Moderna Inc’s chief executive recently told Reuters that if their COVID-19 vaccine proves to be at least 70% effective, the company plans to seek emergency authorization for its use in high-risk groups.
Moderna’s vaccine candidate – mRNA-1273 – is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. As of Wednesday night, Moderna had enrolled 25,296 participants.
But the company may be able to declare victory early if it is able to show that people who got the vaccine fared much better in its trial that people who did not.
In a telephone interview, Stephane Bancel, Moderna’s chief executive officer said: “If the interim readout is deemed by the independent safety committee as positive with 70 or 80 or 90% efficacy, we will indeed consider approval.”
“At such a level of efficacy, if we get there, we can protect a lot of lives in the people at the highest risk, and so, we will consider filing for an EUA for a very limited population,” Bancel said.
He said the Food and Drug Administration will determine whether the benefit of the vaccine to a small group of high-risk individuals outweighs the risk of not having a full readout of safety data from all 30,000 study participants.
An independent safety board will take a first look at Moderna’s data as soon as a total of 53 people in the trial become infected with COVID-19. Moderna is projecting the interim analysis will occur in November, but it could come as early as October.
If most of the people who got sick got the placebo shot, that would indicate the vaccine was protecting those inoculated and could be enough evidence to seek U.S. regulatory approval for Emergency Use Authorization (EUA).
In a conference call with investors on Thursday, Bancel said he expects the company to file for an EUA in 2020, and for full FDA approval.
In a conference call with investors on Thursday, Bancel said he expects the company to file for an EUA in 2020, and for full FDA approval.
