The early landscape of coronavirus disease 2019 vaccine development in the UK and rest of the world.
Ontology highlight
ABSTRACT:
SUBMITTER: Sharpe HR
PROVIDER: S-EPMC7283842 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The coronavirus disease 2019 pandemic exposed weaknesses in multiple domains and widened gender-based inequalities across the world. It also stimulated extraordinary scientific achievement by bringing vaccines to the public in less than a year. In this article, we discuss the implications of current vaccination guidance for pregnant and lactating women, if their exclusion from the first wave of vaccine trials was justified, and if a change in the current vaccine development pathway is necessary. Pregnant and lactating women were not included in the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. Therefore, perhaps unsurprisingly, the first vaccine regulatory approvals have been accompanied by inconsistent advice from public health, governmental, and professional authorities around the world. Denying vaccination to women who, although pregnant or breastfeeding, are fully capable of autonomous decision making is a throwback to a paternalistic era. Conversely, lack of evidence generated in a timely manner, upon which to make an informed decision, shifts responsibility from research sponsors and regulators and places the burden of decision making upon the woman and her healthcare advisor. The World Health Organization, the Task Force on Research Specific to Pregnant Women and Lactating Women, and others have highlighted the long-standing disadvantage experienced by women in relation to the development of vaccines and medicines. It is uncertain whether there was sufficient justification for excluding pregnant and lactating women from the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. In future, we recommend that regulators mandate plans that describe the development pathway for new vaccines and medicines that address the needs of women who are pregnant or lactating. These should incorporate, at the outset, a careful consideration of the balance of the risks of exclusion from or inclusion in initial studies, patient and public perspectives, details of "developmental and reproductive toxicity" studies, and approaches to collect data systematically from participants who are unknowingly pregnant at the time of exposure. This requires careful consideration of any previous knowledge about the mode of action of the vaccine and the likelihood of toxicity or teratogenicity. We also support the view that the default position should be a "presumption of inclusion," with exclusion of women who are pregnant or lactating only if justified on specific, not generic, grounds. Finally, we recommend closer coordination across countries with the aim of issuing consistent public health advice.
| S-EPMC7810027 | biostudies-literature
Project description:The current Coronavirus Disease 2019 (COVID-19) pandemic is causing great alarm around the world. The pathogen for COVID-19 - severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - is the seventh known coronavirus to cause pneumonia in humans. While much remains unknown about SARS-CoV-2, physicians and researchers have begun to publish relevant findings, and much evidence is available on coronaviruses previously circulating in human and animal populations. In this review, we situate COVID-19 in its context as a transboundary viral disease, and provide a comprehensive discussion focused on the discovery, spread, virology, pathogenesis, and clinical features of this disease, its causative coronaviral pathogen, and approaches to combating the disease through immunotherapies and other treatments and vaccine development. An epidemiological survey revealed a potentially large number of asymptomatic SARS-CoV-2 carriers within the population, which may hamper efforts against COVID-19. Finally, we emphasize that vaccines against SARS-CoV-2, which may be developed by 2021, will be essential for prevention of COVID-19.
| S-EPMC8641599 | biostudies-literature
Project description:Coronavirus disease 2019 (COVID-19) continually poses a significant threat to the human race, and prophylactic vaccination is the most potent approach to end this pandemic. Nanotechnology is widely adopted during COVID-19 vaccine development, and the engineering of nanostructured materials such as nanoparticles has opened new possibilities in innovative vaccine development by improving the design and accelerating the development process. This review aims to comprehensively understand the current situation and prospects of nanotechnology-enabled vaccine development against the COVID-19 pandemic, with an emphasis on the interplay between nanotechnology and the host immune system.
