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Moderna, Inc. ( ) is an American pharmaceutical and
biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...
company based in
Cambridge, Massachusetts Cambridge ( ) is a city in Middlesex County, Massachusetts, United States. As part of the Boston metropolitan area, the cities population of the 2020 U.S. census was 118,403, making it the fourth most populous city in the state, behind Boston, ...
that focuses on
RNA therapeutics RNA therapeutics are a new class of medications based on ribonucleic acid (RNA). Research has been working on clinical use since the 1990s, with significant success in cancer therapy in the early 2010s. In 2020 and 2021, mRNA vaccines have been ...
, primarily
mRNA vaccine An mRNA vaccine is a type of vaccine that uses a copy of a molecule called messenger RNA (mRNA) to produce an immune response. The vaccine delivers molecules of antigen-encoding mRNA into immune cells, which use the designed mRNA as a blueprin ...
s. These
vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...
s use a copy of a molecule called
messenger RNA In molecular biology, messenger ribonucleic acid (mRNA) is a single-stranded molecule of RNA that corresponds to the genetic sequence of a gene, and is read by a ribosome in the process of synthesizing a protein. mRNA is created during the p ...
(mRNA) to produce an
immune response An immune response is a reaction which occurs within an organism for the purpose of defending against foreign invaders. These invaders include a wide variety of different microorganisms including viruses, bacteria, parasites, and fungi which could ...
. The company's only commercial product is the
Moderna COVID-19 vaccine The Moderna COVID19 vaccine (INN: elasomeran), sold under the brand name Spikevax, is a COVID-19 vaccine developed by American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedi ...
, marketed as Spikevax. As of 2022, the company has 44 treatment and vaccine candidates, of which 21 have entered
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
s. Targets for vaccine candidates include
influenza Influenza, commonly known as "the flu", is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptoms ...
,
HIV The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...
,
respiratory syncytial virus Respiratory syncytial virus (RSV), also called human respiratory syncytial virus (hRSV) and human orthopneumovirus, is a common, contagious virus that causes infections of the respiratory tract. It is a negative-sense, single-stranded RNA virus. ...
,
Epstein–Barr virus The Epstein–Barr virus (EBV), formally called ''Human gammaherpesvirus 4'', is one of the nine known human herpesvirus types in the herpes family, and is one of the most common viruses in humans. EBV is a double-stranded DNA virus. It is b ...
, the
Nipah virus Nipah virus, scientific name ''Nipah henipavirus'', is a bat-borne virus that causes Nipah virus infection in humans and other animals, a disease with a high mortality rate. Numerous disease outbreaks caused by Nipah virus have occurred in Sout ...
,
chikungunya Chikungunya is an infection caused by the ''Chikungunya virus'' (CHIKV). Symptoms include fever and joint pains. These typically occur two to twelve days after exposure. Other symptoms may include headache, muscle pain, joint swelling, and a ra ...
, a combined single-shot
COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was COVID-19 pandemic in Hubei, identified in Wuhan, China, in December ...
booster and
influenza vaccine Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies fr ...
, a
cytomegalovirus vaccine A Cytomegalovirus vaccine is a vaccine to prevent cytomegalovirus (CMV) infection or curb virus re-activation (symptomatic flare-ups) in persons already infected. Challenges in developing a vaccine include adeptness of CMV in evading the immune sys ...
, and two
cancer vaccine A cancer vaccine is a vaccine that either treats existing cancer or prevents development of cancer. Vaccines that treat existing cancer are known as ''therapeutic'' cancer vaccines or tumor antigen vaccines. Some of the vaccines are "autologous", ...
s. The company's pipeline also includes candidates for
cancer immunotherapy Cancer immunotherapy (sometimes called immuno-oncology) is the stimulation of the immune system to treat cancer, improving on the immune system's natural ability to fight the disease. It is an application of the fundamental research of cancer im ...
using
OX40 ligand OX40L is the ligand for OX40 (also known as CD134 or TNFRSF4) and is stably expressed on many antigen-presenting cells such as DC2s (a subtype of dendritic cells), macrophages, and activated B lymphocytes. The OX40 molecule, conversely, is presen ...
,
interleukin 23 Interleukin 23 (IL-23) is a heterodimeric cytokine composed of an IL-12B (IL-12p40) subunit (which is shared with IL-12) and an IL-23A (IL-23p19) subunit. IL-23 is part of the IL-12 family of cytokines. The functional receptor for IL-23 (the ...
,
IL36G Interleukin-36 gamma previously known as interleukin-1 family member 9 (IL1F9) is a protein that in humans is encoded by the ''IL36G'' gene. Expression ''IL36G'' is well-expressed in the epithelium of the skin, gut, and lung. In the skin ''IL36G ...
, and
interleukin 12 Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B- lymphoblastoid cells ( NC-37) in response to antigenic stimulation. IL-12 belongs to the family of interleukin-12. I ...
as well as, in partnership with
AstraZeneca AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas includin ...
, a
regenerative medicine Regenerative medicine deals with the "process of replacing, engineering or regenerating human or animal cells, tissues or organs to restore or establish normal function". This field holds the promise of engineering damaged tissues and organs by st ...
treatment that encodes
vascular endothelial growth factor A Vascular endothelial growth factor A (VEGF-A) is a protein that in humans is encoded by the ''VEGFA'' gene. Function This gene is a member of the platelet-derived growth factor (PDGF)/vascular endothelial growth factor (VEGF) family and encod ...
to stimulate
blood vessel The blood vessels are the components of the circulatory system that transport blood throughout the human body. These vessels transport blood cells, nutrients, and oxygen to the tissues of the body. They also take waste and carbon dioxide away ...
growth for patients with
myocardial ischemia Coronary artery disease (CAD), also called coronary heart disease (CHD), ischemic heart disease (IHD), myocardial ischemia, or simply heart disease, involves the reduction of blood flow to the heart muscle due to build-up of atherosclerotic pla ...
.


