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J Occup Environ Med ; 64(8): 635-641, 2022 Aug 01.
Article in English | MEDLINE | ID: covidwho-2029126


OBJECTIVE: The aim of the study is to identify factors associated with breakthrough infection among a cohort of Midwestern healthcare personnel (HCP). METHODS: SARS-CoV-2-positive test results between March 1, 2020, and July 31, 2021, were collected from electronic medical records of HCP to identify breakthrough infections. RESULTS: Healthcare personnel who were younger than 35 years, received the Pfizer vaccine, and worked in COVID clinical units had greater adjusted odds of breakthrough infection. COVID infection before full vaccination was associated with reduced odds of breakthrough infection. CONCLUSIONS: Our study concluded that the most vulnerable HCP are younger, working in COVID-19 clinical units, and received Pfizer-BioNTech primary series vaccines. Healthcare personnel who had COVID before vaccination were at reduced risk of breakthrough infection, indicating that supplemental immunity could better protect at-risk HCP groups.

COVID-19 , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Delivery of Health Care , Health Personnel , Humans , SARS-CoV-2
Sci Rep ; 12(1): 11298, 2022 Jul 04.
Article in English | MEDLINE | ID: covidwho-2028705


Reliable serological assays are needed to understand the real impact of COVID-19. In order to compare the efficiency of different COVID-19 vaccines used in the National Vaccination Program in Tunisia, we have developed a quantitative in-house ELISA. The ELISA is based on the ectodomain of the SARS-CoV-2 Spike Baculovirus recombinant protein. We used a panel of 145 COVID-19 RT-PCR positive serum samples and 116 pre-pandemic serum samples as a negative panel. The validation was carried out by comparison to four commercial techniques (Vidas SARS-CoV-2 IgG anti-RBD Biomérieux, Elecsys Anti-Nucleocapsid of SARS-CoV-2 Roche, cPass GenScript and the quantitative Elecsys Anti-RBD of SARS-CoV-2, Roche). For the evaluation of the National Vaccination campaign, we have included 115 recipients who received one of the approved vaccines. The qualitative performances of the developed ELISA gave 96% sensitivity, 97.5% specificity and 0.968 accuracy. For the evaluation of the different brand of vaccines in recipients not previously infected with SARS-CoV-2, it seems that mRNA vaccine of Pfizer/BioNTech has shown a higher efficacy compared to inactivated virus vaccines. COVID-19 convalescent individuals have generated poor antibody responses. Nevertheless, when they are vaccinated with any brand of the COVID-19 vaccines, many of them mounted an exponential increase of the induced immune responses, qualified as a "hybrid vigor immunity". Our developed in-house ELISA seems to be very efficient in evaluating the effectiveness of anti-COVID-19 vaccination. Platforms based on mRNA vaccine are better performing than those based on inactivated virus.

COVID-19 , Viral Vaccines , COVID-19/prevention & control , COVID-19 Vaccines , Enzyme-Linked Immunosorbent Assay , Humans , SARS-CoV-2 , Vaccines, Inactivated , Vaccines, Synthetic , mRNA Vaccines
Rev Panam Salud Publica ; 46, ago. 2022
Article in English | PAHO, PAHOIRIS | ID: covidwho-2026378


[ABSTRACT]. Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determined whether reliance was used in the authorization process. Subgroups of reference national regulatory authorities (NRAs) and non-reference NRAs were compared. Results. 56 authorizations of 10 different COVID-19 vaccines were identified in 18 countries, of which 25 (44.6%) used reliance and 12 (21.4%) did not. For the remaining 19 (33.0%) it was not possible to determine whether reliance was used. Reference agencies used reliance less often (40% of authorizations with a known pathway) compared to non-reference agencies (100%). The median review time was just 15 days and does not meaningfully differ between reliance and non-reliance authorizations. Conclusions. This study demonstrated that for these vaccines, despite reliance pathways being associated with numerous rapid authorizations, independent authorization review times were not considerably longer than reliance reviews; reliance pathways were not a prerequisite for rapid authorization. Nevertheless, reliance pathways provided rapid authorizations in response to the COVID-19 emergency.

[RESUMEN]. Objetivos. Determinar dónde y cuándo se usaron las decisiones de autoridades regulatorias de otras jurisdicciones y la naturaleza de estos mecanismos para autorizar vacunas contra la COVID-19 en América Latina. Métodos. Se realizó un estudio observacional para evaluar las características de todas las autorizaciones de vacunas contra la COVID-19 en América Latina. Para cada autorización se determinó si se emplearon las decisiones de autoridades regulatorias de otras jurisdicciones en el proceso de autorización. Se compararon subgrupos de autoridades regulatorias nacionales (ARN) consideradas de referencia con otras ARN no usadas como referencia. Resultados. Se determinó dónde se otorgaron 56 autorizaciones de 10 vacunas diferentes contra la COVID–19 en 18 países; de estas 56 autorizaciones, 25 (44,6%) hicieron uso de las decisiones de autoridades regulatorias de otras jurisdicciones y 12 (21,4%), no. Para las 19 restantes (33,0%) no fue posible determinar si se hizo uso de las decisiones de autoridades regulatorias de otras jurisdicciones. Los organismos de referencia utilizaron las decisiones de autoridades regulatorias de otras jurisdicciones con menos frecuencia (40% de las autorizaciones con un mecanismo conocido) en comparación con los organismos no usados como referencia (100%). El plazo medio de revisión fue de tan solo 15 días y no difiere significativamente entre las autorizaciones que emplearon decisiones de autoridades regulatorias de otras jurisdicciones y las que no las emplearon. Conclusiones. En este estudio se demostró que, a pesar de que los mecanismos de utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se asocian en muchos casos con autorizaciones rápidas, para estas vacunas los plazos de revisión independiente para la autorización no fueron considerablemente mayores que los de las revisiones que emplearon decisiones de autoridades regulatorias de otras jurisdicciones. También se demostró que para obtener una autorización rápida no se requería la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones. Sin embargo, estos mecanismos proporcionaron autorizaciones rápidas en respuesta a la emergencia por la COVID–19.

