Moderna — the “front-runner” in the race for a Covid-19 vaccine — has just released the news last Thursday that they have finalized phase 3 of their mRNA-1273 vaccine (CNBC). As discussed in our previous article, Frontrunners in Vaccine Formation, Moderna is currently in the process of developing mRNA that encodes for a protein that can work as a drug or vaccine to COVID-19 symptoms.
Pictured above is the Moderna national headquarters in Cambridge, MA. Image is courtesy of Barrons.com
Scientific Procedures and Clinical Trials
Moderna has the key objective in their scientific to assess the safety, reactogenicity and immunogenicity of their vaccination. Put simply, they have been ensuring that their COVID-19 vaccination will show a majority of beneficial health effects and that it will have the ability to invoke immune responses to aid in the battle against COVID-19.
Moderna’s progress in vaccine trials has been commendable for its efficiency. Prior to the release of a vaccine, there are three clinical phases that must occur. Phase 1 ensures the safety of the vaccine on humans. Phase 2 further tests the safety and effectiveness of vaccine. Phase 3 studies the efficacy of the vaccine in preventing negative symptoms and reducing hospitalization (Forbes). Following the completion of these three phases, the new drug will become approved and available for public use.
Moderna began Phase 1 back in March 16 and has dosed 45 participants. Within the 45 participants, there were three different cohorts and each were assigned to one of the following dosages: 25 µg, 100 µg, and 250 µg. Each subject then received 0.5 mL of mRNA-1273 dosages from days 1 and 29 in their deltoid muscles; after 12 months each subject will the be followed-up with. The National Institute of Health (NIH) has helped with Phase 1 study of mRNA-1273 and completed the three cohorts of the 45 participants. They will now be expanding this study to six cohorts of older adults and elderly adults to further ensure the safety for a spectrum of patients (Moderna).
Meanwhile, Phase 2 is well underway. Moderna has enrolled 350 out of their 600 participants. for Phase 2 clinical trials. Within the 600 participants, there are two cohorts: one studying adults ages 18-54 and the other studying adults 55+. However, the transition from Phase 2 to Phase 3 for a human vaccine is statistically difficult as it has a 31% success rate. In addition, after studying the efficacy of the vaccine during Phase 3, there is still a 58% chance of the new drug application to become FDA (US Food and Drugs Administration) approved. Despite these odds, Moderna has worked diligently and will be embarking on Phase 3 in July 2020.
"We look forward to beginning our Phase 3 study of mRNA-1273 with 30, 000 participants in July. Moderna is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease."
- Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna
Starting July, Moderna intends on assigning the 30, 000 participants a placebo, 50 μg or a 100 μg dose of their vaccine. Participants will then be followed up 12 months after their second vaccination. As of June 11, in phase 1, Moderna has had 9 of 12 cohorts enrolled and completed; there will be furthermore follow-ups in the long term (Moderna).
Moderna’s Promising Work
Stéphane Bancel, the CEO of Moderna, has high expectations for mRNA-1273. But what exactly makes Moderna’s vaccine progress that impressive? The mRNA technology is an “elegant idea” as it is designed to direct body cells to produce intracellular, membrane, or secreted proteins to alleviate or prevent symptoms from a range of diseases (Moderna). Another amazing feature of this scientific innovation is that it could potentially combine multiple mRNA variations into a single vaccine and has much manufacturing flexibility due to the nature of RNA (Moderna). In fact, with this same technology, Moderna has succeeded in making vaccinations for MERS, Zika, CMV and others.
Pictured above is the mRNA-1273 vaccine during production. Image courtesy of NationalPost.com
“We know our platform. It works on MERS, Zika, and CMV and so on. When you have the right sequences...you will get neutralizing antibodies."
-Stéphane Bancel
Moderna not only has the experiences, but has the collaborations and resources to further expand their study. Moderna has worked in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and Lonza Facilities in the U.S. and Switzerland. They are also funded by the Biomedical Advanced Research and Development Authority (BARDA), Assistant Secretary for Preparedness and Response (ASPR), and the US Department of Health and Human Services (HHS). Lastly, Moderna not only has manufacturing partnerships with Lonza in the U.S. and Switzerland, but they also have their own manufacturing plants in Massachusetts — both of which are incredibly useful with avoiding human errors and have better accuracy in their study. Thanks to the collaboration and diligence put into this study, there are now more than 1600 participants enrolled under health authorities in the US, Europe, and Australia (Moderna).
Bancel even predicts that there is an 80-90% probability of success and that the vaccine will have the efficacy of above 50%. Moderna can prevent the risk of COVID-19 by half! As of 2021, Moderna’s partnership with Lonza will allow them to produce roughly 500 million to 1 billion doses of mRNA-1273 vaccines(CNBC).
The world can rest assured — our scientific community continue to collaboratively work towards the race to a vaccine. Although these times have brought many uncertainties, this has also been an opportunity for all people of society to make group efforts towards the protection and safety for each other. Moderna is just one of the many promising front-runners with helping this pandemic and there is even more that are also helping us in our battle against the COVID-19 pandemic.
References:
Megtirrell. (2020, June 17). Moderna CEO sees 'high probability' of success with Covid-19 vaccine. Retrieved from https://www.cnbc.com/2020/06/17/moderna-ceo-sees-high-probability-of-success-with-covid-19-vaccine.html
Moderna Advances Late-Stage Development of its Vaccine (mRNA-1273) Against COVID-19. (n.d.). Retrieved from https://investors.modernatx.com/news-releases/news-release-details/moderna-advances-late-stage-development-its-vaccine-mrna-1273
Team, T. (2020, June 15). Moderna Races Ahead, Finalizes Plans For Phase 3 Trials. Retrieved from https://www.forbes.com/sites/greatspeculations/2020/06/15/moderna-races-ahead-finalizes-plans-for-phase-3-trials/#52e6c5245d76
Article Contributors: Katrina Artes, Rahma Osman