This story was updated Oct. 14, at 10:18 a.m., with reports the FDA has flagged an Eli Lilly plant for quality control issues. 

Oct. 13, 2020 -- Johnson & Johnson paused dosing and enrollment in all of its COVID-19 vaccine clinical trials due to an unexplained illness in a study participant, the company announced Monday.

Later in the day, Eli Lilly had to acknowledge a pause of a clinical trial of antibody treatment because of a “potential safety concern,” The New York Times reported, citing emails U.S. government officials sent to researchers.  

Eli Lilly had been testing the treatment on hospitalized COVID patients, all of whom also received remdesivir.

In a statement to the Times, Eli Lily spokesperson Molly McCully confirmed the pause in the trial and said, “Safety is of the upmost importance to Lilly. Lilly is supportive of the decision by the independent (safety monitoring board) to cautiously ensure the safety of the patients participating in this study.”

But that wasn’t the only challenge facing Eli Lilly. Reuters reported late Monday that FDA inspectors found serious quality control problems at the Lilly plant where the antibody drugs are manufactured.

Inspectors in November found data on the company’s manufacturing processes at the New Jersey plant had been deleted and not correctly audited, Reuters reported, citing government inspection documents.

The FDA sent Lilly an “Official Action Indicated” notice as classified the problems as a serious level of violation, Reuters said.

Meanwhile, in the Johnson & Johnson trial, the patient’s illness is being reviewed and evaluated by an independent monitoring board and the company’s doctors that investigate safety data.

“Adverse events -- illnesses, accidents, etc. -- even those that are serious, are an expected part of any clinical study, especially large studies,” according to the announcement.

Outside researchers running the trial received a document about the pause, which STAT news obtained and first reported on Monday. Johnson & Johnson confirmed the pause with STAT but didn’t share any additional details about the patient’s illness.

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Coronavirus in Context: Getting the Message Right on a COVID VaccineWebMD's Chief Medical Officer, John Whyte, speaks with Tamara Coyne-Beasley, MD, endowed chair in Adolescent Medicine, Children's of Alabama, UAB, about getting the message right on a COVID vaccine.973

[MUSIC PLAYING]

JOHN WHYTE: You're watching

Coronavirus in Context.

I'm Dr. John Whyte, Chief

Medical Officer at WebMD.

We've been talking a lot

about vaccines

and when a vaccine might become

available for COVID.

But will people actually take

it?

I mean, we have heart

enough trouble with the flu

vaccine.



So to help provide some insight,

I've asked Dr. Tamera

Coyne-Beasley.

She's Endowed Chair

of Adolescent Medicine

at Children's of Alabama at UAB.

Dr. Coyne-Beasley, thanks

for joining me.



TAMERA COYNE-BEASLEY: Well,

thank you so much

for the invitation.



JOHN WHYTE: Let's start off

with why is it so hard to get

people immunized.

We see with the flu vaccine,

it's often less than 50%.

In HPV, we have a lot

of challenges in getting kids

vaccinated.

Is it an antiscience approach

or--

or what's the problem that we

can learn to help with the COVID

vaccination

if-- if it comes down the road?



TAMERA COYNE-BEASLEY: Well,

that's

such an important question

and thank you for asking me.

But I couldn't answer

that question without reminding

our listeners that today

or this month

is August, which is vaccination

month.

So August is a month that's been

designated by the CDC

to actually talk

about vaccinations

across all ages.



But the question that you're

asking is really

important, because one

of the things

that we've seen not only

through the CDC,

but worldwide, is, uh, more--

more individuals who are

actually hesitant

about getting vaccines.



Now, the question you asked

is why, and how can we use

that information to prepare us

against COVID.

Unfortunately, there are-- are

many reasons why,

and I'd like to talk

a little bit about some of them.



JOHN WHYTE: Sure.



TAMERA COYNE-BEASLEY: Probably

the very first one is that many

of us don't remember the vaccine

preventable diseases

such as smallpox,

or even something like, um,

polio.



