COVID-19: Moderna Gets Its Miracle
In late 2019, the biopharmaceutical company Moderna was facing a series of challenges that not only threatened its ability to ever take a product to market, and thus turn a profit, but its very existence as a company. There were multiple warning signs that Moderna was essentially another Theranos-style fraud, with many of these signs growing in frequency and severity as the decade drew to a close. Part I of this three-part series explored the disastrous circumstances in which Moderna found itself at that time, with the company’s salvation hinging on the hope of a divine miracle, a “Hail Mary” save of sorts, as stated by one former Moderna employee.
While the COVID-19 crisis that emerged in the first part of 2020 can hardly be described as an act of benevolent divine intervention for most, it certainly can be seen that way from Moderna’s perspective. Key issues for the company, including seemingly insurmountable regulatory hurdles and its inability to advance beyond animal trials with its most promising—and profitable—products, were conveniently wiped away, and not a moment too soon. Since January 2020, the value of Moderna’s stock—which had embarked on a steady decline since its IPO—grew from $18.89 per share to its current value of $339.57 per share, thanks to the success of its COVID-19 vaccine.
Yet, how exactly was Moderna’s “Hail Mary” moment realized, and what were the forces and events that ensured it would make it through the FDA’s emergency use authorization (EUA) process? In examining that question, it becomes quickly apparent that Moderna’s journey of saving grace involved much more than just cutting corners in animal and human trials and federal regulations. Indeed, if we are to believe Moderna executives, it involved supplying formulations for some trial studies that were not the same as their COVID-19 vaccine commercial candidate, despite the data resulting from the former being used to sell Moderna’s vaccine to the public and federal health authorities. Such data was also selectively released at times to align with preplanned stock trades by Moderna executives, turning many of Moderna’s highest-ranking employees into millionaires, and even billionaires, while the COVID-19 crisis meant economic calamity for most Americans.
Not only that, but—as Part II of this three-part series will show, Moderna and a handful of its collaborators at the National Institutes of Health (NIH) seemed to know that Moderna’s miracle had arrived—well before anyone else knew or could have known. Was it really a coincidental mix of “foresight” and “serendipity” that led Moderna and the NIH to plan to develop a COVID-19 vaccine days before the viral sequence was even published and months before a vaccine was even considered necessary for a still unknown disease? If so, why would Moderna—a company clearly on the brink—throw everything into and gamble the entire company on a vaccine project that had no demonstrated need at the time?
The Serendipitous Origins of Moderna’s COVID-19 Vaccine
When early January 2020 brought news of a novel coronavirus outbreak originating in Wuhan, China, Moderna’s CEO Stéphane Bancel immediately emailed Barney Graham, deputy director of the Vaccine Research Center at the National Institutes of Health, and asked to be sent the genetic sequence for what would become known as SAR-CoV-2, allegedly because media reports on the outbreak “troubled” him. The date of that email varies according to different media reports, though most place it as having been sent on either January 6th or 7th.
A few weeks before Bancel’s email to Graham, Moderna was quickly approaching the end of the line, their desperately needed “Hail Mary” still not having materialized. “We were freaked out about money,” Stephen Hoge would later remember of Moderna’s late 2019 circumstances. Not only were executives “cutting back on research and other expenditures” like never before, but – as STAT News would later report – “cash from investors had stopped pouring in and partnerships with some drug makers had been discontinued. In meetings at Moderna, Bancel emphasized the need to stretch every dollar and employees were told to reduce travel and other expenses, a frugality there were advised would last several years.”
