ABSTRACT
Introduction: People affected by diabetes are at higher risk for complications from certain vaccine-preventable diseases. Suboptimal vaccination coverages are reported in this population sub-group. The purpose of this study is to estimate the proportion of diabetic patients who express hesitation to the COVID-19 vaccine worldwide.Methods: Seven studies were included in the meta-analysis and systematic review, selected from scientific articles available in the MEDLINE/PubMed, Google Scholar and Scopus databases from 2020 to 2022. The following terms were used for the search strategy: (adherence OR hesitancy OR compliance OR attitude) AND (covid* OR SARS*) AND (vaccin* OR immun*) AND (diabet*).Results: The vaccine hesitation rate among persons with diabetes was 27.8 % (95 %CI = 15.6-41.9 %). In the comparison of vaccine hesitancy between sexes and educational status, the RRs were 0.90 (95 %CI = 0.71-1.15) and 0.88 (95 %CI = 0.76-1.02), respectively. The main reasons of unwillingness were lack of information, opinion that the vaccine was unsafe or not efficient, and fear of adverse events.Conclusions: In order to achieve a high vaccination coverage, multifactorial approach is needed, which requires major social, scientific and health efforts. The success of the vaccination campaign in this population depends on the capillarity and consistency of the interventions implemented.
ABSTRACT
Background. As other indoor sports facilities, swimming pools were closed in Italy from March to May 2020 and from October 2020 to July 2021 due to the outbreak of the COVID-19 pandemic;access to these facilities was restricted to athletes of national relevance. This decision was based on "precautionary principles” and without evidence of a high risk of SARS-COV-2 circulation among swimming pools' attendants. The aim of this paper is to describe the pattern of SARS-COV-2 circulation among swimming athletes in Apulia (Southern Italy). Study design. The study aims to investigate the hypothesis that attending a pool increases the risk of SARSCOV-2 infection. The outcome measure is the incidence of SARS-COV-2 infection among swimming athletes compared with the general population. Methods. This is a retrospective cross-sectional study carried out in Apulia, Southern Italy. The study was performed through the analysis of both the database of the Italian Swimming Federation and the SARS-COV-2 infections in Apulia Region, from July 2020 to August 2021. Results. Among 2,939 federally licensed athletes, 221 had an history of SARS-COV-2 infection from July 2020 to August 2021, with an incidence of 75.2 /1,000. In the general Apulian population, during the same time span, the incidence of SARS-COV-2 infection was 67.3/1,000 and - considering the incidence rate ratio - there is no difference between the two populations (IRR=1.1;95% CI=0.9-1.3;p>0.05). Conclusions. The incidence of SARS-COV-2 infection in Apulian swimmers showed no significant differences with the general population. © Società Editrice Universo (SEU), Roma, Italy
ABSTRACT
Introduction. Healthcare workers on duty at the hospital are at high risk of COVID-19 infection. However, despite the introduction of risk-lowering practices in the hospital setting, there have been many cases of SARS-COV-2 infection among Health Care Workers. Fast and efficient contact tracing and Sars-CoV-2 PCR-based testing of the close contacts of Health Care Workers with confirmed infections are essential steps to limit nosocomial outbreaks. Methods. This cross-sectional study was conducted at Bari Policlinico General University-Hospital (Apulia, Italy) and describes the management of a cluster of SARS-COV-2 infections in three Operative Units. The contact tracing activities and the measures implemented to control the outbreak are described. Results. Among the 186 Health Care Workers active in the cluster setting, there were 9 (4.8%) confirmed cases, including the index case. Due to the outbreak, three Operative Units were closed to limit virus circulation. Health Care Workers with confirmed infections tested negative after a mean of 28.0±6.6 days (range: 13–37) and none required hospitalization.Conclusions. Protection of the health of Health Care Workers during the COVID-19 pandemic should be a public health priority. However, despite recent recommendations and the implementation of protective measures, SARS-COV-2 infections of Health Care Workers remain at a high rate, indicative of the continued high risk of cluster onset in the nosocomial setting. © Società Editrice Universo (SEU), Roma, Italy
ABSTRACT
Abstract: In Italy, at the beginning of the SARS-CoV-2 pandemic, the main organizational model of hospital care was represented by the physical or functional division of hospitals and wards into COVID and non-COVID areas, in order to separate SARS-CoV-2-infected patients from the others. Now that the emergency phase has reached its long-awaited end, it is necessary to develop a new hospital care paradigm that may deal with SARS-CoV-2-positive patients discriminating between those who are hospitalized because of COVID-19 and those who are diagnosed with SARS-CoV-2 infection immediately before or after the first access to healthcare facilities.
ABSTRACT
Background Pregnant and breastfeeding women are at an increased risk of severe illness from COVID-19 compared to people who are not pregnant. Therefore, the CDC recommends COVID-19 vaccination for women who are pregnant, breastfeeding, and trying to become pregnant or who may become pregnant in the future. Despite this, low vaccination coverages are reported in this population sub-group. The purpose of this study is to estimate the proportion of pregnant and breastfeeding women expressing hesitation to the COVID-19 vaccine worldwide. Determinants of vaccine compliance and options suggestedto address vaccine hesitancy were also analyzed. Methods Forty-six studies were included in the meta-analysis and systematic review, selected from scientific articles available in the MEDLINE/PubMed, Google Scholar, and Scopus databases between January 1, 2020 and February 6, 2022. The following terms were used for the search strategy: (adherence OR hesitancy OR compliance OR attitude) AND (covid* OR SARS*) AND (vaccin* OR immun*) AND (pregnan* OR post-partum OR breastfeeding OR lactating). Results The vaccine hesitation rate was 48.4% (95%CI=43.4-53.4%). In a sub analysis by study period, the pooled prevalence of vaccine hesitation was 40.0% (95%CI=31.6-46.6%) considering surveys administered in 2020, 58.0% (95%CI=48.9-66.9%) considering surveys administered in the first semester of 2021, and 38.1% (95%CI=25.9-51.2%) considering surveys administered in the second semester of 2021. The main reasons for vaccine hesitation were lack of information about vaccination, opinion that the vaccine is unsafe, and fear of adverse events for both mother and fetus/child. Conclusions In order to achieve high vaccination coverage, a multifactorial approach is needed, requiring major social, scientific, and health efforts. The success of the vaccination campaign in this population depends on the capillarity and consistency of the interventions implemented. Key messages • Vaccine hesitancy can be a determining factor in the success (or otherwise) of the anti-COVID-19 immunization campaign. • Vaccine hesitancy in pregnant and breastfeeding women is a genuine public health concern worldwide.
ABSTRACT
Introduction: The Istituto Superiore di Sanita and the Agenzia Italiana del Farmaco coordinate the project TheShinISS-Vax, Flu, a post-marketing "active" surveillance of influenza vaccines. We report the results of the investigation using the Self- Controlled Case Series (SCCS) design on influenza vaccine and Guillain-Barre syndrome in vaccinated population aged over than 6 months, during the influenza vaccine campaign 2020-2021 in Italy. Materials and methods: A SCCS multi-regional study was carried out using linked data from Regional Health Care Registries of Valle d'Aosta, Friuli Venezia Giulia, Emilia-Romagna, Toscana, Lazio, Campania, and Puglia. Relative incidence of Guillain-Barre syndrome was estimated, comparing the exposure risk periods (0-41 days from the vaccination day, subdivided in six intervals) with the unexposed period.
ABSTRACT
BACKGROUND AND AIMS: COVID-19 infection in solid organ transplant recipients (SOT) is associated with increased morbidity and mortality due to comorbidities and immunosuppression state (Chaudhry ZS et al, 2020). Although vaccines represent the greatest hope to control COVID-19 pandemic, several studies showed the low immunogenicity of a two-dose mRNA COVID-19 vaccine regimen in SOT as compared with general population (Boyarsky BJ et al, 2021). Based on this evidence, on September 2021, the Italian Medicine Agency (AIFA) authorized a third vaccine administration as additional primary dose to immunocompromised patients. The aim of this study is to evaluate the seroconversion rate after the third dose of BNT162b2 (Pfizer-BioNTech) SARS-CoV-2 mRNA vaccine in kidney transplant recipients (KTRs) and to investigate the baseline factors associated with the absence of the antibody response. METHOD: we performed a prospective and observational study on a monocentric cohort of 329 consecutive Caucasian KTRs given three doses of the BNT162b2 COVID-19 vaccine. Key exclusion criteria were a previous history of COVID-19 infection and transplantation or having underwent chemotherapy treatment within the last year. Antibody response against the spike protein was tested on blood sample collected before the administration of vaccine (T0), at 15 and 90 days after the second dose (T2 and T3, respectively) and one month after the third dose (T5). The level of antibodies was assessed using the Roche Elecsys anti-SARS-CoV-2 S enzyme immunoassay (positive cut-off ≥ 0.8 U/mL). A total of 22 patients were excluded from the analysis because categorized as SARS-CoV-2-pre-immunized according to the antibodies' baseline status (T0) above the positivity cut-off. The Local Ethics Committees approved the study protocol and written informed consent was obtained before enrolment. RESULTS: The study population of 307 KTRs was 57.10 ± 13.10 years, with a predominance of male sex (64.2%). Median time from