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Inactivated COVID-19 vaccines data in immunocompromised individuals are scarce. This trial assessed the immunogenicity of two CoronaVac doses and additional BNT162b2 mRNA vaccine doses in immunocompromised (IC) and immunocompetent (H) individuals. Adults with solid organ transplant (SOT), hematopoietic stem cell transplant, cancer, inborn immunity errors or rheumatic diseases were included in the IC group. Immunocompetent adults were used as control group for comparison. Participants received two CoronaVac doses within a 28-day interval. IC received two additional BNT162b2 doses and H received a third BNT162b2 dose (booster). Blood samples were collected at baseline, 28 days after each dose, pre-booster and at the trial end. We used three serological tests to detect antibodies to SARS-CoV-2 nucleocapsid (N), trimeric spike (S), and receptor binding domain (RBD). Outcomes included seroconversion rates (SCR), geometric mean titers (GMT) and GMT ratio (GMTR). A total of 241 IC and 100 H adults participated in the study. After two CoronaVac doses, IC had lower SCR than H: anti-N, 33.3% vs 79%; anti-S, 33.8% vs 86%, and anti-RBD, 48.5% vs 85%, respectively. IC also showed lower GMT than H: anti-N, 2.3 vs 15.1; anti-S, 58.8 vs 213.2 BAU/mL; and anti-RBD, 22.4 vs 168.0 U/mL, respectively. After the 3rd and 4th BNT162b2 doses, IC had significant anti-S and anti-RBD seroconversion, but still lower than H after the 3rd dose. After boosting, GMT increased in IC, but remained lower than in the H group. CoronaVac two-dose schedule immunogenicity was lower in IC than in H. BNT162b2 heterologous booster enhanced immune response in both groups.

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ABSTRACT Inactivated COVID-19 vaccines data in immunocompromised individuals are scarce. This trial assessed the immunogenicity of two CoronaVac doses and additional BNT162b2 mRNA vaccine doses in immunocompromised (IC) and immunocompetent (H) individuals. Adults with solid organ transplant (SOT), hematopoietic stem cell transplant, cancer, inborn immunity errors or rheumatic diseases were included in the IC group. Immunocompetent adults were used as control group for comparison. Participants received two CoronaVac doses within a 28-day interval. IC received two additional BNT162b2 doses and H received a third BNT162b2 dose (booster). Blood samples were collected at baseline, 28 days after each dose, pre-booster and at the trial end. We used three serological tests to detect antibodies to SARS-CoV-2 nucleocapsid (N), trimeric spike (S), and receptor binding domain (RBD). Outcomes included seroconversion rates (SCR), geometric mean titers (GMT) and GMT ratio (GMTR). A total of 241 IC and 100 H adults participated in the study. After two CoronaVac doses, IC had lower SCR than H: anti-N, 33.3% vs 79%; anti-S, 33.8% vs 86%, and anti-RBD, 48.5% vs 85%, respectively. IC also showed lower GMT than H: anti-N, 2.3 vs 15.1; anti-S, 58.8 vs 213.2 BAU/mL; and anti-RBD, 22.4 vs 168.0 U/mL, respectively. After the 3rd and 4th BNT162b2 doses, IC had significant anti-S and anti-RBD seroconversion, but still lower than H after the 3rd dose. After boosting, GMT increased in IC, but remained lower than in the H group. CoronaVac two-dose schedule immunogenicity was lower in IC than in H. BNT162b2 heterologous booster enhanced immune response in both groups.

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ABSTRACT Introduction: The immune response to different Coronavirus Disease 2019 (COVID-19) vaccines is under-investigated in end-stage kidney disease (ESKD) patients, especially in the Middle East and North Africa. We carried out this research to estimate the effectiveness of COVID-19 immunization in ESKD patients on regular hemodialysis (HD). Methods: In this prospective observational study, we enrolled 60 ESKD patients on regular HD who had completed COVID-19 vaccination and 30 vaccinated healthy participants. Serum levels of severe acute respiratory syndrome coronavirus 2 immunoglobulin G (SARS-COV2 IgG) were quantified 1 month after completing the vaccination schedule, and all participants were followed up from October 2021 to March 2022. The vaccines used in the study were from Pfizer-BioNTech, AstraZeneca, and Sinopharm. Results: The median level of SARS-COV2 IgG was lower in HD patients than in healthy participants (p < 0.001). Regarding the type of COVID-19 vaccination, there was no statistical difference in SARS-COV2 IgG levels among HD patients. During the observation period, none of the HD patients had COVID-19. Conclusion: COVID-19 vaccination appeared to be protective in HD patients for 6 months and the side effects of vaccines were tolerable.

