Is the drug industry being nationalized right beneath our noses?

Why is the government ordering boosters when nobody wants them?

COVID boosters have not precisely been selling like hotcakes over the past year, but that hasn’t deterred the government from placing its orders for the coming fall booster stock. On June 7, the FDA made up its mind about which strain pharmaceutical companies should focus on, deciding that manufacturers should target the JN.1 variant.

This variant was dominant toward the beginning of 2024; by now, however, it is estimated to account for only 3.1 percent of COVID cases. Meanwhile, other variants are taking over, especially the KP.2 and KP.3 variants which together account for almost half of all diagnosed cases.

According to FDA advisers, the decision to focus on JN.1, despite its declining prevalence, was made to enable Novovax to keep up with SARS-CoV-2’s ongoing evolution. Novovax, unlike Pfizer and Moderna, produces a more “traditional,” protein-based vaccine, rather than using mRNA technology, and the design and manufacturing process is extremely lengthy in comparison, similar to other traditional vaccines which have only been brought to market years, rather than months, after their conception.

Novovax responded to the announcement with a declaration that its new COVID shot would be ready by September. Moderna announced that it would be ready a month earlier, in August, and Pfizer assured those interested that it would also be ready by fall, once its application was approved.

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Only mRNA left in the race after competitors knocked out

A week, they say, is a long time in politics. Apparently it is also a long time in the FDA, as by June 14 it had changed its recommendation to the KP.2 variant. Peter Marks, the FDA’s director of Biologics Evaluation and Research, justified the altered plans by stressing the organization’s great concern for the welfare of the American people:

We always say we shouldn’t be chasing strains, but we’re paying an incredibly high premium for mRNA vaccines to be able to have the freshest vaccines.

According to Reuters, Marks “wanted to give people a choice of a KP.2-targeting vaccine, counting on the quick updates possible with messenger RNA shots from Moderna and Pfizer and its partner BioNTech.”

As if to back up these words, Moderna announced that despite the adjustments that would now need to be made, they would still be ready in time for the fall vaccination campaign.

The news wasn’t so good for Novovax, which dropped out of the bidding. Whether or not there is a future market for its JN.1 shot (on which work has already begun) is unclear. The FDA only said that manufacturers should pivot toward the new variant “if feasible.” Allegedly, they want to leave open an option for people still wary of mRNA technology. 

Pfizer, meanwhile, merely stated that it would “hold discussions” regarding the new target strain. It later appeared to fall into step alongside Moderna, insisting that it, too, would be ready with an updated recipe.

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Just Pfizer lied?

Pfizer, however, will struggle far more than Moderna to adapt to the FDA’s whims. Moderna’s operations are far more centralized than those of Pfizer, which are located in a number of countries. Pfizer is also under pressure from two legal cases brought against it (for lying about the efficacy of its shots) by the Attorneys-General of Texas and Kansas. Cutting corners and skipping safety steps while under intense scrutiny is probably not the best of ideas.

Moderna, meanwhile, is not being accused of lying to anyone. Could it be that the company has friends in high places?

One “friend” is a relatively new company called National Resilience, or simply, “Resilience.” This company, founded only four years ago, in 2020, manufactures the mRNA for Moderna. And the friends in high places are the U.S. Department of Defense and the United States International Development Finance Corporation, which have been funding Resilience to the tune of billions of dollars. Google Ventures has also been a contributor, as has the Canadian government.

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Ready for the next pandemic

Speaking after a massive injection of Canadian taxpayer cash into his company, Resilience CEO Rahul Singhvi said,

Resilience was founded during the pandemic to build a better system for manufacturing complex medicines to fight deadly diseases. This partnership with the Government of Canada will help prepare Canada for future pandemics and strengthen the country’s biopharmaceutical ecosystem.

His views were echoed by the Canadian Minister of Innovation, Science, and Industry, who said that,

Today’s contribution to Resilience Biotechnologies Inc. is another important step to support Canada’s leadership in the life sciences sector and to build future pandemic preparedness.

Resilience describes itself as “a manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption” which has been engaged in setting up “a sustainable network of high-tech, end-to-end manufacturing solutions with the aim of ensuring that the medicines of today and tomorrow can be made quickly, safely, and at scale.”

Setting aside the claim to make medicines “safely,” it is certainly true that mRNA “vaccines” can be produced more quickly and in far larger numbers than any previous type of vaccine. With AstraZeneca and J&J (Janssen) now knocked out of the market, this leaves just Pfizer attempting to compete with Moderna-Resilience. It will have to do so with less government support.

