The latest vaccine candidate showed about 95 percent efficacy in a Phase 3 trial.
Things are starting to look up with the COVID-19 coronavirus, as Moderna announced their vaccine candidate is looking promising in Phase 3 testing.
According to a news release, the vaccine candidate mRNA-1273 showed an efficacy rate of 94.5 percent in a Phase 3 study. The company says it intends to seek emergency use authorization for the candidate “in the coming weeks.”
In the primary endpoint of the Phase 3 study of more than 30,000 participants in the U.S. was based on 95 cases, with 90 of those cases in the placebo group and only five observed in the mRNA-1273 group. A further 11 severe cases were observed in the placebo group, while the mRNA-1273 group saw none, the release says.
A primary analysis of the vaccine candidate suggests a broadly consistent safety and efficacy profile across all the evaluated subgroups, according to the release.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” Stéphane Bancel, CEO of Moderna, says in the release. “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. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. They are an inspiration to us all.”
Moderna is the second company to make their vaccine candidate’s positive results public in recent weeks.
Previously, Pfizer and BioNTech’s mRNA-based vaccine candidate, BNT162b2, was found in the first interim efficacy analysis to be more than 90 percent effective in preventing infections in patients without evidence of prior COVID-19 infection. That analysis evaluated 94 confirmed cases in trial participants.
The high efficacy rate came seven days after the second dose of the vaccine candidate meaning that it provides protection 28 days after the initiation of the two-dose schedule. There have not been any serious safety concerns but the study will continue to collect additional safety and efficacy data which will be discussed with regulators worldwide.