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In response to the COVID-19 pandemic, two mRNA vaccines (Comirnaty and Spikevax) received emergency use authorization from the European Medicines Agency. This case report aimed to report a delayed adverse reaction to the mRNA-1273 vaccine against COVID-19 from a Portuguese vaccination center.A case report was performed with medical observation and reported to the Portuguese Pharmacovigilance System, then investigated based on the WHO-UMC Causality Categories. A 66-year-old female patient with a clinical history of dyslipidemia, essential arterial hypertension, obesity, multinodular goitre and cholecystectomy, who presented delayed large cutaneous hypersensitivity reaction following Spikevax COVID-19 mRNA (mRNA-1273) vaccine administration.Our clinical findings (time and clinical appearance), along with evidence of previously reported histological findings, are strongly suggestive of T-cell-mediated hypersensitivity. There is no contraindication to the inoculation of subsequent doses in patients developing these clinical conditions, and vaccination should continue to be strongly encouraged.
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Objective To investigate COVID-19 vaccination status and relevant adverse reactions in patients with psoriasis treated with biological agents, and to explore the effect of COVID-19 vaccination on psoriatic lesions. Methods Clinical data were collected from 572 psoriasis patients aged 18-60 years, who were registered in the management system of psoriasis patients treated with biological agents in the University of Hong Kong-Shenzhen Hospital from May 2019 to June 2021. The COVID-19 vaccination status was investigated by telephone interviews, and the vaccination-related information was obtained by fixed healthcare workers during a fixed time period according to a predesigned questionnaire. Measurement data were compared between two groups by using t test, and enumeration data were compared by using chi- square test or Fisher's exact test. Results The COVID-19 vaccination coverage rate was 43.13%226 casesamong the 524 patients who completed the telephone interview, and was significantly lower in the biological agent treatment group30.79%, 105/341than in the traditional drug treatment group66.12%, 121/183;chi2 = 60.60, P < 0.001. The main reason for not being vaccinated was patients' fear of vaccine safety49.66%, 148/298, followed by doctors' not recommending26.51%, 79/298. In the biological agent treatment group after vaccination, the exacerbation of psoriatic lesions was more common in patients receiving prolonged-interval treatment42.86%, 6/14compared with those receiving regular treatment 4.40%, 4/91;Fisher's exact test, P < 0.001. Skin lesions were severely aggravated in two patients after COVID-19 vaccination, who ever experienced allergic reactions and whose skin lesions did not completely subside after the treatment with biological agents. Conclusions The COVID-19 vaccination coverage rate was relatively low in the psoriasis patients treated with biological agents, and no serious adverse reaction was observed after vaccination. Prolonged-interval treatment due to COVID-19 vaccination ran the risk of exacerbation of skin lesions.Copyright © The Author(s) 2023.
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Vaccines remain the most rigorous and cost-effective weapon of the public health care system against infectious diseases. The development of safe and effective vaccines against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged as an imperative response to the unprecedented morbidity and mortality of the Coronavirus Disease 2019 (COVID-19) pandemic and the subsequent immense pressure on health care systems, families and global society. Despite the typically mild disease course of SARS-CoV-2 in minors, the associated rare but potentially life-threatening complications, as well as the emergence of new highly transmissible variants, led promptly to the extension of COVID-19 vaccine clinical trials in children and adolescents. To date, various COVID-19 vaccine candidates have been successfully trialed in pediatric populations, followed by their incorporation into corresponding vaccination campaigns in both high- and low-income countries. However, the universal COVID-19 vaccination of children and adolescents remains a matter of debate, along with skepticism about their overall safety and benefits in this age group. In this narrative review, we attempt to summarize the multi-faceted burden of COVID-19 on minors, highlighting the favourable safety/effectiveness profile of COVID-19 vaccines in this age group, elucidating the raised concerns and presenting the current implemented vaccination strategies. [ FROM AUTHOR] Copyright of Signa Vitae is the property of Pharmamed Mado Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
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Objective To investigate COVID-19 vaccination status and relevant adverse reactions in patients with psoriasis treated with biological agents, and to explore the effect of COVID-19 vaccination on psoriatic lesions. Methods Clinical data were collected from 572 psoriasis patients aged 18-60 years, who were registered in the management system of psoriasis patients treated with biological agents in the University of Hong Kong-Shenzhen Hospital from May 2019 to June 2021. The COVID-19 vaccination status was investigated by telephone interviews, and the vaccination-related information was obtained by fixed healthcare workers during a fixed time period according to a predesigned questionnaire. Measurement data were compared between two groups by using t test, and enumeration data were compared by using chi- square test or Fisher's exact test. Results The COVID-19 vaccination coverage rate was 43.13%(226 cases)among the 524 patients who completed the telephone interview, and was significantly lower in the biological agent treatment group(30.79%, 105/341)than in the traditional drug treatment group(66.12%, 121/183;chi2 = 60.60, P < 0.001). The main reason for not being vaccinated was patients' fear of vaccine safety(49.66%, 148/298), followed by doctors' not recommending(26.51%, 79/298). In the biological agent treatment group after vaccination, the exacerbation of psoriatic lesions was more common in patients receiving prolonged-interval treatment(42.86%, 6/14)compared with those receiving regular treatment (4.40%, 4/91;Fisher's exact test, P < 0.001). Skin lesions were severely aggravated in two patients after COVID-19 vaccination, who ever experienced allergic reactions and whose skin lesions did not completely subside after the treatment with biological agents. Conclusions The COVID-19 vaccination coverage rate was relatively low in the psoriasis patients treated with biological agents, and no serious adverse reaction was observed after vaccination. Prolonged-interval treatment due to COVID-19 vaccination ran the risk of exacerbation of skin lesions.Copyright © The Author(s) 2023.
