November 30, 2020 - 19:23 AMT
PanARMENIAN.Net - Moderna said Monday, November 30 it will request emergency clearance from the Food and Drug Administration for its coronavirus vaccine after new data confirms the vaccine is more than 94% effective in preventing Covid-19 and was safe, CNBC reports.
Moderna will be the second drugmaker to seek emergency use from the FDA after Pfizer, another front-runner in the Covid-19 vaccine race, applied for the same authorization on Nov. 20. The announcement means some Americans could get the first doses of Moderna’s two-dose vaccine within a few weeks.
The new analysis from Moderna evaluated 196 confirmed Covid infections among the late-stage trial’s 30,000 participants. The company said 185 cases of Covid were observed in the placebo group versus 11 cases observed in the group that received its vaccine. That resulted in an estimated vaccine efficacy of 94.1%, the company said.
The company released on Nov. 16 an early analysis of its phase three trial based on just 95 Covid-19 cases that showed its vaccine was at least 94% effective. Monday’s data provides a more complete picture of the vaccine’s effectiveness.
It also appears to prevent volunteers from getting severely sick from the virus. Of the 30 severe cases of Covid-19 in the trial, none were in the group that received the vaccine, Moderna said. Additionally, there was one Covid-19-related death in the study that occurred in the placebo group, according to the company.
Emergency use authorization means the FDA will allow some adults to receive the vaccine as the agency continues to evaluate data. It isn’t the same as a full approval, which can typically take months. The FDA granted emergency clearance for Gilead Sciences’ remdesivir in May before giving full approval in late October.