History


2005–2009

In 2005,
Derrick Rossi Derrick J. Rossi (born 5 February 1966), is a Canadian stem cell biologist and entrepreneur. He is a co-founder of the biotechnology company Moderna. Early life and education Rossi was born in Toronto as the youngest of five children of a Malt ...
, a 39-year-old postdoctoral fellow in
stem cell In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can differentiate into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type o ...
biology at
Stanford University Stanford University, officially Leland Stanford Junior University, is a private research university in Stanford, California. The campus occupies , among the largest in the United States, and enrolls over 17,000 students. Stanford is consider ...
, studied a paper by Hungarian biochemist
Katalin Karikó Katalin Karikó ( hu, Karikó Katalin, ; born 17 January 1955) is a Hungarian-American biochemist who specializes in RNA-mediated mechanisms. Her research has been the development of in vitro- transcribed mRNA for protein therapies. She co-fo ...
on RNA-mediated immune activation and her co-discovery with American immunologist
Drew Weissman Drew Weissman (born 1959) is an American physician-scientist best known for his contributions to RNA biology. His work helped enable development of effective mRNA vaccines, the best known of which are those for COVID-19 produced by BioNTech/P ...
of the nucleoside modifications that suppress the
immunogenicity Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. It may be wanted or unwanted: * Wanted immunogenicity typically relates to vaccines, where the injectio ...
of
RNA Ribonucleic acid (RNA) is a polymeric molecule essential in various biological roles in coding, decoding, regulation and expression of genes. RNA and deoxyribonucleic acid ( DNA) are nucleic acids. Along with lipids, proteins, and carbohydra ...
. In 2007, Rossi set out to build on their findings as a new assistant professor at
Harvard Medical School Harvard Medical School (HMS) is the graduate medical school of Harvard University and is located in the Longwood Medical Area of Boston, Massachusetts. Founded in 1782, HMS is one of the oldest medical schools in the United States and is consi ...
running his own lab. Rossi developed a method of modifying mRNA first via
transfection Transfection is the process of deliberately introducing naked or purified nucleic acids into eukaryotic cells. It may also refer to other methods and cell types, although other terms are often preferred: "transformation" is typically used to desc ...
into human cells, then dedifferentiating it into
bone marrow Bone marrow is a semi-solid tissue found within the spongy (also known as cancellous) portions of bones. In birds and mammals, bone marrow is the primary site of new blood cell production (or haematopoiesis). It is composed of hematopoietic ce ...
stem cell In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can differentiate into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type o ...
s which could then be further differentiated into desired target cell types.


