Former FDA director: Pfizer full approval should remove doubts about safety of COVID shots

Thank you everyone for joining us

We'll get started in just a moment

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Everyone will get started in just a moment

All right

Welcome to the latest Duke media briefing

I'm Amanda Soliday with Duke University communications today

The FDA granted full approval of the Fighter Covid vaccine

with us to discuss the approval is Dr Mark McClellan

He's a physician and an economist who directs the Duke

Margolis Center for Health Policy is also the former head

of the U

S

Food and Drug Administration

We'll also be sending out a recording to participants afterwards

Thank you

DR Mcclelland

Good to be on with you all

Yeah

All right

We'll get started

Our first question

Dr

McClelland

Do you think full approval of the Pfizer vaccine will

motivate those who are currently unvaccinated against COVID-19 to receive

the shot

I do think it will make a difference

You know maybe not a large number of people running

out and getting a vaccine today but at this point

we've got a little bit over 70% of Americans who

are eligible for the vaccine have gotten at least one

dose

That's about 87 million Americans who are eligible and haven't

And out of those according to some recent surveys about

30% say that the full approval of the Pfizer vaccine

would make a difference in their decisions

So for anybody who does have doubts this should help

overcome it

We don't really we aren't really seeing anything fundamentally new

in the announcement today about the safety and affection of

the vaccine

We know that it's very effective

We know that there are rare temporary side effects but

that the benefits really do seem to clearly outweigh the

risks

And now we've got a lot more comprehensive review of

that data over a longer time period

So that's all come together in one place

And that may make a difference for some of these

individuals who have been hesitant

I do think that we now have very clear evidence

that some of the you know misinformation out there like

the vaccine can cause um fertility issues or can cause

covid or things like that is just not there in

the data

And on the other hand the effectiveness really is in

large scale long term trials now and in the experience

of millions and millions of additional americans and people around

the world who have had the vaccines

The other place that will make a difference is in

the actions of a number of businesses schools and universities

or maybe entertainment venues state and local governments that will

probably take this uh event to move forward with requiring

vaccines and settings where people have to be together and

there is a high risk of transmission with the delta

variant is as widespread as it is

We've already seen announcements today from places like the city

of new york

The pentagon for the U

S

Military additional schools likely to take similar steps in the

coming days

So those things are going to bump up our vaccination

numbers

Excellent

Thank you

Uh now we'll go ahead and take questions

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Okay

Dr Mcclelland we received this question from a few reporters

What do you see are the benefits of full approval

compared to the emergency use authorization For example will the

vaccine be available available Excuse me

A new settings

Do you think the ability to market the vaccine will

help vaccination rates Um I think the most important thing

is the fact that full approval can reassure everyone that

even though we're in the midst of a pandemic and

it seemed like some things are happening quickly

The FDA is applying all of its gold standard regulatory

approaches

Review authorities close audits everything that it does in normal

circumstances when we're not in a pandemic

So that means that I said before not only requiring

very large randomized blinded clinical trials in this case over

40,000 people who volunteered to participate and now in many

cases been followed for well over six months Not only

reviewing lots of data on adverse events on the experiences

of millions of people around the world who have had

the vaccine

Also including review of manufacturing sites and the sites where

the clinical trials were conducted just to make sure that

all the data that was coming in to the FDA

was in fact accurate

So lots of audits

And the agency also goes through person by person

Every patient who has data reported and verifies

It doesn't doesn't just look at the the aggregate numbers

but goes back to the hundreds of thousands of pages

and files of uh of the raw data

So that's all for usual circumstances you know So it

includes questions like well how stable does the vaccine remain

in a ultra cold freezer for months Not normally a

question that you need to know the answer to if

you're trying to get the vaccines and to use quickly

to have an impact on the pandemic

But a lot of evidence that's up to the FDA

is gold standard

Now they did this review faster than usual