transplantation to vaccine was 10 [IQR 5-17] years. Blood analysis at baseline revealed mean eGFR assessed by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation to be 56.95 ± 23.04 mL/min/1.73 m2. The standard immunosuppressive regimen consisted of glucocorticoids in all patients, calcineurin inhibitors (88.6% of patients), antimetabolites (73.3% of patients) and mTOR inhibitors (in 15.6% of patients). The first two doses were administered 21 days apart, and the third dose was administrated 172 ± 4 days after the second dose. In our cohort, 43.3% patients (133/307) responded to the vaccine at T2. The proportion of responders increased to 68.4% (186/272) at T3 (median antibody level: 5.2 [0.40-74.07]). One month after the third dose, a positive antibody titer was detected in 251 of 307 patients (81.8%) (median antibody titre: 1137.50 [9.32- 4189.75]). The response curve starting at T2 and increasing at T3 makes apparent that there is a distinctive kinetic of humoral response in immunocompromised patients compared to immunocompetent individuals (Walsh EE et al., 2020). A multivariate analysis showed that the negative response to the third primary dose was associated with antimetabolite immunosuppressants (P = .001), lower estimated glomerular filtration rate (P < .001) and female sex (P = .04) (Figure 1). No serious adverse events were reported. Neither De novo DSAs nor change in proteinuria were reported after vaccination. The limitation of this study is the absence of assays for cellular immune response. CONCLUSION: Although the exact threshold of antibody titer for protection against SARS-CoV-2 infection remains unclear, the ability of the additional mRNA COVID- 19 vaccine dose to increase both immune response (Figure 2A) and the prevalence of seroconversion rate (Figure 2B) associated with the acceptable safety profile supports its use after an initial 2-dose mRNA COVID-19 primary vaccine series in immunocompromised patients. (Table Presented).
ABSTRACT
BACKGROUND: As other indoor sports facilities, swimming pools were closed in Italy from March to May 2020 and from October 2020 to July 2021 due to the outbreak of the COVID-19 pandemic;access to these facilities was restricted to athletes of national relevance. This decision was based on "precautionary principles" and without evidence of a high risk of SARS-COV-2 circulation among swimming pools' attendants. The aim of this paper is to describe the pattern of SARS-COV-2 circulation among swimming athletes in Apulia (Southern Italy). STUDY DESIGN: The study aims to investigate the hypothesis that attending a pool increases the risk of SARSCOV- 2 infection. The outcome measure is the incidence of SARS-COV-2 infection among swimming athletes compared with the general population. METHODS: This is a retrospective cross-sectional study carried out in Apulia, Southern Italy. The study was performed through the analysis of both the database of the Italian Swimming Federation and the SARS-COV-2 infections in Apulia Region, from July 2020 to August 2021. RESULTS: Among 2,939 federally licensed athletes, 221 had an history of SARS-COV-2 infection from July 2020 to August 2021, with an incidence of 75.2 /1,000. In the general Apulian population, during the same time span, the incidence of SARS-COV-2 infection was 67.3/1,000 and - considering the incidence rate ratio - there is no difference between the two populations (IRR=1.1;95% CI=0.9-1.3;p>0.05). CONCLUSIONS: The incidence of SARS-COV-2 infection in Apulian swimmers showed no significant differences with the general population.
ABSTRACT
INTRODUCTION: Healthcare workers on duty at the hospital are at high risk of COVID-19 infection. However, despite the introduction of risk-lowering practices in the hospital setting, there have been many cases of SARS-COV-2 infection among Health Care Workers. Fast and efficient contact tracing and Sars-CoV-2 PCR-based testing of the close contacts of Health Care Workers with confirmed infections are essential steps to limit nosocomial outbreaks. METHODS: This cross-sectional study was conducted at Bari Policlinico General University-Hospital (Apulia, Italy) and describes the management of a cluster of SARS-COV-2 infections in three Operative Units. The contact tracing activities and the measures implemented to control the outbreak are described. RESULTS: Among the 186 Health Care Workers active in the cluster setting, there were 9 (4.8%) confirmed cases, including the index case. Due to the outbreak, three Operative Units were closed to limit virus circulation. Health Care Workers with confirmed infections tested negative after a mean of 28.0±6.6 days (range: 13-37) and none required hospitalization. CONCLUSIONS: Protection of the health of Health Care Workers during the COVID-19 pandemic should be a public health priority. However, despite recent recommendations and the implementation of protective measures, SARS-COV-2 infections of Health Care Workers remain at a high rate, indicative of the continued high risk of cluster onset in the nosocomial setting.