2010

In 2010, Rossi solicited investment from fellow
Harvard University Harvard University is a private Ivy League research university in Cambridge, Massachusetts. Founded in 1636 as Harvard College and named for its first benefactor, the Puritan clergyman John Harvard, it is the oldest institution of higher le ...
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 Noubar Afeyan (Western hy, Նուպար Աֆէեան; born in 1962) is an American-Canadian entrepreneur, inventor, and philanthropist. He is best known for co-founding the biotechnology company Moderna, through his venture capital firm, Flagship ...
. Together they founded "ModeRNA Therapeutics", named from the combined terms "modified" and "RNA" that just happens to contain "modern".


2011

In 2011, Afeyan, the largest shareholder of Moderna, hired
Stéphane Bancel Stéphane Bancel (born July 20, 1972) is a French billionaire businessman. He is the chief executive officer (CEO) of the American pharmaceutical and biotechnology company Moderna, known for its COVID-19 vaccine. Before joining Moderna, Bancel ...
, previously an executive at
BioMérieux bioMérieux SA is a French multinational biotechnology company founded and headquartered in Marcy-l'Étoile, France, close to Lyon. bioMérieux is present in 44 countries and serves more than 160 countries through a large network of distributors ...
and
Eli Lilly and Company Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Colonel ...
, as CEO.


2012

Within 2 years of its founding, the company reached a
unicorn The unicorn is a legendary creature that has been described since antiquity as a beast with a single large, pointed, spiraling horn projecting from its forehead. In European literature and art, the unicorn has for the last thousand years o ...
valuation.
Patrick Degorce Patrick Degorce (born 1969) is a French hedge fund manager, and the founder and chief executive officer (CEO) of Theleme Partners LLP. Early life Degorce has French nationality, and Swiss residence. Career Degorce was an officer in the French ...
, founder of Theleme Partners, invested in Moderna and provided a $500,000 grant to allow the company to recruit a pair of oncologists. In December 2012, the company raised $40 million.


2013

In March 2013, Moderna and
AstraZeneca AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas includin ...
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 $240million 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 PhaseI trials, AZD8601, a
regenerative medicine Regenerative medicine deals with the "process of replacing, engineering or regenerating human or animal cells, tissues or organs to restore or establish normal function". This field holds the promise of engineering damaged tissues and organs by st ...
treatment which encodes
vascular endothelial growth factor A Vascular endothelial growth factor A (VEGF-A) is a protein that in humans is encoded by the ''VEGFA'' gene. Function This gene is a member of the platelet-derived growth factor (PDGF)/vascular endothelial growth factor (VEGF) family and encod ...
to stimulate
blood vessel The blood vessels are the components of the circulatory system that transport blood throughout the human body. These vessels transport blood cells, nutrients, and oxygen to the tissues of the body. They also take waste and carbon dioxide away ...
growth for patients with
myocardial ischemia Coronary artery disease (CAD), also called coronary heart disease (CHD), ischemic heart disease (IHD), myocardial ischemia, or simply heart disease, involves the reduction of blood flow to the heart muscle due to build-up of atherosclerotic pla ...
undergoing
coronary artery bypass grafting Coronary artery bypass surgery, also known as coronary artery bypass graft (CABG, pronounced "cabbage") is a surgical procedure to treat coronary artery disease (CAD), the buildup of plaques in the arteries of the heart. It can relieve chest pai ...
(CABG) surgery with moderately impaired systolic function. 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 tem celldifferentiation toward cardiovascular cell types" in a significant step for
regenerative medicine Regenerative medicine deals with the "process of replacing, engineering or regenerating human or animal cells, tissues or organs to restore or establish normal function". This field holds the promise of engineering damaged tissues and organs by st ...
. In October 2013, the company was awarded up to $25million by
DARPA The Defense Advanced Research Projects Agency (DARPA) is a research and development agency of the United States Department of Defense responsible for the development of emerging technologies for use by the military. Originally known as the Adv ...
to develop messenger RNA therapeutics. In November 2013, the company raised $110million of equity financing.


