination. To aid commercialization, we present estimates of MR-MAP demand. We created a spreadsheet-based tool to estimate demand for MR-MAPs using data from 180 WHO countries during 2000-2016. Five immunization scenarios were analyzed: (1a) Supplementary Immunization Activities (SIAs) in Gavi, the Vaccine Alliance (Gavi)-eligible countries and (1b) WHO countries where preventive SIAs are routinely conducted; (2) SIAs and outbreak response immunization in all WHO countries; (3) routine immunization (RI) and SIAs in six high-burden measles countries (the Democratic Republic of the Congo, Ethiopia, India, Indonesia, Nigeria, and Pakistan); (4) RI and SIAs in six high-burden countries and Gavi-eligible countries; and (5) hard-to-reach populations. MR-MAP demand varied greatly across scenarios. Forecasts for 2025-2034 estimate from 137 million doses in hard-to-reach populations (scenario 5) to 2.587 billion doses for RI and SIAs in six high-burden countries and Gavi-eligible countries (scenario 4). When policymakers and manufacturers assess MR-MAP demand, they may consider multiple scenarios to allow for a complete consideration of potential markets and public health needs.

Vaccine Potency and Structure of Yeast-Produced Polio Type 2 Stabilized Virus-like Particles.

Poliovirus (PV) is on the brink of eradication due to global vaccination programs utilizing live-attenuated oral and inactivated polio vaccines. Recombinant PV virus-like particles (VLPs) are emerging as a safe next-generation vaccine candidate for the impending polio-free era. In this study, we investigate the production, antigenicity, thermostability, immunogenicity, and structures of VLPs derived from PV serotype 2 (PV2) wildtype strain and thermally stabilized mutant (wtVLP and sVLP, respectively). Both PV2 wtVLP and sVLP are efficiently produced in Pichia pastoris yeast. The PV2 sVLP displays higher levels of D-antigen and significantly enhanced thermostability than the wtVLP. Unlike the wtVLP, the sVLP elicits neutralizing antibodies in mice at levels comparable to those induced by inactivated polio vaccine. The addition of an aluminum hydroxide adjuvant to sVLP results in faster induction and a higher magnitude of neutralizing antibodies. Furthermore, our cryo-EM structural study of both sVLP and wtVLP reveals a native conformation for the sVLP and a non-native expanded conformation for the wtVLP. Our work not only validates the yeast-produced PV2 sVLP as a promising vaccine candidate with high production potential but also sheds light on the structural mechanisms that underpin the assembly and immunogenicity of the PV2 sVLP. These findings may expedite the development of sVLP-based PV vaccines.

Infectious diseases and global security: Analysis of global control and vaccination strategies

Introduction: Given the recent experience with the COVID-19 vaccine campaign, an optimal global policy to control future pandemics and ensure infectious security globally is highly relevant. Objective: The study aims to determine the optimal vaccination strategy to reduce COVID-19 morbidity and mortality during a pandemic.Methods: A systematic search of studies on infectious disease control and vaccination strategies for the period 2000-2023 in PubMed, Scopus, Web of Science and Google Scholar databases using keywords was conducted for the review. Relevant publications, data extraction and systematisation were selected.Results: The findings of the analysis highlight the importance of integrated interventions in global vaccination strategies, including health systems strengthening, innovative technologies for outbreak detection and international collaboration. Vaccination, as an effective preventive measure, significantly reduces the spread of infectious diseases. Vaccination with different types of vaccines has been shown to improve immune response compared to the use of the same type of vaccine. This approach, where the first and second vaccine doses are different, may increase the effectiveness of the immune response.Conclusions: Studies confirm that vaccination reduces the number of cases and deaths, reducing the economic burden. A variety of vaccines, including mRNA, vector, and inactivated vaccines, provide high efficacy in preventing COVID-19 infection and mortality, especially when a heterologous vaccination regimen is used. This review identifies the most effective infectious disease control strategies for the development of global health recommendations

A Modified SIVR Mathematical Model of Covid-19 Post-vaccination Stability Analysis in Kenya

