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      Reactogenicidad e inmunogenicidad tras la inoculación de vacuna frente a SARS-CoV-2 en personal de diálisis Translated title: Reactogenicity and immunogenicity after inoculation of SARS-CoV-2 vaccine in dialysis care workers

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          Abstract

          Resumen Introducción: Ser personal sanitario en activo supone un factor de riesgo elevado para contraer la infección por SARS-CoV-2. La realización de programas de vacunación es la mejor herramienta disponible para enfrentar este problema. En España, los profesionales sanitarios han sido vacunados de manera prioritaria. Objetivo: Evaluar, a través del recuento de anticuerpos en sangre, la inmunogenicidad de las vacunas frente a SARS-CoV-2 en personal de diálisis y los factores relacionados con ella. Material y Método: Estudio observacional descriptivo de corte trasversal, multicéntrico. Se realizó una determinación serológica del recuento de anticuerpos totales anti-proteína "S" en las 12 semanas posteriores a la vacunación. La recogida de datos se realizó a través de un cuestionario ad-hoc, online, anónimo y voluntario. Resultados: 167 participantes, todos vacunados con vacunas ARN. EL 15% había pasado previamente la infección. El 96,4% han desarrollado anticuerpos (media de 15.776±13.640 AU/ml); aquellos profesionales que han pasado previamente la infección tienen un número promedio de anticuerpos significativamente mayor que los que no (23.532 vs 14.381 AU/ml) (p=0,05). La presencia de síntomas como cansancio, cefalea, fiebre y mialgias se asocia, también, a una reactividad significativamente mayor (p=0,004). No existe relación significativa entre la reactividad y sexo, edad, índice de masa corporal (IMC) o lugar de trabajo. Conclusiones: La inmunogenicidad provocada por las vacunas ARN administradas a personal de diálisis ha sido casi total. Padecer efectos adversos post vacunación, como cansancio, cefaleas, fiebre, náuseas y dolores, y haber pasado previamente la infección se asocia con mayor reactividad, manifestada con el desarrollo de mayor número de anticuerpos.

          Translated abstract

          Abstract Introduction: Being an active healthcare worker is a high-risk factor for contracting the SARS-CoV-2 infection. The implementation of vaccination programs is the best option available to solve this problem. In Spain, healthcare professionals have been vaccinated as a matter of priority. Objective: To assess, through blood antibody counts, the immunogenicity of SARS-CoV2 vaccines in dialysis personnel and related factors. Material and Method: Observational, cross-sectional and multicentric descriptive study. Results: 167 participants, all vaccinated with RNA vaccines. 15% have previously passed the infection. 96.4% have developed antibodies (mean of 15,776 +/-13,640). Those professionals who have previously passed the infection have a significantly higher average number of antibodies than those who have not (23,532 vs 14,381) (p=0.05). The presence of symptoms such as fatigue, headache, fever, and myalgia is also related with a significantly greater reactivity (p=0.004). There is no significant relationship between reactivity and sex, age, BMI, or workplace. Conclusions: Immunogenicity caused by RNA vaccines administered to dialysis personnel has been almost complete. Suffering post-vaccination adverse effects such as fatigue, headaches, fever, nausea, pain, and having previously passed the infection is related to a greater reactivity, manifested by the development of an increased number of antibodies.

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          Early rate reductions of SARS-CoV-2 infection and COVID-19 in BNT162b2 vaccine recipients

          In December, 2020, the Israeli Government approved the BNT162b2 COVID-19 vaccine and initiated a national immunisation campaign prioritising health-care workers (HCWs), as in other countries. 1 This campaign coincided with a third wave of COVID-19, peaking at 10 116 daily new cases by mid-January, 2021. The Sheba Medical Centre, Israel's largest hospital with 9647 HCWs, began staff vaccination on Dec 19, 2020. All HCWs, excluding those with previous SARS-CoV-2 infection, were eligible for vaccination. Clinical trial data of BNT162b2 vaccine estimated an early vaccine efficacy in preventing COVID-19 of 52·4% before dose two, and 90.5% on days 2–7 after dose two. 2 A recent analysis of BNT162b2 vaccine data estimated vaccine efficacy of 89–91% during days 15–28 after the first dose. 3 We examined early reductions in SARS-CoV-2 infection and COVID-19 rates in vaccinated HCWs. To assess vaccine-associated rate reductions we analysed a retrospective cohort of 9109 vaccine-eligible HCWs, comparing vaccinated versus unvaccinated. Active daily symptom reporting and immediate same-day testing allowed for prompt (<24h) detection and investigation of exposed or symptomatic HCWs. 4 We defined all HCWs with positive SARS-CoV-2 PCR at Sheba Medical Centre or in the community as cases of SARS-CoV-2 infection. All SARS-CoV-2-infected HCWs were contacted by infection control staff and requested to respond to a contact tracing questionnaire and a clinical questionnaire specifically regarding COVID-19 symptoms. Symptomatic HCWs were defined as COVID-19 cases. We used the number of days each HCW was unvaccinated or days after the first dose as follow-up time. Rate ratios and 95% CIs associated with time after first-dose administration were adjusted for community exposure, using the distribution of probability of a positive contact by means of Poisson regression (appendix). The adjusted estimates were subtracted from 1 to obtain rate reductions. By Jan 24, 2021, of the 9109 eligible staff, 7214 (79%) had received a first dose and 6037 (66%) had received the second dose. 5505 (91%) fully vaccinated HCWs received the second dose on days 21 or 22 after the first dose. 6818 (95%) HCWs were vaccinated at Sheba Medical Centre. All employees vaccinated in the community (n=396) were required to report dates of first and second dose to the Human Resources department at Sheba Medical Centre. Overall, there were 170 SARS-CoV-2 infections among HCWs in the period between Dec 19, 2020, and Jan 24, 2021, of which 99 (58%) HCWs reported symptoms and were designated as COVID-19 cases. Of the 170 HCWs who became infected, 89 (52%) were unvaccinated, 78 (46%) tested positive after the first dose, and three (2%) tested positive after the second dose. Among the 125 infections that could be traced, 87 (70%) were community acquired and there were no nosocomial clusters. 4 Compared with a SARS-CoV-2 infection rate of 7·4 per 10 000 person-days in unvaccinated HCWs, infection rates were 5·5 per 10 000 person-days and 3·0 per 10 000 person-days on days 1–14 and 15-28 after the first dose of the vaccine, respectively. Adjusted rate reductions of SARS-CoV-2 infections were 30% (95% CI 2–50) and 75% (72–84) for days 1–14 and days 15–28 after the first dose, respectively (table ; appendix). Table Rate reductions of SARS-CoV-2 infections and COVID-19 cases in health-care workers at the Sheba Medical Centre, Israel, from December, 2020, to January, 2021 Unvaccinated Vaccinated 1–14 days after first dose 15–28 days after first dose All SARS-CoV-2 positive Number of cases 89 55 26 Number of exposure days 120 575 100 433 88 126 Rate per 10 000 person-days 7·4 5·5 3·0 Rate reduction compared with unvaccinated (95% CI) .. 26% (−4 to 47) 60% (38 to 74) Adjusted rate reduction compared with unvaccinated (95% CI)* .. 30% (2 to 50) 75% (72 to 84) Symptomatic COVID-19 Number of cases 60 28 11 Number of exposure days 120 575 100 433 88 126 Rate per 10 000 person-days 5·0 2·8 1·2 Rate reduction compared with unvaccinated (95% CI) .. 44% (12 to 64) 75% (52 to 87) Adjusted rate reduction compared with unvaccinated (95% CI)* .. 47% (17 to 66) 85% (71 to 92) SARS-CoV-2 positivity was determined by PCR. * Rate ratios of new cases in vaccinated compared with unvaccinated health-care workers each day were adjusted for community exposure rates using Poisson regression (appendix). The adjusted estimates were subtracted from 1 to obtain rate reductions. Compared with a symptomatic COVID-19 rate of 5·0 per 10 000 person-days in unvaccinated HCWs, disease rates were 2·8 and 1·2 per 10 000 person-days on days 1–14 and days 15–28 after the first dose of the vaccine, respectively. Adjusted rate reductions of COVID-19 disease were 47% (95% CI 17–66) and 85% (71–92) for days 1–14 and days 15–28 after the first dose, respectively. The limitations of this study include the observational nature of the study design. Lack of active laboratory surveillance in the cohort might have resulted in an underestimation of asymptomatic cases. Data on vaccine efficacy in preventing asymptomatic SARS-CoV-2 infection are scarce, and our results of rate reductions in SARS-CoV-2 infections, which include asymptomatic HCWs, need further validation through active surveillance and sampling of vaccinated people and unvaccinated controls to ascertain the actual reduction of asymptomatic infection in vaccinated individuals. The early rate reductions seen in HCWs might differ from vaccine efficacy reported in the general population due to their higher exposure risk or due to exposure to more virulent or infectious strains. Our data show substantial early reductions in SARS-CoV-2 infection and symptomatic COVID-19 rates following first vaccine dose administration. Early reductions of COVID-19 rates provide support of delaying the second dose in countries facing vaccine shortages and scarce resources, so as to allow higher population coverage with a single dose. Longer follow-up to assess long-term effectiveness of a single dose is needed to inform a second dose delay policy.
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            Attitudes towards Anti-SARS-CoV2 Vaccination among Healthcare Workers: Results from a National Survey in Italy

