Moderna#COVID-19 vaccine

Moderna was founded in 2010 by Derrick Rossi, Timothy A. Springer, Kenneth R. Chien, Robert S. Langer, and Noubar Afeyan.{{cite news | url=https://www.bostonmagazine.com/health/2013/02/26/moderna-therapeutics-new-medical-technology/ | date=March 2013 | title=The NEXT Next Big Thing | first=Catherine | last=Elton | work=Boston Magazine | archive-date=November 16, 2020 |archive-url=https://web.archive.org/web/20201116154152/https://www.bostonmagazine.com/health/2013/02/26/moderna-therapeutics-new-medical-technology/ | url-status=live}} Stéphane Bancel, the current CEO, was appointed as CEO in 2011.{{cite web | url=https://www.statnews.com/2016/09/13/moderna-therapeutics-biotech-mrna/ | title=Ego, ambition, and turmoil: Inside one of biotech's most secretive startups | first=Damien | last=Garde | date=September 13, 2016 | work=Stat | archive-date=November 16, 2020 | archive-url=https://web.archive.org/web/20201116154313/https://www.statnews.com/2016/09/13/moderna-therapeutics-biotech-mrna/ | url-status=live}} Between 2011 and 2017, Moderna raised $2{{spaces}}billion in venture capital funding.

In November 2024, Moderna Inc. announced that Stéphane Bancel, currently serving as Chief Executive Officer, will step down from his role as Chief Commercial Officer while continuing as CEO. Moderna's President, Stephen Hoge, will take over responsibilities for the company's sales, medical, and research affairs.{{Cite news |date=2024-11-05 |title=Moderna's Bancel Steps Down as Sales Chief, Keeps CEO Role |url=https://www.bloomberg.com/news/articles/2024-11-05/moderna-s-bancel-steps-down-as-sales-chief-keeps-ceo-role?embedded-checkout=true |access-date=2024-11-08 |work=Bloomberg.com |language=en}}

