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      Adverse Events Following mRNA SARS-CoV-2 Vaccination among U.S. Nursing Home Residents

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          Abstract

          Background

          The devastating impact of the SARS-CoV-2 pandemic prompted the development and emergency use authorization of two mRNA vaccines in early 2020. Vaccine trials excluded nursing home (NH) residents, limiting adverse event data that directly apply to this population.

          Methods

          To prospectively monitor for potential adverse events associated with vaccination, we used Electronic Health Record (EHR) data from Genesis HealthCare, the largest NH provider in the United States. EHR data on vaccinations and pre-specified adverse events were updated daily and monitored for signal detection among residents of 147 facilities who received the first dose of vaccine between December 18, 2020 and January 3, 2021. For comparison, unvaccinated residents during the same time period were included from 137 facilities that started vaccinating at least 15 days after the vaccinating-facilities.

          Results

          As of Janary 3, 2021, 8,553 NH residents had received one dose of SARS-CoV-2 vaccine and by February 20, 2021, 8,371 residents had received their second dose of vaccine; 11,072 were included in the unvaccinated comparator group. No significant associations were noted for neurologic outcomes, anaphylaxis, or cardiac events.

          Conclusions

          No major safety problems were detected following the first or second dose of the vaccine to prevent COVID-19 in the study cohort from December 18, 2020 through March 7, 2021.

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          Most cited references 13

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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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              Immunosenescence: Implications for response to infection and vaccination in older people.

              People aged 60 and older represent over 11% of the world population and it is expected to rise 22% by 2050. Population aging is associated to an increased frequency of age-related diseases including higher susceptibility to infections, cancer, cardiovascular and neurodegenerative diseases. Immunosenescence refers to the decline of the immune system associated to aging. It affects both, innate and adaptive immunity limiting the response to pathogens and to vaccines. The analyses of the immune system in elderly individuals determined several immune signatures constituting an immune risk phenotype that predicts mortality. An inverse CD4/CD8 ratio, loss of naïve T cells, increased numbers of terminally-differentiated T cells and oligoclonal expansions of virus-specific T cells constitute hallmarks of immunosenescence. Natural killer (NK) cells are also found severely altered in the elderly. The contribution of latent cytomegalovirus infection to immunosenescence of T and NK cells has been shown. Considering the worldwide ageing of the population in the next decades, the impact of infections will be a real health problem for older individuals requiring preventive strategies. Thus, further studies are required to analyse the bases of immunosenescence and to establish protocols to overcome the age-associated alterations of the immune response in order to define effective vaccines against those pathogens, such as influenza, contributing to increased morbidity and mortality in the elderly.
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                Author and article information

                Journal
                Vaccine
                Vaccine
                Vaccine
                Elsevier Ltd.
                0264-410X
                1873-2518
                28 May 2021
                28 May 2021
                Affiliations
                [a ]Brown University School of Public Health, Providence, RI, USA
                [b ]Warren Alpert Medical School, Brown University, Providence, RI, USA
                [c ]Providence Veterans Administration Medical Center, Center on Innovation in Long-Term Services and Supports, Providence, RI
                [d ]Genesis Healthcare, Kennett Square, PA, USA
                [e ]Rhode Island Quality Institute, Providence, RI, USA
                Author notes
                [* ]Corresponding author at: Brown University, 121 S Main St, Box G-S121-6, Providence, RI 02912.
                Article
                S0264-410X(21)00683-6
                10.1016/j.vaccine.2021.05.088
                8162901
                41b5e194-44a9-4154-844e-c6d084316e82
                © 2021 Elsevier Ltd. All rights reserved.

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                Categories
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                Infectious disease & Microbiology

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