a1) 03/2020 "Although we expect to file BLAs (Biologics License Applications) for our mRNA-based product candidates in the United States and the European Union, mRNA therapies have been classified as gene therapies".
SEC Filing | BioNTech. (2020, March 31). https://investors.biontech.de/financials-filings/sec-filings/
https://investors.biontech.de/static-files/ab71fa6c-64dd-43e4-bf0f-bbecd5a0694d
a2) 10/2020 "Currently, mRNA is classified as a gene therapy product by the FDA."
a3) 11/2020 "The shortening of the usual observation periods increases the risk of side effects remaining undetected during the clinical trial. The accelerated test phases therefore also affect the health policy responsibility of state provision. A further problem arises from the fact that almost all vaccines are currently tested on younger adults and not on older people with a significantly higher risk of severe courses of the disease.
On the Development of Genetic Vaccines Against SARS-CoV-2 - Technological Approaches and Clinical Risks as a Result of Shortened Test Phases | Der Arzneimittelbrief. (2020, November 1).
https://der-arzneimittelbrief.com/artikel/2020/zur-entwicklung-genetischer-impfstoffe-gegen-sars-cov-2-technologische-ansaetze-sowie-klinische-risiken-als-folge-verkuerzter-pruefphasen
a4) 08/2025 US package insert from Comirnaty (BioNTech) (August 2025 version): "COMIRNATY has not been evaluated for its potential to cause carcinogenicity, genotoxicity, or impairment of male fertility."
Research, C. for B. E. and. (2025). COMIRNATY. FDA. https://www.fda.gov/vaccines-blood-biologics/comirnaty
b1) 02/2021 "The changes in the development process were appropriately summarized. Two drug processes were used throughout the development history:
Process 1 (clinical trial material) and Process 2 (commercial process).
Details of the process differences, the rationale for the changes and the results of a comparability study are provided.
Assessment report Comirnaty
Common name: COVID-19 mRNA vaccine (nucleoside-modified)
Procedure No. EMEA/H/C/005735/0000
https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf
b2) 05/2024 "In the case of the COVID-19 mRNA vaccine Comirnaty® from BioNTech/Pfizer (BNT162b2) (Mainz, Germany), these templates are produced by plasmids derived from bacterial cultures [1]. Comirnaty® therefore has a special property: DNA contamination is possible due to the manufacturing process; this can be relevant for all genetically engineered drugs, but is otherwise rarely a problem [2]."
König, B., & Kirchner, J. O. (2024). Methodological Considerations Regarding the Quantification of DNA Impurities in the COVID-19 mRNA Vaccine Comirnaty®. Methods and Protocols, 7(3), Article 3. https://doi.org/10.3390/mps7030041
https://pubmed.ncbi.nlm.nih.gov/38804335/
c1) 09/2022 Excerpts from an interview of the former President of the PEI, Prof. Dr. Klaus Cichutek, with the Berliner Zeitung:
"The Paul-Ehrlich-Institut or another Official Medicines Control Laboratory (OMCL) in Europe itself experimentally tests samples of each batch of COVID-19 vaccines and checks the manufacturer's batch test results.
The respective manufacturer sends randomly selected vaccine samples from the current production batch to the experimentally testing OMCL laboratory, for example the Paul-Ehrlich-Institut...
In addition, a final batch test is also carried out by the company...
The Paul-Ehrlich-Institut carries out the test in accordance with the "Official Control Authoritiy Batch Release (OCABR)" guideline for mRNA vaccines. This means: visual inspection, identity check, potency test in the laboratory (potency assay) (mRNA concentration/mRNA encapsulation), integrity (intact mRNA)...
Berliner Zeitung: Does the PEI check whether residual DNA is present in the released batches? The professors say that DNA, unlike RNA, should not be present.
Prof. Klaus Cichutek: This is a test that is carried out by the manufacturers.
Maier, M. (2022, September 2). Paul-Ehrlich-Institut: President answers questions on vaccination side effects. Berliner Zeitung. https://www.berliner-zeitung.de/wirtschaft-verantwortung/paul-ehrlich-institut-praesident-beantwortet-fragen-zu-impf-nebenwirkungen-li.262815
c2) 11/2024 "Overall, this work confirms that a significant amount of vaccine DNA was present in the tested vaccine batches, above the recommended levels (Rapporteur Rolling Review critical appraisal report, 2020; Klinman et al., 2010). Previous results need to be confirmed on a larger scale, which is technically very easy to do by analyzing a large number of vaccine vials from different batches in different laboratories worldwide"
Raoult, D. (2024). Confirmation of the presence of vaccine DNA in the Pfizer anti-COVID-19 vaccine. https://hal.science/hal-04778576
c3) 12/2024 "We further analyzed the RNA and DNA content of these vials and found large amounts of DNA in all batches after RNase A digestion with concentrations between 32.7 ng and 43.4 ng per clinical dose. This is well above the maximum permissible concentration of 10 ng per clinical dose set by international regulatory authorities.
Kämmerer U, Schulz V, Steger K. BioNTech RNA-Based COVID-19 Injections Contain Large Amounts Of Residual DNA Including An SV40 Promoter/Enhancer Sequence. Science, Public Health Policy and the Law. 2024 Dec 03; v5.2019-2024
https://publichealthpolicyjournal.com/biontech-rna-based-covid-19-injections-contain-large-amounts-of-residual-dna-including-an-sv40-promoter-enhancer-sequence/
c4) 12/2024 "However, these licensed vaccines contain residual DNA at levels exceeding 10 ng per dose. Our results suggest that rigorous and transparent monitoring of DNA contamination may help to increase public confidence in mRNA vaccines...
The potential health risk from small residual DNA fragments is currently unknown. Theoretically, DNA fragments can be directly integrated into the host genome, increasing the risk of insertional mutagenesis. Alternatively, DNA fragments may contain oncogenes that can trigger carcinogenesis when they enter host cells"
Wang, T. J., Kim, A., & Kim, K. (2024). A rapid detection method of replication-competent plasmid DNA from COVID-19 mRNA vaccines for quality control. Journal of High School Science, 8(4), 427-439. https://doi.org/10.64336/001c.127890
c5) 08/2025 "These data demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in the modRNA COVID-19 products tested...
Our findings reinforce existing concerns about vaccine safety and call into question the relevance of guidelines designed prior to the introduction of efficient transfection with LNPs. Despite some obvious limitations, we urge that our work be replicated under forensic conditions and that guidelines be revised to account for high-efficiency DNA transfection and cumulative dosing.
Memory, D. J., Rose, J., & McKernan, K. (2025). Quantification of residual plasmid DNA and SV40 promoter-enhancer sequences in Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada. Autoimmunity, 58(1), 2551517. https://doi.org/10.1080/08916934.2025.2551517
https://www.tandfonline.com/doi/full/10.1080/08916934.2025.2551517
a1) 11/2024 Download the suspected case reports on the website of the Paul-Ehrlich-Institut:
b1) 02/2024 "Based on early data from clinical trials, these vaccines were considered safe and effective for all populations. However, the latest data raises serious concerns about the safety and efficacy of these vaccines. Here we address some of the safety and efficacy concerns identified to date"
Igyártó, B. Z., & Qin, Z. (2024). The mRNA-LNP vaccines-The good, the bad and the ugly? Frontiers in Immunology, 15, 1336906.
https://doi.org/10.3389/fimmu.2024.1336906 https://pubmed.ncbi.nlm.nih.gov/38390323/
b2) 08/2025 "Compelling evidence shows that SARS-CoV-2 and SARS-CoV-2-modified mRNA biologics/vaccines are products of gain-of-function (GOF) research, with genomic features and vaccine outcomes indicative of deliberate manipulation rather than natural evolution. Far from being harmless, these vaccines have caused profound damage by disrupting nearly every system of the human body and contributing to unprecedented morbidity and mortality. From autoimmune diseases and cardiovascular catastrophes to pregnancy complications and aggressive cancers, the pattern of systemic toxicity cannot be dismissed as coincidence"
Zywiec, Andrew & Mavrakakis, Irene & McCullough, Peter & Hulscher, Nicolas & Kheriaty, Aaron & Marik, Paul & Thorp, James & Villa, Marivic & Rixey, Charles & Macie, Lt & Hudson, Abraxas. (2025). COVID-19 Injections: Harms and Damages, a Non-Exhaustive Conclusion. 30. 80-89.
https://www.researchgate.net/publication/395021810_COVID-19_Injections_Harms_and_Damages_a_Non-Exhaustive_Conclusion
c1) 09/2022 A publication from 2022 found that between 230 (age 80+) and 93,000 (age 18-29) people need to be vaccinated to prevent one Covid-related death:
"In the non-elderly population, the "number of people to treat" to prevent a single death is several thousand"
Malhotra, A. (2022). Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based medicine-Part 1. Journal of Metabolic Health, 5(1), Article 1. https://doi.org/10.4102/jir.v5i1.71
https://journalofmetabolichealth.org/index.php/jmh/article/view/71
c2) 01/2023 The NHS (National Health Service) in the UK calculated in spring 2023 that between 300 (age group 70+ years) and 34,200 (age group 5-11 years) basic immunizations are necessary to avoid a single Covid-related hospitalization. To avoid severe hospitalization ("severe hospitalization"), between 2,500 (age 70+) and 112,200 (age 5-11) basic vaccinations were necessary, depending on the age group.
Appendix 1: Estimation of number needed to vaccinate to prevent a COVID-19 hospitalization for primary vaccination, booster vaccination (3rd dose), autumn 2022 and spring 2023 booster for those newly in a risk group. (n.d.). GOV.UK. Retrieved August 24, 2025, from https://www.gov.uk/government/publications/covid-19-vaccination-programme-for-2023-jcvi-interim-advice-8-november-2022/appendix-1-estimation-of-number-needed-to-vaccinate-to-prevent-a-covid-19-hospitalisation-for-primary-vaccination-booster-vaccination-3rd-dose-au
d1) 12/2022 "To prevent one COVID-19 hospitalization over a 6-month period, an estimated 31,207 to 42,836 young adults aged 18 to 29 years will need to receive a third mRNA vaccination. Booster vaccinations for young adults are expected to cause net harm: for each prevented COVID-19 hospitalization, we expect at least 18.5 serious adverse events from mRNA vaccines, including 1.5 to 4.6 cases of booster-associated myopericarditis in men (usually requiring hospitalization). We also expect 1,430 to 4,626 cases of grade ≥3 reactogenicity affecting daily activities (but usually not requiring hospitalization)."