In 2013, the company formed a partnership with AstraZeneca to develop treatments for cardiovascular, metabolic, and renal diseases, as well as cancer. Moderna was also awarded a $25,000,000 grant by DARPA through a program Autonomous Diagnostics to Enable Prevention and Therapeutics: Prophylactic Options to Environmental and Contagious Threats (ADEPT-PROTECT). Its stated goal was to develop an mRNA vaccine with the capability to suppress a global pandemic within 60 days. In January 2014, the company entered an agreement with Alexion Pharmaceuticals to develop treatments against ten diseases.{{Cite web |last=Reidy |first=Chris |date=2014-01-13 |title=Alexion, Moderna announce agreement to develop messenger RNA therapeutics |url=https://www.boston.com/news/innovation/2014/01/13/alexion-moderna-announce-agreement-to-develop-messenger-rna-therapeutics/ |url-status=live |archive-url=https://archive.today/20210702151040/https://www.boston.com/news/innovation/2014/01/13/alexion-moderna-announce-agreement-to-develop-messenger-rna-therapeutics/ |archive-date=2021-07-02 |access-date=2023-06-05 |website=Boston Globe Media Partners |language=en-US}} On January 14, 2014, Moderna announced the creation of its first venture, Onkaido Therapeutics, to focus "exclusively on developing mRNA-based oncology treatments."{{Cite press release |publisher=PR Newswire |date=2014-01-14 |title=Moderna Launches Onkaido Therapeutics to Focus on the Development of mRNA Therapeutics™ in Oncology with $20 Million Capital Commitment |url=https://www.prnewswire.com/news-releases/moderna-launches-onkaido-therapeutics-to-focus-on-the-development-of-mrna-therapeutics-in-oncology-with-20-million-capital-commitment-240111061.html |archive-url=https://web.archive.org/web/20161120035524/http://www.modernatx.com/news-events/press-releases/moderna-launches-onkaido-therapeutics-focus-development-mrna-therapeuticstm |archive-date=2016-11-20 | url-status=live}}{{Cite news |last=Gormley |first=Brian |date=2014-01-15 |title=Moderna Launches Cancer Drug Co. Onkaido Therapeutics With $20M Investment |language=en-US |work=Wall Street Journal |url=http://www.wsj.com/articles/DJFVW00020140114ea1eqwhzn |access-date=2023-06-05 |archive-url=https://web.archive.org/web/20230605073740/https://www.wsj.com/articles/DJFVW00020140114ea1eqwhzn |archive-date=2023-06-05 |issn=0099-9660}} It launched its second venture, Valera, in January 2015, with a focus on "viral, bacterial and parasitic infectious diseases."{{Cite press release | publisher=PR Newswire |date=January 8, 2015 |title=Moderna Launches New Venture Valera LLC for Infectious Diseases |url=https://www.prnewswire.com/news-releases/moderna-launches-new-venture-valera-llc-for-infectious-diseases-300017587.html |archive-url=https://web.archive.org/web/20161119214315/http://www.modernatx.com/news-events/press-releases/moderna-launches-new-venture-valera-llc-infectious-diseases |archive-date=2016-11-19 | url-status=live}}{{Cite web |date=2015-01-12 |title=Moderna Launches New Venture Valera LLC for Infectious Diseases |url=https://www.bionity.com/en/news/151144/moderna-launches-new-venture-valera-llc-for-infectious-diseases.html |url-status=live |archive-url=https://archive.today/20230605165153/https://www.bionity.com/en/news/151144/moderna-launches-new-venture-valera-llc-for-infectious-diseases.html |archive-date=2023-06-05 |access-date=2023-06-05 |website=Bionity |language=en}} Employees of Valera and Moderna developed an mRNA vaccine candidate against Zika virus infection.{{Cite journal |last1=Richner |first1=Justin M. |last2=Himansu |first2=Sunny |last3=Dowd |first3=Kimberly A. |last4=Butler |first4=Scott L. |last5=Salazar |first5=Vanessa |last6=Fox |first6=Julie M. |last7=Julander |first7=Justin G. |last8=Tang |first8=William W. |last9=Shresta |first9=Sujan |last10=Pierson |first10=Theodore C. |last11=Ciaramella |first11=Giuseppe |last12=Diamond |first12=Michael S. |date=2017-02-17 |title=Modified mRNA Vaccines Protect against Zika Virus Infection |url=|journal=Cell |volume=168 |issue=6 |pages=1114–1125.e10 |doi=10.1016/j.cell.2017.02.017 |issn=0092-8674 |pmc=5388441 |pmid=28222903}} Another venture, Elpidera, was announced in May 2015 to continue work on RNA therapies advancing Moderna's work with Alexion.{{Cite press release | publisher=PR Newswire |date=May 12, 2015 |title=Moderna Launches Third Venture Company Elpidera for Rare Diseases |url=https://www.prnewswire.com/news-releases/moderna-launches-third-venture-company-elpidera-for-rare-diseases-300081336.html |archive-url=https://web.archive.org/web/20161012234942/http://www.modernatx.com/news-events/press-releases/moderna-launches-third-venture-company-elpidera-rare-diseases |archive-date=2016-10-12 | url-status=live}}{{Cite web |last=Tirrell |first=Meg |date=2015-05-12 |title=The biotech targeting personalized medicine |url=https://www.cnbc.com/2015/05/12/moderna-therapeutics-is-trying-to-cure-disease-with-mrna-drugs.html |url-status=live |archive-url=https://archive.today/20210410143842/https://www.cnbc.com/2015/05/12/moderna-therapeutics-is-trying-to-cure-disease-with-mrna-drugs.html |archive-date=2021-04-10 |access-date=2023-06-05 |website=CNBC |language=en}}