ABSTRACT
Patients with hematological malignancies (HM) undergoing hematopoietic stem cell transplantation (HSCT) have an increased vulnerability to SARS-Cov-2 (Sharma et al, Lancet Haematology 2020;Ljungman et al, Leukemia 2021), the reason why international guidelines strongly support the need for a protective vaccination for these subjects. The most relevant data currently available on the response to a complete anti-SARS-Cov-2 vaccination cycle in HM patients after HSCT refer to 314 patients reported in a Lithuanian national survey (Maneikis et al, Lancet Haematol 2021). In this study, the median titers of antibodies against SARS-Cov-2, determined 7-21 days after the second vaccination, were comparable to that of healthy controls (HC) in both autologous and allogeneic groups, with no patient found below the protective threshold of 50 arbitrary units (AU)/ml. Notably, the large majority of patients had received the transplant more than 1 year before vaccination. In a prospective, cohort study, we compared 114 patients, who had received an autologous or allogeneic HSCT at least three months before the first dose of vaccination, to 107 HC, matched for age and sex. Study population and HC received two doses of BNT162b2 anti-SARS-Cov-2 mRNA vaccine on days 1 and 21, between April and May 2021. Serological tests were performed by a commercially available immunoassay for the quantitative determination of anti-spike IgG antibodies to SARS-Cov-2. The cut-off for defining responders was 50 or greater AU/ml. Patients and HC samples were collected four weeks after the second dose of the vaccine. Table 1 reports the main clinical characteristics of patients and HC. Eighteen of 114 patients (16%) did not respond (24% in the allogeneic group, 6% in autologous recipients). Overall, median antibodies titers did not differ between HC and the entire cohort of transplanted patients, recipients of allogeneic HSCT, all patients responding to the vaccine or responders in the autologous subgroup (Figure 1A). All autologous HSCT recipients had significantly lower titers of antibodies than HC, while higher levels were found in responders who had received allogeneic HSCT (Figure 1A). Responders in the allogeneic subgroup showed antibodies titers significantly higher than responders in the autologous subgroup (Figure 1B). We further stratified patients in three groups, according to the time elapsed from transplant to vaccination: G1:<1 year;G2:1-5 years;G3:>5 years. Higher antibodies titers were observed in HC compared to all transplanted patients in G1 (Figure 1C), including both allogeneic (Figure 1D) and autologous (Figure 1E) HSCT recipients. No differences emerged in G2 between HC and all patients (Figure 1C), allogeneic (Figure 1D) or autologous (Figure 1E) HSCT recipients. Finally, no differences were found in G3 when comparing HC with all patients (Figure 1C) or allogeneic recipients (Figure 1D), whereas patients in the autologous subgroup showed significantly lower titers than HC (Figure 1E). Myeloma patients with controlled disease showed higher titers than patients with active disease (Figure 1F). According to median age, autologous HSCT recipients older than 57 years had significantly lower antibody levels than younger patients (Figure 1G). Autologous vs allogeneic HSCT, age of all patients and of allogeneic HSCT recipients, sex, type of allogeneic HSCT, conditioning regimen, age and sex of donor, occurrence of GVHD, disease type and single vs double autologous HSCT did not significantly impact on antibody levels (data not shown). No relevant side effects were recorded after vaccination. With a median follow up of 12 weeks, no case of COVID19 occurred among vaccinated patients. In our single center study, patients with a previous history of HSCT tolerated well BNT162b2 vaccine and mounted a potentially protective immune response in the majority of cases one month after two doses of vaccine. However, lack of response was not rare, especially in the allogeneic setting. The main factor associated with the quality of response was the tim from HSCT, with lower responses within the first year from transplant and differences between autologous and allogeneic groups transplanted more than five years before vaccination. Here, a consolidated, complete immune reconstitution in allogeneic HSCT recipients, as well as age and a still active disease in the autologous setting, could have played opposite pivotal roles. [Formula presented] Disclosures: Delia: Gilead: Consultancy;Amgen: Consultancy;abbvie: Consultancy;Jazz pharmaceuticals: Consultancy.