At the tail end of 2019, Graham was in a very different mood than Bancel, having emailed the leader of the coronavirus team at his NIH lab saying, “Get ready for 2020,” apparently viewing the news out of Wuhan in late 2019 as a harbinger of something significant. He went on, in the days before he was contacted by Bancel, to “run a drill he had been turning over in his mind for years” and called his long-time colleague Jason McLellan “to talk about the game plan” for getting a head start on producing a vaccine the world did not yet know it needed. When Bancel called Graham soon afterward and asked about this new virus, Graham responded that he didn’t know yet but that “they were ready if it turned out to be a coronavirus.” The Washington Post claimed that Graham’s apparent foreknowledge that a coronavirus vaccine would be needed before anyone officially knew what type of disease was circulating in Wuhan was a fortunate mix of “serendipity and foresight.”
Dr. Barney Graham and Dr. Kizzmekia Corbett, VRC coronavirus vaccine lead, discuss COVID-19 research with U.S. legislators Sen. Chris Van Hollen, Sen. Benjamin Cardin and Rep. Jamie Raskin, March 6, 2020; Source: NIH
A report in Boston magazine offers a slightly different account than that reported by the Washington Post. Per that article, Graham had told Bancel, “If [the virus] is a coronavirus, we know what to do and have proven mRNA is effective.” Per that report, this assertion of efficacy from Graham referred to Moderna’s early stage human-trial data published in September 2019 regarding its chikungunya vaccine candidate, which was funded by the Defense Advanced Research Projects Agency (DARPA), as well as its cytomegalovirus (CMV) vaccine candidate.
As mentioned in Part I of this series, the chikungunya vaccine study data released at that time included the participation of just four subjects, three of whom developed significant side effects that led Moderna to state that they would reformulate the vaccine in question and would pause trials on that vaccine candidate. In the case of the CMV vaccine candidate, the data was largely positive, but it was widely noted that the vaccine still needed to pass through larger and longer clinical trials before its efficacy was in fact “proven,” as Graham later claimed. In addition, Graham implied that this early stage trial of Moderna’s CMV vaccine candidate was somehow proof that an mRNA vaccine would be effective against coronaviruses, which makes little sense since CMV is not a coronavirus but instead hails from the family of viruses that includes chickenpox, herpes, and shingles.
Bancel apparently had reached out to Graham because Graham and his team at the NIH had been working in direct partnership with Moderna on vaccines since 2017, soon after Moderna had delayed its Crigler-Najjar and related therapies in favor of vaccines. According to Boston magazine, Moderna had been working closely with Graham specifically “on [Moderna’s] quest to bring a whole new class of vaccines to market” and Graham had personally visited Moderna’s facilities in November 2019. Dr. Anthony Fauci, the director of the NIH’s infectious-disease division NIAID, has called his unit’s collaboration with Moderna, in the years prior to and also during the COVID-19 crisis, “most extraordinary.”
The year 2017, besides being the year when Moderna made its pivot to vaccines (due to its inability to produce safe multidose therapies, see Part I), was also a big year for Graham. That year he and his lab filed a patent for the “2P mutation” technique whereby recombinant coronavirus spike proteins can be stabilized in a prefusion state and used as more effective immunogens. If a coronavirus vaccine were to be produced using this patent, Graham’s team would financially benefit, though federal law caps their annual royalties. Nonetheless, it would still yield a considerable sum for the named researchers, including Graham.
However, due to the well-known difficulties with coronavirus vaccine development, including antibody dependent enhancement risk, it seemed that commercial use of Graham’s patent was a pipe dream. Yet, today, the 2P mutation patent, also known as the ’070 patent, is not just in use in Moderna’s COVID-19 vaccine, but also in the COVID-19 vaccines produced by Johnson & Johnson, Novavax, Pfizer/BioNTech, and CureVac. Experts at New York University School of Law have noted that the 2P mutation patent first filed in 2016 “sounds remarkably prescient” in light of the COVID crisis that emerged a few years later while later publications from the NIH (still pre-COVID) revealed that the NIH’s view on “the breadth and importance of the ’070 patent” as well as its potential commercial applications was also quite prescient, given that there was little justification at the time to hold such a view.
