Pediatrician Dr. Peter Hotez Creates New Vaccine: Gives Advice for Families With Young Children Staying Safe During Surge

Dr. Peter Hotez

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Marianne O’Hare: Welcome to Conversations on Health Care with Mark Masselli and
Margaret Flinter a show where we speak to the top thought leaders in
health innovation , health policy , care delivery and the great minds
who are shaping the health care of the future. This week Mark and
Margaret speak with Dr. Peter Hotez , Dean of the National School of
Tropical Medicine at the Baylor College of Medicine, Dr. Hotez ’s team
has developed a low cost vaccine, partnering with India and other
international ent ities to allow poor and developing countries to
produce their own vaccines to address the lack of global vaccine
access. Also a pediatrician , he's concerned about the low vaccination
rate in the U.S. let around the world, allowing for the spread of more
va riants.

Lori Robertson also checks in , the Managing Editor of FactCheck.org .
Look s at misstatements spoken about health policy in the public
domain , separating the fake from the facts, and we end with a bright
idea that’s improving health and well - being in everyday lives. If you
have comments please e - mail us at [email protected] or find us
on Facebook , Twitter , or wherever you listen to Podcast . Now stay
tuned for our interview with Dr. Peter Hotez here on Conv ersations on
Health Care .

Mark Masselli: We begin 2022 with a grim statistic, the seven day average for new
COVID cases in the United States has increased 82% compared with
the previous seven days. The dominant variant is Omicron . We're told
more variants will be on the way until the world can deploy additional
vaccines. Our guest has an intriguing approach that promises hope.

Margaret Flinter: Dr. Peter Hotez of the Texas Children's Hospital Center for vaccine
development has been called a global health wa rrior, the center is in
its third decade as one of the leading vaccine development centers in
the world. And now Dr. Hotez and his colleague have developed
Cor b e vax . It's a low cost open source alternative to the mRNA
vaccines, which we're using here in th e United States, but which have
been slow to roll out in developing and under vaccinated countries
around the globe. But the Indian government has granted emergency
approval for its use .

Mark Masselli: Dr. Hotez, we appreciate you joining us again on Conve rsations o n
Health Care , especially at this critical time and so many questions to
ask about the new vaccine. W h ere the trials were done? What age
range does it cover? How does it work compared to the mRNA
vaccines that we are so familiar with in terms of the Moderna and
Pfizer and tell us about its efficacy?

Dr. Peter Hotez: Well, this is a recombinant protein vaccine that's similar to the
Hepatitis B vaccine that's been in use for 40 years. It's made through

Dr. Peter Hotez

microbial fermentation in yeast, and most paren ts in the U.S. have
given it to their kids or the parents have gotten it for themselves
when they were kids.

So it's got a great safety track record. And the level of neutralizing the
antibody looks pretty exciting in terms of and comparable to the
mRNA or adenovirus vectored vaccines, but at a fraction of the cost
and ability to scale it up. And because this technology is already in
place, in places like in terms of the Recombinant Hepatitis B vaccine,
technology is in place already in Indonesia, Banglades h, Vietnam,
Brazil, and India of course . And so they can easily adopt our approach.

So what we do is we develop the prototype vaccine because we
develop ed the vaccines for neglected diseases of poverty, we have
been doing that for 20 years, and then trans fer the technology with
no patents, no strings attached. Now to India, Indonesia, Bangladesh
and Botswana. India's the furthest along, they have 150 million doses
already ready to go with plans to scale it to a billion doses this year.
And w e have just got released for emergency use authorization. So
everything is really moving pretty well. We could have gone faster had
we some support from the G7 countries. But that's life. But in the
meantime, we're hoping to make up for some l o st time.

Margaret Flinter: Well, Dr. Hotez thinking back to our last conversation with you. I
imagine this has been a n incredibly intense year. Not a lot of sleep, a
lot of work pushing this forward. We want to thank you, as always, for
your work, but tell us more. This is major new s, obviously. And for
India, and the other countries that you've described to have access to
a new vaccine supply, obviously, a huge step forward. But I remember
reading back early in the epidemic responses to vaccines around the
world and India had some o f the same issues , the United States did
around vaccine hesitancy, resistance to vaccines. What are your
people on the ground in India telling you about the willingness of
people now using India as the country where you're launching this
takes up the vacci ne and really moving forward to get people
vaccinated now that they might ha ve a reliable supply of vaccine?

