FDA Advisors Vote to Recommend Moderna Boosters

JOHN WHYTE: Welcome, everyone.

You’re watching Coronavirus

in Context.

I’m Doctor John White, the Chief

Medical Officer at WebMD.

So who exactly needs boosters

and when?

When are we actually going

to see a vaccine for kids?

And should you wait as a parent

for a little while

once they’re available?

And then, what’s the timeline

for antivirals?

When are we going to get more

effective treatments?

Well, joining me today to answer

all these questions that I know

are on your mind,

you’ve been writing in,

is my good friend

and the editor-in-chief

of Medscape, Doctor Eric Topol.

Doc Topol, it’s great to see you

again.

ERIC TOPOL: Great

to be with you, John.

JOHN WHYTE: I want to start off

with boosters.

And can you break it down

for our audience in terms of who

really needs them, is it

8 months, is it six months?

We’ve heard different things.

What’s the science that can

guide listeners to say,

hey, I need to get a booster.

ERIC TOPOL: All right.

Well, there’s hard data.

There’s only one place and one

vaccine, which is Israel.

It’s over 1.1 million Israelis

over age 60, 60 or above,

and they had unequivocal benefit

from the booster

of the third shot.

The waning of the benefit

of the vaccine started around 4

and 1/2, five months.

Clearly, it was there at six

months and just kept growing.

So that group, 60 and older,

irrespective of whether there’s

other health issues,

deserves to get a third shot

of Pfizer.

Now, the question

is, both other vaccines,

like Moderna or J&J,

and also other age groups

and other indications

beyond just 60 and above.

We have several pieces of data

about Moderna and J&J

that shows that that’s going

to need a booster at some point.

And in fact, the problem

is there’s no Israel out there

to give us the data.

So we should have it in the US,

and we don’t.

And that’s a problem.

And we have so many people

with Moderna and J&J vaccines.

There was, as you know,

John, a MMWR that showed the J&J

antibodies after just a matter

of weeks from the vaccine.

And they were really quite low

compared to the Moderna

and Pfizer.

So I would think we should have

called out for the people who

got the one

and done to get the second shot,

whether it’s either Pfizer

or Moderna.

We have these purists that want

to wait for this data

that we’re not going to have

for such a long time.

The problem here is we’re

leaving people vulnerable.

JOHN WHYTE: Right.

ERIC TOPOL: All of this

was a third shot story

from the beginning.

The only question was, when

would the third shot be

necessary?

JOHN WHYTE: Yeah.

ERIC TOPOL: That I think it’s

becoming increasingly clear

that all these vaccines,

whether it’s five months, seven

or eight months, a third shot

is going to be part

of the program to get

the full vaccine effectiveness.

I think that’s where we’re

head–

JOHN WHYTE: Yeah, but is there

going to be a fourth shot,

a fifth shot, a sixth shot?

I mean, does it stop at three?

ERIC TOPOL: I hope not.

But I think the reality is

that we’re relying too much

on neutralizing antibodies

to carry us through,

particularly this Delta period

where it’s so hyperinfectious.

So it’s a perfect storm.

You have both the waning

of time, then you have

this hypertransmissible variant.

Now once we get down to low

circulating levels of virus,

which I hope we’ll get

in the near term, then this

won’t be

as significant a problem.

Now, that also will have

an influence

on subsequent boosters.

If we achieve containment,

the utility of boosters,

once a year let’s say,

will be of less significance.

Plus, there’s a possibility

that we get a much better

memory.

That is because the spacing

in the US was so limited.

That is, three weeks for Pfizer,

four weeks for Moderna.

It should have been at least six

to eight weeks.

So if we start the idea

that we’re going to get a far

better memory of B and T-cells,

that might help prevent the need

for fourth and fifth shots

subsequently.

JOHN WHYTE: All right.

Well, let’s talk about what

other people are talking about.

And what they’re talking

about is, I got Moderna,

I got J&J, so can I get Pfizer

in San Francisco?

Some other studies have allowed

it.

Some experts are suggesting

it actually might be a good idea

if you got Moderna and J&J

to actually get

a different vaccine.

And as you point out,

there are the purists out there

saying, oh, no, we have to wait

for the data.

No mixing and matching.

What’s your advice to folks that

are listening

and that are worried?

ERIC TOPOL: I wish we had more

and better data.