On January 10, three days after the reported initial conversation between Bancel and Graham on the novel coronavirus outbreak in Wuhan, China, Graham met with Hamilton Bennett, the program leader for Moderna’s vaccine portfolio. Graham asked Bennett “if Moderna would be interested in using the new [novel coronavirus] to test the company’s accelerated vaccine-making capabilities.” According to Boston, Graham then mused, “That way . . . if ever there came a day when a new virus emerged that threatened global public health, Moderna and the NIH could know how long it would take them to respond.”
Graham’s “musings” to Bennett are interesting considering his earlier statements made to others, such as “Get ready for 2020” and his team, in collaboration with Moderna, would be “ready if [the virus then circulating in Wuhan, China] turned out to be a coronavirus.” Is this merely “serendipity” and “foresight”, as the Washington Post suggested, or was it something else? It is worth noting that the above accounts are those that have been given by Bancel and Graham themselves, as the actual contents of these critical January 2020 emails have not been publicly released.
When the genetic sequence of SARS-CoV-2 was published on January 11, NIH scientists and Moderna researchers got to work determining which targeted genetic sequence would be used in their vaccine candidate. Later reports, however, claimed that this initial work toward a COVID-19 vaccine was merely intended to be a “demonstration project.”
Other odd features of the Moderna-NIH COVID-19 vaccine-development story emerged with Bancel’s account of the role the World Economic Forum played in shaping his “foresight” when it came to the development of a COVID-19 vaccine back in January 2020. On January 21, 2020, Bancel reportedly began to hear about “a far darker version of the future” at the World Economic Forum (WEF) annual meeting in Davos, Switzerland, where he spent time with “two [anonymous] prominent infectious-disease experts from Europe” who shared with him data from “their contacts on the ground in China, including Wuhan.” That data, per Bancel, showed a dire situation that left his mind “reeling” and led him to conclude, that very day, that “this isn’t going to be SARS. It’s going to be the 1918 flu pandemic.”
This realization is allegedly what led Bancel to contact Moderna cofounder and chairman, as well as a WEF technology pioneer, Noubar Afeyan. Bancel reportedly interrupted Afeyan’s celebration of his daughter’s birthday to tell him “what he’d learned about the virus” and to suggest that “Moderna begin to build the vaccine—for real.” The next day, Moderna held an executive meeting, which Bancel attended remotely, and there was considerable internal debate about whether a vaccine for the novel coronavirus would be needed. To Bancel, the “sheer act of debating” pursuing a vaccine for the virus was “absurd” given that he was now convinced, after a single day at Davos, that “a global pandemic was about to descend like a biblical plague, and whatever distractions the vaccine caused internally at Moderna were irrelevant.”
Bancel spent the rest of his time at the Davos annual meeting “building partnerships, generating excitement, and securing funding,” which led to the Moderna collaboration agreement with the Coalition for Epidemic Preparedness Innovations—a project largely funded by Bill Gates. (Bancel and Moderna’s cozy relationship with the WEF, dating back to 2013, was discussed in Part I as were the Forum’s efforts, beginning well before COVID-19, to promote mRNA-based therapies as essential to the remaking of the health-care sector in the age of the so-called Fourth Industrial Revolution). At the 2020 annual meeting attended by Bancel and others it was noted that a major barrier to the widespread adoption of these and other related “health-care” technologies was “public distrust.” The panel where that issue was specifically discussed was entitled “When Humankind Overrides Evolution.”
As also noted in Part I of this series, a few months earlier, in October 2019, major players in what would become the Moderna COVID-19 vaccine, particularly Rick Bright and Anthony Fauci, had discussed during a Milken Institute panel on vaccines how a “disruptive” event would be needed to push the public to accept “nontraditional” vaccines such as mRNA vaccines; to convince the public that flu-like illnesses are scarier than traditionally believed; and to remove existing bureaucratic safeguards in the vaccine development-and-approval processes.
