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When Will Moderna File for FDA Approval for Its COVID Vaccine?

By Keith Speights - Updated Jun 24, 2021 at 9:49AM

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Very soon.

Pfizer (PFE 3.77%) and BioNTech (BNTX 1.11%) recently submitted for full approval by the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccine. Another company should be hot on their heels, though. In this Motley Fool Live video recorded on May 17, healthcare and cannabis bureau chief Corinne Cardina and Motley Fool contributor Keith Speights discuss when Moderna (MRNA -0.37%) will file for FDA approval of its rival vaccine.

Corinne Cardina: Moderna was, of course, second to get the EUA from the FDA after Pfizer-BioNTech. They've been a couple of steps behind Pfizer and BioNTech with everything. Should we expect that Moderna will be following suit filing for full approval soon?

Keith Speights: Absolutely. In fact, Moderna stated that they plan to file for full FDA approval this month. We're talking just in the matter of the next couple of weeks, Moderna will follow suit after Pfizer and BioNTech. I would anticipate that the company will also seek priority review just as Pfizer has. I also expect they'll get it. I think what we'll see is something similar to what we saw with the EUA, is I think you'll see Pfizer receive full FDA approval toward the end of this year and then maybe a month or so later, a few weeks later, Moderna will also receive full FDA approval.

Cardina: It probably won't change too much for the companies themselves, but I'm curious if you have any thoughts on what it might change for the vaccination efforts. Do you think it might make a difference for someone who is on the fence about getting the vaccine, authorization versus approval? Could it change certain entities requiring people to get vaccines, whether it's for their employees? Do you have any thoughts on that? This is a wild card question I'm throwing to you. [laughs]

Speights: Sure. Yeah. I would think we would at least see some incremental additional adoption of the vaccine from people who might be skeptical right now, who maybe just don't understand the EUA program, and they think it was done in a hurry and maybe some corners were cut, and who might be a little more comfortable with a vaccine, that's on the full FDA approval, so I wouldn't be surprised to see some increased vaccination rates as a result.

In terms of could we see employers start requiring vaccination, I think that's definitely a possibility. I think there will be a lot of pushback in some cases, but I think you could see that happening. It would probably be easier for employers to get away with full FDA approval. I think you could see some of that.

Hopefully everything, the full FDA approval will just be icing on the cake and it will help get more Americans to receive the vaccines and we'll continue to make the incredible progress that we've already made in turning the corner on the pandemic.

Corinne Cardina owns shares of Moderna Inc. Keith Speights owns shares of Pfizer. The Motley Fool recommends Moderna Inc. The Motley Fool has a disclosure policy.

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Stocks Mentioned

Moderna, Inc. Stock Quote
Moderna, Inc.
MRNA
$171.18 (-0.37%) $0.63
Pfizer Inc. Stock Quote
Pfizer Inc.
PFE
$50.11 (3.77%) $1.82
BioNTech SE Stock Quote
BioNTech SE
BNTX
$160.35 (1.11%) $1.76

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