A biotech firm, Moderna, Inc. has announced that ‘mRNA-1273’, their mRNA vaccine against novel coronavirus has shown positive results in the phase 1 clinical trials
In the race for the development of vaccines for the treatment of COVID-19, Moderna Inc., made an announcement on 18th May 2020 about positive results of their mRNA vaccine called mRNA-12731. The Phase I study revealed that the mRNA-1273 vaccine mRNA-1273 triggered an immune response resulting in neutralizing antibody levels in all eight initial participants across the 25 µg and 100 µg dose cohorts. The neutralizing antibody titers reached the same level as seen in patients who had recovered from the COVID-19 disease.
mRNA-1273 vaccine was generally safe and well tolerated. The safety profile was consistent with that observed in prior Moderna clinical studies performed with infectious disease vaccines.
Preclinical studies on mice vaccinated with mRNA-1273, after they had been challenged with SARS-CoV-2 virus showed that mRNA-1273 prevented viral replication and resulted in production of neutralizing antibodies with a titre similar to that produced in patients who took part in Phase I study.
The encouraging results obtained from the Phase 1 study will help initiate the remaining trials soon, with Phase 3 expected to start in July 2020, pending finalization of clinical protocol and if all goes well, the vaccine will see the light of the day, ready to be administered to patients sooner than anticipated, since FDA has given Fast Track designation2 to the project.
1. Moderna, Inc. 2020. Press release – Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Posted 18 May 2020. Available online at https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-interim-phase-1-data-its-mrna-vaccine
2. Moderna, Inc. 2020. Press release – Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Posted 12 May 2020. Available online at https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-mrna-vaccine-mrna