Oct. 7, 2020 -- FDA Commissioner Stephen Hahn, MD, says no COVID-19 vaccine will be approved without input from its vaccine advisory panel -- a step that will slow the process down and require public comment.

That step will be required whether a drugmaker seeks approval for an emergency use authorization or through the regular approval process, Hahn said Wednesday during an interview on “Coronavirus in Context,” a video series hosted by John Whyte, MD, WebMD’s chief medical officer.

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Highlights from Upcoming Interview With FDA CommissionerHighlights from an upcoming full interview between WebMD's Chief Medical Officer, John Whyte, MD, and Stephen M. Hahn, MD, Commissioner, U.S. Food and Drug Administration (FDA).535

[MUSIC PLAYING]

JOHN WHYTE: You're watching

Coronavirus in Context.

I'm Dr. John Whyte,

chief medical officer at WebMD.

Today, I am joined by Dr.

Stephen Hahn.

He's the commissioner of the US

Food and Drug Administration.

Dr. Hahn, thanks for joining me.



STEPHEN HAHN: John, thank you,

really appreciate

the opportunity.

It's great to be part

of this webcast.



JOHN WHYTE: Well, Dr. Hahn,

let's start with the obvious.

How is this process going to be

transparent, when there is

a large number of the public

that are more

interested in these particular

products

than they would be in, you know,

perhaps a diabetes medicine,

or a medicine, you know,

for the heart?



STEPHEN HAHN: As you know,

we have experts at, uh, FDA

in our vaccine division

in the Center for Biologics

and Evaluation

and Research who do this

for a living.

They are great scientists,

doctors, nurses, pharmacists,

statisticians.

And they look

at the primary information,

the raw data that come

from clinical trials

on vaccines.

And they make a decision

about a couple of factors.



One is the safety.

The other is the effectiveness.

And the third is information

about the manufacturing.

And there's a-- a number

of different acronyms

we use for that,

but that's not really important.

What it is is,

are we

confident that the manufacturing

is of high quality, and that

every lot--

every vaccine that comes

off the--

the manufacturing plant--

actually has a high level

of consistency and quality

associated with it?



So those are the data that we

would look at, regardless

of whether it's an emergency use

authorization

or a biological license

application to us.

With a vaccine, it's a little

different than a therapy.

Because this is going to be

given to people who are

presumably healthy,

who don't actually have

COVID-19.

So that changes the balance

somewhat for us.

So we-- we've listed a couple

of criteria that recently came

out in vaccine guidance.



One is we will need to see

effectiveness and safety

data from at least

one well-designed

and performed clinical trial

that is robust,

and that shows data that are

clear and compelling.

We've already said that we would

look at a floor of 50% efficacy.

Now remember, that's a floor,

not a ceiling.

And of course, we want to see

high efficacy, um, if possible.

But the floor will be 50%.



JOHN WHYTE: Give people

a reference for that.

Is-- is 50% good?

Is it

consistent with many other

vaccines?

Maybe compare it

to-- to influenza?

We know pneumonia-- Pneumovax

can be 90% effective.

So explain to us that 50%.

Because I think people

get confused by that.



STEPHEN HAHN: We felt

for this public health emergency

that the most appropriate

floor-- our scientists did--

was 50%.

So that should give you

some perspective on that.



JOHN WHYTE: OK.



STEPHEN HAHN: With respect

to safety, what we said was from

the last dose-- and in some

cases, there are two doses

of vaccine, in some cases,

they're one--

from the last dose of vaccine,

we would need to see follow-up

data of a minimum of two months

after the last dose

of the vaccine in at least 50--

well, in the-- in the median,

which is, you know,

50% of the volunteers who are

on the trial.



[INTERPOSING VOICES]



JOHN WHYTE: And 15,000 people,

is that right?



STEPHEN HAHN: Right, so that's

exactly right.

So it's a trial of 30,000,

and then 15,000 receive placebo,

15,000 receive

the active vaccine.

Now we added something else

to just make sure that we can

ensure safety.

And that is we require a very

robust program to look

at additional safety after, um--

or if-- a vaccine is approved

or authorized.

So in this case in the EUA,

we want to see

this minimum amount of safety

data.

But then we're going to be very

close in terms

of our observation of any diff--

a-- additional safety events.



JOHN WHYTE: So how does that

play in the role of safety?

Because I-- I'll tell you,

on surveying that we've been

doing at WebMD, people are very

concerned about, you know,

getting it in the first three

months.

Everyone's saying,

I'll let you, Dr. Hahn,

get it and see how you do.

We all can't be doing that.



STEPHEN HAHN: So a couple

of things-- one, is our safety

database isn't just

from, uh,

the randomized clinical trial.

Remember, for some

of these vaccines,

which started in humans, uh,

back in the spring,

we have safety data

from those individuals as well.

So we'll look at those totality

of data.

The other thing that we're going

to do, obviously, is this,

um, very active

post-marketing assessment

program.

And we're going to do a very

aggressive approach to that.



And-- and also, remember,

this won't be given to a 100

or 300 million people

in the first three, six months.

There will be a rollout plan

associated with this

as the manufacturing runs up.

And so what we'll want to do--

and again, I don't want

to prejudge that this is going

to happen.

It all depends upon the data.

And remember, the data are going

to be looked

at by our scientists, but also

a vaccine advisory committee.

So I think our scientists feel

that, given the fact that we do

have a-- a-- a robust safety

database up till now, plus

the size of these trials--

which are-- are larger than many

trials for vaccines

in the past--

and the surveillance afterward--

that we can have, uh, confidence

around the safety.



Now that being said, we really

do have to look at the data,

and look at it very closely.

But if you look

at the current situation,

anywhere between 800 and 1,000

people

are dying per day in the United

States, let alone worldwide,

from COVID-19.