Bardosh, K., Krug, A., Jamrozik, E., Lemmens, T., Keshavjee, S., Prasad, V., Makary, M. A., Baral, S., & Høeg, T. B. (2024). COVID-19 vaccine boosters for young adults: A risk benefit assessment and ethical analysis of mandate policies at universities. Journal of Medical Ethics, 50(2), 126-138. https://doi.org/10.1136/jme-2022-108449
https://pubmed.ncbi.nlm.nih.gov/36600579/
a1) 03/2022 "In contrast to disrupted germinal centers (GCs) in lymph nodes during infection, mRNA vaccination stimulates robust GCs containing vaccine mRNA and spike antigen in some cases up to 8 weeks after vaccination"
Röltgen, K., Nielsen, S. C. A., Silva, O., Younes, S. F., Zaslavsky, M., Costales, C., Yang, F., Wirz, O. F., Solis, D., Hoh, R. A., Wang, A., Arunachalam, P. S., Colburg, D., Zhao, S., Haraguchi, E., Lee, A. S., Shah, M. M., Manohar, M., Chang, I., ... Boyd, S. D. (2022). Immune imprinting, breadth of variant recognition, and germinal center response in human SARS-CoV-2 infection and vaccination. Cell, 185(6), 1025-1040.e14. https://doi.org/10.1016/j.cell.2022.01.018
https://pubmed.ncbi.nlm.nih.gov/35148837/
a2) 08/2023 187 days:
"The specific PP spike fragment was found in 50% of the biological samples analyzed, and its presence was independent of SARS-CoV-2 IgG antibody titer. The minimum and maximum time at which PP spike was detected after vaccination was 69 and 187 days, respectively"
Brogna, C., Cristoni, S., Marino, G., Montano, L., Viduto, V., Fabrowski, M., Lettieri, G., & Piscopo, M. (2023). Detection of recombinant spike protein in the blood of individuals vaccinated against SARS-CoV-2: Possible molecular mechanisms. Proteomics. Clinical Applications, 17(6), e2300048. https://doi.org/10.1002/prca.202300048
https://pubmed.ncbi.nlm.nih.gov/37650258/
a3) 04/2024 "Despite their worldwide use, very little is known about how nucleoside modifications in mRNA sequences affect their degradation, transcription and protein synthesis...
In fact, clinical studies now report that modified SARS-CoV-2 mRNA routinely persists for up to a month after injection and can be detected in cardiac and skeletal muscle at sites of inflammation and fibrosis, while the recombinant spike protein can remain in the blood for just over half a year."
Boros, L. G., Kyriakopoulos, A. M., Brogna, C., Piscopo, M., McCullough, P. A., & Seneff, S. (2024). Long-lasting, biochemically modified mRNA, and its frameshifted recombinant spike proteins in human tissues and circulation after COVID-19 vaccination. Pharmacology Research & Perspectives, 12(3), e1218. https://doi.org/10.1002/prp2.1218
https://pubmed.ncbi.nlm.nih.gov/38867495/
a4) 02/2025 709 days:
"Detectable S1 was found in the plasma of 348 participants between 26 and 709 days after last known exposure"
Bhattacharjee, B., Lu, P., Monteiro, V. S., Tabachnikova, A., Wang, K., Hooper, W. B., Bastos, V., Greene, K., Sawano, M., Guirgis, C., Tzeng, T. J., Warner, F., Baevova, P., Kamath, K., Reifert, J., Hertz, D., Dressen, B., Tabacof, L., Wood, J., ... Iwasaki, A. (2025). Immunological and Antigenic Signatures Associated with Chronic Illnesses after COVID-19 Vaccination (p. 2025.02.18.25322379). medRxiv. https://doi.org/10.1101/2025.02.18.25322379
https://www.medrxiv.org/content/10.1101/2025.02.18.25322379v2
a5) 04/2025 17 months:
"In 43.8% of vaccinated patients, spike protein expression was detected, which was predominantly localized in the intima of the cerebral arteries, even up to 17 months after vaccination"
Ota, N., Itani, M., Aoki, T., Sakurai, A., Fujisawa, T., Okada, Y., Noda, K., Arakawa, Y., Tokuda, S., & Tanikawa, R. (2025). Expression of SARS-CoV-2 spike protein in cerebral arteries: Implications for hemorrhagic stroke post-mRNA vaccination. Journal of Clinical Neuroscience, 136. https://doi.org/10.1016/j.jocn.2025.111223
https://pubmed.ncbi.nlm.nih.gov/40184822/
a6) 04/2025 245 days: "Flow cytometry detected S1 in non-classical monocytes (NCM: 11/12 patients) and intermediate monocytes (IM: 8/12) up to 245 days after vaccination, with LC-MS confirming S1, S2 and mutant S1 peptides in all vaccine types - in contrast to PASC, where only S1 was detected."
Patterson, B. K., Yogendra ,Ram, Francisco ,Edgar B., Guevara-Coto ,Jose, Long ,Emily, Pise ,Amruta, Osgood ,Eric, Bream ,John, Kreimer ,Mark, Jeffers ,Devon, Beaty ,Christopher, Vander Heide ,Richard, & and Mora-Rodríguez, R. A. (2025). Detection of S1 spike protein in CD16+ monocytes up to 245 days in SARS-CoV-2-negative post-COVID-19 vaccine syndrome (PCVS) individuals. Human Vaccines & Immunotherapeutics, 21(1), 2494934. https://doi.org/10.1080/21645515.2025.2494934
https://pubmed.ncbi.nlm.nih.gov/40358138/
b1) 12/2020 "the incidence of anaphylaxis associated with the Pfizer SARS-CoV-2 mRNA vaccine appears to be about ten times higher than the incidence reported with all previous vaccines, namely about 1 in 100,000 compared to 1 in 1,000,000, the known and stable incidence of anaphylaxis associated with other vaccines"
Castells, M. C., & Phillips, E. J. (2021). Maintaining Safety with SARS-CoV-2 Vaccines. New England Journal of Medicine, 384(7), 643-649. https://doi.org/10.1056/NEJMra2035343
https://pubmed.ncbi.nlm.nih.gov/33378605/
c1) 01/2021 As early as January 2021, the Australian regulatory authority TGA published a report showing that the mRNA of BNT162b2 (BioNTech) is distributed throughout the body (preclinical data).
Nonclinical Evaluation Report
BNT162b2 [mRNA] COVID-19 vaccine (COMIRNATYTM)
Submission No: PM-2020-05461-1-2
Sponsor: Pfizer Australia Pty Ltd
January 2021
https://www.tga.gov.au/sites/default/files/foi-2389-06.pdf
d1) 08/2024 Vaccinated - died
Histo Atlas. (n.d.). Retrieved August 23, 2025, from https://www.histo-atlas.com/
1) 08/2022 "The myocardial damage observed in these vaccinated hearts differs from typical myocarditis and most closely resembles a catecholamine-mediated stress cardiomyopathy (toxic cardiomyopathy). Understanding that these cases are distinct from typical myocarditis and that a cytokine storm has a known feedback loop with catecholamines can help guide screening and treatment"
Gill, J. R., Tashjian, R., & Duncanson, E. (2022). Autopsy Histopathologic Cardiac Findings in 2 Adolescents Following the Second COVID-19 Vaccine Dose. Archives of Pathology & Laboratory Medicine, 146(8), 925-929. https://doi.org/10.5858/arpa.2021-0435-SA
https://pubmed.ncbi.nlm.nih.gov/35157759/
2) 03/2023 "Histology showed patchy interstitial T-lymphocyte infiltration of the myocardium, predominantly of the CD4-positive subset, associated with mild myocyte damage. Overall, the autopsy findings indicated death due to acute arrhythmogenic heart failure. Thus, myocarditis may be a potentially fatal complication following mRNA-based anti-SARS-CoV-2 vaccination"
Schwab, C., Domke, L.M., Hartmann, L. et al. Autopsy-based histopathological characterization of myocarditis after anti-SARS-CoV-2-vaccination. Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02129-5
https://pubmed.ncbi.nlm.nih.gov/36436002/
3) 08/2024 Vaccinated - died
Histo Atlas. (n.d.). Retrieved August 23, 2025, from https://www.histo-atlas.com/
a1) 08/2023 "In this narrative review, we have demonstrated the role of the SARS-CoV-2 spike protein, particularly the S1 subunit, as pathogenic. It is now also evident that spike proteins widely distributed in the body, produced by mRNA and adenovector DNA gene codes, cause a variety of diseases. The underlying pathophysiological and biochemical mechanisms are currently being elucidated. The lipid nanoparticle carriers for the mRNA and Novavax vaccines also have pathological proinflammatory properties."
