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BACKGROUND: Studies of flares of autoimmune inflammatory rheumatic diseases (AIIRD) after COVID-19 mRNA vaccination are limited by small sample size, short follow up or at risk of selection bias. METHODS: A national retrospective cohort study of consecutive AIIRD patients ≥12 years old, across 8 hospitals who received at least one dose of a COVID-19 mRNA vaccine. Patients were included from the date of 1st vaccine dose and censored at the time of flare or on the date of the clinic visit at least 3 months from cohort entry, whichever came first. Predictors of flare were determined by Cox proportional hazards analysis. FINDINGS: 4627 patients (73% Chinese, 71% female) of median (IQR) age 61 (48, 70) years were included; 42% Rheumatoid arthritis, 14% Systemic lupus erythematosus and 11% Psoriatic arthritis. 47% were in remission, 41% low disease activity, 10% moderate disease activity and 1% in high disease activity. 18% patients flared, of which 11.7% were within the 3-month period of interest. 11.8% patients improved. Median (IQR) time-to-flare was 60 (30, 114) days. 25% flares were self-limiting, 61% mild-moderate and 14% severe. Older patients (53-65 years and >66 years) had a lower risk of flare [HR 0.6 (95% CI 0.5-0.8) and 0.7 (0.6-0.8) respectively]. Patients with inflammatory arthritis and with active disease had a higher risk of flare [HR 1.5 (1.2-2.0) and 1.4 (1.2-1.6), respectively]. Treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), immunosuppression and prednisolone was also associated with an increased risk of flare [HR 1.5 (1.1-2), 1.2 (1.1-1.4) and 1.5 (1.2-1.8) for prednisolone ≤7.5 mg respectively]. INTERPRETATION: There was a moderately high rate of AIIRD flares after mRNA vaccination but also improvement in several patients. Severe flares and hospitalisation were rare. Thus, vaccination remains safe and highly recommended.
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Artrite Reumatoide , Doenças Autoimunes , COVID-19 , Coronavirus , Lúpus Eritematoso Sistêmico , Febre Reumática , Humanos , Feminino , Pessoa de Meia-Idade , Criança , Masculino , Vacinas contra COVID-19/uso terapêutico , Estudos Retrospectivos , Singapura/epidemiologia , COVID-19/epidemiologia , COVID-19/prevenção & controle , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Lúpus Eritematoso Sistêmico/epidemiologia , Prednisolona/uso terapêutico , Vacinas Sintéticas/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Vacinação , Sistema de Registros , Doenças Autoimunes/tratamento farmacológico , Doenças Autoimunes/epidemiologia , Vacinas de mRNARESUMO
BACKGROUND: Data are sparse regarding the safety of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with multiple sclerosis (MS). OBJECTIVE: To estimate (1) the pooled proportion of MS patients experiencing relapse among vaccine recipients; (2) the rate of transient neurological worsening, adverse events, and serious adverse events; (3) the previous outcomes of interest for different SARS-CoV-2 vaccine types. METHODS: Systematic review and meta-analysis of pharmacovigilance registries and observational studies. RESULTS: Nineteen observational studies comprising 14,755 MS patients who received 23,088 doses of COVID-19 vaccines were included. Mean age was 43.3 years (95% confidence interval (CI): 40-46.6); relapsing-remitting, secondary-progressive, primary-progressive MS and clinically isolated syndrome were diagnosed in 82.6% (95% CI: 73.9-89.8), 12.6% (95% CI: 6.3-20.8), 6.7% (95% CI: 4.2-9.9), and 2.9% (95% CI: 1-5.9) of cases, respectively. The pooled proportion of MS patients experiencing relapse at a mean time interval of 20 days (95% CI: 12-28.2) from vaccination was 1.9% (95% CI: 1.3%-2.6%; I2 = 78%), with the relapse risk being independent of the type of administered SARS-CoV-2-vaccine (p for subgroup differences = 0.7 for messenger RNA (mRNA), inactivated virus, and adenovector-based vaccines). After vaccination, transient neurological worsening was observed in 4.8% (95% CI: 2.3%-8.1%) of patients. Adverse events and serious adverse events were reported in 52.8% (95% CI: 46.7%-58.8%) and 0.1% (95% CI: 0%-0.2%) of vaccinations, respectively. CONCLUSION: COVID-19 vaccination does not appear to increase the risk of relapse and serious adverse events in MS. Weighted against the risks of SARS-CoV-2-related complications and MS exacerbations, these safety data provide compelling pro-vaccination arguments for MS patients.
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COVID-19 , Esclerose Múltipla , Adulto , Humanos , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Esclerose Múltipla/complicações , SARS-CoV-2 , VacinaçãoRESUMO
Background: The incidence of breakthrough infection with the emergence of new variants of concern of SARS-CoV-2 is posing a threat, and it is pertinent to understand the role of vaccines in protecting the elderly and people with comorbidities. Objective: The present study was undertaken to understand the natural history of SARS-CoV-2 infection in a closed cohort of the elderly population in an old-age home who have received two doses of COVID-19 vaccination. The study has also undertaken genomic sequencing to identify SARS-CoV-2 variants of concern from an academic perspective. Materials and Methods: A prospective observational study was conducted from March to August 2021 among residents of 11 old-age homes in Kerala who were vaccinated with 2 doses of the COVID-19 vaccine, from 2 weeks following vaccination. Samples with a threshold cycle value of <25 were subjected to targeted sequencing of the spike protein receptor-binding domain coding region. Results: Among the 479 vaccinated individuals, 86 (17.95%) turned positive during the follow-up period. The mean duration of symptoms was 3-5 days, and no hospitalization was required. A phylogenetic analysis of the nucleotide sequences from the samples indicated B.1.617.2 lineage representing the Delta strain. Conclusion: The evidence supports maximizing the vaccine coverage among vulnerable groups to prevent hospitalization and death rate on the verge of the emergence of new variants of SARS-CoV-2.
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COVID-19 , SARS-CoV-2 , Idoso , Humanos , Recém-Nascido , SARS-CoV-2/genética , Vacinas contra COVID-19 , Filogenia , Índia/epidemiologiaRESUMO
Pet ownership and therapy dogs as companion animals and emotional support have potential health benefits. We report the experiences at a COVID-19 vaccination center after authorizing children's vaccines. When the Pfizer-BioNTech vaccine for children aged 5 to 11 years was authorized for emergency use, we adapted the center's space to receive children, adding cartoon posters and balloons and using children's adhesive bandages, among others. Located at a Campus with six health professional schools, medical students dressed as storybook or movie characters. Children were asked to make drawings during the post vaccination observation period. We incorporated therapy dogs as part of our strategy for a child-friendly center during vaccination activities. Parents expressed that the COVID-19 immunization seemed to be better accepted by children as the dogs in the center entertained them. Many children were in close contact with the dogs while receiving the shots, caressing them, or having the small dogs on their laps. Children's drawings reflected colors, flowers, families, images of happiness, dogs with their names, their own pets, and superhero characters. There were no negative images of syringes, injections, or germs. To our knowledge, this was the only vaccine center in Puerto Rico that implemented therapy dogs as a strategy to create a friendly environment for COVID 19 immunization efforts targeted for children. Based on this experience, we encourage the use of therapy dogs in other immunization activities and will further gather prospective data in the future.
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COVID-19 , Vacinas , Criança , Humanos , Animais , Cães , Vacinas contra COVID-19 , Animais de Terapia , Estudos Prospectivos , COVID-19/prevenção & controle , Vacinação , Porto RicoRESUMO
Vaccination against SARS-CoV-2 has been demonstrated to be safe during gestation. Nevertheless, there are no robust data investigating the entity of maternal antibodies' transmission through the placenta to the newborn and the persistence of the antibodies in babies' serum. The objective of this study is to assess the maternal antibody transmission and kinetics among newborns in the first months of life. Women having received one or two doses of anti-SARS-CoV-2 mRNA-vaccines during pregnancy at any gestational age, and their newborns, were recruited and followed-up over 9 months. Ninety-eight women and 103 babies were included. At birth, we observed a significant positive correlation between maternal and neonatal serum anti-SARS-CoV-2 antibody levels and a significant negative correlation between the time since last dose and antibody levels in mothers with two doses. Over the follow-up, the birth antibody level significantly decreased in time according to the received doses number at 3, 6, and 9 months. During the follow-up, we registered 34 dyad SARS-CoV-2 infection cases. The decreasing trend was slower in the SARS-CoV-2 infection group and among breastfed non-infected babies. Antibodies from maternal anti-SARS-CoV-2 vaccination are efficiently transferred via the placenta and potentially even through breast milk. Among newborns, antibodies show relevant durability in the first months of life.
