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      Non‐life‐threatening adverse effects with COVID‐19 mRNA‐1273 vaccine: A randomized, cross‐sectional study on healthcare workers with detailed self‐reported symptoms


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          There are concerns regarding the side effects of the new coronavirus disease 2019 (COVID‐19) mRNA‐1273 vaccine among healthcare workers (HCWs) in the United States. The objective of the study was to investigate the side effects of the mRNA‐1273 vaccine with detailed review of organ systems. A randomized, cross‐sectional study using an independent online survey questionnaire was conducted to collect responses from HCWs. Of all participants, 87.8% (1116/1271) provided complete responses. Of them, 38.7% (432/1116) received the mRNA‐1273 vaccine, among which, 89.35% were females; 425 of these 432 mRNA‐1273 vaccine recipients (98.34%) reported at least one or more symptoms. The results were classified based on the frequency of symptoms reported postvaccination. Of these, 254/432 (58.8%) were able to continue their daily routine activities. 108/432 (25%) temporarily had trouble to perform daily activities, 120/432 (27.78%) required transient time off from work, 17/432 (3.94%) required help from an outpatient provider, 1/432 (0.23%) required help from emergency department, and none of them were hospitalized. Despite the wide array of self‐reported symptoms, 97.02% of the HCWs did not intend to skip the second dose of vaccine. Among all the symptoms reported, localized pain, generalized weakness, headache, myalgia, chills, fever, nausea, joint pains, sweating, localized swelling at the injection site, dizziness, itching, rash, decreased appetite, muscle spasm, decreased sleep quality, and brain fogging were the most commonly reported symptoms (in descending order of occurrence). Most of the symptoms reported were nonlife threatening. Despite the wide array of self‐reported symptoms, there appears to be a higher acceptance for this vaccine.

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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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              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.

                Author and article information

                Renuka.Kadali@harnetthealth.org , dr.kadali1982@gmail.com
                J Med Virol
                J Med Virol
                Journal of Medical Virology
                John Wiley and Sons Inc. (Hoboken )
                05 May 2021
                July 2021
                : 93
                : 7 , Special Issue on New coronavirus (2019‐nCoV or SARS‐CoV‐2) and the outbreak of the respiratory illness (COVID‐19): Part‐XIII ( doiID: 10.1002/jmv.v93.7 )
                : 4420-4429
                [ 1 ] Department of Internal Medicine, Harnett Health System Affiliated with Cape Fear Valley Health System Lillington North Carolina USA
                [ 2 ] Department of Internal Medicine Campbell University Jerry M. Wallace School of Osteopathic Medicine Lillington North Carolina USA
                [ 3 ] Kidzcare Pediatrics Sanford North Carolina USA
                [ 4 ] Department of Statistics North Carolina State University Raleigh North Carolina USA
                [ 5 ] Department of Pediatrics, Division of Pediatric Critical Care Medicine University of Mississippi Medical Center Jackson Mississippi USA
                [ 6 ] Department of Internal Medicine Mayo Clinic Rochester Minnesota USA
                [ 7 ] Department of Gastroenterology and Hepatology Mayo Clinic Rochester Minnesota USA
                [ 8 ] Department of Internal Medicine Temple University Hospital Philadelphia Pennsylvania USA
                Author notes
                [*] [* ] Correspondence

                Renuka A. K. Kadali, Department of Internal Medicine, Harnett Health System and Campbell University School of Osteopathic Medicine, 215 Brightwater Dr, Lillington, NC 27546, USA.

                Email: Renuka.Kadali@ 123456harnetthealth.org and dr.kadali1982@ 123456gmail.com

                Ravali Janagama, Department of Pediatrics, Kidzcare Pediatrics, 145 W Main St, Sanford, NC 27332. Email: ravalirao@ 123456yahoo.com

                © 2021 The Authors. Journal of Medical Virology published by Wiley Periodicals LLC

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                Page count
                Figures: 1, Tables: 4, Pages: 10, Words: 5957
                Research Article
                Research Articles
                Custom metadata
                July 2021
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.0.4 mode:remove_FC converted:02.07.2021

                Microbiology & Virology
                adverse events,covid,covid‐19,moderna,mrna‐1273,side effects,symptoms,sars‐cov‐2,vaccine


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