FDA Advisor Dr. Offit’s Latest Findings on COVID Vaccine & Young Children

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Speaker 1: Welcome to Conversations on Healthcare. This week we welcome Dr. Paul Offit,
director of the Vaccine Education Center at Children's Hospital of Philadelphia,
and member of the FDA Advisory Panel on COVID Vaccine Strategies. Now here
are your host, Mark Masselli and Margaret Flinter.

Mark Masselli : Well first of all we want to thank you for joining us today, but the Biden
Administration plans to end the COVID public health emergency in May. Is that
the right decision, and what [00:00:30] big c hanges could be in the future for
COVID vaccines?

Dr. Paul A. Off...: Right, so well we're certainly in a different place now than we were in 2020, in
January, 2020 when this virus entered this country. At that time we didn't have
monoclonal antibodies, we didn't have vaccines, we didn't have antivirals, and
we had a blank slate in this country for people who were susceptible to the
virus, there were 0% population immunity.

Fast forward more than two years and we have monoclonals, we have vaccines,
and we have antivirals. [00:01:00] Monoclonals have sort of fallen by the
wayside, and we have population immunity that approaches 96%. We're in a
much better position than we were then. And so what now? I mean, are we
going forward? And here's the way I would pu t this together.

I think it is fair to assume this virus is going to be with us for decades, if not
longer. I mean, the two strains of human coronavirus that were first identified in
1960s, probably under the human population in the late 1700s and the lat e
1800s. Flu [00:01:30] has been with us since the mid 1300s. This virus is going to
be with us for a long time.

Secondly, there will be vulnerable populations moving forward. So we need to
identify those populations and make sure that we protect them as best as
possible. So I think it's incumbent upon the CDC to look carefully at the people
who are being hospitalized or being killed by this virus, and identify exactly who
they are. How old are they, what vaccines have they received? When was their
most re cent vaccine? Did they receive antivirals? Did they have [00:02:00]
comorbidities? If so which, so that we can really target our booster dosing
strategy to those groups.

Mark Masselli : To the CDC, is it a little late to be giving them instructions like th is? Is this
something they should have been doing? Have they been keeping the right
information? They've taken a lot of heat over this entire period. There's been a
loss of trust in the public health system, and I think the CDC is at the lead of this,
but is this a new formula for them or [00:02:30] are they already undertaking
some of these?

Dr. Paul A. Off...: I think the hardest thing has been separating those who are admitted with
COVID versus for COVID. I mean for example, at our hospital any child who
comes into the emergency department that is then admitted to the hospital for

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whatever reason will be tested to see whether or not they have COVID. If they
have COVID, and even if they're admitted for something else, they're often
counted as a COVID admis sion, and that's not helpful.

Recently a prominent epidemiology association [00:03:00] said don't test
asymptomatic people who come into the hospital to see whether they had
COVID, because those are often getting counted as admissions. So I think that's
b een the hardest thing, and I think we suffer from not having a national health
system. That's why we often look to places like Israel or Canada which do have
national health systems to kind of try and answer those questions, and that's
not the way it shoul d work because those countries aren't the same as ours in
terms of ethnic population, age, et cetera. So we can do a better job. I think we
should continue to hold the CDCs feet to the [00:03:30] fire to provide that
information.

Margaret Flinte...: Well D r. Offit, the advisory committee that you serve on supports a COVID
vaccine consisting of a single composition for everyone, whether they're
currently vaccinated or not. And as you know many of our audience know the
current approach involves getting two sh ots of the original vaccine spread out
weeks apart, and then one of the new bivalent omicron boosters at least two
months later. Take us through the thinking on why the vote in favor [00:04:00]
of the change.

Dr. Paul A. Off...: I think mostly for simplici ty. So now you basically have the same vaccines that
are given both as a primary series and a booster dose. I don't think there's any
evidence that this bivalent vaccine is going to be dramatically better clinically
than what we already had. And the reason for that is that we have to define
what we want from these vaccines. The only reasonable, the only attainable
goal for this vaccine , is prevention of severe illness. Keep people out of the
hospital, keep them out of the intensive care unit, keep them [00 :04:30] from
dying.

