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2 results on '"Guido Bertolaso"'

1. Balancing Benefits and Harms of COVID-19 Vaccines: Lessons from the Ongoing Mass Vaccination Campaign in Lombardy, Italy

Author

Giovanni Corrao, Federico Rea, Matteo Franchi, Danilo Cereda, Antonio Barone, Catia Rosanna Borriello, Giulia Petra Della Valle, Michele Ercolanoni, Jose Jara, Giuseppe Preziosi, Manuel Maffeo, Francesco Mazziotta, Elisabetta Pierini, Francesco Lecis, Pierfrancesco Sanchirico, Francesco Vignali, Olivia Leoni, Ida Fortino, Massimo Galli, Giovanni Pavesi, and Guido Bertolaso

Subjects
COVID-19, healthcare utilization database, venous thromboembolism, effectiveness, Medicine
Abstract

Background. Limited evidence exists on the balance between the benefits and harms of the COVID-19 vaccines. The aim of this study is to compare the benefits and safety of mRNA-based (Pfizer-BioNTech and Moderna) and adenovirus-vectored (Oxford-AstraZeneca) vaccines in subpopulations defined by age and sex. Methods. All citizens who are newly vaccinated from 27 December 2020 to 3 May 2021 are matched to unvaccinated controls according to age, sex, and vaccination date. Study outcomes include the events that are expected to be avoided by vaccination (i.e., hospitalization and death from COVID-19) and those that might be increased after vaccine inoculation (i.e., venous thromboembolism). The incidence rate ratios (IRR) of vaccinated and unvaccinated citizens are separately estimated within strata of sex, age category and vaccine type. When suitable, number needed to treat (NNT) and number needed to harm (NNH) are calculated to evaluate the balance between the benefits and harm of vaccines within each sex and age category. Results. In total, 2,351,883 citizens are included because they received at least one dose of vaccine (755,557 Oxford-AstraZeneca and 1,596,326 Pfizer/Moderna). A reduced incidence of COVID-19-related outcomes is observed with a lowered incidence rate ranging from 55% to 89% and NNT values ranging from 296 to 3977. Evidence of an augmented incidence of harm-related outcomes is observed only for women aged Conclusions. A favourable balance between benefits and harms is observed in the current study, even among younger women who received Oxford-AstraZeneca.

Published
2022
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2. Eight Good Reasons for Careful Monitoring and Evaluation of the Vaccine Campaign against COVID-19: Lessons Learned through the Lombardy Experience for Dealing with Next Challenges

Author

Giovanni Corrao, Guido Bertolaso, Giovanni Pavesi, Letizia Moratti, Corrao, G, Bertolaso, G, Pavesi, G, and Moratti, L

Subjects
COVID-19 Vaccines, SARS-CoV-2, Health, Toxicology and Mutagenesis, Public Health, Environmental and Occupational Health, Effectivene, Protection persistence, Vulnerability, COVID-19, effectiveness, Observational studie, impact, natural experiment, observational studies, protection persistence, risk factors, safety, vaccine campaign, vaccine platform, variant of concern, vulnerability, Variant of concern, Impact, Vaccine platform, Humans, Medicine, Vaccine campaign, Risk factor, Natural experiment, Safety
Abstract

Background: Using the knowledge gained during the first eleven months of the vaccine campaign in Lombardy, Italy, we provide an overview of the benefits of using reliable, complete, and rapidly available observational data to monitor the progress of the vaccine strategy. Methods: A population-based platform was implemented by linking four registries reporting individual data on: (i) date, type, and dose of vaccine dispensed; (ii) SARS-CoV-2 infections and hospital admissions and deaths due to COVID-19; (iii) inpatient diagnoses and outpatient services supplied by the Regional Health Services (RHS); and the (iv) health registry reporting and updating data on patient status. Background, methods, findings, and implications of eight COVID-19 relevant questions are reported. Results: Before starting the vaccine campaign, we identified high-risk individuals who need to be prioritized. During the vaccine campaign, we: (i) monitored the trend in the speed of the vaccine campaign progression and the number of prevented clinical outcomes; (ii) verified that available vaccines work in real-life, assessed their effectiveness-harm profile, and measured their reduced effectiveness against the delta variant. Finally, we studied the reduced effectiveness of the vaccine over time and identified risk factors of post-vaccine infection and severe illness. Conclusions: The correct use of rapidly available observational data of good quality and completeness generates reliable evidence to promptly inform patients and policymakers.

Published
2022

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