In this paper, the study focused on carrying out a stability analysis on a modified SIR model for the COVID-19 pandemic for the period after vaccination in Kenya. The purpose of the work was to show that whereas the rate and the extent of disease spread amongst the Kenyan people was not as wide spread as happened in other parts of the world, it was necessary for government and policy makers to roll out a robust civic education to convince the majority of the Kenyan population to embrace vaccination as a major containment measure in curbing the spread of COVID-19 and other infectious diseases since the study revealed that the infections drastically reduced to near zero after vaccination except for a few isolated cases that were and still continue to exhibit mild symptoms to none at all. This was attributed to the development of the vaccine which upon a massive campaign by the Kenyan government, led into a significant portion of the population being vaccinated. It is believed this vaccination drive enhanced herd immunity amongst the population. This development has had a significant effect in the control of more recent COVID-19 variants like JN-1 that have remained largely mild and undetected in the country. Both local and global post vaccination stabilities were analyzed for the system using the Lyapunov function. The main objective of the study was therefore to carry out a post vaccination stability analysis by estimating key parameters such as the basic reproduction number, ( R0) and herd immunity threshold (HIT) for infectious diseases by fitting data into the model to enable predictions of future dynamics of the disease. The study used the Next Generation matrix and the least square method besides the Python software to solve generated differential equations of the model for and HIT parameters. Results obtained showed that, there was a significant reduction in infections due to enhanced herd immunity attributed largely to the roll out of vaccination.

Coronavirus disease-19 vaccine uptake, willingness for vaccination, and associated Factors among chronic follow patients attending in the two comprehensive specialized hospitals of Bahir Dar, Ethiopia

BackgroundEven though the disease has spread throughout the world, with millions killed, global COVID-19 vaccination coverage remains low, particularly in developing countries. However, epidemiological data is lacking in the area. Hence, this study aimed to assess COVID-19 uptake, willingness for vaccination, and associated factors.MethodA hospital-based cross-sectional study was conducted from May 1 to June 30, 2022, among patients attending chronic follow-up clinics in the two comprehensive specialized hospitals in Bahir Dar. The total sample size was 423. Participants were selected by a systematic random sampling technique. Data was gathered using a pre-tested questionnaire and analyzed using SPSS version 23. A descriptive analysis was performed. A binary logistic regression analysis was done to assess the association between variables. Variables with a p-value < 0.05 in the multi-variable logistic regression with a 95% confidence interval were considered statistically significant.ResultsThe analysis included 400 out of 423 participants, representing a 95% response rate. The COVID-19 vaccination uptake was 46.8%, while the acceptance was 60.5%. About 56% and 68% of the respondents had good knowledge and a favorable attitude, respectively. Elderly people were 2.7 times more likely to be vaccinated. Similarly, urban residents were 3.94 times more vaccinated. The probability of being vaccinated among respondents with good knowledge and favorable attitudes was 70% and 79%, respectively. The willingness for vaccination increased among those individuals with favorable attitudes (AOR: 1.82). Urban people were less likely to accept vaccination (AOR: 0.46). Some participants misunderstood that vaccination may aggravate their disease condition.ConclusionThe overall COVID-19 vaccine uptake and acceptance for vaccination were low compared to what was estimated by the WHO. Age, residence, knowledge, and attitude were associated with COVID-19 vaccine uptake and acceptance of vaccination. Besides, there was a high level of rumor about the status of the vaccine and risk factors. Hence, special emphasis is warranted to deliver centrally trusted information. Moreover, further nationwide studies are warranted in the future.

HIV Vaccine Development at a Crossroads: New B and T Cell Approaches.

Despite rigorous scientific efforts over the forty years since the onset of the global HIV pandemic, a safe and effective HIV-1 vaccine remains elusive. The challenges of HIV vaccine development have proven immense, in large part due to the tremendous sequence diversity of HIV and its ability to escape from antiviral adaptive immune responses. In recent years, several phase 3 efficacy trials have been conducted, testing a similar hypothesis, e.g., that non-neutralizing antibodies and classical cellular immune responses could prevent HIV-1 acquisition. These studies were not successful. As a result, the field has now pivoted to bold novel approaches, including sequential immunization strategies to drive the generation of broadly neutralizing antibodies and human CMV-vectored vaccines to elicit MHC-E-restricted CD8+ T cell responses. Many of these vaccine candidates are now in phase 1 trials, with early promising results.

Dengue vaccine endgame: why has the global response to exponential demand in the tropics been so slow?

