Interim Estimates of COVID-19 Vaccine Effectiveness in a Mass Vaccination Setting: Data from an Italian Province

none7noAbstract: This retrospective cohort study compared the rates of virologically-confirmed SARS-CoV-2 infections, symptomatic or lethal COVID-19 among the residents of the Italian province of Pescara who received one or two doses of COVID-19 vaccines, versus the unvaccinated. The official data of the National Health System were used, and a total of 69,539 vaccinated adults were compared with 175,687 unvaccinated. Among the subjects who received at least one vaccine dose, 85 infections (0.12%), 18 severe and 3 lethal COVID-19 cases were recorded after an average follow-up of 38 days. Among the unvaccinated, the numbers were 6948 (4.00%), 933 (0.53%) and 241 (0.14%), respectively. The serious adverse event reports—yet unconfirmed—were 24 out of 102,394 administered doses. In a Cox model, adjusting for age, gender, and selected comorbidities, the effectiveness of either BNT162b2, ChAdOx1 nCoV-19 or mRNA-1273 vaccines was higher than 95% in preventing infections (mostly due to B.1.1.7 variant), symptomatic or lethal COVID-19. No differences were observed across genders, and among the 691 subjects who received the second dose of vaccine later than the recommended date. Although preliminary, these findings support current immunization policies and may help reducing vaccine hesitancy.openFlacco, Maria Elena; Soldato, Graziella; Acuti Martellucci, Cecilia; Carota, Roberto; Di Luzio, Rossano; Caponetti, Antonio; Manzoli, LambertoFlacco, Maria Elena; Soldato, Graziella; Acuti Martellucci, Cecilia; Carota, Roberto; Di Luzio, Rossano; Caponetti, Antonio; Manzoli, Lambert

COVID-19 Vaccination Did Not Increase the Risk of Potentially Related Serious Adverse Events: 18-Month Cohort Study in an Italian Province

This cohort study on the entire population of an Italian Province assessed the incidence of potentially vaccine-related serious adverse events (PVR-SAEs) by COVID-19 vaccination status. From January 2021 to July 2022, we extracted all deaths and hospitalizations due to several cardiovascular diseases, pulmonary embolism, and deep vein thrombosis from National Healthcare System official data. During the follow-up, 5743 individuals died, and 2097 were hospitalized for PVR-SAEs. Vaccinated subjects (n = 259,821) did not show an increased risk of all-cause death, non-COVID death, or any PVR-SAEs, as compared to the unvaccinated (n = 56,494). These results were consistent across genders, age-classes, vaccine types, and SARS-CoV-2 infection status and did not vary in Cox models adjusting for age, gender, SARS-CoV-2 infection, and selected comorbidities. In the infected population, any dose of vaccine was associated with a lower likelihood of death and PVR-SAE. In the uninfected population, subjects who received one or two doses showed a significantly higher incidence of most outcomes, likely due to a large selection bias introduced by the Italian restriction policies targeting uninfected subjects who received less than three doses. In conclusion, COVID-19 vaccination was not associated with an increase of mortality or selected PVR-SAEs incidence. Further research is warranted to evaluate the long-term safety of COVID-19 vaccines

COVID-19 Vaccination Effectiveness in the General Population of an Italian Province: Two Years of Follow-Up

We carried out a cohort study on the overall population of the province of Pescara, Italy, to assess the real-world effectiveness of SARS-CoV-2 vaccination against infection, severe, or lethal COVID-19, two years after the start of the vaccination campaign. We included all the resident or domiciled subjects, and extracted the official demographic, vaccination, COVID-19, hospital and co-pay exemption datasets from 1 January 2021, up to 15 February 2023. Cox proportional hazards analyses were adjusted for gender, age, diabetes, hypertension, COPD, major cardio- and cerebrovascular events, cancer, and kidney diseases. Throughout the follow-up (466 days on average), 186,676 subjects received greater than or equal to three vaccine doses (of ChAdOx1 nCoV-19, BNT162b2, mRNA-1273, NVX-CoV2373, or JNJ-78436735), 47,610 two doses, 11,452 one dose, and 44,989 none. Overall, 40.4% of subjects were infected with SARS-CoV-2. Of them, 2.74% had severe or lethal (1.30%) COVID-19. As compared to the unvaccinated, the individuals who received greater than or equal to one booster dose showed a ≥85% lower risk of severe or lethal COVID-19. A massive impact of vaccination was found among the elderly: 22.0% of the unvaccinated, infected individuals died, as opposed to less than 3% of those who received greater than or equal to three vaccine doses. No protection against infection was observed, although this finding was certainly influenced by the Italian restriction policies to control the pandemic. Importantly, during the Omicron predominance period, only the group who received at least a booster dose showed a reduced risk of COVID-19-related death

Risk of SARS-CoV-2 Reinfection 3 Years after the Start of the Pandemic: A Population-Level Observational Study