It's only about three months

That's only about 40% of the time that it usually

takes

I think if you go through all of the information

that was posted summarizing what FDA did you'll see that

there were no corners cut something we're very diligent in

all of this

So I think that's the most important benefit aside from

that

Now that the vaccine is fully approved in principle it

could be used by doctors as they think is appropriate

for their patients

So called off label prescribing in practice

That's a little bit complicated because we are in the

midst of a pandemic

And so all of the purchases for the vaccines now

essentially have gone through big government contracts that are subject

to terms set out by the Centers for Disease Control

on how the vaccines are supposed to be used

So there may be some additional prescribing that goes on

But I think for the most part the most important

benefit is that confidence that FDA has applied its usual

non emergency gold standard review process to this vaccine

Excellent

Thank you

We have a question from Robin Kennedy

When will Madonna and J and J get full FDA

approval Could you talk a little bit about the difference

in timelines for the three vaccines that are used in

the United States

Yes great questions

And remember those vaccines came along later Moderna a few

weeks or so behind Pfizer and Moderna announced early this

summer that it was starting a process of submitting all

the data needed for full approval

And that's been ongoing since june I don't think the

Madonna approval is imminent like within the next week or

two but should be happening within the coming weeks

And I'd look for some more announcements just like you

saw come out of F

D

A

Recently about the impending announcement of the fighter vaccines full

approval expect to see that in the coming weeks

James has a little bit behind that You all know

I'm on the board for for J and J

But the uh the company is is collecting all that

additional longer term follow up data

You know it wasn't the trials were started a little

bit later

The approval happened a few months later

So that's still coming together and I expect that application

to go into the FDA at some point this fall

within the next few months and then approval full approval

maybe a few months after that

So it's running a few months behind uh the Pfizer

and Moderna vaccines

Thank you

Uh We have a question from eric Berman

So he uh some including President biden have urged the

FDA to take this step even sooner for full approval

Do you think it could have been taken earlier Well

I think if you heard from the agency leadership today

they had a press briefing where they announced the full

approval and what had gone into it

Um they really emphasised just how much time and work

this is

So on the one hand we are in the midst

of pandemics

We want to go as quickly as possible

On the other hand because people are viewing this as

a gold standard using the review approaches and requirements that

apply under normal circumstances for that long term follow up

all those checks on manufacturing and auditing the data and

so forth

Um FDA needed to be really careful not to do

anything that after the fact could be viewed as cutting

corners and undermining the confidence that was intended with the

full approval process

So the upshot of that was you had a lot

of people on the agency staff working day and night

intensely over the past few months to shorten the time

to get to a full approval under priority review from

something like eight months down to three

and that's very very fast by FDA standards but done

with the intent of not cutting any corners

Not reducing any of the review process is the audit

processes etc

And I think that's about as fast as it can

possibly go

I do want to emphasize that a lot of people

are viewing this is replacing an experimental approval and that's

not really what we had before

We had was emergency authorization which still required to get

that these very big randomized clinical trials follow up data

on lots and lots of patients continuous updating of that

data while we're seeing about new experience and very rare

side effects during the course of the pandemic

So there weren't really any surprises today in terms of

the evidence on safety effectiveness you have to have been

putting that all together all along the way

So we're not really moving from an experimental phase to

uh to an approval phase so much as we're consolidating

all of that information into a complete review which hopefully

will help build even more confidence in these very effective

vaccines to your point

So millions of americans have already been vaccinated

What have we learned about the vaccines during this period

of emergency use authorization We've learned very importantly that the

basic findings from the beginning about the effectiveness of the

vaccines and the safety of vaccines has held up

So particularly for the Pfizer vaccine with a full approval

The estimated effectiveness was 91% and preventing infection and very

