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EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-321594


Immune-mediated inflammatory diseases (IMIDs) of the joints, gut and skin are treated with inhibitors of inflammatory cytokines. These cytokines are involved in the pathogenesis of coronavirus disease 2019 (COVID-19). Investigating anti-SARS-CoV-2 antibody responses in IMIDs we observed a significantly reduced incidence of SARS-CoV-2 infection in IMID patients treated with cytokine inhibitors compared to patients receiving no such inhibitors and two healthy control populations, despite similar social exposure. Hence, cytokine inhibitors seem to at least partially protect from SARS-CoV-2 infection.Authors David Simon and Koray Tascilar contributed equally to this work. Authors Markus F. Neurath and Georg Schett share senior authorship.

EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-314910


Background: Children are affected rather mildly by the acute phase of COVID-19, but predominantly in children and youths, the potentially severe and life threatening pediatric multiorgan immune syndrome (PMIS) occurs later on. To identify children at risk early on, we searched for antibodies against SARS-CoV-2 and searched for early and mild symptoms of PMIS in those with high levels of antibodies. Methods: In a cross-sectional design, children aged 1-17 were recruited through primary care pediatricians for the study (a), if they had an appointment for a regular health check-up or (b), or if parents and children volunteered to participate in the study. Two antibody tests were performed in parallel and children with antibody levels >97th percentile (in the commercially available test) were screened for signs and symptoms of PMIS and SARS-CoV-2 neutralization tests were performed. Results: We identified antibodies against SARS-CoV-2 in 162 of 2832 eligible children (5.7%) between June and July 2020 in three, in part strongly affected regions of Bavaria. Approximately 60% of antibody positive children showed high levels of antibodies. In those who participated in the follow up screening, 30% showed some mild and minor symptoms similar to Kawasaki disease and in three children, cardiac and neuropsychological symptoms were identified. Symptoms correlated with high levels of non-neutralizing and concomitantly low levels of neutralizing antibodies and lower neutralizing capacity. Conclusions: Children exposed to SARS-CoV-2 should be screened for antibodies and those children with positive antibody responses should undergo a stepwise assessment for late COVID-19 effects.

EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-295758


In this position paper, a large group of interdisciplinary experts outlines response strategies against the spread of SARS-CoV-2 in the winter of 2021/2022 in Germany. We review the current state of the COVID-19 pandemic, from incidence and vaccination efficacy to hospital capacity. Building on this situation assessment, we illustrate various possible scenarios for the winter, and detail the mechanisms and effectiveness of the non-pharmaceutical interventions, vaccination, and booster. With this assessment, we want to provide orientation for decision makers about the progress and mitigation of COVID-19.

EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-292311


Background: The Corona-Vakzin-Konsortium project (CoVaKo) analyses the efficacy and safety of COVID-19 vaccines in a real-world setting and breakthrough infections in Bavaria, Germany. A subproject of CoVaKo aims to identify adverse events of the COVID-19 vaccine and to compare these to adverse events of other vaccines in an online survey. A prior feasibility study was conducted to test study materials for comprehensibility, visual design and motivation to participate and secondly, to test practical implementation and realization in primary care practices and vaccination centres. Methods: : A mixed-methods design was used. Three focus groups with general population participants were performed to evaluate the study materials and survey. Second, a test-roll-out was conducted in vaccination centres and primary care practices, which involved implementation and quantitative evaluation of the online survey. Third, interviews were conducted with participating general practitioners and heads of vaccination centres four weeks after the test-roll-out. Results: : Parts of the study information and registration form proved incomprehensible in the recruitment material and/or online survey. For example, headings were misleading since the COVID-19 vaccination was overemphasized in the title as compared to other vaccinations. Participants requested more information on the procedure and completion time. In 31 days, 2199 participants who received either a COVID-19 vaccination (99 %) or at least one of the control vaccinations (1 %) registered for the study. Participants (strongly) agreed that the registration process was easy to understand, that all relevant information was provided, the completion time was reasonable and technical framework manageable. Physicians and heads of the vaccination centres perceived the study as easy to integrate into their workflow and most of them were willing to participate in the main study. Conclusions: : Our study indicated that capturing adverse events after vaccinations with an online survey is feasible. Testing of materials and surveys provided valuable improvements. Participation of health professionals is important to ensure practicality of the procedures. Flexible adaptation of the study organization to changing structures and requirements is necessary for a successful implementation, especially due to dynamic changes in COVID-19 vaccination strategies. Trial registration: The trial was retrospectively registered at “Deutsches Register Klinischer Studien” (DRKS-ID: DRKS00025881) on Oct 14, 2021.

EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-291796


Background: Due to safety signals after vaccination with COVID-19 vector vaccines, several states recommended to complete the primary immunization series in individuals having received one dose of ChAdOx1 (AstraZeneca) with an mRNA vaccine. However, data on safety and reactogenicity of this heterologous regimen are still scarce. The aim of this study was therefore to compare the reactogenicity and the frequency of medical consultations after boost vaccination in a heterologous regimen with ChAdOx1 and mRNA-vaccines (BNT162b2, BioNTech/Pfizer or mRNA-1273, Moderna) to homologous regimens with ChAdOx1 or mRNA-vaccines, respectively.Methods: In an observational cohort study reactogenicity and safety were assessed 14 to 19 days (short-term) and 40 to 56 days (long-term) after the boost vaccination using web-based surveys. In the short-term survey solicited and unsolicited reactions were assessed. The long-term survey focussed on health problems leading to medical consultation after the vaccination, including those that were not suspected to be vaccine-related.Findings: In total, 9146 participants completed at least one of the surveys (ChAdOx1/ChAdOx1: n = 552, ChAdOx1/mRNA: n = 2382, mRNA/mRNA: n = 6212). In the short-term survey, 86 % with ChAdOx1/mRNA regimen reported at least one reaction, in the ChAdOx1/ChAdOx1 and mRNA/mRNA cohorts 58 % and 76 %, respectively (age and sex adjusted p < 0·0001). In the long-term survey, comparable proportions of individuals reported medical consultation (ChAdOx1/ChAdOx1 vs. ChAdOx1/mRNA vs. mRNA/mRNA: 15 % vs. 18 % vs. 16 %, age and sex adjusted p = 0·398). Female gender was associated with a higher reactogenicity and more medical consultations. Younger age was associated with a higher reactogenicity, whereas elderly people reported more medical consultations.Interpretation: Although the short-term reactogenicity with the heterologous regimen was higher than with the homologous regimes, other factors such as higher efficacy and limited resources during the pandemic may prevail in recommending specific regimens.Funding: Bavarian Ministry of Science and Art.Declaration of Interest: LW, NL own(ed) stocks of BioNTech, the investments were made before being involved in the project. The other authors declare not to have any conflict of interests.Ethical Approval: The Ethics Committee of the Friedrich Alexander University approved the study (47_21 B, 01.03.2021 and 161_21 B, 12.05.2021). All participants consented to participate.