Introduction
Moderna, founded in the year 2010, is a pharmaceutical biotechnology company that is based in Massachusetts, Cambridge. The company focuses on RNA therapeutics as a whole, and mRNA vaccines in particular. These Moderna vaccines are all based on the same technology – using a copy of the molecule, messenger RNA (mRNA), to produce an immunological response in the body. Moderna was founded as a result of the determination of its co-founders to provide new and improved vaccines for the diseases which have plagued us over the years.
To date, the only product launched in the market by Moderna is the much-eagerly anticipated Moderna COVID-19 vaccine. In addition to this, the company has some other vaccines which are at various phases of clinical trials currently. These under-trial vaccines candidates are aimed to provide immunological protection against diseases like HIV, influenza, the ‘Nipah’ virus, the ‘Epstein-Barr’ virus, a combined COVID-19 vaccine to be administered at a single dose, chikungunya, and others.
Moderna was founded in the year 2010 when the company’s co-founders got together to set up a company that would conduct research and develops products on RNA. The company was named “Mode-RNA therapeutics”, which would go on to be later named Moderna. The name is reported to be inspired by two terms – ‘modified’ and ‘RNA’, and the presence of the term ‘modern’ has been stated to be a pure coincidence. Over the years, the company has grown to be a success in its field and continues to work on new ideas.
The history of Moderna can be divided into several phases according to the work accomplished during that particular phase and we shall be looking at all these phases in detail.
2005-2009: The early days:
- Rossi’s research: It all began in the year 2005 when Derrick Rossi, a postdoctoral fellow in stem cell biology at Stanford University, studied a paper by a Hungarian biochemist, Katalin Kariko, who had studied the effects of RNA-mediated immune activation. She had also discovered the nucleoside modifications that help in suppressing the immunogenicity of RNA.
It was not until 2007 when Rossi decided to take matters into his own hands to try and find out new facts about the area where he believed there was much left to be discovered.
- The initial success: The efforts of Rossi did not prove to be futile as he succeeded in developing a method of modifying messenger RNA – first, via transfection into living human cells, and then, dedifferentiating it into bone marrow stem cells. He also found out that this could be further differentiated into the desired target cell types.
2010-2016:
- Moderna is created: This is the phase where Moderna was set up officially, and the company crossed significant milestones during this period. It was in 2010 when Rossi had approached fellow Harvard University faculty member, Timothy Springer. Rossi spoke about his ideas to Springer, who immediately liked them, and the decision to try and establish a company dedicated to research on mRNA was agreed upon.
- The co-founders: Then, Springer managed to solicit co-investment from Kenneth R. Chien, Bob Langer, and Venture Studio Flagship Ventures – all of which is run by the American-Canadian philanthropist, Noubar Afeyan. These people set up the company titled Moderna therapeutics (inspired from modified + RNA, as already mentioned). This is how the company was finally set up in September 2010.
- The hiring of CEO and unicorn valuation: In the following year, Noubar Afeyan, who was and is the largest shareholder of the company to date, hired the highly experienced Stephane Blancel as the company’s CEO. The newly hired CEO lived up to the expectations and led the company to a unicorn valuation within 2 years of its foundation. The tremendous success of the company was attributed to the research and growth possibilities the field provided.
- Significant achievements during the period: It was also during this period that the company underwent many significant financial achievements.
- Moderna and AstraZeneca deal: In March 2013, a five-year deal was signed between Moderna and AstraZeneca with the view of discovering, developing, and commercializing mRNA for commercial purposes, specifically in the treatment of cardiovascular, renal, and metabolic diseases. The deal was reported to be worth around $240 million which was to be paid upfront to Moderna and included payments at a later stage too.
The deal is still the highest deal of its kind in the pharmaceutical department and the price paid upfront is the largest sum paid up to date for a deal of this kind where none of the products have been in the clinical trial phase already before the deal is signed. It is important to be noted though that only one product from this deal has made it past the Phase I trials as of today.
- DARPA deal: There were also many significant achievements by Moderna in the year 2013 when it received up to $25 million from the DARPA to develop messenger RNA therapeutics. In November 2013, the company also managed to raise $110 million through equity financing.