The principle immunological component associated with protection against
severe disease is really T - cells, T helper cells, and especially cytotoxic T - cells. The
good news about this virus, if there's any good news that can come of a
pa ndemic virus, is if you look at the original strain, the SARS - CoV - 2 strain that
first came into this country, the Wuhan - 1 strain and that original variant,
D614G, if you look at that original strain, Wuhan - 1, and compared to the current
strains like XBBB15 , there's still 80 to 85% [00:05:00] conservation between
those two strains in terms of T - cell recognition, that's why you're still protected
against severe disease. I mean, when Omicron for example first raised its head
in southern Africa it clearly swept across that region and caused a lot of illness,
but there was a disproportion rise in hospitalizations, which you didn't see, or
deaths, because people were still largely protected against severe disease.

Mark Masselli : One troubling figure in all of thi s is only 15% [00:05:30] of people eligible for the
COVID booster shot that targets the Omicron variant that you described have

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gotten it. I really wonder if this is an indictment on the public health community.
Where have we gone wrong in our message, and how much of an increase in
Americans receiving the COVID vaccine can we expect with the new single shot
makeup?

Dr. Paul A. Off...: Not much more would be my prediction. See, I just think that the... I'm not sure
this is a failure of public [00:06:00] hea lth messaging as much as it's a
perception by the public that this pandemic is largely over. I mean I rode the
subway yesterday to see the Eagles 49ers game and that subway was packed,
and no one was wearing a mask. Think about where we were two years ago, no
one would have done that. We were scared to death of human contact. That's
not true anymore.

So I think the reason that you're not seeing an uptake in booster dosing, I think
is because there's booster fatigue at this point, or vaccine fatigue, and I just
don't think people [00:06:30] perceive this as a risk. Or at least I'd like to think
that those who perceive it as a risk or those who are most likely at risk, which
are those high risk populations, people over 75, people who have multiple
comorbiditi es, and people who are immune compromised, those are the risk
groups moving forward.

Margaret Flinte...: It's interesting, maybe those folks are sitting out the Eagles game and watching
it from home and saying yep, nobody else is going to be wearing a mask on that
subway so I'll sit it out too.

But in all seriousness Dr. Offit, as we talk with you [00:07:00] the Committee
recommendations still needs CDC approval for the single composition of the
vaccine, and that single shot will be the updated bivalent ve rsion. Over these
last couple of years we've certainly often seen there can be disagreements
between different of the body's charged with making these decisions. Is there
any reason to think that the CDC will not see things as you do?

Dr. Paul A. Off...: N o, no. I think the CDC will approve this vaccine [00:07:30] as both the priming
series to go along with, to harmonize it with the booster dosing. I think that that
will happen.

I'm optimistic about where we are actually, I think we're in a much better pla ce
than where we were before. And I'm telling you if I rode the subway yesterday
and didn't get COVID then I think we're pretty good because I don't know if
you've ever been on subways in Japan where they kind of push people in to
pack them in so that ever ybody can fit, it was like that yesterday on the subway,
or Sunday.

Mark Masselli : Yeah. Speaking of Japan, [00:08:00] pandemic's global, what are you hearing
from your colleagues around the globe in terms of their efforts? Are we seeing
anything that mig ht be considered a best practice and how countries are
handling it? What do you hear? What do you see?

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Dr. Paul A. Off...: Right now I think if there's a failure, I think it's the failure to really make sure
that a hundred percent of people on this globe h ave gotten vaccinated. I mean,
because that will definitely lessen the risk of severe disease.

This is a short incubation period of mucosal [00:08:30] infection. Even if 100% of
the world were vaccinated, and even if this virus never created variants, it
would still circulate. It would still cause asymptomatic infection. It would still
cause mild disease. But such as the nature of a short incubation period virus.

I mean, look at rotavirus. Rotavirus is an intestinal pathogen, but it like SARS -
CoV - 2 is a m ucosal infection that has a short incubation period. We instituted a
vaccine in this country in 200, in babies the uptake is probably 90 to 95%, and
we've virtually eliminated [00:09:00] hospitalizations from that virus, and that's
a virus that is stable, that doesn't create variants.