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Anticorpos Antivirais , Vacinas contra COVID-19 , COVID-19 , SARS-CoV-2 , Humanos , Feminino , Gravidez , COVID-19/imunologia , COVID-19/prevenção & controle , Recém-Nascido , Vacinas contra COVID-19/imunologia , Vacinas contra COVID-19/administração & dosagem , Adulto , SARS-CoV-2/imunologia , Anticorpos Antivirais/imunologia , Anticorpos Antivirais/sangue , Vacinação , Complicações Infecciosas na Gravidez/imunologia , Complicações Infecciosas na Gravidez/virologia , LactenteRESUMO
The coronavirus disease 2019 (COVID-19) pandemic has underscored the importance of mRNA vaccines. The mechanism for how such vaccines work is related to the core biology topic of the central dogma, which students often misunderstand despite its importance. Therefore, we wanted to know whether students can apply their biology knowledge of central dogma to the real-world issue of how mRNA COVID vaccines work. Accordingly, we asked college biology students of different expertise levels how the COVID vaccine worked. Later, we cued them by telling them the vaccine contains mRNA and asked them what the mRNA does. We used thematic analysis to find common ideas in their responses. In the uncued condition, fewer than half of the students used central dogma-related ideas to explain what was in the vaccine or how the vaccine worked. Inaccurate ideas were present among all groups of biology students, particularly entering biology majors and non-biology majors, including the idea that the COVID vaccines contain a weakened, dead, or variant form of the COVID virus. After students were cued, many more students in all expertise groups expressed central dogma-related themes, showing that students could apply the knowledge of central dogma if prompted. Advanced biology majors were much more likely to state that the vaccines code for a viral protein, indicating their advanced application of central dogma concepts. These results highlight inaccurate ideas common among students and show changes in the ability to apply knowledge with student expertise level, which could inform future interventions to support student learning about vaccines and central dogma.
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This is a response to Marchand & Masoud's response letter regarding my criticism "Response to Dr. Somovilla del Saz's letter to the editor regarding "Risk of all-cause and cardiac-related mortality after vaccination against COVID-19: A meta-analysis of self-controlled case series studies."" The response is a defense of the initial criticism to the paper regarding the validity of the inclusion of Ladapo´s paper.
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COVID-19 , Humanos , COVID-19/prevenção & controle , VacinaçãoRESUMO
Due to the COVID-19 pandemic, many children missed their routine vaccinations globally. There is insufficient evidence on the trends in vaccination coverage in the private healthcare sector in South Africa. This study explored the changes in childhood vaccination patterns (non-COVID vaccines) in the private healthcare sector in South Africa using medicine claim data. Using the information on medication claims from a South African pharmaceutical benefit management (PBM) company, we performed a quantitative cross-sectional analysis comparing the period before (2018-2019) and during the COVID-19 pandemic (2020-2021). All patients who made claims within the study period were included. This study included 67,830 children aged two years and younger. In particular, from 2018 to 2021, boys (52%) outnumbered girls (48%). Pharmacists consistently held the predominant prescriber role before and during the COVID-19 pandemic. The proportion of children receiving non-COVID-19 vaccines was higher before the pandemic (60%) than during the pandemic (55%). Furthermore, there was a notable decline of 5% in measles vaccination rates during the children's first year of life, while a notable increase was observed for measles (5%), hepatitis A (7.7%), and the pentavalent vaccine (5%) during the second year of life. Governments and private healthcare providers must take action to enhance vaccination coverage rates for children in their first year of life to prevent a resurgence of vaccine-preventable diseases. The results obtained in this study underscore the significance of implementing vaccine catch-up campaigns to address missed vaccination opportunities arising from the impact of the COVID-19 pandemic. Moreover, pharmacists emerged as the predominant healthcare providers responsible for administering vaccinations within the private healthcare sector in South Africa, both prior and during the COVID-19 pandemic. Their pivotal role in the vaccination process warrants due recognition and should not be underestimated.