[RESUMO]. Objetivos. Mapear a tempestividade e a natureza do uso de decisões regulatórias de outras autoridades (reliance regulatório) para autorização de vacinas contra a COVID-19 na América Latina. Métodos. Em um estudo observacional, foram avaliadas as características de todas as autorizações de vacinas contra COVID-19 na América Latina. Para cada autorização, foi determinado se foram utilizadas decisões de outras autoridades regulatórias para embasar o processo de autorização. Foram comparados subgrupos de autoridades reguladoras nacionais (ARN) de referência (ARNr) e ARN não consideradas de referência. Resultados. Foram identificadas 56 autorizações de 10 vacinas diferentes contra a COVID-19 em 18 países, das quais 25 (44,6%) utilizaram decisões de outras ARN como base para o registro e 12 (21,4%) não. Para as 19 (33,0%) autorizações restantes, não foi possível determinar se decisões de outras ARN foram utilizadas. As ARNr utilizaram decisões de outras autoridades com menos frequência (40% das autorizações com via regulatória conhecida) em comparação com as ARN não consideradas de referência (100%). A mediana do tempo de tramitação foi de apenas 15 dias, sem diferença significativa entre processos nos quais foram utilizadas decisões de outras agências e processos que não as utilizaram. Conclusões. Este estudo demonstrou que, para estas vacinas, apesar de o uso do reliance regulatório estar associado a várias autorizações rápidas, os tempos de tramitação não foram consideravelmente maiores em autorizações independentes do que quando foram utilizadas decisões de outras ARN; o reliance regulatório não foi um pré-requisito para autorização rápida. No entanto, o uso de tais processos viabilizou autorizações rápidas em resposta à emergência de COVID-19.

Regulatory Frameworks for Health , COVID-19 , Health Priorities , Latin America , Global Health , Drug Approval , COVID-19 Vaccines , Drug Utilization Review , Regulatory Frameworks for Health , Health Priorities , Global Health , Drug Approval , COVID-19 Vaccines , Drug Utilization Review , Regulatory Frameworks for Health , Global Health , Drug Approval , COVID-19 Vaccines
Rev Panam Salud Publica ; 46, ago. 2022
Article in English | PAHO, PAHOIRIS | ID: covidwho-2026377


[ABSTRACT]. There is a lack of real-world surveillance studies on reports of adverse events associated with COVID-19 vaccination, as well as comparative analyses of adverse events from vaccines with different platforms. This observational, descriptive, retrospective study based on secondary data describes the adverse events following immunization (AEFIs) related to the first 145 000 doses of COVID-19 vaccines delivered in Aracaju municipality, Sergipe state, northeast Brazil. Records of AEFIs were collected using the e-SUS Notifica database for January 19 to April 30, 2021. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for AEFIs and the type of COVID-19 vaccine, either CoronaVac (Sinovac–Butantan) or Oxford–AstraZeneca (Fiocruz). A total of 474 AEFIs (32.7 events/10 000 doses) from 254 individuals were reported and analyzed, and all of them were classified as non-serious. There was an association between the use of the CoronaVac vaccine and headache (OR = 2.1; 95% CI: 1.4–3.2), pain at the injection site (OR = 9.6; 95% CI: 3.9–23.8), lethargy (OR = 5.2; 95% CI: 1.8–14.8), fatigue (OR = 10.1; 95% CI: 2.4–42.3), diarrhea (OR = 4.4; 95% CI: 1.5– 12.5) and cold-like symptoms (OR = 8.0; 95% CI: 1.9–34.0). However, the proportion of individuals reporting fever was higher among those who received the Oxford–AstraZeneca vaccine (OR = 3.1; 95% CI 1.5–6.4). This population-based observational study strengthens the evidence for the safety and tolerability of the CoronaVac and Oxford–AstraZeneca vaccines used against COVID-19.