In 2015, the company formed a partnership with Merck & Co. to develop treatments for cancer, and in 2016 the company formed a partnership with Vertex Pharmaceuticals to develop treatments for cystic fibrosis.{{cite news | title=Moderna in line for $240m licensing deal | work=The Boston Globe | first=Robert | last=Weisman | date=March 21, 2013 | url-access=limited | url=https://www.bostonglobe.com/business/2013/03/20/moderna-therapeutics-receive-million-license-its-technology-drug-giant-astrazeneca/VAFlMn2lZaCDZ6A0oyHKSI/story.html | archive-date=November 16, 2020 | archive-url=https://web.archive.org/web/20201116154149/https://www.bostonglobe.com/business/2013/03/20/moderna-therapeutics-receive-million-license-its-technology-drug-giant-astrazeneca/VAFlMn2lZaCDZ6A0oyHKSI/story.html | url-status=live}}{{cite web |title=Moderna: Strategic collaborators |url=https://www.modernatx.com/partnerships/strategic-collaborators? |publisher=Moderna, Inc. |access-date=11 February 2023 |date=2023}}{{cite web |title=Vertex and Moderna hammer out $315 million+ deal to treat cystic fibrosis using mRNA technology |url=https://www.biospace.com/article/vertex-and-moderna-hammer-out-315-million-deal-to-treat-cystic-fibrosis-using-mrna-technology-/ |publisher=BioSpace |access-date=11 February 2023 |date=6 July 2016}} In January 2016, the Bill & Melinda Gates Foundation committed to provide at least $20 million in grant funding to the company. In 2017, Alexion terminated its partnership with Moderna after safety issues prevented their work from reaching human trials.{{Cite news | url=https://www.statnews.com/2017/07/27/moderna-alexion-partnership/ | title=Key partner cuts ties with brash biotech startup Moderna, raising big questions about its pipeline | first=Damian | last=Garde | work=Stat | date=July 27, 2017}}

In July 2018, the company opened a 200,000 square foot facility in Norwood, Massachusetts for manufacturing, preclinical and clinical work.{{Cite news | url=https://www.bizjournals.com/boston/news/2018/07/17/modernas-110m-norwood-site-built-with-expansion.html | title=Moderna's $110M Norwood site built with expansion hopes | first=Allison | last=DeAngelis | work=American City Business Journals | date=July 17, 2018}} In December 2018, Moderna (ticker symbol: MRNA) became a public company via the largest initial public offering of a biotechnology company in history, raising $621{{spaces}}million by selling 27 million shares at $23 per share.{{cite news | url=https://fortune.com/2018/12/08/moderna-ipo-biotech-future/ | first=Sy | last=Mukherjee | work=Fortune | title=Moderna Had the Biggest Biotech IPO Ever. Here's What That Says About the Industry's Future | date=December 8, 2018 | archive-date=November 16, 2020 | archive-url=https://web.archive.org/web/20201116154242/https://fortune.com/2018/12/08/moderna-ipo-biotech-future/ | url-status=live}}{{cite web | url=https://www.businessinsider.com/biotech-moderna-prices-initial-public-offering-2018-12 | title=Moderna just priced the biggest IPO in biotech history, valuing the startup at $7.5 billion | first=Lydia | last=Ramsey | work=Business Insider | date=December 7, 2018 | archive-date=November 16, 2020 | archive-url=https://web.archive.org/web/20201116154155/https://www.businessinsider.com/biotech-moderna-prices-initial-public-offering-2018-12?r=US&IR=T | url-status=live}}

The first mRNA vaccine developed by Moderna was for influenza in 2015, and its first antibody encoded by mRNA was in 2019. In 2023, Moderna acquired OriCiro Genomics, a Japanese manufacturer of genetic engineering tools, in its first acquisition.{{cite web | first=Hayden | last=Schmidt |url=https://pharmanewsintel.com/news/moderna-to-buy-japanese-firm-oriciro-in-its-first-ever-acquisition |publisher=PharmaNews Intelligence |title=Moderna to Buy Japanese Firm OriCiro in Its First-Ever Acquisition |date=5 January 2023}}