So we do have for AstraZeneca,

which is a close cousin

to the Johnson and Johnson.

And there, if you had

that vaccine,

the adenoviral vector, and then

you’ve got an mRNA vaccine,

either Moderna or Pfizer,

the immune response was the best

we could get

from any combinations

of vaccines, including two mRNA

vaccines or two AstraZeneca.

So if you extrapolate that, I do

agree that if you had J&J, you

really– it would be wise to get

a Pfizer or Moderna

as your second shot.

JOHN WHYTE: What about if you

got Moderna?

ERIC TOPOL: Yeah, if you got

Moderna, I think, it doesn’t

probably matter.

I mean, remember, you’re well

aware of the dose of the mRNA is

triple in the Moderna as

compared to Pfizer.

JOHN WHYTE: Right.

ERIC TOPOL: Are actually

a little bit more than that.

So if you get Pfizer,

except for that dose

and the spacing,

it’s pretty

close to interchangeable.

I can’t imagine getting the shot

that doesn’t follow the lane

of Moderna or Pfizer

makes that big a deal.

But the booster that Moderna has

applied for when it formally

is EU aid

is for 50, half the dose of what

it used–

JOHN WHYTE: A lower dose, right.

ERIC TOPOL: Yeah.

So that may reduce the side

effects, which initially, there

was somewhat increased side

effects with Moderna as compared

to Pfizer.

JOHN WHYTE: But here’s where

the confusion that I hope you

can help clarify for folks.

So we’re saying folks need

boosters, then we have the CDC

director, say walk, not

run, to get a booster,

because you’re protected

from severe disease.

And some will argue that’s what

vaccinations really are supposed

to do.

So how important is it to get it

at six months?

Can you wait nine months,

a year?

I mean, it should it

be on your priority list to-do

this fall and winter.

ERIC TOPOL: If you’re

60 and over,

I would say it should be

on your priority list to-do

as you approach six months.

Because the longer you wait, the

more vulnerable.

That is, if you’re

out and about,

you’re going to have

some exposure.

The more exposures you have,

ultimately it’s

cumulative in terms of the risk

of the infection.

The point here is that this is

the ultimate, that is,

prevention of hospitalizations.

This is not just preventing

symptomatic infections,

the severe illness.

So that’s where the older age

group, it’s really important

short of age 60.

Then we’re talking

about infections,

symptomatic infection.

The chance that you’re going

to really block

hospitalizations, at least

from the data we have right now,

is not nearly as impressive.

JOHN WHYTE: OK.

I want to move to kids 5 to 12.

That’s what everyone is talking

about as well.

And I’m not going to ask you

when you think it’s going to be

authorized.

What I want to talk about what

we know so far and we don’t have

all the information.

But we know it’s roughly 2,200

kids in that entire age range

of 5 to 12.

So not a lot of kids

studied over two months.

How concerned are you about

do we have enough data in terms

of looking at safety

and efficacy for kids

5 through 11?

ERIC TOPOL: Yeah, so we’re

talking about the trial

of Pfizer which use a third

of the dose as in adults

and teens.

So it’s instead of 30

micrograms, it’s 10 micrograms.

Now, it was a 2 to 1

randomization, so 2/3

of the 2,200

or back in 1,500 children

got the vaccine.

So what can you say about that?

Well, there was a nice antibody

response.

So that’s good.

There were no significant safety

problems that were encountered,

that’s good.

You can’t really talk

about rare side effects.

So we saw in teens

the myocarditis propped up

in one in tens of thousands

of kids.

And we can’t really say that

much, because you only have

1,500 as a denominator.

Most likely, though,

because these doses are so low,

already we started

with a vaccine that had much

lower dose than Moderna.

Now, we’ve taken one third

of that.

So the chances of getting

these rare side effects are low.

But we’ll know much more once

that program gets going,

because very quickly parents are

very eager to get their kids

vaccinated,

so they don’t have problems

with school.

And we’ll within weeks

if there’s going to be

some rare side effect if it’s

going to crop up.

I doubt it, but it’s possible.

JOHN WHYTE: But what do you do

for an 11 and 1/2-year-old,

right?

So the 12-year-old is getting

the full dose that every adult

got as part of the Pfizer.

Yet, they’re getting a third

of the dose, in theory,

depending upon what happens

with authorization or approval,

of someone six months older

than they are?

