Oct. 8, 2020 -- Regeneron and Eli Lilly, two pharmaceutical companies that have created antibody therapy drugs for COVID-19, applied for FDA emergency use authorizations on Wednesday -- the same day President Donald Trump posted a video calling the antibody drugs a “cure.”

Trump received Regeneron’s monoclonal antibody drug combination after his coronavirus diagnosis last week. He called the therapeutic drug a cure, although there’s not enough scientific data to fully determine whether the therapy is effective in COVID-19 patients. There is no known cure for the coronavirus.

“It was, like, unbelievable,” he said in a video posted on Twitter on Wednesday. “I felt good immediately.”

Trump vowed to make the drugs available for free to anyone who needs them, particularly older adults who may face severe COVID-19. He said the drugs were even more important to him than a COVID-19 vaccine and he’d like to ship doses to hospitals across the country as “soon as we can.”

“I want everybody to be given the same treatment as your president,” he said. “I feel great. I feel perfect.”

Regeneron’s experimental monoclonal antibody therapy is still being tested in large clinical trials but has been available to a small group of patients under the FDA’s compassionate use guideline, which requires individual approval, as was given for Trump. At this time, the company has enough manufactured doses for about 50,000 patients, the company posted on its website on Wednesday.

“If an EUA [emergency use authorization] is granted, the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution,” according to the statement. “We expect to have doses available for 300,000 patients in total within the next few months.”

The “cocktail” antibody, as it has been called, combines two lab-created monoclonal antibodies to block the effects of COVID-19 on the body. The antibodies target two parts of the coronavirus, including the spike protein that allows the virus to dig into healthy cells and replicate quickly. The therapy reduces viral load and the time it takes for symptoms to clear up, the company announced a few days before Trump was given the treatment.

Coronavirus in Context: Are Treatments More Important Than a Vaccine?WebMD's Chief Medical Officer, John Whyte, MD, speaks with Davey Smith, MD, Chief, Division of Infectious Diseases, University of California, San Diego, about the ACTIV partnership and the possibility that treatments for COVID are more important than a vaccine.632

[MUSIC PLAYING]

JOHN WHYTE: Welcome, everyone.

You're watching Coronavirus

in Context.

I'm Dr. John Whyte,

chief medical officer at WebMD.

Can't turn on the news

and not hear

about a potential COVID vaccine.

But should we really be talking

more about potential treatments?

Is that one of the most

effective strategies

to return to some sense

of normal?

To help provide answers

and insights into the role

of therapeutics, I've asked Dr.

Davey Smith.

He is the head of the Division

of Infectious Disease

and Global Health at UC San

Diego.

Dr. Smith, thanks for joining

me.



DAVEY SMITH: Thanks, John.

Thanks for having me.



JOHN WHYTE: I want to start off

with the ACTIV trial.

And doctors are always

good for acronyms.

So ACTIV stands for--

I want to get it right.

It's the Accelerating COVID-19

Therapeutic Interventions

and Vaccines.

It's a--



DAVEY SMITH: That is correct.



JOHN WHYTE:

--public-private partnership

with NIH.

What's that all about?



DAVEY SMITH: Yeah, that's

a good question.

So there's a program at the US

government called Operation Warp

Speed.

And they developed

this public-private partnership

that they termed ACTIV

to develop these coronavirus

vaccines and coronavirus

treatments, basically as a way

to efficiently and very quickly

get some good vaccines

and therapies out to the public.



JOHN WHYTE: You're

a big proponent of therapeutics,

that we need to get treatments

more accelerated, as well

as any potential vaccine.

Is that right?



DAVEY SMITH: That is correct.

I'm very much a fan.

If we could get a vaccine,

that would be absolutely great.

But we also need therapies.

And we know, from our HIV

experience, that therapies can

really help people live longer,

but also be used to control

an epidemic.

It both decreases the chance

for somebody to get sick,

but also decreases the chance

of somebody spreading it.

And those treatments could also

be used as prophylaxis.

So it really is--

it could really be a very good

tool in our tool box

to stop the pandemic.



JOHN WHYTE: Do you think

HIV/AIDS is a--

is a good comparison?

In many ways,

that's multi-drug therapy

as well.

And-- and there's

been some preliminary data

to suggest that one-drug therapy

is not going to be

sufficient for COVID.



DAVEY SMITH: I don't really

know.

I think those therapies--

I think those trials still need

to be done.

I think in the hospital setting,

it is probably going to take

more than one drug to--

for treatment for COVID.

But in the outpatient setting,

one drug might be enough.



JOHN WHYTE: So tell us where we

are on treatments.

People are talking

about remdesivir,

dexamethasone, monoclonal

antibodies.

Where exactly are we?



DAVEY SMITH: So right now, in--

in the hospital-- so when

somebody gets severely sick,

we have some therapies that seem

to have a good signal

for working.

And that's like remdesivir

or dexamethasone.

And there's this new drug called

[INAUDIBLE] that's coming out,

or berry.

But we do not have

a single treatment

for outpatients.