2014

In January 2014,
Alexion Pharmaceuticals Alexion Pharmaceuticals is an American pharmaceutical company headquartered in Boston, Massachusetts that specializes in orphan drugs to treat rare diseases. It became an independent subsidiary of AstraZeneca in 2021. Its products include eculi ...
paid Moderna $100million for ten product options to develop
rare disease A rare disease is any disease that affects a small percentage of the population. In some parts of the world, an orphan disease is a rare disease whose rarity means there is a lack of a market large enough to gain support and resources for discove ...
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.


2017

In November 2017, Moderna employees safely tested mRNA technology in
Sprague-Dawley rat A laboratory rat or lab rat is a brown rat of the subspecies '' Rattus norvegicus domestica'' which is bred and kept for scientific research. While less commonly used for research than mice (see laboratory mouse), rats have served as an importa ...
s and
cynomolgus monkeys The crab-eating macaque (''Macaca fascicularis''), also known as the long-tailed macaque and referred to as the cynomolgus monkey in laboratories, is a cercopithecine primate native to Southeast Asia. A species of macaque, the crab-eating macaqu ...
at the Montreal and Sherbrooke facilities of
Charles River Laboratories Charles River Laboratories International, Inc., is an American pharmaceutical company specializing in a variety of preclinical and clinical laboratory, gene therapy and cell therapy services for the Pharmaceutical, Medical device and Biotechnolo ...
. They found, among other things, that "mRNA is a
labile Lability refers to something that is constantly undergoing change or is likely to undergo change. Biochemistry In reference to biochemistry, this is an important concept as far as kinetics is concerned in metalloproteins. This can allow for th ...
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.


2018

In 2018, the company rebranded as "Moderna Inc." and further increased its portfolio of vaccine development. In July 2018, the company opened a 200,000 square foot facility in
Norwood, Massachusetts Norwood is a town and census-designated place in Norfolk County, Massachusetts, United States. Norwood is part of the Greater Boston area. As of the 2020 census, the population was 31,611. The town was named after Norwood, England. Norwood is ...
for manufacturing, preclinical and clinical work. In December 2018, Moderna became a
public company A public company is a company whose ownership is organized via shares of stock which are intended to be freely traded on a stock exchange or in over-the-counter markets. A public (publicly traded) company can be listed on a stock exchange (l ...
via the largest biotech
initial public offering An initial public offering (IPO) or stock launch is a public offering in which shares of a company are sold to institutional investors and usually also to retail (individual) investors. An IPO is typically underwritten by one or more investment ...
in history, raising $621million (27 million shares at $23 per share).


2019

In May 2019, the company together with
Merck Sharp & Dohme Merck & Co., Inc. is an American multinational pharmaceutical company headquartered in Rahway, New Jersey, and is named for Merck Group, founded in Germany in 1668, of whom it was once the American arm. The company does business as Merck Sharp ...
, entered a Phase I clinical trial for mRNA-5671 vaccine in combination with
pembrolizumab Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast canc ...
for the treatment of solid tumors with driver mutations in the
KRAS ''KRAS'' (Kirsten rat sarcoma virus) is a gene that provides instructions for making a protein called K-Ras, a part of the RAS/MAPK pathway. The protein relays signals from outside the cell to the cell's nucleus. These signals instruct the cell ...
gene.


