Covid-19 erased the regulatory and trial-related hurdles that Moderna could never surmount before. Yet, how did Moderna know that COVID-19 would create those conditions months before anyone else, and why did they later claim that their vaccine being tested in NIH trials was different than their commercial candidate?
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.”
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?