[RESUMEN]. Hay una carencia de estudios de vigilancia en el mundo real sobre la notificación de eventos adversos asociados a la vacunación contra la COVID-19, así como de análisis comparativos de los eventos adversos de vacunas con diferentes plataformas. En este estudio observacional, descriptivo y retrospectivo basado en datos secundarios se describen los eventos adversos supuestamente atribuibles a la vacunación o inmunización (ESAVI) relacionados con las primeras 145 000 dosis de vacunas contra la COVID-19 administradas en el municipio de Aracaju, estado de Sergipe, en la región Noreste de Brasil. Se recopilaron registros de los ESAVI del 19 de enero al 30 de abril del 2021 con la base de datos e-SUS Notifica. Se calcularon las razones de posibilidades (OR, por su sigla en inglés) y los intervalos de confianza (IC) del 95 % para los ESAVI y el tipo de vacuna contra la COVID-19 (CoronaVac [Sinovac-Butantan] o bien Oxford-AstraZeneca [Fiocruz]). Se notificaron y analizaron un total de 474 ESAVI (32,7 eventos/10 000 dosis) de 254 personas, y todos se clasificaron como no graves. Se encontró una relación entre el empleo de la vacuna CoronaVac y la cefalea (OR = 2,1; IC del 95 %: 1,4–3,2), dolor en el lugar de la inyección (OR = 9,6; IC del 95 %: 3,9–23,8), letargo (OR = 5,2; IC del 95 %: 1,8–14,8), cansancio (OR = 10,1; IC del 95 %: 2,4–42,3), diarrea (OR = 4,4; IC del 95 %: 1,5–12,5) y síntomas similares al resfriado (OR = 8,0; IC del 95 %: 1,9 a 34,0). Sin embargo, la proporción de pacientes que notificaron fiebre fue mayor entre los que recibieron la vacuna de Oxford-AstraZeneca (OR = 3,1; IC del 95 %: 1,5 a 6,4). Este estudio observacional poblacional refuerza la evidencia sobre la seguridad y tolerabilidad de las vacunas CoronaVac y Oxford-AstraZeneca empleadas contra la COVID-19. Palabras clave COVID-19; SARS-CoV-2; vacunas contra la COVID-19; efectos colaterales y reacciones adversas relacionados

[RESUMO]. Faltam estudos de vigilância no mundo real sobre relatórios de eventos adversos associados à vacinação contra a COVID-19, bem como análises comparativas de eventos adversos decorrentes de vacinas com diferentes plataformas. Este estudo observacional, descritivo e retrospectivo baseado em dados secundários descreve os eventos adversos pós-vacinação (EAPV) relacionados com as primeiras 145 mil doses de vacinas contra a COVID-19 entregues no município de Aracaju, capital do estado de Sergipe, na região Nordeste do Brasil. Os registros de EAPV foram coletados usando o sistema e-SUS Notifica com referência ao período de 19 de janeiro a 30 de abril de 2021. Razões de chances (odds ratios, ORs) e intervalos de confiança (IC) de 95% foram calculados para os EAPV e o tipo de vacina contra a COVID-19: CoronaVac (Sinovac-Butantan) ou Oxford-AstraZeneca (Fiocruz). Um total de 474 EAPV (32,7 eventos/10 mil doses) de 254 indivíduos foram relatados e analisados, e todos foram classificados como não graves. Houve uma associação entre o uso da vacina CoronaVac e cefaleia (OR = 2,1; IC 95%: 1,4-3,2), dor no local da injeção (OR = 9,6; IC 95%: 3,9-23,8), letargia (OR = 5,2; IC 95%: 1,8-14,8), cansaço (OR = 10,1; IC 95%: 2,4-42,3), diarreia (OR = 4,4; IC 95%: 1,5-12,5 e sintomas gripais (OR = 8,0; IC 95%: 1,9-34,0). Contudo, a proporção de indivíduos que relataram febre foi superior entre os que receberam a vacina Oxford-AstraZeneca (OR = 3,1; IC 95%: 1,5-6,4). Este estudo observacional de base populacional reforça as evidências da segurança e tolerabilidade das vacinas CoronaVac e Oxford-AstraZeneca usadas contra a COVID-19.

COVID-19 , SARS-CoV-2 , COVID-19 Vaccines , Drug-Related Side Effects and Adverse Reactions , Injection Site Reaction , COVID-19 Vaccines , Drug-Related Side Effects and Adverse Reactions , Injection Site Reaction , COVID-19 Vaccines , Drug-Related Side Effects and Adverse Reactions , Injection Site Reaction
Rev Panam Salud Publica ; 46, ago. 2022
Article in English | PAHO, PAHOIRIS | ID: covidwho-2026376


[ABSTRACT]. Objective. To characterize the epidemiological and clinical profile of individuals more likely to become infected with SARS-CoV-2 after the fully vaccination schedule in order to profile priority groups to receive a booster dose in situations of vaccine doses shortage as well as for maintenance of personal protective care. Methods. This cross-sectional study used data from hospitalized COVID-19 patients aged ≥18 years, who had been fully vaccinated and had a SARS-CoV-2 infection positive diagnosis collected from the SIVEP-Gripe database (Influenza Epidemiological Surveillance Information System) from January 18, 2021 to September 15, 2021. Demographic data, clinical symptoms and preexisting medical conditions (comorbidities) were analyzed. The primary outcome was in-hospital death. Results. The majority of hospitalized patients with vaccine breakthrough infection were ≥60 years old, male, with critical or severe COVID-19. The fatality rate was extremely high (50.27%) and more pronounced in elderly groups. The most prevalent symptoms were cough, dyspnea, respiratory distress, and low blood oxygen saturation. The most frequent comorbidities were heart disease and diabetes. High fatality rates were observed among patients admitted to the intensive care units (72.88%) and those who required invasive mechanical ventilation (87.82%). The main risk factors for an unfavorable outcome were older age, respiratory compromise, inactivated virus vaccine immunization, and preexisting medical conditions. Conclusions. We characterized the profile of hospitalized Brazilian patients with COVID-19 vaccine breakthrough infection and the risk factors for an unfavorable outcome. These data allow to identify priority groups to receive a booster dose and to continue using personal protection.