| S-EPMC9349967 | biostudies-literature
Project description:Coronavirus disease 2019 (COVID-19), beginning in December 2019, has spread worldwide, leading to the death of millions. Owing to the absence of definitive treatment, vaccination against COVID-19 emerged as an effective strategy against the spread of the pandemic. Acceptance of the COVID-19 vaccine has advanced considerably, and vaccine-related research has significantly increased over the past three years. This study aimed to evaluate the content and external characteristics of COVID-19 vaccine-related literature for tracking research trends related to the global COVID-19 vaccine with the means of bibliometrics and visualization maps. A total of 18,285 records in 3499 journals were retrieved in the Web of Science Core Collection database and included in the final analysis. China was the first to focus on COVID-19 vaccine research, while European and American countries started late but developed rapidly. The USA and the UK are the top contributors to COVID-19 vaccine development, with the largest number of publications. The University of Washington and Harvard Medical School were the leading institutions, while Krammer, F. from Icahn School of Medicine at Mount Sinai was the author most active and influential to the topic. The New England Journal of Medicine had the highest number of citations and the highest TLS, and was the most cited and influential journal in the field of COVID-19 vaccine research. COVID-19 vaccine research topics and hotspots focused on populations' attitudes towards vaccination, immunity-related information analysis of spike proteins, the effectiveness and side effects of the COVID-19 vaccine, and the public management of epidemic transmission. The findings of this study provide the global status, research hotspots and potential trends in the field of COVID-19 vaccine research, which will assist researchers in mastering the knowledge structure, and evaluating and guiding future developmental directions of COVID-19 vaccine.
| S-EPMC9959778 | biostudies-literature
Project description:Objective: To study the potential effect of COVID-19 on the endometrium of affected symptomatic women. Design: Preliminary study of the endometrial transcriptomes in women with COVID-19 through RNA sequencing. Setting: Hospital and university laboratories. Subjects: Women with COVID-19 lacking SARS-CoV-2 infection in endometrial tissue. Intervention/Exposure: Endometrial biopsy collection. Main outcomes measures: Endometrial gene expression and functional analysis of patients with COVID-19 versus uninfected individuals. Results: COVID-19 systemic disease alters endometrial gene expression in 75% of women, with patients exhibiting a preponderance of 163 up-regulated (e.g., UTS2, IFI6, IFIH1, BNIP3) and 72 down-regulated genes (e.g., CPZ, CDH3, IRF4) (FDR<0.05). A total of 161 dysregulated functions (36 up-regulated and 125 down-regulated) were typically enriched in COVID-19 endometria, including upregulation in pathways involved in response to virus and cytokine inflammation, highlighting upregulation of a COVID-19 response pathway. Conclusion: COVID-19 affects endometrial gene expression despite the absence of SARS-CoV-2 particles in endometrial tissues.
2024-04-22 | GSE202553 | GEO
Project description:A significant correlation has been shown between the binding antibody responses against original severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein and vaccine efficacy of 4 approved coronavirus disease 2019 vaccines. We therefore assessed the immune response against original SARS-CoV-2 elicited by the adjuvanted S-Trimer vaccine, SCB-2019 + CpG/alum, in the same assay and laboratory. Responses to SCB-2019 were comparable or superior for antibody to original and Alpha variant when compared with 4 approved vaccines. The comparison accurately predicted success of the recently reported efficacy trial of SCB-2019 vaccine. Immunogenicity comparisons to original strain and variants of concern should be considered as a basis for authorization of vaccines.
| S-EPMC8763959 | biostudies-literature
Project description:Individuals on immunosuppressive (IS) therapy have increased mortality from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and delayed viral clearance may lead to new viral variants. IS therapy reduces antibody responses following coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccination; however, a comprehensive assessment of vaccine immunogenicity is lacking. Here we show that IS therapy reduced neutralizing, binding, and nonneutralizing antibody functions in addition to CD4 and CD8 T-cell interferon-γ responses following COVID-19 mRNA vaccination compared to immunocompetent individuals. Moreover, IS therapy reduced cross-reactivity against SARS-CoV-2 variants. These data suggest that the standard COVID-19 mRNA vaccine regimens will likely not provide optimal protection in immunocompromised individuals.