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COVID-19 vaccines have reduced both lethality and hospitalization rates of the novel coronavirus disease. Nevertheless, multiple side effects have been reported in the literature, most often are harmless. We report two cases of acute myocarditis, hospitalized in the emergency department for chest pain occurring after the second dose of mRNA vaccine AstraZeneca. The SARS-Cov-2 infection was ruled out in both patients with a negative PCR obtained by nasal swabs and normal thoracic CT scans. Both patients had high levels of high-sensitive cardiac troponin I. Acute coronary syndromes were excluded with cardiac catheterization. Cardiac Magnetic resonance imaging (MRI) showed signs in favor of acute myocarditis. The evolution was favorable for both patients after being put on anti-inflammatory treatment. The universality and accumulation of reports concerning acute myocarditis following COVID vaccination, in the absence of any other diagnostic element that could explain the myocardial injury, establish a strong causal link, although the etiopathogenesis of such injury remains poorly elucidated.
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Vacinas contra COVID-19 , COVID-19 , Miocardite , Humanos , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Miocardite/diagnóstico , Miocardite/etiologia , SARS-CoV-2 , Vacinação , VacinasRESUMO
BACKGROUND: The aim of this study was to evaluate the efficacy and safety of COVID-19 vaccines in patients undergoing haemodialysis in Italy compared to the general population. METHODS: In this cohort study, 118 dialysis centres from 18 Italian Regions participated. Individuals older than 16 years on dialysis treatment for at least 3 months, who provided informed consent were included. We collected demographic and clinical information, as well as data on vaccination status, hospitalisations, access to intensive care units and adverse events. We calculated the incidence, hospitalisation, mortality, and fatality rates in the vaccinated dialysis cohort, adjusted for several covariates. The incidence rates of infection in the dialysis cohort and the general population were compared through Standardised Incidence Rate Ratio. RESULTS: The study included 6555 patients vaccinated against SARS-CoV-2 infection according to the schedule recommended in Italy. Between March 2021 and May 2022, there were 1096 cases of SARS-CoV-2 infection, with an incidence rate after completion of the three-dose vaccination cycle of 37.7 cases per 100 person-years. Compared to the general population, we observed a 14% reduction in the risk of infection for patients who received three vaccine doses (Standardised Incidence Rate Ratio: 0.86; 95% Confidence Interval: 0.81-0.91), whereas no statistically significant differences were found for COVID-19-related hospitalisations, intensive care unit admissions or death. No safety signals emerged from the reported adverse events. CONCLUSIONS: The vaccination program against SARS-CoV-2 in the haemodialysis population showed an effectiveness and safety profile comparable to that seen in the general population.
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Vacinas contra COVID-19 , COVID-19 , Diálise Renal , Humanos , Estudos de Coortes , COVID-19/epidemiologia , COVID-19/prevenção & controle , Itália/epidemiologiaRESUMO
Under-vaccination is a complex problem that is not simple to address whether this is for routine childhood immunization or for coronavirus disease 2019 (COVID-19) vaccination. Vaccination mandates has been one policy instrument used to try to increase vaccine uptake. While the concept may appear straight forward there is no standard approach. The decision to shift to a more coercive mandated program may be influenced by both functional and/or political needs. With mandates there may be patient and/or public push back. Anti-mandate protests and increased public polarization has been seen with COVID-19 vaccine mandates. This may negatively impact on vaccine acceptance ie, be counterproductive, causing more harm than overall good in the longer term. We need a better understanding of the political and functional needs that drive policy change towards mandates as well as cases studies of the shorter- and longer-term outcomes of mandates in both routine and pandemic settings.
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COVID-19 , Vacinas , Criança , Humanos , Vacinas contra COVID-19 , Coerção , COVID-19/prevenção & controle , PolíticaRESUMO
INTRODUCTION: Vaccines prevent disease and disability; save lives and represent a good assessment of health interventions. Several systematic reviews on the efficacy and effectiveness of COVID-19 vaccines have been published, but the immunogenicity and safety of these vaccines should also be addressed. AREAS COVERED: This systemic investigation sought to explain the efficacy, immunogenicity, and safety of new vaccination technologies against SARS-CoV-2 in people over 18 years old. Original research studying the effectiveness on mRNA, protein subunit vaccines, and viral vector vaccines against SARS-CoV-2 in people over 18 years old was analyzed. Several databases (Web of Science, Scopus, MEDLINE and EMBASE) were searched between 2012 and November 2022 for English-language papers using text and MeSH terms related to SARS-CoV-2, mechanism, protein subunit vaccine, viral vector, and mRNA. The protocol was registered on PROSPERO, CRD42022341952. Study quality was assessed using the NICE methodology. We looked at a total of six original articles. All studies gathered and presented quantitative data. EXPERT OPINION: Our results suggest that new vaccinations could have more than 90% efficacy against SARS-CoV-2, regardless of the technology used. Furthermore, adverse reactions go from mild to moderate, and good immunogenicity can be observed for all vaccine types.