[RESUMEN]. Objetivo. Caracterizar el perfil clínico y epidemiológico de las personas con mayores probabilidades de contraer la infección por el SARS-CoV-2 luego de tener el esquema completo de vacunación, con el fin de definir los grupos de prioridad para la aplicación de la dosis de refuerzo en situaciones de escasez de dosis de vacunación, así como para el mantenimiento de los equipos de protección personal. Métodos. En este estudio transversal se emplearon datos de pacientes mayores de 18 años hospitalizados con COVID-19 que habían recibido la pauta completa de vacunación y tenían un diagnóstico positivo de infección por SARS-CoV-2, recabados de la base de datos SIVEP-Gripe (Sistema de Información de Vigilancia Epidemiológica de la Gripe) en el periodo comprendido entre el 18 de enero del 2021 y el 15 de septiembre del 2021. Se analizaron datos demográficos, síntomas clínicos y trastornos médicos preexistentes (comorbilidades). El resultado primario fue la muerte hospitalaria. Resultados. La mayoría de los pacientes vacunados hospitalizados fueron varones mayores de 60 años con infección crítica o grave por el virus de la COVID-19. La tasa de letalidad fue extremadamente elevada (50,27 %) y más pronunciada en los grupos de edad avanzada. Los síntomas más prevalentes fueron tos, disnea, dificultad respiratoria y baja saturación de oxígeno en sangre. Las comorbilidades más frecuentes fueron las cardiopatías y la diabetes. Se observaron altas tasas de letalidad entre los pacientes ingresados en las unidades de cuidados intensivos (72,88 %) y los que necesitaron ventilación mecánica invasiva (87,82 %). Los principales factores de riesgo para un resultado desfavorable fueron la edad avanzada, dificultades respiratorias, inmunización con vacunas de virus inactivados y trastornos médicos preexistentes. Conclusiones. Se caracterizaron el perfil de los pacientes brasileños vacunados hospitalizados con COVID-19 por infección irruptiva de vacuna y los factores de riesgo de un resultado desfavorable. Estos datos permiten identificar los grupos de prioridad para recibir la dosis de refuerzo y continuar utilizando protección personal.

[RESUMO]. Objetivo. Caracterizar o perfil epidemiológico e clínico dos indivíduos mais propensos a se infectar com SARS-CoV-2 após o esquema vacinal completo, a fim de traçar o perfil dos grupos prioritários para receberem uma dose de reforço em situações de escassez de doses vacinais, bem como para manutenção dos cuidados de proteção individual. Métodos. Este estudo transversal utilizou dados de pacientes hospitalizados com COVID-19 com idade ≥18 anos, esquema vacinal completo e diagnóstico positivo de infecção por SARS-CoV-2, coletados do banco de dados SIVEP-Gripe (Sistema de Informação da Vigilância Epidemiológica da Gripe) de 18 de janeiro a 15 de setembro de 2021. Foram analisados dados demográficos, sintomas clínicos e problemas médicos preexistentes (comorbidades). O desfecho primário foi óbito intra-hospitalar. Resultados. A maioria dos pacientes hospitalizados com infecção devido a escape vacinal tinha ≥60 anos, era do sexo masculino e tinha um quadro de COVID-19 grave ou gravíssimo. A letalidade foi extremamente alta (50,27%) e mais pronunciada nos grupos de pessoas idosas. Os sintomas mais prevalentes foram tosse, dispneia, desconforto respiratório e baixa saturação de oxigênio no sangue. As comorbidades mais frequentes foram cardiopatia e diabetes. Altas taxas de letalidade foram observadas entre os pacientes internados em unidades de terapia intensiva (72,88%) e os que precisaram de ventilação mecânica invasiva (87,82%). Os principais fatores de risco para um desfecho desfavorável foram idade avançada, comprometimento respiratório, imunização com vacina de vírus inativado e problemas médicos preexistentes. Conclusões. Caracterizamos o perfil dos pacientes brasileiros hospitalizados com infecção por COVID-19 devido a escape vacinal e os fatores de risco para desfecho desfavorável. Esses dados permitem identificar grupos prioritários para receber dose de reforço e continuar os cuidados de proteção individual.

SARS-CoV-2 , COVID-19 Vaccines , Risk Factors , Brazil , COVID-19 Vaccines , Risk Factors , Brazil , Risk Factors
Pan Afr Med J ; 41: 293, 2022.
Article in English | MEDLINE | ID: covidwho-2025511


