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1.
EuropePMC;
Preprint in English | EuropePMC | ID: ppcovidwho-327502

ABSTRACT

Objectives To investigate the association between SARS-CoV-2 mRNA vaccines, BNT162b2 and mRNA-1273, and myocarditis/pericarditis. Design Self-Controlled Case Series study (SCCS) using national data on COVID-19 vaccination and emergency care/hospital admissions. Setting Italian Regions (Lombardia, Friuli Venezia Giulia, Veneto, Lazio). Participants 2,861,809 individuals, aged 12-39 years, vaccinated with the first doses of mRNA vaccines (2,405,759 BNT162b2 and 456,050 mRNA-1273) between 27 December 2020 and 30 September 2021. Main outcome measures First diagnosis of myocarditis/pericarditis within the study period. The incidence of events in the exposure risk periods (0-21 days from the vaccination day, subdivided in three equal intervals) for first and second dose was compared with baseline period. The SCCS model was fitted using conditional Poisson regression to estimate Relative Incidences (RI) and Excess of Cases (EC) per 100,000 vaccinated by dose, age, gender and brand. Results During the study period, 441 participants aged 12-39 years developed myocarditis/pericarditis (346 BNT162b2 and 95 mRNA-1273). During the 21-day risk interval there were 114 cases of myocarditis/pericarditis (74 BNT162b2 and 40 mRNA-1273) corresponding to a RI of 1.27 (0.87-1.85) and 2.16 (1.50-3.10) after first and second dose, respectively. An increased risk of myocarditis/pericarditis at [0-7) days was observed after first [RI=6.55;95% Confidence Interval (2.73-15.72);EC per 100,000 vaccinated=2.0 (1.5-2.3)] and second dose [RI=7.59 (3.26-17.65);EC=5.5 (4.4-5.9)] of mRNA-1273 and after second dose of BNT162b2 [RI=3.39 (2.02-5.68);EC=0.8 (0.6-1.0)]. In males, an increased risk at [0-7) days was observed after first [RI=12.28, 4.09-36.83;EC=3.8 (3.1-4.0)] and second dose [RI=11.91 (3.88-36.53);EC=8.8 (7.2-9.4)] of mRNA-1273 and after second dose of BNT162b2 [RI=3.45 (1.78-6.68);EC=1.0 (0.6-1.2)]. In females, an increased risk at [0-7) days was observed after second dose of BNT162b2 [RI=3.38 (1.47-7.74);EC=0.7 (0.3-0.9)]. At [0-7) days an increased risk following second dose of BNT162b2 was observed in the 12-17 years old [RI=5.74, (1.52-21.72);EC=1.7 (0.7-1.9)] and in 18-29 years old [RI=4.02 (1.81-8.91);EC=1.1 (0.6-1.3)]. At [0-7) days an increased risk after first [RI=7.58 (2.62-21.94);EC=3.5 (2.4-3.8)] and second [RI=9.58 (3.32-27.58);EC=8.3 (6.7-9.2)] dose of mRNA-1273 was found in 18-29 years old and after first dose in 30-39 years old [RI=6.57 (1.32-32.63);EC=1.0 (0.3-1.1)]. Conclusions This population-based study indicates that mRNA vaccines were associated with myocarditis/pericarditis in the population younger than 40 years, whereas no association was observed in older subjects. The risk increased after the second dose and in the youngest for both vaccines, remained moderate following vaccination with BNT162b2, while was higher in males following vaccination with mRNA-1273. The public health implication of these findings should be weighed in the light of the overall efficacy and safety profile of both vaccines.

