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      COVID-19 vaccine safety and effectiveness at 3 months in institutionalized old people

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          Abstract

          Background

          Older age and associated comorbid conditions increase the risk of severe form of COVID-19 and death. The SARS-CoV-2 vaccination campaign began in France in December 2020 targeting institutionalized older population before having been evaluated in this population. The objective of our study was to assess the tolerability of vaccination 21 days (D21) and 90 days after the first vaccination (D90) in institutionalized old people. Secondary objective was to assess its effectiveness (mortality, hospitalization and occurrence of COVID) at D21 and D90.

          Methods

          People living in nursing homes or in long-term hospitalization facilities in France were included 12-2020-06-2021. They were divided into SARS-CoV-2 vaccinated and unvaccinated groups. Vaccine tolerability was prospectively assessed by the occurrence of health events at D21 and D90 (local and systemic side effects, geriatric syndromes, cardiovascular events). Vaccine efficacy was assessed by the occurrence of COVID-19 and serious adverse events (unscheduled hospitalization and all-cause mortality).

          Results

          The mean age of the 2595 participants was 86 years, 83% received COVID-19 vaccine. There were no significant difference between the vaccinated and unvaccinated for systemic or local adverse events at D21 and D90. At D90, vaccinated participants had significantly fewer SARS-CoV-2 infections (odds ratio (95% confidence interval) = 0.35 (0.22–0.58)), fewer deaths or hospitalizations (0.50 (0.31–0.81)), fewer cardiovascular events (0.28 (0.12–0.64)) and fewer pressure ulcers (0.38 (0.17–0.88)).

          Conclusions

          In this prospective cohort study, COVID-19 vaccine in a very old institutionalized geriatric population had a reassuring safety profile and a protective effect on COVID-19, hospitalizations and deaths, cardiovascular events and pressure ulcers.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12877-024-05609-7.

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          Most cited references31

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          Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study

          Summary Background In December, 2019, a pneumonia associated with the 2019 novel coronavirus (2019-nCoV) emerged in Wuhan, China. We aimed to further clarify the epidemiological and clinical characteristics of 2019-nCoV pneumonia. Methods In this retrospective, single-centre study, we included all confirmed cases of 2019-nCoV in Wuhan Jinyintan Hospital from Jan 1 to Jan 20, 2020. Cases were confirmed by real-time RT-PCR and were analysed for epidemiological, demographic, clinical, and radiological features and laboratory data. Outcomes were followed up until Jan 25, 2020. Findings Of the 99 patients with 2019-nCoV pneumonia, 49 (49%) had a history of exposure to the Huanan seafood market. The average age of the patients was 55·5 years (SD 13·1), including 67 men and 32 women. 2019-nCoV was detected in all patients by real-time RT-PCR. 50 (51%) patients had chronic diseases. Patients had clinical manifestations of fever (82 [83%] patients), cough (81 [82%] patients), shortness of breath (31 [31%] patients), muscle ache (11 [11%] patients), confusion (nine [9%] patients), headache (eight [8%] patients), sore throat (five [5%] patients), rhinorrhoea (four [4%] patients), chest pain (two [2%] patients), diarrhoea (two [2%] patients), and nausea and vomiting (one [1%] patient). According to imaging examination, 74 (75%) patients showed bilateral pneumonia, 14 (14%) patients showed multiple mottling and ground-glass opacity, and one (1%) patient had pneumothorax. 17 (17%) patients developed acute respiratory distress syndrome and, among them, 11 (11%) patients worsened in a short period of time and died of multiple organ failure. Interpretation The 2019-nCoV infection was of clustering onset, is more likely to affect older males with comorbidities, and can result in severe and even fatal respiratory diseases such as acute respiratory distress syndrome. In general, characteristics of patients who died were in line with the MuLBSTA score, an early warning model for predicting mortality in viral pneumonia. Further investigation is needed to explore the applicability of the MuLBSTA score in predicting the risk of mortality in 2019-nCoV infection. Funding National Key R&D Program of China.
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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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              Remdesivir for the Treatment of Covid-19 — Final Report

              Abstract Background Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious. Methods We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. Results A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%). Conclusions Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.)
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                Author and article information

                Contributors
                olivier.hanon@aphp.fr
                Journal
                BMC Geriatr
                BMC Geriatr
                BMC Geriatrics
                BioMed Central (London )
                1471-2318
                23 December 2024
                23 December 2024
                2024
                : 24
                : 1032
                Affiliations
                [1 ]Université de Paris, EA 4468, APHP, Hôpital Broca, ( https://ror.org/01m11mf96) Paris, France
                [2 ]Gérontopôle d’Ile-de-France, Paris, France
                [3 ]USLD and EHPAD, hôpital de Plaisir Grignon, Plaisir, France
                [4 ]USLD and EHPAD Centre de gérontologie Les Abondances, Boulogne-Billancourt, France
                [5 ]APHP, Hôpital Sainte Périne, ( https://ror.org/03h9w0610) Paris, France
                [6 ]Université Paris-Saclay, APHP, Hôpital Paul Brousse, ( https://ror.org/05n7yzd13) Villejuif, France
                [7 ]Université de Montpellier, CHRU Montpellier, ( https://ror.org/051escj72) Montpellier, France
                Article
                5609
                10.1186/s12877-024-05609-7
                11664901
                39716131
                8e5bfd99-f9f9-455d-ba59-7afdac87f3f0
                © The Author(s) 2024

                Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, 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 you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. 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-nc-nd/4.0/.

                History
                : 14 November 2023
                : 5 December 2024
                Categories
                Research
                Custom metadata
                © BioMed Central Ltd., part of Springer Nature 2024

                Geriatric medicine
                covid-19,covid-19 vaccine,geriatric population,nursing home,institutionalization

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