2020

In March 2020, the
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) approved
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
s for the Moderna COVID‑19 vaccine candidate, with Moderna receiving investment of $483million from
Operation Warp Speed Operation Warp Speed (OWS) was a public–private partnership initiated by the United States government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The firs ...
.
Moncef Slaoui Moncef Mohamed Slaoui (; ; ary, منصف السلاوي, ; born July 22, 1959) is a Moroccan-born Belgian-American researcher who served as the head of Operation Warp Speed (OPWASP) under President Donald Trump from 2020 to 2021. Slaoui is t ...
, then a member of the board of directors of Moderna, was appointed head scientist for the Operation Warp Speed project. In July 2020, the
Moderna COVID-19 vaccine The Moderna COVID19 vaccine (INN: elasomeran), sold under the brand name Spikevax, is a COVID-19 vaccine developed by American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedi ...
candidate was shown to be
immunogenic Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. It may be wanted or unwanted: * Wanted immunogenicity typically relates to vaccines, where the injectio ...
in a PhaseI trial involving 45 volunteers aged 18–55 years. On November 16, 2020, an interim analysis of PhaseIII clinical trials, which involved over 30,000 patients, showed that the
Moderna COVID-19 vaccine The Moderna COVID19 vaccine (INN: elasomeran), sold under the brand name Spikevax, is a COVID-19 vaccine developed by American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedi ...
candidate was 94.1% effective in preventing
COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was COVID-19 pandemic in Hubei, identified in Wuhan, China, in December ...
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 An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Act of Congress, Acts of ...
(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 The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...
. On January 8, 2021, mRNA-1273 was authorized for use in the
United Kingdom The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and North ...
. Moderna partnered with Swiss contract manufacturer
Lonza Group Lonza Group is a Swiss multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, headquartered in Basel, with major facilities in Europe, North America and South Asia. Lonza was established under that name in ...
to produce the vaccine.


2021

On March 15, 2021,
Phase I clinical trials The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...
began for mRNA-1283, primarily intended to be used as a COVID-19 vaccine booster. On June 25, 2021, the
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
added a warning about rare cases of
myocarditis Myocarditis, also known as inflammatory cardiomyopathy, is an acquired cardiomyopathy due to inflammation of the heart muscle. Symptoms can include shortness of breath, chest pain, decreased ability to exercise, and an irregular heartbeat. The ...
, a heart inflammation, associated with both Moderna and Pfizer/BioNTech vaccines to their respective fact sheets. On August 17, 2021, the
United Kingdom The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and North ...
's
Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...
approved Moderna's Covid vaccine for use in children aged 12 to 17 years. In July 2021, the company's
mRNA vaccine An mRNA vaccine is a type of vaccine that uses a copy of a molecule called messenger RNA (mRNA) to produce an immune response. The vaccine delivers molecules of antigen-encoding mRNA into immune cells, which use the designed mRNA as a blueprin ...
for
influenza Influenza, commonly known as "the flu", is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptoms ...
, code name mRNA-1010, entered Phase I clinical trials. In August 2021, the company received fast track designation from the
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
for its
respiratory syncytial virus vaccine A respiratory syncytial virus vaccine (RSV vaccine) is a vaccine which prevents infection by respiratory syncytial virus. , no licensed vaccine against RSV exists. Attempts to develop an RSV vaccine began in the 1960s with an unsuccessful inactiv ...
. In September 2021, the company began work on a combined
COVID-19 vaccine A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an e ...
booster and
influenza vaccine Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies fr ...
. That same month, it entered an agreement with
biomanufacturing Biomanufacturing is a type of manufacturing or biotechnology that utilizes biological systems to produce commercially important biomaterials and biomolecules for use in medicines, food and beverage processing, and industrial applications. Biomanufa ...
company National Resilience to manufacture genetic components for its COVID-19 products at its facility in
Mississauga Mississauga ( ), historically known as Toronto Township, is a city in the Canadian province of Ontario. It is situated on the shores of Lake Ontario in the Regional Municipality of Peel, adjoining the western border of Toronto. With a popul ...
,
Ontario Ontario ( ; ) is one of the thirteen provinces and territories of Canada.Ontario is located in the geographic eastern half of Canada, but it has historically and politically been considered to be part of Central Canada. Located in Central Ca ...
.