IntroductionThere has been a dramatic global surge in dengue fever (DF) in recent years, with a projected 100-400 million cases annually and large outbreaks expected every 3-4 years. This concerning scenario is in sharp contrast to the very low availability of dengue vaccines to meet this spiraling demand, particularly affecting developing countries in Latin America and Africa. In our study, we aim to identify current vaccine development constraints, from a technological perspective, based on clinical trials and patent landscape data.MethodsThis study was conducted in a two-step methodology. First, candidates and launched products and methods used in the development or as part of DF vaccines were identified from the Cortellis Drug Discovery Intelligence (CDDI) platform. Second, the Derwent Innovation database was used to retrieve patent documents related to dengue vaccines. Data were collected in the period 2014-2024 (to identify the candidate and or launched vaccines) and 2018-2022 (to identify patent documents) with claims involving applications for dengue vaccine development. We presented these descriptive data in the following format: quantitative and qualitative assessments describing the vaccine development scenario and the claimed vaccine technologies.ResultsOur study indicated that 65% of dengue vaccines are still in phase 1 of development. The few current dengue vaccines that have reached phase 3 (1) and launched (2) have shown limited levels of individual protection for one or more dengue serotypes and there is an anemic pipeline of the next generation of more effective tetravalent dengue vaccines. Although the intelligent use of multiple dengue vaccine formulations in immunization campaigns can result in effective protection against all serotypes at the population level, the implementation of this is complex and challenging. The results of our study thus provide evidence of a worrisome global situation regarding the development of new dengue vaccine candidates.ConclusionTo reverse this scenario, there is an urgent need to implement new knowledge governance approaches and business models to stimulate an exponential increase in global vaccine development funding for dengue and several other vaccines.

Collecting and reporting adverse events in low-income settings—perspectives from vaccine trials in the Gambia

BackgroundDespite Africa’s significant infectious disease burden, it is underrepresented in global vaccine clinical trials. While this trend is slowly reversing, it is important to recognize and mitigate the challenges that arise when conducting vaccine clinical trials in this environment. These challenges stem from a variety of factors peculiar to the population and may negatively impact adverse event collection and reporting if not properly addressed.MethodsAs a team of clinical researchers working within the MRCG (Medical Research Council Unit The Gambia), we have conducted 12 phase 1 to 3 vaccine trials over the past 10 years. In this article, we discuss the challenges we face and the strategies we have developed to improve the collection and reporting of adverse events in low-income settings.Outcome.Healthcare-seeking behaviors in the Gambia are influenced by spiritual and cultural beliefs as well as barriers to accessing orthodox healthcare; participants in trials may resort to non-orthodox care, reducing the accuracy of reported adverse events. To address this, trial eligibility criteria prohibit self-treatment and herbal product use during trials. Instead, round-the-clock care is provided to trial participants, facilitating safety follow-up.Constraints in the healthcare system in the Gambia such as limitations in diagnostic tools limit the specificity of diagnosis when reporting adverse events. To overcome these challenges, the Medical Research Council Unit maintains a Clinical Services Department, offering medical care and diagnostic services to study participants.Sociocultural factors, including low literacy rates and social influences, impact adverse event collection. Solicited adverse events are collected during home visits on paper-based or electronic report forms.Community engagement meetings are held before each study starts to inform community stakeholders about the study and answer any questions they may have. These meetings ensure that influential members of the community understand the purpose of the study and the risks and benefits of participating in the trial. This understanding makes them more likely to support participation within their communities.ConclusionConducting ethical vaccine clinical trials in resource-limited settings requires strategies to accurately collect and report adverse events. Our experiences from the Gambia offer insights into adverse event collection in these settings.

Canadian Association for the Study of the Liver Single Topic Conference on Hepatitis B Virus: ‘Progress toward hepatitis B elimination in Canada’

Hepatitis B virus (HBV) infection affects &gt;290 million people worldwide, including ∼250,000 Canadians, and it stands as a leading cause of end-stage liver disease and liver cancer. The World Health Assembly has set goals for HBV elimination by 2030, aiming for a &gt;90% reduction in incidence and a 65% reduction in deaths compared to 2015. However, as of 2023, no countries were on track to achieve these targets. In Canada, challenges in HBV elimination persist due to the lack of a universal birth dose vaccine and interprovincial disparities in screening and care linkage. The Canadian Association for the Study of the Liver (CASL) and the Canadian Hepatitis B Network hosted the Inaugural Progress toward Hepatitis B Elimination Meeting in Calgary, Alberta, Canada (September 29, 2023 to October 1, 2023). This collaborative platform brought together national and international clinicians, laboratory providers, public health researchers, policymakers, and community-based organizations interested in HBV and hepatitis Delta virus (HDV) / HBV coinfection. The workshop was held during the National Day of Truth and Reconciliation (September 30, 2023) to commemorate the tragic legacy of residential schools in Canada, and it highlighted the need to promote meaningful reconciliation with Indigenous peoples. Key outcomes of the summit included establishing objectives for HBV elimination, advocating for adherence to global targets, universal screening and birth dose vaccination, equitable access to antiviral treatment across all provinces/territories, and addressing special populations. This overview highlights the presentations and emphasizes the importance of collaboration among stakeholders, public health agencies, and government entities to strive for HBV elimination in Canada.

