July 27 (UPI) -- Drugmaker Moderna said Monday it has begun a 30,000-patient, third-stage clinical trial for its COVID-19 vaccine candidate -- a day after receiving an additional $472 million from the U.S. government.
Called the COVE, or Coronavirus Efficacy, study, the trial is being performed at 100 clinical research sites in collaboration with the National Institute of Allergy and Infectious Diseases and the U.S. Biomedical Advanced Research and Development Authority, or BARDA.
Moderna said it has begun dosing human participants.
"We are grateful to the efforts of so many inside and outside the company to get us to this important milestone," Moderna CEO Stephane Bancel said in a statement.
"We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic."
Moderna said Sunday it received the new federal funding to support late-stage clinical development as part of the Trump administration's Operation Warp Speed initiative to find a COVID-19 vaccine.
BARDA has so far allocated nearly $1 billion in total funding to Moderna for its vaccine candidate, mRNA-1273. Phase 1 trial results showed the vaccine spurred antibody reactions in all 45 participants, with no serious side-effects, following two injections over the course of four weeks.
The primary endpoint of the new, larger study will be preventing COVID-19. Secondary endpoints include preventing severe COVID-19 cases and infection by SARS-CoV-2, the novel coronavirus that causes the disease.
"The company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021," Moderna said.
Moderna's vaccine candidate is the fifth to enter third-stage studies and the second outside of China, according to the World Health Organization. Britain's University of Oxford and European drugmaker AstraZeneca started a combined Phase 2/3 study in May.