REMINDER: Moderna Wasn’t Able to Bring a Product to Market Before ‘Warp Speed’

Here is an extensive overview of how literally every single one of Moderna’s mRNA products either failed or did not come to market prior to “Warp Speed.” This list includes source evidence and studies evincing the dangerous nature of mRNA/lipid nanoparticle technology.

At this point it’s common to hear people say something along the lines of “prior to COVID-19 all animal trials involving mRNA vaccines and gene therapies ended when all the animals died.” But while this isn’t exactly true, what is true is that Moderna—the biotech company considered by many to be at the forefront of mRNA gene therapy—was never able to bring a product to market prior to the “Warp Speed” effort for the COVID-19 “vaccines.” To illustrate this inability, here’s a list of some of Moderna’s biggest mRNA product failures.

Note that even though some of these failures are obvious, much of the time Moderna keeps its supposed trial progress tightly under wraps. (Very tightly.) Meaning all the public had or has to go on is an outline of the company’s failures.


One of Moderna’s most glaring failures developing an mRNA gene therapy product came when it was unable to develop a treatment for Crigler-Najjar syndrome. Crigler-Najjar syndrome, a severe genetic disorder characterized by high levels of a toxic substance called bilirubin in the blood, was thought to be a perfect candidate for Moderna as a disease to treat because of its rarity; according to MedlinePlus the syndrome is thought to affect fewer than 1 in 1 million newborns worldwide. Treating Crigler-Najjar was also considered “low-hanging fruit” for mRNA therapy because the disease is due to a single genetic defect, and calls for lipid nanoparticle delivery to the liver, which is relatively easy to target.

Moderna, founded in 2011 and headquartered in Cambridge, Massachusetts, teamed up with “global, science-led biopharmaceutical company” Alexion for the mRNA treatment. But, as a 2017 article in STAT noted, the project became “indefinitely delayed” when it “never proved safe enough to test in humans” according to “several former Moderna employees and collaborators who worked closely on the project.”

In another 2017 article STAT noted that Alexion decided to write off its $100-million partnership with Moderna (established in 2014) as their work on a Crigler-Najjar syndrome treatment “repeatedly ran into safety issues and never made it into human trials.” In a BusinessWire release Moderna saved face by noting that Alexion’s decision to terminate its contract was “one of several actions” the company took to reshape its Research and Development (R&D) strategy. (One month prior to the elimination of the partnership STAT reported that investment giant Fidelity, an investor in Moderna, had cut its internal valuation of the company by $1.7 billion.)

Unfortunately, beyond STAT’s report it seems there is very little information regarding Moderna’s Crigler-Najjar treatment available to the public. A search of doesn’t turn up anything, and it isn’t necessary for companies to report the results of Phase I clinical trials.

Moderna did publish a study in 2018, “Quantitative Systems Pharmacology Model of hUGT1A1‐modRNA Encoding for the UGT1A1 Enzyme to Treat Crigler‐Najjar Syndrome Type 1,” that looked at the injection of mRNA delivered with lipid nanoparticles in Gunn rats. The company reported it was able to “restore hepatic expression of UGT1A1 [a gene encoding for the enzyme, UDP-glucuronosyltransferases], allowing [for] normal glucuronidation and clearance of bilirubin in patients.” Meaning the company had ostensibly provided a proof of concept; in this case, showing it could deliver the mRNA encoding for the UGT1A1 enzyme inside of liver cells via a lipid-nanoparticle delivery method.


Along with its failed mRNA treatment for Crigler-Najjar syndrome Moderna’s mRNA Zika virus vaccine has also failed to make it to market. At least as of 2022, after the effort began six years ago.

In a 2016 article from STAT author Damian Garde notes that Moderna actually had to pivot away from more ambitious mRNA treatments (like the one for Crigler-Najjar) to vaccines because it failed at developing the former products. “The choice to prioritize vaccines came as a disappointment to many in the company, according to a former manager,” Garde notes in his article. The author quotes the manager as asking the question: “‘why would you start with a clinical [vaccine] program that has very limited upside and lots of competition?’”

Garde provides a possible answer to that question by noting mRNA therapies’ major downside: delivery of mRNA into the cell is very difficult. The process, Garde notes, “has long bedeviled the whole field” because of the necessary use of nanoparticles. He adds that “nanoparticles can lead to dangerous side effects, especially if a patient has to take repeated doses over months or years.”

Pivoting to vaccines, Moderna began development on several of them—nine, in fact, according to a 2017 Fierce Pharma article—including two for Zika virus. Moderna began phase 1 trials for the “more advanced” Zika vaccine candidate, “mRNA-1325,” in 2016; after the Biomedical Advanced Research and Development Authority (BARDA) awarded the company a $125 million grant for the research. The Fierce Pharma article notes that, around its publication date, the trials were “progressing as planned and [would] have readouts in the coming months.”

Six years later, however, and Moderna still hasn’t brought an mRNA vaccine for Zika virus to market.

Moderna has, however, published data on its Zika virus vaccine candidate. In 2017, in the journal Cell—with a grant from DARPA (the Defense Advanced Research Projects Agency) and Tony Fauci’s NIAID, as well as a $100 million “pledge” from the Bill and Melinda Gates Foundation—Justin M. Richner et al. published the study, “Modified mRNA Vaccines Protect Against Zika Virus Infection.” In the study, Richner, who leads the Richner Lab at the University of California Berkeley, and his team note they were able to engineer a modified mRNA vaccine encoding for structural genes of the wild-type Zika virus and inject it into mice using a lipid-nanoparticle delivery method. In turn, allowing the scientists to study the animals’ immune response.

Richner et al. note they were able to elicit an immune response from their test mice. The scientists were even able to develop neutralizing immunity in most mice, especially those who had been “boosted” with a second dose. The team first looked at healthy and immunocompromised mice; boosting some, but not others. The healthy mice were then infected with the wild-type Zika virus strain on either day 56 or day 126 after vaccination. The immunocompromised mice were introduced to the virus 42 days after vaccination. Up until at least 30 days after the challenge from the wild-type virus, the vaccinated mice survived, while 60% of the unvaccinated group did not.

When the scientists looked at issues with antibody dependent enhancement (ADE), however, there was a different story. To study the effects of ADE the scientists infected vaccinated mice with the Dengue virus, which is closely related to Zika. Mice vaccinated with the wild-type Zika virus vaccine, or an alternate version of the vaccine with a genetic sequence from a Japanese encephalitis virus inserted, all “uniformly [suffered from] lethal infection and severe disease due to antibody enhancement….” The scientists were able to develop a vaccine type (IgEsig-prM-E FL) that generated protection against Zika and “resulted in significantly less morbidity and mortality,” although all versions of the vaccine unequivocally led to some level of ADE. (By day 5, survival rate for mice vaccinated with IgEsig-prM-E FL dropped to 80%; meaning 20% of the vaccinated mice had died thanks to ADE induced by the vaccine.)



In July of 2019 Moderna began a Phase 1, Randomized, Placebo-Controlled, Dose-Ranging Study with 120 human participants for one particular Zika virus candidate. The study was completed in March of 2021, although no study results have been posted to as of this writing.

Despite the fact Moderna hasn’t published its findings from its Phase 1 trial, it has already moved on to its Phase 2 trial for one of its two Zika vaccine candidates, dubbed “mRNA-1893.” (mRNA-1893 is the candidate that completed its Phase 1 trial in March of 2021.) The Phase 2 trial began in June of 2021, and is set to end in September of 2023. As of 2019 the Food and Drug Administration (FDA) had also given Moderna a “Fast Track” designation for its mRNA Zika virus vaccine. Fast Track is “designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need.”

Footnote: In a comment published in 2021 in The Lancet Infectious Diseases titled “Zika vaccines: can we solve one problem without creating another one?,” Associate Professor of Infectious Diseases and Microbiology at the University of Pittsburgh Ernesto T A Marques and Priscila M S Castanha, a visiting researcher at the university, wrote of the daunting obstacles an mRNA vaccine for Zika faces. One obstacle the authors emphasize particularly helps to highlight the observed outcome of Moderna’s preclinical look at antibody dependent enhancement (ADE):

“We know from decades of research that flavivirus immune interactions can be associated with poor clinical outcomes and immunopathogenesis. The great paradox in dengue infections is a well known example: one previous dengue exposure does not provide protection to a subsequent infection by a different serotype; but instead, it increases the risk for development of severe dengue disease.”

