Moderna Includes Arizona In Expanded Coronavirus Vaccine Trials
American biotechnology company Moderna has begun the process of conducting Phase III trials of its coronavirus vaccine.
The trials will involve 30,000 volunteers at 89 sites nationwide — four of them in Arizona.
Two weeks ago, Moderna published the results of its Phase I trial, the first human trial of a coronavirus vaccine by an American company.
Phase I clinical trials take a detailed look at a few dozen to 100 people over a week to a month, and represent the first safety evaluations of a drug in human subjects. Phase II trials expand this pool to several hundred participants and identify risks and dosages. Phase III trials go global and involve thousands.
Although the latter two phases can each take years, many companies are working with health authorities to substantially curtail the process to speed a coronavirus response, in some case by combining phases.
Moderna's Phase I trials reported a rapid and strong immune response against SARS-CoV-2, the virus that causes COVID-19. Subjects reportedly tolerated the vaccine without significant problems.
When recruitment begins in Arizona, adults without a history of SARS-CoV-2 infection and who are not feverish, pregnant, breastfeeding or immunosuppressed can register with Hope Research Institute at its Chandler, Peoria or Phoenix locations, or with the Quality of Life Medical and Research Center in Tucson.
Subjects will receive two injections 28 days apart. Half of participants will receive a saltwater placebo, while the remainder receive Moderna's messenger RNA vaccine, dubbed mRNA-1273.
An mRNA vaccine instructs the body's own genetic machinery to produce one of the virus's telltale proteins. Like a mugshot or a wanted poster, this protein shows the immune system what to be on the lookout for.
Such vaccines show a great deal of promise and lend themselves to rapid production, but lack a proven track record.
Drug company Pfizer also has begun a late-stage human vaccine trial but not in Arizona.