JOHN WHYTE: Polio.



TAMERA COYNE-BEASLEY: So

therefore, we don't even

understand or remember

the success of vaccines.

So they're really a victim

of their success.

And because they've been so

effective, we don't remember

the diseases that people

actually died from.



And then I think there are

people who have questions

about the effectiveness

and safety of vaccines,

even though they are one

of the most safe and effective

things

that we have

in the medical market.

They're marketed more-- I mean,

they're protected more

and evaluated more than any

medications we take or any--

any medical devices.



And then I must say, um, Dr.

Whyte, there's also lots

of misinformation

that's promulgated,

not only on the internet,

but also through social media.

And then you mentioned

a little bit about the antitrust

or the antivaccinators.



They actually really have lots

of theories, or that some people

might call conspiracy theories,

about certain things being

a hoax, or certain conditions

not actually being that

significant, or an infringement

on people's liberties.

So the important thing to do,

and what we can learn as we

think about providing--

or coming to, hopefully,

a COVID-19 vaccine,

is looking at those things that

have caused individuals

to be hesitant,

and to work to actually make

sure that we can address

those issues.



JOHN WHYTE: But in fairness,

people could say we work

on the flu vaccine every year

to try to get people vaccinated,

and we barely can crack 50%.



TAMERA COYNE-BEASLEY: Right.



JOHN WHYTE: You know, I want

to tell you about this poll

that we've done at WebMD where

27% of respondents

said they would not get

a COVID vaccine

in the first three months.

You know, let me see how someone

else does.

Dr. Coyne-Beasley, let me see

how your response is.



TAMERA COYNE-BEASLEY: Yes, OK.



JOHN WHYTE: So how does that

help if we're trying to get

people to be vaccinated,

have a sense of herd immunity?

That-- that's not going to be

good enough, is it?



TAMERA COYNE-BEASLEY: Right

right.

So no.

To achieve herd immunity

with the COVID vaccine,

we need upwards of 70--

60% to 75%, and actually, really

more than that to get herd

immunity.

So we really have got to work

really hard in understanding

people's hesitancy.



One thing you already alluded to

is that we won't have long term

safety data, as we do with most

vaccines.

And so that will be,

you know, part of the challenge.

And so hopefully, what we'll

be able to demonstrate and see

is that we'll vaccinate,

perhaps, some of the people

who are at greatest risk first.



I want to make sure that, uh, we

talk about the fact

that you mentioned flu vaccine,

and that's going to be really,

really important.

Because as we know, the COVID-19

actually really impacts

the respiratory system, um,

probably the most intense

or what we understand the most

about it.



It'll be important for people

to get their flu vaccine,

because you don't already want

a compromised respiratory

system.

So while flu vaccine has been

really--

you know, the uptake has been

less than what we would desire,

we really need to work

hard to make that--

make sure that flu vaccine

uptake is great as a way

to actually pre-- prevent,

you know, deaths that can come

from getting COVID disease

among people who aren't

vaccinated.



JOHN WHYTE: And we don't want

to overload the system.

We know that, you know,

tens of thousands of people

die of flu every year.

Hundreds of thousands

are hospitalized.

We don't want to superimpose

that on, you know,

a COVID pandemic.



You know, I want to talk

a little bit about,

um, you know, the FDA threshold

for approval, as you know,

is 50% effective.

You know, some vaccinations are

much more in terms of pneumonia,

you know, shingles.

And in our survey,

more than a third of people

said that they wouldn't take

a vaccine that was 50% effective

and has mild side effects.



So when we think about educating

the public about what that

means, and Dr. Fauci has been

talking about 50% effective,

do we need better terms?

Is-- how do we more, you know,

accurately communicate

to patients and the public

what's going on?

Is 50% good enough?



TAMERA COYNE-BEASLEY: Yeah.

Well, truth-- you know, ideally,

50% would be--

we'd want something that would

be better than that.

