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Zeile 227: − *Evert K Dienemann T Brochhausen C et al. Autopsy findings after long-term treatment of COVID-19 patients with microbiological correlation. Virchows Arch. 2021; 479: 97-108+ − *Fitzek A Schadler J Dietz E et al. Prospective postmortem evaluation of 735 consecutive SARS-CoV-2-associated death cases. Sci Rep. 2021; 11: 19342 − *Gagiannis D Umathum VG Bloch W et al. Antemortem vs Postmortem Histopathologic and Ultrastructural Findings in Paired Transbronchial Biopsy Specimens and Lung Autopsy Samples From Three Patients With Confirmed SARS-CoV-2. Am J Clin Pathol. 2021; − *Hirschbuhl K Dintner S Beer M et al. Viral mapping in COVID-19 deceased in the Augsburg autopsy series of the first wave: A multiorgan and multimethodological approach. PLoS One. 2021; 16e0254872 − *Schaller T Hirschbuhl K Burkhardt K et al. Postmortem Examination of Patients With COVID-19. JAMA. 2020; 323: 2518-2520 − *Wong DWL Klinkhammer BM Djudjaj S et al. Multisystemic Cellular Tropism of SARS-CoV-2 in Autopsies of COVID-19 Patients. Cells. 2021; 10 − *Hooper JE Padera RF Dolhnikoff M et al. A Postmortem Portrait of the Coronavirus Disease 2019 (COVID-19) Pandemic: A Large Multi-institutional Autopsy Survey Study. Arch Pathol Lab Med. 2021; 145: 529-535 − *Fortarezza F Pezzuto F Hofman P et al. COVID-19 Pulmonary Pathology: The Experience of European Pulmonary Pathologists throughout the First Two Waves of the Pandemic. Diagnostics. 2022; 12: 95 − *von Stillfried S Bulow RD Rohrig R Knuchel-Clarke R Boor P DeRegCovid Autopsy registry can facilitate COVID-19 research. EMBO Mol Med. 2020; 12: e12885 − *Haberecker M Schwarz EI Steiger P et al. Autopsy-Based Pulmonary and Vascular Pathology: Pulmonary Endotheliitis and Multi-Organ Involvement in COVID-19 Associated Deaths. Respiration. 2021; : 1-11 − *Edler C Schroder AS Aepfelbacher M et al. Dying with SARS-CoV-2 infection-an autopsy study of the first consecutive 80 cases in Hamburg, Germany. Int J Legal Med. 2020; 134: 1275-1284 − *Satturwar S Fowkes M Farver C et al. Postmortem Findings Associated With SARS-CoV-2: Systematic Review and Meta-analysis. Am J Surg Pathol. 2021; 45: 587-603 − *Calabrese F Pezzuto F Fortarezza F et al. Pulmonary pathology and COVID-19: lessons from autopsy. The experience of European Pulmonary Pathologists. Virchows Arch. 2020; 477: 359-372 − *Wichmann D Sperhake JP Lutgehetmann M et al. Autopsy Findings and Venous Thromboembolism in Patients With COVID-19: A Prospective Cohort Study. Ann Intern Med. 2020; 173: 268-277 − *Kula BE Clancy CJ Hong Nguyen M Schwartz IS Invasive mould disease in fatal COVID-19: a systematic review of autopsies. Lancet Microbe. 2021; 2 (e405-e14) − *Ledford H. Autopsy slowdown hinders quest to determine how coronavirus kills. 7 May 2020. https://www.nature.com/articles/d41586-020-01355-z. (Accessed 1 December 2021).
