"This is a pivotal moment in the development of our COVID-19 vaccine candidate," Stéphane Bancel, CEO of Moderna, said in a press release on Monday. "Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease. This milestone is only possible because of the hard work and sacrifices of so many."
In a trial, per CNN, 15,000 participants were administered a placebo. 90 of these participants are said to have contracted COVID-19 over the course of several months. Of those cases, 11 are described as having been severe examples. Meanwhile, another group of 15,000 trial participants were given the actual vaccine. Only five of those participants got COVID-19, none of whom developed severe cases.
"We look forward to the next milestones of submitting for an EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study," Bancel said Monday. "We remain committed to and focused on doing our part to help end the COVID-19 pandemic."
An EUA is an Emergency Use Authorization, a decision which the Moderna team says will be backed up by final safety and efficacy data.
Speaking on the Today show early Monday, Dr. Anthony Fauci—director of the National Institute of Allergy and Infectious Diseases—noted the need for the Trump administration to start taking seriously the process of a transition to the Biden-Harris administration. Even as the pandemic continues in the U.S., Trump has thus far refused to concede the 2020 election despite losing.
"The virus is not going to stop and call a timeout while things change," Dr. Fauci said. "The virus is just going to keep going. The process is just going to keep going. This is something that just is now going in the very, very, strong right direction. The vaccines are effective. We want to get it approved as quickly as we possibly can. We want to get doses to people starting in December and then we want to really get the ball rolling as we get into January, February, and March. We want a smooth process with that and the way you do that is by essentially having the two groups speak to each other and exchange information."