All told, around 30,000 adults of both sexes will be recruited for the study, which should run for approximately three months. Participants will receive one intramuscular injection of either 100 micrograms of mRNA-1273 or a placebo on day 1 and on day 29. The trial will be conducted across 87 locations throughout the U.S.
If the trial launches on time, it would fulfill a promise made by Moderna of a July start. Earlier this month, there was speculation that the phase 3 trial would be delayed due to the company’s modifications of the testing protocol. There were also reports that Moderna and government health officials were at odds over various aspects of the trials, although both sides maintain this isn’t the case.
The company, which is relatively new compared to larger peers who are also developing coronavirus vaccine candidates, has never conducted a clinical trial of this size. And unlike many of those rivals, it has never had a single product approved.
Yet the results it has released from earlier testing on mRNA-1273 are very encouraging, and the vaccine candidate is moving rather quickly through the clinical trials process. As a result, numerous healthcare experts and industry observers believe Moderna has a strong chance of being the first to market with a coronavirus vaccine.