2022

On April 7, 2022, Moderna and the
University of Toronto The University of Toronto (UToronto or U of T) is a public research university in Toronto, Ontario, Canada, located on the grounds that surround Queen's Park. It was founded by royal charter in 1827 as King's College, the first institution ...
announced a new partnership to “develop new tools to prevent and treat
infectious diseases An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable dise ...
,” including in the realms of “
molecular genetics Molecular genetics is a sub-field of biology that addresses how differences in the structures or expression of DNA molecules manifests as variation among organisms. Molecular genetics often applies an "investigative approach" to determine the ...
,
biomedical engineering Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare purposes (e.g., diagnostic or therapeutic). BME is also traditionally logical sciences ...
, and
biochemistry Biochemistry or biological chemistry is the study of chemical processes within and relating to living organisms. A sub-discipline of both chemistry and biology, biochemistry may be divided into three fields: structural biology, enzymology and ...
. The collaboration is a joint venture across U of T's Faculties of Applied Science and Engineering and
Medicine Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care pract ...
. In April 2022, Moderna announced plans to build a $180 million vaccine factory in
Montreal Montreal ( ; officially Montréal, ) is the List of the largest municipalities in Canada by population, second-most populous city in Canada and List of towns in Quebec, most populous city in the Provinces and territories of Canada, Canadian ...
, forming a 10-year partnership with the Canadian federal government, province of
Quebec Quebec ( ; )According to the Canadian government, ''Québec'' (with the acute accent) is the official name in Canadian French and ''Quebec'' (without the accent) is the province's official name in Canadian English is one of the thirtee ...
, and
McGill University McGill University (french: link=no, Université McGill) is an English-language public research university located in Montreal, Quebec, Canada. Founded in 1821 by royal charter granted by King George IV,Frost, Stanley Brice. ''McGill Universit ...
to produce 100 million ''Spikevax'' doses annually and expand vaccine research capabilities.


Financial data


NIH vaccine patent dispute

Moderna is involved in a patent dispute with the
NIH The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
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.


Pfizer and BioNTech patent lawsuits

On August 26, 2022, Moderna sued
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...
and
BioNTech BioNTech SE ( ; or short for Biopharmaceutical New Technologies) is a German biotechnology company based in Mainz that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases. It develops ...
in both Massachusetts and Germany, accusing the
Pfizer–BioNTech COVID-19 vaccine The Pfizer–BioNTech COVID-19 vaccine ( INN: tozinameran), sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with Amer ...
of violating the patent on Moderna's
mRNA vaccine An mRNA vaccine is a type of vaccine that uses a copy of a molecule called messenger RNA (mRNA) to produce an immune response. The vaccine delivers molecules of antigen-encoding mRNA into immune cells, which use the designed mRNA as a blueprin ...
technology.


See also

*
DNA vaccine A DNA vaccine is a type of vaccine that transfects a specific antigen-coding DNA sequence into the cells of an organism as a mechanism to induce an immune response. DNA vaccines work by injecting genetically engineered plasmid containing the D ...
*
CureVac CureVac N.V. is a German biopharmaceutical company that develops therapies based on messenger RNA (mRNA). Legally domiciled in the Netherlands and headquartered in Tübingen, Germany, the company was founded in 2000 by Ingmar Hoerr (CEO), S ...


Notes


References


External links

* * {{authority control 2010 establishments in Massachusetts 2018 initial public offerings American companies established in 2010 Biotechnology companies of the United States Biotechnology companies established in 2010 Companies based in Cambridge, Massachusetts Health care companies based in Massachusetts COVID-19 vaccine producers Medical research Pharmaceutical companies of the United States