Parry, P. I., Lefringhausen, A., Turni, C., Neil, C. J., Cosford, R., Hudson, N. J., & Gillespie, J. (2023). "Spikeopathy": COVID-19 Spike Protein Is Pathogenic, from Both Virus and Vaccine mRNA. Biomedicines, 11(8), 2287. https://doi.org/10.3390/biomedicines11082287
https://pubmed.ncbi.nlm.nih.gov/37626783/
b1) 01/2023 "It has been shown that the expression levels of numerous miRNAs change after COVID-19 vaccination. Thus, the altered expression levels of circulating miRNAs could influence the severity of the disease after infection. miRNAs encoded by SARS-CoV-2 can influence the host's immune response. It is likely that the impaired expression of these small molecules may contribute to the onset of other longer-term diseases. Dysregulation of the host miRNA spectrum, which modulates the expression of several genes, can directly or indirectly influence the development of cancer. In fact, several miRNAs can act as oncogenes or tumor suppressor genes. For example, recent studies have shown that miRNA-451 (miR-451), which is downregulated after COVID-19 vaccination, is involved in various physiological and pathological processes in humans"
Stati, G., Amerio, P., Nubile, M., Sancilio, S., Rossi, F., & Di Pietro, R. (2023). Concern about the Effectiveness of mRNA Vaccination Technology and Its Long-Term Safety: Potential Interference on miRNA Machinery. International Journal of Molecular Sciences, 24(2), 1404. https://doi.org/10.3390/ijms24021404
https://pubmed.ncbi.nlm.nih.gov/36674919/
b2) 05/2024 "The SARS-CoV-2 spike protein plays a key role in the invasion of human cells by SARS-CoV-2 by binding to the receptor angiotensin-converting enzyme 2 (ACE2) on the surface of the human host cell. We show here that Spike can alter p53 transcriptional activity in wild-type p53-expressing cancer cells, based on a decrease in p53-responsive reporter activity and a decrease in selected p53 targets such as p21(WAF1) or TRAIL death receptor DR5 at the protein level"
Zhang, S., & El-Deiry, W. S. (2024). Transfected SARS-CoV-2 spike DNA for mammalian cell expression inhibits p53 activation of p21(WAF1), TRAIL Death Receptor DR5 and MDM2 proteins in cancer cells and increases cancer cell viability after chemotherapy exposure. Oncotarget, 15, 275-284. https://doi.org/10.18632/oncotarget.28582
https://pubmed.ncbi.nlm.nih.gov/38709242/
b3) 05/2024 "In addition, the mRNA vaccines were found to inhibit important immunological signaling pathways, thereby impairing early interferon signaling. In the context of COVID-19 vaccination, this inhibition ensures adequate spike protein synthesis and reduced immune activation. There is evidence that the addition of 100% N1-methyl-pseudouridine (m1Ψ) to the mRNA vaccine stimulated cancer growth and metastasis in a melanoma model, while unmodified mRNA vaccines produced opposite results, suggesting that COVID-19 mRNA vaccines may promote cancer development"
Rubio-Casillas, A., Cowley, D., Raszek, M., Uversky, V. N., & Redwan, E. M. (2024). Review: N1-methyl-pseudouridine (m1Ψ): Friend or foe of cancer? International Journal of Biological Macromolecules, 267, 131427. https://doi.org/10.1016/j.ijbiomac.2024.131427
https://pubmed.ncbi.nlm.nih.gov/38583833/
b4) 09/2025 "Overall cancer risks were assessed using multivariable Cox regression models, and data were expressed as hazard ratios (HRs) and 95% confidence intervals (CIs). The HRs for thyroid cancer (HR, 1.351; 95% CI, 1.206-1.514), gastric cancer (HR, 1.335; 95% CI, 1.130-1.576), colorectal cancer (HR, 1.283; 95% CI, 1.122-1.468), lung cancer (HR, 1.533; 95% CI, 1.254-1.874), breast cancer (HR, 1.197; 95% CI, 1.069-1.340) and prostate cancer (HR, 1.687; 95% CI, 1.348-2.111) increased significantly one year after vaccination."
Kim, H. J., Kim, M.-H., Choi, M. G., & Chun, E. M. (2025). 1-year risks of cancers associated with COVID-19 vaccination: A large population-based cohort study in South Korea. Biomarker Research, 13(1), 114. https://doi.org/10.1186/s40364-025-00831-w
https://pubmed.ncbi.nlm.nih.gov/41013858/
c1) 11/2024 "Download the suspected case reports on the website of the Paul-Ehrlich-Institut:
https://www.pei.de/SharedDocs/Downloads/DE/newsroom/dossiers/rohdaten-sicherheitsberichte/download-xls-uaw-daten-2020-12-27-bis-2023-12-31.html?nn=169638&cms_dlConfirm=true
https://www.pei.de/SharedDocs/Downloads/DE/newsroom/dossiers/rohdaten-sicherheitsberichte/download-xls-uaw-daten-2024-01-01-bis-2024-06-30.html?nn=169638&cms_dlConfirm=true
d1) 08/2025 "Cumulative reports showed a steady increase in both carditis diseases (myocarditis & pericarditis), with a sharp increase in 2021 following the introduction of COVID-19 vaccines. For both diseases, the COVID-19 mRNA vaccine accounted for the largest proportion of reports, with 76.16% for myocarditis and 88.15% for pericarditis.
Cho, J., Jo, H., Park, J., Oh, J., Kim, H., Kim, S., Lee, H., Jo, Y., Jeong, J., Lee, S., Woo, H. G., Smith, L., López Sánchez, G. F., Rhee, S. Y., Yang, J. M., & Yon, D. K. (2025). Top 10 drugs most frequently associated with adverse events of myocarditis and pericarditis. Scientific Reports, 15(1), 28849. https://doi.org/10.1038/s41598-025-13234-6
https://pubmed.ncbi.nlm.nih.gov/40770014/
a1) 04/2023 "The bivalent COVID-19 vaccine administered to working-age adults provided moderate overall protection against COVID-19, while the BA.4/5 lineages were the dominant circulating strains, less protection when the BQ lineages were dominant, and no efficacy when the XBB lineages were dominant"
Shrestha, N. K., Burke, P. C., Nowacki, A. S., Simon, J. F., Hagen, A., & Gordon, S. M. (2023). Effectiveness of the Coronavirus Disease 2019 Bivalent Vaccine. Open Forum Infectious Diseases, 10(6), ofad209. https://doi.org/10.1093/ofid/ofad209
https://pubmed.ncbi.nlm.nih.gov/37274183/
a2) 12/2024 "The adjusted ORs for COVID-19 infection in vaccinated individuals compared to unvaccinated individuals were 1.85 (95% CI: 1.33-2.57, p < 0.001).
The probability of contracting COVID-19 increased with the number of vaccine doses: one to two doses (OR: 1.63, 95% CI: 1.08-2.46, p = 0.020), three to four doses (OR: 2.04, 95% CI: 1.35-3.08, p = 0.001) and five to seven doses (OR: 2.21, 95% CI: 1.07-4.56, p = 0.033).
The study observed a higher reported incidence of COVID-19 infections in vaccinated individuals during the pandemic, which increased with the number of vaccine doses received. This paradoxical result may be influenced by several factors, including immune response mechanisms such as antibody-dependent enhancement (ADE) or the original antigenic sin, behavioral changes, and exposure risk"
Nakatani, E., Morioka, H., Kikuchi, T., Fukushima, M., Nakatani, E., Morioka, H., Kikuchi, T., & Fukushima, M. (2024). Behavioral and Health Outcomes of mRNA COVID-19 Vaccination: A Case-Control Study in Japanese Small and Medium-Sized Enterprises. Cureus, 16(12). https://doi.org/10.7759/cureus.75652
https://www.cureus.com/articles/313843-behavioral-and-health-outcomes-of-mrna-covid-19-vaccination-a-case-control-study-in-japanese-small-and-medium-sized-enterprises#!/
a3) 03/2025 "The participants (91.3% male; mean age 69.9 years) comprised 587,137 pairs of vaccinated and unvaccinated individuals. Over a median follow-up period of 176 days (range: 118 to 211 days), the VE (Vaccine Effectiveness) was -3.26% (95% CI, -6.78% to -0.22%) against documented SARS-CoV-2 infection, 16.64% (CI, 6.47% to 25.77%) against SARS-CoV-2-associated hospitalizations and 26.61% (CI, 5.53% to 42.32%) against SARS-CoV-2-associated deaths. When estimated at 60, 90 and 120 days, VE against documented infections (14.21%, 7.29% and 3.15%), hospitalizations (37.57%, 30.84% and 25.25%) and deaths (54.24%, 44.33% and 30.25%), respectively, showed a significant decrease.
Ioannou, G. N., Berry, K., Rajeevan, N., Li, Y., Yan, L., Huang, Y., Lin, H.-M., Bui, D., Hynes, D. M., Rowneki, M., Bohnert, A., Boyko, E. J., Iwashyna, T. J., Maciejewski, M. L., Smith, V. A., Berkowitz, T. S. Z., O'Hare, A. M., Viglianti, E. M., Aslan, M., & Bajema, K. L. (2025). Effectiveness of the 2023-to-2024 XBB.1.5 COVID-19 Vaccines Over Long-Term Follow-up: A Target Trial Emulation. Annals of Internal Medicine, 178(3), 348-359. https://doi.org/10.7326/ANNALS-24-01015
https://pubmed.ncbi.nlm.nih.gov/39903865/
a4) 04/2025 "Elevated IgG4 levels and higher ratios of non-cytophil to cytophil antibodies after booster vaccination were significantly associated with an increased risk of breakthrough infections.
In addition, an increased ratio of non-cytophil to cytophil antibodies correlated with decreased functionality, including neutralization.
These results suggest a possible link between IgG4 induction by mRNA vaccination and a higher risk of breakthrough infections, which calls for further investigation into vaccination strategies to ensure sustained protection"
Pérez, C. M., Ruiz-Rius, S., Ramírez-Morros, A., Vidal, M., Opi, D. H., Santamaria, P., Blanco, J., Vidal-Alaball, J., Beeson, J. G., Molinos-Albert, L. M., Aguilar, R., Ruiz-Comellas, A., Moncunill, G., & Dobaño, C. (2025). Post-vaccination IgG4 and IgG2 class switch associates with increased risk of SARS-CoV-2 infections. Journal of Infection, 90(4). https://doi.org/10.1016/j.jinf.2025.106473
https://pubmed.ncbi.nlm.nih.gov/40113142/
a5) 08/2025 "In both analyses, we show that more SARS-CoV-2 vaccinations are associated with a higher risk of influenza-like respiratory illness and work absenteeism. For influenza-like respiratory illnesses, the association is stronger with a shorter time interval to vaccination than with the number of vaccinations, suggesting that the effect diminishes over time...
Based on our data, we conclude that SARS-CoV-2 booster vaccination does not help protect healthcare workers in a post-pandemic situation. SARS-CoV-2 vaccination may even temporarily increase the likelihood of symptomatic infection and work absenteeism.
Dörr, T., Lacy, J., Ballouz, T., Cusini, A., Grässli, F., Haile, S., Kocan, E., Möller, J. C., Puhan, M. A., Schlegel, M., von Kietzell, M., Rütti, M., Stocker, R., Vuichard Gysin, D., Kahlert, C. R., Kuster, S. P., & Kohler, P. (2025). Association of SARS-CoV-2 vaccination status with risk of influenza-like illness and loss of workdays in healthcare workers. Communications Medicine, 5(1), 347. https://doi.org/10.1038/s43856-025-01046-8
https://pmc.ncbi.nlm.nih.gov/articles/PMC12335509/
b1) 04/2022 "SARS-CoV-2-naive vaccinated individuals had a 13.06-fold increased risk (95% confidence interval [CI], 8.08-21.11) of breakthrough infection with the delta variant compared to unvaccinated, previously infected individuals if the first event (infection or vaccination) occurred in January and February 2021. The increased risk was also significant for symptomatic disease.
When infection was allowed to occur at any time between March 2020 and February 2021, evidence of waning naturally acquired immunity was demonstrated, although SARS-CoV-2-naive vaccinated individuals still had a 5.96-fold (95% CI: 4.85-7.33) increased risk of breakthrough infection and a 7.13-fold (95% CI: 5.51-9.21) increased risk of symptomatic disease.
Gazit, S., Shlezinger, R., Perez, G., Lotan, R., Peretz, A., Ben-Tov, A., Herzel, E., Alapi, H., Cohen, D., Muhsen, K., Chodick, G., & Patalon, T. (2022). Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Naturally Acquired Immunity versus Vaccine-induced Immunity, Reinfections versus Breakthrough Infections: A Retrospective Cohort Study. Clinical Infectious Diseases, 75(1), e545-e551. https://doi.org/10.1093/cid/ciac262
https://pubmed.ncbi.nlm.nih.gov/35380632/
1) 10/2023 Excerpt from a letter from EMA Director Emer Cooke to Members of the European Parliament:
"You state that the vaccines should be administered according to the licensed indications "only to individuals seeking personal protection and that they are not licensed for the purpose of reducing transmission or infection rates (transmission control)". They also state that the approved indication is not consistent with the uses advertised by "pharmaceutical companies, politicians and healthcare professionals".
They rightly point out that COVID-19 vaccines are not licensed to prevent transmission from one person to another. The indications are only for the protection of the vaccinated persons. The product information on COVID-19 vaccines clearly states that the vaccines are intended for active immunization to prevent COVID-19. In addition, the EMA's assessment reports on the authorization of the vaccines refer to the lack of data on portability.
2) 10/2021 "Nevertheless, fully vaccinated individuals with breakthrough infections have a similar maximum viral load to unvaccinated cases and can efficiently transmit the infection in domestic settings, including to fully vaccinated contacts"
Singanayagam, A., Hakki, S., Dunning, J., Madon, K. J., Crone, M. A., Koycheva, A., Derqui-Fernandez, N., Barnett, J. L., Whitfield, M. G., Varro, R., Charlett, A., Kundu, R., Fenn, J., Cutajar, J., Quinn, V., Conibear, E., Barclay, W., Freemont, P. S., Taylor, G. P., ... Lackenby, A. (2022). Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: A prospective, longitudinal, cohort study. The Lancet Infectious Diseases, 22(2), 183–195. https://doi.org/10.1016/S1473-3099(21)00648-4
https://pubmed.ncbi.nlm.nih.gov/34756186/
3) 10/2021 RKI protocol, October 29, 2021:
"FAQ on the risk of transmission by vaccinated persons must be amended. Previously stated that it was negligible from a PH (public health) perspective"
https://rki-transparenzbericht.de/
4) 09/2022 "We found no significant effect of vaccination status alone on Ct levels, even when vaccine product or gender were taken into account. When we examined a subset of low Ct samples (<25), we detected infectious viruses at similar frequencies and titers in samples from vaccinated and unvaccinated individuals. These data suggest that vaccinated individuals infected with delta variants may shed infectious SARS-CoV-2 and may play a role in the spread of COVID-19.
Riemersma, K. K., Iii, L. A. H., Wilson, N. A., Minor, N., Eickhoff, J., Grogan, B. E., Kita-Yarbro, A., Halfmann, P. J., Segaloff, H. E., Kocharian, A., Florek, K. R., Westergaard, R., Bateman, A., Jeppson, G. E., Kawaoka, Y., O'Connor, D. H., Friedrich, T. C., & Grande, K. M. (2022). Shedding of infectious SARS-CoV-2 despite vaccination. PLOS Pathogens, 18(9), e1010876. https://doi.org/10.1371/journal.ppat.1010876
https://pubmed.ncbi.nlm.nih.gov/36178969/
5) 09/2022 "Among 26,675 households (8,568 with the Omicron VOC), we identified 14,140 secondary infections within a follow-up period of 1 to 7 days. The secondary infection rate was 29% in households infected with Omicron and 21% in households infected with Delta. For Omicron, the probability of infection was 1.10 times (95% CI: 1.00-1.21) higher for unvaccinated, 2.38 times (95% CI: 2.23-2.54) higher for fully vaccinated and 3.20 times (95% CI: 2.67-3.83) higher for contacts vaccinated with a booster compared to Delta. We conclude that the transition from Delta to Omicron VOC was primarily due to immune evasion and to a lesser extent due to an inherent increase in baseline transmissibility of the Omicron variant."
Lyngse, F. P., Mortensen, L. H., Denwood, M. J., Christiansen, L. E., Møller, C. H., Skov, R. L., Spiess, K., Fomsgaard, A., Lassaunière, R., Rasmussen, M., Stegger, M., Nielsen, C., Sieber, R. N., Cohen, A. S., Møller, F. T., Overvad, M., Mølbak, K., Krause, T. G., & Kirkeby, C. T. (2022). Household transmission of the SARS-CoV-2 Omicron variant in Denmark. Nature Communications, 13(1), 5573. https://doi.org/10.1038/s41467-022-33328-3
https://pubmed.ncbi.nlm.nih.gov/36151099/
a1) 02/2021 Comirnaty (BioNTech) was never approved to prevent severe progression, but only to prevent infection. Statement from the EMA (Assessment Report):
"Active immunization for the prevention of COVID-19 disease caused by the SARS-CoV-2 virus in persons aged 16 years and older. Use of the Comirnaty vaccine should be in accordance with official guidelines."
a2) 12/2023 "Compared to the unvaccinated, those who had only received older versions of COVID-19 vaccines did not have a significantly lower risk of COVID-19 disease, including hospitalizations"
Tartof, S. Y., Slezak, J. M., Frankland, T. B., Puzniak, L., Hong, V., Ackerson, B. K., Stern, J. A., Simmons, S., Jodar, L., & McLaughlin, J. M. (2023). BNT162b2 XBB1.5-adapted Vaccine and COVID-19 Hospital Admissions and Ambulatory Visits in US Adults (p. 2023.12.24.23300512). medRxiv. https://doi.org/10.1101/2023.12.24.23300512
https://www.medrxiv.org/content/10.1101/2023.12.24.23300512v1
b1) 02/2024 Germany:
"In the second and third year of the pandemic, a significant positive correlation between the increase in excess mortality and COVID-19 vaccinations can be observed, which urgently requires further research into possible negative effects of COVID-19 vaccinations"
Kuhbandner, Christof & Reitzner, Matthias. (2024). Differential Increases in Excess Mortality in the German Federal States During the COVID-19 Pandemic. 10.13140/RG.2.2.13098.18880. https://www.researchgate.net/publication/378124684_Differential_Increases_in_Excess_Mortality_in_the_German_Federal_States_During_the_COVID-19_Pandemic
b2) 05/2025 Austria:
"In other words, a particularly high and increasing excess mortality rate occurs both in regions and in time windows with high vaccination rates. Such a pattern is contrary to the expectation that COVID-19 vaccinations should prevent severe or even fatal courses of COVID-19 and thus reduce mortality.
Reitzner, Matthias. (2025). Excess Mortality in Austria during the COVID-19 Pandemic. Austrian Journal of Statistics. 54. 36-58. 10.17713/ajs.v54i4.2032. https://www.researchgate.net/publication/392262994_Excess_Mortality_in_Austria_during_the_COVID-19_Pandemic
c1) 08/2024 Australia:
"Table 3 shows ... that excess deaths are significantly related to booster vaccinations, with the relationship being significant at the 1 percent level... In the second row, there is a very similar bivariate regression relationship between excess deaths and total immunizations, which is significant at the 1 percent level... The third row of Table 3 shows that there is also a similar relationship between excess deaths and the recently vaccinated cohort by state, which is also significant at the 1 percent level...
These first three rows of results suggest that there is a consistent relationship between excess deaths and vaccinations."
Allen, David. (2024). The correlation between Australian Excess Deaths by State and Booster Vaccinations. Medical Research Archives. 12. 10.18103/mra.v12i7.5485. https://www.researchgate.net/publication/382807266_The_correlation_between_Australian_Excess_Deaths_by_State_and_Booster_Vaccinations
c2) 01/2023 In a two-week period, hospitalized COVID-19 cases and deaths in New South Wales (Australia) were evaluated by vaccination status.
- Of 1,415 hospitalized cases with known vaccination status, all were vaccinated at least once, 810 (57%) even at least four times.
- Of 105 cases with known vaccination status in the intensive care unit (ICU), all were vaccinated at least once, 58 (55%) even at least four times.
- Of 88 deceased cases with known vaccination status, 82 (93%) were vaccinated at least once, and 6 (7%) were unvaccinated. 53 (60%) were vaccinated at least four times.
https://www.health.nsw.gov.au/Infectious/covid-19/Documents/weekly-covid-overview-20221231.pdf
d1) 11/2021 "The correlation between excess mortality in the federal states and their vaccination rate when weighted with the relative population of the federal state is 0.31. This figure is surprisingly high and would be expected to be negative if vaccination reduced mortality. For the period under consideration (week 36 to week 40, 2021), the following therefore applies: the higher the vaccination rate, the higher the excess mortality rate.