Dr. Peter Hotez: Well , we're hoping hesitancy will be lower than some of the other
technologies. Because, you know, people of India have already be en
getting a vaccine of this technology for four decades. So they're
familiar with it, they know it s excellent safety profile. So hopefully,
that will mitigate it against that somewhat. The other issue is making
certain that India will donate doses to the COVAX sharing facility,
that's going to be also important.

So it's going to be a mixture of vaccines used within India, but also
exported to the world, and India has that track record as well. And as I
say, w here India's the first out of the starting gate, we're hoping to
make similar progress with Indonesia, Bangladesh and in southern

Dr. Peter Hotez

Africa. And if we can get additional support from the U.S. government
or others, we can make this arrangement with still other countries as
well. And the advantage of the tec hnology we're not constr ained like
we are with mRNA and/ or adenovirus, where there's limits on the
amount s you can make , the sky is the limit for this technology.

Mark Masselli: You know, we recently had Dr. H a seltine and Dr. Topol on who were
complaining about the lack of sort of global leadership, that ’s sort of
fallen apart, you just mentioned the G7 countries were sort of an
obstacle, talk to us a little more about the difficulty that you
encounter or the what needs to be -- what road needs to be cleare d.
So that we can start disseminating what sounds like a very easy to
produce vaccine. And again, we're, I know, it hasn't had a peer review
article been published on it yet, but talk a little bit about the global
partnerships or lack of?

Dr. Peter Hotez: Well , actually, by the way, we've had about seven publications on our
vaccine. So all of , we’ve put everything in the public domain. So every
aspect of its production, its features, its characteristics is out there,
and you can just go to the PubMed index and put my name in and
you'll see a fair amount of details about the vaccine .

The clinical data has not been published yet. And that's because we,
we provide the vaccine with no strings attached. So it's owned by the
company, Biological E in India, just li ke it's owned by Biof arma in
Indonesia, and Incepta in Bangladesh. And they work out the
publication plan with the Indian regulators. And they say it should be
forthcoming very soon. And actually probably will happen faster than
the pharma companies did af ter their vaccines were released for
emergenc y use .

So their vaccines had a three to seven teen week lag before the
publication came out after emergency use , I think it'll actually happen
faster. So that's moving forward. But and I think that's an important
point that we don't, there's this concept in global health that we
practice everyone talks about, called decolonization, and that we're
not trying to own the technology. We're trying to give it to the
countries to empower the country so they can, they can be out in the
lead. So it's looking really exciting. And all that information itself
what's coming.

Margaret Flinter: Dr. Hotez, I think that, you know, for those of us just kind of on the
frontlines trying to respond to all of our communities and our
pat ients. It's a little bit of whiplash this year with COVID. We think
we're doing better we think we're doing worse. Delta arrives. Omicron
comes in, I will tell you just on the front lines, we're seeing just such
dramatic increases in infection. I know that just mirrors the national
data. But maybe you could just tell our listeners is the vaccine that
you've developed another tool in the toolbox of vaccines, but one

Dr. Peter Hotez

that we believe can be more readily available and distributed because
of how you've approache d this in terms of the ownership at the
country level? Or is there? Is there anything fundamentally different
in terms of effectiveness or effectiveness based on the number of
doses? Or is it one more good tool or something fundamentally
different? Just he lp our readers get a handle on that, if you would?