In early 2023, the company in collaboration with Merck won breakthrough status from the FDA for its mRNA-4157/V940 drug candidate, a cancer vaccine.{{cite journal | title=Precision medicine meets cancer vaccines |journal=Nature Medicine | date=16 June 2023| volume=29 | issue=6 | page=1287 | doi=10.1038/s41591-023-02432-2 | pmid=37328586 | s2cid=259184146 | doi-access=free }}{{cite journal | last1=Bafaloukos|first1=Dimitrios |date=2023|title=Evolution and Progress of mRNA Vaccines in the Treatment of Melanoma: Future Prospects|journal=Vaccines|volume= 11|issue= 3|page=636 |doi=10.3390/vaccines11030636|pmid=36992220 |pmc=10057252 |doi-access=free }}

In July 2023, the company entered into an agreement with the Chinese government to develop mRNA drugs for exclusive use in China.{{Cite news |url=https://www.ft.com/content/a9e9bc51-34a9-455c-a7ae-7b9f8c4cb15a |last1=Kuchler |first1=Hannah |last2=Mancini |first2=Donato Paolo |title=US biotech Moderna strikes deal to develop mRNA drugs in China |work=Financial Times | date=July 5, 2023}}

In May 2024, the mRNA vaccine Mresvia was approved for medical use in the United States by the US Food and Drug Administration (FDA) for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older,{{cite press release | title=Moderna Receives U.S. FDA Approval for RSV Vaccine Mresvia | publisher=Moderna | via=Accesswire | date=31 May 2024 | url=https://www.accesswire.com/870069/moderna-receives-us-fda-approval-for-rsv-vaccine-mresvia | access-date=31 May 2024}}{{cite press release | title=FDA Roundup: May 31, 2024 | website=U.S. Food and Drug Administration (FDA) | date=31 May 2024 | url=https://www.fda.gov/news-events/press-announcements/fda-roundup-may-31-2024 | archive-url=https://web.archive.org/web/20240531194102/https://www.fda.gov/news-events/press-announcements/fda-roundup-may-31-2024 | url-status=dead | archive-date=May 31, 2024 | access-date=31 May 2024}} {{PD-notice}} the third RSV vaccine approved in the United States.

{{Main|Moderna COVID-19 vaccine}}

From 2020 to 2021, Moderna received $955{{spaces}}million from Operation Warp Speed to accelerate development of its COVID-19 vaccine, with $4.9{{spaces}}billion committed in total for producing 300 million vaccine doses.{{cite web | first=Miriam | last=Valverde |title=How Pfizer's and Moderna's COVID-19 vaccines are tied to Operation Warp Speed |url=https://www.politifact.com/article/2020/nov/19/pfizer-moderna-covid-19-vaccines-and-operation-war/ |publisher=PolitiFact |access-date=12 February 2023 |date=19 November 2020}}{{cite web |title=Operation Warp Speed Contracts for COVID-19 Vaccines and Ancillary Vaccination Materials |url=https://crsreports.congress.gov/product/pdf/IN/IN11560| first=Simi V. | last=Siddalingaiah |publisher=Congressional Research Service, United States Government|access-date=12 February 2023 |date=1 March 2021}}

In March 2020, the Food and Drug Administration approved clinical trials for the Moderna COVID‑19 vaccine candidate, and in December, the vaccine, mRNA-1273, was issued an emergency use authorization in the United States.{{cite news | title=Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine | url=https://www.nih.gov/news-events/news-releases/statement-nih-barda-fda-emergency-use-authorization-moderna-covid-19-vaccine | publisher=National Institutes of Health | date=December 18, 2020}}{{cite journal | title=Moderna COVID vaccine becomes second to get US authorization | journal=Nature | date=2020-12-18 | doi=10.1038/d41586-020-03593-7 | url=https://www.nature.com/articles/d41586-020-03593-7 | access-date=2023-02-12| last1=Ledford | first1=Heidi | pmid=33340017 | s2cid=243212854 | url-access=subscription }} In 2022, it gained FDA approval both for the monovalent vaccine, Spikevax, and a bivalent booster.{{cite web |title=Moderna COVID-19 vaccines |url=https://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/moderna-covid-19-vaccine |publisher=US Food and Drug Administration |access-date=11 February 2023 |date=15 December 2022}}

