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      Subjektives Wohlbefinden und Arbeitsfähigkeit von Krankenhauspersonal nach SARS-CoV-2-Immunisierung mit dem mRNS-Impfstoff BNT162b2 – Ergebnisse einer anonymen Umfrage Translated title: Subjective well-being and ability to work of hospital staff after SARS-CoV2 immunization with the mRNA vaccine BNT162b2

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          Zusammenfassung

          Einleitung  Seit dem 27.12.2020 wurden in Deutschland unter anderem MitarbeiterInnen des Gesundheitssystems mit dem Vakzin BNT162b2 gegen das SARS-Coronavirus-2 geimpft. Erste Beobachtungen zeigten, dass es insbesondere bei jüngeren Geimpften zu Nebenwirkungen kommen kann. In dieser Studie wurde am Beispiel von KlinikmitarbeiterInnen das selbstempfundene Wohlbefinden nach der jeweils ersten und zweiten Dosis des Impfstoffes untersucht.

          Methoden  Anonymisierter Online-Fragebogen, einmalig ausfüllbar durch alle MitarbeiterInnen nach Erhalt der zweiten Dosis von BNT162b2. Die Ausprägung von Nebenwirkungen wurde über eine ordinale numerische Rating-Skala mit Werten zwischen 0 und 10 abgefragt. Weitere wesentliche Datenpunkte waren Alter, Geschlecht und Berufsgruppe. Die Arbeitsfähigkeit in den Folgetagen der Injektionen wurde ebenfalls durch Selbstangabe erhoben.

          Ergebnisse  Es wurden Daten von 555 Befragten ausgewertet. Das mittlere Alter lag bei 40,25 Jahren (Standardabweichung 12,35). 56 % der Befragten waren weiblich, 44,3 % gehörten zum ärztlichen, 42,9 % zum pflegerischen Dienst und 12,8 % waren anderen Berufsgruppen mit COVID-19-Patientenkontakt zuzuordnen. Etwa 2 % aller Mitarbeiter verspürten überhaupt keine Nebenwirkungen. Häufigste Nebenwirkung waren Schmerzen an der Injektionsstelle. In absteigender Häufigkeit folgten Müdigkeit, Kopfschmerzen und Myalgien. Nach der ersten Dosis gaben 3 Viertel der Befragten an, die Impfung insgesamt gut vertragen zu haben, nach der zweiten Dosis war es nur noch die Hälfte. Nach der ersten Dosis fühlten sich über 90 % der Befragten am Folgetag wieder arbeitsfähig, nach der zweiten Dosis gab ein Drittel an, erst am zweiten Tag wieder arbeitsfähig gewesen zu sein. 2,2 % aller MitarbeiterInnen mussten sich nach der ersten, 19,5 % nach der zweiten Dosis für mindestens einen Tag arbeitsunfähig melden.

          Schlussfolgerung  Die Impfung mit BNT162b2 führte – insbesondere nach der zweiten Dosis – häufig zu Nebenwirkungen. Diese hatten in 19 % der Befragten eine Krankmeldung nach der zweiten Dosis zur Folge. Dennoch würden sich 95 % aller Befragten wieder für eine Coronavirus-Impfung entscheiden.

          Abstract

          Background  Since December 27, 2020, employees of the health system in Germany have been vaccinated against the SARS coronavirus-2 with the vaccine BNT162B2. Initial observations show that especially among younger vaccinated people side effects are common. In this study, using the example of clinic employees, the self-perceived well-being after the first and second dose of the vaccine was examined.

          Methods  Anonymized online questionnaire to be filled out once by all employees after the second dose of BNT162B2 was offered. The severity of side effects was queried using an ordinal numerical rating scale with values between 0 and 10. Other key data points were age, gender, and occupational group. The ability to work in the days following the injections was recorded by self-reporting.

