CAMBRIDGE, Mass. (WECT) - In the first interim analysis of Moderna’s Phase 3 coronavirus efficacy (COVE) study, its COVID-19 vaccine candidate (mRNA-1273) met a high enough success rate to apply for Emergency Use Authorization (EUA) with the U.S. Federal Drug Administration (FDA).
The statistics of the primary endpoint of the Phase 3 COVE study are based on the number of positive COVID-19 cases confirmed two weeks after study participants received a second dose of the vaccine.
In this first analysis, of the 95 cases of COVID-19 observed, only five were detected in the vaccine test group versus 90 in the placebo group. This resulted in a vaccine efficacy rate of 94.5%.
The 95 cases of COVID-19 included 15 adults ages 65+ and 20 individuals identifying as being from diverse communities including 12 Hispanic or LatinX, four Black or African Americans, three Asian Americans and one multiracial.
At a secondary endpoint, 11 severe cases of COVID-19 were detected, all of which occurred in the placebo group.
No significant safety concerns were reported, and the vaccine was generally well tolerated with few side effects. The most notable side effects included injection site pain, fatigue, muscle pain, joint pain, and headache.
“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. 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,” said Moderna’s Chief Executive Officer Stéphane Bancel.
Moderna’s Phase 3 COVE study enrolled more than 30,000 participants in the U.S. with the early participants receiving their first dose of the trial vaccine at the end of July. Moderna’s COVE study enrollment process was executed by PPD, which is locally headquartered in Wilmington. In response to today’s announcement, PPD released this statement.
“We are proud of our longstanding relationship with Moderna, which has played an important role in helping to accelerate the execution of its COVID-19 vaccine program,” said PPD Chairman and CEO David Simmons.
Although preliminary results indicate the vaccine appears to be safe and effective, analysis of the results is still ongoing, and more COVID-19 cases may accrue that may alter the efficacy rate.
Based on preliminary data, Moderna will submit for an EUA with the U.S. FDA in the coming weeks; it also plans to submit applications for authorizations to regulatory agencies worldwide.
Following U.S. FDA approval for Emergency Use Authorization, Moderna is on track to manufacture 500 million to one billion doses globally in 2021.
Click here to learn more about Moderna’s vaccine candidate, mRNA-1273.