Since July, researchers at the Brigham have been enrolling patients in the United States’ first phase 3 trial of a COVID-19 vaccine candidate. The Brigham site is funded by the National Institutes of Health as part of the COVID-19 Prevention Network, which is recruiting 30,000 participants at locations nationwide.
The COVE study is testing the effectiveness and safety of mRNA-1273 to see if it can prevent COVID-19. Data from the phase 1 trial of mRNA-1273 showed the vaccine induced an anti-SARS-CoV-2 immune response in all 45 participants.
In the phase 3 trial, participants are randomized to receive either two 100 microgram injections of mRNA-1273 or two shots of a saline placebo. Participants will be followed for up to two years after the second dose of the vaccine.
Lindsey Baden, MD, an infectious diseases specialist at the Brigham and an expert in vaccine development for viral diseases, is the study’s co-principal investigator.
“This is the first phase 3 trial testing the effectiveness of a vaccine against COVID-19, and we’ve been working diligently across industry, academia, and government to pave a path for launching this trial rapidly and safely,” says Baden. “Our goal has been to launch this important trial and develop a rapid, high-quality process for vaccine trials to come.”
On December 15, FDA scientists confirmed the vaccine’s safety, with an efficacy rate of 94.1%. Two days later, the FDA approved the vaccine for emergency use.