|Headquarters||200 Technology Square|
Cambridge, Massachusetts, U.S.
|Revenue||US$18.5 billion (2021)|
|US$13.3 billion (2021)|
|US$12.2 billion (2021)|
|Total assets||US$24.7 billion (2021)|
|Total equity||US$14.1 billion (2021)|
|Owner||Stéphane Bancel (7.8%)|
Noubar Afeyan (5.0%)
Robert S. Langer (2.9%)
Stephen Hoge (1.3%)
Number of employees
|Footnotes / references|
Moderna, Inc., (// mə-DUR-nə) is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines. These vaccines use a copy of a molecule called messenger RNA (mRNA) to produce an immune response.
The company's only commercial product is the Moderna COVID-19 vaccine, marketed as Spikevax. As of 2022, the company has 44 treatment and vaccine candidates, of which 21 have entered clinical trials. Targets for vaccine candidates include influenza, HIV, respiratory syncytial virus, Epstein–Barr virus, the Nipah virus, chikungunya, a combined single-shot COVID-19 booster and influenza vaccine, a cytomegalovirus vaccine, and two cancer vaccines. The company's pipeline also includes candidates for cancer immunotherapy using OX40 ligand, interleukin 23, IL36G, and interleukin 12 as well as, in partnership with AstraZeneca, a regenerative medicine treatment that encodes vascular endothelial growth factor A to stimulate blood vessel growth for patients with myocardial ischemia.
In 2005, Derrick Rossi, a 39-year-old postdoctoral fellow in stem cell biology at Stanford University, studied a paper by Hungarian biochemist Katalin Karikó on RNA-mediated immune activation and her co-discovery with American immunologist Drew Weissman of the nucleoside modifications that suppress the immunogenicity of RNA.
Rossi developed a method of modifying mRNA first via transfection into human cells, then dedifferentiating it into bone marrow stem cells which could then be further differentiated into desired target cell types.
In 2010, Rossi solicited investment from fellow Harvard University faculty member and serial entrepreneur Timothy A. Springer. Springer invested $5 million in the company and solicited additional investments from Kenneth R. Chien, Bob Langer, and Venture Studio Flagship Ventures, run by Noubar Afeyan. Together they founded "ModeRNA Therapeutics", named from the combined terms "modified" and "RNA" that just happens to contain "modern".
In 2011, Afeyan, the largest shareholder of Moderna, hired Stéphane Bancel, previously an executive at BioMérieux and Eli Lilly and Company, as CEO. Within 2 years of its founding, the company reached a unicorn valuation. In December 2012, the company raised $40 million.
In March 2013, Moderna and AstraZeneca signed a five-year exclusive option agreement to discover, develop, and commercialize mRNA for treatments in the therapeutic areas of cardiovascular, metabolic, and renal diseases, and selected targets for cancer. The agreement included a $240 million upfront payment to Moderna, "one of the largest ever initial payments in a pharmaceutical industry licensing deal that does not involve a drug already being tested in clinical trials". Only one candidate from this partnership has passed Phase I trials, AZD8601, a regenerative medicine treatment which encodes vascular endothelial growth factor A to stimulate blood vessel growth for patients with myocardial ischemia undergoing coronary artery bypass grafting (CABG) surgery with moderately impaired systolic function.[a]
In September 2013, the company reported that it was able to improve heart function in mice and enhance their long-term survival with a "redirection of their [stem cell] differentiation toward cardiovascular cell types" in a significant step for regenerative medicine.
In November 2013, the company raised $110 million of equity financing.
In January 2014, Alexion Pharmaceuticals paid Moderna $100 million for ten product options to develop rare disease treatments, including for Crigler-Najjar syndrome, using Moderna's mRNA therapeutics platform. Although CEO Bancel expected the platform to enter human trials in 2016, the program with Alexion was scrapped in January 2017 after animal trials showed that Moderna's treatment would never be safe enough for humans.
In November 2017, Moderna employees safely tested mRNA technology in Sprague-Dawley rats and cynomolgus monkeys at the Montreal and Sherbrooke facilities of Charles River Laboratories. They found, among other things, that "mRNA is a labile biological molecule and therefore requires the use of protective delivery systems to effectively harness its potential," as the mRNA spread beyond the injection site and was found in the liver, spleen, bone marrow and heart.
In 2018, the company rebranded as "Moderna Inc." and further increased its portfolio of vaccine development.
In May 2019, the company together with Merck Sharp & Dohme, entered a Phase I clinical trial for mRNA-5671 vaccine in combination with pembrolizumab for the treatment of solid tumors with driver mutations in the KRAS gene.
In March 2020, the Food and Drug Administration (FDA) approved clinical trials for the Moderna COVID‑19 vaccine candidate, with Moderna receiving investment of $483 million from Operation Warp Speed. Moncef Slaoui, then a member of the board of directors of Moderna, was appointed head scientist for the Operation Warp Speed project.
On November 16, 2020, an interim analysis of Phase III clinical trials, which involved over 30,000 patients, showed that the Moderna COVID-19 vaccine candidate was 94.1% effective in preventing COVID-19 with only minor flu-like side effects. The trials were completed on November 30, 2020, which confirmed the interim results and that the vaccine candidate was 100% effective in preventing severe cases of COVID-19.
On December 18, 2020, mRNA-1273 was issued an emergency use authorization (EUA) in the United States. On December 23, 2020, it was authorized for use in Canada. On January 6, 2021, it was authorized for use in the European Union. On January 8, 2021, mRNA-1273 was authorized for use in the United Kingdom.
On June 25, 2021, the Food and Drug Administration added a warning about rare cases of myocarditis, a heart inflammation, associated with both Moderna and Pfizer/BioNTech vaccines to their respective fact sheets.
On August 17, 2021, the United Kingdom's Medicines and Healthcare products Regulatory Agency approved Moderna's Covid vaccine for use in children aged 12 to 17 years.
On April 7, 2022, Moderna and the University of Toronto announced a new partnership to “develop new tools to prevent and treat infectious diseases,” including in the realms of “molecular genetics, biomedical engineering, and biochemistry. The collaboration is a joint venture across U of T's Faculties of Applied Science and Engineering and Medicine.
In April 2022, Moderna announced plans to build a $180 million vaccine factory in Montreal, forming a 10-year partnership with the Canadian federal government, province of Quebec, and McGill University to produce 100 million Spikevax doses annually and expand vaccine research capabilities.
|Net income (loss)|
Vaccine patent dispute
Moderna is involved in a patent dispute with the NIH over its COVID-19 vaccine. According to the NIH, three of its scientists played a major role in developing the vaccine over four years of collaboration. After first refuting the shared patent application entirely, Moderna postponed the final payment for filing the application, thereby leaving the patent application unfiled as of December 2021.
- The relative success of AZD8601 is attributed to the fact that Moderna has been able to inject mRNA direct into the heart muscle without needing a drug delivery system. However, only the heart and some skin areas are capable of absorbing "naked mRNA".
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At the 100-microgram dose, the one Moderna is advancing into larger trials, all fifteen patients experienced side effects, including fatigue, chills, headache, muscle pain, and pain at the site of injection. All side effects were considered mild or moderate. A higher, 250-microgram dose led to more serious reactions and has been set aside.
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- Strauss, Marine (January 6, 2021). "UPDATE 1-European Commission gives final approval to Moderna vaccine". Reuters.
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- Official website
- Business data for Moderna, Inc.: