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 entered a new phase of the race to develop a vaccine early next year.
The Boston-based biotechnology said Monday that it had started the first Phase III study of a vaccine in the US, a large-scale trial that is usually the last before a new product is submitted for regulatory approval.
The company’s shares rose as much as 10.6 percent before reducing some of its earnings.
Its testing is conducted in conjunction with the US National Institutes of Health at sites across the US, 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 “long goal” but the “right goal for the American people.”
Stéphane Bancel, executive director of Moderna, told CNBC that he estimated the vaccine had a 75 percent chance of meeting the Food and Drug Administration’s requirement of being 50 percent effective.
“We hope that this trial will demonstrate the potential of our vaccine to prevent COVID-19, so that we can overcome this pandemic,” it said in a statement.
It took only 42 days for Moderna to receive the genetic sequence of SARS-CoV-2, the virus behind COVID-19, to produce a vaccine for the test. The results of their first trial showed that all 45 participants produced antibodies, and they expect the efficacy data from their Phase II trial to be available in late August or September.
The company was able to move fast because it uses novel technology based on messenger ribonucleic acid, which transcribes the genetic code of a virus into 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 test this month, while others at Operation Warp Speed, including Johnson & Johnson and Novavax, hope to start their phase three tests in the fall. AstraZeneca, which is partnering with the University of Oxford, has started a test designed to combine Phase II and Phase III stages at sites in the UK, South Africa, and Brazil, and the company is expected to start at EE sites. USA In short.
In its phase III trial, Moderna and the NIH will test whether it can prevent symptomatic COVID-19 disease. They will also see how effective it is in preventing all COVID-19 infections, even those without symptoms, and what impact it has on people who need hospitalization.
The test will be conducted at more than 100 sites chosen to reflect a variety 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 the age of 65, who are more likely to develop serious illness and have immune systems that are less likely to respond robustly to a vaccine.
Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, said initial tests indicated the vaccine was safe and triggered an immune response in recipients.
“Although facial coatings, physical distancing, and adequate isolation and quarantine of infected people and contacts can help us mitigate the spread of SARS-CoV-2, we urgently need a safe and effective preventive vaccine to control this pandemic,” he said. .
© 2020 The Financial Times Ltd. All rights reserved. It should not be redistributed, copied, or modified in any way.