| S-EPMC8690024 | biostudies-literature
Project description:A series of epidemiological explorations has suggested a negative association between national bacillus Calmette-Guérin (BCG) vaccination policy and the prevalence and mortality of coronavirus disease 2019 (COVID-19). However, these comparisons are difficult to validate due to broad differences between countries such as socioeconomic status, demographic structure, rural vs. urban settings, time of arrival of the pandemic, number of diagnostic tests and criteria for testing, and national control strategies to limit the spread of COVID-19. We review evidence for a potential biological basis of BCG cross-protection from severe COVID-19, and refine the epidemiological analysis to mitigate effects of potentially confounding factors (e.g., stage of the COVID-19 epidemic, development, rurality, population density, and age structure). A strong correlation between the BCG index, an estimation of the degree of universal BCG vaccination deployment in a country, and COVID-19 mortality in different socially similar European countries was observed (r 2 = 0.88; P = 8 × 10-7), indicating that every 10% increase in the BCG index was associated with a 10.4% reduction in COVID-19 mortality. Results fail to confirm the null hypothesis of no association between BCG vaccination and COVID-19 mortality, and suggest that BCG could have a protective effect. Nevertheless, the analyses are restricted to coarse-scale signals and should be considered with caution. BCG vaccination clinical trials are required to corroborate the patterns detected here, and to establish causality between BCG vaccination and protection from severe COVID-19. Public health implications of a plausible BCG cross-protection from severe COVID-19 are discussed.
| S-EPMC7395502 | biostudies-literature
Project description:ObjectivesThe longitudinal and systematic evaluation of immunity in coronavirus disease 2019 (COVID-19) patients is rarely reported.MethodsParameters involved in innate, adaptive, and humoral immunity were continuously monitored in COVID-19 patients from onset of illness until 45 days after symptom onset.ResultsThis study enrolled 27 mild, 47 severe, and 46 deceased COVID-19 patients. Generally, deceased patients demonstrated a gradual increase of neutrophils and IL-6 but a decrease of lymphocytes and platelets after the onset of illness. Specifically, sustained low numbers of CD8+ T cells, NK cells, and dendritic cells were noted in deceased patients, while these cells gradually restored in mild and severe patients. Furthermore, deceased patients displayed a rapid increase of HLA-DR expression on CD4+ T cells in the early phase, but with a low level of overall CD45RO and HLA-DR expressions on CD4+ and CD8+ T cells, respectively. Notably, in the early phase, deceased patients showed a lower level of plasma cells and antigen-specific IgG, but higher expansion of CD16+CD14+ proinflammatory monocytes and HLA-DR-CD14+ monocytic-myeloid-derived suppressor cells (M-MDSCs) than mild or severe patients. Among these immunological parameters, M-MDSCs showed the best performance in predicting COVID-19 mortality, when using a cutoff value of ≥10%. Cluster analysis found a typical immunological pattern in deceased patients on day 9 after onset, which was characterized as the increase of inflammatory markers (M-MDSCs, neutrophils, CD16+CD14+ monocytes, and IL-6) but a decrease of host immunity markers.ConclusionsThis study systemically characterizes the kinetics of immunity of COVID-19, highlighting the importance of immunity in patient prognosis.
| S-EPMC8586656 | biostudies-literature
Project description:In about 20 days since the diagnosis of the first case of the 2019 novel coronavirus (2019-nCoV) in Korea on January 20, 2020, 28 cases have been confirmed. Fifteen patients (53.6%) of them were male and median age of was 42 years (range, 20-73). Of the confirmed cases, 16, 9, and 3 were index (57.2%), first-generation (32.1%), and second-generation (10.7%) cases, respectively. All first-generation and second-generation patients were family members or intimate acquaintances of the index cases with close contacts. Fifteen among 16 index patients had entered Korea from January 19 to 24, 2020 while 1 patient had entered Korea on January 31, 2020. The average incubation period was 3.9 days (median, 3.0), and the reproduction number was estimated as 0.48. Three of the confirmed patients were asymptomatic when they were diagnosed. Epidemiological indicators will be revised with the availability of additional data in the future. Sharing epidemiological information among researchers worldwide is essential for efficient preparation and response in tackling this new infectious disease.
| S-EPMC7285424 | biostudies-literature