This claim, taken in accordance with Moderna’s ADE results from the Richner et al. study, highlight how difficult it is to prime the body for one disease without making it more susceptible to another one.


As Fierce Pharma reported in 2017, Moderna began working on a vaccine candidate for Chikungunya—an infection caused by the Chikungunya virus that results in fever and potentially long-lasting joint pain; and, very rarely, death—in 2015. In 2013 DARPA had awarded Moderna up to $25 million to develop antibody-producing drugs against “infectious diseases and other biological threats.” In 2015, the grant was expanded to support vaccines, including a Chikungunya candidate.

Despite the fact that Moderna began, and presumably completed, its Phase 1 trial for its Chikungunya vaccine candidate, there is incomplete information about it online. Indeed, a search for the candidate, mRNA-1388, on doesn’t turn up any results. In a comprehensive 2018 filing with the Securities and Exchange Commission, however, the company did note “The Phase 1 trial for mRNA-1388 in the United States is fully enrolled, has generated safety and tolerability data, and demonstrated immunogenicity through approximately six months post dosing.” The filing does not contain the entirety of the actual trial data, but notes the company deployed its vaccine in healthy adults (18 to 49 years of age). At day 196 after vaccination there were 40 participants in the vaccinated arm of the study, split between three different dosages. Two of the participants who received the 100-µg dose of the vaccine experienced grade 3+ (severe) adverse reactions. At the same dosage level, joint stiffness was also experienced by 21% of participants.


Along with the severe adverse reactions all participants in the study at any dosage level experienced adverse reactions, including headache, fatigue, nausea, and, in some cases, a hardening of the skin.

Moderna has, however, released the phase 1 trial data from another one of its Chikungunya candidates, mRNA-1944. In December of 2021 Tal Zaks—Moderna’s chief medical officer until September 2021—et al. published “A phase 1 trial of lipid-encapsulated mRNA encoding a monoclonal antibody with neutralizing activity against Chikungunya virus” in the journal Nature Medicine. The phase 1 trial included 38 healthy adults (age 18-50) and tested three different dosages of mRNA-1944 for safety and efficacy. Zaks et al. concluded that “mRNA-1944 may offer a therapeutic option for the prevention and treatment of [Chikungunya] infection,” but added “additional longer-term studies in larger populations are needed.” A claim that seems to be a nod to a phase 2 trial. However, an article from Fierce Biotech posted in November of 2021 states that Moderna “removed [mRNA-1944] from its pipeline after wrapping up a phase 1 dose-escalation study.” Post Warp Speed, after seven years in development, Fierce Biotech reported “Moderna [had] consigned mRNA-1944 to the scrapheap.”

It’s unclear why Moderna scrapped plans for its Chikungunya virus vaccine, although there were “mild to moderate” adverse events reported amongst 50% of participants in the Phase 1 trial from Zaks et al. One participant experienced two grade 3+ (severe) adverse events, including an increase in white blood cell count paired with a rapid heart rate.


According to a timeline on Moderna’s site, “Moderna’s Key Milestones and Advancements,” the company introduced the first initiated in-human dosing for its candidate for an H10N8 flu vaccine, mRNA-1440, in 2015. In 2016, the company initiated its first in-human dosing trial for mRNA-1851, an mRNA vaccine aimed at protecting against avian flu H7N9. As of January 2022, however, neither has come to market. Or even completed phase 2 clinical trials.

In terms of progress so far, Moderna has published preclinical data on the vaccines in the journal Molecular Therapy and phase 1 trial data in the journal Vaccine. (The company is—also—currently in the midst of Phase 1/2 trials in the Southern Hemisphere and Phase 2 trials in the Northern Hemisphere for a seasonal flu vaccine. The ongoing trials, which began in July of 2021, aim to test the safety and efficacy of mRNA-1010, a seasonal influenza vaccine, in 680 healthy adults 18-years-old and up. The end date for the trials is June 15, 2022.)