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RESUMO Introdução: A resposta imune a diferentes vacinas contra a doença do coronavírus 2019 (COVID-19) é pouco investigada em pacientes com doença renal em estágio terminal (DRET), especialmente no Oriente Médio e norte da África. Realizamos esta pesquisa para estimar a eficácia da imunização contra a COVID-19 em pacientes com DRET em hemodiálise regular (HD). Métodos: Nesse estudo observacional prospectivo, inscrevemos 60 pacientes com DRET em HD regular que haviam concluído o esquema de vacinação contra a COVID-19 e 30 participantes saudáveis vacinados. Os níveis séricos de imunoglobulina G da síndrome respiratória aguda grave do coronavírus 2 (SARS-COV2 IgG) foram quantificados um mês após a conclusão do esquema vacinal, e todos os participantes foram acompanhados de outubro de 2021 a março de 2022. As vacinas utilizadas no estudo eram da Pfizer-BioNTech, AstraZeneca e Sinopharm. Resultados: O nível mediano de SARS-COV2 IgG foi menor em pacientes em HD do que em participantes saudáveis (p < 0,001). Com relação ao tipo de vacinação contra a COVID-19, não houve diferença estatística nos níveis de SARS-COV2 IgG entre pacientes em HD. Durante o período de observação, nenhum dos pacientes em HD teve COVID-19. Conclusão: A vacinação contra a COVID-19 pareceu ser eficaz na proteção de pacientes em HD por 6 meses e os efeitos colaterais das vacinas foram toleráveis.

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BACKGROUND: Evidence regarding effectiveness of BNT162b2 mRNA COVID-19 vaccine against Omicron in Latin America is limited. We estimated BNT162b2 effectiveness against symptomatic COVID-19 in Brazil when Omicron was predominant. METHODS: This prospective test-negative, case-control study was conducted in Toledo, Brazil, following a mass COVID-19 vaccination with BNT162b2. Patients were included if they were aged ≥12 years, sought care for acute respiratory symptoms in the public health system between November 3, 2021 and June 20, 2022, and were tested for SARS-CoV-2 using RT-PCR. In the primary analysis, we determined the effectiveness of two doses of BNT162b2 against symptomatic COVID-19. RESULTS: A total of 4,574 were enrolled; of these, 1,758 patients (586 cases and 1,172 controls) were included in the primary analysis. Mean age was 27.7 years, 53.8 % were women, and 90.1 % had a Charlson comorbidity index of zero. Omicron accounted for >97 % of all identified SARS-CoV-2 variants, with BA.1 and BA.2 accounting for 84.3 % and 12.6 %, respectively. Overall adjusted estimate of two-dose vaccine effectiveness against symptomatic COVID-19 was 46.7 % (95 %CI, 19.9 %-64.6 %) after a median time between the second dose and the beginning of COVID-19 symptoms of 94 days (IQR, 60-139 days). Effectiveness waned from 77.7 % at 7-29 days after receipt of a second dose to <30 % (non-significant) after ≥120 days. CONCLUSION: In a relatively young and healthy Brazilian population, two doses of BNT162b2 provided protection against symptomatic Omicron infection. However, this protection waned significantly over time, underscoring the need for boosting with variant-adapted vaccines in this population prior to waves of disease activity. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov number, NCT05052307 (https://clinicaltrials.gov/ct2/show/NCT05052307).

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COVID-19 , Humanos , Femenino , Adulto , Masculino , COVID-19/epidemiología , COVID-19/prevención & control , SARS-CoV-2 , Vacunas contra la COVID-19 , Vacuna BNT162 , Brasil/epidemiología , Estudios de Casos y Controles , Estudios Prospectivos , Programas de Inmunización

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OBJECTIVE: To report intermediate cardiac magnetic resonance (CMR) findings of coronavirus disease 2019 (COVID-19) vaccine-associated myopericarditis (C-VAM) and compare with classic myocarditis. STUDY DESIGN: Retrospective cohort study including children diagnosed with C-VAM from May 2021 through December 2021 with early and intermediate CMR. Patients with classic myocarditis from January 2015 through December 2021 and intermediate CMR were included for comparison. RESULTS: There were 8 patients with C-VAM and 20 with classic myocarditis. Among those with C-VAM, CMR performed at a median 3 days (IQR 3, 7) revealed 2 of 8 patients with left ventricular ejection fraction <55%, 7 of 7 patients receiving contrast with late gadolinium enhancement (LGE), and 5 of 8 patients with elevated native T1 values. Borderline T2 values suggestive of myocardial edema were present in 6 of 8 patients. Follow-up CMRs performed at a median 107 days (IQR 97, 177) showed normal ventricular systolic function, T1, and T2 values; 3 of 7 patients had LGE. At intermediate follow-up, patients with C-VAM had fewer myocardial segments with LGE than patients with classic myocarditis (4/119 vs 42/340, P = .004). Patients with C-VAM also had a lower frequency of LGE (42.9 vs 75.0%) and lower percentage of left ventricular ejection fraction <55% compared with classic myocarditis (0.0 vs 30.0%), although these differences were not statistically significant. Five patients with classic myocarditis did not receive an early CMR, leading to some selection bias in study design. CONCLUSIONS: Patients with C-VAM had no evidence of active inflammation or ventricular dysfunction on intermediate CMR, although a minority had persistent LGE. Intermediate findings in C-VAM revealed less LGE burden compared with classic myocarditis.