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COVID-19 , Vacinas Virais , Humanos , Adolescente , Subunidades Proteicas , Vacinas contra COVID-19/efeitos adversos , SARS-CoV-2 , RNA Mensageiro , COVID-19/prevenção & controle , Vacinas de Subunidades Antigênicas/efeitos adversos , Anticorpos Antivirais , Imunogenicidade da VacinaRESUMO
Marchand and colleagues conducted a meta-analysis examining COVID vaccine effects on all-cause and cardiac-related mortality. Findings aligned with previous research, showing no association with all-cause mortality. However, cardiac-related mortality exhibited a 6% increase post-vaccination. Concerns arise from reliance on a non-peer-reviewed study (Ladapo, 2022) influencing results significantly. Sensitivity analyses were lacking, undermining result robustness, particularly in gender-specific outcomes. Adherence to PRISMA guidelines for transparency and thoroughness could strengthen conclusions. This study underscores vaccine safety scrutiny, yet the influence of biased sources and absence of sensitivity testing warrant careful consideration.
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Vacinas contra COVID-19 , COVID-19 , Humanos , Vacinas contra COVID-19/efeitos adversos , Vacinação/efeitos adversos , COVID-19/prevenção & controleRESUMO
Since the spread of the coronavirus flu in 2019 (hereafter referred to as COVID-19), millions of people worldwide have been affected by the pandemic, which has significantly impacted our habits in various ways. In order to eradicate the disease, a great help came from unprecedentedly fast vaccines development along with strict preventive measures adoption like lockdown. Thus, world wide provisioning of vaccines was crucial in order to achieve the maximum immunization of population. However, the fast development of vaccines, driven by the urge of limiting the pandemic caused skeptical reactions by a vast amount of population. More specifically, the people's hesitancy in getting vaccinated was an additional obstacle in fighting COVID-19. To ameliorate this scenario, it is important to understand people's sentiments about vaccines in order to take proper actions to better inform the population. As a matter of fact, people continuously update their feelings and sentiments on social media, thus a proper analysis of those opinions is an important challenge for providing proper information to avoid misinformation. More in detail, sentiment analysis (Wankhade et al. in Artif Intell Rev 55(7):5731-5780, 2022. 10.1007/s10462-022-10144-1) is a powerful technique in natural language processing that enables the identification and classification of people feelings (mainly) in text data. It involves the use of machine learning algorithms and other computational techniques to analyze large volumes of text and determine whether they express positive, negative or neutral sentiment. Sentiment analysis is widely used in industries such as marketing, customer service, and healthcare, among others, to gain actionable insights from customer feedback, social media posts, and other forms of unstructured textual data. In this paper, Sentiment Analysis will be used to elaborate on people reaction to COVID-19 vaccines in order to provide useful insights to improve the correct understanding of their correct usage and possible advantages. In this paper, a framework that leverages artificial intelligence (AI) methods is proposed for classifying tweets based on their polarity values. We analyzed Twitter data related to COVID-19 vaccines after the most appropriate pre-processing on them. More specifically, we identified the word-cloud of negative, positive, and neutral words using an artificial intelligence tool to determine the sentiment of tweets. After this pre-processing step, we performed classification using the BERT + NBSVM model to classify people's sentiments about vaccines. The reason for choosing to combine bidirectional encoder representations from transformers (BERT) and Naive Bayes and support vector machine (NBSVM ) can be understood by considering the limitation of BERT-based approaches, which only leverage encoder layers, resulting in lower performance on short texts like the ones used in our analysis. Such a limitation can be ameliorated by using Naive Bayes and Support Vector Machine approaches that are able to achieve higher performance in short text sentiment analysis. Thus, we took advantage of both BERT features and NBSVM features to define a flexible framework for our sentiment analysis goal related to vaccine sentiment identification. Moreover, we enrich our results with spatial analysis of the data by using geo-coding, visualization, and spatial correlation analysis to suggest the most suitable vaccination centers to users based on the sentiment analysis outcomes. In principle, we do not need to implement a distributed architecture to run our experiments as the available public data are not massive. However, we discuss a high-performance architecture that will be used if the collected data scales up dramatically. We compared our approach with the state-of-art methods by comparing most widely used metrics like Accuracy, Precision, Recall and F-measure. The proposed BERT + NBSVM outperformed alternative models by achieving 73% accuracy, 71% precision, 88% recall and 73% F-measure for classification of positive sentiments while 73% accuracy, 71% precision, 74% recall and 73% F-measure for classification of negative sentiments respectively. These promising results will be properly discussed in next sections. The use of artificial intelligence methods and social media analysis can lead to a better understanding of people's reactions and opinions about any trending topic. However, in the case of health-related topics like COVID-19 vaccines, proper sentiment identification could be crucial for implementing public health policies. More in detail, the availability of useful findings on user opinions about vaccines can help policymakers design proper strategies and implement ad-hoc vaccination protocols according to people's feelings, in order to provide better public service. To this end, we leveraged geospatial information to support effective recommendations for vaccination centers.