But I think we really have

to put in-- one of the things

that we've learned

as physicians, and particularly

through the Vaccine

Confidence Project,

is that we have to stop talking

about numbers,

because numbers aren't really

tangible to people.



And so one of the ways

antivaxxers,

or people who don't like

vaccines,

have been able to have--

be effective,

is you talk about stories.

But we want to talk

about true stories.

We want to talk about the lives

that are saved.

We want to talk

about the grandparents.

We want to talk

about the young infant baby who

was been too young to be

immunized.



So it's really talking about

and appealing to those things

that are important to people.

Things that they value,

their family members, the things

that they do in their community,

and not just talking

about deaths, but also talking

about disabilities.

Like, how it can change

their lives in terms of,

you know, if we're thinking

about, say,

meningococcal disease

and meningococcemia,

and they might lose limbs.



I mean, there are

various aspects to, um, diseases

that I think we need to talk

about and humanize more aside

from just using the numbers.

And I think we need to have

strong, consistent messages.

I think, as providers,

we need to be more actively

engaged.



And many of us are.

But it's about even calling--

you know, don't just wait

for someone to come

into your office.

Actually calling them.

We call those recall messages,

to come in and get the vaccines,

giving them

strong recommendations,

and really finding out what

their concerns are, what

is their hesitancy about,

and trying to actually address

that.



But, uh, I think that we want

a vaccine as effective as it can

be.

If the-- the FDA approves it,

it's-- it will be effective.

And the-- the thing we need

to think about

is if you had the choice to save

the life of your child, wouldn't

you take it, even if it was

only, you know-- and I don't

want people to misunderstand.

50% effective does not mean,

like, it's like flipping a coin.

It's actually more

effective than that.

Um, when you take it--



JOHN WHYTE: Is it?

No, I'm teasing you.



TAMERA COYNE-BEASLEY: Wouldn't

you take it?

It's more than-- it's not

like flipping a coin.



JOHN WHYTE: I know.

I see that.



TAMERA COYNE-BEASLEY: And so--

so it's not like, well, I'll

take my chances.



JOHN WHYTE: But what

about people that say it seems

rushed?

And in some ways,

we're having great success

because of innovation,

but it's just like in baking

or cooking.

You can't cut down, you know, 30

minutes to 22 and you can't cut,

you know, 2 cups of flour

to 1 and 1/2.

It's not going to work out.

And it seems like,

to many people,

that it seems rushed.

Do you think it--

it seems rushed?



TAMERA COYNE-BEASLEY: Well,

if you call it Warp Speed,

it makes it very difficult

for it not to seem rushed.

And again, that's

one of the challenges

that we'll face when

this vaccine comes out, aside

from the fact

that there is no long term

safety data.



But if you're listening

to the scientists, the goal

is to make this--

make this vaccine produced

quicker than normal.

But the-- we're still--

the scientists are still very

interested in making sure

that there are

methodical, clinical trials that

look at efficacy,

and look at safety,

and don't cut corners.



So yes, it may be faster.

And that's really because

of the urgency of this disease.

This disease already, in less

than a year, has killed more

individuals than we get

from our annual flu epidemics.

So it's highly contagious.

It leads to many more deaths.



And so that's the urgency.

But you need to balance

the urgency by not cutting

scientific corners.

And so we are relying

on our scientific community

to do that,

and that is the expectation

of what we will do.



JOHN WHYTE: OK.

Referring to the poll,

women were significantly more

likely--

there was a higher percentage

of women who said they would not

take the vaccine if it's

only 50% effective.

So how does that play into how

we're going to communicate

messages?

Often, you know, moms, wives,

daughters are the ones

in the family who bring everyone

else to the doctor.



TAMERA COYNE-BEASLEY: Right.



JOHN WHYTE: So, in some ways,

do we need a more

concerted effort to educate

women who seem to be having

some concerns

about the effectiveness

of the vaccine?



TAMERA COYNE-BEASLEY:

So absolutely.