So people, before they get

sick-- so they have early COVID.

And some of those

will progressed to needing

the hospital.

We just don't have a treatment

for those people yet.

And that's one of the reasons

that ACTIV-2 is testing

those drugs.



JOHN WHYTE: What are some

of the drugs they're testing?

Are they mostly drugs that are

already approved and indicated

for some other disease?

Or are you also thinking

about new molecules?



DAVEY SMITH: So right now, we

are looking at drugs that were

made specifically to target

SARS-CoV-2.

So this-- the first ones that

are going to be used

are called

monoclonal antibodies.

And they are antibodies that

have been-- humanized antibodies

that are specifically targeted

to SARS CoV-2--

and so not repurposed drugs.



JOHN WHYTE: But those drugs are

hard to make, are they not?

There's challenges

in manufacturing.

And then we have to sometimes

worry about potential side

effects given

the immune response.

Can you give us a--

a quick primer on-- on the role

of monoclonal antibodies?



DAVEY SMITH: Sure,

so monoclonal antibodies are

made from people who got

the virus.

And then some of those people

made really potent antibodies.

And we were able to select out

those, and then grow those up,

and turn those into drugs.

And that process is, uh,

complicated and, um, can be very

expensive to make.

But there are

about 20-some-odd companies

or groups out there have made

these monoclonal antibodies

specifically targeting SARS

CoV-2.



And we've progressed a long way

into figuring out how to safely

produce

those monoclonal antibodies now.

So I'm very optimistic that one

of those, if not more than one

of those,

will be ready to use soon

for COVID-19.



JOHN WHYTE: I'm going to put you

on the spot a little.



DAVEY SMITH: OK.



JOHN WHYTE: What does soon mean?

Is that six months?

Is it a year?

Is it three months?

What's your best bet?



DAVEY SMITH: December.

So my best bet is, by the end

of the year,

I think we will have a pretty

good new--

monoclonal antibody that will

keep people out of the hospital.

That is-- that is I'm

optimistic.

And I-- i-- I--

I do believe that.



JOHN WHYTE: Can we drive

manufacturing for

monoclonal antibodies to--

to the level that we need?



DAVEY SMITH: That's

a good question.

We really need to figure out

how much capacity each

of these companies

has to drive manufacturing.

Operation Warp Speed has really

stepped in to say, OK, if we

find a good target,

we're going to-- they are going

to help drive manufacturing as

well, especially for some

of these smaller companies

that might not have

the resources to be able to do

so.



JOHN WHYTE: Yeah, you know, I--

I'm looking at some

of the information on Operation

Warp Speed.

And it's interesting that you

point out how Operation Warp

Speed is also

about therapeutics.

But all the news seems to be

around just vaccine development.

Is that a disservice,

in any way, to innovation?



DAVEY SMITH: I don't know

about it it's a disservice.

But I do know that the oxygen

in the room

is all being taken up

by coronavirus vaccines.

And I get it.

Because we talk about vaccines

so much in terms of everybody

needs to get their flu vaccines.

And there's the anti-vaxxers

with measles, et cetera.

And we think that having

a good vaccine will get us out

of the pandemic.



I am less, uh,

optimistic on that point.

I think we also need treatments.

And the reason that I say

that is the FDA

has said that half--

they will approve

a coronavirus vaccine that works

50% of the time.

If I get a coronavirus vaccine--

which I will--

if it works 50% of the time,

but then I get exposed

in the hospital, then I still

have a 50% chance of getting

sick.

And I really need to have

a therapy that's going to keep

me from getting

sicker and perhaps dying,

even if we do have a vaccine

that works 50% of the time.



JOHN WHYTE: And that might be

50% with two immunizations

as well, correct?



DAVEY SMITH: That's right,

it might be two immunizations.

We also don't know how long

that vaccine might last.

In regular coronavirus

infections,

the regular circulating

coronavirus infections,

we know that immunity wanes

pretty quickly.

So we don't know what

the duration of these vaccines

will actually work.

But if I had a treatment,

I would be a lot--

I would be a lot more optimistic

of opening up, uh, businesses,

et cetera

so that when somebody gets sick,

I have something

that I can do for them.



I'm an infectious disease doc.

And I see lots of people

with coronavirus infections

and--

get pretty sick.

And I want to be able to help

them.

But at the moment, I--

I have nothing, really, to offer

them before they get

into the hospital.



JOHN WHYTE: And if people aren't

willing to take the vaccine

because of concerns

that it was rushed or safety,

then we still concomitantly have

to be developing treatments,

correct?



DAVEY SMITH: That-- that

is correct.

So if-- so you can just-- we

talk a lot about, quote,

"herd immunity."

But you can think of this,

that if you have a vaccine that

only works half the time,

and only half the people take

it,

you're never going to have

enough immunity within a--

in a population

to really get rid

of that epidemic spread,

as we call it, with this virus.

So we still need a treatment.

Um, and that's what ACTIV-2 is

doing.

We're really hoping that, uh, we

can develop a treatment that

then can keep people out

of the hospital.