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Turbocharge or warp-speed, it’s all the same

Resilience doesn’t speak in terms of “warp-speed” production, but the language it uses on its website is quite similar:

Turbocharge your vaccine development. Now more than ever, global vaccine innovators need a biomanufacturing partner with the ability to adapt skillfully and the capacity to scale rapidly. Enter Resilience.

Like Moderna, and unlike Pfizer, Resilience appeared on the scene together with COVID and its actions in the aftermath are, so far, its only real claim to fame:

The industry’s response to COVID-19 has made it clear that vaccines made right – meaning “safe, efficacious and readily available” – will find a market, whether or not they’re in the headlines.

And like Moderna, (and unlike Pfizer), Resilience is almost solely focused on innovative, gene-based treatments, including, but not restricted to, mRNA technology:

We’re not looking to introduce incremental change; instead, our modular approach to next-generation vaccine manufacturing is designed to integrate novel biological, analytical or press-related technologies that can leapfrog the industry forward.

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Fast-track to innovation

Prior to the COVID era, science by-and-large did move incrementally and somewhat cautiously, with plenty of time allotted to checking and double-checking anything new. In fact, mRNA technology has been around for quite a while but was never used in any marketed product prior to the COVID shots due to safety and efficacy concerns. Resilience seems undaunted by such considerations. Virtually everything about what they do sounds novel — they describe non-traditional research and processes that regular people have never heard of, such as “viral vectors,” “potency assays,” and “virus-like particles.”

They also insinuate that they have a “fast-track” to getting all these novel drugs approved:

[We have a] seasoned regulatory team with an average of 20+ years of experience working alongside product development leaders to provide CMC [chemistry, manufacturing, and controls] and regulatory support from pre-clinical development to licensure [emphasis added].

Regulatory support could mean many things, and certainly no company could openly boast of insider connections to the FDA for fast-tracking its products for approval. What is known about FDA fast-tracking is that it is often based on tiny (and substandard) preliminary studies of drugs that are deemed to show special promise. Once the FDA green-lights a drug for fast-tracking, it eases the approval path by working together with the company to design clinical trials and present them in a good light.

Why might the FDA want to do all that for Resilience? After all, the FDA is an independent government agency, isn’t it?

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FDA in Moderna’s pocket?

Duane Avant is Resilience’s Chief Quality Officer. Earlier this year, he celebrated the FDA’s approval of the company’s Center of Excellence for GMP Viral Vector Manufacturing and cited another “major milestone” for the company when the FDA performed a pre-approval inspection at its RTP facility and “the site became an approved facility to manufacture suspension LVV [lentiviral vector]…"

Avant, like other key people working for Resilience, has a background in Pharma, having worked for several of the big companies. Resilience also has several other team members with relevant backgrounds, such as Susan Desmond-Hellmann, who is a former CEO at the Bill & Melinda Gates Foundation. Resilience’s own CEO, Singhvi, was previously an operating partner in Flagship Pioneering which played a major role in founding Moderna.

Resilience also has two ex-FDA commissioners on its board of directors — Mark McClellan and Scott Gottlieb.

McClellan served as FDA commissioner between 2002 and 2004, but Gottlieb only left the FDA in 2019. Shortly before he left, he was involved in a major change in policy at the organization regarding its inspections of biological facilities. Prior to the change, the FDA had to send its inspectors to such facilities at least once in two years; after May 2019, this was no longer required. This affected facilities producing vaccines, biologics, autoimmune medications, and some cancer drugs.

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The emergency never ends

While the FDA has continued with some inspections since Gottlieb's change, there has been no follow-up for facilities found to be non-compliant with regulations. For example, Moderna was inspected in September of 2023 and failed to demonstrate cGMP (current Good Manufacturing Practice) compliance. There were no consequences, though.

The same was true a year earlier, when its Catalent plant in Indiana was inspected and serious issues were discovered relating to quality control, including “lack of procedures to prevent contamination.” This was a plant where Moderna’s booster shots were being prepared. What happened that time? Also nothing. The booster shots enjoy an added layer of protection from oversight given that they are issued under an EUA (emergency use authorization). They could be shipped even if found to be adulterated — as they were.

With regular, non-EUA drugs, the manufacturers do face liability if found to have caused harm to consumers, but uncovering the source of the harms is no simple task, especially if the FDA is not diligently inspecting sites. (Of course, the FDA was established precisely in order to diligently inspect and prevent such issues of adulteration  from occurring.)