That panel took place less than two weeks after the Event 201 simulation, jointly hosted by the World Economic Forum, the Bill & Melinda Gates Foundation, and the Johns Hopkins Center for Health Security. Event 201 simulated “an outbreak of a novel zoonotic coronavirus” that was “modeled largely on SARS but . . . more transmissible in the community setting by people with mild symptoms.” The recommendations of the simulation panel were to considerably increase investment in new vaccine technologies and industrial approaches, favoring rapid vaccine development and manufacturing. As mentioned in Part I, the Johns Hopkins Center for Health Security had also conducted the June 2001 Dark Winter simulation that briefly preceded and predicted major aspects of the 2001 anthrax attacks, and some of its participants had apparent foreknowledge of those attacks. Other Dark Winter participants later worked to sabotage the FBI investigation into those attacks after their origin was traced back to a US military source.
It is hard to imagine that Bancel, whose company had long been closely partnered with the World Economic Forum and the Gates Foundation, was unaware of the exercise and surprised by the closely analogous event that transpired within three months. Given the accounts given by Bancel, Graham, and others, it seems likely there is more to the story regarding the origins of Moderna’s early and “serendipitous” push to develop a COVID-19 vaccine. In addition, given that Moderna was in dire financial circumstances at the time, it seems odd that the company would gamble everything on a vaccine project that was opposed by the few investors that were still willing to fund Moderna in January/February 2020. Why would they divert their scant resources towards a project born only out of Barney Graham’s “musings” that Moderna could try to test the speed of its vaccine development capabilities and Bancel’s doomsday view that a “biblical plague” was imminent, especially when their investors opposed the idea?
Moderna Gets to Bypass Its Long-Standing Issues with R & D
Moderna produced the first batch of its COVID-19 vaccine candidate on February 7, one month after Bancel and Graham’s initial conversation. After a sterility test and other mandatory tests, the first batch of its vaccine candidate, called mRNA-1273, shipped to the NIH on February 24. For the first time in a long time, Moderna’s stock price surged. NIH researchers administered the first dose of the candidate into a human volunteer less than a month later, on March 16.
Controversially, in order to begin its human trial on March 16, regulatory agencies had to allow Moderna to bypass major aspects of traditional animal trials, which many experts and commentators noted was highly unusual but was now deemed necessary due to the urgency of the crisis. Instead of developing the vaccine in distinct sequential stages, as is the custom, Moderna “decided to do all of the steps [relating to animal trials] simultaneously.” In other words, confirming that the candidate is working before manufacturing an animal-grade vaccine, conducting animal trials, analyzing the animal-trial data, manufacturing a vaccine for use in human trials, and beginning human trials were all conducted simultaneously by Moderna. Thus, the design of human trials for the Moderna vaccine candidate was not informed by animal-trial data.
This should have been a major red flag, given Moderna’s persistent difficulties in getting its products past animal trials. As noted in Part I, up until the COVID-19 crisis, most of Moderna’s experiments and products had only been tested in animals, with only a handful able to make it to human trials. In the case of the Crigler-Najjar therapy that it was forced to indefinitely delay, toxicity concerns related to the mRNA delivery system being used had emerged in the animal trials, which Moderna was now greenlighted to largely skip. Given that Moderna had subsequently been forced to abandon all multidose products because of poor results in animal trials, being allowed to skip this formerly insurmountable obstacle was likely seen as a boon to some at the company. It is also astounding that, given Moderna’s history with problematic animal trials, more scrutiny was not devoted to the regulatory decision to allow Moderna to essentially skip such trials.
