An investigational vaccine developed by drugmaker Moderna and the National Institute of Allergy and Infectious Diseases began phase three trials on Monday, becoming the first U.S. candidate to reach that step in testing.
About 30,000 adult volunteers are set to be enrolled in the trial, according to CNN, which added that the first patient was dosed at a site in Savannah, Ga. A trial group will receive two 100 microgram injections of the candidate while a control group receives a placebo, both about four weeks apart, the network noted.
“We are pleased to have started the Phase 3 COVE study,” Moderna CEO Stéphane Bancel said in a statement. “We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic.”
According to data published in the New England Journal of Medicine, earlier testing induced immune responses in all volunteers. Mild side effects included chills, headaches, muscle pain and fatigue, but the vaccine was generally safe.
Several drug manufacturers, including Moderna, are receiving support from the federal government through its Operation Warp Speed program, with the company announcing Sunday that the Biomedical Advanced Research and Development Authority has provided $472 million more for the phase three study and later development, for a total of $955 million thus far.
The World Health Organization lists about 25 potential vaccines in clinical trials worldwide. Phase one of trials usually analyzes whether a drug induces an immune response in a small number of people, while a phase two trial expands the study to people with characteristics similar to those of the intended vaccine recipients. Phase three trials typically involve thousands of subjects and tests for safety and efficacy.