The “Risk Factors” section of Moderna’s Form 10-K filing for the fiscal year ending December 31, 2021, is alarming for anyone who received the pharmaceutical giant’s mRNA gene-therapy jab. Filed with the U.S. Securities and Exchange Commission (SEC) to inform current shareholders or potential investors about Moderna’s performance, the 37-page section of the 160-page filing discloses the uncertainty surrounding the company’s COVID-19 “investigational medicines” and mRNA technology in general—which the company calls “the software of life.” Other sections are equally revealing and emphasize Moderna’s unwavering goal of advancing mRNA technologies that facilitate the future development of gene-therapy medicines for myriad applications.
Highlighting Moderna’s nearly ten-year obsession with mRNA technology, the filing states that, in strategic alliance with the Defense Advanced Research Projects Agency (DARPA), Moderna (trade symbol MRNA) has been working on messenger RNA therapeutics since its “first modality”—prophylactic vaccines. A 2013 Moderna press release reveals the then three-year-old company received up to $25 million from DARPA to expand the “revolutionary new treatment modality” of mRNA products. The SEC filing clarifies that “modality” refers to technologies it believes “could enable a new group of potential mRNA medicines with shared product features.” Currently, Moderna has seven modalities, which include mRNA-based cancer vaccines. The company explains its potential advantages in these areas, stating:
“Our potential advantages in these areas include: (1) mRNA can produce hard-to-make or complex proteins, (2) mRNA can replace defective genes, and (3) LNP (lipid nano-particle) delivery allows for repeat dosing.”
Strategic Foundation Alliances
Finally, Moderna’s collaboration with research institutes and foundations includes the Institute for Life Change Medicines (ILCM) and The Bill and Melinda Gates Foundation. In Sept. 2021, Moderna entered into an agreement with ILCM to develop a new mRNA therapeutic for Crigler-Najjar Type I (CN-1). The Filing reports ILCM received no upfront fees or downstream payments from Moderna and will be responsible for the clinical development of the new drug.
Collaborating on mRNA schemes for more than five years, Moderna and The Bill and Melinda Gates Foundation entered into a “global health project framework agreement” in Jan. 2016 to advance mRNA-based development projects for various infectious diseases. Gates committed up to $20 million in grant funding to support Moderna’s initial project linked to the evaluation of antibody combinations in a preclinical setting as well as the conduct of a first-in-human Phase 1 clinical trial of a potential mRNA medicine to help prevent HIV infections.
Notably, Moderna’s CEO Stéphane Bancel and Bill Gates were two of the “health, medicine, and biopharma leaders” attending the World Economic Forum’s (WEF) annual meeting in Jan. 2019, along with WHO Director-General Tedros Adhanom Ghebreyesus. President Trump, Frances Collins, Mike Pompeo, Steve Mnuchin and other U.S. leaders canceled their trips. The pre-pandemic meeting focused on progress in vaccine development and financial investments in global health. With that target in mind, global health experts discussed appropriate actions to confront new biological threats not yet been identified, which they called “Disease X.” Elaborating on the Gates Foundation’s continuing relationship with Moderna, the filing states:
“Follow-on projects, which could bring total potential funding under the framework agreement up to $100 million (including the HIV antibody project) to support the development of additional mRNA-based projects for various infectious diseases, can be proposed and approved until the sixth anniversary of the framework agreement, subject to the terms of the framework agreement, including our obligation to grant to the Bill & Melinda Gates Foundation certain non-exclusive licenses.”
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With over 170 issued or allowed U.S. patents or applications (some related to COVID-19 and facing lawsuits) and more than 110 granted or allowed patents outside of the U.S. (and over 430 additional patents pending), Moderna assumes no accountability for the risk factors associated with its products. This lack of liability includes its FDA fast-tracked mRNA-based COVID-19 “vaccine,” which the filing declares is Moderna’s only commercial product and source of product revenues.
The filing explains that mRNA drug development faces many obstacles, including substantial clinical and regulatory risks, as well as the “negative perception” of the “efficacy, safety, or tolerability of any investigational medicines.” Moreover, if labeled as “gene therapy” by the FDA, mRNA drugs may be subject to additional regulatory requirements.Undoubtedly, the question of whether it is possible to safely and efficiently get genetic material (polynucleotides) into the nucleus of the majority of cells in the human body to halt illness (for COVID-19, this experimentation is being done via Moderna’s synthetic mRNA spike protein) or so that any genetic defect (or transhuman genetic improvements) can be made leaves many experts, including Dr. Robert Malone, shouting “stop.” Importantly, Malone insists that these synthetic mRNA-like molecules may account for many unusual effects and “striking adverse events” associated with this new class of “vaccines.” He explains:
“This is why there is so much concern about the possibility that the mRNA-like polynucleotides used in the ‘RNA vaccines’ may travel into the nucleus (where the DNA chromosomes reside) and insert or recombine with a cellular genome after reverse transcription (RNA->DNA). Normally, with DNA-based gene therapy technologies, the FDA requires genotoxicity studies for this reason, but the FDA did not treat the ‘mRNA vaccine” technology as a gene therapy product’.“
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With the recent reporting of Moderna recalling thousands of COVID jabs in Europe due to contamination, the company explains it faces “intense competition” concerning its COVID-19 jab, and its “vaccine” may not “continue to compete favorably with existing or future products.”
Indeed, the emergency use authorization (EUA) of Moderna and Pfizer’s “vaccines” rushed them into the market and was based on the FDA’s determination that there were no existing effective treatments for COVID. Still, Moderna’s filing points out that competitor vaccines, or other treatments, may prove to be safer, more effective, more convenient, have fewer side effects, be easier to ship or distribute, or be developed at a lower cost than its vaccine. Ivermectin and Hydroxychloroquine, which government experts and legacy news outlets immediately censored, are two such treatments that come to mind. The filing explains:
“The actual or perceived success or failure of other entities may adversely impact our ability to commercialize our COVID-19 vaccine. We also will face competition from products that have already been approved and accepted by the medical community for the treatment of conditions we target.”
In addition to safety and efficacy concerns, the exhaustive list of risk factors associated with Moderna’s mRNA “investigational products” covers everything from production flaws to potential bribery, cyberattacks, and climate change. However, many experts insist the most considerable risk is the ongoing mRNA COVID-19 gene therapy experiment itself.
Thanks to DARPA, the FDA, NIH, the World Economic Forum (WEF), and the World Health Organization (WHO), the current COVID-19 “vaccine” experimentation on humanity—which Moderna hopes will soon include infants and young children—undeniably lays the foundation for The Great Reset. Many argue that the goal is to advance mRNA technology while people fear COVID-19. Keenly aware of the uncertainty and the possibility of its collapse, Moderna states in the filing:
“Certain features in our development candidates and investigational medicines, including those related to mRNA, chemical modifications, surface chemistries, LNPs, and their components, may result in risks that apply to some or all of our programs and modalities. As our development candidates and investigational medicines progress, we or others may determine that:
certain of our risk allocation decisions were incorrect or insufficient;
we made platform-level technology mistakes;
individual programs or our mRNA science in general has technology or biology risks that were unknown or under-appreciated;
our choices on how to develop our infrastructure to support our scale will result in an inability to manufacture our investigational medicines for clinical trials or otherwise impair our manufacturing;
or we have allocated resources in such a way that we cannot recover large investments or rapidly re-direct capital.
As we progress our programs through clinical development, new technical challenges may arise that cause an entire modality to fail. Additionally, any portfolio spanning risks, whether known or unknown, if realized in any one of our programs, would have a material and adverse effect on our other programs and on our business as a whole.”