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      Effectiveness of COVID-19 vaccines against severe COVID-19 among patients with cancer in Catalonia, Spain

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          Abstract

          Patients with cancer were excluded from pivotal randomized clinical trials of COVID-19 vaccine products, and available observational evidence on vaccine effectiveness (VE) focused mostly on mild, and not severe COVID-19, which is the ultimate goal of vaccination for high-risk groups. Here, using primary care electronic health records from Catalonia, Spain (SIDIAP), we built two large cohorts of vaccinated and matched control cancer patients with a primary vaccination scheme ( n = 184,744) and a booster ( n = 108,534). Most patients received a mRNA-based product in primary (76.2%) and booster vaccination (99.9%). Patients had 51.8% (95% CI 40.3%−61.1%) and 58.4% (95% CI 29.3%−75.5%) protection against COVID-19 hospitalization and COVID-19 death respectively after full vaccination (two-doses) and 77.9% (95% CI 69.2%−84.2%) and 80.2% (95% CI 63.0%−89.4%) after booster. Compared to primary vaccination, the booster dose provided higher peak protection during follow-up. Calibration of VE estimates with negative outcomes, and sensitivity analyses with slight different population and COVID-19 outcomes definitions provided similar results. Our results confirm the role of primary and booster COVID-19 vaccination in preventing COVID-19 severe events in patients with cancer and highlight the need for the additional dose in this population.

          Abstract

          Observational studies are needed to understand the effectiveness of COVID-19 vaccines in groups not included in randomised controlled trials, such as patients with cancer. Here, the authors estimate effectiveness of COVID-19 primary and booster vaccine doses in individuals in Catalonia, Spain using primary care data.

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          Most cited references68

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          A Novel Coronavirus from Patients with Pneumonia in China, 2019

          Summary In December 2019, a cluster of patients with pneumonia of unknown cause was linked to a seafood wholesale market in Wuhan, China. A previously unknown betacoronavirus was discovered through the use of unbiased sequencing in samples from patients with pneumonia. Human airway epithelial cells were used to isolate a novel coronavirus, named 2019-nCoV, which formed a clade within the subgenus sarbecovirus, Orthocoronavirinae subfamily. Different from both MERS-CoV and SARS-CoV, 2019-nCoV is the seventh member of the family of coronaviruses that infect humans. Enhanced surveillance and further investigation are ongoing. (Funded by the National Key Research and Development Program of China and the National Major Project for Control and Prevention of Infectious Disease in China.)
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            Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention

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              Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

              Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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                Author and article information

                Contributors
                otavio.ranzani@isglobal.org
                tduarte@idiapjgol.org
                Journal
                Nat Commun
                Nat Commun
                Nature Communications
                Nature Publishing Group UK (London )
                2041-1723
                19 June 2024
                19 June 2024
                2024
                : 15
                : 5088
                Affiliations
                [1 ]GRID grid.11899.38, ISNI 0000 0004 1937 0722, Pulmonary Division, Heart Institute (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, , Universidade de São Paulo, ; São Paulo, Brazil
                [2 ]GRID grid.11899.38, ISNI 0000 0004 1937 0722, Serviço de Oncologia Clínica, Instituto do Câncer do Estado de São Paulo (ICESP), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, , Universidade de São Paulo, ; São Paulo, Brazil
                [3 ]GRID grid.452479.9, Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), ; Barcelona, Spain
                [4 ]Universitat Autònoma de Barcelona, ( https://ror.org/052g8jq94) Bellaterra (Cerdanyola del Vallès), Spain
                [5 ]ISGlobal, Hospital Clínic-Universitat de Barcelona, ( https://ror.org/03hjgt059) Barcelona, Spain
                [6 ]Department of Medical Informatics, Erasmus University Medical Center, ( https://ror.org/018906e22) Rotterdam, The Netherlands
                Author information
                http://orcid.org/0000-0002-0051-9537
                http://orcid.org/0000-0001-8765-3044
                http://orcid.org/0000-0002-4677-6862
                http://orcid.org/0000-0002-8274-0357
                Article
                49285
                10.1038/s41467-024-49285-y
                11187152
                38898035
                27e52bb8-2c39-4867-8bab-6d074227e69e
                © The Author(s) 2024

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 2 November 2023
                : 28 May 2024
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                © Springer Nature Limited 2024

                Uncategorized
                oncology,cancer,epidemiology,sars-cov-2,vaccines
                Uncategorized
                oncology, cancer, epidemiology, sars-cov-2, vaccines

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