Moderna’s mRNA COVID-19 Vaccine 94.1% Effective at Final Analysis

Moderna announced Monday that the primary efficacy analysis of the phase 3 COVE study showed that its experimental mRNA-based COVID-19 vaccine mRNA-1273 had an efficacy rate of 94.1%, confirming the level observed at the first interim analysis. The company noted that the latest data were based on 196 cases of coronavirus infection, of which 185 cases were observed in the placebo group versus 11 in the mRNA-1273 group.

According to Moderna, the analysis included 30 severe cases of COVID-19, all of which occurred in the placebo group and none in the mRNA-1273 vaccinated group. The drugmaker added that there was one COVID-19-related death in the study, to date, which occurred in the placebo group. Meanwhile, results showed that efficacy was consistent across age, race and ethnicity, and gender demographics.

Regulatory requests in US, EU

Chief medical officer Tal Zak said “this is as black and white as an effect on a population will be. Your chances of actually being sick if you’ve been vaccinated are decreased 20-fold.” Zaks noted that while the vaccine caused significant influenza-like symptoms in some participants, this “goes hand-in-hand with having such a potent vaccine.”

Moderna said that based on the results it plans to request an emergency-use authorization (EUA) from the FDA, as well as conditional approval from the European Medicines Agency. The company indicated that the FDA is likely to hold an advisory committee meeting to review mRNA-1273 on December 17. “We will file today for an [EUA] and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe,” including Health Canada, SwissMedic and the UK’s Medicines and Healthcare products Regulatory Agency, CEO Stéphane Bancel remarked.