The mRNA Vaccine: Clinical Trial on Humans

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  • Source: UncoverDC
  • 09/19/2023

As COVID-19 vaccines—including Moderna and Pfizer-NBioTech's mRNA "gene-therapy" jabs—continue to be promoted and mandated as the primary "treatment" against SARS-CoV-2, other alternative therapies have been around for just as long as the vaccines but have been heavily censored by government agencies. With substantial funding from the U.S. Defense Department's Advanced Research Projects Agency (DARPA) since 2011, mRNA vaccine technology took center stage as a treatment for COVID, with both mRNA "vaccines" receiving Emergency Use Authorization (EUA). Still, one element missing from the emerging treatment was clinical proof of its effectiveness. 

Despite Years of Study, mRNA Vaccines Lacked Trial on Large Scale

A 2017 article published in Nature called "The 'anti-hype' vaccine" starts by remarking that the idea of "vaccines-on-demand" is an "alluring, yet misleadingly simple, concept," adding that "such a vaccine would enable rapid-response agents against pandemic threats." Ignored for years, using RNA as a starting point for immunotherapy "ticks many of the boxes for a vaccine-on-demand offering advantages in manufacture, flexibility, scalability, and cost of goods." Nonethelessclinical validation faced challenging obstacles, "such as antigen discovery, product formulation, and delivery." 

The first mRNA vaccine to be injected into humans was a prostate cancer product developed by CureVac. Despite $110 million in funding from Bill Gates and German billionaire Dietmar Hopp in 2015, the product failed to improve survival over the standard of care in patients with prostate cancer. With sustained interest across the board—including the commitment from DARPA, specifically its Biological Technology Office (BTO) in D.C.— the failure of Curevac's mRNA prostate vaccine didn't stop funding, and research continued. At the time, Matt Hepburn, program manager at DARPA's BTO, whose primary focus is having "platforms in place that can respond quickly in the case of a pandemic," commented:

"We like to think of ourselves as [funders of] early-breakthrough, high-risk, things that would not normally be funded. If you were going to do a safe biomedical research program with incremental approaches to solving a problem, that would not be us. Our mindset, day, night, 24/7, is what do we need to do to be ready for the next pandemic." 

2013 mRNA Pre-Clinical Trial on Rats

mRNA vaccines had their first opportunity to halt a pandemic in 2013 during an outbreak of H7N9, a deadly strain of Asian lineage Avian Influenza A in China. With funding from DARPA and Biomedical Advanced Research and Development Authority (aka BARDA, which supports the application and delivery side as opposed to the development side), scientists at Novartis took a gene sequence deposited in GenBank by the Chinese Center for Disease Control and Prevention and endeavored to make a vaccine "based on the electronic sequence." Andrew Geall, who was managing Novartis's mRNA vaccine program at the time, said:

"We were lucky enough to be collaborating with Craig Venter's teams, so we made a vaccine in 8 days, put it in mice in 13 days, and showed that, indeed, it works." 

Interestingly, Venter's companies, Synthetic Genomics (whose research also focuses on synthetic biofuels and animal products, along with Bill Gates) and Synthetic Genomics Vaccines, began working on "next-generation synthetic RNA replicon platforms" to develop vaccines for livestock in 2017. The same year, Synthetic Genomics partnered with Duke Human Vaccine Institute on DARPA's recently funded Pandemic Prevention Platform (P3), which "aimed at establishing a system capable of halting viral pandemics within 60 days." An October 26, 2017 press release announced:

The Duke Human Vaccine Institute has received a $12.8 million, 30-month grant from the U.S. Department of Defense, Defense Advanced Research Projects Agency (DARPA) to develop a system capable of halting viral pandemics within 60 days.

The program, called DARPA Pandemic Prevention Platform (P3), seeks to combine expertise in virology, immunology and clinical manufacturing to rapidly identify and respond to disease outbreaks such as SARS, pandemic influenza and Zika before they spread widely.

As noted by Geall, the Novartis mRNA vaccine "worked" in that it raised neutralizing antibodies after "one injection of 1 mg and all protect mice had HI titers considered protective after two doses." The study results were thrilling to DARPA, who had just handed its recently funded Moderna Zika program to BARDA. Hepburn stated:

“What you are seeing in the field now is that using a nucleic acid to get the body to do what you want it to do, whether it's a vaccine or other responses, is really exploding. We find that profoundly exciting.”

Human mRNA Clinical Trial Continues

Fast forward three years to 2020 and the introduction of the COVID-19 pandemic, and, even with all of DARPA's research and funding, a system was not in place capable of halting a viral pandemic in three months. As we close in on year two of the pandemic, the safety and efficacy of the two mRNA vaccines against COVID-19 continue to wane, and uncertainty about the vaccines persists. Meanwhile, as promising alternative treatments options remain censored by government agencies, funding for mRNA vaccines and mRNA therapeutics continues to take center stage.

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