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Moderna's Coronavirus Vaccine Candidate 100% Effective at Preventing Severe COVID-19

By Cory Renauer - Nov 30, 2020 at 9:50AM

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The company released successful clinical trial results that will support an upcoming request for Emergency Use Authorization of mRNA-1273.

On Monday morning, Moderna ( MRNA 11.79% ) 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. 

Getting a vaccine injection.

Image source: Getty Images.

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 -2.96% ) and BioNTech ( BNTX 4.17% ) 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.

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis – even one of our own – helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.

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Stocks Mentioned

Moderna, Inc. Stock Quote
Moderna, Inc.
$368.51 (11.79%) $38.88
Pfizer Inc. Stock Quote
Pfizer Inc.
$52.40 (-2.96%) $-1.60
BioNTech SE Stock Quote
BioNTech SE
$362.52 (4.17%) $14.52

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