Moderna 

is an American pharmaceutical and biotechnology company based in Cambridge,

Massachusetts. It focuses on drug discovery, drug development, and vaccine technologies based
exclusively on messenger RNA (mRNA).[8][9]
Moderna's technology platform inserts synthetic nucleoside-modified mRNA (modRNA) into
human cells. This mRNA then reprograms the cells to prompt immune responses. It is a novel
technique, previously abandoned due to the side effects of inserting mRNA into cells.[10][11][12] As of
November 2020, the Moderna COVID-19 vaccine candidate, mRNA-1273, had shown preliminary
evidence of 94% efficacy in preventing COVID-19 disease in a Phase III trial, with only minor flu-
like side effects. This led to its submission for emergency use authorization (EUA) in Europe,
the United States, and Canada.[13][14] On December 18, 2020, mRNA-1273 was issued an EUA in
the United States.[15] It was authorized for use in Canada on December 23, 2020,[16][17] as well as in
the European Union on January 6, 2021.[18] Subsequently the mRNA-1273 was authorized in
the United Kingdom on 8 January 2021.[19]

Contents

 1History
o 1.12010–2016
o 1.22018–2020
 2Overview
o 2.1Leadership
o 2.2Board
 3COVID-19 vaccine
 4See also
 5Notes
 6References
 7External links

History[edit]
2010–2016[edit]

Moderna headquarters in Cambridge, Massachusetts

In 2010, ModeRNA Therapeutics was formed to commercialize the research of stem

cell biologist Derrick Rossi. Rossi had developed a method of modifying mRNA by
first transfecting it into human cells, then dedifferentiating it into stem cells which could then be
further redifferentiated into desired target cell types.[20][21] Rossi approached fellow Harvard
University faculty member Tim Springer, who solicited co-investment from Kenneth Chien, Bob
Langer, and venture capital firm Flagship Ventures.[21][22]
In 2011, the CEO of Flagship Ventures (now Flagship Pioneering), Noubar Afeyan, brought in
European pharma sales and operations executive Stéphane Bancel as CEO.[21][10] Afeyan
personally owned 19.5% of Moderna and was the largest single shareholder, while his fund,
Flagship Pioneering, owned 18%.[23]
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.[10][24][25] The
agreement included a $240 million upfront payment to Moderna, a payment that was "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",[24] and an 8% share in Moderna.[23] As of May 2020,
only one candidate has passed Phase I trials, a treatment for myocardial ischemia, labelled
AZD8601.[a][27]
In January 2014, Moderna and Alexion Pharmaceuticals entered a $125 million deal for orphan
diseases in need of therapies. Alexion paid Moderna $100 million for 10 product options to
develop rare-disease treatments, including for Crigler-Najjar syndrome, using Moderna's mRNA
therapeutics platform.[28] By 2016, Bancel told an audience of JPMorgan Chase investors that the
work with Alexion would shortly enter human trials. However, by 2017, the program with Alexion
had been scrapped as the animal trials showed that Moderna's treatment would never be safe
enough for use in humans.[10][12]
In February 2016, an op-ed in Nature criticized Moderna for not publishing any peer-reviewed
papers on its technology, unlike most other emerging and established biotech companies, and
compared its approach to that of the controversially failed Theranos.[29] In September
2018, Thrillist published article titled, "Why This Secretive Tech Start-Up Could Be The Next
Theranos",[30] criticizing its reputation for secrecy and the absence of scientific validation or
independent peer-review of its research, though having the highest valuation of any U.S. private
biotech company at more than $5 billion.[10][11] A former Moderna scientist told Stat: "It's a case of
the emperor's new clothes. They're running an investment firm, and then hopefully it also
develops a drug that's successful".[10]