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Vaccines having aided in escaping the majority of the population from immunological naïvety, our strategies are now shifting towards an increased focus on identifying and protecting the extremely vulnerable. We here describe the results of testing 12 patients, those with lymphoid malignancies having been targeted their B-cells for therapy with rituximab-containing regimens or a Bruton tyrosine kinase inhibitor, for anti-SARS-CoV-2 spike antibodies after receiving the BNT162b2 mRNA vaccine doses. The interval from last dosing of B-cell depletion therapy to SARS-CoV-2 vaccination was at median 5.3 (range 3.1–6.6) months. Using the ‘seroprotection' threshold of 775 [BAU/mL] for the anti-spike antibody titer, our finding points out the crucial unresponsiveness of the targeted population with 0/12 (0%) achieving ‘seroprotection'. Although IgG seroconversion was observed in 4/12 (33%), supporting the overall benefit of vaccination, the figures still point out a potential need for optimization of practice. IgA was further less responsive (unsuccessful ‘seroconversion' in 11/12 (92%)), implicating an underlying class switch defect. Those with depletion on B-cells are caught at a dilemma between, being too early and too late on receiving SARS-CoV-2 vaccines. They wish to get over their immunological naïvety at the earliest, while, in order to assure quality immune memory, are also required to hold the patience for their B-cells to repopulate. Although it remains an issue whether intensified vaccine schedules and/or regimens will lead to stronger immunogenicity or more effective boosters for non-responders, we shall take advantage of every increasing evidence in order to optimize current options. © 2022 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases
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In December 2019 a new human coronavirus emerged in Wuhan, China, which is known as SARS-CoV2. The clinical course of the disease known as coronavirus disease 2019 (COVID-19) ranges from mild respiratory symptoms to severe lung failure. The virus is currently rapidly spreading around the world and pushing health systems to the limits of their capacity due to the exponential increase in the number of cases. The origin of SARS-CoV2 lies in the bat coronavirus pool and has now emerged in the human population due to interspecies transmission. Molecular diagnostic methods have been established in a very short time and a number of clinical studies on the effectiveness of different antiviral drugs are ongoing. The development of a vaccine using different approaches is also under investigation.Considering the high number of cases and mortality rates of up to 9% there is an urgent need for action. This article summarizes the current state of knowledge on human coronaviruses with a strong focus on the current data on SARS-CoV2. Due to the daily changing level of knowledge, the article reflects the status up to 21 March 2020.
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DNA vaccines have inherent advantages compared to other vaccine types, including safety, rapid design and construction, ease and speed to manufacture, and thermostability. However, a major drawback of candidate DNA vaccines delivered by needle and syringe is the poor immunogenicity associated with inefficient cellular uptake of the DNA. This uptake is essential because the target vaccine antigen is produced within cells and then presented to the immune system. Multiple techniques have been employed to boost the immunogenicity and protective efficacy of DNA vaccines, including physical delivery methods, molecular and traditional adjuvants, and genetic sequence enhancements. Needle-free injection systems (NFIS) are an attractive alternative due to the induction of potent immunogenicity, enhanced protective efficacy, and elimination of needles. These advantages led to a milestone achievement in the field with the approval for Restricted Use in Emergency Situation of a DNA vaccine against COVID-19, delivered exclusively with NFIS. In this review, we discuss physical delivery methods for DNA vaccines with an emphasis on commercially available NFIS and their resulting safety, immunogenic effectiveness, and protective efficacy. As is discussed, prophylactic DNA vaccines delivered by NFIS tend to induce non-inferior immunogenicity to electroporation and enhanced responses compared to needle and syringe.
