Moderna Inc. announced over the weekend that it dosed its first participants in each age cohort with its COVID-19 vaccine in the company’s Phase 2 study. In a release, the biotechnology company explained that the study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Some 600 people are expected to take part in the study (around 300 18- to 55-year-olds and the same number of people over the age of 55), who will be tracked for 12 months. Participants will be given a placebo, or a dose of 50 or 100 micrograms at each vaccination.
Earlier this month, the US Food and Drug Administration granted mRNA-1273 Fast Track designation. The company’s chief scientist is Israeli-born Tal Zaks, who earlier this month told N12 that he is “not surprised that the vaccine works.” He highlighted that the company has already been successful in developing vaccines for eight other viruses, including several specifically targeting respiratory infections. Moderna released early data from its Phase 1 trial on May 18, that showed the vaccine produced protective antibodies in a small group of eight healthy volunteers. The study was not designed to prove that the vaccine works, Reuters explained in an article published that day. But the report did “offer an early glimmer of hope” that Moderna’s mRNA-1273 could provide protection against the novel virus. The Phase 1 study was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, which will be submitting the data to a peer-reviewed clinical publication. Moderna said in its release that the company anticipates collaborating with NIAID on a Phase 3 study by July. Source
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