In the preclinical data from Molecular Therapy, published in April of 2017, Zaks et al. claim they were able to show their vaccines for H10N8 and H7N9 were, in essence, relatively safe and effective. The “lipid nanoparticle (LNP)-formulated, modified mRNA vaccines…generated rapid and robust immune responses in mice, ferrets, and nonhuman primates,” the authors wrote. The authors reported their vaccines induced strong immune reactions and protection against infection in mice and ferrets. The same report included interim results from a first-in-human, escalating-dose, phase 1 study for its H10N8 vaccine, which showed “very high seroconversion rates, demonstrating robust prophylactic immunity in humans.”

As for adverse events, many from “mild to moderate” were reported by the 23 vaccinated participants. In fact, those 23 participants reported 163 adverse events, 107 of which were “mild,” and 52, “moderate.” The adverse events were very similar to symptoms of flu infection and included: injection site pain, headache, chills, fever, and throat pain. Zaks et al. reported four “severe” adverse events from three participants; including severe injection site pain, hardening of the skin, and “chills/common cold.”

The phase 1 trial data, likewise, resulted in many adverse events; a shocking amount of which were severe. Moderna even decided to jettison the entire cohort from the H10N8 trial that had been vaccinated intradermally with 50-µg doses. “[Intradermal 50-µg H10N8] vaccination was associated with high rates of solicited [adverse events]…and the sponsor elected to discontinue enrollment of these cohorts,” the authors wrote.


There were 201 participants randomized in the H10N8 study; 145 received intramuscular vaccination and 56 received intradermal vaccination. Moderna notes that not only were the intradermal cohorts that received 50-µg doses jettisoned, the second vaccination in the 75-µg dose group was also halted due to “minimal safety concerns in the previously completed 100-µg dose group.” Along with these stoppages, Moderna also reported injection site pain in 80-90% of participants. Approximately half experienced symptoms including myalgia, fatigue, and headaches. There were five Grade 3 adverse events, three in the 100-µg cohort and two in the 75-µg.”

In the intramuscular 400-µg dose group, two participants experienced Grade 3 solicited adverse events within 24 hours of the first vaccination. The events “resolved spontaneously,” but met study pause rules. After safety review, further 400-µg-dose vaccinations were stopped. 


Along with its failed Crigler-Najjar treatment and Chikungunya vaccine, and (indefinitely?) in-develop Zika and influenza vaccines, Moderna’s other product lines have also been duds. In 2017 BioSpace reported that Moderna had highlighted 13 different mRNA vaccines and gene therapies for its investors. Since then, here are where those 13 stand in their development timeline:

AZD-8601 – an mRNA therapy to increase levels of vascular endothelial growth factor-A for patients with heart failure or who need help post-heart attack. (Partnered with AstraZeneca.) Phase 1 trials completed; no registered Phase 2 trials as of this writing.

mRTNA-1440 –  the vaccine for influenza A virus subtype H10N8. No registered Phase 2 trials as of this writing.

mRNA-1851 – the vaccine for influenza A subtype H7N9. No registered Phase 2 trials as of this writing.

mRNA-1777 – an mRNA vaccine for Respiratory-syncytial-virus-infections . (Partnered with Merck.) Phase 1 clinical trial results were published on May 4, 2021. No registered Phase 2 trials.

mRNA-1388failed Chikungunya vaccine.

mRNA-1325failed Zika virus vaccine. Moderna discontinued testing the Zika vaccine, mRNA-1325, after it failed to stimulate antibodies to the virus.

mRNA-1706 – Moderna’s second version of its Zika mRNA vaccine that contains the same active pharmaceutical ingredient as the mRNA-1325 Zika mRNA vaccine, but also utilizes one of the company’s “next generation, novel formulations,” V1GL, which is supposedly a “next-generation lipid nanoparticle technology.” mRNA-1706 was replaced by mRNA-1893.

mRNA-1647 – a vaccine for Cytomegalovirus (CMV). mRNA-1647 is currently in Phase 3 clinical trials that are scheduled to end in 2025.

mRNA-1653 – a vaccine for Human Metapneumovirus (HMPV) and Parainfluenza virus (PIV3). mRNA-1653 is currently in Phase 1 clinical trials, which are scheduled to end in March of 2023.

mRNA-4157 – an mRNA-based personalized cancer vaccine. (Partnered with Merck.) In Phase 1 clinical trials scheduled to end in June, 2022.

mRNA-2416 – This mRNA treatment is an “OX40L Immunotherapy.” (OX40L is a co-stimulatory protein that boosts T cells in their fight against cancer cells.) In Phase 1/2 trials scheduled to end in September of 2022.