ABSTRACT
Background and aims: Solid organ transplant recipients (SOTRs) have been considered as an extremely vulnerable population in respect to SARS-CoV-2 infection. We aimed to assess the incidence and lethality rate of SARS-CoV-2 infection in different organ transplant settings using the liver as a comparator. Methods: In this nationwide population-based study we compared the crude incidence and lethality rates of SARS-CoV-2 infection [95% Bonferroni adjusted CI (Ba-CI)] among Italian LTRs as compared to non-liver SOTRs and to general population. The following independent groups had been compared: Italian general population, all SOTRs, liver transplant recipients (LTRs) and non-Liver SOTRs in area with different incidence of infection. Incidence rate ratio (IRR) and lethality rate ratio (LRR) was assessed. Community risk exposures in transplant settings were assessed. Results: From February 21 to June 22, 2020, there were 450 cases of SARS-CoV-2 infections over 14168 LTRs (n=89) and 29815 non-liver SOTRs (n= 361). A significantly lower risk of infection [IRR 0.56 (Ba-CI 0.34-0.92), 0.45 (Ba-CI 0.26-0.79), 0.52 (Ba-CI 0.36-0.75)] and a lower lethality rate ratio [(LRR 0.61 (Ba-CI 0.23-1.57), 0.37 (0.08-1.76), 0.52 (0.23-1.18] was found among LTRs as compared to non-liver SOTRs in the three areas. Excluding Lombardy, the risk of infection and lethality in LTRs was lower compared to general population. Non-Liver SOTRs showed an increased risk of infection and lethality at all geographic levels compared to general population. No significant difference in the adherence to mitigation policies was found. Conclusions: Liver transplantation was associated with a significantly lower risk of SARS-CoV-2 infection and lethality in respect to non-liver solid organ transplants. A separate evaluation of organ-specific risk stratification analysis and vaccination responses in transplant population is needed.
ABSTRACT
Abstract: On February 9, 2021, the Italian Ministry of Health made the "Covid-19 vaccine AstraZeneca" (now "Vaxzevria") available for use in the anti-COVID-19 vaccination campaign. However, in early March, the media reported that five people died a few days after receiving the vaccine. The reaction among both those already vaccinated and the vaccine candidates was one of near panic. The subsequent events have had long-lasting consequences, as 10-20% of vaccine candidates have since refused vaccination with the AstraZeneca vac-cine, so in addition to the delay in vaccination, ~200,000 doses of it were not administered. The goal of the vaccination campaign in Italy, when operating at full capacity, was to administer 500,000 doses per day, for a total of 3,500,000 doses per week. In this large amount of people, it is statistically certain that a certain number of subjects will develop non-vaccine related health problems or even die from causes unrelated to having been vaccinated. At this time in history, press reports must be inspired by a strong sense of responsibility and awareness of the potential consequences of misinformation; this is particularly true, especially because also the social media get inevitably involved.
Subject(s)
COVID-19 Vaccines , COVID-19 , Mass Media , Attitude to Health , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Health Knowledge, Attitudes, Practice , Humans , Immunization Programs , Public Health , VaccinationABSTRACT
Introduction. Monoclonal Gammopathy of Undetermined Significance (MGUS) is a pre-malignant plasma cell disorder reported in approximately 3% of individuals aged > 50 years, characterized by a low risk (about 1% per year) of evolution into “overt” myeloma or other lymphoproliferative diseases. It is classified as IgM-MGUS (15%) and non-IgM-MGUS (80-85%). MGUS is usually asymptomatic, but a higher risk of deep venous thrombosis and infection has been reported. In March 2020, “Coronavirus Disease 2019” (COVID-19) outbreak has been declared a pandemic by the World Health Organization. Regarding outcome of COVID-19 in patients with plasma cell dyscrasia, many papers have been published about multiple myeloma (MM), reporting a higher fatality rate respect to general population, while few data are available about the outcome of SARS-CoV-2 infection in patients with MGUS. Methods. We collected clinical data on MGUS Apulian patients with SARS- CoV-2 infection, tested by RT-PCR on nasopharyngeal swabs between March 1st, 2020 and April 30st, 2021. Among 1454 MGUS patients followed at our center, 91 were found SARS-CoV-2 positive, enrolled in this observational, retrospective study and compared with 182 age and sex-matched normal controls. Clinical data collected regarded: symptoms, hospitalization, hospitalization in