Nonetheless, the virus still circulates in the community, still causes mild disease
in the community. So I think we have to have a reasonable expectation for this
vaccine in terms of what it can and can't do. But globally, I do think we have
maybe 70% of people in this world who've been vaccinated, but 30% haven't,
and we need to make sure they're vaccinated. And I think every year three and a
half to 4 million children are born in this country who are going to be
susceptible to this virus, and we need [00:09:30] to make sure I think they get
vaccinated.

Mark Masselli : Yeah.

Margaret Flinte...: Well Dr. Offit, here we are in January, we're still in flu season, but it began
months ago I guess in terms of people getting their va ccines. What do you think
about the advice for Americans to get the flu shot and the COVID vaccine at the
same time? I'm sure quite a bit happened this past fall, but we know the FDA is
starting a study to look at potential safety concerns that could resul t from giving
the COVID, Omicron shots at the same time as the flu shots. [00:10:00] What
are your thoughts on that?

Dr. Paul A. Off...: Well, we certainly need to have this studied thoroughly before we recommend
it to be given at the same time. I think ma ny people are giving it at the same
time. What worries me about then, this isn't exactly your question, but the flu
analogy has been sort of made with this vaccine, meaning that every year now
we, the FDA Vaccine Advisory Committee, like we do in March to pick flu strains
for a September rollout, will be meeting in June to pick strains for a September
rollout for [00:10:30] SARS - CoV - 2 virus vaccines.

I mean, these two viruses are very different. I mean when we pick flu strains we
look at countries that hav e winters that precede ours, Australia, South America,
to predict what strains come into this country, and we better be right. Because
if we miss, if we're wrong on picking the strain, a miss is a mile, and that's
happened. If you look in the last 10 years for example, if you pick the wrong

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H3N2 strain, which we've done, and you get a vaccine that does not match the
circulating strain, you have [00:11:00] pretty much 0% protection, including
against severe disease. That's not this virus. I mean this virus, you are still largely
protected against severe disease if you've been naturally infected or vaccinated
or both, because of the conservation of those T - cell regions. So this isn't flu. Flu
is a strange specific phenomenon, that doesn't seem to be true here. So I think I
don't see the flu analogy for this virus.

Margaret Flinte...: I think that's a very important point for people to hear, haven't heard it stated
so clearly, so thank you, Dr. Offit.

Mark Masselli : But I do [00:11:30] want to challenge it a little because I thought the mRNA
vaccination process really allowed us much shorter time. That in fact the old
model would have been if we missed it by a mile we were in big trouble, but
isn't the development of the mRNA an opportunity to have a second ch ance
here, or is it still so clunky and cumbersome that we can't make mid - course
correction? I thought this was one of the advantages of [00:12:00] seeing the
new process that got developed?

Dr. Paul A. Off...: You're right. I mean, the mRNA process is qui cker I think than say the flu vaccine
process, and the flu vaccine remember, there's a variety of different flu
vaccines. There's this sort of inactivated vaccine, which is enhanced for
hemagglutinate. There's flu block, there's high dose vaccines, there's squalene
adjuvanted vaccines. There's a variety of different flu vaccines.

But look how hard it is to pick strains. I mean so for example, in January,
[00:12:30] February when Omicron BA.1 rolled into the United States both
companies, Moderna and Pfizer, made a BA.1 bivalent vaccine. We, the FDA
Vaccine Advisor Committee, sat down in June '20 to consider the data from that
bivalent BA.1 containing vaccine, which and the other part of that was the
Wuhan - 1 strain. Well by the time we sat down BA.1 was gone. So the thing was
okay, well let's make a BA.4, BA.5 containing vaccine and move forward with
that. Well now here we are starting in November, December, BA. [00:13:00] 4
was gone, BA.5 is virtually gone. So this isn't flu. And I think that oh, do we really
want to try and chase these variants given that you still are largely protected
against severe disease no matter what you got really.

Margaret Flinte...: Well Dr. Offit pivoting just a little bit, you're an author of a new research article
in JAMA Pediatr ics with a headline COVID - 19 Vaccines and Young Children,
Reassuring Evidence for Parents, which I think will be reassuring just that you
have that headline. [00:13:30] But tell us what was the basis for your being able
to offer reassuring evidence, and ma ybe specifically since parents heard so
much about myocarditis as a possible complication of the vaccine, what did you
find?