2.
Tumori ; : 3008916211073771, 2022 Feb 08.
Article in English | MEDLINE | ID: covidwho-1673723

ABSTRACT

INTRODUCTION: This study assesses the risk of infection and clinical outcomes in a large consecutive population of cancer and non-cancer patients tested for SARS-CoV-2 status. METHODS: Study patients underwent SARS-CoV-2 molecular-testing between 22 February 2020 and 31 July 2020, and were found infected (CoV2+ve) or uninfected. History of malignancy was obtained from regional population-based cancer registries. Cancer-patients were distinguished by time between cancer diagnosis and SARS-CoV-2 testing (<12/⩾12 months). Comorbidities, hospitalization, and death at 15 September 2020 were retrieved from regional population-based databases. The impact of cancer history on SARS-CoV-2 infection and clinical outcomes was calculated by fitting a multivariable logistic regression model, adjusting for sex, age, and comorbidities. RESULTS: Among 552,362 individuals tested for SARS-CoV-2, 55,206 (10.0%) were cancer-patients and 22,564 (4.1%) tested CoV2+ve. Irrespective of time since cancer diagnosis, SARS-CoV-2 infection was significantly lower among cancer patients (1,787; 3.2%) than non-cancer individuals (20,777; 4.2% - Odds Ratio (OR)=0.60; 0.57-0.63). CoV2+ve cancer-patients were older than non-cancer individuals (median age: 77 versus 57 years; p<0.0001), were more frequently men and with comorbidities. Hospitalizations (39.9% versus 22.5%; OR=1.61; 1.44-1.80) and deaths (24.3% versus 9.7%; OR=1.51; 1.32-1.72) were more frequent in cancer-patients. CoV2+ve cancer-patients were at higher risk of death (lung OR=2.90; 1.58-5.24, blood OR=2.73; 1.88-3.93, breast OR=1.77; 1.32-2.35). CONCLUSIONS: The risks of hospitalization and death are significantly higher in CoV2+ve individuals with past or present cancer (particularly malignancies of the lung, hematologic or breast) than in those with no history of cancer.

3.
Cancer Med ; 10(21): 7781-7792, 2021 11.
Article in English | MEDLINE | ID: covidwho-1432369

ABSTRACT

BACKGROUND: It is well established that cancer patients infected with SARS-CoV-2 are at particularly elevated risk of adverse outcomes, but the comparison of SARS-CoV-2 infection risk between cancer patients and cancer-free individuals has been poorly investigated on a population-basis. METHODS: A population-based study was thus conducted in Friuli Venezia Giulia region, northeastern Italy, to estimate prevalence and determinants of SARS-CoV-2 infection among cancer patients, as compared to cancer-free individuals, and to evaluate adverse outcomes of SARS-CoV-2 infection. The study included 263,042 individuals tested for SARS-CoV-2 in February-December 2020 with cancer history retrieved through the regional cancer registry. Odds ratios (ORs) of SARS-CoV-2 positivity, with corresponding 95% confidence intervals (CIs), were calculated using multivariable logistic regression models, adjusted for sex and age. Hazard ratios (HRs) adjusted for sex and age for intensive care unit (ICU) admission and all-cause death were estimated using Cox models. RESULTS: Among 26,394 cancer patients tested for SARS-CoV-2, the prevalence of infection was 11.7% versus 16.2% among 236,648 cancer-free individuals, with a corresponding OR = 0.59 (95% CI: 0.57-0.62). The prevalence was much higher (29% in both groups) during the second pandemic wave (October-December 2020). Among cancer patients, age ≥80 years and cancer diagnosis ≥13 months before SARS-CoV-2 testing were the major risk factors of infection. Among 3098 infected cancer patients, the fatality rate was 17.4% versus 15.8% among 23,296 negative ones (HR = 1.63, 95% CI: 1.49-1.78), and versus 5.0% among 38,268 infected cancer-free individuals (HR = 1.23, 95% CI: 1.12-1.36). No significant differences emerged when considering ICU admission risk. CONCLUSION: Albeit cancer patients reported reduced SARS-CoV-2 infection risk, those infected showed higher mortality than uninfected ones and infected cancer-free population. Study findings claim for continuing to protect cancer patients from SARS-CoV-2, without reducing the level of oncologic care.