intensive care unit, death. Calculations were carried out using Stata MP17. Results. Mean age of whole group (n. 273) was 65,3+/-13,3 years (range: 29-89), with no statistically-significant differences (p=0,734) observed between MGUS-group (65,6+/-13,3;range: 29-89 years) and controls-group (65,2+/- 13,4;range: 29-89 years). Mean number of comorbidities in the whole group was 1,2+/-1,2 (range: 0-5) and no statistically-significant differences (p=0,844) were found between MGUS-group (1,3+/-1,3;range: 0-5) and control group (1,2+/- 0,9;range: 0-3). About MGUS-subtypes, the most frequent was IgG-kappa (n=36;39,6%), followed by IgG-lambda (n=27;29,7%) and IgM-kappa (n=6;6,6%). Regarding MGUS risk-stratification, application of Mayo Clinic model identified 22 patients (24,2%) with low risk, 22 (24,2%) with low-intermediate risk, and 3 (3,3%) with high-intermediate risk;in 44 patients (48,3%) this data was missing. Immunoparesis was present in 13 cases (14,3%) and absent in 55 (60,4%), missing in 23 (25,3%). No patient developed MM or a lymphoproliferative disease progression during and immediately after COVID-19. Rates of symptoms (59,3% vs 56%), hospitalization (20,9% vs 14,3%), hospitalization in intensive care unit (11% vs 8,8%) and death (8,8% vs 5,5%) were slightly higher in MGUS group than controls (Table 1), but these differences were not statistically significant. A statistically significant association (p<0,05), was observed between higher age and death in both groups. Lastly, incidence of SARS-CoV-2 infection in MGUS patients (6,2%) was not statistically significant different from that observed in the population of the Puglia region (5,8%) in the same period. Conclusions. To our knowledge, this report is the largest study of patients with MGUS and SARS-CoV-2 infection to date. In our study patients with MGUS did not show an increased incidence of this infection compared to the general population and did not appear to represent a risk factor for poor outcome in COVID-19. [Formula presented] Disclosures: No relevant conflicts of interest to declare.
ABSTRACT
Thalassemia is an inherited blood disorder characterized by defective hemoglobin production, ineffective erythropoiesis and chronic hemolytic anemia. Patients with both transfusion-dependent thalassemia (TDT) and non-transfusion dependent thalassemia (NTDT) have risk factors associated with severe SARS-CoV-2 infection including iron overload, endocrinopathies, massive splenomegaly or previous splenectomy and coagulopathy (Motta et al, Am J Hematol, 95: E198-E199., 2020). Although vaccination is encouraged for these patients, data on the efficacy and safety of anti Sars-CoV-2 vaccines are limited (Karimi, M, et al, Br J Haematol, 190: e137-e140, 2020;Mandana Zafari, et al, Hemoglobin, 45:1, 1-4, 2021) due to exclusion of these patients from clinical trials. In a single center, prospective, cohort study we compared 67 patients affected by TDT to 61 healthy controls (HC), matched for age and sex. Study population and HC received two doses of BNT162b2 anti-SARS-Cov-2 mRNA vaccine on days 1 and 21, between April 1st and May 15 th, 2021. Serological tests were performed by a commercially available immunoassay for the quantitative determination of anti-spike IgG antibodies to SARS-CoV-2. The results were reported as Arbitrary Units (AU)/mL, with a cut-off for defining response as 50 or greater AU/ml. Patients and HC samples were collected four weeks after the second dose of vaccine. Median age of patients was 43 years (range 19-77), 39% of them were male and 61% were female. Median age of HC was 39 years (range 19-86), 43% of them were male and 57% were female. All controls achieved a response (50 or greater AU/mL) to vaccination, whereas 66/67 (98,5%) patients responded. Antibody titers were significantly higher (p=0.0005) in the HC group (mean 9863 ± 7784;median 7712, range 1206-51664) compared to patients (mean 7945 ± 12326;median 4025, range 19-89202) (Figure 1). When analyzing the patients' factors, age, sex, transfusion interval, serum ferritin level, and spleen size did not impact on the response to vaccination. With a median follow-up of 12 weeks, no relevant side effects were recorded after vaccination and no case of COVID19 occurred among vaccinated TDT patients. In conclusion, BNT162b2 anti-SARS-Cov-2 mRNA vaccine demonstrated efficacy and safety in our cohort of TDT patients. Response rate was similar to that of HC. Nevertheless, antibody titers in TDT patients were significantly lower than in HC. Further observations are ongoing to assess duration of response, efficacy and possible factors influencing this finding. [Formula presented] Disclosures: No relevant conflicts of interest to declare.