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COVID-19 , Miocarditis , Niño , Humanos , Miocarditis/diagnóstico por imagen , Miocarditis/etiología , Volumen Sistólico , Medios de Contraste , Función Ventricular Izquierda , Estudios Retrospectivos , Vacunas contra la COVID-19/efectos adversos , Gadolinio , Imagen por Resonancia Magnética , Espectroscopía de Resonancia Magnética , Imagen por Resonancia Cinemagnética , Valor Predictivo de las Pruebas

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More than 600 healthcare workers died due to COVID-19 infection until January 2022 in Ecuador. Even though the COVID-19 vaccines are safe, local and systemic reactions were reported among physicians. This study aims to analyze the adverse events of COVID-19 with an emphasis on comparing the homologous and heterologous booster doses in physicians that received three approved vaccines in Ecuador. An electronic survey was performed in Quito, Ecuador, directed at physicians who were vaccinated with the three doses of COVID-19 vaccines. A total of 210 participants were analyzed after administering any dose of the vaccines. At least one AE was identified in 60.0% (126/210) of the sample after the first dose, 52.40% (110/210) after the second dose, and 75.2% (158/210) after the booster dose. The most frequent AEs were localized pain, myalgia, headache, and fever. At least one drug was used in 44.3% of the population after the first dose, 37.1% after the second dose, and 63.8% in the booster dose. Heterologous booster produces more AEs compared with homologous booster (80.1% vs. 53.8%), and 77.3% of participants reported that interfered with daily activities. Similar studies agree that reactogenicity occurs mainly with heterologous vaccination compared to homologous vaccination. This situation affected physicians' performance in daily activities and led them to use medication for the symptoms. In the future, it is recommended to perform cohort studies, where adverse events that are associated with vaccine boosters in the general population can be analyzed longitudinally, thus improving the level of evidence of the results.

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OBJECTIVE: This study aimed to identify factors predicting pneumonia in adults with coronavirus disease 2019 (COVID-19) during the Omicron variant (B.1.1.529) emergence. We also evaluated, in fully vaccinated (BNT162b2 or AZD1222) individuals, if the time (<6 or ≥6 months) elapsed since the last shot was received was associated with the risk of severe illness. STUDY DESIGN: A retrospective cohort study was conducted in Mexico. METHODS: Data from 409,493 were analyzed, and risk ratios (RRs) and 95% confidence intervals (CIs) were computed through generalized linear models. RESULTS: We documented a total of 3513 COVID-19 pneumonia cases (69.5 per 100,000 person-days). In multiple analyses, a protective effect was observed in vaccinated adults (RR = 0.996, 95% CI 0.995-0.997). Male gender, increasing age, and smoking were associated with a greater risk of pneumonia. Individuals with chronic comorbidities (pulmonary obstructive disease, type 2 diabetes mellitus, arterial hypertension, kidney disease, and immunosuppression) were also at higher risk. Among fully vaccinated subjects (n = 166,869), those who had received the last shot at 6 more months were at increased risk for developing pneumonia (RR = 1.002, 95% CI 1.001-1.003). CONCLUSIONS: Our results suggest that the first-generation BNT162b2 and AZD1222 vaccines reduce the risk of COVID-19 pneumonia during the Omicron emergence. We also found that adults with longer interval from the administration of the second shot to illness onset were at increased risk of severe manifestations.

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COVID-19 , Diabetes Mellitus Tipo 2 , Neumonía , Adulto , Vacuna BNT162 , COVID-19/epidemiología , COVID-19/prevención & control , ChAdOx1 nCoV-19 , Diabetes Mellitus Tipo 2/complicaciones , Humanos , Masculino , Estudios Retrospectivos , SARS-CoV-2

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Background and Objectives: This study aims to evaluate the effectiveness of the BNT162b2 COVID-19 (coronavirus disease 2019) in preventing severe symptomatic laboratory-confirmed infection among healthcare workers in a real-world scenario. Materials and Methods: A cross-sectional analysis of a prospective cohort study was conducted. Subjects with onset illness from January to February 2021 were eligible and classified according to the number of vaccine doses received (single-shot, n = 8; two-shot, n = 12; unvaccinated, n = 290). Results: The vaccine effectiveness against severe illness was 100% in the single and two-shot group. The presented results suggest that vaccination reduces the frequency of severe symptomatic COVID-19 in working-age adults. Conclusions: Efforts focusing on maximizing the number of immunized subjects in the study population may reduce associated economic and social burdens.

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Vacunas contra la COVID-19 , COVID-19 , Adulto , Vacuna BNT162 , Estudios Transversales , Personal de Salud , Humanos , Estudios Prospectivos , SARS-CoV-2

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An outbreak of severe acute respiratory syndrome coronavirus 2 caused by the Gamma variant of concern infected 24/44 (55%) employees of a gold mine in French Guiana (87% symptomatic, no severe forms). The attack rate was 60% (15/25) among fully vaccinated miners and 75% (3/4) among unvaccinated miners without a history of infection.

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COVID-19 , SARS-CoV-2 , Guyana Francesa/epidemiología , Oro , Humanos