ERIC TOPOL: Yeah, well,

good question.

I mean, you go with the plan.

The plan is that you get

a good immune response,

and it’s probably good enough.

I think, we always learn more.

You made a very astute qualifier

about the two months.

That is, these data are two

months, just

like the initial vaccines

for adults.

And that we’ll only learn about

whether that dose is short

for the 11 and 1/2-year-old

as we look at data six months

and a year from now.

So it’s hard to know.

JOHN WHYTE: But the trial

for adults was around 40,000

people around the world

and multiple trials were done.

We’re talking about 2,200 kids.

We were talking before we came

on about MMWR, Morbidity

and Mortality Weekly Report,

that the CDC puts out–

and we’ll show it on screen–

where it talks

about hospitalizations in kids

and adolescents

throughout the pandemic.

It’s been in the news,

especially about the increase

in the number

of hospitalizations for kids

through the past couple

of months.

But the reality is, when we look

at the graph,

for 5 to 11-year-olds they’re

the group that have the lowest

hospitalization rate, including

compared to kids younger

than five.

So the assessment has been

by some people.

I want to hear your thoughts

on it that, hey, Dr. Topol, this

isn’t a true public health

emergency in where emergency use

authorization powers are

appropriate.

Sure, we don’t want kids to be

hospitalized.

We don’t want kids to die

of a disease that could be

preventable.

But are we moving too fast as we

talk about vaccination in kids?

ERIC TOPOL: Well, there’s

different ways to look at this.

To say that the reason to have

a broad vaccination program

in young kids

is to block hospitalizations is

probably not the primary motive,

but rather, to break the chain

of transmission.

So if you’re trying to break

the chain of transmission,

you want to get 85%,

90% of the population

vaccinated.

And so, kids are a part of it,

they’re a vector

in this whole process.

I mean, there’s certainly

a conduit of getting

transmission to other kids

and adults, family members,

and household contacts, et

cetera.

So this is an issue.

Now, we do know,

as you’ve seen

from the Children’s Hospitals

Association and American Academy

of Ped, we just have coming down

from the highest

children-infected

and hospitalized

in the whole pandemic because

of Delta.

And this is the problem,

we’re not talking about waning

of immunity.

We’re talking about because it

had a really hypertransmissible

variant.

Now, if, let’s say,

we get Delta contained really

well, which doesn’t look

particularly sanguine,

but let’s say it does,

in the weeks ahead.

Well then, the urgency

is different.

But if we are still looking

at 90,000 cases a day,

high children involvement,

and then all

of these hospitalizations,

did not help to break this chain

and to protect kids,

because some of them

do get hospitalized.

And you saw

the pediatric hospitals

in the Southeast, the ICUs were

full.

The worst situation we’ve had

in the entire epidemic,

and when there’s vaccinations

galore.

So my sense is that this urgency

is where we are now.

If we are able to achieve very

low levels of cases,

it’s a different story.

It’s a circulating virus,

not just in the country

but in a particular location, is

a very important determinant

of this decision.

The other thing is, if you’re

a reluctant parent,

you’re worried about side

effects, you could just wait

a few weeks to see what’s going

on out there.

We’ll know–

JOHN WHYTE: Well, everyone can’t

wait a few weeks, though.

To be fair.

If we all as parents say,

we’re going to wait a few weeks,

so–

ERIC TOPOL: There are so many

eager parents, you don’t have

to worry.

You don’t have to worry.

But actually, I think,

it’s perfectly reasonable

to go ahead.

But John, I think we could be

looking at–

this is going to be probably

late October or early November

at the best to get the go ahead.

We could be looking at a much,

hopefully, I mean,

I’m the optimist as you know,

a more favorable situation where

it’s not such an urgent issue.

JOHN WHYTE: Yeah.

Well, one metrics that makes us

a little discouraged, Dr. Topol,

is the rate of vaccinations

over the last couple of months.

We have slowed down

dramatically, and we know there

is a lot of hesitancy.

Where are we on antivirals?

Where are we on really good

treatments in the form

of a pill?

I mean, we have injections,

subcutaneous infusions, in terms

of monoclonal antibodies,

we have some benefit

of Remdesivir, but we really

don’t have a simple pill.

But there’s

some encouraging news

about that.

What’s your perspective

on the availability soon

of some type of antiviral

to treat most cases of COVID?

