Moderna, Inc

Company information

• Date founded: 2010
• Industry: Pharmaceutical, biotechnology
• Corporate headquarters: Cambridge, Massachusetts
• Type: Public

Overview

Moderna is a US-based pharmaceutical and biotechnology company that focuses on using messenger RNA (mRNA) technology to create medical treatments and vaccines. Moderna’s mRNA technology prompts the body’s cells to produce an immune response to a foreign invader without ever having the infectious agent enter the body. The company was founded in 2010 and worked on research and development in relative secrecy for most of the following decade. In 2020, Moderna announced that its technology could be used to make a vaccine to fight COVID-19, a potentially fatal respiratory illness that was rapidly spreading across the globe. Moderna’s vaccine was approved for emergency use in the United States in December 2021, and millions of doses of the vaccine were distributed across the world. The success of the vaccine resulted in Moderna posting its first profitable quarter since its inception.

History

The body’s immune system has several weapons to fight invading bacteria and viruses, but first it must recognize the enemy in order to destroy it. When the immune system encounters a foreign invader, it produces antibodies that specifically target that virus or bacteria. The immune system also has the ability to “remember” the invader and produce antibodies to fight it in the future. Traditional vaccines use a dead or weakened form of the invader to trigger this immune response in the body.

In the late twentieth century, scientists began testing a new technology that used messenger RNA to prompt an immune response. Messenger RNA is a strand of genetic material in the cell that carries instructions from the DNA in the nucleus to tiny molecular machines called ribosomes. The ribosomes make proteins according to the specifics of the DNA’s instructions.

Biomedical researchers began to see the potential of the process in fighting disease. If they could give the mRNA the proper instructions, it could be used to create antibodies or enzymes that could target specific illnesses or regrow tissue. By 2005, scientists had overcome a key obstacle in developing an mRNA vaccine by finding a way to “hide” the vaccine molecules from the immune system.

In 2009, Harvard Medical School biologist Derrick Rossi successfully used mRNA technology to reprogram adult cells to act like embryonic stem cells, specialized cells that can turn into any other cell in the body. In 2010 Rossi showed his work to his colleague Timothy Springer, and together they presented the discovery to Robert Langer, a pioneering biomedical engineer at the Massachusetts Institute of Technology (MIT). Langer recognized the potential impact that Rossi’s work could have on the future of biomedicine. Within days, the men enlisted money from venture capitalist Noubar Afeyan to fund a start-up company. Later that year, Afeyan, Langer, Rossi, Springer, and another Harvard doctor, Kenneth Chien, formed Moderna Therapeutics, taking the name from a combination of the words "modified" and "RNA."

Despite not having a single successful product on the market or making any of its research public, Moderna still managed to raise two billion dollars in venture capital by 2018 based on the promise of mRNA alone. While the company’s initial attempts to develop mRNA drug therapy fell short, its work on using the technology to produce a revolutionary new method for vaccines was more successful. In 2018 the company was renamed Moderna, Inc., and became publicly traded in the largest initial public offering in biotech history.

In late 2019, Chinese doctors reported an outbreak of a new virus in the central province of Hubei. The disease caused by the virus—eventually dubbed coronavirus disease 2019, or COVID-19—was highly contagious and could cause serious respiratory illness or death. By March 2020, the World Health Organization (WHO) had declared the spread of COVID-19 a global pandemic. In January 2020, Moderna officials decided that their decade of research put them in a perfect position to create a COVID-19 vaccine using mRNA technology. All they needed was the virus’s genetic code, which Chinese scientists had mapped and made public in early January. The US National Institutes of Health also offered substantial support to develop a vaccine, with the US government investing billions of dollars in research and development.

Because the technology for producing an mRNA vaccine already existed and the company had experience developing experimental vaccines, Moderna was able to complete work on the first doses of its vaccine by February 2020. It began clinical trials that March, and by December, the US Food and Drug Administration (FDA) had approved the vaccine for emergency use. Early testing showed Moderna’s vaccine to be 94 percent effective in preventing COVID-19. The company soon began distributing hundreds of millions of doses of the vaccine around the world; in the US and many other nations, the shots were provided free to the public as part of government efforts to control the pandemic. Moderna's vaccine quickly became the second most widely administered COVID-19 vaccine in the US, trailing only a vaccine developed by the company Pfizer. As a result of its success, Moderna posted its first-ever profitable financial quarter in 2021 and made more than $800 million in revenue in 2020. In the second quarter of 2021, the company reported revenue of $2.8 billion.

In August 2021 the FDA approved a booster dose of Moderna's COVID-19 vaccine for immunocompromised people. Later that year, booster eligibility was expanded to anyone age eighteen or older, as research increasingly showed the effectiveness of an initial vaccination declined over time, especially with the emergence of new COVID-19 variants. (Studies did suggest that even a single dose still helped reduce the risk of severe illness long-term.) Moderna's vaccine, by then marketed as Spikevax, received full FDA authorization for recipients eighteen years or older in January 2022. That June, the FDA emergency use authorization was extended to include people from six months to sixteen years old.

While the COVID-19 pandemic continued, by 2023 society had largely returned to normal operations and demand for vaccines had begun to fall. The US government announced that as the national public health emergency came to an end, it would stop purchasing COVID-19 vaccines to be distributed to the public for free. As a result, Moderna prepared to make its vaccine commercially available. In early 2023 the company announced that it would raise the price of its vaccine from the approximately $26 per dose it had charged the government to $130 per dose. This 400 percent increase drew criticism from some public health advocates and politicians, especially as Moderna had already registered about $21 billion in profits from its vaccine by that point.

Meanwhile, even as it continued providing updated COVID-19 vaccines, Moderna had begun to explore various other treatments and fields of research. For example, it partnered with the pharmaceutical company Merck to research and develop vaccines that could direct the immune system to target specific cancer cells, joined with the biotech company AstraZeneca in researching mRNA technology that could regenerate blood vessels in patients with heart disease, and worked on an mRNA solution to treating cystic fibrosis. As the viral disease mpox had remained a significant, evolving threat in African countries while starting to have more of a global impact by the mid-2020s, the company also began work on a potentially more effective mRNA vaccine to combat this disease as well.

Impact

Moderna rapidly rose from an experimental start-up to a major player in the pharmaceutical industry. The company's innovative mRNA vaccine, coupled with several other vaccines approved by the FDA in late 2020 and early 2021, had a significant early impact in slowing the spread of COVID-19. However, hesitancy by some people toward getting vaccinated hampered efforts to get the pandemic under control. Much disinformation about COVID-19 and vaccines circulated, and Moderna and other biotech companies often found themselves scrutinized by conspiracy theorists. Nevertheless, Moderna had great financial success with its vaccine. This, in turn, generated criticism of profiteering from some observers, though others considered it simply an example of strong business practice.

Biotechnology experts noted that Moderna’s COVID-19 vaccine would likely pave the way for mRNA technology to be used in making vaccines for many more illnesses.

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