Overview of Covid-19 Injections:
Experimental Covid-19 injections are currently administered under “emergency use authorization” (United States), “conditional marketing authorization” (European Union), “provisional approval” (Australia and New Zealand), and similar emergency provisions in other countries. National regulatory agencies granted the authorizations following abbreviated clinical trials and without long-term safety testing.
In the U.S., three injections have emergency use status: the messenger RNA (mRNA) injections developed by (1) Pfizer with German partner BioNTech and (2) biotechnology firm Moderna in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and (3) the adenovirus-vectored injection made by Janssen, a Johnson & Johnson (J&J) subsidiary. None has, as yet, received full approval, but the Food and Drug Administration (FDA) declares it is “pulling out all the stops” to fully approve the Pfizer/BioNTech injection by early September 2021.1 Moderna and J&J are also preparing to seek full approval.
Outside the U.S., many OECD countries have also “conditionally” authorized the Oxford/AstraZeneca injection, which, like J&J’s shot, uses an adenovirus vector. The World Health Organization lists all four injections (plus China’s Sinopharm) for emergency use globally.
Though marketed as “vaccines,” both types of Covid-19 injections (mRNA and adenovirus) are experimental gene therapy. All four injections share the same end goal of getting genetic instructions into a person’s cells and “tricking” the cells into making coronavirus spike protein.
mRNA injections: Vaccine developers openly describe the never-before-authorized mRNA approach as a means of “programming a person’s cells”2 or (using Moderna’s terminology) deploying new “software.”3 From their inception, mRNA injections have displayed an intrinsic inflammatory component.4 Both mRNA injections use lipid nanoparticles (LNPs) as an in-built “gene delivery” or “carrier” system that transports synthetic mRNA into the cytoplasm; the LNPs not only shield the mRNA and promote cellular uptake but also function as adjuvants, “revving up” the immune system. The LNPs are coated with polyethylene glycol (PEG), a controversial polymer—synthetic and nondegradable—associated with adverse immune responses. Moderna has acknowledged that the LNPs “could lead to significant adverse events,”5 and FDA has identified PEG as the likely culprit responsible for anaphylactic reactions.6
The expert group Doctors for COVID Ethics cites existing pharmacokinetic evidence and warns that the mRNA injections can be expected to cause blood clotting, grave harm to female fertility and to breastfed infants, and cumulative toxicity after multiple injections.7 Immunologist Bart Classen—who cautions that adverse events can occur several years after vaccination—is concerned that the mRNA injections could create new mechanisms of harm as well as prion-like neurodegenerative diseases like Parkinson’s.8 Since the injections’ U.S. debut, thousands of Americans have reported serious reactions.9
Adenovirus vector injections: Instead of mRNA, the J&J and AstraZeneca injections use genetically modified common cold viruses as a Trojan horse to “shuttle” spike protein DNA (genetic instructions) into the cells. Studied for several decades, adenovirus-vectored injections have a “checkered past” as a “failed gene therapy.”10 In late 2019, FDA approved an adenovirus-vectored Ebola vaccine, and the technology has also been deployed in experimental Zika and HIV vaccines,11 but J&J’s Covid-19 injection is the first to be authorized (on an emergency basis) for general population use.12 Both the J&J and AstraZeneca injections contain polysorbate 80, which is structurally similar to PEG and has been associated with hypersensitivity reactions, including anaphylaxis.13 Adverse event reports following J&J injections have forced FDA to issue warnings about potentially fatal blood clots and Guillain-Barré syndrome (GBS), a condition involving peripheral nerve damage.14 Many individuals have also reported blood clots following AstraZeneca injections. The Oxford/AstraZeneca research team had to call several time-outs during clinical trials after trial participants developed transverse myelitis, a condition, like GBS, that produces nerve damage.15 Two-thirds who experience transverse myelitis remain permanently disabled; 4% to 7% of those who develop GBS die.
Adverse Event Reporting and Databases:
In the months since the Covid-19 injections’ rollout, national databases in the U.S. and Europe have received tens of thousands of reports of adverse events.16 These numbers are sure to vastly undercount vaccine injuries because both are “passive” reporting systems (i.e., systems that rely on the willingness and ability of injured individuals and health care professionals to submit reports). The following is a selected list of databases that make adverse event reports available to the public:
Vaccine Adverse Event Reporting System (VAERS), Department of Health and Human Services (U.S.)
VAERS is a voluntary reporting system co-administered by the CDC and FDA. Dr. Sherri Tenpenny estimates that VAERS data represent approximately 10% of actual adverse events. A Harvard study commissioned in 2010 by the federal government produced an even lower estimate, concluding that less than 1% of adverse events get reported.17 It has been estimated that VAERS is about nine weeks behind in publishing adverse events reported following Covid-19 injections.18
VAERS reports are accessible through the CDC Wonder search engine or through the more user-friendly MedAlerts search engine maintained by the National Vaccine Information Center (NVIC). MedAlerts also offers more powerful search capabilities and more extensive reporting.
