Biotechnology company Moderna has begun final phase testing of its COVID-19 vaccine, known as mRNA-1273, to determine if it is safe and effective before being submitted for regulatory approval.
“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” National Institutes of Health (NIH) Director Francis Collins said in announcing the start of Moderna’s large phase three trial.
“The launch of this Phase 3 trial in record time while maintaining the most stringent safety measures demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity toward a common goal.”
Moderna, which is based in Cambridge, Massachusetts, has given the first doses of its experimental COVID-19 vaccine to participants in a trail of 30,000 people who do not have COVID-19. One-third of all participants would be over-65s, who are both more likely to develop severe disease and have immune systems less likely to respond robustly to a vaccine.
The trial is designed to evaluate the safety of mRNA-1273 and to determine if the vaccine can prevent symptomatic COVID-19 after two doses. As secondary goals, the trial also aims to study whether the vaccine can prevent severe COVID-19 or laboratory-confirmed SARS-CoV-2 infection with or without disease symptoms. The trial also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19, among other objectives.
Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 100 microgram (mcg) injections of mRNA-1273 or two shots of a saline placebo. The trial is blinded, so the investigators and the participants will not know who is assigned to which group.
Moderna took just 42 days from receiving the genetic sequence of Sars-Cov-2, the virus behind COVID-19, to produce a vaccine for testing. Results from its trial of 45 people showed all produced antibodies and it expects efficacy data from its Phase II trial to be available in late August or September.
The company was able to move fast because it uses a novel technology based on messenger ribonucleic acid, which transcribes the genetic code of a virus inside a human cell, to teach the immune system to recognise it. A vaccine using this technology has never been approved by the US Food and Drug Administration.
Pfizer and its German partner BioNTech may start their Phase III trial this month, while others in the Trump administration’s Operation Warp Speed including Johnson & Johnson and Novavax hope to begin their phase three trials in the Northern Hemisphere in autumn.
AstraZeneca, which is partnering with the University of Oxford, has begun a trial designed to blend the Phase II and Phase III stages at sites in the UK, South Africa and Brazil. It is expected to start at US sites soon.
President Trump said it was “the fastest a vaccine for a novel pathogen has ever gone”. Trump said other vaccines were also heading into final trials soon.
“We’ve shaved years off of the time that it takes to develop a vaccine. In some cases, many years,” he said at a North Carolina facility manufacturing vaccines being developed by another company, Novavax.
Stéphane Bancel, Moderna’s chief executive, told CNBC that he estimated the vaccine had a 75% chance of meeting the US Food and Drug Administration’s requirement of being 50% effective.
“We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic,” he said in a statement.
Dr Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, said the early-stage testing had indicated the vaccine was safe and generating an immune response in recipients.
“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate Sars-Cov-2 spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic,” he said.
The coronavirus pandemic continues to kill with 3,837 victims across 89 countries on Monday alongside infections that were recorded across the world. India recorded the greatest number of deaths on Monday.