Pathologie-Konferenz (Querdenkenbewegung) (Quelltext anzeigen)
Version vom 9. März 2026, 17:18 Uhr
, Gestern um 17:18→Literatur zum Thema COVID-19 Krankheit und pathologische Befunde / Studien
Datei:Arne Burkhardt Spike Spermien.jpg|Unter Berufung auf Arne Burkhardt: absurde Erzählung bei twitter/X, dass Impfungen zu männlicher Sterilität führen würden. Mit Stand von 2024 wurden mehr als 14 Milliarden Impfdosen verimpft, ohne dass eine Sterilität bei Männern zu beobachten ist
Datei:Arne Burkhardt Spike Spermien.jpg|Unter Berufung auf Arne Burkhardt: absurde Erzählung bei twitter/X, dass Impfungen zu männlicher Sterilität führen würden. Mit Stand von 2024 wurden mehr als 14 Milliarden Impfdosen verimpft, ohne dass eine Sterilität bei Männern zu beobachten ist
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==Literatur==
*Adam Achs, Tatiana Sedlackova, Lukas Predajna, Jaroslav Budis, Maria Bartosova, Vladimir Zelnik, Diana Rusnakova, Martina Melichercikova, Marta Miklosova, Veronika Gencurova, Barbora Cernakova, Tomas Szemes, Boris Klempa, Juraj Kopacek & Silvia Pastorekova: ''Systematic analysis of COVID-19 mRNA vaccines using four orthogonal approaches demonstrates no excessive DNA impurities'', npj Vaccines volume 10, Article number: 259 (13. Dezember 2025)<br>''Abstract - Despite substantial evidence for benefits of vaccination in mitigating the COVID-19 pandemic, the use of mRNA vaccines faces skepticism built on coincidental health events occurring after vaccination without proven causality. One of the claims regarding excessive amounts of residual DNA from the vaccine manufacturing process has arisen from misinterpretation of improperly conducted analyses. Here, we assessed the quantity, quality and identity of residual DNA in mRNA vaccines based on thoroughly performed and properly interpreted orthogonal methods, including qPCR, fluorometry, capillary electrophoresis and short-read DNA sequencing. Our results show that the quantity of residual DNA in all 15 analysed batches of Comirnaty and Spikevax vaccines is below approved limits and that it consists of small fragments originating from the template used to transcribe mRNA during vaccine production. We demonstrate that reliable mRNA vaccine analysis for DNA impurities requires rigorous application of well-controlled methods that minimise mutual interference of vaccine components.''
...''
Given that the quality and purity of the active substance, i.e. mRNA, is thoroughly controlled during the manufacturing process, and that the final vaccine formulation is complex, manufacturers do not recommend quantifying residual DNA in the final vaccine product due to measurement interference with the vaccine’s basic components (mRNA and LNPs). They also explicitly do not recommend quantifying residual DNA in vaccines after their expiration date, as well as in cases of improper storage and handling3. It is important to note that residual DNA is tested for every manufactured batch at the mRNA production stage, and that there is no mechanism for additional residual DNA to be introduced after mRNA production or change/increase after vaccine expiry.
Despite these facts, the public domain contains reports on the evaluation of residual DNA in final COVID-19 mRNA vaccine products. According to the results of analyses published in the form of peer-reviewed scientific publications in reputable scientific journals and the statements by regulatory and control authorities, the amount of residual DNA does not exceed the established limit of 10 ng per vaccine dose2,4,8,9,10.
On the other hand, there are several reports that claim highly excessive amounts of residual DNA based on technically inconsistent analyses, and present unsubstantiated suppositions related to its impact on human health11,12,13,14. Such ideas spread via social media and statements of public figures, where they receive considerable attention. This fuels public concerns and undermines trust in scientific and medical evidence. It then leads to increased doubts about the importance of vaccination and ultimately endangers public health.
In Slovakia, a major controversy was recently sparked by an article published in the HSOA Journal of Angiology & Vascular Surgery15. The paper, accepted just 11 days after the manuscript submission, describes an analysis of expired batches of the Comirnaty and Spikevax vaccines using the multiplex qPCR method including mRNA reverse transcription, which exhibited serious technical deficiencies as detailed further in the Discussion. Based on data misinterpretation, the authors erroneously concluded that the vaccines contain “significant amounts of residual DNA” in “nanogram to microgram quantities of expression vector dsDNA per dose”. They also present alarming hypotheses about the effects of residual DNA on the human body, referencing only three publications of the co-author (in addition to two EMA and FDA Guidelines and three GenBank entries)15.
In order to clarify this issue, we aimed to provide an assessment of the quantity, quality and identity of residual DNA in mRNA vaccines that aligns with the standard, rigorous approaches accepted in the scientific community. To meet this aim, we utilised several orthogonal methods with thorough application of controls, biological and technical replicates, and respecting established scientific knowledge about the molecular characteristics of mRNA vaccine components, with an emphasis on minimising their mutual interference. The workflow of the accomplished approaches fulfilling these criteria is illustrated in Fig. 1.
Overall, we analysed the presence of DNA in the vaccines using 8 different combinations of primers and targets. The outputs from these qPCR tests of all analysed vaccine batches are summarised in Fig. 3 and individually shown in Figs. S3–S5. Results were initially expressed as the number of copies per µl of sample, and subsequently calculated to the number of copies per vaccine dose. Since regulatory standards are established as the total amount of DNA in nanograms per vaccine dose, and not in copy numbers, we then converted this copy number data to nanograms of DNA per dose, based on the molecular weight of the template plasmid DNA. The results obtained by the analysis of all vaccine batches using all qPCR assays demonstrated no presence of excessive residual DNA.
