Moderna has given the first doses of its experimental COVID-19 vaccine to participants in what will be a 30,000-person trial as the United States enters a new phase of the race to develop a vaccine early next year.
The Boston-based biotech said Monday it had begun its first Phase III trial of a vaccine in the US, a large-scale trial that is usually the last before a new product is submitted to regulatory authorities for approval.
The company’s shares rose a whopping 10.6 percent before some of their profits were taken away.
The trial is being conducted in collaboration with the US National Institutes of Health at US locations, under the federal government’s public-private partnership Operation Warp Speed. Francis Collins, the NIH director, said having a vaccine by the end of 2020 was a “stretcher goal” but the “right goal for the American people.”
Stéphane Bancel, the CEO of Moderna, told CNBC he estimated the vaccine had a 75 percent chance of meeting the Food and Drug Administration’s requirement of being 50 percent effective.
“We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19 so we can beat this pandemic,” he said in a statement.
It took Moderna just 42 days to receive the genetic sequence of SARS-CoV-2, the virus behind COVID-19, to produce a test vaccine. Results from the first study showed that all 45 participants produced antibodies, and it expects efficacy data from the phase II trial to be available by the end of August or September.
The company was able to act quickly because it uses a new technology based on messenger ribonucleic acid, which transcribes the genetic code of a virus in a human cell, to teach the immune system to recognize it. But a vaccine that uses this technology has not yet been approved by the FDA.
Pfizer and its German partner BioNTech may also begin their Phase III trial this month, while others in Operation Warp Speed, including Johnson & Johnson and Novavax, hope to begin their Phase Three trials in the fall. AstraZeneca, which is partnering with the University of Oxford, has commenced a trial designed to combine the Phase II and Phase III phases at sites in the UK, South Africa and Brazil, and is expected to start shortly in US locations.
In its phase III trial, Moderna and the NIH will test whether it can prevent symptomatic COVID-19 disease. They will also look at how effective it is in preventing all COVID-19 infections, even those without symptoms, and how it impacts people who need hospitalization.
The trial will be conducted in more than 100 locations chosen to reflect a range of demographics and to ensure that the most vulnerable populations are also there. mr. Bancel told CNBC that a third of all participants would be over 65s, who are both more likely to develop serious disease and have immune systems that are less likely to respond vigorously to a vaccine.
Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, said the early-stage testing showed the vaccine was safe and elicited an immune response in recipients.
“While face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us reduce the spread of SARS-CoV-2, we urgently need a safe and effective preventive vaccine to ultimately bring this pandemic under control,” he said.
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