Study on excess mortality: "The higher the vaccination rate, the higher the excess mortality" - Südthüringer Rundschau - Meinungsfreudig. Independent. Close to the people. (2021, November 19). https://www.rundschau.info/studie-zur-uebersterblichkeit-je-hoeher-die-impfquote-desto-hoeher-die-uebersterblichkeit/
a1) 04/2023 "The risk of COVID-19 infection also varied depending on the number of COVID-19 vaccine doses previously received. The higher the number of previously received vaccinations, the higher the risk of contracting COVID-19."
Shrestha, N. K., Burke, P. C., Nowacki, A. S., Simon, J. F., Hagen, A., & Gordon, S. M. (2023). Effectiveness of the Coronavirus Disease 2019 Bivalent Vaccine. Open Forum Infectious Diseases, 10(6), ofad209. https://doi.org/10.1093/ofid/ofad209
https://pubmed.ncbi.nlm.nih.gov/37274183/
b1) 01/2023 "Here we report that several months after the second vaccination, SARS-CoV-2-specific antibodies increasingly consisted of non-inflammatory IgG4, which were further boosted by a third mRNA vaccination and/or breakthrough infections with SARS-CoV-2 variants. IgG4 antibodies among all spike-specific IgG antibodies increased on average from 0.04% shortly after the second vaccination to 19.27% shortly after the third vaccination. This induction of IgG4 antibodies was not observed after homologous or heterologous SARS-CoV-2 vaccination with adenoviral vectors"
Irgang, P., Gerling, J., Kocher, K., Lapuente, D., Steininger, P., Habenicht, K., Wytopil, M., Beileke, S., Schäfer, S., Zhong, J., Ssebyatika, G., Krey, T., Falcone, V., Schülein, C., Peter, A. S., Nganou-Makamdop, K., Hengel, H., Held, J., Bogdan, C., ... Tenbusch, M. (2023). Class switch toward noninflammatory, spike-specific IgG4 antibodies after repeated SARS-CoV-2 mRNA vaccination. Science Immunology, 8(79), eade2798. https://doi.org/10.1126/sciimmunol.ade2798
https://pubmed.ncbi.nlm.nih.gov/36548397/
b2) 05/2023 "However, new evidence suggests that the increase in IgG4 levels observed after repeated vaccination with mRNA vaccines may not be a protective mechanism, but rather an immune tolerance mechanism to the spike protein that could favor unimpeded SARS-CoV2 infection and replication by suppressing natural antiviral responses. Increased IgG4 synthesis due to repeated mRNA vaccinations with high antigen concentrations may also cause autoimmune diseases and promote cancer growth and autoimmune myocarditis in susceptible individuals"
Uversky, V. N., Redwan, E. M., Makis, W., & Rubio-Casillas, A. (2023). IgG4 Antibodies Induced by Repeated Vaccination May Generate Immune Tolerance to the SARS-CoV-2 Spike Protein. Vaccines, 11(5), 991. https://doi.org/10.3390/vaccines11050991
https://pubmed.ncbi.nlm.nih.gov/37243095/
b3) 12/2024 "In summary, we report increased spike-specific IgG4 levels in children one year after BNT162b2 vaccination, similar to the effect observed in adults. Although our study is not predictive of population-level effects due to small cohort size, it provides insight into the longitudinal dynamics of spike-specific IgG subclass composition in children. IgG4 responses should receive more attention in the context of health and disease, particularly in the context of mRNA vaccination."
Kobbe, R., Rau, C., Schulze-Sturm, U., Stahl, F., Fonseca-Brito, L., Diemert, A., Lütgehetmann, M., Addo, M. M., Arck, P., & Weskamm, L. M. (2024). Delayed Induction of Noninflammatory SARS-CoV-2 Spike-Specific IgG4 Antibodies Detected 1 Year After BNT162b2 Vaccination in Children. The Pediatric Infectious Disease Journal, 43(12), 1200. https://doi.org/10.1097/INF.0000000000004488
https://pubmed.ncbi.nlm.nih.gov/39078156/
b4) 07/2025 "Further research is needed to understand the role of IgG4 in acute and long-term protection against infectious diseases, as it is currently unclear whether high IgG4 titers provide protection or suppress natural antiviral responses"
Siebner, A. S., Griesbaum, J., Huus, K. E., Flügge, J., Hopfensperger, K., Michel, T., Schneiderhan-Marra, N., Sauter, D., Kremsner, P. G., Ley, R. E., Dulovic, A., & Esen, M. (2025). Class switch toward IgG2 and IgG4 is more pronounced in BNT162b2 compared to mRNA-1273 COVID-19 vaccinees. International Journal of Infectious Diseases, 159, 107990. https://doi.org/10.1016/j.ijid.2025.107990
https://pubmed.ncbi.nlm.nih.gov/40681092/
a1) 01/2023 "The safety profile of nucleoside-modified synthetic mRNA (hereafter "nms-mRNA") is far from fully understood. Attempts to assess biodistribution, cellular uptake, endosome escape, translation rates, functional half-life and inactivation kinetics of synthetic mRNA, rates and duration of vaccine-induced antigen expression in different cell types, and potential interactions with the host genome have been bypassed. One of the major safety concerns with the introduction of nms mRNA, as contained in the two approved mRNA COVID-19 vaccines, is the possibility that such modifications may ultimately lead to epigenetic and/or genomic changes in dividing and non-dividing cells.
Acevedo-Whitehouse, K., & Bruno, R. (2023). Potential health risks of mRNA-based vaccine therapy: A hypothesis. Medical Hypotheses, 171, 111015. https://doi.org/10.1016/j.mehy.2023.111015
https://pubmed.ncbi.nlm.nih.gov/36718314/
a2) 06/2023 "The mode of action of COVID-19 mRNA vaccines should classify them as gene therapy products (GTPs), but they have been excluded by regulatory authorities. Some of the tests they have undergone as vaccines have produced non-compliant results in terms of purity, quality and batch homogeneity. The broad and sustained biodistribution of mRNAs and their protein products, which has been incompletely studied due to their classification as vaccines, raises safety issues. Post-marketing studies have shown that mRNA passes into breast milk and could have adverse effects on breastfed infants. Long-term expression, integration into the genome, transfer to the germline, passage into sperm, embryo/fetal and perinatal toxicity, genotoxicity and tumorigenicity should be investigated in light of adverse events reported in pharmacovigilance databases."
Banoun, H. (2023). mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues. International Journal of Molecular Sciences, 24(13), 10514. https://doi.org/10.3390/ijms241310514
https://pubmed.ncbi.nlm.nih.gov/37445690/
b1) 07/2022 "However, adverse events (AEs) have been observed following vaccination that are associated with a proinflammatory effect of the lipid nanoparticles used or the administered mRNA (i.e. of the vaccine formulation) as well as the unique nature, expression pattern, binding profile and pro-inflammatory effects of the antigens produced - spike protein (S) and/or its subunits/peptide fragments - in human tissues or organs.
Trougakos, I. P., Terpos, E., Alexopoulos, H., Politou, M., Paraskevis, D., Scorilas, A., Kastritis, E., Andreakos, E., & Dimopoulos, M. A. (2022). Adverse effects of COVID-19 mRNA vaccines: The spike hypothesis. Trends in Molecular Medicine, 28(7), 542-554. https://doi.org/10.1016/j.molmed.2022.04.007
https://pubmed.ncbi.nlm.nih.gov/35537987/
b2) 08/2023 "Pharmacokinetic transfection through body tissue distant from the injection site by lipid nanoparticles or viral vector carriers means that "spikeopathy" can affect many organs. The inflammatory properties of the nanoparticles used to transport the mRNA; N1-methylpseudouridine used to extend synthetic mRNA function; the widespread biodistribution of the mRNA and DNA codes and translated spike proteins; and autoimmunity due to the production of foreign proteins in the human body all contribute to the deleterious effects"
Parry, P. I., Lefringhausen, A., Turni, C., Neil, C. J., Cosford, R., Hudson, N. J., & Gillespie, J. (2023). "Spikeopathy": COVID-19 Spike Protein Is Pathogenic, from Both Virus and Vaccine mRNA. Biomedicines, 11(8), 2287. https://doi.org/10.3390/biomedicines11082287
https://pubmed.ncbi.nlm.nih.gov/37626783/
b3) 01/2025 "COVID-19 vaccination campaigns around the world have failed to meet basic standards of safety and efficacy, leading to mounting evidence of significant harm. More than 81,000 physicians, scientists, researchers and concerned citizens, 240 elected government officials, 17 public health professional and physician organizations, 2 state Republican parties, 17 county Republican parties and 6 scientific studies from around the world have called for the withdrawal of COVID-19 vaccines from the market.
Hulscher N, Bowden M T, McCullough P A.. Review: Calls for Market Removal of COVID-19 Vaccines Intensify as Risks Far Outweigh Theoretical Benefits. Science, Public Health Policy and the Law. 2025 Jan 28; v6.2019-2025 https://publichealthpolicyjournal.com/review-of-calls-for-market-removal-of-covid-19-vaccines-intensify-risks-far-outweigh-theoretical-benefits/
a1) 06/2021 "Rare severe allergic side effects such as anaphylaxis or other allergic reactions may occur after vaccination. Confirmed allergic reactions to vaccines may be caused by residues of non-human proteins, preservatives or stabilizers in the vaccine formulation (also known as adjuvants). There are two potential allergenic/immunogenic adjuvants in COVID-19 vaccines: Polyethylene glycol (PEG) and polysorbate 80."
Kim, M.-A., Lee, Y. W., Kim, S. R., Kim, J.-H., Min, T. ki, Park, H.-S., Shin, M., Ye, Y.-M., Lee, S., Lee, J., Choi, J.-H., Jang, G. C., & Chang, Y.-S. (2021). COVID-19 Vaccine-associated Anaphylaxis and Allergic Reactions: Consensus Statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group. Allergy, Asthma & Immunology Research, 13(4), 526-544. https://doi.org/10.4168/aair.2021.13.4.526
https://pmc.ncbi.nlm.nih.gov/articles/PMC8255352/
b1) 10/2022 "Signs of chronic cardiomyopathy and mild acute lymphohistiocytic myocarditis and vasculitis were present in the heart. Although this patient had no history of COVID-19, immunohistochemistry for SARS-CoV-2 antigens (spike and nucleocapsid proteins) was performed. Surprisingly, only the spike protein, but no nucleocapsid protein could be detected within the inflammatory foci in both the brain and the heart, especially in the endothelial cells of small blood vessels. Since no nucleocapsid protein could be detected, the presence of the spike protein must be attributed to the vaccination rather than a viral infection. The results confirm previous reports of encephalitis and myocarditis caused by gene-based COVID-19 vaccines"
Mörz, M. (2022). A Case Report: Multifocal Necrotizing Encephalitis and Myocarditis after BNT162b2 mRNA Vaccination against COVID-19. Vaccines, 10(10), 1651. https://doi.org/10.3390/vaccines10101651
https://pubmed.ncbi.nlm.nih.gov/36298516/
b2) 08/2024 "Conclusion 7-1: The evidence supports a causal relationship between the vaccine BNT162b2 and myocarditis.
Conclusion 7-2: The evidence supports a causal relationship between the vaccine mRNA-1273 and myocarditis."
Bass, A. R., Stratton, K., Kumova, O. K., & Rosenberg, D. (eds.) (with Committee to Review Relevant Literature Regarding Adverse Events Associated with Vaccines, Board on Population Health and Public Health Practice, Health and Medicine Division, & National Academies of Sciences, Engineering, and Medicine). (2024). Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration. National Academies Press. https://doi.org/10.17226/27746
https://nap.nationalacademies.org/catalog/27746/evidence-review-of-the-adverse-effects-of-covid-19-vaccination-and-intramuscular-vaccine-administration
b3) 08/2025 US package insert of Comirnaty (BioNTech) (August 2025 version):
"Analyses of postmarketing data from the use of licensed or approved mRNA COVID-19 vaccines, including COMIRNATY, have shown an increased risk of myocarditis and pericarditis, with symptoms usually occurring in the first week after vaccination. The observed risk was highest in males aged 12 to 24 years."
Research, C. for B. E. and. (2025). COMIRNATY. FDA. https://www.fda.gov/vaccines-blood-biologics/comirnaty
https://www.fda.gov/vaccines-blood-biologics/comirnaty
a1) 12/2021 "Here we present evidence that Acuitas LNPs used in preclinical studies of nucleoside-modified mRNA vaccines are highly pro-inflammatory in mice. Intradermal and intramuscular injection of these LNPs resulted in rapid and strong inflammatory responses characterized by massive neutrophil infiltration, activation of various inflammatory pathways and production of various inflammatory cytokines and chemokines"
Ndeupen, S., Qin, Z., Jacobsen, S., Bouteau, A., Estanbouli, H., & Igyártó, B. Z. (2021). The mRNA-LNP platform's lipid nanoparticle component used in preclinical vaccine studies is highly inflammatory. iScience, 24(12), 103479. https://doi.org/10.1016/j.isci.2021.103479
https://pubmed.ncbi.nlm.nih.gov/34841223/
a2) 09/2022 "The mRNA-LNP-based SARS-CoV-2 vaccine is highly pro-inflammatory, and its synthetic ionizable lipid component, which is responsible for triggering inflammation, has a long half-life in the body. Since chronic inflammation can lead to immune system exhaustion and lack of responsiveness, we wanted to investigate the effects of prior exposure to mRNA-LNP on adaptive immune responses and innate immune fitness"
Qin, Z., Bouteau, A., Herbst, C., & Igyártó, B. Z. (2022). Pre-exposure to mRNA-LNP inhibits adaptive immune responses and alters innate immune fitness in an inheritable fashion. PLOS Pathogens, 18(9), e1010830. https://doi.org/10.1371/journal.ppat.1010830
https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1010830
a3) 04/2024 "The viral or vaccine spike protein can cause various serious impairments and dysfunctions in the human body, including MCAS. The latter can be triggered by a natural infection with SARS-CoV-2 or directly induced by a vaccination or booster vaccination against COVID-19. This occurs due to a dysfunction of the renin-angiotensin system (RAS) and an overactivation of the AT1R and Toll-like receptors (TLR), which control innate immunity (and thus adaptive or acquired immunity). In patients with this syndrome, mast cells show hyperactivation, causing them to release excessive and inappropriate chemical mediators"
Fajloun, Z., Khattar, Z. A., & Sabatier, J.-M. (n.d.). SARS-CoV-2 or Vaccinal Spike Protein can Induce Mast Cell Activation Syndrome (MCAS). Infectious Disorders - Drug Targets, 25(1), 12-14. https://doi.org/10.2174/0118715265319896240427045026
https://pubmed.ncbi.nlm.nih.gov/38693735/
a4) 10/2025 "After injection, LNPs undergo rapid biotransformation, including PEG-lipid cleavage, biodistribution and cellular uptake, which cannot be fully captured by current analytical techniques.
Importantly, endosome escape leading to endosome disruption and payload release occurs within a narrow time window, is often inefficient, and results in inconsistent delivery. In addition, lipid metabolites, cell membrane modulation and adduct formation pose poorly characterized risks"
Gutschi, Luz & Seger, Falko. (2025). Complexity, unpredictability and safety challenges of lipid nanoparticles -A multidisciplinary narrative review. (2025, October 10). ResearchGate. https://www.researchgate.net/publication/396321059_Complexity_unpredictability_and_safety_challenges_of_lipid_nanoparticles_-A_multidisciplinary_narrative_review
b1) 03/2021 "We hypothesize that SARS-CoV-2 enters the central nervous system (CNS) via ACE2 receptors present on BMVEC (human brain microvascular endothelial cells) and NHA (normal human astrocytes), alters tight junction (TJ) proteins, leading to disruption of the integrity of the blood-brain barrier, which in turn results in neuroinvasion of microglia. Overall, SARS-COV-2 exacerbates neuroinflammation, increases oxidative stress and thus contributes to neuronal cell death.
Reynolds, J. L., & Mahajan, S. D. (2021). SARS-COV2 Alters Blood Brain Barrier Integrity Contributing to Neuro-Inflammation. Journal of Neuroimmune Pharmacology: The Official Journal of the Society on NeuroImmune Pharmacology, 16(1), 4-6. https://doi.org/10.1007/s11481-020-09975-y
https://pubmed.ncbi.nlm.nih.gov/33405097/
b2) 06/2025 "Both spike protein (SP) units (from infection and injection) interfere with ACE2, among others, and act on different cells, tissues and organs. Both SPs are able to cross the blood-brain barrier and can trigger acute and chronic neurological symptoms. Such SP-associated pathologies (spikeopathies) are further neurological proteinopathies with thrombogenic, neurotoxic, neuroinflammatory and neurodegenerative potential for the human nervous system, especially the central nervous system. The potential neurotoxicity of SP from ASP needs to be critically investigated as ASPs (anti-SARS-CoV-2 products) have been administered to millions of people worldwide."
Posa, A. (2025). Spike protein-related proteinopathies: A focus on the neurological side of spikeopathies. Annals of Anatomy - Anatomischer Anzeiger, 260, 152662. https://doi.org/10.1016/j.aanat.2025.152662
https://pubmed.ncbi.nlm.nih.gov/40254264/
b3) 09/2025 "It is now known that COVID-19 mRNA "vaccines" downregulate a number of important signaling pathways related to infection control and cellular homeostasis. Capillary endothelial mRNA and spike proteins likely disrupt the blood-brain barrier and increase the risk of devastating central nervous system infections in certain individuals. We found an increase in the incidence of life-threatening bacterial infections of the central nervous system, including the formation of brain abscesses, according to VAERS data. This suggests a gross violation of the blood-brain barrier and possibly impaired opsonization and phagocytosis by neutrophils/macrophages."
.
Cosgrove, Kirstin & Thorp, James & Rogers, Claire & Hatfill, Steven & Hulscher, Nicolas & McCullough, Peter. (2025). COVID-19 mRNA Vaccination: Implications for the Central Nervous System. 10.5281/zenodo.17148117.
https://www.researchgate.net/publication/395581251_COVID-19_mRNA_Vaccination_Implications_for_the_Central_Nervous_System
c1) 04/2024 "Although the long-term effects of BNT162b2 mRNA Covid-19 vaccine on cardiovascular events may be limited, endothelial dysfunction may be at least partially involved in thrombotic events that occur relatively early after Covid-19 vaccination. In addition, we cannot exclude that the deleterious effects of the BNT162b2 mRNA Covid-19 vaccine on vascular function are stronger in patients with advanced atherosclerosis than in healthy individuals and that the impairment of vascular function caused by Covid-19 vaccination lasts longer in these patients"
Yamaji, T., Harada, T., Hashimoto, Y., Nakano, Y., Kajikawa, M., Yoshimura, K., Goto, C., Han, Y., Mizobuchi, A., Yusoff, F. M., Kishimoto, S., Maruhashi, T., Nakashima, A., & Higashi, Y. (2024). Effects of BNT162b2 mRNA Covid-19 vaccine on vascular function. PloS One, 19(4), e0302512. https://doi.org/10.1371/journal.pone.0302512
https://pubmed.ncbi.nlm.nih.gov/38687730/
d1) 05/2023 A review of 166 studies in the journal Vaccines entitled "IgG4 Antibodies Induced by Repeated Vaccination May Generate Immune Tolerance to the SARS-CoV-2 Spike Protein" (IgG4 antibodies induced by repeated vaccination may generate immune tolerance to the SARS-CoV-2 spike protein) summarizes the results of the studies, that the risk of contracting SARS-CoV-2 is significantly increased after a few months. The IgG4 dampens the immune system so as not to cause an overreaction (after prolonged alertness following permanent spike production).
Uversky, V. N., Redwan, E. M., Makis, W., & Rubio-Casillas, A. (2023). IgG4 Antibodies Induced by Repeated Vaccination May Generate Immune Tolerance to the SARS-CoV-2 Spike Protein. Vaccines, 11(5), 991.
https://doi.org/10.3390/vaccines11050991
https://pubmed.ncbi.nlm.nih.gov/37243095/
d2) 08/2023 "Six months after vaccination with BNT162b2, there was a sustained decrease in cytokine responses to viral, but not bacterial, stimulants.
Vaccination with BNT162b2 in children alters cytokine responses to heterologous stimulants, especially one month after vaccination"
Noé, A., Dang, T. D., Axelrad, C., Burrell, E., Germano, S., Elia, S., Burgner, D., Perrett, K. P., Curtis, N., & Messina, N. L. (2023). BNT162b2 COVID-19 vaccination in children alters cytokine responses to heterologous pathogens and Toll-like receptor agonists. Frontiers in Immunology, 14. https://doi.org/10.3389/fimmu.2023.1242380
https://pubmed.ncbi.nlm.nih.gov/37691937/
d3) 04/2024 "The results of this cohort study suggest that mRNA vaccination was associated with mucosal immunity in individuals without prior SARS-CoV-2 infection, but to a much lesser extent than in previously infected individuals"
Gorochov, G., Ropers, J., Launay, O., Dorgham, K., da Mata-Jardin, O., Lebbah, S., Durier, C., Bauer, R., Radenne, A., Desaint, C., Vieillard, L.-V., Rekacewicz, C., Lachatre, M., Parfait, B., Batteux, F., Hupé, P., Ninove, L., Lefebvre, M., Conrad, A., ... Paul, S. (2024). Serum and Salivary IgG and IgA Response After COVID-19 Messenger RNA Vaccination. JAMA Network Open, 7(4), e248051. https://doi.org/10.1001/jamanetworkopen.2024.8051
https://pubmed.ncbi.nlm.nih.gov/38652471/
d4) 05/2025 "Natural infection induces and enhances IgA and IgG in oral fluid and serum; vaccination does not induce or enhance specific IgA in saliva; IgG can be detected in saliva after vaccination, but only at high IgG concentrations in serum ; IgA is important for SARS-CoV-2 neutralization activity by oral fluid, but serum IgG and other factors may also contribute"
Paul, M. J., Hudda, M. T., Pallett, S., Groppelli, E., Boariu, E., Finardi, N. F., Wake, R., Sofat, N., Biddle, K., Koushesh, S., Dwyer-Hemmings, L., Cook, R., & Ma, J. K.-C. (2025). Mucosal immune responses to SARS-CoV-2 infection and COVID-19 vaccination. Vaccine, 56, 127175. https://doi.org/10.1016/j.vaccine.2025.127175
https://pmc.ncbi.nlm.nih.gov/articles/PMC12286911/
e1) 12/2024 "This article highlights the high prevalence of antibodies against G protein-coupled receptors and RAS-related molecules in a series of patients with PACVS (Post-Acute COVID-19 Vaccination Syndrome), none of whom had previously had a COVID-19 infection. The search for a correlation between symptoms and antibody levels revealed the potential importance of autoantibodies against ACE2, ATR1, PAR1, MAS1, ADRA2A, CHRM3 and STAB1 in the pathogenesis of PACVS, a still poorly defined syndrome. Of note, all patients with PACVS present with a variety of symptoms, with asthenia, memory loss, neuralgia, orthostatic or resting tachycardia and muscle pain being the most common. In addition, patients who test positive for autoantibodies against the spike protein receptor ACE2 are more likely to exhibit symptoms such as hypertension, headaches, gastritis, skin bleeding, edema or rashes compared to ACE2-negative patients"
Mantovani, M., Bellavite, P., Fazio, S., Di Fede, G., Tomasi, M., Belli, D., & Zanolin, E. (2024). Autoantibodies Targeting G-Protein-Coupled Receptors and RAS-Related Molecules in Post-Acute COVID Vaccination Syndrome: A Retrospective Case Series Study. Biomedicines, 12(12), 2852. https://doi.org/10.3390/biomedicines12122852
https://pubmed.ncbi.nlm.nih.gov/39767757/
f1) 10/2024 "In summary, Treg responses to mRNA injections and the subsequent expression of the mRNA-encoded SARS-CoV-2 spike protein can disrupt the immune defense and lead to accelerated development of autoimmune diseases and cancer. The processes described here are consistent with epidemiological findings and case reports.
f2) 11/2024 "In Germany, more and more people with statutory health insurance are being diagnosed with autoimmune diseases. Between 2012 and 2022, the billing data from statutory health insurance physicians shows an increase from 7.06 to 8.61 percent - a relative increase of 22 percent. This is shown in a new study by the Central Institute for Statutory Health Insurance Physician Care (Zi). It was published as part of the healthcare atlas (2024, DOI: 10.20364/VA-24.05)."
Ärzteblatt, D. Ä. G., ed. German. (2024, November 7). Prevalence of autoimmune diseases increased. German Medical Journal. https://www.aerzteblatt.de/news/praevalenz-von-autoimmunerkrankungen-gestiegen-6c16972c-7e2b-47f7-8f8a-836a4135b7c8
f3) 06/2025 "In 109 included studies, relapses or relapses in patients with autoimmune diseases were reported in almost 60% of studies, while about a quarter described new-onset autoimmune diseases in people without prior autoimmunity. Several mechanisms of action have been identified linking COVID-19 vaccination and autoimmune diseases, including adjuvant-induced autoimmune inflammatory syndrome, molecular mimicry, bystander effects, immune system activation and interactions with immunosuppressive and disease-modifying therapies. Serious adverse events were also documented, but were less frequent than mild or moderate adverse events. The efficacy of the vaccines was claimed, but empirical evidence was often lacking.
Chaufan, C., Manwell, L., Heredia, C., & McDonald, J. (2025). COVID-19 Vaccination and Autoimmune Disorders: A Scoping Review (No. 2025060831). Preprints. https://doi.org/10.20944/preprints202506.0831.v1
https://www.preprints.org/manuscript/202506.0831/v1
g1) 11/2021 "We could not find a clear association, but there may be a possible link between the COVID-19 vaccine and shingles. Large-scale studies could help to understand the cause-and-effect relationship"
Desai, H. D., Sharma, K., Shah, A., Patoliya, J., Patil, A., Hooshanginezhad, Z., Grabbe, S., & Goldust, M. (2021). Can SARS-CoV-2 vaccine increase the risk of reactivation of Varicella zoster? A systematic review. Journal of Cosmetic Dermatology, 20(11), 3350-3361. https://doi.org/10.1111/jocd.14521
https://pubmed.ncbi.nlm.nih.gov/34719084/
h1) 10/2024 "The results showed an increased incidence of MCI (mild cognitive impairment) and AD (Alzheimer's disease) in vaccinated individuals, particularly those who had received mRNA vaccines, within three months of vaccination. The mRNA vaccine group had a significantly higher incidence of AD (odds ratio [OR]: 1.225; 95% confidence interval [CI]: 1.025-1.464; P ¼ 0.026) and MCI (OR: 2.377; CI: 1.845-3.064; P < 0.001) compared to the non-vaccinated group.
Roh, J. H., Jung, I., Suh, Y., & Kim, M.-H. (2024). A potential association between COVID-19 vaccination and development of Alzheimer's disease. QJM: An International Journal of Medicine, 117(10), 709-716. https://doi.org/10.1093/qjmed/hcae103
https://pubmed.ncbi.nlm.nih.gov/38806183/
a1) 02/2024 "In the second and third year of the pandemic, a significant positive correlation between the increase in excess mortality and COVID-19 vaccinations can be observed, which urgently requires further research into possible negative effects of COVID-19 vaccinations"
Kuhbandner, Christof & Reitzner, Matthias. (2024). Differential Increases in Excess Mortality in the German Federal States During the COVID-19 Pandemic. 10.13140/RG.2.2.13098.18880. https://www.researchgate.net/publication/378124684_Differential_Increases_in_Excess_Mortality_in_the_German_Federal_States_During_the_COVID-19_Pandemic
a2) 03/2023 Japan:
"The total mortality in 2020 is below and in 2021 within the expected limits of the annual random fluctuations in mortality trends from 2005 to 2019 (see Figure 1). This does not indicate a classic pandemic with unusually high mortality, nor does it suggest mass casualties due to the coronavirus measures in Japan in 2020 and 2021. In 2022, however, the mortality rate is extremely elevated at 8.37% (6.74, 9.97), which is more than double the average excess in the years of earthquakes and tsunamis in Japan."
Germany:
"In contrast to Japan, there are no significant deviations from the long-term mortality trend over the entire period from 2005 to 2020. In 2021 and 2022, however, a highly significant excess mortality rate of more than 5% can be observed. This excess mortality is therefore well outside the detection limit of the trend analysis method used. This method enables an estimation accuracy of under- or excess mortality in individual years of approx. ±2% (Japan) to ±3% (Germany): see the width of the confidence intervals in Table 3 and Table 6.
This accuracy is therefore sufficient to detect or exclude excess or below-average mortality of ±2% to ±3% above expectations.
Scherb, H., & Hayashi, K. (2023). Annual All-Cause Mortality Rate in Germany and Japan (2005 to 2022) With Focus on The Covid-19 Pandemic: Hypotheses And Trend Analyses. Medicine and Clinical Science, 5(2). https://doi.org/10.33425/2690-5191.1077
https://www.sciencexcel.com/article/citation/annual-cause-mortality-rate-germany-japan-focus-covid-pandemic-hypotheses-trend-analyses
a3) 04/2023 "The slow rise in deaths among young people and the abrupt increase among the elderly since the start of mass vaccinations in Germany on December 27, 2020 could well be a consequence of the deadly side effects of mRNA vaccinations. The examples presented here point in the same direction as an observation from Malta: "For every 1% increase in the vaccination rate, the absolute number of emergency admissions increased by 0.9%" [4]."
