COVID-19 vaccines effectiveness against symptomatic disease and severe outcomes, 2021-2022: a test-negative case-control study.

OBJECTIVES: This study evaluated the effectiveness of COVID-19 vaccines in preventing symptomatic and severe disease. STUDY DESIGN: This was an observational test-negative case-control study. METHODS: Study participants were adults with at least one symptom included in the World Health Organization COVID-19 definition who sought health care in a public emergency department between 1 November 2021 and 2 March 2022 (corresponding with the fifth pandemic wave in Portugal dominated by the Omicron variant). This study used multivariable logistic regression models to estimate and compare the odds ratio of vaccination between test-positive cases and test-negative controls to calculate the absolute and relative vaccine effectiveness. RESULTS: The study included 1059 individuals (522 cases and 537 controls) with a median age of 56 years and 58% were women. Compared with the effectiveness of the primary vaccination scheme that had been completed ≥180 days earlier, the relative effectiveness against symptomatic infection of a booster administered between 14 and 132 days earlier was 71% (95% confidence interval [CI]: 57%, 81%; P < 0.001). The effectiveness of the primary series against symptomatic infection peaked at 85% (95% CI: 56%, 95%) between 14 and 90 days after the last inoculation and decreased to 34% (95% CI: -43%, 50%) after ≥180 days. CONCLUSIONS: Despite the known immunological evasion characteristics of the Omicron variant, results from this study show that vaccine effectiveness increases after booster administration. COVID-19 vaccine effectiveness decreases to less than 50% between 3 and 6 months after completion of the primary cycle; therefore, this would be an appropriate time to administer a booster to restore immunity.

Humoral Response After Three Doses of SARS-CoV-2 Vaccines in Hemodialysis Patients

Background: Hemodialysis patients (HDP) are at higher risk of exposing and developing severe coronavirus disease 2019 (COVID-19). To protect this population, the Portuguese government implemented an early vaccination of these patients in the national COVID-19 immunization plan. Nevertheless, the humoral response to the two doses of BNT162b2 on HDP was lower than the one expected in the general population, leading us to believe that a third dose is of high importance at this group of patients. This study aims to determine the humoral response to the third dose of SARS-CoV-2 mRNA vaccine. Method(s): A single center observational prospective study was conducted following HDP receiving SARS-CoV-2 mRNA vaccines in a Portuguese center. Specific anti-Spike IgG quantification 3 weeks after first and second doses, and 3 months after the third dose, was used to determine absolute values and non-responders (NR). Result(s): A total of 59 patients were enrolled in this study, 33.4% of them were female and the median age was 71.3 years old. About 44% of the patients had COVID-19, all of them after the immunization with two doses of BNT162b2 vaccine. All of them suffered from mild to moderate disease. The median IgG anti-Spike S1 level after the second dose was 43.71AU/mL, with an IQR of 53, whereas 3 months after the third dose was of 473.5AU/mL, with an IQR of 1403.8 (Figure 1). The rate of NR (IgG anti-Spike S1 levels <1AU/mL) also had a high variation with the number of the doses administrated -14% of the patients after the second dose versus 0% after the third dose. After the last immunization, only 20% of the patients remained weak responders (IgG anti-Spike S1 < 150AU/mL). Age, sex, hemoglobin, ferritin, parathyroid hormone (PTH), C-Reactive Protein (CPR) and albumin did not impact on the response to the vaccine. Conclusion(s): Most of HDP responded strongly to the third dose of SARS-CoV-2 vaccine, even though the IgG anti-Spike levels were only measured 3 months after the administration. There is no analytical feature that can predict the response to the vaccine. Therefore, every hemodialysis patient would benefit from the administration of a third vaccine dose at least six months after receiving the second one.

PRIOR EXPOSURE TO IMMUNOSUPPRESSIVE AGENTS AND COMORBIDITIES ARE ASSOCIATED WITH WORSE OUTCOMES OF SARS-COV2 INFECTION IN PH-NEG CHRONIC MYELOPROLIFERATIVE NEOPLASMS: RESULTS OF EPICOVIDEHA SURVEY

Background: Philadelphia-negatie chronic myeloproliferatie neoplasms (MPN) typically incur high rates of thrombosis and infections and cytoreductie drugs may modulate such risks. Aims: The present analysis aims at assessing the seerity and outcomes of MPN facing coronairus disease 2019 (COVID-19). Hence, we aimed to assess the impact of immunosuppressie agents and comorbidity burden in COVID- 19 outcome. Methods: The EPICOVIDEHA registry is an online surey (www.clinicalsureys.net) that has collected since April 2020 until January 2022 5,445 cases of COVID-19 in indiiduals with baseline haematological malignancies (Salmanton-García et al, 2021 Hemasphere) The surey is promoted by the European Hematology Association - Infectious Diseases Working Party (EHA-IDWP) and has been approed centrally by the Institutional Reiew Board and Ethics Committee of Fondazione Policlinico Uniersitario A. Gemelli - IRCCS - Uniersità Cattolica del Sacro Cuore, Rome, Italy (Study ID: 3226). Results: Oerall, 308 patients (5.6%) with MPN were obsered for a median of 102 days (IQR: 21-223, range 22-97) after COVID-19 diagnosis. Median age at infection was 69 years (IQR: 58-77, range 22-97) and at least one comorbidity was reported from most of the indiiduals (62.6%, n = 193). A large portion of patients had a history of cardiopathy (n=109, 35.4%), diabetes (n=40, 15.9%), or chronic pulmonary disease (n=44, 14.3%). Myelofibrosis (MF) (n=140, 45.4%) was the most prealent baseline malignancy, with 18 MF patients (12.9%) reporting 3 or more comorbidities. Out of the whole cohort, 72 patients (42.8% of MF) receied immunosuppressige therapies including steroids, immunomodulatory drugs (IMiDs) or JAK-inhibitors. Hospitalization and consecutie admission to intensie care unit was required for 187 (60.7%) and 45 (24%) patients, respectiely. At multiariate logistic regression, Hospital admission was predicted by age >70 years (OR 2.809;95% CI 1.651-4.779), exposure to immunosuppressie therapies (OR 2.802;95% CI 1.5380-5.103) and comorbidity burden. During the study follow-up (median 101 days;range 21-222) 84 patients deceased after a median time of 14 days (IQR: 8-49, range 0-457) since COVID-19 diagnosis. The fatality rate (FR) decreased from 40.3% (50 out of 124) in the first two quarters of year 2020 to 15.8% (3 out of 19) in the first two quarters of year 2021 (p<0.05). Death was principally attributable to COVID-19 in 58 patients (69.0%) and contributable by COVID-19 in 15 (17.9%). FR was particularly high (54 out of 140, 38.6%) in MF patients and in patients receiing immunosuppressie agents (32 out of 86, 37%). Moreoer, FR increased from 13.0% in indiiduals with no comorbidity to 36.0% and 62.1% in those with >2 or >3 comorbidities, respectiely. More specifically, three comorbidities independently increased the FR: chronic cardiopathy (HR 1.653;95%CI 1.017-2.687), chronic pulmonary disease (HR 1.847;95% CI 1.097-3.109), and diabetes mellitus (HR 1.712;95% CI 1.006-2.914). A heay comorbidity burden, namely 3 or more comorbidities (HR 2.956;95% CI 1.403-6.227), adanced age, namely >70 years (HR .809;95% CI 1.651-4.779), myelofibrosis (HR 2.501;95% CI 1.384-4.519), and ICU admission (HR 2.669;95% CI 1.641-4.342) independently predicted FR. (MF) (n=140, 45.4%) was the most prealent baseline malignancy, with 18 MF patients (12.9%) reporting 3 or more comorbidities. Out of the whole cohort, 72 patients (42.8% of MF) receied immunosuppressige therapies including steroids, immunomodulatory drugs (IMiDs) or JAK-inhibitors. Hospitalization and consecutie admission to intensie care unit was required for 187 (60.7%) and 45 (24%) patients, respectiely. At multiariate logistic regression, Hospital admission was predicted by age >70 years (OR 2.809;95% CI 1.651-4.779), exposure to immunosuppressie therapies (OR 2.802;95% CI 1.5380-5.103) and comorbidity burden. During the study follow-up (median 101 days;range 21-222) 84 patients deceased after a median time of 14 days (IQR: 8-49, range 0-457) since COVID-19 diagnosis. The fatality rate (FR) dec eased from 40.3% (50 out of 124) in the first two quarters of year 2020 to 15.8% (3 out of 19) in the first two quarters of year 2021 (p<0.05). Death was principally attributable to COVID-19 in 58 patients (69.0%) and contributable by COVID-19 in 15 (17.9%). FR was particularly high (54 out of 140, 38.6%) in MF patients and in patients receiing immunosuppressie agents (32 out of 86, 37%). Moreoer, FR increased from 13.0% in indiiduals with no comorbidity to 36.0% and 62.1% in those with >2 or >3 comorbidities, respectiely. More specifically, three comorbidities independently increased the FR: chronic cardiopathy (HR 1.653;95%CI 1.017-2.687), chronic pulmonary disease (HR 1.847;95% CI 1.097-3.109), and diabetes mellitus (HR 1.712;95% CI 1.006-2.914). A heay comorbidity burden, namely 3 or more comorbidities (HR 2.956;95% CI 1.403-6.227), adanced age, namely >70 years (HR .809;95% CI 1.651-4.779), myelofibrosis (HR 2.501;95% CI 1.384-4.519), and ICU admission (HR 2.669;95% CI 1.641-4.342) independently predicted FR. Summary/Conclusion: COVID-19 infection led to a particularly dismal outcome in patients exposed to immunosuppressie agents and in those with chronic heart or pulmonary diseases, or diabetes. These data allow to tailor future strategies for preenting seere COVID-19 in MPN patients. (Table Presented).

B-CELL MALIGNANCIES TREATED WITH TARGETED DRUGS AND SARS-COV-2 INFECTION. A EUROPEAN HEMATOLOGY ASSOCIATION SURVEY (EPICOVIDEHA)

Background: Patients with lymphoproliferatie diseases (LPD) appear particularly ulnerable to SARS-CoV-2 infection, partly because of the effects of the anti-neoplastic regimens (chemotherapy, signaling pathway inhibitors, and monoclonal antibodies) on the immune system. The real impact of COVID-19 on the life expectancy of patients with different subtypes of lymphoma and targeted treatment is still unknown. Aims: The aim of this study is to describe and analyse the outcome of COVID-19 patients with underlying LPD treated with targeted drugs such as monoclonal antibodies (obinutuzumab, ofatumumab, brentuximab, niolumab or pembrolizumab), BTK inhibitors (ibrutinib, acalabrutinib), PI3K inhibitors (idelalisib), BCL2 inhibitors (enetoclax) and IMIDs, (lenalidomide). Methods: The surey was supported by EPICOVIDEHA registry. Adult patients with baseline CLL or non-Hodgkin Lymphoma (NHL) treated with targeted drugs and laboratory-confirmed COVID-19 diagnosed between January 2020 and January 2022 were selected. Results: The study included 368 patients (CLL n=205, 55.7%;NHL n=163, 44.3%) treated with targeted drugs (Table 1). Median follow-up was 70.5 days (range 19-159). Most used targeted drugs were ITKs (51.1%), anti-CD20 other than rituximab (16%), BCL2 inhibitors (7.3%) and lenalidomide (7.9%). Of note, only 16.0% of the patients were accinated with 2 or more doses of accine at the onset of COVID-19. Pulmonary symptoms were present at diagnosis in 244 patients (66.2%). Seere COVID-19 was obsered in 47.8 % patients while 21.7% were admitted to to intensie care unit (ICU), being 55 (26.8%) CLL patients and 25 (15.3%) NHL patients. More comorbidities were reported in patients with seere-critical COVID-19 compared to those with mild- asymptomatic infection (p=0.002). This difference was releant in patients with chronic heart diseases (p=0.005). Oerall, 134 patients (36.4%) died. Primary cause of death was COVID-19 in 92 patients (68.7%), LPD in 14 patients (10.4%), and a combination of both in 28 patients (20.9%).Mortality was 24.2% (89/368) at day 30 and 34.5%(127/368) at day 200. After a Cox multiariable regression age >75 years (p<0.001, HR 1.030), actie malignancy (p=0.011, HR 1.574) and admission to ICU (p<0.00, HR 4.624) were obsered as risk factors. Surial in patients admitted to ICU was 33.7% (LLC 38.1%, NHL 24%). Mortality rate decreased depending on accination status, being 34.2% in not accinated patients, 15.9-18% with one or two doses, decreasing to 9.7% in patients with booster dose (p<0.001). There was no difference in OS in NLH s CLL patients (p=0.344), nor in ITKs s no ITKs treated patients (p=0.987). Additionally, mortality rate dropped from the first semester 2020 (41.3%) to last semester 2021 (25%). Summary/Conclusion: - Our results confirm that patients with B--mallignancies treatted with targeted drugs hae a high risk off seere infection (47.8%) and mortality (36.4%) from COVID-19. - Pressence of comorbidities,, especially heart disease,, is a risk factor for seere COVIID--19 infection in ourr series. - Age >75 years,, actie mallignancy att COVIID--19 onset and ICU admission were mortality risk factors. - COVIID--19 acination was a protectie factor for mortality,, een iin this popullation wiitth humorall immunity impairment. - The learning cure in the management of the infection throughout the pandemiic and the deelopmentt off COVIID--19 treatments showed benefit in this partticullarlly ullnerablle popullation? (Table Presented).

PREVALENCE OF SARS-COV-2 CELLULAR AND HUMORAL IMMUNITY IN DIALYSIS PATIENTS AFTER 8 MONTHS OF VACCINATION CAMPAIGN IN PORTUGAL

BACKGROUND AND AIMS: Immunization of dialysis dependent patients remains the single most important protective approach in prevention of serious COVID-19 infection. This study aims to characterize the prevalence of humoral and cellular immunity in maintenance dialysis patients (MDP) in a Nephrology Centre, 8 months after vaccination onset. METHOD: A single-center cross-sectional study enrolling patients on peritoneal (PD) and haemodialysis (HD) from a public-funded Portuguese Nephrology Centre. This study evaluated both humoral and cellular immunity to the COVID-19 vaccination. Humoral response was measured as specific IgG (S-RBD IgG), and cellular response as T-cell reactivity through IFN-γ quantification as response to antigen (IGRA). Further demographic and clinical variables were obtained to assess the risk factors of low immunity. RESULTS: Of the 86 patients enrolled, 79.4% and 84.1% showed humoral and cellular immunity, respectively. Quantitatively, IgG S-RBD titers correlated with specific T-cell reactivity (ρ = 0.58, P < 0.001). Vaccination before dialysis initiation was associated with an absent cellular response (P = .006). Subgroup analysis associated high comorbidity burden (quantified through the Charlson comorbidity index) and low serum albumin levels as predictors of immunity (P < 0.05, variable). PD patients showed lower cellular response (297.1 mUI/mL versus 695.4 mUI/mL, P = 0.03) at 8 months following BNT162b2. CONCLUSION: The prevalence of humoral and cellular immunity against SARSCoV-2 in vaccinated Portuguese MDP is high. Vaccination in imminent pre-dialysis patients, high comorbidity burden and low serum albumin are some of the identified risk factors for absent immunity. PD-associated effector memory T-cell changes are suggested as contributing to the difference verified in cellular response.

Food Insecurity in Portugal during the COVID-19 Pandemic: Prevalence and Associated Sociodemographic Characteristics

Introduction: The current worldwide COVID-19 pandemic has been having a considerable impact not only on health but also on the economy of societies, emphasizing food insecurity as a significant public health concern. Aim: The objective of this study was to characterize the scenario of food insecurity in Portugal during the COVID-19 pandemic and explore its related sociodemographic characteristics. Methodology: This is a cross-sectional study, using data from an online survey, performed from November 2020 until February 2021, including 882 residents aged 18 years or older in Portugal. Data on sociodemographics and food security status were collected, the latter was evaluated using the United States Household Food Security Survey Module: Six-Item Short Form. Crude and adjusted logistic regression models were performed (covariates: education, household income perception, and the working status during the COVID-19 pandemic). The odds ratio (OR) and respective 95% confidence intervals (CI) were estimated. Results: Most participants were women (71.3%), with a mean age of 36.8 years (SD 11.0). Food insecurity prevalence was 6.8%. Less-educated individuals (≤12 years of schooling;OR 2.966;95% CI 1.250-7.042), and those who were and remained unemployed since the beginning of the pandemic (OR 2.602;95% CI 1.004-6.742) had higher odds of belonging to a food-insecure household, regardless of education, working status during the COVID-19 pandemic, and household income perception. Moreover, lower odds of belonging to a food-insecure household were observed among those reporting a comfortable household income (OR 0.007;95% CI 0.001-0.062) than those who perceived their household income as insufficient, independently of education and the working status during the COVID-19 pandemic. Conclusions: These findings highlight the population groups that are at a greater risk of food insecurity during the current COVID-19 pandemic. Effective public health strategies should be developed aiming to address food insecurity during this crisis, especially among the higher risk groups.

TEACHERS'S MEDIA LITERACY AND EMERGENCY REMOTE TEACHING IN THE COVID-19 PANDEMIC

In this text, we present the results of a research conducted in 2020 that, using an online survey, sought to identify the perception of elementary and high school teachers, who were performing emergency remote teaching, about their media literacy skills. The data obtained in the questionnaire were subjected to descriptive analyzes and to chi-square test, in order to identify possible associations between different variables. Among the main results, we highlight the high perception of media literacy skills by teachers, as well as the use of these skills in emergency remote education. The tests indicated an association between the custom of proposing media literacy practices at school before the pandemic and a greater perception and use of these skills by teachers in remote education. It was also identified, among state school teachers, a low perception of competence to understand the use that big techs make of their data, indicating that they may be vulnerable to large private groups that manage these platforms and also poorly prepared to guide your students on the topic. We reaffirm the need for a critical approach to media literacy, focusing not only on knowledge about the use of user data, but also on the functioning of algorithms, which is essential for understanding how the so-called digital capitalism operates, and for the exercise of social practices of use of media, especially at a time when we've become dependent on technologies for study, work and social relationships due to the physical distance imposed by the Covid-19 pandemic.

Impact of the COVID-19 pandemic on tuberculosis services.

BACKGROUND: In Portugal, Outpatient Tuberculosis Centres (OTBC) are responsible for the diagnosis, treatment, screening and prevention of tuberculosis (TB), and only severe or resistant cases are hospitalized. AIM: To understand how infection control norms and standards were applied and how these centres responded during the pandemic. METHOD: We sent an electronic questionnaire to all coordinators of OTBC. The questionnaire included questions on infection control during the COVID-19 pandemic and evaluation of the functioning of the OTBC in two periods: during the 1st National State of Emergency and after 1 year. RESULTS: Thirty-two responses were obtained (52.5%). The infection control norms were globally applied; diagnosis, treatment, and prevention were kept, and contact screening was only affected during the 1st State of Emergency. However, half of the respondents (53.1%) believed that there were diagnostic delays during the 1st State of Emergency, rising to 68.8% after 1 year. Only 31.3% performed Directly Observed Therapy (DOT) in all patients during the 1st State of Emergency, and 59.4% after 1 year. Half the inquiries expected an increase in TB incidence in the near future. CONCLUSION: The pandemic affected OTBC functioning, although the services were kept open; diagnostic delay and DOT appliance were the most affected.

Acute and Post-Acute COVID-19 Severity and Mortality in Patients with Hematologic Malignancies: A Population-Based Registry Study

Introduction: The severity of acute clinical outcomes and mortality in hematologic malignancy (HM) patients infected by SARS-CoV-2 was exhaustively documented in the first weeks of the pandemic. A consistent increased mortality compared to non-cancer patients was observed across studies. In this study we aimed to estimate survival in COVID-19 HM patients by type of malignancy, to describe acute and post-acute clinical outcomes, and to compare outcomes in early and later pandemic periods. Methods: In this population-based registry study sponsored by the Madrid Society of Hematology (Asociación Madrileña de Hematología y Hemoterapia), we collected de-identified data on clinical characteristics, treatment and acute and post-acute outcomes in adult patients with hematologic malignancies and confirmed SARS-CoV-2 infection within the Madrid region of Spain. Our case series included all eligible patients admitted to 26 regional health service hospitals and 5 private healthcare centers between February 28, 2020 and February 18, 2021 with a coverage of 98% on a population of 6.6 million inhabitants. The study outcomes were all-cause mortality, severity of disease (WHO), oxygen support, ICU admission, and follow-up symptoms and signs and complications. Survival probabilities were estimated with the actuarial method and reported overall and stratified by type of malignancy and for two study periods (early cohort,-COVID-19 diagnosis from February 28 to 31 May, 2020, and later cohort, up to February 18, 2021). Results: Of the 1408 patients reported to the HEMATO-MADRID COVID-19 registry, 1166 were included in the present analyses;839 (72%) had a lymphoid malignancy, including 325 (28%) with non-Hodgkin lymphoma, 50 (4%) with Hodgkin lymphoma and 263 (23%) with multiple myeloma;and 327 (28%) had a myeloid malignancy, including 115 (10%) with myelodysplastic syndrome, 92 (8%) with acute myeloid leukemia (AML) and 87 (7%) with Philadelphia chromosome (Ph)-negative myeloproliferative neoplasms. Overall COVID-19 clinical severity was classified as critical in 19% of patients, severe in 36%, moderate in 22%, and mild in 22%;10% were admitted to an ICU;8% were on mechanical ventilation and 19% on noninvasive ventilation. Mild disease increased between early and later period from 15% to 38% of patients;severe disease decreased from 42% to 24%, p<0.001. COVID-19 treatment with steroids increased from 38% to 59%, p<0.001. At follow-up, 22% reported persistent symptoms related to COVID-19 at 2 months, 16% at 4 months and 14% at 6 months. 381 of 1166 (33%) patients died. Overall 30-day survival was 68%;2 and 3-month overall survival probabilities were 56% and 53%, respectively. Survival was more favorable for patients with myeloproliferative neoplasms (82%, 69% and 65% at 30-days, 2 and 3 months, respectively) than for those with lymphoid malignancies (68%, 56% and 54%) or myelodysplastic syndrome/acute myeloid leukemia (61%, 51%, 46%), p=001. 285 (37%) patients died in the early period vs 96 (24%) in the later, p<0.001, but median (interquartile range) follow-up time was much higher in the early vs later, 45 (20-116) days vs. 26 (11-86), respectively. Overall survival was not different between periods, p=0.5 (hazard ratio [95%C], 0.93 [0.73-1.17]). In the later cohort, 30 and 60-day survival probabilities were 71% and 56% vs. 67% and 56% in the early cohort Conclusions. A population-based registry in Spain provided strong evidence that although COVID-19 severity decreased over year 1 of the pandemic, mortality remained high, and survival was stable over time in the group of patients with hematological malignancy infected by SARS-Coc-2. A relevant proportion of the infected patients (1 in 6) referred persistent symptoms attributable to COVID-19. The improved clinical management of severe COVID-19 in non-cancer patients that followed the dissemination of evidence-based recommendations did not translate in more favorable survival in patients with hematological malignancies. Research is needed to address the specific characteristics nd improve the clinical management of this vulnerable population. Disclosures: Martinez-Lopez: Novartis: Consultancy, Speakers Bureau;BMS: Consultancy, Research Funding, Speakers Bureau;Janssen: Consultancy, Speakers Bureau;Incyte: Consultancy, Research Funding, Speakers Bureau;Roche: Consultancy, Research Funding, Speakers Bureau;Astellas: Research Funding, Speakers Bureau. Jiménez-Yuste: Pfizer: Consultancy, Honoraria, Research Funding;Grifols: Consultancy, Honoraria, Research Funding;CSL Behring: Consultancy, Honoraria, Research Funding;Sanofi: Consultancy, Honoraria, Research Funding;Bayer: Consultancy, Honoraria, Research Funding;NovoNordisk: Consultancy, Honoraria, Research Funding;BioMarin: Consultancy;Sobi: Consultancy, Honoraria, Research Funding;Octapharma: Consultancy, Honoraria, Research Funding;Takeda: Consultancy, Honoraria, Research Funding;F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Research Funding. Kwon: Gilead: Honoraria.

Humoral response to pfizer BNT162b2 in peritoneal and hemodialysis patients: A comparative study

Background: Generalized immunization against COVID19 has become the cornerstone in prevention of Sars-CoV-2. Maintenance dialysis patients (MDP) are at higher risk of both exposure and mortality. Efficacy and security of Pfizer BNT 162b2 vaccine is well documented for the general population, but not in MDP, particularly in peritoneal dialysis (PD) patients. This study aims to compare humoral response between HD and PD patients. Methods: Observational prospective study including MDP on HD or PD program from a Portuguese middle-sized Nephrology Center, who received Pfizer-BNT162b2. Specific anti-Spike IgG was measured as arbitrary units per milliliter (AU/mL) on two separate occasions, corresponding to the first and second doses' humoral response. The two groups were compared both for absolute value and number of non-responders (NR) after both inoculations. Demographic data was also obtained and compared. Results: Of 73 patients enrolled, 67 were eligible for the final study: 42 HD and 25 PD patients. PD group developed significantly higher antibody titers both after first (Med 5.44 vs 0.99;p<0.01) and second dose (Med 170.43 vs 65.81;p<0.01). HD status was associated with non-responding after the first dose (Phi=0.383;p<0.01), but not after the second one (p=0.08). Age, Charlson Comorbidity Index and dialysis vintage were lower in the PD group (p<0.01;p=0.02;p<0.01, respectively). Conclusions: This study demonstrated a better humoral response to immunization with Pfizer BNT162b2 in PD patients, when comparing to HD patients, after both inoculations. Both groups showed substantial humoral response after just one dose of the vaccine. Older age and higher comorbidity burden may explain the relative immunogenicity deficit.

Predicting factors of humoral response to pfizer BNT 162B2 in hemodialysis patients

Background: Immunization against COVID19 has become the cornerstone in prevention of Sars-CoV-2. Maintenance Hemodialysis (HD) patients are at higher risk of both exposure and mortality. This study aims to describe humoral immunogenicity and suggest risk factors for low or absent response to Pfizer BNT162b2 in an HD cohort. Methods: Observational prospective study including a group of HD patients followed in a Portuguese Nephrology Center who received BNT162b2. Anti-Spike IgG measured as arbitrary units per milliliter (AU/mL) was obtained on two separate occasions, corresponding to the first and second doses' humoral response. Absolute IgG value, rate of Non-Responders (NR), IgG<1AU/mL after each dose, and Weak-Responders (WR), under Percentile 25 after each dose, were evaluated for risk factors that included demographic and analytical variables. Results: IgG anti-Spike levels showed a strong correlation with CCI and PTH after each inoculation (ρ=-0.64;-0.66/ ρ=0.56/0.65, respectively;p<0.01). Higher CCI and lower PTH was observed in NR subgroup after the 1st (p<0.01), whereas with the 2nd there was a lower albumin and PTH (p=0.01) and an association with female sex (p<0.01). Similarly, WR also showed higher CCI and lower PTH after the 1st (p=0.02) and 2nd doses (p<0.01), adding older age (p=0.03) and lower albumin (p=0.05) to the 2nd. After both inoculations, WR subgroup was associated with age over 75 yo (p=0.03);female sex (p=0.01), CCI over 8 (p=0.01), CVC over AVF/AVG (p<0.01), dialysis vintage under 24 mo (p=0.01) and PTH under 150 μg/L (p<0.01). A model combining CCI, sex (male) and vascular access (CVC) as a regression model associated those factors to WR after the 2nd dose with OR (95% CI): 1.81 (1.06-3.08);0.05 (0.01-0.65);13.55 (1.06-174.18), respectively (p=0.01). Conclusions: Older age, high CCI, low PTH and albumin, CVC over AVF/AVG and recently started dialysis (less than 2 years) relate to lower response. High comorbidity burden is suggested as a more significant risk factor than age alone. THe role of PTH as a marker of low immunogenicity in the HD population should be target of further investigation. Signalization of HD patients at risk of low response may play a key role in policy making, namely the necessity for booster doses, follow-up measurements and isolation methods.