Animal studies conducted on Moderna’s COVID-19 vaccine did identify problems that should have informed human trials, but this did not happen because of the regulatory decision. For example, animal reproductive toxicity studies on the Moderna COVID-19 vaccine that are cited by the European Medicines Agency found that there was reduced fertility in rats that received the vaccine (e. g., overall pregnancy index of 84.1% in vaccinated rats versus 93.2% in the unvaccinated) as well as an increased proportion of aberrant bone development in their fetuses. That study has been criticized for failing to report on the accumulation of vaccine in the placenta as well as failing to investigate the effect of vaccine doses administered during key pregnancy milestones, such as embryonic organogenesis. In addition, the number of animals tested is unstated, making the statistical power of the study unknown. At the very least, the 9 percent drop in the fertility index among vaccinated rats should have prompted expanded animal trials to investigate concerns of reproductive toxicity before testing in humans.
Yet, Moderna declined to further investigate reproductive toxicity in animal trials and entirely excluded reproductive toxicity studies from its simultaneous human trials, as pregnant women were excluded from participation in the clinical trials of its vaccine. Despite this, pregnant women were labeled a priority group for receiving the vaccine after Emergency Use Authorization (EUA) was granted for the Moderna and Pfizer/BioNTech vaccines. Per the New England Journal of Medicine, this meant that “pregnant women and their clinicians were left to weigh the documented risks of Covid-19 infection against the unknown safety risks of vaccination in deciding whether to receive the vaccine.”
Moderna only began recruiting for an “observational pregnancy outcome study” of its COVID-19 vaccine in humans in mid-July 2021, and that study is projected to conclude in early 2024. Nevertheless, the Centers for Disease Control recommends the use of Moderna’s COVID-19 vaccine in “people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future.” This recommendation is largely based on the CDC’s publication of preliminary data on mRNA COVID-19 vaccine safety in pregnant women in June 2021, which is based on passive reporting systems in use within the United States (i. e., VAERS and v-safe).
Even in the limited scope of this study, 115 of the 827 women who had a completed pregnancy during the study lost the baby, 104 of which were spontaneous abortions before 20 weeks of gestation. Of these 827 pregnant women, only 127 had received a mRNA vaccine before the 3rd trimester. This appears to suggest an increased risk among those women who took the vaccine before the 3rd trimester, but the selective nature of the data makes it difficult to draw any definitive conclusions. Despite claims from the New England Journal of Medicine that the study’s data was “reassuring”, the study’s authors ultimately stated that their study, which mainly looked at women who began vaccination in the third trimester, was unable to draw “conclusions about spontaneous abortions, congenital anomalies, and other potential rare neonatal outcomes.” This is just one example of the problems caused by “cutting corners” with respect to Moderna’s COVID-19 vaccine trials in humans and animals, including those conducted by the NIH.
Meanwhile, throughout February, March and April, Bancel was “begging for money” as Moderna reportedly lacked “enough money to buy essential ingredients for the shots” and “needed hundreds of millions of dollars, perhaps even more than a billion dollars” to manufacture its vaccine, which had only recently begun trials. Bancel, whose tenure at Moderna had long been marked by his ability to charm investors, kept coming up empty-handed.
Then, in mid-April 2020, Moderna’s long-time cooperation with the US government again paid off when Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) awarded the company $483 million to “accelerate the development of its vaccine candidate for the novel coronavirus.” A year later, the amount invested in Moderna’s COVID-19 vaccine by the US government had grown to about $6 billion dollars, just $1.5 billion short of the company’s entire value at the time of its pre-COVID IPO.
BARDA, throughout 2020, was directly overseen by the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), led by the extremely corrupt Robert Kadlec, who had spent roughly the last two decades designing BARDA and helping shape legislation that concentrated many of the emergency powers of HHS under the Office of the ASPR. Conveniently, Kadlec occupied the powerful role of ASPR that he had spent years sculpting at the exact moment when the pandemic, which he had simulated the previous year via Crimson Contagion, took place. As mentioned in Part I, he was also a key participant in the June 2001 Dark Winter exercise. In his capacity as ASPR during 2020, Kadlec oversaw nearly all major aspects of the HHS COVID-19 response and had a key role in BARDA’s funding decisions during that period, as well as in the affairs of the NIH and the Food and Drug Administration as they related to COVID-19 medical countermeasures, including vaccines.