Dr. Paul A. Off...: Right. So when we sit down to make decisions at the FDA Vaccine Advisory
Committee, we always base it on only t he data that we have. And for the five to

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11 year old, you had studies of a few thousand children, but then you've made a
recommendation for millions and millions of children. So you don't [00:14:00]
know whether or not that few thousand children ends up b eing predictive of
what happens in a larger group.

With this Watanabe Study done that was published in JAMA Pediatrics is it
looked at millions of children who've received this vaccine. And so there were
two things that were reassuring there. One is we di dn't know whether this
vaccine would prevent this multi - system inflammatory disease of children, this
post - infectious inflammatory disease, but it appears to according to these data.
And also you didn't really know the instance of myocarditis, you knew tha t it
was highest in that 16 to 17 year old [00:14:30] male, primarily within a few
days of that second dose, as high as one in 6,600. But you didn't know for the
five to 11 year old, and you were worried because you knew that for that
younger male it was h igher than it was say for an older male. So what happens
when you get younger and younger? Well the answer here was the incidence
was one per 500,000, which is extraordinarily rare, and roughly in the same
category for your chance of being struck by lightn ing every year in the United
States.

Mark Masselli : I want to [00:15:00] ask about President Biden and his declaration, or at least
the administration has let the public know that they plan to end the public
health emergency hopefully in May, though there 's some battling going on for
extending that. But what are your thought? Are we past this point now where
we can move on from the public health emergency, and what do you worry
about if the May date [00:15:30] holds?

Dr. Paul A. Off...: Right. We should pr obably never make predictions about this virus because
you're always wrong, but I'll try anyway.

Mark Masselli : Go ahead.

Dr. Paul A. Off...: I think my prediction is that this virus is going to enter the pantheon of winter
respiratory viruses, which also caused severe suffering and hospitalizations and
death. I mean, two years before SARS - CoV - 2 entered this country, which was in
January, 2020, influenza caused 800,000 hospitalizations and 60,000 deaths. I
mean, RSV [00:16:00] typically kills between 6,000 to 10,000 elderly Americans
every year. Parainfluenza causes tens of thousands of hospitalizations and
thousands of deaths. So they're all killers, they're all bad.

And what I see is I see sort of SARS - CoV - 2 sort of entering that route, which is
interest ing in terms of how we move forward because you could argue... I have
friends for example, who have children and they're trying to decide whether to
send them to school. So if they have upper respiratory tract symptoms and they
test to see whether they hav e COVID, and if they don't they go [00:16:30] great,
I can send them to school. But there are other viruses out there like RSV, flu and
para flu, that also are a problem.

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And so I think maybe moving forward the smartest thing to do is for people who
are a t risk, who clearly would benefit from an antiviral, they should test. And if
they're positive treat with an antiviral. But for everybody else assume you have
a virus which can be severe for other people and stay home if you can. And if
you can't stay home then wear a mask when you go into work. Which is it's sort
of done in many countries, say in Southeast Asia, [00:17:00] it's just not our
culture.

Mark Masselli : So good to go with the public health emergency just with some more detailed
instructions for people?

Dr. Paul A. Off...: I think that's right. I mean, you could argue every year flu is a public health
emergency. We don't treat it that way, but it certainly kills tens of thousands of
people every year.

Margaret Flinte...: Well Dr. Offit, I wonder if you could take us inside your practice and that of your
colleagues at Children's Hospital of Philadelphia. You're seeing parents, you
have the recommendation for vaccine against [00:17:30] COVID for children's six
months and older, and those five and ol der to get the boosters. What happens
when a parent says no maybe today, take us inside those conversations. Do you
have a strategy to encourage people, motivational interviewing, just more
information, what happens when you get the no?

Dr. Paul A. Off...: Well you can sort of understand at some level. I mean, we're talking about
COVID. If you look at who dies from COVID, [00:18:00] it's primarily the over 75
year old nursing home resident. I think 93% of all deaths are in people over 55.
But you can die as a child. I mean, if you're less than 18, the number of deaths is
in sort of 1,500 range, so it's about a thousand. You're a thousandth fold less
likely to die as a child than an older adult, but that doesn't mean that it can't
happen. And so that's what w e try and talk about is that a choice not to get a
vaccine, it's not a riskier choice, it's just a choice to take a different risk, and this
is what that risk looks like.