If there is a highly effective

vaccine that appears

safe in this data set that we're

talking about,

we will consider--

I'm not saying, we'll do it--

but we would consider

authorization, um, in order--

if the data suggest it--

to prevent additional deaths

associated with COVID-19.



Now, I-- I will not prejudge.

And this is not my saying

that we will do it.

I'm just saying that this is

what FDA does.

If we do not feel that the data

are, uh, supportive of-- enough

of safety, we won't authorize.

That is for sure.



JOHN WHYTE: And I think that's

an important message, you know?

And finally, I want to ask you

about morale.

Tell us about the morale.

And you know, let's be honest,

eh, I'm sure it can be

challenging if-- if one feels

there is an attack on science,

if one reads that it's

a political hit job, in terms

of trying to-- to put out

good information.

How are people feeling?



STEPHEN HAHN:

So, um, throughout this

pandemic, um, our folks at FDA--

17,000-plus-- John, you know

them yourself personally--

have been absolutely remarkable.

They have stepped up

to the plate to serve

the American public.

John, our workload has doubled

during this pandemic.

So not only are we working

on COVID-19, but all

of our regular work, cancer drug

approvals, cardiac drugs,

our-- all of our user fee

deadlines.



We're-- we're meeting those--

those-- those parameters

and those deadlines.

We're doing our regular work.

And at the same time,

we're responding

to the public health crisis.

These are

remarkable public servants.

They have not looked back.

They have stepped up

to the plate, and they've done

tremendous work.



So of course, one's tired.

There's a large workload.

We're trying to stay

focused on the public health,

uh, commitment that we all have.

And of course, I think,

you know,

the external-- externalities

that we always hear in the press

and elsewhere-- it-- it does

take a toll.

There's no question about it.

One thing I can tell you,

though, that I am incredibly

proud of

is the amazing resiliency

of our folks.

We spent a lot of time--

the leadership, center

directors-- focusing on how we

can help build resiliency,

but al-- also how we can best

support our incredible staff

at FDA.



I want to tell your listeners,

but the entire American public,

America's FDA is there for them.

They have been there for them.

They do nothing except do--

use science and data to make

decisions.

They've done that up till now.

We will continue to do that.

I have absolute confidence

and faith in them.

And I am incredibly

proud of them as a work force.



JOHN WHYTE: Well, Dr. Hahn,

I want to thank you for taking

the time.

And, you know, I want to clarify

to our audience there were

no questions that were

off-limits in our discussion

today.

You've been very gracious

with your time.

And-- and I want to thank you

for clarifying, um,

and providing answers for what's

on people's mind, as well

as the dedicated

work that-- that you

and, you know, the thousands

of people that work at FDA,

literally all over the globe.

Um, so thank you, Dr. Hahn.



STEPHEN HAHN: John, thank you,

and my--

I-- I really appreciate you

and your organization,

and asking these questions.

You know, we talked a little bit

about what increases trust.

Transparency.

It's being able to answer

the questions that need to be

answered.

And I appreciate you're doing

that, thank you.



JOHN WHYTE: Thank you.



[MUSIC PLAYING]

John Whyte, MD, MPH, Chief Medical Officer, WebMD.<br>Stephen M. Hahn, MD, Commissioner, U.S. Food and Drug Administration (FDA)./delivery/aws/a0/04/a00497c8-5dbb-387d-beec-5c5fa9397fef/Hahn_100720-highlights_,4500k,2500k,1000k,750k,400k,.mp410/07/2020 12:00:0018001200stephen_hahn_100720_1800x1200/webmd/consumer_assets/site_images/article_thumbnails/video/covid19-images/stephen_hahn_100720_1800x1200.jpg091e9c5e8200ce87

Hahn’s comments come the day after Trump accused the FDA of a “political hit job” with tougher COVID-19 vaccine approval standards and concerns among citizens about the safety of the vaccine.

“There will be a transparent, open-to-the-public discussion about the data,” Hahn said. “We want the public to comment. This dialogue is very important.”

The Vaccines and Related Biological Products Advisory Committee is scheduled to meet Oct. 22, but only general information about vaccine development will be discussed, he said. Public comments for that FDA meeting will be accepted through 11:59 p.m. on Oct. 15, the FDA says.

The FDA released new safety standards for COVID-19 vaccines Tuesday that will make it nearly impossible to get a vaccine to market before the election -- as Trump had asked. The new rules require vaccine makers to follow clinical trial participants for at least 2 months to rule out safety issues before seeking emergency use authorization for a vaccine.

On Tuesday night Trump put out a critical tweet and tagged Hahn, saying: “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA”

While Hahn said political interference, media coverage, and other issues can “take a toll” on people who work at the FDA, he said morale at the agency is good.

When asked if a vaccine might be approved before the end of the calendar year, Hahn said, “It’s possible. I won’t speculate on it because I don’t know when the data will be mature.” He added, “The time frame will depend on complexity and amount of data.”

On the topic of testing, Hahn said the FDA is focusing on three kinds of tests: point-of-care, rapid-result, and home collection.

He said rapid-result tests appear to be the most accurate when used according to the label. The label for the Abbott ID NOW test, for example, says its use is for people showing symptoms of having the coronavirus. According to news reports, White House staff have relied heavily on rapid tests as a way to prevent COVID transmission instead of mask wearing and social distancing.

Trump and his wife, first lady Melania Trump, tested positive for the virus Thursday. Since then, numerous close associates to the president have tested positive.

WebMD Health News

Sources

"Coronavirus in Context," October 7, 2020. 

FDA.gov: “Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement,” "Emergency Use Authorization for Vaccines to Prevent COVID-19."

Twitter: @realDonaldTrump, Oct. 6, 2020.

FDA: "ID NOW COVID-19."

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