COVID-19 Vaccine Candidate Is 94.5% Effective

Moderna’s COVID-19 vaccine candidate is 94.5% effective, the company has announced in a press release.

The announcement comes after the independent, National Institutes of Health-appointed Data Safety Monitoring Board for the phase 3 COVE study of the vaccine candidate, mRNA-1273, determined that the trial had met the statistical criteria prespecified in the study protocol for efficacy.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” Moderna Chief Executive Officer Stéphane Bancel said. “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.”

The COVE study’s primary endpoint is based on the analysis of COVID-19 cases confirmed and adjudicated beginning 2 weeks after the vaccine’s second dose.

This interim analysis was based on 95 cases of COVID-19, including 15 cases among adults aged older than 65 years and 20 cases among participants of diverse racial backgrounds. Of the 95 cases, 90 were from the placebo group and 5 were from the mRNA-1273 group.

Severe cases of COVID-19 in this first interim analysis were also analyzed. In total, there were 11 severe cases, and these occurred only among the placebo group.

According to the researchers, the vaccine was generally well-tolerated. A majority of adverse events—which included fatigue, myalgia, arthralgia, and headache—were mild or moderate in severity and short-lived in duration.

The vaccine’s safety and efficacy profiles appear to be consistent across all evaluated subgroups, according to preliminary analysis.

“Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months). Moderna also plans to submit applications for authorizations to global regulatory agencies,” according to the press release.

—Colleen Murphy

Reference:

Moderna’s COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the phase 3 COVE study. News release. Moderna. November 16, 2020. Accessed November 18, 2020. https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy