CAMBRIDGE, Mass. – Biotechnology company Moderna Therapeutics, based in Cambridge, announced on May 7 that mRNA-1273, its vaccine candidate for COVID-19, has been approved by the Food and Drug Administration (FDA) to enter a second phase of development in a clinical trial involving approximately 600 people.
The goal of the Phase 2 tests is to ascertain safety of the vaccine and attempt to replicate positive results. Two vaccinations of mRNA-1273 at one of two dosages, or placebos, will be given to healthy adult volunteers 28 days apart, and their condition will be tracked for 12 months after the second vaccination. It was also announced Moderna intends to begin the third phase of trials, testing on thousands of people to see how well the vaccine works, early this summer. Moderna hopes to have the final vaccine approved as early as 2021.
Moderna CEO Stéphane Bancel added, “We are accelerating manufacturing scale-up and our partnership with Lonza [a Swiss company] puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective.” It hopes to make one billion doses per year.
Moderna is one of over a dozen companies throughout the world racing to prepare a vaccine for COVID-19. The Chinese company CanSino Biologics reported that it would start its Phase 2 trials in early April while some other companies, like Pfizer and its partner BioNTech, are beginning combined Phase 1 and 2 trials.
These companies are using various approaches to developing vaccines. Moderna uses messenger RNA to create COVID-19’s spike protein, which in turn will hopefully induce the production in healthy humans of antibodies to recognize and fight the coronavirus. Its Phase 1 trial commenced in Seattle on 45 healthy adults in March and is also taking place at two other sites in the US. If it succeeds, this will be the first vaccine ever produced by means of messenger RNA.
Moderna was granted up to $483 million of federal funds last month from the Biomedical Advanced Research and Development Authority (BARDA) to develop the vaccine for FDA licensing.