Scherb, H., & Hayashi, K. (2023). Letter Rejoinder: "Körblein A. Letter Re: 'Annual All-Cause Mortality Rate in Germany and Japan (2005 to 2022) With Focus on The Covid-19 Pandemic: Hypotheses And Trend Analyses. Med Clin Sci. 2023; 5(2):1-7.' By Scherb H, Hayashi K." Med Clin Sci. 2023; 5(3):1-1. Medicine and Clinical Science, 5(4). https://doi.org/10.33425/2690-5191.1084
https://www.sciencexcel.com/article/citation/letter-rejoinder-korblein-letter-re-annual-cause-mortality-rate-germany-japan-focus-covid-pandemic-hypotheses-trend-analyses-med-clin-sci-scherb-h-hayashi-k-med-clin-sci-
a4) 10/2024 Switzerland:
"In summary, the picture remains of high excess mortality, which persists despite major vaccination campaigns, indeed, in the younger age groups has only picked up speed with the onset of vaccination - and of a federal office that does everything it can to make the clear statements of its own death figures disappear behind the veil of a non-transparent excess mortality calculation.
Beck, K. (2025): Excess mortality in Switzerland - an attempt at concealment. In: Seeling, D. (ed.) 2025: Anthology Long/Post COVID and mRNA vaccination side effects, 3rd ed. https://www.sound-of-truth.com/de/shop/buecher/long-covid-modrna-impfnebenwirkungen/1/
b1) 08/2024 "Berlin, August 2, 2024 - Respiratory-related sick leave has recently reached new highs. This is the result of an analysis by the BARMER Institute for Health Systems Research (bifg), which examined the rates of sick leave in calendar weeks (CW) 22 to 27 of the years 2018 to 2024. Sick leave due to other respiratory tract infections such as sinusitis or bronchitis as well as banal infections such as the common cold were examined.
BARMER. (2024, August 2). BARMER analysis - highs in respiratory illnesses | BARMER. https://www.barmer.de/presse/presseinformationen/pressearchiv/barmer-analyse-hoechststaende-bei-atemwegs-krankschreibungen-1276512
b2) 01/2025 "Hamburg, January 7, 2025: For the first time, there was a jump of almost 40 percent in the number of days absent from work from 2021 to 2022... A third of the additional days of absence since 2022 are also due to increased waves of colds and coronavirus infections. These are the key findings of the special analysis on the record sickness rate. According to the study, the new option of taking sick leave by telephone does not lead to an increase in days of absence. According to their own information, only a few employees are also taking sick leave.
DAK analysis shows causes for record sickness rate. (2025, January 7). Press. https://www.dak.de/presse/bundesthemen/politik-unternehmensnachrichten/dak-analyse-zeigt-ursachen-fuer-rekordkrankenstand-_88050
b3) 08/2025 "Hamburg, August 5, 2025. In the first half of 2025, respiratory illnesses caused a high sickness rate. There was a 13 percent increase in days lost due to flu and colds compared to the same period last year. This was particularly noticeable due to the wave of colds in January and February.
Wave of flu and colds keeps sickness rates at a high level. (2025, August 5). Press. https://www.dak.de/presse/bundesthemen/gesundheitsreport/grippe-und-erkaeltungswelle-haelt-krankenstand-auf-hohem-niveau_144770
c1) 03/2016 "The mortality rate for biopsy-proven myocarditis is 20% after one year and approx. 56% after 4-5 years. Long-term survival rates after 11 years vary between 45% for acute, non-fulminant myocarditis and 93% for fulminant myocarditis. It should be noted that giant cell myocarditis has a significantly poorer 5-year survival rate (below 20%)."
Luetkens, J. A., Nähle, C. P., & Dörner, J. (2016). Diagnosis, imaging and differential diagnosis of myocarditis. Radiologie up2date, 16, 55–73. https://doi.org/10.1055/s-0042-102041
https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0042-102041
c2) 08/2020 "We found significant long-term (10-year) mortality in patients with biopsy-confirmed myocarditis (39.3% all-cause, 27.3% cardiac, and 10.9% sudden cardiac death); 101 patients (55.2%) had LGE. The presence of LGE was associated with more than double the risk of death (hazard ratio [HR], 2.40; 95% CI], 1.30-4.43), which increased to an HR of 3.00 (95% CI, 1.41-6.42) for cardiac death and to an HR of 14.79 (95% CI, 1.95-112.00) for sudden cardiac death; all P ≤ 0.009."
Greulich, S., Seitz, A., Müller, K. A. L., Grün, S., Ong, P., Ebadi, N., Kreisselmeier, K. P., Seizer, P., Bekeredjian, R., Zwadlo, C., Gräni, C., Klingel, K., Gawaz, M., Sechtem, U., & Mahrholdt, H. (2020). Predictors of Mortality in Patients With Biopsy-Proven Viral Myocarditis: 10-Year Outcome Data. Journal of the American Heart Association, 9(16), e015351. https://doi.org/10.1161/JAHA.119.015351
https://pubmed.ncbi.nlm.nih.gov/32787653/
d1) 03/2025 "The long-term effects of mRNA-based genetic modifications are still largely unknown, necessitating a cautious approach. While these technologies hold promise for disease prevention, they also carry potential risks ranging from genetic instability to autoimmune reactions and intergenerational effects"
Jabir, M., Sakil, M., Tufael2, & Azizur. (2025). Unintended Genetic Consequences of mRNA Vaccines: Evaluating Risks of Transcriptional Disruption, HLA Alteration, and Genomic Integration. Journal of Precision Biosciences, 7(1), 1-11. https://doi.org/10.25163/biosciences.7110287
https://publishing.emanresearch.org/Journal/FullText/6039
d2) 03/2025 "The rapid rise of mRNA technology, particularly in the form of COVID-19 vaccines, has been hailed as a revolutionary breakthrough in modern medicine. However, behind the excitement lies a sinister truth: the reckless and dangerous insertion of encrypted genetic code into the human exome. The mRNA vaccine technology not only alters the immune response, but also the structure of our DNA. This technology represents a catastrophic change that risks permanently mutating the human genome and could trigger an irreversible cascade of genetic damage"
Palacios-Castrillo, Ronald. (2025). mRNA Vaccines: A Catastrophic Experiment. 10.71010/AJCMR.2025-e198. https://www.researchgate.net/publication/389314193_mRNA_Vaccines_A_Catastrophic_Experiment
a1) 06/2025 "During the study period, there were about 1,300,000 women aged 18 to 39 years in the Czech Republic, and the proportion of women vaccinated against COVID-19 increased from January 2021 until it reached a stable value of about 70% at the end of 2021. At least from June 2021, the number of successful conceptions per 1000 women was significantly lower among vaccinated women than among non-vaccinated women before vaccination. In addition, SC (successful conception) rates for the vaccinated group were much lower than would have been expected based on their proportion of the total population...
The overall fertility rate in the Czech Republic decreased from 1.83 births per 1000 women in 2021 to 1.62 in 2022 and 1.45 in 2023."
Manniche, V., Fürst, T., Schmeling, M., Gilthorpe, J. D., & Hansen, P. R. (2025). Rates of successful conceptions according to COVID-19 vaccination status: Data from the Czech Republic. International Journal of Risk & Safety in Medicine, 09246479251353384. https://doi.org/10.1177/09246479251353384
https://pubmed.ncbi.nlm.nih.gov/40534497/
a2) 07/2025 "The total fertility rate, often referred to as the birth rate, fell to 1.35 children per woman in 2024. It was therefore 2% lower than in 2023, when the fertility rate was 1.38 children per woman, taking into account the corrected population figure from the 2022 census. According to the Federal Statistical Office (Destatis), the decline slowed significantly in 2024. In 2022 and 2023, the birth rate had fallen by 8% and 7% respectively compared to the previous year.
Decline in the fertility rate weakened significantly in 2024. (n.d.). Federal Statistical Office. Retrieved August 26, 2025, from https://www.destatis.de/DE/Presse/Pressemitteilungen/2025/07/PD25_259_12.html
a3) 06/2025 "Analysis of 226,395 singleton pregnancies in Israel from 2016 to 2022 shows that COVID-19 vaccination with the first dose at weeks 8 to 13 was associated with an above-expected number of miscarriages of about 13 versus 9 expected cases per 100 exposed pregnancies, i.e. almost 3.9 (95% CI: [2.55-5.14]) additional fetal losses above the expected value per 100 pregnancies. Most of the excess fetal losses occurred after 20 weeks' gestation, with almost half occurring after 25 weeks' gestation. Similarly, women vaccinated at weeks 8-13 with dose 3 had a higher than expected number of miscarriages, with almost 1.9 (95% CI: 0.39-3.42]) additional miscarriages above the expected value per 100 pregnancies.
Guetzkow, Josh & Patalon, Tal & Gazit, Sivan & Høeg, Tracy & Fraiman, Joseph & Segal, Yaakov & Levi, Retsef. (2025). Observed-to-Expected Fetal Losses Following mRNA COVID-19 Vaccination in Early Pregnancy. 10.1101/2025.06.18.25329352. https://www.researchgate.net/publication/392883862_Observed-to-Expected_Fetal_Losses_Following_mRNA_COVID-19_Vaccination_in_Early_Pregnancy
b1) 02/2024 "As shown in Figure 6A, the same pattern can also be observed at the level of correlations with the vaccination rate of a federal state (rate of second vaccinations at the end of the year in the age group 18-59; no more precise age breakdown available) for stillbirths as for excess mortality "
.Kuhbandner, Christof & Reitzner, Matthias. (2024). Differential Increases in Excess Mortality in the German Federal States During the COVID-19 Pandemic. 10.13140/RG.2.2.13098.18880. https://www.researchgate.net/publication/378124684_Differential_Increases_in_Excess_Mortality_in_the_German_Federal_States_During_the_COVID-19_Pandemic
c1) 04/2025 "Our results suggest that both mRNA and inactivated COVID-19 vaccines can impair ovarian reserve in rats, primarily through accelerated follicle loss and alterations in apoptosis signaling pathways during follicle formation. Given these observations in the rat model, further studies on the effects of the vaccines on the human ovarian reserve are needed.
Karaman, E., Yavuz, A., Karakas, E., Balcioglu, E., Karaca, B., Doganay, H. N., Sacinti, K. G., & Yildiz, O. (2025). Impact of mRNA and Inactivated COVID-19 Vaccines on Ovarian Reserve. Vaccines, 13(4), 345. https://doi.org/10.3390/vaccines13040345
https://pubmed.ncbi.nlm.nih.gov/40333243/