A Massachusetts biotech company has announced that its RNA-based vaccine is more than 94 percent effective at preventing COVID-19.
Earlier this month, Pfizer and BioNTech reported that their vaccine had more than 90 percent efficacy, and early data for the Sputnik V’s vaccine suggested it had a 92 percent efficacy. However, the Russian-made vaccine is under criticism since it has not been tested on enough people in advanced studies to confirm the vaccine’s effectiveness.
Moderna’s new vaccine is based on a clinical trial involving 30,000 participants.
The first clinical batch of mRNA-1273, the mRNA vaccine that encodes cells to produce a modified form of the coronavirus spike protein, was completed on February 7, 2020. On March 16, scientists conducted the first study and later administered the second one on May 29. On July 28, The New England Journal of Medicine published the results of the nonhuman primate preclinical viral challenge study evaluating mRNA-1273.
That same month, more than 30,000 Americans participated in Moderna’s study, dubbed the COVE study. The company administered a placebo vaccine to half the group, while the other half received a 100 µg dose level. In the first analysis, there were 95 cases of COVID-19, which included 90 in the placebo group and only five in the vaccine group.
The mRNA-1273 vaccine creates messenger ribonucleic acid (mRNA) sequences that complement a deoxyribonucleic acid (DNA) strand. The DNA strand stores the genetic instructions to make proteins. The mRNA travels from the nucleus of the cell to the cytoplasm, which houses ribosomes for making proteins. Proteins are the molecular machinery of cells. The ribosomes then follow the mRNA’s instructions to create the protein, which in this case is the coronavirus spike protein. The protein will enable the immune system to recognize COVID-19 and learn how to make an antibody to fight it.
To create the mRNA sequence, scientists will engineer an optimized strand with the right physical properties and proteins to synthesize it into the corresponding mRNA sequence. The technology platform to create the mRNA acts as an operating system on a computer aimed at producing the genetic code that instructs the ribosomes.
Moderna’s Research Engine allows scientists to create new vaccines using digital drug design tools and then powers an automated production facility to manufacture the drug. Scientists use Moderna’s cloud-based Drug Design Studio to request mRNAs for a specific protein, and then the protein target automatically creates a sequence. Later, scientists can tailor the protein from a five-prime untranslated region to a three-prime untranslated region. The Sequence Designer module also contains ever-improving rule sets to automatically tailor an entire mRNA sequence using prior data. The data is then passed onto the modular synthesis robotics using Moderna’s automation platforms.
With these unprecedented times, uncertainties remain. There are still many questions surrounding the vaccine: How long will the vaccine’s effects last? Can it prevent people from transmitting the virus? Will the vaccine work with high-risk individuals?
Moderna plans to submit an Emergency Use Authorization application with the U.S. Food and Drug Administration and additional authorization applications to global regulatory agencies. The biotech company expects to have approximately 20 million doses of mRNA-1273 for Americans by the end of 2020 and over 500 million for the rest of the world some time in 2021.