On Monday morning, Moderna (MRNA +4.47%) released a highly encouraging primary efficacy analysis for its coronavirus vaccine candidate, mRNA-1273. The company also promised to submit a request for Emergency Use Authorization to the Food and Drug Administration by the end of the day.
With that efficacy analysis in hand, the FDA has scheduled an independent advisory committee meeting to publicly discuss the authorization request on Dec. 17. The FDA isn't obligated to follow the advice of the independent experts it meets with, but they usually land on the same page when it comes to interpreting clinical trial data.
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The primary efficacy analysis of the 30,000-patient Cove study that Moderna published today makes authorization seem likely. After 196 trial volunteers tested positive for COVID-19, investigators found 185 were among people randomized to receive a placebo. Just 11 confirmed cases of COVID-19 occurred among patients given mRNA-1273, which works out to a 94.1% efficacy rate.
It's important to note that none of the COVID-19 cases that occurred among patients vaccinated with mRNA-1273 turned severe. A similar coronavirus vaccine candidate from Pfizer (PFE +0.21%) and BioNTech (BNTX 0.25%) will be the subject of an independent advisory committee meeting with the FDA on Dec. 10. Unlike Moderna, Pfizer and BioNTech can't claim their vaccine candidate was 100% effective at preventing severe COVID-19.
About two days before Moderna's advisory committee meeting, the FDA will publish briefing documents that describe in detail any potential safety issues that could trip mRNA-1273 as it races toward the finish line. This will be the first time we see what government regulators who are privy to details that Moderna hasn't shared with the rest of us have to say about the company's vaccine candidate.