Subject(s)
COVID-19/epidemiology , Neoplasms/virology , Aged , Aged, 80 and over , COVID-19/mortality , Female , Humans , Intensive Care Units/statistics & numerical data , Italy/epidemiology , Male , Middle Aged , Mortality , Neoplasms/epidemiology , Prevalence , Retrospective Studies
4.
Epidemiol Prev ; 44(5-6 Suppl 2): 226-234, 2020.
Article in English | MEDLINE | ID: covidwho-1068143

ABSTRACT

OBJECTIVES: to describe the clinical and demographical characteristics of COVID-19 infected people in the Friuli Venezia Giulia Region (FVG, Northern Italy). DESIGN: retrospective cohort study with an individual level record linkage procedure of different administrative databases. SETTING AND PARTICIPANTS: the cohort included 3,010 patients residing in FVG who tested positive for COVID-19 between 1 March and 15 May 2020, 2020. Regional hospital admissions and deaths without hospital admissions up to June 1st, 2020 were analysed. Determinants of the probability of a highly severe illness were investigated in terms of hospitalisations or death without hospital admission. MAIN OUTCOME MEASURES: COVID-19 patients were identified from regional epidemiological data warehouse. Demographical and clinical variables such as gender, age, patient's comorbidities, vaccinations, ARBs/sartans prescriptions, and geographical residence variables were collected by linking different databases. Descriptive analyses were performed. Logistic multivariate regressions were used to estimate the probability of hospitalisation or death, whichever came first. Model coefficients and odds ratios (OR) were reported. RESULTS: COVID-19 population in FVG had a mean age of 60 years and 59% were females. The study found that 37% had hypertension while patients with cardiologic diseases, diabetes, and cancer were around 15%; 22% of the cases were residing in retirement homes. Approximately 30% received flu or pneumococcal vaccination and a similar proportion of patients had at least one prescription of ARBs /sartans in the previous 6 months. Statistical models showed a higher probability of a worst course of disease for males, elderly, highly complicated (in terms of resource use) subjects, in the presence of cardiologic diseases, diabetes, and pneumococcal vaccination. People living in retirement homes had a lower probability of hospitalisation/death without hospital admission. The cohort was divided into two groups: COVID-19 patients infected in the territory and infected in retirement homes. Among COVID-19 patients infected in the territory, the probability of hospitalisation/death was higher for males, for older individuals, and for those with comorbidities. Diabetes resulted to be a risk factor (OR 1.79; 95%CI 1.23-2.62), as well as pneumococcal vaccination (OR 1.64; 95%CI: 1.18-2.29), which is a likely proxy of fragile patients with pulmonary disease. The flu vaccination showed a potential protective effect with a 40% lower probability of hospitalisation or death (OR 0.62; 95%CI 0.44-0.85). Among the retirement homes cohort group, a higher probability of a bad course of disease emerged for males and for more complex patients. CONCLUSIONS: the greatest risk of hospitalisation/death as a measure of more severe illness was confirmed for males, elderly, and for individuals with comorbidities. Flu vaccination seemed to have had a protective effect while pneumococcal vaccination likely identified a group of high-risk patients to be actively monitored. For patients infected in the territory, different hospitalisation strategies were implemented by the regional health districts.


Subject(s)
COVID-19/epidemiology , Pandemics , Age Distribution , Aged , Angiotensin II Type 1 Receptor Blockers/pharmacology , Angiotensin Receptor Antagonists/pharmacology , Catchment Area, Health , Comorbidity , Databases, Factual , Female , Homes for the Aged/statistics & numerical data , Hospital Mortality , Hospitalization/statistics & numerical data , Humans , Italy/epidemiology , Male , Medical Record Linkage , Middle Aged , Multivariate Analysis , Pneumococcal Vaccines , Residence Characteristics , Retrospective Studies , Sex Distribution , Vaccination/statistics & numerical data
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