Results of the fluorometric assessment of residual DNA isolated from all vaccine batches by two alternative methods are summarised in Fig. 5. In accordance with the qPCR analysis, quantity of residual DNA was in all cases below the limits set by the regulatory guidelines. The differences between the data obtained from each extraction method reflect variations in extraction yields between the two methods. Moreover, different vaccine vials were used for each extraction method.
Fig. 8: Fragment analysis of Comirnaty and Spikevax vaccines using the DNF-464 HS Large Fragment Kit 50 kb.
Fig. 8: Fragment analysis of Comirnaty and Spikevax vaccines using the DNF-464 HS Large Fragment Kit 50 kb.
Representative electro-pherograms of all analysed batches of (A) Comirnaty and (B) Spikevax vaccines show no presence of excessive quantity of residual DNA. Some batches exhibited faint peaks around 60 and/or 300 bp. System-generated quantitative data from the entire electro-pherogram (including noise) as well as biological and technical replicates are shown in the Supplementary information. The control sample included physiological saline treated by Triton X-100 and RNase A alongside the vaccine samples. Unexpired vaccine batches are marked with an asterisk.
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Capillary electrophoresis also allows for evaluation of RNA integrity in vaccines by directly detecting the size and relative abundance of RNA fragments using a dedicated RNA kit. The mRNA degradation process can occur during incorrect storage, transport, or handling, especially when the vaccine’s expiration date has passed. We decided to perform the analysis of RNA integrity because most of the available vaccine batches were past their expiration date for an extended period. For this purpose, we used vaccine samples treated by Triton X-100 as described in ‘Methods’.
Results of the mRNA integrity evaluation of all analysed vaccine batches are graphically displayed in Fig. 9. Out of the 15 analysed vaccine samples, all 6 Spikevax batches and 1 Comirnaty batch showed average mRNA integrity below 50%. This was not surprising given their expiration date. Noteworthy, the batches with decreased mRNA integrity exhibited turbid appearance, in contrast to the clear appearance of non-expired batches (Fig. 10). Taking together the results of the fluorometry and the results of capillary electrophoresis, it is possible to conclude that the analysed vaccines contained sufficient amounts of mRNA, but its integrity was not properly preserved particularly in the expired batches.
Overall, our findings provide independent confirmation of the regulatory compliance of mRNA vaccines with respect to residual DNA content. In addition to supporting ongoing public vaccination programs, this study also demonstrates the value of transparent, science-based investigations in addressing misinformation and strengthening vaccine confidence. Future research may explore the dynamics of DNA degradation over extended storage or evaluate alternative purification technologies, though our findings indicate no current need for concern under existing manufacturing practices.
==Literatur zum Thema COVID-19 Krankheit und pathologische Befunde / Studien==
==Literatur zum Thema COVID-19 Krankheit und pathologische Befunde / Studien==
*Bosmuller H Traxler S Bitzer M et al. The evolution of pulmonary pathology in fatal COVID-19 disease: an autopsy study with clinical correlation. Virchows Arch. 2020; 477: 349-357
*Bosmuller H Traxler S Bitzer M et al. The evolution of pulmonary pathology in fatal COVID-19 disease: an autopsy study with clinical correlation. Virchows Arch. 2020; 477: 349-357
*Elezkurtaj S Greuel S Ihlow J et al. Causes of death and comorbidities in hospitalized patients with COVID-19. Sci Rep. 2021; 114263
*Elezkurtaj S Greuel S Ihlow J et al. Causes of death and comorbidities in hospitalized patients with COVID-19. Sci Rep. 2021; 114263
==Literatur zum Thema Mikroskopie und Sub-Visible Particles==
==Literatur zum Thema Mikroskopie und Sub-Visible Particles==
*Grant E. Frahm,Alex W. T. Pochopsky,Tessa M. Clarke,Michael J. W. Johnston : Evaluation of Microflow Digital Imaging Particle Analysis for Sub-Visible Particles Formulated with an Opaque Vaccine Adjuvant, PLOS one 29.2.2016
*Grant E. Frahm,Alex W. T. Pochopsky,Tessa M. Clarke,Michael J. W. Johnston : Evaluation of Microflow Digital Imaging Particle Analysis for Sub-Visible Particles Formulated with an Opaque Vaccine Adjuvant, PLOS one 29.2.2016