Introduction: coronavirus is a communicable disease that produces severe morbidity and mortality in the globe and more than three million people died due to COVID-19. Pregnant mothers are at higher risk of COVID-19 viral infection, with great morbidity and mortality. Thus, the purpose of this research is to assess the level of COVID-19 vaccine acceptability, determinants, and hesitancy among pregnant mothers attending antenatal care at Debre Markos town, public health institutions, Debre Markos, Northwest Ethiopia. Methods: a mixed study was conducted among 350 pregnant mothers attending antenatal care at Debre Markos town health institutions and the participants were selected by consecutive sampling techniques. The collected data were entered into EPI Info version 7 and then exported to SPSS version 25 for data cleaning and analysis. The level of COVID-19 vaccine acceptability was determined through descriptive statistics, whereas its determinants were identified by binary logistic regression analyses. Variables with p-value < 0.05 in multivariable were considered as significantly associated factors. The qualitative data were collected by an unstructured interviewer guide using in-depth interview data collection methods. Study participants were selected purposively until the required data was saturated. The data was analysed under selected themes based on the guide and summarized manually. Results: sixty-five (18.5%) of the respondents accept the COVID-19 vaccine [95% CI: 13, 23]. Maternal age [AOR: 3.281 (95% CI: 1.184, 9.092)], chronic medical illness [AOR: 0.170 (95% CI: 0.051, .562)], information about COVID-19 vaccine [AOR: 4.063 (95% CI: 1.462, 11.293)], pregnancy-induced medical conditions [AOR: 4.131 (95% CI: 1.055, 16.183) were identified as significant determinants of COVID-19 vaccine acceptability. From the quantitative wing. The qualitative finding implied that misconception, fear of medical complications, lack of trust in its effectiveness, and religious constraints were the common reasons for vaccine hesitancy. Conclusion: COVID-19 vaccine acceptability by pregnant mothers attending ANC at Debre Markos town public health institutions is very low. The health care providers and health extension workers shall create information about the COVID-19 vaccine on its importance and side effects.

COVID-19 , Prenatal Care , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Cross-Sectional Studies , Ethiopia , Female , Humans , Mothers , Pregnancy , Public Health
Int J Public Health ; 67: 1604226, 2022.
Article in English | MEDLINE | ID: covidwho-2023032


Objectives: This study examined factors associated with COVID-19 vaccination intention at the very beginning of the vaccination campaign in a representative sample of the population in southern Switzerland. Methods: In March 2021, we measured vaccination intention, beliefs, attitudes, and trust in a sample of the Corona Immunitas Ticino study. Results: Of the 2681 participants, 1933 completed the questionnaire (response rate = 72%; 55% female; meanage = 41, SD = 24, rangeage = 5-91). Overall, 68% reported an intention to get vaccinated. Vaccination intention was higher in social/healthcare workers, and increased with age, trust in public health institutions, and confidence in the vaccine efficacy. Prior infection of a family member, predilection for waiting for more evidence on the safety and efficacy of the vaccine, and for alternative protective means were negatively associated with intention. Conclusion: In view of needs of COVID-19 vaccine boosters and of suboptimal vaccination coverage, our results have relevant public health implications and suggest that communication about vaccine safety and efficacy, and aims of vaccination programs, should be bi-directional, proportionate, and tailored to the concerns, expectations, and beliefs of different population subgroups.

COVID-19 Vaccines , COVID-19 , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/therapeutic use , Child , Child, Preschool , Cross-Sectional Studies , Female , Humans , Intention , Male , Middle Aged , SARS-CoV-2 , Switzerland , Vaccination , Young Adult
Front Immunol ; 13: 954121, 2022.
Article in English | MEDLINE | ID: covidwho-2022737


Although tremendous effort has been exerted to elucidate the pathogenesis of severe COVID-19 cases, the detailed mechanism of moderate cases, which accounts for 90% of all patients, remains unclear yet, partly limited by lacking the biopsy tissues. Here, we established the COVID-19 infection model in cynomolgus macaques (CMs), monitored the clinical and pathological features, and analyzed underlying pathogenic mechanisms at early infection stage by performing proteomic and metabolomic profiling of lung tissues and sera samples from COVID-19 CMs models. Our data demonstrated that innate immune response, neutrophile and platelet activation were mainly dysregulated in COVID-19 CMs. The symptom of neutrophilia, lymphopenia and massive "cytokines storm", main features of severe COVID-19 patients, were greatly weakened in most of the challenged CMs, which are more semblable as moderate patients. Thus, COVID-19 model in CMs is rational to understand the pathogenesis of moderate COVID-19 and may be a candidate model to assess the safety and efficacy of therapeutics and vaccines against SARS-CoV-2 infection.

COVID-19 , SARS-CoV-2 , Animals , COVID-19 Vaccines , Humans , Macaca fascicularis , Proteomics
Am J Public Health ; 112(9): 1253-1256, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-2022191


Tailored public health messaging encouraging COVID-19 vaccination may help increase vaccination rates and decrease the burden of COVID-19. We conducted a three-part COVID-19 vaccine uptake public health campaign disseminated on Facebook between April and June 2021. Our first campaign focused on reaching Black and Latinx communities; our second campaign focused on addressing vaccine access and scheduling in Latinx communities; and our third campaign focused on religious communities. Overall, we reached 25 million individuals with 171 million views across the United States. (Am J Public Health. 2022;112(9):1253-1256.

COVID-19 , Social Media , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Health Promotion , Humans , Public Health , United States/epidemiology , Vaccination
PLoS One ; 17(7): e0270868, 2022.
Article in English | MEDLINE | ID: covidwho-2021857


