Safety of mRNA Vaccines Administered During the First Twenty-Four Months of the International COVID-19 Vaccination Program

Authors

  • Eliana Romero Director of Clinical Research at the Neurodiversity Foundation, https://www.ndfnd.org/home/mission
  • Shawn Fry NeuroDiversity Foundation
  • Brian Hooker Children’s Health Defense Chief Scientific Officer and Biology Professor, Simpson University, Redding, CA

DOI:

https://doi.org/10.56098/ijvtpr.v3i1.70

Keywords:

COVID mRNA vacine, adverse events, myocarditis, menstrual irregularities, cerebrovascular events, whistleblower, VAERS, v-safe, EudraVigilance, DMED

Abstract

Two mRNA-based COVID injectables were granted emergency use authorization in both children and adults in 2021 after an accelerated approval process that allowed the manufacturers to fast-track their products. We analyzed data from regulatory surveillance and self-reporting systems such as Defense Medical Epidemiology Database (DMED); EudraVigilance; Eurostat; German health insurers; the Israeli Ministry of Health; the Natural Cycles App; Public Health Scotland; the United Kingdom’s (UK) Office for National Statistics (ONS); UK’s yellow card reporting system; the Vaccine Adverse Event Reporting System (VAERS); and V-Safe After Vaccination Health Checker entries to find long-term adverse events of the COVID products that cannot be captured during the expedited safety analyses. In this observational study, we analyzed non-foreign VAERS data for selected symptoms reported after COVID, influenza, and pertussis vaccines and calculated rates per dose administered as well as proportion of total reports received. We also looked at DMED data and compared annual incidence rates of selected conditions by taking into account the total number of military personnel for each study-year. Our data show, among other trends, increases in adverse event reports if we compare COVID products to influenza and pertussis vaccines and statistically significant higher numbers of hospital encounters in military personnel, as well as increases in incidences of thromboembolic conditions, such as menstrual abnormalities, myocarditis, and cerebrovascular events after the implementation of COVID injection mandates, compared to the preceding five years. We verified these observations using data from EudraVigilance; the UK’s ONS; German health providers; and Eurostat. Our meta-analysis of both national and international vaccine adverse events emphasizes the importance of re-evaluating public health policies that promote universal mass injection and multiple boosters for all demographic groups. In combination with informal reports from reliable witnesses, limitations of the safety trials, and the decreased lethality of new strains, our research demonstrates that the cost (both monetary and humanitarian) of injecting healthy people, and especially children, outweighs any claimed though unvalidated benefits.

Author Biography

  • Eliana Romero, Director of Clinical Research at the Neurodiversity Foundation, https://www.ndfnd.org/home/mission

    Romero holds a PhD in Molecular and Human Genetics from Baylor College of Medicine. She has worked with some of the top neurogeneticists in the world and has helped dozens of research hospitals, from local to national, from private to public, from novices to leaders in clinical research to improve their operations, designs, and published work.

References

CHMP, C. f. M. P. f. H. U. (2021). Assessment Report COVID-19 Vaccine Moderna. https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf

Abbasi, J. (2020). Younger Adults Caught in COVID-19 Crosshairs as Demographics Shift. JAMA, 324(21), 2141-2143. https://doi.org/10.1001/jama.2020.21913

Alberer, M., Gnad-Vogt, U., Hong, H. S., Mehr, K. T., Backert, L., Finak, G., Gottardo, R., Bica, M. A., Garofano, A., Koch, S. D., Fotin-Mleczek, M., Hoerr, I., Clemens, R., & von Sonnenburg, F. (2017). Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial. Lancet, 390(10101), 1511-1520. https://doi.org/10.1016/S0140-6736(17)31665-3

Avolio, E., Carrabba, M., Milligan, R., Kavanagh Williamson, M., Beltrami, A. P., Gupta, K., Elvers, K. T., Gamez, M., Foster, R. R., Gillespie, K., Hamilton, F., Arnold, D., Berger, I., Davidson, A. D., Hill, D., Caputo, M., & Madeddu, P. (2021). The SARS-CoV-2 Spike protein disrupts human cardiac pericytes function through CD147 receptor-mediated signalling: a potential non-infective mechanism of COVID-19 microvascular disease. Clin Sci (Lond), 135(24), 2667-2689. https://doi.org/10.1042/CS20210735

Bahl, K., Senn, J. J., Yuzhakov, O., Bulychev, A., Brito, L. A., Hassett, K. J., Laska, M. E., Smith, M., Almarsson, O., Thompson, J., Ribeiro, A. M., Watson, M., Zaks, T., & Ciaramella, G. (2022). Preclinical and Clinical Demonstration of Immunogenicity by mRNA Vaccines against H10N8 and H7N9 Influenza Viruses. Mol Ther, 30(8), 2874. https://doi.org/10.1016/j.ymthe.2022.07.013

