Gilead’s remdesivir is emerging as the first treatment of the new coronavirus (COVID-19) infection, but Moderna’s investigational vaccine, mRNA-1273, is likely to become the first vaccine against the deadly virus, observers said.
Moderna is a U.S. biotech company, based in Cambridge, Mass. The company developed the experimental vaccine with the National Institute of Allergy and Infectious Diseases (NIAID), a unit of the U.S. National Institutes of Health.
Earlier, the NIAID and researchers of the University of Texas at Austin (UT) identified the structure of proteins, called “spikes,” on the surface of the new coronavirus, the NIH said. Like other coronaviruses, the COVID-19 has spikes that bind to human cells, allowing the virus to enter the human body. If this process is stopped, coronavirus infection can be prevented or slowed.
After Chinese scientists shared the genome of a COVID-19 isolate to a global database, the U.S. researchers at the NIAID and UT used it to identify the structure of the spike, according to the NIH.
“The spike undergoes a massive rearrangement as it fuses the virus and cell membranes. The researchers confirmed that the initial spike stabilized in its prefusion conformation is more likely to preserve targets for infection-blocking antibodies induced by a vaccine,” the NIH said in a news release.
Based on this study, the NIAID researchers and Moderna developed a messenger RNA (mRNA) vaccine, which orders the body’s cells to express the spike in its “prefusion conformation” to elicit an immune response, the NIH said.
Moderna said it received the fund from the Coalition for Epidemic Preparedness Innovations (CEPI) to manufacture a batch of mRNA-1273 vaccines.
CEPI offered funds for COVID-19 vaccine development not only to Moderna but three other entities – Inovio Pharmaceuticals led by Korean American CEO, the University of Queensland, and CureVac.
Among the four, Moderna became the first to test the COVID-19 vaccine candidate in a clinical trial.
Moderna recently announced that it released the first batch of mRNA-1273 to be used in the phase-1 study by the NIAID in the U.S. The trial is to be completed in late April, and the outcome will be available by July or August, news reports said.
Gilead also plans to release the outcome of the phase-3 trial on antiviral drug remdesivir for the treatment of the COVID-19 infection. The company was able to schedule the phase-3 study on remdesivir quickly because it had been developing the agent as a candidate treatment for the Ebola virus infection.
Even though Moderna developed mRNA-1273 from scratch to prevent COVID-19 infection, it took less than two months from identifying the genome sequencing of the virus to manufacturing the first vials for a trial.
“The collaboration across Moderna, with NIAID, and with CEPI has allowed us to deliver a clinical batch in 42 days from sequence identification,” said Juan Andres, chief technical operations and quality officer at Moderna, in a statement. “This would not have been possible without our Norwood manufacturing site, which uses leading-edge technology to enable flexible operations and ensure high-quality standards are met for clinical-grade material.”
Moderna’s manufacturing plant, located in Norwood, Mass., produces the company’s various pipelines, including vaccines and therapeutics. The company has produced and released over 100 batches from the site for clinical trials, Moderna said.
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