Vaccine hesitancy is a global health challenge in controlling the virulence of pandemics. The prevalence of vaccine hesitancy will put highly vulnerable groups, such as the elderly or groups with pre-existing health conditions, at a higher risk, as seen with the outbreak of the pandemic Covid-19. Based on the trends of vaccine hesitancy in the state of Sabah, located in East Malaysia, this study seeks to identify several variables that contribute to vaccine hesitancy. In addition to this, this study also determines which groups are affected by vaccine hesitancy based on their demographics. This study is based on a sampling of 1,024 Sabahan population aged 18 and above through an online and face-to-face questionnaire. The raw data was analysed using the K-Means Clustering Analysis, Principal Component Analysis (PCA), Mann-Whitney U Test, Kruskal-Wallis Test, and frequency. The K-Means Clustering found that more than half of the total number of respondents (Cluster 2 = 51.9%) tend to demonstrate vaccine hesitancy. Based on the PCA analysis, six main factors were found to cause vaccine hesitancy in Sabah: confidence (var(X) = 21.6%), the influence of local authority (var(X) = 12.1%), ineffectiveness of mainstream media (var(X) = 8.4%), complacency (var(X) = 7.4%), social media (var(X) = 6.4%), and convenience issues (var(X) = 5.8%). Findings from both Mann-Whitney U and Kruskal-Wallis tests demonstrate that several factors of group demographics, such as employment status, level of education, religion, gender, and marital status, may explain the indicator of vaccine hesitancy. In particular, specific groups tend to become vaccine hesitancy such as, unemployed, self-employed, students, male, single, level of education, and Muslim. Findings from this empirical study are crucial to inform the relevant local authorities on the level of vulnerability among certain groups in facing the hazards of COVID-19. The main contribution of this study is that it seeks to analyse the factors behind vaccine hesitancy and identifies which groups more likely hesitant toward vaccines based on their demographics.

COVID-19 Vaccines , COVID-19 , Aged , COVID-19/epidemiology , COVID-19/prevention & control , Health Knowledge, Attitudes, Practice , Humans , Malaysia/epidemiology , Male , Vaccination , Vaccination Hesitancy
PLoS One ; 17(7): e0270504, 2022.
Article in English | MEDLINE | ID: covidwho-2021838


INTRODUCTION: COVID-19 vaccination effectively reduces severe disease and death from COVID-19. However, both vaccine uptake and intention to vaccinate differ amongst population groups. Vaccine hesitancy is highest amongst specific ethnic minority groups. There is very limited understanding of the barriers and facilitators to COVID-19 vaccine uptake in Black and South Asian ethnicities. Therefore, we aimed to explore COVID-19 vaccination hesitancy in primary care patients from South Asian (Bangladeshi/Pakistani) and Black or Black British/African/Caribbean/Mixed ethnicities. METHODS: Patients from the above ethnicities were recruited using convenience sampling in four London general practices. Telephone interviews were conducted, using an interpreter if necessary, covering questions on the degree of vaccine hesitancy, barriers and potential facilitators, and decision-making. Interviews were transcribed verbatim and thematically analysed. Data collection and analysis occurred concurrently with the iterative development of the topic guide and coding framework. Key themes were conceptualised through discussion with the wider team. RESULTS: Of thirty-eight interviews, 55% (21) of these were in Black or Black British/African/Caribbean/Mixed ethnicities, 32% (12) in Asian / British Asian and 13% (5) in mixed Black and White ethnicities. Key themes included concerns about the speed of vaccine roll-out and potential impacts on health, mistrust of official information, and exposure to misinformation. In addition, exposure to negative messages linked to vaccination appears to outweigh positive messages received. Facilitators included the opportunity to discuss concerns with a healthcare professional, utilising social influences via communities and highlighting incentives. CONCLUSION: COVID-19 has disproportionately impacted ethnic minority groups. Vaccination is an effective strategy for mitigating risk. We have demonstrated factors contributing to vaccine reluctance, hesitancy and refusal and highlighted levers for change.

COVID-19 , Vaccines , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Ethnic and Racial Minorities , Ethnicity , Health Knowledge, Attitudes, Practice , Humans , Minority Groups , Primary Health Care , Vaccination
PLoS One ; 17(6): e0270060, 2022.
Article in English | MEDLINE | ID: covidwho-2021817


BACKGROUND: An ideal test for COVID-19 would combine the sensitivity of laboratory-based PCR with the speed and ease of use of point-of-care (POC) or home-based rapid antigen testing. We evaluated clinical performance of the Diagnostic Analyzer for Selective Hybridization (DASH) SARS-CoV-2 POC rapid PCR test. METHODS: We conducted a cross-sectional study of adults with and without symptoms of COVID-19 at four clinical sites where we collected two bilateral anterior nasal swabs and information on COVID-19 symptoms, vaccination, and exposure. One swab was tested with the DASH SARS-CoV-2 POC PCR and the second in a central laboratory using Cepheid Xpert Xpress SARS-CoV-2 PCR. We assessed test concordance and calculated sensitivity, specificity, negative and positive predictive values using Xpert as the "gold standard". RESULTS: We enrolled 315 and analyzed 313 participants with median age 42 years; 65% were female, 62% symptomatic, 75% had received ≥2 doses of mRNA COVID-19 vaccine, and 16% currently SARS-CoV-2 positive. There were concordant results for 307 tests indicating an overall agreement for DASH of 0.98 [95% CI 0.96, 0.99] compared to Xpert. DASH performed at 0.96 [95% CI 0.86, 1.00] sensitivity and 0.98 [95% CI 0.96, 1.00] specificity, with a positive predictive value of 0.85 [95% CI 0.73, 0.96] and negative predictive value of 0.996 [95% CI 0.99, 1.00]. The six discordant tests between DASH and Xpert all had high Ct values (>30) on the respective positive assay. DASH and Xpert Ct values were highly correlated (R = 0.89 [95% CI 0.81, 0.94]). CONCLUSIONS: DASH POC SARS-CoV-2 PCR was accurate, easy to use, and provided fast results (approximately 15 minutes) in real-life clinical settings with an overall performance similar to an EUA-approved laboratory-based PCR.