Ball, P. (2021). The lightning-fast quest for COVID vaccines - and what it means for other diseases. Nature, 589(7840), 16-18. https://doi.org/10.1038/d41586-020-03626-1

Barda, N., Dagan, N., Ben-Shlomo, Y., Kepten, E., Waxman, J., Ohana, R., Hernan, M. A., Lipsitch, M., Kohane, I., Netzer, D., Reis, B. Y., & Balicer, R. D. (2021). Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med, 385(12), 1078-1090. https://doi.org/10.1056/NEJMoa2110475

Bentov, Y., Beharier, O., Moav-Zafrir, A., Kabessa, M., Godin, M., Greenfield, C. S., Ketzinel-Gilad, M., Ash Broder, E., Holzer, H. E. G., Wolf, D., Oiknine-Djian, E., Barghouti, I., Goldman-Wohl, D., Yagel, S., Walfisch, A., & Hersko Klement, A. (2021). Ovarian follicular function is not altered by SARS-CoV-2 infection or BNT162b2 mRNA COVID-19 vaccination. Hum Reprod, 36(9), 2506-2513. https://doi.org/10.1093/humrep/deab182

Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age. (2022, June 17, 2022). https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children

Coronavirus vaccine - summary of Yellow Card reporting. (2022). https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

Costeira, R., Lee, K. A., Murray, B., Christiansen, C., Castillo-Fernandez, J., Ni Lochlainn, M., Capdevila Pujol, J., Macfarlane, H., Kenny, L. C., Buchan, I., Wolf, J., Rymer, J., Ourselin, S., Steves, C. J., Spector, T. D., Newson, L. R., & Bell, J. T. (2021). Estrogen and COVID-19 symptoms: Associations in women from the COVID Symptom Study. PLoS One, 16(9), e0257051. https://doi.org/10.1371/journal.pone.0257051

COVID-19 wider impact on the health care system. (2023). https://scotland.shinyapps.io/phs-covid-wider-impact/

Does the COVID-19 Vaccine Affect Fertility? Here’s What the Experts Say. (2021). MU Healthcare. Retrieved December 1, 2022, from https://www.muhealth.org/our-stories/does-covid-19-vaccine-affect-fertility-heres-what-experts-say

Dugas, C., & Slane, V. H. (2022). Miscarriage. In StatPearls. https://www.ncbi.nlm.nih.gov/pubmed/30422585

Early Pregnancy Loss. (2022, January 2022). The American College of Obstatricians and Gynecologists. Retrieved December 1, 2022 from https://www.acog.org/womens-health/faqs/early-pregnancy-loss

Edelman, A., Boniface, E. R., Benhar, E., Han, L., Matteson, K. A., Favaro, C., Pearson, J. T., & Darney, B. G. (2022). Association Between Menstrual Cycle Length and Coronavirus Disease 2019 (COVID-19) Vaccination: A U.S. Cohort. Obstet Gynecol, 139(4), 481-489. https://doi.org/10.1097/AOG.0000000000004695

Emergency Use Authorization. (2022, 12/08/2022). FDA. Retrieved June 3, 2022 from https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Excess mortality - statistics. (2022). https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Excess_mortality_-_statistics#Excess_mortality_in_the_EU_between_January_2020_and_November_2022

Ferrer-Vaquer, A., & Hadjantonakis, A. K. (2013). Birth defects associated with perturbations in preimplantation, gastrulation, and axis extension: from conjoined twinning to caudal dysgenesis. Wiley Interdiscip Rev Dev Biol, 2(4), 427-442. https://doi.org/10.1002/wdev.97

Fung, G., Luo, H., Qiu, Y., Yang, D., & McManus, B. (2016). Myocarditis. Circ Res, 118(3), 496-514. https://doi.org/10.1161/CIRCRESAHA.115.306573

Halsell, J. S., Riddle, J. R., Atwood, J. E., Gardner, P., Shope, R., Poland, G. A., Gray, G. C., Ostroff, S., Eckart, R. E., Hospenthal, D. R., Gibson, R. L., Grabenstein, J. D., Arness, M. K., Tornberg, D. N., & Department of Defense Smallpox Vaccination Clinical Evaluation, T. (2003). Myopericarditis following smallpox vaccination among vaccinia-naive US military personnel. JAMA, 289(24), 3283-3289. https://doi.org/10.1001/jama.289.24.3283

Heart attack deaths in 2019, 2020, 2021, and 2022. (2022, 7 March 2022). Office for National Statistics. Retrieved January 31, 2023 from https://www.ons.gov.uk/aboutus/transparencyandgovernance/freedomofinformationfoi/heartattackdeathsin201920202021and2022

Hicks, K. H. (2021). Mandatory Coronavirus Disease 2019 Vaccination of DoD Civilian Employees. Retrieved from https://media.defense.gov/2021/Oct/04/2002867430/-1/-1/0/MANDATORY-CORONAVIRUS-DISEASE-2019-VACCINATION-OF-DOD-CIVILIAN-EMPLOYEES-OSD008990-21-RESP-FINAL.PDF

Johnson, R. (2022). In P. S. o. Investigations (Ed.), (pp. 3): Ron Johnson U.S. Senator for Wisconsin.