- The company also made a breakthrough during this period when lab tests conducted by them during this period confirmed that they had been able to improve heart function in mice. This, they said was an important achievement in the pathway of regenerative medicines.
- Rare failed deal: The company was also offered $100 million for ten product options to come up with a cure for rare diseases like the Crigler-Najjar syndrome, using the mRNA technology. The initial results for the tests conducted in the lab were disappointing, however, as the results indicated that humans would not be able to survive the same amount of the drugs as was being administered to the animals. This resulted in the deal being called off, and this is perhaps the only failure of the Moderna company since its inception.
2017:
- mRNA technology tested: 2017 marked another important milestone in the history of Moderna as the employees safely tested the much-awaited mRNA technology in Sprague-Dawley rats and cynomolgus monkeys. The results were very encouraging for the ongoing experiments being conducted in the laboratory and an important observation was found, which stated that mRNA required usage of protective delivery systems to harness its full potential.
- This could be understood by observing the fact that mRNA is usually spread beyond the injected site and was found in the spleen, liver, bone marrow, and even heart. These observations laid the foundation for the more complicated research to follow at Moderna.
2018-2019:
- Rebranding: This is the period when the company was rebranded as ‘Moderna Inc.’ and further increased the vaccine development portfolio. In July 2018, the company opened its new facility at Norwood, Massachusetts, a location that continues to be the hub of manufacturing and clinical work of the company.
- IPO offered: Moderna went public in the year 2019 by raising $621 million in its IPO, which is to date, the largest Initial Public Offering (IPO) in the pharmaceutical sector. The recent pandemic has also seen the value of Moderna shares soaring and the shares returned handsome profits.
2020-2021:
- The Moderna COVID-19 vaccine: This may fall in the more recent past of the company but may well be the most important phase of the company. Moderna was successful in bringing in one of the first and best Covid-19 vaccines to the market during this phase. The vaccine candidate emerged to be the preferred choice of many because of the high efficacy rates as well as the negligible side effects produced. The vaccine efficiency rate of 94.1% is one of the best results produced by any vaccine to date. It is also important to note that the Moderna Covid-19 vaccine has brought a good amount of trust and reputation to the company, as this was the first product ever to be marketed by Moderna.
- Clinical trials: The vaccine is sold under the brand name Spikevax and Moderna got the necessary support from the US National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA). The vaccine was approved by the FDA in March 2020 for clinical trials. The trials that followed showed desirable results and the vaccine was found to produce the desired amount of immunological response in humans. Initially, tests were carried out on people belonging to the age group between 18 and 45 years. The age limit was later expanded. The reason behind such a decision was that people from the lower age groups would be expected to handle any kind of side effects much better.
- Approval at places: the trials were completed on November 30, 2020, the results which came out were more than satisfactory as the vaccine candidate was found to be effective in preventing serious cases in 100% of the cases. Consequently, the vaccine was given the nod for emergency use in the United States in December 2020, and the European Union soon followed suit.
- Other vaccines in development: There are also several other vaccine candidates of Moderna which have entered clinical trials in the year 2021. In July, the influenza vaccine entered trials and the company also began working on a combined vaccine to protect against the Covid-19 virus and influenza. Moderna also managed to get fast track designation from the FDA for its respiratory syncytial virus vaccine, which is in the works currently. Thus, it can be said that 2021 has proved to be quite an eventful year for the company.
Criticisms faced:
- Moderna has not managed to keep shy of any criticisms in its otherwise smooth path until now. There were reports in 2017 that accused Moderna of not publishing any of the peer reviews conducted by it, unlike the other emerging start-ups. There were also articles published which directly attacked the company’s secretive policies and the absence of scientific validation and peer reviews on most of the research papers published. However, the company took notice of these claims and acted accordingly as they became more open in their procedures once the clinical trials got underway.
- In May 2020, there was the instance of a Moderna board member, who held around $10 million stakes at the company, leaving the job for accepting a role of Chief Scientist at a government organization. It was during this period that the federal government made a huge investment in the company. Many accused this to be a case of ‘conflict of interest.’