Rotavirus Infections: A 2-Year Comprehensive Review in Admitted Pediastric Patients Amid Conflicting National Policies.

Highlighting rotavirus (RV) as a significant food and waterborne pathogen, particularly affecting infants and children, causing serious gastrointestinal infections and dehydration, is important. It should be noted that there are significant debates regarding the effectiveness and outcomes of RV vaccination. In contrast to Turkey's nonmandatory vaccination policy, many developed countries implement mandatory vaccination policies, raising questions about their impact on disease prevalence and healthcare expenditures. Our study aims to comprehensively understand RV infections in Turkey and compare them with countries that have mandatory vaccination policies. We found similar, and even better, hospitalization rates, length of hospital stays, and laboratory parameters demonstrating the effectiveness of Turkey's independent vaccination approach. These findings contribute valuable insights to global vaccination strategies and disease control.

The Clinical Effectiveness of Single-Dose Human Papillomavirus Vaccination.

The human papillomavirus (HPV) vaccine was initially approved for a three-dose regimen. Due to resource limitations, budget constraints, low acceptance, and poor adherence, global vaccination coverage is only 15%. A single-dose regimen could simplify logistics, reduce costs, and improve accessibility. However, its clinical effectiveness remains debatable. This review systematically searched PubMed, Embase, and Cochrane Library, including 42 clinical studies, to assess the effectiveness of a single-dose HPV vaccination for preventing HPV infections, cervical abnormalities, and genital warts. We summarized the effectiveness of bivalent, quadrivalent, and nonavalent vaccines across different age groups and buffer periods, and analyzed the factors contributing to the inconsistency of results. The review also provides insights into designing robust future research to inform single-dose HPV vaccination policies and guidelines, highlighting the need for further research to refine vaccination strategies.

Global Status Report for the Verification of Measles and Rubella Elimination, 2022.

Since the World Health Assembly (WHA) in 2012 endorsed the Global Vaccine Action Plan (GVAP), which included regional measles and rubella elimination goals by 2020, global progress towards verification of measles and rubella elimination has been incremental. Even though the 2020 elimination goals were not achieved, commitment towards achieving measles and rubella elimination has been firmly established in the Immunization Agenda 2030 (IA2030) and the Measles and Rubella Strategic Framework (MRSF) 2021-2030. In 2023, the six Regional Verification Commissions for measles and rubella elimination (RVCs) reviewed data as of 31 December 2022 and confirmed that 82 (42%) Member States have been verified for measles elimination, and 98 (51%) Member States have been verified for rubella elimination. The six RVCs are composed of independent public health and immunization experts who are well-placed to support accelerating measles and rubella elimination. RVCs should be leveraged not only to review elimination documents but also to advocate for and champion public health programming that supports measles and rubella activities. The verification of elimination process is one of many tools that should be deployed to reinforce and accelerate efforts towards achieving a world free of measles and rubella.

Whole-Genome Analysis of the Influenza A(H1N1)pdm09 Viruses Isolated from Influenza-like Illness Outpatients in Myanmar and Community-Acquired Oseltamivir-Resistant Strains Present from 2015 to 2019.

In this study, we describe the genetic characteristics of influenza A(H1N1)pdm09 strains detected in Myanmar from 2015 to 2019. Whole genomes from 60 A(H1N1)pdm09 virus isolates were amplified using real-time polymerase chain reaction and successfully sequenced using the Illumina iSeq100 platforms. Eight individual phylogenetic trees were retrieved for each segment along with those of the World Health Organization (WHO)-recommended Southern Hemisphere vaccine strains for the respective years. A(H1N1)pdm09 viruses from 2015 were found to belong to clade 6B, those from 2016 to 6B.1, 2017 to 6B.1A, and 2019 to 6B.1A.5a, and were genetically distinct from the Southern Hemisphere vaccine strains for the respective seasons, A/California/7/2009 and A/Michigan/45/2015. We observed one virus with intra-subtype reassortment, collected in the 2015 season. Importantly, three viruses possessed the H275Y substitution in the neuraminidase protein, appearing to be community-acquired without the prior administration of neuraminidase inhibitors. These viruses exhibited highly reduced susceptibility to oseltamivir and peramivir. This study demonstrates the importance of monitoring genetic variations in influenza viruses that will contribute to the selection of global influenza vaccines.