Psychological Impact of the COVID-19 Pandemic and Social Determinants on the Portuguese Population: Protocol for a Web-Based Cross-sectional Study.

BACKGROUND: The COVID-19 outbreak and consequent physical distance measures implemented worldwide have caused significant stress, anxiety, and mental health implications among the general population. Unemployment, working from home, and day-to-day changes may lead to a greater risk of poor mental health outcomes. OBJECTIVE: This paper describes the protocol for a web-based cross-sectional study that aims to address the impact of the COVID-19 pandemic on mental health. METHODS: Individuals from the general population aged 18 years or more and living in Portugal were included in this study. Data collection took place between November 10, 2020, and February 10, 2021. An exponential, nondiscriminative, snowball sampling method was applied to recruit participants. A web-based survey was developed and shared on social media platforms (eg, Facebook, Instagram, Twitter, LinkedIn, and WhatsApp groups) and through e-mail lists for recruitment of the seeds. RESULTS: Data analysis will be performed in accordance with the different variables and outcomes of interest by using quantitative methods, qualitative methods, or mixed methods, as applicable. A total of 929 individuals had completed the web-based survey during the 3-month period; thus, our final sample comprised 929 participants. Results of the survey will be disseminated in national and international scientific journals in 2021-2022. CONCLUSIONS: We believe that the findings of this study will have broad implications for understanding the psychological impact of the COVID-19 pandemic on Portuguese residents, as well as aspects related to the informal economy. We also hope that the findings of this study are able to provide insights and guidelines for the Portuguese government to implement action. Finally, we expect this protocol to provide a roadmap for other countries and researchers that would like to implement a similar questionnaire considering the related conclusions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/28071.

Thrombotic events and COVID-19 vaccines.

COVID-19 vaccines are considered promising agents in the control of the pandemic. Although their safety was assessed in randomised clinical trials, severe adverse events (AEs) have been reported after large-scale administration. This study aims to evaluate thromboembolic AEs reported after vaccination in a real-world context and how they led to the interruption of vaccination campaigns. We also review the benefits and risks of the vaccines approved in the European Union and provide recommendations. A review of the literature was performed using Medline/PubMed electronic database as well as institutional and pharmacovigilance official reports. Our findings show that vaccine-induced prothrombotic immune thrombocytopenia has been suggested as a very rare AE associated with viral vector vaccines. Unusual thrombotic events combined with moderate-to-severe thrombocytopenia were reported mainly in women under 60 years of age. As safety signals emerged, Vaxzevria and Janssen´s COVID-19 vaccine campaigns have been paused while investigations proceed. On the other hand, the number of deep vein thrombosis and pulmonary embolism reports have not increased. Post-marketing surveillance indicated that mRNA vaccines are safe and should continue to be used. The thrombotic events report rate is not increased in people over 60 years. As they are at greater risk for COVID-19 complications and death, no vaccine restrictions are recommended in this group. Risk factors for vaccine-induced prothrombotic immune thrombocytopenia should be established so that evidence-based decisions can be made. Systematic monitoring of COVID-19 vaccine safety is essential to ensure that the benefits of vaccination outweigh the risks.

Prognosis of COVID-19 through Regressive Objective regression methodology in Villa Clara and Cuba

The COVID-19 pandemic affecting planet earth has had a peculiar development in Cuba. The objective of the research was to model, using the Regressive Objective Regression (ROR) methodology, a set of parameters (confirmed cases, severe, critical and deaths) inherent to the SARS CoV-2 (COVID-19) pandemic, so far in 2020 in Cuba. The parameters analyzed were: deaths, serious and critical cases, as well as confirmed cases in the municipality of Santa Clara, Villa Clara province and Cuba. Mathematical models were obtained through ROR methodology that explain the behaviour of these cases, depending on the variable to be studied, 6, 4, 10 and 14 days in advance. This made it possible to make long-term forecasts, allowing measures to be taken in clinical services, and thus avoiding and reducing the number of deaths and complications in patients. It is concluded that COVID-19, despite being a new disease in the world, can be followed by means of ROR mathematical modeling, which allows to reduce the number of dead, serious and critical patients for a better management of the pandemic.