Moderna’s Vaccine: The New End Game
Recently, Gilead Sciences made headlines with their drug, Remdesivir, being approved by the FDA for helping fight COVID-19 in patients with extreme cases. This innovation brought society one step closer to winning the battle against the virus that has resulted in a pandemic and worldwide lockdown that is so unlike anything yet experienced. However, a treatment such as Remdesivir will not help us win the war. That is where Moderna Inc comes into the picture. Moderna is an American biotechnology company in Cambridge, Massachusetts. Their specialty is drug discovery and development based on messenger RNA. Messenger RNA (mRNA) is a form of genetic material that is naturally produced by our bodies. Its function is to encode instructions designed to control protein production in a given cell. Moderna’s vaccine, mRNA-1273, intends to use our body's natural protein production processes to create proteins to fight off the coronavirus.
mRNA-based vaccines are just one of the methods used to fight a virus. There are treatments, vaccines, DNA-based vaccines, mRNA-based vaccines, or a pandemic adjuvant platform. The mRNA-based vaccine holds many advantages over the other approaches but is most closely related to the DNA-based vaccine approach. The difference is that mRNA vaccines have a few critical benefits in comparison to a DNA-based approach that make it the optimal approach. According to a white paper released by Moderna, mRNA-based vaccines require a lower dosage, can be produced in a smaller factory, and do not require any special delivery method into the body, such as Gene Guns. These vaccines also have no risk of integration within the patient's DNA because the vaccine never enters the nucleus (1). Our body’s “machinery” that interprets mRNA is located in the cells’ cytoplasm, so the mRNA floats in the cytoplasm as it is translated into millions of copies of a single protein until the mRNA is degraded through natural processes in the body. With a DNA-based vaccine, the DNA must enter the nucleus so that it can be transcribed into mRNA. This process risks the vaccine being integrated into the patient’s DNA. Integration of a DNA-based vaccine can cause mutations in the host's DNA which could be dangerous for the host. Overall, the mRNA-based vaccines are cheaper and faster to produce than most other vaccines. However, there are still no mRNA vaccines out on the market as of March 2020. (2) This is what makes Moderna’s work so revolutionary.
As mentioned above, the vaccine candidate that Moderna has chosen was named mRNA-1273. The messenger RNA is encoded with instructions for a perfusion-stabilized form of the Spike (S) protein on the novel coronavirus. (5) This means that the S protein is stuck in a form that is favorable for the vaccine to recognize and target the virus. Easier recognition allows researchers to create vaccines that are more effective and long-lasting. This S protein is critical for fusion and infection of the host cell. By targeting this protein, Moderna’s vaccine limits or eliminates the virus’s ability to infect a host cell. Currently, Moderna’s vaccine is preparing for Phase 2 and Phase 3 clinical trials. It was recently given “Fast-Track” status by the FDA. This is a special situation in which the FDA streamlines the process for proceeding through each phase of clinical trials for extremely critical or high-need drugs. The company has successfully completed Phase 1 trials and is awaiting the final published results. With regards to the Phase 2 trials, the company submitted its protocols for the trials to the FDA in April. Moderna intends to enroll 600 patients that will be evenly divided into two age groups: 18-55 and 55+. Each patient will receive either a placebo, 50 ug dose, or a 250 ug dose of the vaccine during the first visit and second visit (after 12 months). (3) Phase 3 clinical trial protocols are also being finalized so they can be submitted to the FDA for further review.4 Both trials aim to test the effectiveness and safety of the vaccine during periods of short- and long-term exposure to the vaccine. Moderna hopes to launch into the next phases as soon as they have received the results from Phase 1 and can properly assess how to proceed going forward. The hope is that these trials can begin by Summer 2020 so that results and further steps can be known by late Fall 2020.
This leaves us with a question: what does this mean for us and quarantine? It means hang tight and be patient. mRNA-1273 shows promise, and the FDA has given this candidate its full attention. Moderna is also working closely with the Biomedical Advanced Research and Development Authority (BRADA) which is a department under the U.S. Department of Health and Human Services. The vaccine, unfortunately, will not be done next week or next month and the future is not certain, but Moderna’s candidate has huge potential. However, this cannot be confirmed until Phase 1 results are released. Keep maintaining an appropriate amount of distance from people and continue to wear facemasks. The vaccine is on its way, don’t lose hope!
Citations:
1. “Moderna.” Moderna, Moderna Inc. , May 2017, https://www.modernatx.com/sites/default/files/RNA_Vaccines_White_Paper_Moderna_050317_v8_4.pdf.
2. Linares-Fernández, Sergio, et al. “Tailoring MRNA Vaccine to Balance Innate/Adaptive Immune Response.” Trends in Molecular Medicine, vol. 26, no. 3, 2020, pp. 311–323., doi:10.1016/j.molmed.2019.10.002.
3. “Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of MRNA Vaccine (MRNA-1273) Against Novel Coronavirus.” Moderna, Inc., 27 Apr. 2020, investors.modernatx.com/news-releases/news-release-details/moderna-announces-ind-submitted-us-fda-phase-2-study-mrna.
4. “Moderna Receives FDA Fast Track Designation for MRNA Vaccine (MRNA-1273) Against Novel Coronavirus.” Moderna, Inc., 12 May 2020, investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-mrna-vaccine-mrna.
5. “Moderna Ships MRNA Vaccine Against Novel Coronavirus (MRNA-1273) for Phase 1 Study.” Moderna, Inc., 24 Feb. 2020, investors.modernatx.com/news-releases/news-release-details/moderna-ships-mrna-vaccine-against-novel-coronavirus-mrna-1273.