Kucia, M., Ratajczak, J., Bujko, K., Adamiak, M., Ciechanowicz, A., Chumak, V., Brzezniakiewicz-Janus, K., & Ratajczak, M. Z. (2021). An evidence that SARS-Cov-2/COVID-19 spike protein (SP) damages hematopoietic stem/progenitor cells in the mechanism of pyroptosis in Nlrp3 inflammasome-dependent manner. Leukemia, 35(10), 3026-3029. https://doi.org/10.1038/s41375-021-01332-z

Levin, A. T., Hanage, W. P., Owusu-Boaitey, N., Cochran, K. B., Walsh, S. P., & Meyerowitz-Katz, G. (2020). Assessing the Age Specificity of Infection Fatality Rates for COVID-19: Systematic Review, Meta-Analysis, & Public Policy Implications. NBER Working Paper Series. Retrieved January 31, 2023, from https://www.nber.org/system/files/working_papers/w27597/w27597.pdf

Mascolo, A., di Mauro, G., Fraenza, F., Gaio, M., Zinzi, A., Pentella, C., Rossi, F., Capuano, A., & Sportiello, L. (2022). Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study. Front Immunol, 13, 965171. https://doi.org/10.3389/fimmu.2022.965171

Mason, J. W., O'Connell, J. B., Herskowitz, A., Rose, N. R., McManus, B. M., Billingham, M. E., & Moon, T. E. (1995). A clinical trial of immunosuppressive therapy for myocarditis. The Myocarditis Treatment Trial Investigators. N Engl J Med, 333(5), 269-275. https://doi.org/10.1056/NEJM199508033330501

Mathieu, E., Ritchie, H., Rodés-Guirao, L., Appel, C., Giattino, C., Hasell, J., Macdonald, B., Dattani, S., Beltekian, D., Ortiz-Ospina, E., & Roser, M. (2022, 11/02/2022). Coronavirus (COVID-19) Vaccinations. Our World in Data. https://ourworldindata.org/covid-vaccinations?country=USA

Mevorach, D., Anis, E., Cedar, N., Bromberg, M., Haas, E. J., Nadir, E., Olsha-Castell, S., Arad, D., Hasin, T., Levi, N., Asleh, R., Amir, O., Meir, K., Cohen, D., Dichtiar, R., Novick, D., Hershkovitz, Y., Dagan, R., Leitersdorf, I., . . . Alroy-Preis, S. (2021). Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med, 385(23), 2140-2149. https://doi.org/10.1056/NEJMoa2109730

Military Community Demographics. (2022). Military One Source. Retrieved November 30,2022 from https://www.militaryonesource.mil/data-research-and-statistics/military-community-demographics/

Muhaidat, N., Alshrouf, M. A., Azzam, M. I., Karam, A. M., Al-Nazer, M. W., & Al-Ani, A. (2022). Menstrual Symptoms After COVID-19 Vaccine: A Cross-Sectional Investigation in the MENA Region. Int J Womens Health, 14, 395-404. https://doi.org/10.2147/IJWH.S352167

Ndeupen, S., Qin, Z., Jacobsen, S., Estanbouli, H., Bouteau, A., & Igyarto, B. Z. (2021). The mRNA-LNP platform's lipid nanoparticle component used in preclinical vaccine studies is highly inflammatory. bioRxiv. https://doi.org/10.1101/2021.03.04.430128

Pardi, N., Hogan, M. J., Porter, F. W., & Weissman, D. (2018). mRNA vaccines - a new era in vaccinology. Nat Rev Drug Discov, 17(4), 261-279. https://doi.org/10.1038/nrd.2017.243

Renner, V. (2022). Datenanalyst Tom Lausen: KBV-Daten Belegen Massiven Anstieg Plötzlicher Todesfälle Seit Impfstart. https://report24.news/datenanalyst-tom-lausen-kbv-daten-belegen-massiven-anstieg-ploetzlicher-todesfaelle-seit-impfstart/?feed_id=25562

Schwab, C., Domke, L. M., Hartmann, L., Stenzinger, A., Longerich, T., & Schirmacher, P. (2022). Autopsy-based histopathological characterization of myocarditis after anti-SARS-CoV-2-vaccination. Clin Res Cardiol, 1-10. https://doi.org/10.1007/s00392-022-02129-5

