Earlier this week, the United Kingdom became the first country to approve Moderna’s reformulated version of its COVID-19 vaccine, which claims to provide protection against both the original form of the virus and the significantly less lethal but more transmissible Omicron variant. The product was approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) with the support of the UK government’s Commission on Human Medicines.
Described by UK officials as a “sharpened tool” in the nation’s continued vaccination campaign, the reformulated vaccine combines the previously approved COVID-19 vaccine with a “vaccine candidate” targeting the Omicron variant BA.1. That vaccine candidate has never been previously approved and has not been the subject of independent study. The MHRA approved the vaccine based on a single, incomplete human trial currently being conducted by Moderna. The company promoted incomplete data from that trial in company press releases in June and July. The study has yet to be published in a medical journal or peer reviewed. No concerns have been raised by any regulatory agency, including the MHRA, regarding Moderna’s past history of engaging in suspect and likely illegal activity in past product trials, including for its original COVID-19 vaccine.
The approval comes shortly before several Western countries, including the UK, plan to conduct a massive COVID-19 booster vaccination campaign this fall. Moderna has also noted that approval for its Omicron booster vaccine are pending in the US, EU, Australia and Canada – all of which are also planning fall vaccination campaigns focused on COVID-19. The company’s CEO, Stéphane Bancel, has called the reformulated vaccine “our lead candidate for a Fall 2022 booster.”
However, unlike the company’s original COVID-19 vaccine, the genetic material, or messenger RNA (mRNA), for this new vaccine, including the newly formulated genetic material meant to provide protection against the Omicron variant, is being manufactured, not by Moderna, but by a relatively new company that has received hardly any media attention, despite its overt links to US intelligence. Last September, it was quietly announced that a company called National Resilience (often referred to simply as Resilience) would begin manufacturing the mRNA for Moderna COVID-19 vaccine products. Under the terms of the multi-year agreement, “Resilience will produce mRNA for the Moderna COVID-19 vaccine at its facility in Mississauga, Ontario, for distribution worldwide.”
National Resilience was founded relatively recently, in November 2020, and describes itself as “a manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.” It has since been building “a sustainable network of high-tech, end-to-end manufacturing solutions with the aim to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale.” It furtherplans to “reinvent biomanufacturing” and “democratize access to medicines,” namely gene therapies, experimental vaccines and other “medicines of tomorrow.”
In pursuit of those goals, the company announced it would “actively invest in developing powerful new technologies to manufacture complex medicines that are defining the future of therapeutics, including cell and gene therapies, viral vectors, vaccines, and proteins.” It was founded with the reported intention “to build a better system for manufacturing complex medicines to fight deadly diseases” as a way to improve post-COVID “pandemic preparedness.”
The company initially marketed its manufacturing capabilities as “the Resilience platform”, and offers principally “RNA Modalities”, including RNA development for vaccines, gene editing and therapeutics; and “Virus Production”, including viral vectors, oncolytic viruses (i.e. a virus engineered to preferentially attack cancer cells), viruses for use in vaccine development and gene-edited viruses for unspecified purposes. It is worth noting that, to date, many controversial “gain-of-function” experiments have justified modifying viruses for the same purposes as described by National Resilience’s Virus Production capabilities. In addition, National Resilience offers product formulations and other modalities, such as biologics and cell therapies, to its clientele and the “Virus Production” of its website has since been removed.
National Resilience, being such a young company, has very few clients and there is little publicly available information on its manufacturing capabilities aside from the company’s website. The firm only acquired its first commercial manufacturing plant in March 2021, located in Boston, MA and purchased from Sanofi, followed shortly thereafter by the acquisition of another separate plant located in Mississauga, Ontario, Canada. Makeovers were announced for the plants, but little is publicly known about their progress. Prior to the acquisitions, the company had been subleasing a Bay area facility in Fremont, California. Reporters were puzzled at the time as to why a company with roughly 700 employees at the time had acquired a total of 599,00 square feet of manufacturing space after having only emerged from stealth less than 6 months prior.
In April 2021, National Resilience acquired Ology Bioservices Inc., which had received a $37 million contract from the US military the previous November to develop an advanced anti-COVID-19 monoclonal antibody treatment. This acquisition also provided National Resilience with its first Biosafety Level 3 (BSL-3) laboratory and the ability to manufacture cell and gene therapies, live viral vaccines and vectors and oncolytic viruses.
Despite being in the earliest stages of developing its “revolutionary” manufacturing capabilities, National Resilience entered into a partnership with the Government of Canada in July of last year. Per that agreement, the Canadian government plans to invest CAD 199.2 million (about $154.9 million) into National Resilience’s Ontario-based subsidiary, Resilience Biotechnologies Inc. Most of those funds are destined for use in expanding the Ontario facility that Resilience acquired last March and which is now manufacturing the mRNA for Moderna’s COVID-19 products. Canada’s Minister of Innovation, Science and Industry, François-Philippe Champagne, asserted at the time that the investment would “build future pandemic preparedness” and help “to grow Canada’s life science ecosystem as an engine for our economic recovery.” More recently, in 2022, the company has announced a few new clients – Takeda, Opus Genetics and the US Department of Defense.