I mean, [00:18:30] our hospital now has about 10 children in the hospital with
suffe ring from COVID, and it's hard to watch, especially when they've made the
choice not to get the vaccine, or the family has also made the choice not to get
the vaccine for parents and siblings because this is preventable. And it's hard to
watch a child come in, struggle for breath, being put on face mask oxygen, and
then having to be sedated, brought up to the intensive care unit, intubated
because of pneumonia, when it's a preventable disease. So you try and make
that case [00:19:00] of what it looks like t o take this different risk, and without
being too heavy handed.

The most dramatic thing to me in 2020 when we didn't have anything to
specifically prevent this virus infection was missing. I'd never seen anything like
that before. I mean, here were childr en who usually had either an asymptomatic
infection or a mild infection that was only picked up because they'd had a friend

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or family member who had contracted COVID, and then they're fine, the
symptoms go away, they're running and playing, and one month l ater [00:19:30]
they come back to the hospital with high fever, pneumonia, liver involvement,
kidney involvement, heart involvement, occasionally going to the intensive care
unit with severe myocarditis. I've never seen something that dramatic before,
and it was primarily the five to 13 year old sort of peeking at the nine year old.
And so prevent it, if you can prevent it, safely prevent it.

Mark Masselli : I was thinking about back in 2020 when we didn't have a vaccine and then we
thought maybe it was the traditional development. We all learned about
[00:20:00] something called the mRNA vaccine, which was 20 years old but
nonetheless it reemerged. And tell me past COVID what benefits are we seeing
from technology coming up? What's out there that you're exc ited about in the
research that's going on?

Dr. Paul A. Off...: Right. Certainly the mRNA vaccines for SARS - CoV - 2 was a perfect fit. I mean, I
can tell you this to [00:20:30] me is the greatest single medical advance in my
lifetime. And as you can tell sin ce you see me on the screen I'm old, so my
lifetime includes the development of the polio vaccine.

It's remarkable, and it's held up. I mean now two plus years into this mRNA
technology you still have excellent protection against severe disease assuming
y ou're not in a high risk group. So that's amazing.

Will it be as applicable to in other infections? So actually when people are
worried about the [00:21:00] mRNA technology because they think it's new, it's
not as you know, it's not new. I mean starting i n 2005 researchers working on
mRNA vaccines for example, to try and prevent a human immunodeficiency
virus. Now people are looking at it as a universal flu vaccine, as a better malaria
vaccine, so we'll see.

I mean, I trained in an influenza lab many deca des ago, and the guy who was the
head of the lab, Walter Gerhardt, said to me something I'll never forget, which is
if you want a research career that lasts for the rest of your life study influenza.
So [00:21:30] although we talk about trying to make univ ersal influenza vaccines
or an HIV vaccine that works, those two viruses have really been resistant to
that. And I don't think this is going to be the magical answer, but it would be
great if it was. So we'll see. I mean, certainly we'll see how it goes mo ving
forward.

Margaret Flinte...: Absolutely. Well Dr. Offit, we were looking back to when you joined us in 2021,
and you called yourself at the time a vaccine skeptic and said it's fine to be
skeptical of anything that [00:22:00] you put in your body, but skepticism can go
overboard. And we note that you also made the contribution through your book
over a decade ago called Deadly Choices, How The Anti - Vaccine Movement
Threatens Us All. What's your take on where we are with that movement at this
point. That preceded COVID for sure, certainly mandatory vaccines and

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immunizations have brought out a lot from that community, but what's your
status of what the public health community has done [00:22:30] and can do
about the anti - VAX movement in terms of trying to really protect the public's
health going forward, not just from COVID, but from all the things that we have
vaccines against?

Dr. Paul A. Off...: Yeah. I can safely say I was dead wrong in predicting what would happen with
the anti - vaccine movement as thi s virus entered the country. Because really the
anti - vaccine movement, to some extent on its heels. I mean, it sort of thrived in
the early 1980s with the airing of a show called DPT Vaccine Roulette claiming
that [00:23:00] the pertussis vaccine caused pe rmanent harm, and it really took
off then. And then it went further with the notion that MMR vaccine, the
measles, mumps, rubella vaccine caused autism. Also untrue. And then it really
started to take its hits.

