Biotech giant Moderna launched the world’s largest coronavirus vaccine trial Monday, with roughly 30,000 volunteers, to test for effectiveness and safety.
“We are pleased to have started the Phase 3 COVE study,” said Stephane Bancel, the company’s CEO. “We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic.”
Moderna will enroll about 30,000 people across 89 sites to test shots developed in part by the National Institutes of Health. In the Phase 3 study, called the COVE, or Coronavirus Efficacy, half of all participants will receive two shots of the vaccine candidate 28 days apart, and the other half will receive two shots of a placebo. Testing will also aim to determine if the shots of the vaccine can protect from severe infections of COVID-19 and death.
Researchers will monitor volunteers for side effects after the doses are administered, as well as for signs that the vaccine protects them from getting COVID-19. Preliminary testing results from Moderna found that volunteers experienced only minor side effects, such as fatigue and fever. While several vaccine candidates in addition to Moderna’s have been shown to induce immune responses, none have been shown to protect against the coronavirus disease.
Vaccine candidates from Johnson & Johnson and biotech company Novavax will get underway in the fall. Pfizer will launch a large human trial later this summer to determine whether its vaccine candidate is effective, having signed a $1.95 billion agreement with the Department of Health and Human Services and the Defense Department to develop 100 million doses of the vaccine when it is proven safe.
As several vaccine candidates enter human trials, new daily cases of COVID-19 mount. Over 4.2 million infections have been confirmed across the United States, and about 147,000 people have died.