mRNA-2905 –  Interleukin 12 (IL-12) Immunotherapy. (IL-12 helps to activate the immune system.) No Phase 1, 2, or 3 trials listed on

mRNA AD-8601 (AZD8601) – gene therapy with mRNA encoding for vascular endothelial growth factor-A (VEGF-A), which may lead to the creation of more blood vessels and subsequently improve blood supply. (Partnered with AstraZeneca.) mRNA AD-8601 (AZD8601) is currently in Phase 2 trials. In November of 2021 Moderna and AstraZeneca reported “Positive Phase IIa results” demonstrating the gene therapy “met the primary endpoint of safety and tolerability in patients with heart failure.” There were 11 participants.


1. Moderna CEO Stéphane Bancel Is a Businessman First

Not only have all of Moderna’s efforts at developing an mRNA vaccine or gene therapy failed to-date, but its CEO, Stéphane Bancel—who isn’t a medical doctor, and doesn’t even hold a PhD in any scientific discipline—is also driven by money and power. In fact, the CEO has seemingly spent his career focused solely on the financial bottom line.

STAT notes in a 2016 article that Bancel, at that time age 44, “had no experience running a drug development operation when one of biotech’s most successful venture capitalists tapped him to lead Moderna.” STAT goes on to note that Bancel had “spent most of his career in sales and operations, not science.”

STAT reports that Bancel, who has two master’s degrees in engineering and chemical engineering, as well as an MBA from Harvard—went into sales at pharma giant Eli Lilly, subsequently rising through the company’s operational ranks to become the company’s head of Belgian operations. In 2007, at 34-years-old, Bancel became CEO of the French diagnostics firm bioMérieux; bioMérieux, which has approximately 13,000 employees as of 2022, provides diagnostic solutions (reagents, instruments, software, services, etc.).

With mRNA, “you can just turn the crank and get a lot of products going into development,” Bancel told STAT. A sentiment that may give insight into the way he sees mRNA/lipid nanoparticle technology: a way to crank out a lot of products. All of which, as of this writing, have failed to come to market for Moderna.

“It’s a case of the emperor’s new clothes,” a former Moderna scientist told STAT in regards to the company’s product line. “They’re running an investment firm, and then hopefully it also develops a drug that’s successful.”

STAT also noted that “interviews with more than 20 current and former employees and associates suggest Bancel has hampered progress at Moderna because of his ego, his need to assert control and his impatience with the setbacks that are an inevitable part of science.”

As of this writing, Bancel, who owns 9% of Moderna, holds approximately $5.2 billion in shares in the publicly traded company. In 2019, prior to the emergency authorization of Moderna’s COVID-19 vaccine, Moderna was trading at roughly one seventh its current value, giving Bancel an average of $400 million in stock.

Not incidentally, Bancel is also a Venture Partner at Flagship Pioneering, a venture capital firm that invests in life sciences and healthcare companies.

2. Moderna Is Under Intense Financial Pressure

Bancel is not only business-minded, but Moderna itself is also consistently compelled to deliver good financial news and ever-growing revenue. Moderna went public in 2018—obviously prior to having any product on the market—and, up until COVID-19, had been failing to deliver on its promises of cutting-edge mRNA technology.

Founded in 2011, STAT reports that Moderna reached unicorn status—a $1 billion valuation—in only two years. Placing it amongst other tech unicorns like AirBnB and SoFi. When the company went public in ’18, its share price was at $23, giving the company a market cap of $7.32 billion. As of January 30, 2022, the company’s market cap is $64.7 billion. (At one point in 2021, the company hit an all-time-high share price of $456.)

To justify such an enormous valuation, even the valuation at its initial public offering (IPO), Moderna needs to look and behave like a company cranking out successes; even though it hasn’t been.

Prior to COVID-19, Bancel had to talk up his company’s “unbelievable” future. STAT reported that Bancel had “promised” that Moderna’s treatment for Crigler-Najjar syndrome would enter human trials in 2016. Of course that did not happen, and Moderna eventually jettisoned its Crigler-Najjar treatment altogether.

