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      COVID-19 and Vaccination in the Setting of Neurologic Disease : An Emerging Issue in Neurology

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      , MD , , MD, PhD, , MD, , MD, , MD, , MD, , MPH, , MD, on behalf of the Quality Committee of the American Academy of Neurology
      Neurology
      Lippincott Williams & Wilkins

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          Abstract

          The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has left many unanswered questions for patients with neurologic disorders and the providers caring for them. Elderly and immunocompromised patients are at increased risk for severe symptoms due to COVID-19, and the virus may increase symptoms of underlying neurologic illness, particularly for those with substantial bulbar and respiratory weakness or other neurologic disability. Emerging SARS-CoV-2 vaccines offer substantial protection from symptomatic infection, but both patients and providers may have concerns regarding theoretical risks of vaccination, including vaccine safety and efficacy in the context of immunotherapy and the potential for precipitating or exacerbating neurologic symptoms. In this statement on behalf of the Quality Committee of the American Academy of Neurology, we review the current literature, focusing on COVID-19 infection in adults with neurologic disease, in order to elucidate risks and benefits of vaccination in these individuals. Based on existing evidence, neurologists should recommend COVID-19 vaccination to their patients. For those patients being treated with immunotherapies, attention should be paid to timing of vaccination with respect to treatment and the potential for an attenuated immune response.

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          Most cited references53

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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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            Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China

            The outbreak of coronavirus disease 2019 (COVID-19) in Wuhan, China, is serious and has the potential to become an epidemic worldwide. Several studies have described typical clinical manifestations including fever, cough, diarrhea, and fatigue. However, to our knowledge, it has not been reported that patients with COVID-19 had any neurologic manifestations.
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              mRNA vaccines — a new era in vaccinology

              mRNA vaccines represent a promising alternative to conventional vaccine approaches because of their high potency, capacity for rapid development and potential for low-cost manufacture and safe administration. However, their application has until recently been restricted by the instability and inefficient in vivo delivery of mRNA. Recent technological advances have now largely overcome these issues, and multiple mRNA vaccine platforms against infectious diseases and several types of cancer have demonstrated encouraging results in both animal models and humans. This Review provides a detailed overview of mRNA vaccines and considers future directions and challenges in advancing this promising vaccine platform to widespread therapeutic use.
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                Author and article information

                Journal
                Neurology
                Neurology
                neurology
                neur
                NEUROLOGY
                Neurology
                Lippincott Williams & Wilkins (Hagerstown, MD )
                0028-3878
                1526-632X
                12 October 2021
                12 October 2021
                : 97
                : 15
                : 720-728
                Affiliations
                From The Johns Hopkins School of Medicine (E.B.M., M.K.), Baltimore, MD; The University of Virginia Medical Center (K.K.), Charlottesville; The University of Miami Miller School of Medicine (I.H.), FL; Nationwide Children's Hospital (A.D.P.), Columbus, OH; The National Institutes of Health (A.N.), Bethesda, MD; The American Academy of Neurology (B.S.), Minneapolis; and The Mayo Clinic (L.K.J.), Rochester, MN.
                Author notes
                Correspondence Dr. Marsh ebmarsh@ 123456jhmi.edu

                Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

                This article was reviewed and approved for publication by the Quality Committee and board members of the American Academy of Neurology on March 12, 2021.

                The Article Processing Charge was funded by the authors.

                Author information
                http://orcid.org/0000-0002-2385-5074
                http://orcid.org/0000-0003-2588-7325
                http://orcid.org/0000-0002-8001-8440
                http://orcid.org/0000-0001-9313-1541
                http://orcid.org/0000-0003-0927-5855
                http://orcid.org/0000-0002-5851-8705
                Article
                NEUROLOGY2021174018 00011
                10.1212/WNL.0000000000012578
                8575134
                34326180
                b1912b58-06a6-49f7-a02e-983d175942d8
                Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

                This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

                History
                : 05 May 2021
                : 19 July 2021
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