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Regeneron asks FDA for emergency authorization of COVID-19 antibody therapy

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"Dr. Natalie West, Johns Hopkins University Assistant Professor of Medicine, joins Yahoo Finance's Kristin Myers to discuss the COVID-19 vaccine race as 23 states see a rise in infections. "

Video Transcript

KRISTIN MYERS: Pharmaceutical company Regeneron, as I had mentioned earlier, applied for emergency approval of their COVID-19 treatment. So to chat more about this, we're joined now by Dr. Natalie West, Johns Hopkins University assistant professor of medicine and the associate program director for the pulmonary and critical care fellowship. So Doctor, I want to start with that request for that approval. It's coming after the president said that-- you know, that this treatment had cured him. Dr. Fauci even at least gave some sort of support to that as well. Do you think that Americans at large should start taking this treatment, and should they be given this emergency approval?

NATALIE WEST: So I think there are several things to consider to answer that question. Number one, what is Regeneron? Number two, where is it in clinical trials? And number three, actually, what is it meant by emergency use authorization?

So Regeneron is a monoclonal antibody. So what that means is there is identical immune cells that target a very specific part of COVID-19. And right now, it's been approved for compassionate use. And what that means is when someone's critically ill, without any other therapeutic option, the FDA can be asked to approve, on a case-by-case basis, use of that medicine.

Emergency use authorization is generally when the FDA allows unapproved drugs or products to be used during a health crisis or emergency-- for instance, a pandemic. This can happen when the drug looks to be beneficial and it may be effective. But let's contrast that to what we're normally used to when the FDA approves a drug. Usually, in the full-blown approval, the drug has gone through all phases of clinical trial, we have robust safety data, and we know it's effective. And we also know what side effects to look for.

So Regeneron, in what we know so far, it's being tested in those patients that are sicker and need hospitalization, those patients who were outpatient, so don't need to come into the hospital, and those people that have been exposed but tested negative. And so far, what we know from a press release is that in the outpatients, those that were not hospitalized, the first 275 patients that enrolled were reported the results on. And it does look promising. The viral loads were reduced, as well as the number of days that people had symptoms-- so six to eight days of symptoms as opposed to 13 days. However-- I must note that there's no safety concerns thus far.

And while I think that sounds promising, I hold pause until we have robust safety data. Usually, the phase three trials need thousands of individuals to participate, and we know that a drug is safe. And so I think it's not a clear-cut decision on whether this gets approved or not because we don't know about the safety yet.

KRISTIN MYERS: So on that point of safety, it was mentioned last night during the vice presidential debate. We heard from the California senator and vice presidential candidate Kamala Harris on this issue saying that she would not trust the president. Take a listen.

KAMALA HARRIS: If the public health professionals, if Dr. Fauci, if the doctors tell us that we should take it, I'll be the first in line to take it, absolutely. But if Donald Trump tells us I should-- that we should take it, I'm not taking it.

KRISTIN MYERS: So Doctor, I would love for you to react to what she said. I mean, does the senator have a point here? Should Americans be fearful of taking a first-generation vaccine, particularly if it is touted and publicized by the president?

NATALIE WEST: So I think many members of the medical community highly respect Doctor Fauci and I agree with his recommendations on masks, social distancing, hand-washing, and robust clinical trials on vaccines. There are a number of clinical trials that are going on for vaccines, but we have to follow strict guidelines in order to prove safety and efficacy. And as Ken just noted, the CDC just released stricter guidelines and basically said that in order to have an emergency use authorization for a vaccine, that robust safety data was going to have to be shown.

So I think what Senator Harris was saying is, you know, let's let the scientists speak about science. Leave the politics to the politicians. Let's hear from vaccine safety from the medical community and make that decision.

KRISTIN MYERS: Well, to that point, Doctor, how worrying is it for you, as a medical professional, that a large portion of Americans, a large portion of the population don't trust scientists, don't trust doctors or even, frankly, the White House to take a vaccine against a deadly virus because of how much politics have been involved in this discussion of the pandemic?

NATALIE WEST: I think that's the reason why we need robust clinical trials. I can understand that if we rush this process that people are not going to feel safe in taking the vaccine. I think in order to get the majority of our nation vaccinated, you have to have robust clinical trials that gets all the way to the end of the phase three trials and that there's really safe data. Because otherwise, we're not going to get to where we need to be.

KRISTIN MYERS: All right, well, we will leave that there. Dr. Natalie West, Johns Hopkins University assistant professor of medicine, thanks so much for joining us today.

NATALIE WEST: Thank you.