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These 2 Companies May Be the Next to Enter the U.S. Vaccine Market

By Adria Cimino - Mar 4, 2021 at 9:41AM

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One is already selling vaccine elsewhere.

The U.S. Food and Drug Administration has granted Emergency Use Authorization to the vaccines of Pfizer (PFE -0.23%), Moderna (MRNA 4.97%), and Johnson & Johnson (JNJ 1.13%). In this Motley Fool Live video recorded on Feb. 26, 2021, healthcare and cannabis bureau chief Corinne Cardina and contributor Adria Cimino discuss the next two candidates nearing the U.S. finish line -- a pharmaceutical company and a biotech company.

Corinne Cardina: Let's talk about the companies that may be next up after Johnson & Johnson. What do we know about the next cohort of vaccine makers? Where are they in trials and when do you think we could be looking at decisions on an Emergency Use Authorization in the U.S. for AstraZeneca (AZN -0.18%) and Novavax (NVAX 11.12%)?

Adria Cimino: Sure. Well, AstraZeneca, so far, more than 50 countries have granted emergency authorization for the vaccine, that's including their home country of the U.K., the European Union, and Canada. But the U.S., so far, is the one that we're still waiting on. That's because there's still a phase 3 trial ongoing and so we're still waiting for results from that. I would think that once we get those results -- and that should be soon I would think because of the timing of when the trial started and everything -- I think that that will be soon, and then we can imagine that they will be considered. So we'll see how that goes. There have been some bumps for AstraZeneca because of some of the problems, the handling of new strains over in Europe, etc., but we'll see how it goes in the U.S.

As far as Novavax, Novavax is another one that is coming up soon. Rolling reviews have begun for Novavax's vaccine candidate. Those reviews have begun in the U.S., the U.K., Europe, and Canada. Apparently, the CEO of Novavax is hoping that the FDA would consider data from the U.K. trial as the basis of an Emergency Use Authorization -- because the data they reported from phase 3 was from a U.K. trial. They also have a trial going on in the U.S. and Mexico, and that trial has just completed enrollment. So we'll have to wait a little bit longer for data from the U.S. trial.

The idea is: Is the FDA going to go for data from the U.K. trial, or is it going to wait for the U.S. data? I'm thinking it will probably wait for the U.S. data, being that we're not in an extremely urgent situation right now. I'm thinking that we might have to wait a little bit longer. But we expect that it's possible as early as the end of March, maybe in April. It will be the spring, I would think. That's something to look forward to.

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Stocks Mentioned

Novavax, Inc. Stock Quote
Novavax, Inc.
$57.15 (11.12%) $5.72
Pfizer Inc. Stock Quote
Pfizer Inc.
$52.31 (-0.23%) $0.12
Johnson & Johnson Stock Quote
Johnson & Johnson
$179.52 (1.13%) $2.01
AstraZeneca PLC Stock Quote
AstraZeneca PLC
$65.95 (-0.18%) $0.12
Moderna, Inc. Stock Quote
Moderna, Inc.
$149.95 (4.97%) $7.10

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