COVID-19 , Adult , COVID-19/diagnosis , COVID-19 Testing , COVID-19 Vaccines , Clinical Laboratory Techniques/methods , Cross-Sectional Studies , Female , Humans , Male , Point-of-Care Systems , Polymerase Chain Reaction , SARS-CoV-2/genetics , Sensitivity and Specificity
PLoS One ; 17(6): e0269917, 2022.
Article in English | MEDLINE | ID: covidwho-2021809


The purpose of this study was to identify factors associated with the increase in the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S1) protein and neutralizing antibody titer following SARS-CoV-2 vaccination. This observational study was conducted among healthcare workers working for a private hospital group in Fukushima Prefecture, Japan. Two blood samples were obtained from each participant. The first sample was obtained before the first dose of BNT162b2 (Pfizer-BioNTech) vaccine, and a second sample was obtained approximately 6 weeks later. Immunoglobulin G (IgG) antibody against the SARS-CoV-2 spike (S1) protein, immunoglobulin M (IgM) antibody against SARS-CoV-2 N-protein, and neutralizing activity were measured using the chemiluminescent immunoassay with iFlash 3000. A total of 231 healthcare workers who agreed to participate, and were negative for anti-SARS-CoV-2 IgM antibodies at enrollment, were included in the analysis. All participants had elevated IgG antibodies and neutralizing activity above the cutoff values. A total of 174 (75.3%) and 208 (90.0%) participants experienced adverse reactions after the first and second vaccine doses, respectively. Younger age, female sex, not taking immunosuppressive or antipyretic analgesic medication regularly, a lack of local adverse reactions after the first dose, and the presence of adverse reactions (fever, muscle, and joint pain) after the second dose were associated with higher IgG antibody titers and neutralizing activity. Intake of analgesic antipyretic for adverse reactions to vaccines was not significantly associated with antibody and neutralizing activity titer production. Immune responses after vaccination may differ among individuals, and continued countermeasures to prevent SARS-CoV-2 infection are vital.

Antipyretics , COVID-19 , Antibodies, Neutralizing , Antibodies, Viral , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Female , Health Personnel , Humans , Immunoglobulin G , Immunoglobulin M , SARS-CoV-2 , Spike Glycoprotein, Coronavirus , Vaccination
PLoS One ; 17(6): e0269727, 2022.
Article in English | MEDLINE | ID: covidwho-2021799


As a member state of the European Union, where vaccines against COVID-19 are available and affordable, Bulgaria reports the lowest immunization coverage and the most pronounced vaccine distrust. The present study aimed to assess the self-reported adverse reactions following COVID-19 vaccination as a possible tool to increase the trust in vaccines. A cross-sectional survey-based study, covering 761 vaccinated respondents, was conducted in Plovdiv (469 with an mRNA vaccine and 292 with an adenoviral vector vaccine). Descriptive statistics parametric and non-parametric methods were applied. Statistical significance was set at p<0.05. The median age of the respondents was 42 years, females (72.5%). At least one adverse reaction was reported in 89.9% of those immunized with mRNA vaccine and 93.8% in the adenoviral vector vaccine group (p>0.05). They were mild to moderate and resolved within several days. The levels of local reactions were comparable: 91.7% in those who received mRNA and 89.7% in those who received an adenoviral vector vaccine (p = 0.366). The most common types of systemic reactions were fatigue, headache, and muscle pains. An association was found between the systemic reactions and the type of vaccine administered: 59.7% in mRNA recipients and 89.4% in adenoviral vector vaccinees (p<0.001). None of the registered systemic reactions required medical attention. There were 3 reports of generalized urticaria after an mRNA and 2 after an adenoviral vector vaccine. The reported reactions are relatively high but expected and no adverse events have been reported that are not listed in the official Summary of Product Characteristics.

COVID-19 Vaccines , COVID-19 , Viral Vaccines , Adult , Bulgaria , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cross-Sectional Studies , Female , Humans , RNA, Messenger , Self Report , Vaccination , Vaccines, Synthetic/adverse effects , Viral Vaccines/adverse effects , mRNA Vaccines
PLoS One ; 17(7): e0269487, 2022.
Article in English | MEDLINE | ID: covidwho-2021789


Vaccine hesitancy and refusal remain a major concern for healthcare professionals and policymakers. Hence, it is necessary to ascertain the underlying factors that promote or hinder the uptake of vaccines. Authorities and policy makers are experimenting with vaccine promotion messages to communities using loss and gain-framed messages. However, the effectiveness of message framing in influencing the intention to be vaccinated is unclear. Based on the Theory of Planned Behaviour (TPB), this study analysed the impact of individual attitude towards COVID-19 vaccination, direct and indirect social norms, perceived behavioural control and perceived threat towards South Indian millennials' intention to get vaccinated. The study also assessed the effect of framing vaccine communication messages with gain and loss framing. Data was collected from 228 Millennials from South India during the COVID-19 pandemic from September to October 2021 and analysed using PLS path modelling and Necessary Condition Analysis (NCA). The findings reveal that attitudes towards vaccination, perceived threat and indirect social norms positively impact millennials' intention to take up vaccines in both message frames. Further, independent sample t-test between the framing groups indicate that negative (loss framed message) leads to higher vaccination intention compared to positive (gain framed message). A loss-framed message is thus recommended for message framing to promote vaccine uptake among millennials. These findings provide useful information in understanding the impact of message framing on behavioural intentions, especially in the context of vaccine uptake intentions of Millennials in South India.

COVID-19 Vaccines , COVID-19 , COVID-19/epidemiology , COVID-19/prevention & control , Health Promotion , Humans , Intention , Pandemics
PLoS One ; 17(6): e0269299, 2022.
Article in English | MEDLINE | ID: covidwho-2021778


The second wave of the COVID-19 pandemic left the Indian healthcare system overwhelmed. The severity of a third wave will depend on the success of the vaccination drive; however, even with a safe and effective COVID-19 vaccine, hesitancy can be an obstacle to achieving high levels of coverage. Our study aims to estimate the population's acceptance of the COVID-19 vaccine in an Indian district. A pilot community-based cross-sectional study was conducted from March-May 2021. The data was collected from eight primary health centres in Tamil Nadu. The eligible study participants were interviewed using a self-constructed questionnaire. A total of 3,130 individuals responded to the survey. Multinomial logistic regression was performed to assess the factors influencing COVID-19 vaccine hesitancy and refusal. Results of our study showed that 46% percent (n = 1432) of the respondents would accept the COVID-19 vaccine if available. Acceptance for the COVID-19 vaccine was higher among males (54%), individuals aged 18-24years (62%), those with higher education (77%), having the higher income (73%), and employed (51%). Individuals with no education (OR: 2.799, 95% CI = 1.103-7.108), and low income (OR: OR: 10.299, 95% CI: 4.879-21.741), were significant predictors of vaccine hesitancy (p < 0.05). Living in urban residence (OR: 0.699, 95% CI = 0.55-0.888) and age between 18 to 25 years (OR: 0.549, 95% CI = 0.309-0.977) were protective factor of COVID-19 vaccine hesitancy. While individuals in the age group 25-54years (OR = 1.601, 95%CI = 1.086-2.359), fewer education (OR = 4.8, 95% CI = 2.448-9.412,), low income (OR = 2.628, 95% CI = 1.777-3.887) and unemployment (OR = 1.351, 95% CI = 1.06-1.722) had high odds of refusing the COVID-19 vaccine. Concerns and suspicions about the safety of the COVID-19 vaccine (63%) was the major reasons causing hesitancy towards the COVID-19 vaccine The public health authorities and government need to design, develop and implement targeted interventions to enhance awareness about COVID-19 vaccines, and barriers and enablers to vaccine acceptance among individuals across diverse settings. Emphasis on involving local and religious leaders, ASHA workers, community healthcare workers, Anganwadi workers, and auxiliary nurse midwives can help to overcome context-specific barriers in areas of low COVID-19 vaccine acceptance, especially in rural settings.

COVID-19 , Urination Disorders , Adolescent , Adult , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Cross-Sectional Studies , Humans , India/epidemiology , Male , Pandemics , Patient Acceptance of Health Care , Vaccination , Young Adult
PLoS One ; 17(4): e0266410, 2022.
Article in English | MEDLINE | ID: covidwho-2021652


BACKGROUND: Monitoring COVID-19 infection risk among health care workers (HCWs) is a public health priority. We examined the seroprevalence of SARS-CoV-2 among HCWs following the fall infection surge in Minnesota, and before and after COVID-19 vaccination. Additionally, we assessed demographic and occupational risk factors for SARS-CoV-2 infection. METHODS: We conducted two rounds of seroprevalence testing among a cohort of HCWs: samples in round 1 were collected from 11/22/20-02/21/21 and in round 2 from 12/18/20-02/15/21. Demographic and occupational exposures assessed with logistic regression were age, sex, healthcare role and setting, and number of children in the household. The primary outcome was SARS-CoV-2 IgG seropositivity. A secondary outcome, SARS-CoV-2 infection, included both seropositivity and self-reported SARS-CoV-2 test positivity. RESULTS: In total, 459 HCWs were tested. 43/454 (9.47%) had a seropositive sample 1 and 75/423 (17.7%) had a seropositive sample 2. By time of sample 2 collection, 54% of participants had received at least one vaccine dose and seroprevalence was 13% among unvaccinated individuals. Relative to physicians, the odds of SARS-CoV-2 infection in other roles were increased (Nurse Practitioner: OR[95%CI] 1.93[0.57,6.53], Physician's Assistant: 1.69[0.38,7.52], Nurse: 2.33[0.94,5.78], Paramedic/EMTs: 3.86[0.78,19.0], other: 1.68[0.58,4.85]). The workplace setting was associated with SARS-CoV-2 infection (p = 0.04). SARS-CoV-2 seroprevalence among HCWs reporting duties in the ICU vs. those working in an ambulatory clinic was elevated: OR[95%CI] 2.17[1.01,4.68]. CONCLUSIONS: SARS-CoV-2 seroprevalence in HCW increased during our study period which was consistent with community infection rates. HCW role and setting-particularly working in the ICU-is associated with higher risk for SARS-CoV-2 infection.

COVID-19 , SARS-CoV-2 , COVID-19/epidemiology , COVID-19 Vaccines , Child , Health Personnel , Humans , Seroepidemiologic Studies