Moderna announced today that its messenger RNA vaccine candidate for COVID-19 met the primary endpoint of efficacy, according to the study’s first interim analysis.
Moderna announced today that an interim analysis of its phase 3 trial for mRNA-1273, its vaccine candidate against the coronavirus disease 2019 (COVID-19), showed 94.5% efficacy rate for the vaccine in preventing disease.
The Department of Defense’s (DOD) Operation Warp Speed (OWS) has invested in several vaccine candidates for COVID-19, including Moderna’s messenger RNA vaccine, in order to adhere to its goal of distributing tens of millions of doses of COVID-19 vaccine to Americans by January 2021. OWS has allocated $1.5 billion to Moderna alone for 100 million COVID-19 vaccine doses as well as manufacturing support. Moderna is on track to manufacture between 500 million and 1 billion doses globally in 2021, according to the news release.
The COVE study was reviewed by the independent, NIH-appointed Data Safety Monitoring Board (DSMB). This first interim analysis incorporated the observation of 95 cases: 90 cases of COVID-19 in the placebo group and 5 cases in the mRNA-1273 group, contributing to a point estimate of vaccine efficacy of 94.5% (p<0.0001).
The DSMB did not report any significant safety concerns and deemed the vaccine to be generally well tolerated, according to Moderna’s news release. Adverse events (AEs) tended to be mild to moderate and short-lived; they included injection site pain (2.7%), fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%), and redness at the injection site (2.0%).
With these favorable results, Moderna plans to request an Emergency Use Authorization (EUA) to the FDA in the coming weeks, once final safety and efficacy data are determined.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible,” said Stéphane Bancel, chief executive officer of Moderna.
“This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can protect COVID-19 disease, including severe disease,” Bancel said.