COVID-19 infection originated in Wuhan, China in December 2019 and crippled human health globally in no time. The public health emergency required urgent efforts to develop and test the efficacy and ...safety of vaccines to combat the COVID-19 pandemic. The emergency use approval has been granted to COVID-19 vaccines before the completion of conventional phases of clinical trials. However, there is no comprehensive review of safety data reported from the vaccine trials, which is critical information to inform the policies in order to improve uptake of COVID-19 vaccines and mitigate the risk aversion perceived due to the COVID-vaccine side effects. This study aims to systematically review and synthesize the evidence on the safety data from the published COVID-19 vaccine trials. This study followed PRISMA guidelines. We searched three major electronic databases (PubMed, Embase, and Google Scholar) for published studies between Dec 2019 and 2020. Eligible study designs were randomized trials and pre-and post-intervention evaluations. Descriptive findings of included studies were reported stratified by target population, setting, outcomes, and overall results. From PubMed, Embase, WHO database, and Google Scholar screened titles and abstracts, 11 studies were identified in this review. Most of the reactions reported were mild to moderate whereas a few with severe intensity. All reactions resolved within 3–4 days. The commonly reported local adverse events were pain at the site of injection, swelling, and redness. The systemic reactions included fever, fatigue, myalgia, and headache. Some trials also reported laboratory derangements like decreased hemoglobin, increased bilirubin, altered SGOT and SGPT. None of these alterations were clinically manifested and were self-limiting. Few clinical trials reported serious adverse events, but they were unrelated to vaccination. This systematic review indicates that COVID-19 vaccines can be safe with no serious adverse events. However, long-term post-marketing surveillance data, particularly in high-risk vulnerable populations (elderly and those with co-morbidities, pregnant women, and children) is warranted to ensure the safety of COVID-19 vaccines.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Alors que les premiers vaccins contre la COVID-19 arrivent sur le marché, la question de la sécurité de ces produits émerge dans le débat public. L’inquiétude majeure porte sur l’apparition possible ...d’effets indésirables, notamment dans le cadre de l’utilisation de technologies pharmaceutiques inédites à l’instar de l’ARNm. Il est important de rappeler aux patients comme aux professionnels qu’un vaccin est non seulement un médicament à part entière, mais aussi un médicament spécial : biologique et immunologique. En conséquence, son encadrement est draconien, et malgré l’urgence, aucune exigence n’a été revue la baisse. La rapidité de mise sur le marché résulte tant des essais cliniques adaptés que de procédures d’évaluation optimisées.
As the first vaccines against COVID-19 arrive on the market, the question of the safety of these products arises in the public debate. The major concern is about the possible occurrence of adverse effects, particularly in the context of the use of novel pharmaceutical technologies such as mRNA. It is important to remind both patients and professionals that a vaccine is not only a medicinal product in its own right, but also a special medicinal product: biological and immunological. As a result, its supervision is draconian, and despite the urgency, no requirements have been lowered. The speed of marketing is the result both of adapted clinical trials and optimized evaluation procedures.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Résumé Contexte Les effets possibles des vaccins contre la COVID-19 sur la santé reproductive et la fertilité masculine, en particulier, ont fait l’objet d’intenses discussions de la part de la ...communauté scientifique et du public depuis leur introduction pendant la pandémie. Sur les médias et les plateformes de médias sociaux, de nombreuses allégations ont été soulevées concernant les effets délétères des vaccins contre la COVID-19 sur la qualité du sperme, sans preuves scientifiques. En réponse à ce conflit émergent, nous avons conçu cette étude pour évaluer et déterminer l’effet du vaccin COVID-19 à ARNm de Pfizer-BioNTech sur la fertilité masculine représentée par les paramètres d’analyse du sperme. Résultats En comparant les paramètres du sperme des participants avant et après la vaccination, aucun effet statistiquement significatif sur le volume de sperme, le pH ou la concentration normale et la morphologie de spermatozoïdes, n’a été montré. Cependant, il y avait des différences statistiquement significatives sur la mobilité totale des spermatozoïdes (P = 0,05) et sur leur mobilité progressive (P = 0,02). Ces différences sont cliniquement insignifiantes étant donné que les deux lectures avant et après la vaccination se situaient dans des fourchettes normales, selon les directives manuelles de l’OMS pour l’examen et le traitement du sperme humain. Conclusion Nos données indiquent que le vaccin à ARNm COVID-19 de Pfizer-BioNTech n’a aucun effet délétère sur les paramètres du sperme. Mots-Clés COVID-19, Analyse du Sperme, Vaccin COVID-19 à ARNm de Pfizer-BioNTech, Infertilité masculine