EudraVigilance (27 European countries), European Medicines Agency
The European Medicines Agency maintains a database of suspected adverse drug reactions accessible to the general public (see box for “Healthcare professionals, patients and the general public”). Under the letter “C,” reports can be generated for the various Covid-19 injections.
VaxxTracker offers “a safe place to report negative side-effects” of Covid-19 injections and “acts independently from all government, pharmaceutical, or lobbying groups.” Currently, about 80% of all records on the site are imported from VAERS, while the remainder are entered directly by physicians and the public. The site’s Covid-19 statistics page groups adverse events into about 20 different categories.
UK Medical Freedom Alliance (UKMFA) (global)
The UKMFA publishes a physician-compiled weekly round-up of COVID-19 vaccine safety reports and news. See “Vaccine Safety Update Weekly Reports – The Daily Sceptic” and “UKMFA Collated Data – Adverse Reactions Summary document” (the latter collates media reports of adverse events from around the world and is regularly updated).
Additional reporting and compilations of adverse event data are available at:
Children’s Health Defense: https://childrenshealthdefense.org/
The COVID Blog: https://thecovidblog.com/
Vaccine Impact News: https://vaccineimpact.com/
Comprehensive, high-integrity medical and scientific information, including briefs and reports summarizing what is known about the risks of Covid-19 injections and adverse events, is available (and routinely updated) at the following websites:
America’s Frontline Doctors (AFLDS): AFLDS’ website includes information about Covid-19 treatments, “issue briefs” on post-vaccination complications and other topics, and numerous other resources.
Doctors for COVID Ethics (D4CE): Among the excellent resources provided by this group of doctors and scientists from 30 countries are “Letter to physicians: Four new scientific discoveries regarding the safety and efficacy of COVID-19 vaccines,” which warns that “all physicians must reconsider the ethical issues surrounding COVID-19 vaccination,” and a 23-page Expert Statement outlining the serious risks of the Pfizer injection (European brand name Comirnaty) in children.
Children’s Health Defense (CHD): In addition to reporting on vaccine safety topics via its flagship online news outlet The Defender, CHD offers a “Fighting COVID Mandates” toolkit and related resources, a series of eBooks (including eBooks on vaccine mandates and protection of individual rights), a research library, and a “Community Corner.”
2. See “COVID-19 vaccine candidates show gene therapy is a viable strategy.” American Society of Gene + Cell Therapy, November 17, 2020. https://www.asgct.org/research/news/november-2020/covid-19-moderna-nih-vaccine.
7. See Michael Palmer and Sucharit Bhakdi, “The Pfizer mRNA vaccine: pharmacokinetics and toxicity,” Doctors for COVID Ethics, July 23, 2021, https://doctors4covidethics.org/the-pfizer-mrna-vaccine-pharmacokinetics-and-toxicity/.
8. See https://scivisionpub.com/pdfs/covid19-rna-based-vaccines-and-the-risk-of-prion-disease-1503.pdf and https://scivisionpub.com/pdfs/covid19-vaccine-associated-parkinsons-disease-a-prion-disease-signal-in-the-uk-yellow-card-adverse-event-database-1746.pdf.
9. See, for example, https://childrenshealthdefense.org/defender/doctors-ethics-halt-pfizer-covid-vaccines-adolescents/ and https://childrenshealthdefense.org/defender/rfk-jr-the-defender-podcast-dr-charles-hoffe-adverse-health-effects-covid-vaccine/.
11. See Buchbinder et al., “Use of adenovirus type-5 vectored vaccines: a cautionary tale,” published in The Lancet in October 2020: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32156-5/fulltext.
13. See https://childrenshealthdefense.org/defender/inactive-ingredients-covid-vaccines-allergic-reactions/.
14. See https://childrenshealthdefense.org/defender/fda-warning-jj-vaccine-serious-rare-autoimmune-disorder/.
16. As of July 23, 2021, well over half a million adverse events (n=518,770) had been reported to VAERS (including “foreign reports” estimated to be 10% of the total); these include nearly 12,000 deaths, 20% of which occurred within 48 hours of injection (see https://childrenshealthdefense.org/defender/vaers-cdc-vaccinated-spread-covid-serious-vaccines-injuries-surge/). Through July, injury reports published by EudraVigilance for 27 European countries had reached nearly two million (n=1,960,607), including 20,525 deaths (see https://healthimpactnews.com/2021/20595-dead-1-9-million-injured-50-serious-reported-in-european-unions-database-of-adverse-drug-reactions-for-covid-19-shots/). See also, https://doctors4covidethics.org/us-adverse-events-by-symptom-across-vaccines/.
18. See VAERS Analysis, June 23, 2021, https://vaersanalysis.info/2021/06/23/what-is-the-backlog-in-terms-of-time-for-the-publishing-of-vaers-records-for-covid-19-vaccines/.