“Moderna has raked in investor cash from the likes of billionaire Andreas Halvorsen’s Viking Global Investors and Wellington Management,” Forbes reported in 2016. “Pitchbook puts its valuation at $4.7 billion—more than any publicly traded biotech without a drug on the market,” the outlet added. In total, Forbes said Moderna had by that point raised $1.9 billion “from eager partners and investors.”

STAT reported in 2017 that one former Moderna employee said that Moderna’s technology “would have to be a miraculous, Hail Mary sort of save for them to get to where they need to be on their timelines.” The employee added that “Either [Bancel] is extremely confident that it’s going to work, or he’s getting kind of jittery that with a lack of progress he needs to put something out there.” Of course, this was the year prior to the company’s IPO.

Moderna “has signed a number of high-profile deals for a lot of money, and is said to have a large number of development projects going, but no one really knows any key details about how their mRNA-based technology works (or how well),” influential biotech blogger Derek Lowe wrote in a post in 2015. “I don’t think I’ve ever seen a startup biopharma company that has so much money so early, and apparently has so much going on, that people still know so few details about,” the blogger added. (In 2021, in a post about Moderna’s flu vaccine, Lowe wrote “that we all were very, very fortunate that [mRNA] technology worked as well as it has during the pandemic.”)

In the 2022 World Economic Forum video above, Bancel, now a billionaire, says that “[Moderna’s] goal is to be able to have a single annual booster so we don’t have compliance issues where people don’t want to get two to three shots per winter; but they get one dose where [they] get a booster for corona and a booster for flu and RSV.”

3. Aside from Warp Speed No Company Has Been Able to Develop mRNA Vaccines/Gene Therapies Using Lipid Nanoparticles

A fact that seems to get lost in the COVID-19 vaccination debate is that, prior to Warp Speed, no company in the biotech industry had been able to get mRNA/lipid nanoparticle technology to work. Beginning in 1995 FDA-approved treatments using lipid nanoparticles began to come to market, but not a single one was paired with mRNA capable of safely producing proteins in vivo.

In a 2020 communication, Stephen Allan, who serves as chemical company Evonik’s Health Care Communications officer, listed the 16 products using lipid nanoparticles available on the market at that point. Not a single one delivered mRNA into the cell. (Onpattro, a medication for damaged peripheral nerves, uses siRNA, or “short interfering RNA.” siRNA, also known as a “silencing RNA,” is not capable of coding for proteins.)

In 2018 Reuters reported that Moderna said that “No mRNA medicines have ever been approved to date by the U.S. Food and Drug Administration or other regulatory agency, marking the regulatory path uncertain….” Reuters went on to note that Moderna’s mRNA treatment for treating coronary artery disease, developed with AstraZeneca, met the main goal in an early-stage trial. (A phase 2 trial for the treatment involving 11 participants concluded in June of 2021.)

On the CDC’s own website, the agency notes that “mRNA vaccines are newly available to the public but have been studied for decades.” The CDC adds that “mRNA vaccines have been studied before for flu, Zika, rabies, and cytomegalovirus (CMV).” Note how the agency says the “mRNA vaccines have been studied,” not approved.

Science lecturer Ruth Sharratt has been commenting on the development of mRNA vaccines since the industry turned to them for COVID-19. In a series of rapid responses in the British Medical Journal (The BMJ), she argues that age-adjusted mortality rates for those more than 21 days out from their first dose are double that of unvaccinated people. Sharratt puts succinctly the problems Moderna and other biotech companies—still—face in developing mRNA treatments in a March 2021 correspondence:

“I’m not surprised there is confusion about the quantity of mRNA in the [COVID vaccines]. One of the problems with mRNA is the need to find the ‘sweet spot’ as to quantity. Too much and it could be lethal, too little and it is destroyed by the body. This was the problem with Moderna’s attempt at finding a cure for Crigler-Najjar syndrome.

It is likely that neither Pfizer nor Moderna know what the ideal quantity is or even if there is a single quantity which works for everyone. We do for example know that girls respond differently from boys to various vaccines. We cannot then assume that ‘one size fits all.'”

According to Our World in Data, as of January 2022 Moderna had administered approximately 204 million doses of its COVID-19 “vaccine” in the U.S. Pfizer-BioNTech, which uses the same mRNA/lipid nanoparticle technology, had administered nearly 316 million doses.

Feature image: fletcher

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