Moderna Set to Initiate Phase 3 Trial of COVID-19 Vaccine in July

(Cambridge, MA, USA) will begin Phase 3 trial of its experimental COVID-19 vaccine in July that will involve 30,000 patients aged as young as 18 years as well as elderly Americans.

This information was shared by Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, in an interview with the editor of JAMA. Fauci stated that the “randomized placebo” controlled trial of Moderna’s vaccine against the novel coronavirus (SARS-CoV-2) would include mainly US sites, although it would also include international sites.

Last week, Moderna had begun dosing the first participants in each age cohort in the company’s Phase 2 study of its mRNA vaccine candidate (mRNA-1273) against the novel coronavirus. The Phase 2 study, being conducted by Moderna under its own Investigational New Drug (IND) application, will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. However, Dr. Fauci confirmed that the work is well underway for initiating a much larger Phase 3 trial that will begin in early July. A Phase 3 trial is considered to be the final stage ahead of potential approval by the US Food and Drug Administration and would make the COVID-19 vaccine available across the country.

“We are preparing the sites for the Phase 3 study,” Dr. Fauci, America's top infectious disease expert, told Dr. Howard Bauchner, editor of JAMA during the interview. “The real business end of this all is the Phase 3 trial that starts in the first week in July.”

Meanwhile, speaking at a Wall Street Journal Tech Health Conference, Dr. Fauci said that he was 'cautiously optimistic' that the US would have an effective coronavirus vaccine 'within a reasonable period of time' but expressed concern over the lack of clarity on how long the vaccine protection would last. “What is a big unknown is what the durability of that protection is,' Dr. Fauci said during the conference. “Is it going to be a year, two years or even maybe, unfortunately, six months or less? Then we have a secondary problem. We may have overcome the first problem of getting a vaccine, but then you're in a logistical situation.”

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