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      COVID-19 Outbreaks in Nursing Homes Despite Full Vaccination with BNT162b2 of a Majority of Residents

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          Abstract

          Background

          It is not known if widespread vaccination can prevent the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in subpopulations at high risk, like older adults in nursing homes (NH).

          Objective

          The objective of the study was to know if coronavirus disease 2019 (COVID-19) outbreaks can occur in NH with high vaccination coverage among its residents.

          Methods

          We identified, using national professional networks, NH that suffered COVID-19 outbreaks despite having completed a vaccination campaign, and asked them to send data, using predefined collecting forms, on the number of residents exposed, their vaccination status and the number, characteristics, and evolution of patients infected. The main outcome was to identify outbreaks occurring in NH with high vaccine coverage. Secondary outcomes were residents' risk of being infected, developing severe disease, or dying from COVID-19 during the outbreak. SARS-CoV-2 infection was defined by a positive reverse transcriptase-polymerase chain reaction. All residents were serially tested whenever cases appeared in a facility. Unadjusted secondary attack rates, relative risks, and vaccine effectiveness during the outbreak were estimated.

          Results

          We identified 31 NH suffering an outbreak during March–April 2021, of which 27 sent data, cumulating 1,768 residents (mean age 88.4, 73.4% women, 78.2% fully vaccinated). BNT162b2 was the vaccine employed in all NH. There were 365 cases of SARS-CoV-2 infection. Median secondary attack rates were 20.0% (IQR 4.4%–50.0%) among unvaccinated residents and 16.7% (IQR 9.5%–29.2%) among fully vaccinated ones. Severe cases developed in 42 of 80 (52.5%) unvaccinated patients, compared with 56 of 248 (22.6%) fully vaccinated ones (relative risks [RR] 4.17, 95% CI: 2.43–7.17). Twenty of the unvaccinated patients (25.0%) and 16 of fully vaccinated ones (6.5%) died from COVID-19 (RR 5.11, 95% CI: 2.49–10.5). Estimated vaccine effectiveness during the outbreak was 34.5% (95% CI: 18.5–47.3) for preventing SARS-CoV-2 infection, 71.8% (58.8–80.7) for preventing severe disease, and 83.1% (67.8–91.1) for preventing death.

          Conclusions

          Outbreaks of COVID-19, including severe cases and deaths, can still occur in NH despite full vaccination of a majority of residents. Vaccine remains highly effective, however, for preventing severe disease and death. Prevention and control measures for SARS-CoV-2 should be maintained in NH at periods of high incidence in the community.

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          Most cited references38

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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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            Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

            Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)
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              The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

              Much of biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Eighteen items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
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                Author and article information

                Journal
                Gerontology
                Gerontology
                GER
                Gerontology
                S. Karger AG (Allschwilerstrasse 10, P.O. Box · Postfach · Case postale, CH–4009, Basel, Switzerland · Schweiz · Suisse, Phone: +41 61 306 11 11, Fax: +41 61 306 12 34, karger@karger.com )
                0304-324X
                1423-0003
                21 March 2022
                21 March 2022
                : 1-9
                Affiliations
                [1] aService de gériatrie à orientation cardiologique et neurologique, APHP, Sorbonne Université, Hôpitaux universitaires Pitie-Salpêtrière-Charles Foix, Ivry-sur-Seine, France
                [2] bFaculté de médecine, Sorbonne Université, Paris, France
                [3] cINSERM, IMRB, Université Paris Est Créteil, Creteil, France
                [4] dService de Médecine Gériatrique et Thérapeutique, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France
                [5] eFaculté de médecine, CNRS UMR 7284/INSERM U108, Institute for Research on Cancer and Aging Nice (IRCAN), Université Côte d'Azur, Nice, France
                [6] fHôpital Bretonneau, APHP, Université de Paris, Paris, France
                [7] gCollégiale de Gériatrie de l'APHP, Paris, France
                [8] hCHU de Montpellier, Université de Montpellier, Montpellier, France
                [9] iConseil National Professionnel de Gériatrie, Baillargés, France
                [10] jHôpital Broca, APHP, Université Paris-Descartes, Paris, France
                [11] kGérond'If, Gérontopôle d'Ile-de-France, Paris, France
                Author notes
                *Carmelo Lafuente-Lafuente, carmelo.lafuente@ 123456aphp.fr
                Article
                ger-0001
                10.1159/000523701
                9058997
                35313315
                e81044a1-a52e-4592-9340-60d6e0cd797a
                Copyright © 2022 by S. Karger AG, Basel

                This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.

                History
                : 7 September 2021
                : 10 February 2022
                Page count
                Figures: 1, Tables: 2, References: 39, Pages: 9
                Categories
                Clinical Section: Research Article

                coronavirus disease 2019,severe acute respiratory syndrome coronavirus 2,vaccination,outbreak,older adults,nursing home

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