And I don't like to, you know,

bi-- do gender bias at all.

But the literature, it actually

does show us that--

that women are generally

the individuals who bring

their children to the doctor

and who encourage members

of their families

to get vaccinated.



So one of the first things that

will be important

is trying to get this efficacy

as high as possible, right?

So if you get it above 50-- the

lower it is, the less confident

people are going to be.

So getting it as high as we can

in terms of its efficacy

and effectiveness is--

will be really, really

important.



The other thing that will be

important again is trying

to work with women

and find out what are the things

that are important to them.

And again, this is a vaccine--

it's called the Vaccine

Confidence Project that's being

done not only in the United

States, but also, um,

throughout the world,

um, really looking at what are

the things that actually

motivate people.



And this is a new time.

We can't use the things that we

used to use before.

Like, as clinicians,

we used to say,

give people the facts.

Give the people facts.

That's what they need.

That's-- you know, that's not

what people want anymore.

People want a fact.



JOHN WHYTE: We're overwhelming

them with facts.



TAMERA COYNE-BEASLEY: Yeah.

We're overwhelming them

with facts.

Don't get me wrong.

They want the facts.

But how do those facts relate

to me and my family?

What are the benefits of me

doing this, and what are

the harms of me not doing it?



And I don't think we focus so

much on what are the harms that

can come from you from not doing

this, and then also placing it

in a family context.

So it's not just about you.

And I'd like to think that we

still believe in helping others,

although it may not always

be evident.



But what can this

do to the teacher

that your kid is going

to go into school with and be

exposed to?

What are the potential, you

know, ramifications of not being

vaccinated for your mother,

your child's grandmother,

and your-- your friends

and families?



And so I agree.

The first thing I would really

like to do

is to try to find the most

effective vaccine.

And-- and one

of the things that we have

working in our favor, hopefully,

is, as you're aware,

there are many companies that

are actually trying

to manufacture this vaccine.



And one of the things I have

done as part of my career

has actually been involved

and engaged in-- in evaluating

vaccines.

I do vaccine research as well as

creating policies, the vaccine

recommendations that come up

the advisory community

immunization practices.



JOHN WHYTE: I'm going to put you

on the spot.



TAMERA COYNE-BEASLEY: All right.



JOHN WHYTE: How optimistic are

you that, if and when the COVID

vaccine comes out, or multiple

of them,

that we're going to get

to that 65% to 70%

vaccination rate

that we likely need?



TAMERA COYNE-BEASLEY: Yeah,

you're putting me on the spot,

aren't you?



JOHN WHYTE: Mm-hmm.



TAMERA COYNE-BEASLEY: So I

am going to be incredibly

optimistic, and I'm going to say

that we are.

Because this the-- this is what

I believe will be the challenge.

I think that we're going to have

a very difficult fall

and difficult winter.



And when

we're-- and unfortunately, you

know, I actually don't really

want to predict this.

But, you know, there's--

there certainly is some evidence

to suggest that we may have

another surge, OK?

And we're probably--

your listeners are probably

coming from all

around the country.



And one of the things that we've

known or seen as we have

reintroduced young people

into school,

and particularly college

students who aren't necessarily

social distancing, that we're

seeing clusters of disease

pop up all over the place.



Couple that also with a--

with the normal flu season

and an increase in COVID-19

diseases, I suspect that it'll

appear even more urgent

to people that we can get,

hopefully, uptake as high-- you

know, higher.

Because I think people will--

will start to see even more

urgency.



There have been almost,

you know, 200,000 people who

have died,

and it is likely to get higher.

And when people start having

that as a personal experience,

like, it's my child,

or it's my parent,

or it's my husband, um,

or my partner,

it's a different kind

of experience.



And so it's my hope not

that those things will happen,

but that we will actually

be able to achieve a higher

rate of immunization

than we would have with flu

by itself.

And again, coupling flu

and other vaccine preventable

diseases as making you healthier

and safer against COVID-19,

I think, is really important.