El sitio de noticias ro.sputnik.md es la versión en lengua rumana de la plataforma web de noticias Sputnik, propiedad del gobierno ruso, uno de los principales canales utilizados por el Kremlin para ...difundir información errónea y desinformación a través de las fronteras rusas. La presente investigación pretende identificar en los textos mediáticos de ro.sputnik.md los marcos asociados a las vacunas anti-COVID-19 y los valores noticiosos utilizados para construir el discurso informativo sobre la vacunación. Para mapear los marcos mediáticos y las construcciones léxicas y discursivas, la investigación propone un enfoque mixto basado en el contenido, en el que el análisis automatizado del texto (frecuencia, co-ocurrencia, ngramas) se combina con el análisis temático y del discurso. En el corpus se identifican seis marcos de énfasis (N=1.165): Superioridad de la vacuna rusa Sputnik V, efectos fatales/secundarios de las vacunas autorizadas por la UE, limitaciones de los derechos y libertades individuales, lucha de las autoridades de la ue y/o rumanía, protección de los niños/adolescentes y conspiración de las grandes farmacéuticas. Los resultados muestran que al valor noticioso de negatividad se asocian fórmulas discursivas específicas: muerte, efectos secundarios (coágulos de sangre, trombosis, coagulación), restricciones e interdicciones o advertencias (grave, riesgo, pánico), mientras que al valor noticioso de conflicto se asocian el vocabulario bélico (defensa, batalla, pólvora) y al elitismo, actores conocidos (líderes estatales, <> famosos) y países (actores internacionales poderosos, vecinos significativos). The news site ro.sputnik.md is the Romanian language version of the Sputnik news website platform, owned by the Russian government, one of the main channels used by the Kremlin to disseminate mis- and disinformation across Russian borders. The current research aims to identify the frames associated with anti-COVID-19 vaccines, and the news values employed in constructing news discourse on vaccination in ro.sputnik.md media texts. To map the media frames and the lexical and discursive constructions, the research proposes a mixed methods content-based approach, where automated text analysis (frequency, co-occurrence, n-grams) is combined with thematic and discourse analysis. Six emphasis frames are identified in the corpus (N=1,165): Superiority of the Russian Sputnik V Vaccine, Fatal/Side Effects of EU Authorized Vaccines, Limitations of Individual Rights and Freedoms, EU and/or Romanian Authorities' Struggle, Children and Teenagers' Protection, and Big Pharma Conspiracy. The findings show that specific discursive patterns are associated with the negative news value: death, side effects (blood clot, thrombosis, coagulation), restrictions, and interdictions or warnings (serious, risk, negative, panic, etc.), while the conflict news value is associated with warfare vocabulary (defense, threat, battle, fire, gunpowder, etc.); and eliteness, with well-known actors (state leaders, European leaders, famous "conspirators") and countries (powerful international actors, meaningful neighbours). PALABRAS CLAVE | KEYWORDS Marcos mediáticos, valores noticiosos, análisis de contenido, análisis textual, vacuna COVID-19, Sputnik News. Media framing, news values, content analysis, textual analysis, COVID-19 vaccine, Sputnik News.
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IZUM, KILJ, NUK, ODKLJ, PILJ, PNG, SAZU, UL, UM, UPUK
Les vaccins contre le SRAS-CoV-2 sont administrés dans le monde entier. La plupart des effets secondaires sont légers et spontanément résolutifs, avec peu de cas signalés de réactions graves. Nous ...rapportons un cas de vascularite leucocytoclasique avec insuffisance rénale aiguë à la suite d’un vaccin à SARS-CoV-2 inactivé, unique pour sa présentation visuelle spectaculaire et sa réponse rapide au traitement. Il s’agit d’un homme âgé de 58 ans présentant de la fièvre, des arthralgies et un purpura vasculaire au niveau des quatre membres, le tout associé à une insuffisance rénale aiguë nécessitant une hémodialyse neuf jours après la vaccination anti-COVID-19. La biopsie cutanée a révélé une vascularite leucocytoclasique et la biopsie rénale une néphrite tubulo-interstitielle aiguë. Le purpura vasculaire s’est résolu 7 jours après le début du traitement par prednisone, mais le patient a conservé une insuffisance rénale chronique modérée. L’analyse et les enquêtes sur les complications et les événements indésirables induits par les vaccins anti-COVID-19 pourraient améliorer notre compréhension de la pathogenèse sous-jacente.