The risk of SARS-CoV-2 reinfections changes as new variants emerge, but the follow-up time for most of the available evidence is shorter than two years. This study evaluated SARS-CoV-2 reinfection rates in the total population of an Italian province up to three years since the pandemic’s start. This retrospective cohort study used official National Healthcare System data on SARS-CoV-2 testing and vaccinations, demographics, and hospitalizations in the Province of Pescara, Italy, from 2 March 2020 to 31 December 2022. A total of 6541 (5.4%) reinfections and 33 severe and 18 lethal COVID-19 cases were recorded among the 121,412 subjects who recovered from a primary infection. There were no severe events following reinfection in the young population, whereas 1.1% of reinfected elderly died. A significantly higher reinfection risk was observed among females; unvaccinated individuals; adults (30–59 y); and subjects with hypertension, COPD, and kidney disease. Up to three years after a primary SARS-CoV-2 infection, the majority of the population did not experience a reinfection. The risk of severe COVID-19 following a reinfection was very low for young and adult individuals but still high for the elderly. The subjects with hybrid immunity showed a lower reinfection risk than the unvaccinated

Predictors of SARS-CoV-2 Infection and Severe and Lethal COVID-19 after Three Years of Follow-Up: A Population-Wide Study

In this cohort study, the general population of an Italian Province was followed for three years after the start of the pandemic, in order to identify the predictors of SARS-CoV-2 infection and severe or lethal COVID-19. All the National Healthcare System information on biographical records, vaccinations, SARS-CoV-2 swabs, COVID-19 cases, hospitalizations and co-pay exemptions were extracted from 25 February 2020 to 15 February 2023. Cox proportional hazard analysis was used to compute the relative hazards of infection and severe or lethal COVID-19, adjusting for age, gender, vaccine status, hypertension, diabetes, major cardiovascular diseases (CVD), chronic obstructive pulmonary disease (COPD), kidney disease or cancer. Among the 300,079 residents or domiciled citizens, 41.5% had ≥1 positive swabs during the follow-up (which lasted a mean of 932 days). A total of 3.67% of the infected individuals experienced severe COVID-19 (n = 4574) and 1.76% died (n = 2190). Females, the elderly and subjects with diabetes, CVD, COPD, kidney disease and cancer showed a significantly higher risk of SARS-CoV-2 infection. The likelihood of severe or lethal COVID-19 was >90% lower among the youngest, and all comorbidities were independently associated with a higher risk (ranging from +28% to +214%) of both outcomes. Two years after the start of the immunization campaign, the individuals who received ≥2 doses of COVID-19 vaccines still showed a significantly lower likelihood of severe or lethal disease, with the lowest risk observed among subjects who received at least one booster dose

Control and prevention measures for legionellosis in hospitals: A cross-sectional survey in Italy

Risk assessment, environmental monitoring, and the disinfection of water systems are the key elements in preventing legionellosis risk. The Italian Study Group of Hospital Hygiene of the Italian Society of Hygiene, Preventive Medicine, and Public Health and the Italian Multidisciplinary Society for the Prevention of Health Care-Associated Infections carried out a national cross-sectional survey to investigate the measures taken to prevent and control legionellosis in Italian hospitals. A multiple-choice questionnaire was developed, comprising 71 questions regarding hospital location, general characteristics, clinical and environmental surveillance, and control and preventive measures for legionellosis in 2015. Overall, 739 hospitals were enrolled from February to June 2017, and 178 anonymous questionnaires were correctly completed and evaluated (response rate: 24.1%). The survey was conducted using the SurveyMonkey® platform, and the data were analyzed using Stata 12 software. Of the participating hospitals, 63.2% reported at least one case of legionellosis, of which 28.2% were of proven nosocomial origin. The highest case numbers were reported in the Northern Italy, in hospitals with a pavilion structure or cooling towers, and in hospitals with higher numbers of beds, wards and operating theaters. Laboratory diagnosis was performed using urinary antigen testing alone (31.9%), both urinary antigen testing and single antibody titer (17.8%), or with seroconversion also added (21.5%). Culture-based or molecular investigations were performed in 28.8% and 22.1% of the clinical specimens, respectively. The water systems were routinely tested for Legionella in 97.4% of the hospitals, 62% of which detected a positive result (> 1000 cfu/L). Legionella pneumophila serogroup 2–15 was the most frequently isolated species (58.4%). The most common control measures were the disinfection of the water system (73.7%), mostly through thermal shock (37.4%) and chlorine dioxide (34.4%), and the replacement (69.7%) or cleaning (70.4%) of faucets and showerheads. A dedicated multidisciplinary team was present in 52.8% of the hospitals, and 73% of the hospitals performed risk assessment. Targeted training courses were organized in 36.5% of the hospitals, involving nurses (30.7%), physicians (28.8%), biologists (21.5%), technicians (26.4%), and cleaners (11%). Control and prevention measures for legionellosis are present in Italian hospitals, but some critical aspects should be improved. More appropriate risk assessment is necessary, especially in large facilities with a high number of hospitalizations. Moreover, more sensitive diagnostic tests should be used, and dedicated training courses should be implemented