Moderna's Phase 3 COVID-19 Vaccine Trial Will Begin Later This Month

The WHO marked the six-month anniversary of the COVID-19 outbreak on June 29th. After six grueling months of widespread deaths and economic shutdowns, people are desperate for a glimmer of hope. For many, Moderna’s mRNA vaccine—which saw human trials in a record-breaking 63 days—is more than just a glimmer of hope, it’s a potential solution. 



While the Massachusetts-based biotech company has experienced its fair share of setbacks, with modifications of the testing protocol delaying its phase 3 trial, the trial is still set to begin in July. Here’s what it will look like. 

On January 11th, Chinese authorities released the genetic sequence of COVID-19. Fast forward a month, and Moderna has already shipped the first clinical batch of its frontrunner vaccine candidate, mRNA-1273, to the NIH. Phase 1 begins—and reveals promising results. 

Moderna’s early-stage trial demonstrated the production of neutralizing antibodies in 8 participants, and binding antibodies in all participants. On May 12th, Moderna’s vaccine received the FDA’s Fast Track designation, rapidly accelerating its regulatory review process. 

While Moderna is progressing quickly through clinical trials—with many industry experts predicting that mRNA-1273 will be the first COVID-19 vaccine to reach the market—the company is still somewhat new to the game. 

Compared to its established competitors, Moderna has never conducted a clinical trial of comparable size to the one it plans on launching later this month. Nor has it had a single product approved. 



Moderna’s Phase 2 trial involved 600 participants across eight states. Participants were screened based on physical exams and were segmented into two age groups: adults above and below the age of 55. 

Phase 3 will be fifty times the size of phase 2, involving 30,000 individuals across 87 locations. Participants will be randomly selected to receive the experimental 100-microgram dose or a placebo. Immunizations will take place on the first day of the trial, as well as 29 days later. 



Ultimately, Moderna’s success is only a piece of the puzzle. Globally, over a hundred COVID-19 vaccine candidates are undergoing clinical trials, with many demonstrating encouraging peer-reviewed results. Should Moderna’s mRNA-1273 fail to live up to its expectations, many other candidates are ready to offer continued hope.