high effectiveness and preventing hospitalization

That's slightly lower than numbers that went into the emergency

use authorization back in December

I think you can attribute that to a bit longer

follow up and also the fact that we're dealing with

some more challenging variants now variants that are much more

transmissible and easier to cause infection

So it's really good news that effectiveness data is holding

up as as well as it did on the safety

side

The trials of tens of thousands of people found no

evidence of serious long term side effects and no side

effects that showed up really after the first few the

first hours to today's to a few weeks after the

vaccines we have learned more about the rare occurrence of

what's called uh pericarditis or are my associates a cardiac

muscle inflammation especially in younger males

But at a very very low rate an order of

magnitude lower than the risk of contracting covid infections and

the risk of serious long term consequences including for the

heart from people who have covid infections

Even young people

So it doesn't didn't really change the picture at all

in terms of very high benefits rate very effective vaccine

very rare side effects

But it's more complete now

We've got more data on a lot more people

We've been able to see that and you know well

over 100,000 pregnant women uh the vaccine is protective doesn't

cause any adverse effects there

Really

A more comprehensive picture to fill out what we saw

early on in the emergency use evidence

That's good to hear

We have several questions about vaccine mandates

So what type of impact do you believe this approval

will have on vaccine mandates around the country We saw

today that the military will not require vaccinations

How about companies local government Yeah I I expect we'll

see more

You know it's important to know that under U

S

Law for emergency use of a vaccine

Companies universities other institutions already had quite broad authority if

there is good reason from the standpoint of the safety

of their workplace to require vaccination in that there has

to be an out for people who have medical reasons

not to be vaccinated and for people of religious reasons

not to be vaccinated

But that's going to carry over now to the full

approval situation so companies can do it before

I think they're gonna be more confident now and think

they'll get more acceptance from their workers to the extent

that was a concern about the level of evidence on

safety and effectiveness that we have again we didn't really

learn anything new today about that

But it is a very much more complete process with

the report that's now out there in the public domain

So while we already had a number of businesses schools

entertainment venues requiring vaccination or proof of a negative test

or something like that those numbers are going to go

up significantly

That probably is going to drive the bigger impact of

the full full approval on vaccination rates of this country

Probably even more than the remaining people who are having

doubts and potentially willing to be convinced that you're going

to see it more in workplaces

That's going to encourage people to really think about the

safety and effectiveness data and maybe get around to to

getting the vaccine and I think that's gonna be helpful

for creating safe workplaces schools entertainment venues everything else we

need to move beyond this pandemic

Thank you

We have a question from Caroline Hicks

When can we expect Pfizer to get full approval for

kids 12 through 15

It's a good question

So that data was still being collected

Remember that that study was a few months behind the

study for approval in 16 and older

I am sure that the FDA is going to review

that data quickly as Pfizer submits it they already have

submitted a good deal of it

But because it came in later and because full approval

requires as we've talked about that longer term follow up

there's only so much you can do to move that

process along

So I'd expect a bit later this fall for that

People are also asking about this is kind of implications

for kids under 12 who are not authorized yet even

for emergency use

And those studies are still ongoing

So they're larger studies underway now

They're trying to get it right In terms of dozing

The doses are going to be lower but you want

to find one that induces a strong immune response and

has but not too strong

So not too many avoidable side effects

I don't know of any serious side effects showing up

in those studies yet but they just haven't been completed

So that's probably also going to be uh a late

this year um phenomenon when we get the emergency approval

for kids under in the 5 to 12 age range

Great

We also have a question from Andrea Blandford um she

wants to know what effect you think the full approval

for the Pfizer vaccine will have on air travel in

the US

And she mentions that right now

People traveling internationally must show a negative covid test before

flying back into the country

Do you think this approval will affect that policy I