According to National Resilience’s executives, the company’s ambitions apparently go far beyond manufacturing RNA and viruses. For instance, Resilience CEO Rahul Singhvi has claimed that the company is seeking to build “the world’s most advanced biopharmaceutical manufacturing ecosystem.” Yet, Singhvi has declined to offer much in the way of specifics when it comes to exactly how the company plans to become the planet’s most elite biomanufacturing company.
In an interview with The San Francisco Business Times, Singhvi states that Resilience is looking to fill its massive manufacturing plants with “technologies and people that can set and apply new standards for manufacturing cell therapies and gene therapies as well as RNA-based treatments.” Prior to Resilience, Singhvi was CEO of NovaVax and an operating partner at Flagship Pioneering, which played a major role in the creation and rise of Moderna.
Singhvi has further insisted that National Resilience is “not a therapeutics company, not a contractor and not a tools company” and instead aims “to boost production using the new therapeutic modalities” such as RNA-based treatments, which have become normalized in the COVID-19 era. Whereas contract manufacturers “are like kitchens, with pots and pans ready for any recipe,” “what we’re trying to do is fix the recipes,” Singhvi has explained. One member of Resilience’s board of directors, former FDA Commissioner and Pfizer Board member Scott Gottlieb, has described the company as seeking to act as the equivalent of Amazon Web Services for the biotechnology industry.
Essentially, Resilience bills itself as offering solutions that will allow “futuristic” medicines, including mRNA vaccines, to be produced more quickly and more efficiently, with the apparent goal of monopolizing certain parts of the biomanufacturing process. It also appears poised to become the manufacturer of choice for mRNA vaccines and experimental therapeutics in the event of a future pandemic, which some public health “philanthropists” like Bill Gates have said is imminent.
Perhaps the company’s most noteworthy ambition relates to their claims that they support clients through the government regulatory process. Given the company’s emphasis on speedy mass production of experimental gene therapies, its stated intention of getting the “futuristic” medical products it manufactures to market as quickly as possible seems at odds with the slower, traditional regulatory processes. Indeed, one could easily argue that the approvals of mRNA vaccines for the first time in human history during the COVID-19 crisis were only possible because of the major relaxing of regulatory procedurse and safety testing due to the perceived urgency of the situation.
Resilience seems intent on seeing that phenomenon repeat itself. As previously mentioned, the company claims to allow for the setting and application of “new standards for manufacturing cell therapies and gene therapies” and also says it plans to become a “technology-aggregating standards bearer that helps therapies come to market more efficiently.” It previously offered on its website “regulatory support” and “strategy consulting” to clients, suggesting that it would seek to mediate between clients and government regulators in order to fulfill its goal of having the products it manufactures taken to market more quickly. In addition, upon launch, the company claimed it planned to obtain unspecified “regulatory capabilities.” If so, it is certainly notable that former top Food and Drug Administration (FDA) officials are either on the company’s board or, as will be noted shortly, played a major role in the company’s creation.
The People Behind Resilience
Resilience was co-founded by Biotech venture capitalist Robert Nelsen, who is known for listening “to science’s earliest whispers, even when data are too early for just about anyone else.” Nelsen was one of the earliest investors in Illumina, a California-based gene-sequencing hardware and software giant that is believed to currently dominate the field of genomics. As mentioned in a previous Unlimited Hangout investigation, Illumina is closely tied to the DARPA-equivalent of the Wellcome Trust known as Wellcome Leap, which is also focused on “futuristic” and transhumanist “medicines.” Nelsen is now chairman of National Resilience’s board, which is a “Who’s Who” of big players from the US National Security State, Big Pharma and Pharma-related “philanthropy.”
However, while Nelsen has been given much of the credit for creating Resilience, he revealed in one interview that the idea for the company had actually come from someone else – Luciana Borio. In July of last year, Nelsen revealed that it was while talking to Borio about “her work running pandemic preparedness on the NSC [National Security Council]” that had “helped lead to the launch of Nelsen’s $800 million biologics manufacturing startup Resilience.”
At the time of their conversation, Borio was the vice president of In-Q-tel, the venture capital arm of the CIA that has been used since its creation in the early 2000s to found a number of companies, many of which act as Agency fronts. Prior to In-Q-Tel, she served as director for medical and biodefense preparedness at the National Security Council during the Trump administration and had previously been the acting chief scientist at the FDA from 2015 to 2017.
Borio is currently a senior fellow for global health at the Council on Foreign Relations, a consultant to Goldman Sachs, a member of the Bill Gates-funded vaccine alliance CEPI, and a partner at Nelsen’s venture capital firm ARCH Venture Partners, which funds Resilience. Nelsen’s ARCH previously funded Nanosys, the company of the controversial scientist Charles Lieber. Around the time of her conversation with Nelsen that led to Resilience’s creation, Borio was co-writing a policy paper for the Johns Hopkins Center for Health Security that recommended linking COVID-19 vaccination status with food stamp programs and rent assistance as a possible means of coercing certain populations to take the experimental vaccine.
Borio is hardly Resilience’s only In-Q-Tel connection, as the CEO of In-Q-Tel, Chris Darby, sits on the company’s board of directors. Darby is also on the board of directors of the CIA Officers Memorial Foundation. Darby was also recently a member of the National Security Commission on Artificial Intelligence (NSCAI), where members of the military, intelligence community and Silicon Valley’s top firms argued for the need to reduce the use of “legacy systems” in favor of AI-focused alternatives as a national security imperative. Among those “legacy systems” identified by the NSCAI were in-person doctor visits and even receiving medical care from a human doctor, as opposed to an AI “doctor.” The NSCAI also argued for the removal of “regulatory barriers” that prevent these new technologies from replacing “legacy systems.”
Another notable board member, in discussing Resilience’s intelligence ties, is Drew Oetting. Oetting works for Cerberus Capital Management, the firm headed by Steve Feinberg who previously led the President’s Intelligence Advisory Board under the Trump administration. Cerberus is notably the parent company of DynCorp, a controversial US national security contractor tied to numerous scandals, including scandals related to sex trafficking in conflict zones. Oetting is also part of the CIA-linked Thorn NGO ostensibly focused on tackling child trafficking that was the subject of a previous Unlimited Hangout investigation.
Oetting is also the co-founder of 8VC, a venture capital firm that is one of the main investors in Resilience. 8VC’s other co-founder is Joe Lonsdale and Oetting “started his career” as Lonsdale’s chief of staff. Lonsdale is the co-founder, alongside Peter Thiel and Alex Karp, of Palantir, a CIA front company and intelligence contractor that is the successor to DARPA’s controversial Total Information Awareness (TIA) mass surveillance and data-mining program. In addition, Oetting previously worked for Bill Gates’ investment fund.
Also worth noting is the presence of Joseph Robert Kerrey, former US Senator for Nebraska and a former member of the conflict-of-interest-ridden 9/11 Commission, on Resilience’s board. Kerrey is currently managing director of Allen & Co., a New York investment banking firm that has hosted an annual “summer camp for billionaires” since 1983. Allen & Co. has long been a major player in networks where organized crime and intelligence intersect, and is mentioned repeatedly throughout my upcoming book One Nation Under Blackmail. For instance, Charles and Herbert Allen, who ran the firm for decades, had considerable business dealings with organized crime kingpins and frontmen for notorious gangsters like Meyer Lansky, particularly in the Bahamas. They were also business partners of Leslie Wexner’s mentors A. Alfred Taubman and Max Fisher as well as associates of Earl Brian, one of the architects of the PROMIS software scandal – which saw organized crime and intelligence networks cooperate to steal and then compromise the PROMIS software for blackmail and clandestine intelligence-gathering purposes. Allen & Co. was a major investor in Brian’s business interests in the technology industry that Brian used in attempts to bankrupt the developers of PROMIS, Inslaw Inc. and to market versions of PROMIS that had been compromised first by Israeli intelligence and, later, the CIA.
In addition to these intelligence-linked individuals, the rest of Resilience’s board includes the former CEO of the Bill & Melinda Gates Foundation, Susan Desmond-Hellmann; former FDA Commissioner and Pfizer board member, Scott Gottlieb; two former executives at Johnson & Johnson; former president and CEO of Teva Pharmaceuticals North American branch, George Barrett; CalTech professor and board member of Alphabet (i.e. Google) and Illumina, Frances Arnold; former executive at Genentech and Merck, Patrick Yang; and Resilience CEO Rahul Singhvi.
To Boost or Not to Boost
It is certainly telling that the normal publicity-hungry Moderna has said so little about its partnership with Resilience and that Resilience, despite its ambitious plans, has also avoided the media limelight. Considering Moderna’s history and Resilience’s connections, there may be more to this partnership than meets the eye and concerned members of the public would do well to keep a very close eye on Resilience, its partnerships, and the products it is manufacturing.
Given that we now live in a world where government regulatory decisions on the approval of medicines are increasingly influenced by corporate press releases and normal regulatory procedures have fallen by the wayside for being too “slow,” there is likely to be little scrutiny of the genetic material that Resilience produces for the “medicines of tomorrow.” This seems to be already true for Moderna’s recently retooled COVID-19 vaccine, as there has been no independent examination of the new genetic sequence of mRNA used in the Omicron-specific vaccine candidate or its effects on the human body in the short, medium or long-term. For those who are skeptical of the outsized role that intelligence-linked companies are playing in the attempted technological “revolution” in the medical field, it is best to consider Resilience’s role in the upcoming fall vaccination campaign and in future pandemic and public health scenarios before trying its “futuristic” products.