Enlarge /. A research associate works in the Moderna Therapeutics Inc. laboratory in Cambridge, Massachusetts.
Moderna gave the first doses of its experimental COVID-19 vaccine to participants in a 30,000-person study when the US entered a new phase in the race to develop a vaccine early next year.
Boston-based biotechnology announced on Monday that it has started the first phase III study of a vaccine in the United States. This large-scale study is usually the last one before a new product is submitted for regulatory approval.
The company's shares rose up to 10.6 percent before reducing part of their earnings.
The trial will be conducted in collaboration with the U.S. National Institutes of Health at sites in the U.S. as part of the federal government’s public-private partnership Operation Warp Speed. Francis Collins, the NIH director, said that a vaccine by the end of 2020 is a "target" but the "right target for the American people".
Stéphane Bancel, managing director of Moderna, told CNBC that he estimated that the vaccine had a 75 percent chance of meeting the Food and Drug Administration's requirement to be 50 percent effective.
"We are looking forward to this study, which demonstrates the potential of our vaccine to prevent COVID-19 so that we can overcome this pandemic," he said in a statement.
It took Moderna only 42 days to get the genetic sequence of SARS-CoV-2, the virus behind COVID-19, and to make a vaccine for testing. The results of the earliest study showed that all 45 participants produced antibodies, and the efficacy data from the Phase II trial are expected to be available in late August or September.
The company has been able to move quickly by using a novel messenger ribonucleic acid-based technology that transcribes the genetic code of a virus in a human cell to help the immune system recognize it. However, a vaccine using this technology has not yet been approved by the FDA.
Pfizer and its German partner BioNTech can also start the Phase III trial this month, while others in Operation Warp Speed, including Johnson & Johnson and Novavax, hope to start their Phase 3 studies in the fall. AstraZeneca, which works with Oxford University, has started a study to combine phases II and III at locations in the UK, South Africa and Brazil. The company is expected to launch at locations in the U.S. shortly.
In its Phase III study, Moderna and the NIH will test whether it can prevent symptomatic COVID-19 disease. They will also examine how effective it is at preventing all COVID-19 infections, including those without symptoms, and how it affects people in need of hospitalization.
The study will be conducted at more than 100 locations that have been selected to reflect a range of demographics and to ensure that they include the most vulnerable populations. Mr. Bancel told CNBC that a third of all participants would be over 65, both of whom are more likely to develop serious diseases and have an immune system that is less likely to respond to a vaccine.
Anthony Fauci, director of the National Institutes for Allergy and Infectious Diseases, said the early-stage tests had shown that the vaccine was safe and triggered an immune response in the recipient.
"Although face covering, physical distancing, and proper isolation and quarantine of infected people and contacts can help us reduce the spread of SARS-CoV-2, we urgently need a safe and effective preventive vaccine to ultimately fight this pandemic," said he.
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