          Results  Data from 555 respondents were evaluated. The mean age was 40.25 years (standard deviation 12.35). 56 % of the respondents were female, 44.3 % belonged to the medical service, 42.9 % to the nursing service and 12.8 % were assigned to other professional groups with COVID-19 patient contact. Around 2 % of all employees did not experience any side effects at all. The most common side effect was pain at the injection site. Fatigue, headaches and myalgia followed with decreasing frequency. After the first dose, ¾ of the respondents said they had tolerated the vaccination well overall, after the second dose it was only half. After the first dose, over 90 % of the respondents felt that they were able to work again on the following day, after the second dose one third stated that they were only able to work again on the second day. 2.2 % of all employees had to report that they were unable to work for at least one day after the first dose and 19.5 % after the second dose.

          Conclusions  Vaccination with BNT162B2 frequently leads to side effects, especially after the second dose. Perception of side effects resulted in 19 % of those questioned being sick after the second dose. Nevertheless, 95 % of all respondents would choose a coronavirus vaccination again.

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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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            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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              Incorporation of pseudouridine into mRNA yields superior nonimmunogenic vector with increased translational capacity and biological stability.

              In vitro-transcribed mRNAs encoding physiologically important proteins have considerable potential for therapeutic applications. However, in its present form, mRNA is unfeasible for clinical use because of its labile and immunogenic nature. Here, we investigated whether incorporation of naturally modified nucleotides into transcripts would confer enhanced biological properties to mRNA. We found that mRNAs containing pseudouridines have a higher translational capacity than unmodified mRNAs when tested in mammalian cells and lysates or administered intravenously into mice at 0.015-0.15 mg/kg doses. The delivered mRNA and the encoded protein could be detected in the spleen at 1, 4, and 24 hours after the injection, where both products were at significantly higher levels when pseudouridine-containing mRNA was administered. Even at higher doses, only the unmodified mRNA was immunogenic, inducing high serum levels of interferon-alpha (IFN-alpha). These findings indicate that nucleoside modification is an effective approach to enhance stability and translational capacity of mRNA while diminishing its immunogenicity in vivo. Improved properties conferred by pseudouridine make such mRNA a promising tool for both gene replacement and vaccination.
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                Author and article information

                Journal
                Dtsch Med Wochenschr
                Dtsch Med Wochenschr
                10.1055/s-00000011
                Deutsche Medizinische Wochenschrift (1946)
                Georg Thieme Verlag KG (Rüdigerstraße 14, 70469 Stuttgart, Germany )
                0012-0472
                1439-4413
                August 2021
                09 July 2021
                1 August 2021
                : 146
                : 16
                : e58-e64
                Affiliations
                [1 ]Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Freiburg
                [2 ]Ärztlicher Leiter Chirurgie Notfallzentrum und Zentrales Impfzentrum, Universitätsklinikum Freiburg
                [3 ]Leitender Klinik-Apotheker, Universitätsklinikum Freiburg
                [4 ]Department Innere Medizin, Medizinische Intensivtherapie, Universitätsklinikum Freiburg
                [5 ]Leitender Ärztlicher Direktor, Universitätsklinikum Freiburg
                [6 ]Leitender Betriebsarzt, Universitätsklinikum Freiburg
                Author notes
                Korrespondenzadresse PD Dr. med. Johannes Kalbhenn Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Freiburg Hugstetter Straße 5579106 Freiburg im BreisgauDeutschland+49/7 61/27 02 31 21+49/7 61/27 02 34 00 Johannes.kalbhenn@ 123456uniklinik-freiburg.de
                Author information
                http://orcid.org/0000-0001-7551-5082
                Article
                10.1055/a-1520-2127
                8378907
                34243217
                adc7f13c-e39b-4156-bae6-93f8c1432abb
                The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

                This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited.

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                covid-19,impfung,sars-cov-2,nebenwirkung,arbeitsunfähigkeit,personalplanung,vaccination,sars-cov2,side effects,incapacity for work,personnel planning

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