FDA Advisors Vote to Recommend Moderna Boosters

By | October 15, 2021

This story has been updated.Oct. 14, 2021 — A panel of experts that advises the FDA on vaccine decisions voted unanimously Thursday to approve booster doses of Moderna’s COVID-19 vaccine.The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose — half the dose used in the primary series of shots — to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:The agency is not bound by the committee’s vote but usually follows its recommendations.Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.

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.

0Shares