Cambridge, Massachusetts-based Moderna Therapeutics has received fast-track approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate, mRNA-1273. The company’s chief medical officer, Tal Zaks, M.D., Ph.D., has become a ubiquitous presence on American news programs, explaining how the FDA action allows the company to swiftly proceed to Phase 2 testing of the vaccine, which is expected to begin in weeks.
Zaks explained that the company has had positive results from Phase 1 tests, which involve testing on a small number of healthy humans (about 45 people) to determine if a vaccine produces an immune response that protects against the virus.
According to Moderna, the vaccine proceeding to Phase 2 testing was developed within 42 days of the company obtaining genetic information on the coronavirus. By comparison, it took researchers more than 20 months to start human tests of the vaccine for SARS, an older coronavirus, according to a journal paper written by Dr. Anthony Fauci.
“By about the end of the year, the start of next year, there’s a reasonable likelihood that we’ll see this vaccine on the market, at least on the American market,” he said in a television interview from Moderna headquarters.
Moderna Therapeutics has been a pioneer in the development of messenger RNA (mRNA) Therapeutics across a range of therapeutic applications. mRNA technology platform, which aims to make drugs that direct cells in the body to make proteins to prevent or fight disease.
It makes use of messenger ribonucleic acid, a molecule vital to the proper functioning of the body’s cells. The mRNA approach can produce vaccines faster and more economically than traditional methods, according to UK health policy think tank PHG Foundation.
The Phase 2 studies will include approximately 600 healthy volunteers, half aged 18-55 years old and half over 55 years old, and randomly assigned to receive either a placebo or one of two doses of Moderna’s experimental vaccine. Each participant will receive two shots since early studies suggest two injections might be necessary to jump-start the immune system to generate protection against the COVID-19 virus. Each patient will be monitored for a year as the researchers track their immune responses.
Moderna president Dr. Stephen Hoge said the company plans to launch Phase 3, which is the final stage of human testing, when Phase 2 studies are complete this summer.
Moderna is not the only drug company hoping to find a viable COVID-19 vaccine. Pharma giants Johnson & Johnson and GlaxoSmithKline are also working on vaccines, as are nearly two dozen U.S. companies and dozens more worldwide.
“Submitting this (investigative new-drug application) is an important next step in the clinical development of our mRNA vaccine against SARS-CoV-2, and we are moving rapidly to potentially address this global health emergency,” Zaks said in a statement.
Zaks, a former head of Sanofi Global Oncology, joined Moderna in 2015. He received his M.D. and Ph. D. from the Ben Gurion University in Israel and conducted post-doctoral research at the US National Institutes of Health (the NIH). He completed his clinical training in internal medicine at Temple University Hospital followed by a fellowship in medical oncology at the University of Pennsylvania.
Moderna is privately held and currently has strategic agreements with AstraZeneca, Alexion Pharmaceuticals, and Merck.