ERIC TOPOL: Right.

Though, this is really

important, because it goes back

to the earlier things

you were bringing up.

It’s about how are we going

to need fourth boosters,

fifth shots, and whatnot?

If we had really good antivirals

that you could have

in your medicine cabinet

or carry it around with you when

you travel,

and an exposure or at

the earliest symptoms

possible symptoms,

it was perfectly safe.

This would be all we need.

But there hasn’t been a nearly

enough emphasis on the drugs

side effects.

Now, Remdesivir is very weak,

and the studies are mixed.

But there are better

direct antivirals.

Remember Remdesivir was

a repurposed drug.

Now, there are drugs that have

very high

viral Sars-CoV-2 neutralization

that are in clinical trials.

So maybe we’ll see a pill.

But also, we have inhalation

interferon preparations that

could just take a puff of that

and that would be

at the earliest possible time.

There are going to be some more

drugs down the–

JOHN WHYTE: But when?

People want to know when.

ERIC TOPOL: Yeah.

Well, you know what?

I’ll tell you, it would happen

a lot sooner if we’d given it

as much attention.

Ultimately, it’s not going to be

just a vaccine story.

It’s going to involve

medications and rapid test,

and that’s how we’ll eventually

live with this virus

for the years to come.

And it won’t really interfere

with our lives

as it is right now.

JOHN WHYTE: As folks know,

you’ve been one of the leading

voices throughout this pandemic.

Your Twitter handle– and we’ll

show it on screen–

is a must-read for anyone that

wants to know the latest going

on on COVID.

I have no idea how you have time

to make all these graphs

and descriptions and summaries.

But I want to ask you, Dr.

Topol, since you’ve been

involved in this throughout,

what’s the one thing you might

have changed

in the communication strategy

on the rollout

of these vaccines?

ERIC TOPOL: Well, that’s

a tough one.

Thanks, John, by the way.

That’s very kind of you.

I think, there’s just so many.

It’s hard to just pick one.

But I think, the problem we had

is we didn’t take

on the anti-science vigorously

before even the vaccines started

to go out.

It is nuke it, you know?

That you’re going to hear this

or that, or this or that,

in fact, we couldn’t even

imagine what people were going

to make up.

That you’ll become infertile,

that you would be impotent–

JOHN WHYTE: Magnetized.

ERIC TOPOL: –magnetized.

Who would even dream this stuff

up?

But what I would have done

is basically prepare the public,

knowing once the vaccines,

the first trials came in 95%

efficacy, what I would have been

doing is taking on all

these entities.

This is what you’ll hear from so

and so, so and so,

and so and so, and then calling

them out.

And unfortunately, this is

the state we’re in,

because that large proportion

of the country, we’re talking

about a very substantial 30%

plus, they are basically

transfixed.

They’ve been– their minds have

been inculcated

with this complete cockamamie

stuff.

And now, how do you reverse it?

Because they’re entrenched.

So I think, that would have been

the thing that if we had done

that– and we still haven’t done

it, by the way– we still have

not called these sources out

at the highest levels.

JOHN WHYTE: And then, finally,

are we still going to be talking

about COVID in May?

I mean, we’ll still talk

but, hopefully, talk

about other things.

But are we going to be talking

about COVID in May?

ERIC TOPOL: Of 2022?

JOHN WHYTE: Hopefully, not 2023.

In 2022.

ERIC TOPOL: Yeah, no, I actually

think we won’t be talking

about it like we are now.

The only caveat would be we’ve

got to get this containment,

so we don’t get something worse

than Delta.

But if we don’t get something

worse than Delta, which is what

I’m certainly hoping for,

we will be good.

We will be good much sooner

than that.

This idea that we have to wait

till spring

to achieve containment, that’s

what I think that’s

overly pessimistic.

We can do better than that.

JOHN WHYTE: Well, Dr. Topol,

I want to thank you for taking

the time today.

Always providing your insight.

Everyone needs to check out

your Twitter feed,

and we’ll check in with you

obviously before May.

For sure.

ERIC TOPOL: I hope so.

John, it’s always a delight

to talk to you.

I guess, I should be calling you

Dr. White, since you called me

Dr. Topol.

JOHN WHYTE: No, no.

ERIC TOPOL: But, really, always

enjoy it.

Thank you.

JOHN WHYTE: Thank you.

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