            Coronavirus disease 2019 (COVID-19) has afflicted tens of millions of people, fostering and unprecedent effort in vaccine development and distribution. Healthcare workers (HCW) play a key role in vaccine promotion and patient guidance, and it is likely that hesitancy among this population will have a major impact on the adoption of a successful immunization policy. To investigate HCW attitudes towards anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination, we developed an anonymous online cross-sectional survey. 1723 Italian HCW responded. Overall, 1155 (67%) intended to be vaccinated, while 443 (26%) were not sure and 125 (7%) declared refusal. In multivariate analysis, factors associated with hesitancy were using Facebook as the main information source and being a non-physician HCW, while predictors of acceptance included younger age, being in close contact with high-risk groups and having received flu vaccination during the 2019–2020 season. Reasons for hesitancy included lack of trust in vaccine safety (85%) and receiving little (78%) or conflicting (69%) information about vaccines. According to our results, adequate investment in vaccine education for healthcare personnel appears to be urgently needed, prioritizing non-physicians and information quality spread through social media. We hope that our data could help governments and policy-makers to target communication in the ongoing COVID-19 vaccination campaign.
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              Humoral Response to SARS-CoV-2-Vaccination with BNT162b2 (Pfizer-BioNTech) in Patients on Hemodialysis

              mRNA-based SARS-CoV-2 vaccines offer a preventive strategy against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infections that is of interest in the care of patients on hemodialysis (HDP). We measured humoral immune responses in 72 HDP after standard vaccination with two doses of the mRNA-based SARS-CoV-2 vaccine BNT162b2 (Pfizer-BioNTech). Antibody responses were evaluated with an anti-SARS-CoV-2 IgG ChemiLuminescent ImmunoAssay (CLIA) two weeks after the second dose. In addition, SARS-CoV-2 IgG was determined in a control of 16 healthy healthcare workers (HCW). The control group of HCW has shown a strong antibody response with a median (MD (Q1; Q3)) antibody titer of 800.0 AU/mL (520.5; 800.0). In comparison to HCW, HDP under 60 years of age responded equally (597.0 AU/mL (410.5; 800.0), p = 0.051). However, the antibody responses of the HDP negatively correlated with age (r 2 = 0.2954 p < 0.0001), leading to significantly lower antibody titers in HDP over 60 years (280.0 AU/mL (45.7; 477.0), p < 0.0001). To thoroughly understand the immunogenicity of the new mRNA-based vaccines in HDP, longitudinal data on the effectiveness and durability of antibody responses are needed. Modifications of immunization schedules should be considered in HDP with low or without antibody responsiveness after standard vaccination to boost immune reactivity and prolong protective effects in these vulnerable patients.
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                Author and article information

                Journal
                enefro
                Enfermería Nefrológica
                Enferm Nefrol
                Sociedad Española de Enfermería Nefrológica (Madrid, Madrid, Spain )
                2254-2884
                2255-3517
                September 2021
                : 24
                : 3
                : 262-270
                Affiliations
                [2] Madrid orgnameFundación Renal Íñigo Álvarez de Toledo España
                [4] Segovia orgnameFundación Renal Íñigo Álvarez de Toledo orgdiv1Centro Los Olmos España
                [3] Orense orgnameFundación Renal Íñigo Álvarez de Toledo orgdiv1Centro Orense España
                [1] Getafe Madrid orgnameFundación Renal Íñigo Álvarez de Toledo orgdiv1Centro Los Llanos 2 España
                Article
                S2254-28842021000300262 S2254-2884(21)02400300262
                10.37551/s2254-28842021023
                f2db2906-8b0f-426e-ab32-2648851a7350

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                History
                : 10 August 2021
                : 21 July 2021
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 20, Pages: 9
                Product

                SciELO Spain

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                hemodiálisis,personal sanitario,vacuna,SARS-CoV-2,coronavirus,hemodialysis,health care worker,vaccine

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