On May 1, 2020, Moderna announced a ten-year manufacturing agreement with the Lonza Group, a multinational chemical and biotech company based in Switzerland. Per the agreement, Lonza would build out vaccine production sites for Moderna’s COVID-19 vaccine, first in the US and Switzerland, before expanding to Lonza’s facilities in other countries. The scale of production discussed in the agreement was to produce 1 billion doses of Moderna’s COVID-19 vaccine annually. It was claimed that the ten-year agreement would also focus on other products, even though it was well known at the time that other Moderna products were “nowhere close to being ready for the market.” Moderna executives would later state that they were still scrambling for the cash to manufacture doses at the time the agreement with Lonza was made.
The decision to forge a partnership to produce that quantity of doses annually suggests marvelous foresight on the part of Moderna and Lonza that the COVID-19 vaccine would become an annual or semiannual affair, given that current claims of waning immunity could not have been known back then because initial trials of the Moderna vaccine had begun less than two months earlier and there was still no published data on its efficacy or safety. However, as will be discussed Part III of this series, Moderna needs to sell “pandemic level” quantities of its COVID-19 vaccine every year in order to avoid a return of the existential crises it faced before COVID-19 (for more on those crises, see Part I). The implications of this, given Moderna’s previous inability to produce a safe product for multidosing and lack of evidence that past issues were addressed in the development of its COVID-19 vaccine, will also be discussed in Part III of this series.
It is also noteworthy that, like Moderna, Lonza as a company and its leaders are closely affiliated with the World Economic Forum. In addition, at the time the agreement was reached in May 2020, Moncef Slaoui, the former GlaxoSmithKline executive, served on the boards of both Moderna and Lonza. Slaoui withdrew from the boards of both companies two weeks after the agreement was reached to become the head of the US-led vaccination-development drive Operation Warp Speed. Moderna praised Slaoui’s appointment to head the vaccination project.
By mid-May, Moderna’s stock price—whose steady decline before COVID-19 was detailed in Part I —had tripled since late February 2020, all on high hopes for its COVID-19 vaccine. Since Moderna’s stock had begun to surge in February, media reports noted that “nearly every progress update—or media appearance by Moderna CEO Stephane Bancel—has been gobbled up by investors, who seem to have an insatiable appetite for the stock.” Bancel’s tried-and-tested method of keeping Moderna afloat on pure hype, though it was faltering before COVID-19, was again paying off for the company thanks to the global crisis and related panic.
Some critics did emerge, however, calling Moderna’s now $23 billion valuation “insane,” especially considering that the company had posted a net loss of $514 million the previous year and had yet to produce a safe or effective medicine since its founding a decade earlier. In January 2020, Moderna had been worth a mere $5 billion, $2 billion less than its valuation at its December 2018 IPO. If it hadn’t been for the onset of the COVID crisis and a fresh injection of hype, it seems that Moderna’s valuation would have continued to shrink. Yet, thankfully for Moderna, investors were valuing Moderna’s COVID-19 vaccine even before the release of any clinical data. Market analysts at the time were forecasting Moderna’s 2022 revenue at about $1 billion, a figure based almost entirely on coronavirus vaccine sales, since all other Moderna products were years away from a market debut. Yet, even with this forecasted revenue, Moderna’s stock value in mid-May 2020 was trading at twenty-three times its projected sales, a phenomenon unique to Moderna among biotech stocks at the time. For comparison, the other highest multiples in biotech at the time were Vertex Pharmaceutical and Seattle Genetics, which were then trading at nine and twelve times their projected revenue, respectively. Now, with the implementation of booster shot policies around the world, revenue forecasts for Moderna now predict the company will make a staggering $35 billion in COVID-19 vaccine sales through next year.
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Fri, 10/29/2021 – 12:15