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Heart muscle inflammations were reported following SARS-CoV-2 messenger ribonucleic acid (RNA) vaccination by the Disease Control Centers in America, and cases of these inflammations reported as adverse effects of this COVID-19 vaccine application increased 1000 times since April 2021. A male individual, 18-year-old received vaccination with mRNA-1273 vaccine, and after a while attended the Emergency Department at King Abdulaziz University Hospital, Jeddah, Saudi Arabia. Upon presentation, the patient complained of a history of chest pain, and he had a high troponin level along with new-onset electrocardiogram changes. During his stay in hospital the patient's blood circulation status remained stable, and no evidence of another infectious or immune cases was found. Although these vaccines are a must and very advantageous in fighting COVID-19 and their benefits are far beyond their risks, although it seems that there is a risk of myopericarditis cases. Under such conditions it is essential to rely on early diagnosis for control and deal with the possible cases of morbidity and mortality associated with these conditions.
Subject(s)
COVID-19 Vaccines , COVID-19 , Myocarditis , Adolescent , Humans , Male , 2019-nCoV Vaccine mRNA-1273 , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Inflammation , Myocarditis/etiology , Myocarditis/diagnosis , SARS-CoV-2 , VaccinationABSTRACT
The safety of COVID-19 vaccines, as was the case last year, remains a large part of the focus in this volume. COVID-19 placed a large magnifying glass on both vaccines, specifically vaccine safety. This was most readily apparent as the number of records in VAERS ballooned to about 10 times the size from 2020 to 2021 (Vaccine Adverse Event Reporting System (VAERS), 2022) [S]. While we have added and/or improved VAERS during COVID-19, including adding or improving other vaccine safety surveillance tools like v-safe and vaccine safety datalink (Blumenthal, Phadke, et al., 2021) [MC], there is still room for improvement in these pharmacovigilance tools (Rizk et al., 2021) [r]. A major global initiative in this realm is the Global Vaccines Safety Blueprint 2.0 (GVSB2.0) (Organization, 2021, pp. 2021–2023) [S]. We wholeheartedly endorse these initiatives, which could significantly improve vaccine safety. As noted in past SEDA issues, clinicians should be mindful of the risks of AEs and SAEs associated with each individual vaccine.
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In this paper we compared brand-specific COVID-19 vaccine effectiveness (VE) during August 2021 in persons born 1962-1971 and vaccinated during June. For SARS-CoV-2 symptomatic infection, protection was lower for Janssen (56%;CI95%: 53-59) or AstraZeneca [Vaxzevria] (68%;CI95%: 65-70), compared to Pfizer-BioNTech [Comirnaty] (78%;CI95%: 77-78), AstraZeneca/Pfizer (86%;CI95%: 80-90) or Moderna [Spikevax] (89%;CI95%: 88-90). VE against hospitalization was ranged 86% for Janssen to 97%-98% for other vaccines.
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Acute pericarditis is an inflammation of the pericardium accompanied by chest pain, pericardial effusion, and electrocardiographic (ECG) changes. It is mainly caused by viruses, followed by bacterial and other infections, tumors, underlying diseases, trauma, medications, and environmental factors. Several reports have emerged on pericarditis as a potential side effect associated primarily with mRNA vaccines, particularly in male adolescents after the second dose. However, the exact mechanism of COVID-19 vaccine-induced pericarditis remains elusive. The most common clinical presentation seen in patients is the elevation in troponin level, as well as C-reactive protein. To exclude other etiologies causing pericarditis, a meticulous diagnostic workup is performed. Thus, a detailed history and physical examination and the timing and type of the vaccine are important. Owning to the novel etiology of pericarditis caused by the COVID-19 vaccine, treatment is based on the patient's symptoms and diagnostic workup, including pain management and nonsteroidal anti-inflammatory agents with or without colchicine. However, dual therapy with intravenous immune globulins and/or corticosteroids may be beneficial in severe cases. This chapter will emphasize the emerging adverse events of vaccineinduced pericarditis, summarizing its epidemiology, pathogenesis, clinical presentation, diagnosis, management, and limitation. © 2022 Nova Science Publishers, Inc.