2018–2020[edit]
In 2018, the company rebranded as "Moderna Inc." with the ticker symbol MRNA, and further
increased its portfolio of vaccine development.[9] In December 2018, Moderna became the largest
biotech initial public offering in history, raising $621 million (27 million shares at $23 per share) on
NASDAQ, and implying an overall valuation of $7.5 billion for the entire company.[31][32] The year-
end 2019 SEC filings showed that Moderna had accumulated losses of $1.5 billion since
inception, with a loss of $514 million in 2019 alone, and had raised $3.2 billion in equity since
2010.[9][23] As of December 2020, Moderna was valued at $60 billion.[33]
In March 2020, in a White House meeting between the Trump administration and pharmaceutical
executives, Bancel told the president that Moderna could have a COVID-19 vaccine ready in a
few months.[9] The next day, the FDA approved clinical trials for the Moderna vaccine candidate,
with Moderna later receiving investment of $483 million from Operation Warp Speed.[9] Moderna
board member, Moncef Slaoui, was appointed head scientist for the Operation Warp Speed
project.[9]

Overview[edit]
Moderna develops mRNAs that are delivered in lipid nanoparticle, using mRNA
with pseudouridine nucleosides. Candidates are designed to have improved folding
and translation efficiency via insertional mutagenesis.[34]
The Moderna COVID-19 vaccine candidate, mRNA-1273, was shown in a Phase I trial to
be immunogenic in a small number of volunteers aged 18–55 years.[35] As of December 2020, no
mRNA vaccine had completed Phase III clinical trials or had been licensed for prophylactic use
against COVID-19, although the Moderna and Pfizer COVID-19 vaccines had been approved for
marketing under emergency use authorizations from the FDA and regulatory agencies in other
countries.[36][37]
Leadership[edit]
Since 2011, Moderna has been led by CEO Stéphane Bancel, a French businessman with a
pharmaceutical sales and operations background.[10][9] Bancel has been described as having a
secretive approach to Moderna, and as being a tough operator.[10][9] Though never having worked
with RNA before, Stat noted that Bancel "is listed as a co-inventor on more than 100 of Moderna's
early patent applications, unusual for a CEO who is not a PhD scientist".[10] After Noubar Afeyan
and Robert Langer, Bancel is the largest individual shareholder in the company.[38]
Stephen Hoge, M.D., is president and a former McKinsey & Company management consultant
who joined in 2012; he is the fourth-largest individual shareholder in the company.[38][5]
David Meline is CFO.[5]

Board[edit]
Noubar Afeyan, CEO of Flagship Pioneering, has been the chairman of Moderna's board of
directors since 2011.[39] Afeyan who has a Ph.D. in biochemical engineering[40] holds his interest in
Moderna through various Flagship Pioneering vehicles. At the 2018 IPO, documents filed stated
that Afeyan owned 19.5% of the company, while Flagship owned 18%, thus giving Afeyan control
over 37.5% of the company.[23]
In May 2020, board member Dr. Moncef Slaoui resigned from the company to become Chief
Scientist for the Trump administration's "Operation Warp Speed", a group designed to accelerate
the development of a vaccine for the coronavirus. Slaoui continued to hold more than $10 million
in stock options in the company in his new role while the federal government invested
$483 million in the company to assist in coronavirus vaccine trials. Senator Elizabeth
Warren called the holding a conflict of interest and stated that Slaoui should have divested his
options.[41]

COVID-19 vaccine[edit]
Main article: mRNA-1273
See also: COVID-19 vaccine and RNA vaccine

Moderna COVID-19 Vaccine, codenamed mRNA-1273, is a COVID-19 vaccine developed by

the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced
Research and Development Authority (BARDA), and Moderna. It is administered by two
0.5 mL doses given by intramuscular injection given four weeks apart.[42]
On 18 December 2020, mRNA-1273 was issued an Emergency Use Authorization by the United
States Food and Drug Administration (FDA).[43][44][45][46] It was authorized for use in Canada on 23
December 2020,[47][48] in the European Union on 6 January 2021,[49] and in the United Kingdom on 8
January 2021.[50]