Moderna announced earlier this week that an interim analysis of its phase 3 trial for mRNA-1273, its vaccine candidate against Covid-19, returned 94.5% efficacy rate for the vaccine in participants with and without prior infection.
The COVE study review was conducted by the independent NIH-appointed Data Safety Monitoring Board (DSMB). The 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 reported no significant safety concerns and deemed the vaccine to be mostly well-tolerated, according to Moderna's press release. Adverse events tended to be mild to moderate and short-lived; they included redness at the injection site (2.0%), site pain (2.7%), pain (4.1%), headache (4.5%), arthralgia (5.2%), myalgia (8.9%) and fatigue (9.7%).
The study participants were recruited in around 150 clinical trials in the US, Brazil, Germany, South Africa, Turkey, and Argentina.
Moderna’s announcement comes on the back of promising reports from Pfizer and Novavax last week regarding their respective Covid-19 vaccine candidates. The Department of Defense's (DOD) Operation Warp Speed (OWS) has funded several vaccine candidates for Covid-19, including the mRNA-1273, in order to meet up to its promise of distributing tens of millions of doses of Covid-19 vaccines to Americans by January 2021.
Moderna intends to submit an official request for an Emergency Use Authorization (EUA) to the FDA in the coming weeks, once final efficacy and safety data are verified.
“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,” declared Stephane Bancel, the CEO 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,” Bancel concluded.