Conclusion
It is thus seen that Moderna has succeeded in doing exactly what was the primary motive behind setting up the company. The Covid-19 vaccine has proved to be essential and crucial in preventing the rapid spread of the ongoing pandemic. The company’s vaccine was one of the first to be launched in the market and that also resulted in increasing the valuation and potential of the country by huge margins. As of today, the company makes a net profit on the vaccines, though the latest variants of the coronavirus are a cause of concern. There is research being conducted to study the effects of these forms of the virus. But there is enough evidence in the history of the company that is not one to give up hope and would effectively come up with an even better solution to counter the problems faced (if any).
Frequently Asked Questions:
We took a look at the most searched for questions on the web about Moderna, and all things related to it. In this section, we have compiled the most relevant questions along with the appropriate answers.
Question. How much did Moderna earn from the Covid-19 vaccine?
Moderna has made tremendous profits from its only marketable product – the Moderna Covid-19 vaccine. The 2021 third-quarter sales report shows that Moderna made sales of US $5 billion worldwide. The report also states that the company expects to make around USD 18 billion annually from the Covid-19 vaccine alone.
Some reports go on to state that Moderna, along with a couple of other vaccine makers – Pfizer and BioNTech, makes a profit at the rate of $1000/second at present solely contributed to the sale of vaccines. There have been accusations by a large section of people including journalists, politicians, and all other sections of the society alike, that these companies ought to cut on their profit margins to provide better access to the low-developed countries and people from all sections of the society.
Question. Why does Moderna have only one product in the market as of now?
Although the company has been working on some vaccines, the only product which has seen the light of the day is the now very well-known Moderna Covid-19 vaccine. As many as 15 other vaccine candidates are in the trial phase of vaccine development. The company’s pipeline shows the plans for developing vaccines for the major ailments which have plagued humankind the most. These candidates include vaccines for Aids, influenza, vaccines for different viruses – ‘Nipah’, ‘Epstein-Barr’, cytomegalovirus, and cancer.
The Covid-19 vaccine as of now has proved to be extremely effective and even offers protection against the latest variants like Delta, Delta Plus, Omicron, etc. The efficient handling of the manufacturing and distribution procedure for the Covid-19 vaccines has silenced doubters who had questioned the inexperience of Moderna.
Question. Is the Moderna Covid 19 vaccine safe and effective?
The US Food and Drug Association (FDA) licensed the Moderna vaccine to be administered for emergency use to protect against the deadly SARS-Cov-2 virus. The Moderna vaccine was among the first candidates to be given the nod by the FDA and is certified to be safe for people aged 18 years or older. The side effects may include temporary fever, redness and swelling around the injected area, temporary nausea. Appropriate medicines like Paracetamol can be used to relieve one of the side effects.
Tests conducted in the lab and the trials concluded that a fully vaccinated person, i.e., a person who has received both doses of the Moderna Covid-19 vaccine, will have 94.1% fewer chances to be affected by the virus. In other words, the vaccine is 94.1% effective in preventing COVID-19. The figure is one of the highest efficacy rates posted by any of the vaccine candidates. Even if someone is affected by the virus after receiving both doses of the vaccine, Moderna claims that he/she would not be taken seriously ill and home isolation should be enough for them to recover completely.
Question. Why do we need to take 2 doses of the Moderna Covid-19 vaccine?
There have been some doubts and questions over the reasons why people are being asked to take 2 doses of the Covid-19 vaccines for a few of the vaccine candidates and 1 dose for the others. It has been suggested by Moderna and the FDA that the Moderna vaccine needs to be administered twice in around 28 days to provide the best immunological response. The reason behind this is that the initial tests conducted seemed to suggest that the immunity provided after a single dose was rather weak. As such, it was deemed necessary that two doses of the same vaccine be taken, for the effectiveness rate of the vaccine to go up to 94.1%. Not only Moderna, but a host of other companies like AstraZeneca (the Oxford-developed vaccine), Pfizer, etc. – all require two doses to be administered for producing the best results.