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Contrary to what is true for adults, little is known about pediatric long COVID (LC). Studies enrolling children are relatively few and extremely heterogeneous. This does not allow to draw definitive conclusions on the frequency and pathogenesis of pediatric LC and limits the development of appropriate and effective measures to contain the clinical, social and economic impact of this condition on the pediatric population. Depending on the methods used to collect and analyze data, studies have found that the incidence rate of pediatric LC may vary from about 25% to less than 5%. However, despite true prevalence of pediatric LC cannot be exactly defined, studies comparing children with previous COVID-19 and uninfected controls have shown that most of the clinical manifestations detected in infected children, mainly mood symptoms, mental health disorders and heart abnormalities could be diagnosed with similar frequency and severity in uninfected subjects also. This seems to indicate that SARS-CoV-2 is the cause of pediatric LC only in a part of children and other factors play a relevant role in this regard. Pandemic itself with the persistent disruption of child lives may have caused persistent stress in all the pediatric population causing mood symptoms, mental health disorders or several organ and body system functional alterations, regardless SARS-CoV-2 infection. These suppositions suggest the need for long-term physical control of all the children after COVID-19 especially when they were already suffering from an underlying disease or have had a severe disease. Moreover, attention should be paid to the assessment of change in children's emotional and behavioral functioning in order to assure adequate interventions for the best emotional and behavioral well being. However, whatever its origin, it seems highly likely that the prevalence of the pediatric LC is set to decline in the future. Preliminary observations seem to suggest that recently developed SARS-CoV-2 variants are associated with less severe COVID-19. This suggests that, as already seen in adults, a lower number of pediatric virus-associated LC cases should occur. Furthermore, the use of COVID-19 vaccines, reducing incidence and severity of SARS-CoV-2 infection, may reduce risk of LC development. Finally, elimination of restrictive measures should significantly reduce mood symptoms and mental health disorders.
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Introduction: The COVID-19 pandemic has resulted in more than 6.5 million deaths worldwide yet. Vaccination against the SARS-CoV-2 virus is a reliable way out of the pandemic, however, vaccination rate reaches only 58% in the Slovak Republic. Concerns about the adverse reactions of vaccines are one of the reasons for the low vaccination rate. Objective: The aim of our analysis was to review reported suspicions of adverse reactions (ARs) of registered COVID-19 vaccines (Comirnaty, Vaxzevria, Spikevax), which State Institute for Drug Control received from healthcare professionals and patients in the period from 1 January 2021 to 31 May 2021. Methods: Data were collected from the State Institute for Drug Control database, a retrospective analysis was carried out focusing on trends in the number of all reports of suspicions of adverse reactions sent to the State Institute for Drug Control during the previously mentioned period. We analysed the Retrieved data were analysed with the usage of descriptive statistics and comparison to historical data on drug adverse reactions in Slovakia was performed. Results: During the evaluation period, 5,763 reported suspicions of adverse reactions were analysed, overall, there was a significant (p < 0.0001) increase in the number of reported adverse reactions fivefold. 93% of ARs (n = 5,346) were reported for COVID-19 vaccines. In comparison of the extentof all adverse reactions, there is clearly a statistically significant difference between all types of vaccines administered at that time (p ≤ 0.0001). No statistically significant difference (p ≤ 0.238) was identified between Spikevax and Comirnaty in the proportion of serious adverse reactions. However, a significantly higher (p ≤ 0.00001) proportion of reported suspicions of serious adverse reactions was observed after the administration of Vaxzevria. Conclusion: This is the first analysis conducted in Slovakia aimed to reported adverse reactions in relation to the administration of COVID-19 vaccines. The rate of spontaneously reported suspected adverse reactions has been insufficient in the past for a long time; during the period from January to May 2021 the reporting rate increased due active calls for adverse reactions reporting. In concordance with European data, Vaxzevria had a significantly higher ratio of reported suspicions of serious adverse reactions.
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Cutaneous vasculitides encompass a heterogeneous group of clinicopathological entities, which may occur as single-organ vasculitis of the skin or present as skin-limited variant of systemic vasculitis (i.e., skin-limited ANCA-associated vasculitis), and are triggered by various factors, including infections, drugs and vaccines. The COVID-19 pandemic has challenged us with a variety of both disease- and vaccine-associated skin manifestations, including vasculitis. Among the latter, cutaneous small-vessel vasculitis, previously known as leukocytoclastic vasculitis, seems to be the most reported in either scenario, i.e., natural infection and vaccination. Vasculopathy without true vasculitic changes on histology develops in but a minority of cases, mostly severe/critical COVID-19 patients, and appears to be the result of endothelial injury due to pauci-immune thromboembolic mechanisms. Herein, we provide an overview of the available literature on COVID-19-associated and anti-SARS-CoV-2-vaccine-associated cutaneous vasculitis. Although evidence is mostly limited to isolated reports, with a proportion of cases lacking histopathological confirmation, ample overlap with pre-pandemic forms is shown.
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Correlates of protection for COVID-19 vaccines are urgently needed to license additional vaccines. We measured immune responses to four COVID-19 vaccines of proven efficacy using a single serological platform. IgG anti-Spike antibodies were highly correlated with ID50 neutralization in a validated pseudoviral assay and correlated significantly with efficacies for protection against infection with wild-type, alpha and delta variant SARS-CoV-2 virus. The protective threshold for each vaccine was calculated for IgG anti-Spike antibody. The mean protective threshold for all vaccine studies for WT virus was 154 BAU/ml (95 %CI 42-559), and for studies with antibody distributions that enabled precise estimation of thresholds (i.e. leaving out 2-dose mRNA regimens) was 60 BAU/ml (95 %CI 35-102). We propose that the proportion of individuals with responses above the appropriate protective threshold together with the geometric mean concentration can be used in comparative non-inferiority studies with licensed vaccines to ensure that new vaccines will be efficacious.
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COVID-19 , SARS-CoV-2 , Anticorpos Neutralizantes , Anticorpos Antivirais , Vacinas contra COVID-19 , Humanos , Glicoproteína da Espícula de CoronavírusRESUMO
Coronavirus disease is a highly infectious viral disease caused by severe acute respiratory syndrome virus (SARS nCoV2). It was declared a pandemic within a few months of identification of its index case. The spread of COVID-19 across the globe was rampant, overwhelming healthcare systems and crippling global economies. Since the world was caught off guard by the pandemic, vaccine programs had to be rolled out in emergency to curb its spread. Ten vaccines have been granted Emergency Use Authorization thus far. Much of the side effects we know today are post-marketing adverse effects. Most of them are mild like myalgia and injection-site reactions, but a few of them such as post-vaccination autoimmune diseases have alerted the medical community. These include vaccine-induced thrombotic thrombocytopenia, autoimmune hepatitis, myocarditis, and Graves' disease. We attempt to summarize the diverse autoimmune phenomena reported after COVID-19 vaccination, with an aim to sensitize the medical community so that they can be better equipped in management when confronted with these diseases. This review by no means refutes the potential benefit of COVID-19 vaccination which has consolidated its place in preventing infections and substantially reducing severity and mortality.