Search the VAERS Database. (2022). https://medalerts.org/vaersdb/index.php

Shimabukuro, T. T., Kim, S. Y., Myers, T. R., Moro, P. L., Oduyebo, T., Panagiotakopoulos, L., Marquez, P. L., Olson, C. K., Liu, R., Chang, K. T., Ellington, S. R., Burkel, V. K., Smoots, A. N., Green, C. J., Licata, C., Zhang, B. C., Alimchandani, M., Mba-Jonas, A., Martin, S. W., . . . Team, C. D. C. v.-s. C.-P. R. (2021). Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. N Engl J Med, 384(24), 2273-2282. https://doi.org/10.1056/NEJMoa2104983

Shirbhate, E., Pandey, J., Patel, V. K., Kamal, M., Jawaid, T., Gorain, B., Kesharwani, P., & Rajak, H. (2021). Understanding the role of ACE-2 receptor in pathogenesis of COVID-19 disease: a potential approach for therapeutic intervention. Pharmacol Rep, 73(6), 1539-1550. https://doi.org/10.1007/s43440-021-00303-6

Smith, D. J. (2020). Coronavirus Disease 2019 Vaccine Guidance. Retrieved from https://media.defense.gov/2020/Dec/08/2002548508/-1/-1/0/CORONAVIRUS-DISEASE-2019-VACCINE-GUIDANCE.PDF

Statistics Kingdom. (2022). Retrieved February 3, 2023 from https://www.statskingdom.com/p_value.html

Sun, C. L. F., Jaffe, E., & Levi, R. (2022). Increased emergency cardiovascular events among under-40 population in Israel during vaccine rollout and third COVID-19 wave. Sci Rep, 12(1), 6978. https://doi.org/10.1038/s41598-022-10928-z

Surveillance of Myocarditis (Inflammation of the Heart Muscle) Cases Between December 2020 and May 2021 (Including). (2021, 02.06.2021). Israel Ministry of Health. https://www.gov.il/en/departments/news/01062021-03

Thacker, P. D. (2021). Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial. BMJ, 375, n2635. https://doi.org/10.1136/bmj.n2635

Thorp, J. A., Renz, T., Northrup, C., Lively, C., Breggin, P., & Bartlett, R. (2022). Patient Betrayal: The Corruption of Healthcare, Informed Consent and the Physician-Patient Relationship. The Gazette of Medical Sciences, 3(1), 46-69. https://doi.org/10.46766/thegms.medethics.22021403

Towbin, J. A., Lowe, A. M., Colan, S. D., Sleeper, L. A., Orav, E. J., Clunie, S., Messere, J., Cox, G. F., Lurie, P. R., Hsu, D., Canter, C., Wilkinson, J. D., & Lipshultz, S. E. (2006). Incidence, causes, and outcomes of dilated cardiomyopathy in children. JAMA, 296(15), 1867-1876. https://doi.org/10.1001/jama.296.15.1867

Trogstad, L. (2022). Increased Occurence of Menstrual Disturbances in 18- to 30-Year-Old Women After COVID-19 Vaccination. SSRN. https://ssrn.com/abstract=3998180

V-Safe After Vaccination Health Checker for COVID-19 Vaccine. (2022). Centers for Disease Control and Prevention. Retrieved November 30, 2022 from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html

The Vaccine Adverse Event Reporting System (VAERS) Request. (2022). https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=C5FD04572F907F7F4AEACA04CDC3

Wesselink, A. K., Wise, L. A., Hatch, E. E., Rothman, K. J., Mikkelsen, E. M., Stanford, J. B., McKinnon, C. J., & Mahalingaiah, S. (2016). Menstrual cycle characteristics and fecundability in a North American preconception cohort. Ann Epidemiol, 26(7), 482-487 e481. https://doi.org/10.1016/j.annepidem.2016.05.006

Winter, L. (2021). Scientists Reverse Engineer mRNA Sequence of Moderna Vaccine [News & Opinion]. The Scientist. https://www.the-scientist.com/news-opinion/scientists-reverse-engineer-mrna-sequence-of-moderna-vaccine-68640

Witberg, G., Barda, N., Hoss, S., Richter, I., Wiessman, M., Aviv, Y., Grinberg, T., Auster, O., Dagan, N., Balicer, R. D., & Kornowski, R. (2021). Myocarditis after Covid-19 Vaccination in a Large Health Care Organization. N Engl J Med, 385(23), 2132-2139. https://doi.org/10.1056/NEJMoa2110737

Downloads

Published

2023-04-11

How to Cite

Safety of mRNA Vaccines Administered During the First Twenty-Four Months of the International COVID-19 Vaccination Program. (2023). International Journal of Vaccine Theory, Practice, and Research , 3(1), 891-910. https://doi.org/10.56098/ijvtpr.v3i1.70

Similar Articles

11-20 of 36

You may also start an advanced similarity search for this article.

Most read articles by the same author(s)

1 2 3 4 5 6 > >>