SARS-CoV-2 vaccines are being administered worldwide. Most side effects are mild and self-limiting with few reported cases of severe reactions. We report a case of leukocytoclastic vasculitis with acute kidney failure following aninactivated SARS-CoV-2 vaccine, unique for its dramatic visual presentation and its rapid response to treatment. This is the case of a 58years-old man presenting with fever, arthralgias and vascular purpura on his limbs associated with acute kidney failure requiring hemodialysis nine days after anti-COVID-19 vaccination. Skin biopsy revealed a leukocytoclastic vasculitis and a renal biopsy showed an acute tubulointerstitial nephritis. The vascular purpura resolved 7days after initiating treatment with prednisone but the patient remains in chronic renal failure. The analysis and investigation of the complications and adverse events induced by anti-COVID-19 vaccines could increase our understanding of the underlying pathogenesis.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ
Ante la preocupación que las vacunas autorizadas contra el SARS-CoV-2 pierdan eficacia y efectividad disminuyendo su capacidad de prevenirlo y debido a las variantes que existen, la fitoterapia sigue ...siendo un tema relevante. El objetivo fue: Determinar el estado vacunal y uso de la fitoterapia en estudiantes universitarios con COVID-19, de la Universidad Nacional Autónoma de Tayacaja, Huancavelica. Investigación cuantitativa, descriptiva, transversal y retrospectiva, se aplicó a través del Google Form, una encuesta Ad Hoc elaborada por las autoras y validada por 3 expertos. Reportándose que la mayoría (55,7%) enfermó estando vacunado recurriendo a fitoterapia según costumbres ancestrales. Palabras clave: vacuna contra la COVID-19, plantas medicinales, estudiantes vacunados. (Fuente: DeCS BIREME) Given the great concern that authorized vaccines against SARS-CoV-2 lose efficacy and effectiveness, decreasing their ability to prevent COVID-19 due to the variants that exist, the use of phytotherapy remains a relevant issue; therefore, the present quantitative, descriptive, cross-sectional and retrospective study describes the vaccination status and use of phytotherapy in university students with COVID-19, to whom an Ad Hoc survey prepared by the authors and validated by 03 experts was applied through the Google Form. It was reported that the majority (55,7%) became ill while vaccinated by resorting to phytotherapy according to ancestral customs. Key words: COVID-19 vaccine; medicinal plants; vaccinated students. (Source: DeCS BIREME)
Estudiar la prevalencia de anticuerpos neutralizantes en el personal sanitario y de apoyo tras la administración de la segunda dosis de vacuna BNT162b2 (Pfizer–BioNTech).
En diciembre 2021 llevamos a ...cabo un estudio en el Departamento de Salud de Orihuela, Alicante (España), formado por 1.500 trabajadores. En los participantes del estudio, recogimos variables demográficas y realizamos un test «point-of-care» (POC) de inmunocromatografía para medir la presencia de anticuerpos neutralizantes (OJABIO® SARS-CoV-2 Neutralizing Antibody Detection Kit, fabricado por Wenzhou OJA Biotechnology Co., Ltd.- Wenzhou, Zhejiang, China) antes de la administración de la tercera dosis de vacuna.
Obtuvimos información completa de 964 (64%) trabajadores, siendo 290 varones y 674 mujeres. La edad media fue de 45,8 años (mín: 18, máx: 68) y el tiempo desde la última dosis (TUD) de vacuna fue 40,5 semanas (mín: 1,71; máx: 47,71). Un total de 131 (13,5%) habían padecido infección por SARS-CoV-2 confirmada mediante RT-PCR. La proporción de sujetos con presencia de anticuerpos neutralizantes fue de 38,5%. En el análisis multivariable el TUD de vacuna (razón de probabilidades ajustada ORa semana: 1,07; IC 95%: 1,04; 1,09) y la infección previa por SARS-CoV-2 (ORa: 3,7; IC 95%: 2,39; 5,63) mostraron asociación estadísticamente significativa con la presencia de anticuerpos neutralizantes.
El TUD de vacuna y la infección previa por SARS-CoV-2 determinaron la presencia de anticuerpos neutralizantes en 38,5% del personal sanitario y personal de apoyo.
To study the prevalence of neutralizing antibodies in healthcare workers and healthcare support personnel after the administration of the second dose of the BNT162b2 vaccine (Pfizer-BioNTech).
In December 2021, we undertook a study in the Health Department in Orihuela, Alicante (Spain), which consists of 1500 workers. We collected demographic variables about the study participants, and we performed a «point-of-care» immunochromatography test to measure the presence of neutralizing antibodies (OJABIO® SARS-CoV-2 Neutralizing Antibody Detection Kit, manufactured by Wenzhou OJA Biotechnology Co., Ltd. Wenzhou, Zhejiang, China) before the administration of the third dose of the vaccine.
We obtained complete information about 964 (64%) workers, which consisted of 290 men and 674 women. The average age was 45,8 years (min. 18, max. 68) and the average time since the last dose of the vaccine was 40,5 weeks (min. 1,71, max. 47,71). A total of 131 participants (13,5%) had suffered infection by SARS-CoV-2 confirmed using RT-PCR. The proportion of participants who showed presence of neutralizing antibodies was 38,5%. In the multivariable analysis, the time since the last dose of the vaccine (aOR week: 1,07; 95%CI: 1,04; 1,09) and previous infection by SARS-CoV-2 (aOR: 3,7; 95CI: 2,39; 5,63) showed a statistically significant association with the presence of neutralizing antibodies.
The time since the administration of the last dose of the vaccine and the previous infection by SARS-CoV-2 determined the presence of neutralizing antibodies in 38,5% of the healthcare workers and support workers.
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