부산대학교 도서관

Using 4 data-sources (Spain, Italy, United Kingdom) data and a 1:1 matched cohort study, we aimed to estimate vaccine effectiveness (VE) in preventing SARS-CoV-2 infections with hospitalisations (±30 days) and death (±56 days) in general population and clinical subgroups with homologous/heterologous booster schedules (Comirnaty-BNT and Spikevax-MOD original COVID-19 vaccines) by comparison with unboosted individuals, during Delta and beginning of Omicron variants. Hazard Ratio (HR, by Cox models) and VE ([1-HR]*100) were calculated by inverse probability weights. Between December 2020-February 2022, in adults without prior SARS-CoV-2 infection, we matched 5.5 million people (>1 million with immunodeficiency, 343,727 with cancer) with a booster (3rd) dose by considering doses 1 and 2 vaccine brands and calendar time, age, sex, region, and comorbidities (immunodeficiency, cancer, severe renal disease, transplant recipient, Down Syndrome). We studied booster doses of BNT and MOD administered after doses 1 and 2 with BNT, MOD, or Oxford-AstraZeneca during a median follow-up between 9 and 16 weeks. BNT or MOD showed VE ranging from 70 to 86% across data sources as heterologous 3rd doses, whereas it was 42-88% as homologous 3rd doses. Depending on the severity and available follow-up, 3rd-dose effectiveness lasted between 1 and 5 months. In people with immunodeficiency and cancer, protection across data sources was detected with both heterologous (VE = 54-83%) and homologous (VE = 49-80%) 3rd doses. Overall, both heterologous and homologous 3rd doses with BTN or MOD showed additional protection against the severe effects of SARS-CoV-2 infections for the general population and for patients at potentially high risk of severe COVID-19 (elderly, people with immunodeficiency and cancer) in comparison with two doses schemes during Delta or early Omicron periods. The early VE after vaccination may be due to less testing among vaccinated pairs and unknown confounders, deserving cautious interpretation. The VE wane over time needs further in-depth research to properly envisage when or whether a booster of those vaccines should be administered.
Competing Interests: Declaration of Competing Interest All the authors declare financial support was provided by European Medicines Agency and the following financial interests/personal relationships which may be considered as potential competing interests: Elisa Martin Merino (corresponding author): Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and Agencia Española de Cooperación Internacional para el Desarrollo (AECID) paid a presentation in a course ‘Farmacovigilancia de las vacunas frente a la COVID-19’; Unpaid collaboration in observational studies with Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) for the “Grupo de Trabajo de Efectividad Vacunación COVID-19. Spanish Ministry of Health. ISCIII.CNE. Spanish Agency of Medicines and Medical Devices.” Riefolo Fabio is an employee of TEAMIT Institute, consulting research company that participates in financially supported studies for European Medicines Agency and related healthcare authorities, pharmaceutical companies, and the European Union. Ylenia Ingrasciotta is the CEO of the academic spin-off “INSPIRE srl” of the University of Messina, which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.) and from pharmaceutical Companies (Chiesi Italia, Kyowa Kirin s.r.l., Daiichi Sankyo Italia S.p.A.). Karin Swart-Polinder is an employee of the PHARMO Institute for Drug Outcomes Research. This independent research institute performs financially supported studies for the government and related healthcare authorities and several pharmaceutical companies.
(Copyright © 2023. Published by Elsevier Ltd.)