JOHN WHYTE: So therapeutics

along with immunization

is the real way to return

to some sense of normal.

Is that right?



DAVEY SMITH: I think we need

both.

I-- I think that it would be

very good if we at least had

a treatment so that when people

got sick,

we could keep them out

of the hospital and from dying.

And that would really buy us

a lot of time

to have

a good, developed, and safe,

effecat--

effective vaccine.



JOHN WHYTE: Why haven't we

gotten a vaccine for HIV?

Wh-- what's [INAUDIBLE]

the commitment we've-- have

towards COVID.

People have been working 20

years.



DAVEY SMITH: Yeah, a vaccine--

HIV is just such

a different virus.

It has so much more genetic, uh,

mutability.

So it just mutates so much

better than coronavirus.

I-- I do have some skepticism

about coronavirus vaccines.

I think that maybe

the first generation will work

a little bit, but not, probably,

very well, and maybe have

some duration problems, um,

which is also what we see

with HIV vaccine, um, issues.

Um--



JOHN WHYTE: Why do you have

that skepticism?



DAVEY SMITH: Uh, because I know

that in regular coronavirus

infections,

our immunity wanes pretty

quickly.

And the other thing

is that people who don't have

severe, uh,

SARS CoV-2 infection-- so they

don't get COVID.

They have this asymptomatic--

we don't see them mounting much

of an immune response at all.

So I'm not sure how a vaccine

that basically introduces

some viral antigens in there

to stimulate an immune response

can really, uh, generate, uh,

a durable immune response.

So that's what I'm

worried about.



JOHN WHYTE: Well, Dr. Smith,

I want to thank you for taking

the time today to-- to help

educate us all about what's

happening in terms

of therapeutics,

especially in relation

to vaccines.

And-- and hopefully,

we'll-- we'll have the timeline,

uh, that you're suggesting.



DAVEY SMITH: Yeah, I--

I-- I really hope so.

And thank you so

much for allowing me to come

and talk to you.



JOHN WHYTE: And I want to thank

everyone for watching

Coronavirus in Context.

I'm Dr. John Whyte.

John Whyte, MD, MPH, Chief Medical Officer, WebMD.<br>Davey Smith, MD, Chief, Division of Infectious Diseases, University of California, San Diego./delivery/aws/47/5f/475f9b19-1d18-30ae-a33d-6182c6f08cdc/Smith_092520d2_,4500k,2500k,1000k,750k,400k,.mp410/05/2020 12:00:0018001200Smith_092520_1800x1200/webmd/consumer_assets/site_images/article_thumbnails/video/covid19-images/Smith_092520_1800x1200.jpg091e9c5e8200655b

Early study data shows that the Regeneron therapy is safe and has few side effects, according to CNN. Human clinical trials began in June, and late-stage trials started in July. Some scientists are awaiting more data and a peer review to decide how well the drug works.

“I would withhold judgment on this until we see the data,” Richard Besser, former acting director of the CDC and now head of the Robert Wood Johnson Foundation, told CNN.

“You know these early results that keep coming out from companies in press releases strike me as being ... much more about the stock price than they are about science,” he said.

At least 70 other COVID-19 antibody treatments are being tested. Among those, Eli Lilly also submitted a request to the FDA on Wednesday for emergency use authorization of its single monoclonal antibody therapy. The company expects to submit an application for its combination therapy in November.

The company could have 100,000 doses available this month and 1 million doses ready by late December, according to CNN.

“Our expectation is that there shouldn’t be a cost to patients,” Daniel Skovronsky, MD, the chief scientific officer for Eli Lilly, told CNN on Wednesday.

Alongside the requests for FDA emergency use authorizations, both companies will continue to study the antibody therapies in large clinical trials, which will provide better data on safety and how well the treatments work.

“Randomized clinical trials to answer these questions are now a priority,” Martin Landray, PhD, an epidemiologist at the University of Oxford, told the Science Media Centre in the U.K.

There is a “way to go” before the data shows whether these antibody drugs can effectively reduce severe forms of COVID-19, he said. This requires important data on hospital admissions, the length of hospital stays, the need for mechanical ventilation, and survival rates among coronavirus patients.

“It is encouraging to see that both Eli Lilly and Regeneron have active plans for much larger trials in a range of different settings, including residential care homes, outpatients, and hospital inpatients,” Landray said.

Show Sources

Mashable: “Trump falsely claims there’s ‘a cure’ for COVID-19 in rambling Facebook, Twitter posts.”

Regeneron: “Statement on REGN-COV2 Emergency Use Authorization Request,” “Regeneron’s REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients.”

CNN: “Regeneron asks FDA for emergency authorization of its Covid-19 antibody therapy given to Trump last week,” “Eli Lilly seeks EUA from FDA for Covid-19 antibody treatment.”

Eli Lilly: “Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs.”

Science Media Centre: “Expert reaction to press release from Lilly on their neutralizing antibodies being trialed as treatment for COVID-19.”

© 2020 WebMD, LLC. All rights reserved. View privacy policy and trust info