don't think it's going to affect it in the short

run

The challenge we have now is that our covid rates

around the country are so high and covid rates in

many other countries also high in some cases rising we

know that people can have breakthrough cases with vaccines

We also know for the Pfizer vaccine Madonna and J

and J

Those cases are likely to be much less serious

Was still very strong protection against hospitalization but for purposes

of air travel safety quarantining and things like that

You really want to make sure that people have negative

test that they're not in a position where they could

transmit the virus even if they're not having that many

symptoms

So I expect those testing requirements are going to stick

around until we see the covid rates come down

And right now we're still at very high rates in

the United States and many parts of the country the

ones that have been hardest hit this summer especially in

the south in some of the midwest Missouri Arkansas and

so forth

Those rates do appear to be coming down or either

at peak or are heading or getting very close to

it

But we still got weeks ahead

Very high rates of code in the community high rates

of transmission risks of transmission that schools reopen as we

have college football games et cetera

So I think that we're not going to see a

big reduction in the caseloads very quickly

It's just another reminder how important it is to get

vaccinated You have another policy question from beth wang do

you think full approval and increased vaccine mandates could eventually

lead to the federal government requiring vaccine passports or getting

involved in vaccine passport efforts

It's a good question that the biden administration than pretty

clear all along that they do not and kind of

underlying do not see a federal role in requiring or

administering a vaccine passport system

Uh That said we've seen a number of state and

local governments impose something like vaccine requirements for indoor dining

for major sports events for indoor big entertainment events

Uh and I expect to see more of that happening

also expect to see more of it happening through the

private sector

So Live Nation for example a group that has collaborated

with us on an effort that Duke Margolis is involved

with the covid collaborative Covid safe zones initiatives just google

labs and mouthful covid collaborative and covid safe zones

Um companies like Live Nation are participating in this effort

That includes steps like requiring vaccines proof of vaccination or

a negative covid test to attend Alive indoor concert event

Um those are steps that will promote more safety and

with hopefully not too much disruption for people but it

doesn't mean that it's going to be a federally mandated

system

This would be a system implemented by local governments businesses

um uh schools et cetera to have appropriate safety for

their particular circumstances

Thank you

We have a lot of questions coming in and I'll

try to get to them in the time we have

allocated

Um we have a question from course Steeg what could

full FDA approval mean for companies to return to office

plans

I think the most important thing for companies return to

offices to have safe conditions in the office and vaccination

definitely helps with that

So this will as we've just been talking about perhaps

lead more businesses I should say it will lead more

businesses to have a requirement for vaccination in their workforce

That's probably the single most important step to reducing risk

of transmission and keeping people safe in the workforce and

when they go home their families back into the communities

afterwards

There are other steps that employers can take to help

their employees get back to work safely ventilation is really

important

Some distancing masks at least fall the covid rates in

the community or high

We have seen that when you implement this combination of

steps and maybe having some regular testing of employees along

with that or students in the case of schools you

can detect outbreaks before they spread you can create a

quite safe workplace

So I think employers will be looking at this approval

as maybe a reason to push a bit more on

the vaccination expectations a requirement in the workplace along with

those other steps

So I think business can get back to work

But as long as we have high covid rates they

need to be thinking about this combination of steps great

thank you along those lines we have a question from

Daniel Pierce which industries outside of the health care system

And I suppose the military from what we've seen today

do you see leading the way for vaccine mandates in

the wake of FDA approval That's a great question

You know we're seeing it really all over the economy

So just one more time I guess I plugged that

uh covid collaborative covid safe zones

It's a collaborative effort among a range of public health

experts former um government leaders in public health from Republican

Democratic administrations the last five administrations and collaboration with many