In April 2022, Moderna announced plans to build a $180 million vaccine factory in Montreal, forming a 10-year partnership with the Government of Canada, Quebec, and McGill University to produce 100 million Spikevax doses annually and expand vaccine research capabilities.{{cite news |title=Moderna facility in Montreal area expected to produce 100 million vaccine doses by 2024 |url=https://www.cbc.ca/news/canada/montreal/moderna-montreal-facility-mrna-1.6435636 |work=CBC News |date=29 April 2022}} The plant is scheduled to supply COVID-19 vaccines in the fall of 2025.{{Cite web |title=Moderna will supply COVID-19 vaccines made in Laval by fall 2025 |url=https://montrealgazette.com/news/local-news/moderna-will-supply-covid-19-vaccines-made-in-laval-by-fall-2025 |website=The Gazette}}

In February 2023, the company agreed to pay $400 million to the National Institutes of Health, Dartmouth College, and Scripps Research to settle a dispute over the rights to a chemical technique that was used in the vaccine.{{Cite news | url=https://www.nytimes.com/2023/02/23/science/moderna-covid-vaccine-patent-nih.html | title=After Long Delay, Moderna Pays N.I.H. for Covid Vaccine Technique | first=Benjamin | last=Mueller | work=The New York Times | date=February 23, 2023 | url-access=limited}}

Arbutus Biopharma filed a patent infringement lawsuit against Moderna in 2022, alleging that Arbutus developed lipid nanoparticles that enclose Modern'a vaccine's mRNA payload.{{Cite news |date=2024-04-03 |title=Moderna shares fall after judge sides with Arbutus in patent fight |url=https://www.reuters.com/legal/moderna-shares-fall-after-judge-sides-with-arbutus-patent-fight-2024-04-03/ |access-date=2024-05-19 |work=Reuters}} In April 2023, a court affirmed a decision to cancel a patent by Arbutus Biopharma in connection with the dispute.{{Cite news | url=https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-fends-off-arbutus-appeal-covid-19-vaccine-patent-fight-2023-04-11/ | title=Moderna fends off Arbutus appeal in COVID-19 vaccine patent fight | first=Blake | last=Brittain | work=Reuters | date=April 11, 2023}} In April 2024, however, the court issued an order that strengthened Arbutus's arguments by interpreting patents at issue in the manner Arbutus had urged.

Several legal cases between Moderna and Pfizer and BioNTech in various countries, alleging that the Pfizer–BioNTech COVID-19 vaccine violates the patent on Moderna's mRNA vaccine technology, are ongoing.{{Cite news |last1=Robbins |first1=Rebecca |last2=Gross |first2=Jenny |title=Moderna Sues Pfizer and BioNTech Over Covid Vaccine Technology |url=https://www.nytimes.com/2022/08/26/business/moderna-covid-vaccine-lawsuit.html |work=The New York Times |date=August 26, 2022 |issn=0362-4331}}

In November 2024, British pharmaceutical company GlaxoSmithKline (GSK) filed a lawsuit against Moderna Inc. in a U.S. federal court in Delaware, alleging that Moderna's COVID-19 vaccine Spikevax and RSV vaccine mResvia infringe on GSK’s patents related to messenger RNA (mRNA) technology. According to the complaint, Moderna's use of lipid nanoparticles—crucial for delivering fragile mRNA into the human body—violates several GSK patents covering similar delivery innovations.{{Cite news |last=Brittain |first=Blake |date=16 October 2024 |title=GSK sues Moderna for US patent infringement over COVID, RSV vaccines |url=https://www.reuters.com/business/healthcare-pharmaceuticals/glaxosmithkline-sues-moderna-us-patent-infringement-over-covid-vaccines-2024-10-15/ |access-date=8 November 2024 |work=Reuters}}

This lawsuit follows a similar legal action GSK brought against Pfizer and BioNTech earlier in 2024, claiming patent infringement over their mRNA-based COVID-19 vaccine. GSK’s latest litigation seeks unspecified monetary damages from Moderna.

• DNA vaccine
• CureVac

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