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A Pharma company by any other name would smell as sweet

Gottlieb left the FDA in 2019 and Resilience(-Moderna) was established in 2020. Therefore, although Gottlieb’s actions taken while at the FDA’s helm appear to have aided and abetted Resilience, there’s no way he could have had Resilience in mind when removing the requirement for regular inspections, right?

Well, wrong. Resilience was founded in 2020, but Ology Bioservices was founded back in 2000 (although it has undergone a couple of name changes since). In 2013, Ology was awarded a Department of Defense contract to establish the government’s ADM (Advanced Development and Manufacturing) center in Alachua, Florida. It’s no coincidence that Resilience’s headquarters are also in Alachua, Florida, because Resilience acquired Ology in 2021.

As an interesting aside, the DoD-ADM, as it is called, has, among its departments, a Level 3 Biosafety laboratory where research into airborne and potentially lethal toxins and microbes is conducted.

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Don’t say ‘protégé’ — say ‘partner’

If you ask the government, it won’t tell you that it runs Moderna-Resilience. It will say that it is engaged in a productive private-public sector partnership that benefits everyone.

Government has been engaging in such “partnerships” for a very long time, of course. Occasionally they are brought to light, to live a brief day in the public glare, only to be quickly put back to bed so that everyone can go back to pretending that the United States is a free-market capitalist country with none of that nasty nationalization of key infrastructure that was a feature of failed states such as the USSR (and China?).

It’s easy enough to find examples of government “cooperating with” private industries toward the noblest goals, such as getting people to take COVID shots, or blocking their access to “misinformation.”

As recently as this year, at a conference titled “A New Global Health Security Strategy,” ex-Senator Richard Burr (who was instrumental in founding BARDA—the Biomedical Advanced Research Development Authority, under the auspices of the government’s Health and Human Services) described this partnership very nicely, not only looking back at COVID but also forward to the next pandemic (threat):

... I see the private sector as a crucial component to the overall success ... when H5N1 first appeared as a potential pandemic threat, we did something in government that I don’t think everybody thought we could do. We actually partnered with private companies to build vaccine capacity...

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The Amazon of the drug world

Speaking at the same conference was Stephanie Psaki (sister of Jen), representing the White House. She pointed out another key aspect of this partnership — “private” entities needing swift access to information that comes from the government:

... one of the pieces that the private sector has said over and over again is that they need a clear signal that there will be demand for a larger supply.

And who better placed than Resilience-Moderna to cater to this larger supply? As former FDA commissioner Gottlieb has stated:

It is critical that we adopt solutions that will protect the manufacturing supply chain, and provide more certainty around drug development and the ability to scale up the manufacturing of safe, effective, but also more complex products that science is making possible. RESILIENCE will enable these solution by combining cutting edge technology, an unrivaled pool of talent, and the industry’s first shared service business model. Similar to AMAZON Web Services, RESILIENCE will empower drug development with the tools to more fully align discovery, development, and manufacturing; while offering new opportunities to invest in downstream innovations in formulation and manufacturing earlier, while products are still being conceived and developed [emphasis added].

What Gottlieb seems to be envisioning (or perhaps merely describing?) is a Pharma model that provides customers with everything from a to z, from the ideas to the production to the marketing. Government’s contribution is providing the people mandated to be injected with the products.

For investors, a business model backed largely by the Department of Defense may be an attractive proposition, offering a virtual guarantee of success (in the money-making line, if not in the production of safe and effective products).

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And we’ll leave Pfizer holding the (vaccine-injured) baby

Admittedly, this notion of the DoD being highly involved in drug development goes back a long way, at least to 2009 when an evaluation by DARPA (the government’s Defense Advance Research Projects Agency) resulted in a decision to adopt a state-controlled biodefense program:

... [DARPA evaluation] identified an unmet need to rapidly develop, license, and manufacture biological MCMs [medical countermeasures] required to protect military and civilian populations during time of CBRN crisis, which includes naturally occurring pandemics as well as deliberate attacks.

And notionally, Resilience-Moderna is not a government subsidiary.

Notionally, the attorneys-general of Texas and Kansas are also quite logical in their decision to only pursue Pfizer for alleged crimes in relation to the COVID shots. They probably know something about the inner workings of Moderna which reassures them that nothing there amounted to a violation of regulations.

It’s just curious and thought-provoking that Pfizer has become the fall guy for all the residual anger and hatred over everything COVID-related, while Moderna-Resilience and the U.S. Department of Defense plow ahead toward the next round of pandemic planning.

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With thanks to Sasha Latypova for her peerless investigative journalism; much of the information provided here is derived directly or indirectly from her Substack.

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