businesses around the country and among the ones that are

participating our airlines it's a close proximity and important for

the staff to be protected

Important to contain outbreaks through other steps to like a

good ventilation

So United Airlines has been part of this um uh

manufacturing and food processing companies where people have to work

in close proximity

So Tyson's foods has uh imposed or taking some of

these similar steps around vaccination and ventilation masking where needed

other steps to keep our workplaces stay safe

I mentioned live nation before that's in the entertainment field

And there also are over 600 colleges and universities that

have imposed either a strong encouragement or I think increasingly

requirements for vaccination for students but also for for faculty

and staff uh and all of those are our businesses

or schools or universities where people come into close proximity

just by the nature of the enterprise

And if we want to have all of those activities

take place safely this fall

It's really important to take the steps that we know

work including vaccination to enable them to occur safely

Thank you

Uh Another question about the FDA process and timeline

So um will the Pfizer vaccine need to be modified

as new forms of the virus appear And if that

happens will the FDA approval process need to restart or

what will happen in that in that situation Well there

are no plans for the short term discussion around potential

boosters and uh for the U

S

Population

Especially those in higher risk groups who got vaccinated early

on and no plans for a modified vaccination for that

in the short term

In fact right now Pfizer and Moderna and J

And J

R

Completing studies and submitting the data from those studies of

what happens when people get a booster dose

That's going to be really important for the upcoming decisions

by the FDA and the C

D

C

And I know the administration got out a little bit

in front of this this past week

That's because they want to make sure that we're ready

as soon as possible in case that evidence shows as

some of it seems to suggest that boosters may be

needed for higher risk individuals at least and those who

got vaccinated early as soon as they a month from

now

But those studies are going to come in and that's

what is mainly about an additional dose of the vaccines

that you already got

So that's where the focus is for the fall

I would expect that when those studies are completed they

will get added to the label for the F

D

A

Full approval of Pfizer

And then when it comes Madonna uh and J and

J later this year there also is work underway about

what happens when you cross vaccines those switch from you

know one vaccine to the other

So from A J and J

M

R N

A or M R N A to uh to J

and J

And what the impacts of those combinations would be

There's some reason to think it may actually be beneficial

for people but those are still some time off

And they're also a modified M

R

N

A

Vaccines that are more reflective of DELTA you know not

the ones we have now

We're designed you know a couple of variants ago

Uh those are in testing as well but probably wouldn't

get into use until early next year

And when FDA already has a very very strong base

For an approved product

These product modifications sometimes can occur depends really on the

circumstances and what the data shows sometimes can occur without

quite the same degree of additional evidence collection because you

already got such a strong base of evidence with the

full approval

But those are going to be more issues around the

modify vaccines I think as we head into 2022 not

for the issues with decisions about boosters over the next

few months

Excellent

Thank you

I think we have time for a couple more

We have another good question from Daniel Pierce

He wants to know if parents um Should or shouldn't

read too much into the FADA

Not yet approving or giving full approval for Children 12

to 15 years old

Yeah absolutely

Should not

This is just again it's a matter of the requirements

for full approval in terms of long term data for

a large number of individuals

The time to audit and review all that data at

the at the person by person level

It just takes time for that day to come in

It takes a little bit of time

Even with FDA working day and night to review it

Um if there were any concerns about the use of

vaccine emerging in people 12 to 15 you would be

hearing about it

It's something that FDA staying on top of and just

like we saw with the other rare side effects that

have turned up in frequently with the vaccines they start

being used in millions of people

Uh there will be a close review of that not

only by FDA but by CDC as all that data

comes together

So the fact that we're not seeing anything like that

turning up is a good indication that that so far

at least as all that additional longer term data is

accumulating being reviewed FDA is not seeing anything in the

way of new concerns about the 12 to 15 population

Thank you

Dr Mcclelland you have time for one more question

Okay what would you say to someone who is still

skeptical about receiving the Pfizer vaccine even even after this

full approval Yeah

And there are there are people like that

There are people who just said you know they're not

going to do it

Um you know I think the most effective approaches I've

seen or once where you start out not by telling

them look here is the full approval but by asking

the questions you know what is it that their concerns

are And once you go through those particular concerns whether

it's about you know where these vaccines seem to have

come along too quickly

Well actually if you go back and look the technology

has been developed over a decade or more in all

of them

And uh we have a lot of experience from from

all that time about the vaccines and what they do

and don't do or if it's about certain kinds of

side effects that people have heard about on the internet

and there really is a lot of misinformation out there

Unfortunately

Um looking closely at what the evidence is on that

That's an area where the full approval should be helpful

because like a very comprehensive compilation of everything that's been

seen in association with these vaccines and very comprehensive review

of what adverse events could be attributed to the vaccines

Or it may be some some other issues like thinking

that they're not at high risk because they're younger

Um well what we're seeing now unfortunately is lots of

hospitalizations and some significant cases of long covid post acute

symptoms that are fairly serious in young athletes in kids

uh that are happening at a much higher rate

If you just go out and look at the data

now happening at a much higher rate than any of

the rare side effects that people have been worried about

could theoretically be associated with the vaccine

I think talking through all those things with individuals many

of them are going to have to confront this a

little bit more clearly because they're likely to face requirements

for vaccine at work or in going out to dinner

or in going to events at clubs or entertainment venues

Uh so I hope people can know where to go

for for good answers on all of that

And the full approval definitely puts a lot more evidence

out there

Excellent

Thank you to Dr Mark McClellan McClellan

Excuse me for sharing your time and perspective

I'd like to say that Duke host weekly media briefings

So if you'd like to attend future briefings please email

Duke News at Duke dot e d u

In the meantime please stay well and thank you