As data sort of generated showing that these fears about vaccines weren't true,
the anti - vaccine people were more and more marginalized, but they had been
included on committees like the Advisory Committee For Immunization Practice,
or the FDA Vaccine Advisory Committee. They had moved into [00:23:3 0] the
mainstream and then they were pushed farther and farther away.

To me, I thought the death knell was the elimination of a philosophical
exemption against vaccines to allow for a vaccine opt - out in California. I thought
that really marked the end. Bu t then what happened was, and it was never a
politics to this, on the left it was kind of all things natural, don't put anything
into my body that's unnatural, the sort of gluten free, casing free, vistenale free,
dolphin free crowd. [00:24:00] And you saw that with the sort of measles
outbreak in Southern California in 2010, that was a liberal community in the
Disneyland area that allowed for that. And on the right, it was always libertarian
government off my back, don't tell me what to do thing. It's beco me solely that.
I think the anti - vaccine movement hooked in to the Republican right really on
this, with this don't tell me what to do, don't mandate anything, and a lot of the
support came from that.

And this is the first infectious disease [00:24:30] in human history where your
political affiliation determines whether to some extent you're going to live or
die. I mean, hence the name Red COVID. I've never seen anything like that. They
really hooked into that. And during the insurrection in January 6th, t here were
the anti - vaccine activists a couple blocks down the road with their platform and
their folks, and so that's what surprised me. That it's really hooked in to that
government off my back notion that is prevalent at least among some in this
country.

Mark Masselli : [00:25:00] Yeah, though most of those leaders in the House and the Senate who
might espouse that, as soon as they're sick they're off to their Reed Medical
Center getting great care and listening to the providers who they would listen to
o n this issue. But that's another matter.

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I want to... One final question, Dr. Lena Wen stated in the Washington Post that
the medical community is "over counting the amount of COVID deaths and
hospitalizations," and she cited sources claiming that most pa tients diagnosed
with COVID are actually in the hospital for [00:25:30] some other illness,
obviously set off a firestorm. What do you think of her point of view?

Dr. Paul A. Off...: Yeah, so the only data I've really seen on this, at least in published fo rm, was a
study by Klann Kale, ANN, out of Massachusetts General Hospital. Well what
that group did was they evaluated medical records, they went through medical
records one by one to try and answer the question if they were diagnosed with
COVID were they receiving steroids like dexamethasone? Were they receiving
supplemental oxygen for their pneumonia? And [00:26:00] they found that
roughly 26% of those case reports, and they were looking at in Massachusetts,
Pennsylvania, and Illinois, that there were mis classified as being admitted for
COVID, and it could vary anywhere from 0% to 75%. So I think there is some
element of that. It's unclear to me how common that is. I mean, now you've had
sort of pushback on the other side saying if anything, COVID hospital izations and
deaths are underrated.

But it's really hard to evaluate in some ways because let's suppose you have a
severe heart disease or [00:26:30] a lung disease, and then COVID sort of puts
you over the top, is that a COVID death? I mean much in the s ame way that flu
did that, or RSV did that, and so it's defining that has been difficult. But I guess
just looking at what goes on in our hospital I can tell you things are a lot better
from where they were.

Margaret Flinte...: And that's the good news. Dr . Offit, we know you and the Committee will meet
again in a few months to select a strain for the vaccines that will be rolled out
this fall, and we hope that you'll join us again once that decision [00:27:00] is
made. Thank you for being with us today. An d to our audience you can learn
more about conversations on healthcare and can sign up for our updates at
chcradio.com. Dr. Offit, thank you so much again.

Dr. Paul A. Off...: My pleasure.

Mark Masselli : All righty. Are you going to go out to the Super Bo wl or what?

Dr. Paul A. Off...: I don't think so.

Mark Masselli : Oh come on.

Dr. Paul A. Off...: It's a tough one. I'm a season ticket holder, so when you're a season ticket
holder you get into this lottery automatically to see whether you happen to win
a Super Bowl ticket, but I didn't win, so [00:27:30] I don't know. I think probably
not. Maybe the owner will invite me.

Mark Masselli : Good, thank you for taking this time, really appreciate it.

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Margaret Flinte...: Thanks for all your wonderful work, appr eciate it.
Dr. Paul A. Off...: Thank you. Thanks for saying that. Take care.

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