JOHN WHYTE: Well, Dr.

Coyne-Beasley, I want to thank

you for sharing your insights

today, and I want to share

with the audience

that you were the very first

physician, the first resident

that I ever worked with on day

one of my internship

in internal medicine.



And many years later, I still

remembered when I saw your name,

because I still remember I was

struck by your--

your tactical skills,

your procedural skills, just

your overall knowledge

of medicine.

But also your compassion

for patients as well.



So I'm just delighted that I was

able to connect with you today

and to get your thoughts on what

we need to do, uh, to get people

safe and make them aware

of the safety and efficacy

of all vaccinations,

and hopefully COVID-19 as well.



TAMERA COYNE-BEASLEY: Thank you,

Dr. Whyte.

It's a pleasure, once again,

to be with you.



JOHN WHYTE: And thank you

for watching Coronavirus

in Context.



[MUSIC PLAYING]

John Whyte, MD, MPH. Chief Medical Officer, WebMD, <br>Tamara Coyne-Beasley, MD Endowed Chair in Adolescent Medicine, Children's of Alabama, UAB/delivery/aws/2d/ae/2dae80e6-26bd-35ad-9e83-7dd64b2ce659/CoyneBeasley_082820E_,4500k,2500k,1000k,750k,400k,.mp409/02/2020 16:44:0018001200CoyneBeasley_082820_1800x1200/webmd/consumer_assets/site_images/article_thumbnails/video/covid19-images/CoyneBeasley_082820_1800x1200.jpg091e9c5e81fc0ff7

“We must respect this participant’s privacy,” the company said. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

The pause allows the company to determine whether the illness is related to the COVID-19 vaccine and whether to resume the study.

In its announcement, Johnson & Johnson explained the difference between a study pause and a regulatory hold of a clinical trial. A study pause temporarily halts the dosing and recruitment of new patients so safety data can be reviewed, and a regulatory hold is an enforced stop to a trial by an outside regulatory health agency, such as the FDA. Study pauses are usually communicated with the researchers but not the public, whereas a regulatory hold is disclosed with the public.

For this study pause, the independent review board met Monday to review the case, STAT reported. The late-stage clinical trial began on Sept. 23, and 60,000 participants are set to be enrolled in the U.S. and other countries.

As compared with other COVID-19 vaccine candidates in late-stage trials, the Johnson & Johnson vaccine doesn’t need to be frozen and requires one dose instead of two.

Last month, AstraZeneca paused its COVID-19 vaccine trial to investigate an illness in a patient in the U.K. The study resumed about a week later in the U.K. and other countries but is still on hold in the U.S.

The study pause isn’t an immediate concern, Ashish Jha, MD, dean of the Brown University School of Public Health, told CNN.

“This is completely expected, and it’s just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3,” he said.

“We want the vaccine to be safe and we’ve got to let the process play out, and it’s going to take a while,” Jha said. “To me it’s reassuring that companies are acting responsibly and pausing when they need to.”

The Johnson & Johnson announcement is further setback for the company's timeline. The FDA announced last week that it wants drug makers to have at least two months of safety data before requesting authorization from the FDA to distribute the vaccine. 

Previously, Pfizer CEO Albert Bourla has said that sufficient data could be ready by late October. The two-month requirement could make that no longer possible. Top leaders at Moderna, AstraZeneca and Johnson & Johnson have said their clinical trial timelines are longer. Full FDA approval would require more data and occur sometime in early to mid-2021.

WebMD Health News Brief

Sources

Johnson & Johnson: “Johnson & Johnson Temporarily Pauses All Dosing in Our Janssen COVID-19 Vaccine Candidate Clinical Trials.”

STAT News: “Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant.”

CNN: “Johnson & Johnson pauses Covid-19 vaccine trial after ‘unexplained illness.’”

Reuters.com: “Exclusive: FDA faults quality control at Lilly plant making Trump-touted COVID drug”

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