Moderna (MRNA -0.37%) is currently running a phase 2 clinical trial for mRNA-1273, its investigational vaccine for SARS-CoV-2, the coronavirus that causes COVID-19. This trial will enroll 600 healthy participants, each of whom will receive two doses of the vaccine, 28 days apart. The trial is testing the vaccine's safety, reactogenicity (the dosage that begins to cause expected side effects), and immunogenicity (its ability to trigger an immune response in the body). However, while phase 2 is still underway, Moderna has already finalized the protocol for a phase 3 study of mRNA-1273, which it says will start in July.
Moderna will collaborate with the National Institutes of Health (NIH) to conduct this phase 3 trial, which will enroll about 30,000 participants in the U.S. The primary endpoint for the trial will be "the prevention of symptomatic COVID-19 disease"; secondary endpoints include the prevention of infection by SARS-CoV-2 and the prevention of severe cases of COVID-19.
Moderna's efforts to develop a vaccine for COVID-19 have been funded in part by the Biomedical Advanced Research and Development Authority (BARDA). On April 16, the company announced that it had received a grant of up to $483 million from the federal agency to help speed up the development of mRNA-1273. With further help from BARDA, Moderna is looking to manufacture up to 1 billion doses of mRNA-1273 a year starting in 2021, assuming the candidate proves effective and receives the green light from regulators.
Moderna is already considered one of the leaders in the race to develop a vaccine for SARS-CoV-2. It was one of five pharmaceutical companies picked by the Trump administration to receive extra support as part of Operation Warp Speed, which is meant to accelerate the development of a vaccine for the deadly disease. Now that Moderna has announced its intentions to start a phase 3 clinical trial next month, the company may receive even more attention from investors.