Dr. Peter Hotez: Well, the differences is it’s produced locally, and meant to empower
the low and middle income countries to produce their own vaccine.
And it can be scaled locally and can be distributed l ocally. So and if
you , and in terms of the nature of the technology, since there's
already widespread experience locally to manufacture it. We think
this is one that could be made in the billions of doses very quickly.
And so if you're talking about vaccin ating the southern hemisphere ,
the Global South, we think this , this could move quite quickly. I mean,
that the truth is had we a fraction of the funding that Moderna ha d or
Pfizer had from public sources, who knows the country , the world
might have been v accinated by now. And we would never have heard
of something called Omicron . And so that's where the lack of
leadership comes is the G7 countries and the U.S. government have
not had that commitment to vaccinating the global south. And as a
result, Delta a rose out of an unvaccinated population in India earlier
this year, and last year, and now Omicron out of Southern Africa. And
we're going to have other variants of concern arise until we make that
commitment to vaccinate the world. And this will be an impo rtant
first step.

Margaret Flinter: Got it. Oh, that's a pretty important addition to the tool box. Thank
you for clarifying that.

Mark Masselli: President Biden just spoke to the American people about the surging
Omicron variant and the need to beef up ou r supplies of therapeutics.
He announced that the government was buying 10 million more doses
of the Pfizer, anti viral . I'm wondering if you could tell us why this
therapeutic is so necessary in our toolkit to contain the severe disease
into lower hospita lizations from COVID.

Dr. Peter Hotez: Well, you know, two of our three monoclonal antibodies appear not
to work against Omicron , the one from Regeneron, and the one from
Lilly . So that's a problem. And all we have in terms of effective
therapeutics right now is the monoclonal antibody from
GlaxoSmithKline /Vir . And that's only available in limited quantities in
hospital formularies. And the Remdesivir , which has to be given
parenterally . So having Paxlovid , the Pfizer medication will help a lot.
And if we c ould get that sooner rather than later, that can also make a
big difference. And so that is also a priority. But a reason why this
Omicron epidemic is so dangerous, we have knocked out some tools
that we have in our toolbox for treating it. A lot of health care

Dr. Peter Hotez

providers are getting sick and can’t attend to the patients that are
going into hospitals and the hospitalizations are rising. So even
though on average, Omicron , may not be as severe as some of the
previous lineages that aggregate effect of knocking healthcare
providers out of the workforce of not having adequate treatment
tools creates a very dangerous situation for the country.

Margaret Flinter: Yeah, we're certainly seeing that on the frontlines here in the United
States every day. But I wonder if I can ask you the strategy of how this
really becomes available throughout the world . Are you working with
the World Health Organization , is that part of your strategy, as you
think about how this vaccine could really get to all corners of the
globe and t ry and bring this pandemic to an end?

Dr. Peter Hotez: It is and also the developing country vaccine manufacturers. In fact,
they call themselves the developing country vaccine manufacturers
network are now working with the World Health Organization for
em ergency use listing globally. So while we have started those
discussions with the WHO were also in on some of those discussions.
Because to get this pre qualified by the World Health Organization
makes it much easier to for Biological E to export the vacci ne to other
countries. And so we're moving forward on that as quick as possible.

Mark Masselli: You know, we're entering 2022, Happy New Year, but it's the th ird
year of the pandemic. We have had a million cases, positive cases the
other day, I wonder if y ou can give our listeners a sense of, of the arc
of this COVID virus , pandemic that's going on? What's your sense of
what to be hopeful about ? And what keeps you up at night?

Dr. Peter Hotez: Well, I do think this will subside and, and based on the kinetic s of the,
or the, the curve of this Omicron wave in the UK, in South Africa,
hopefully it starts to go down as quickly as it's gone up. And whether
or not it plateaus for a while remains to be seen. But eventually, this
will pass and then we've got to deci de what the world looks like post
O micron we know, the all likely Omicron is probably not going to
produce much in the way of durable protection, people will still need
to get vaccinated. So that's got to be a priority. It means defeat ing this
very aggress ive anti vaccine activities that are causing people to
needlessly lose their lives by being defiant of vaccines. 200,000
Americans since June 1, who refused vaccines lost their lives. So anti
vaccine , anti science activities are a top killer in the United States. So
we 've got to figure out how to conquer that. And lastly, we've got to
vaccinate the world to prevent the new variants from emerging. If we
can do those things we can get out of it, but it's still a pretty high bar.

Margaret Flinter: Dr. Hotez , I think as the world knows you are a pediatrician, you a r e a
professor in the department of pediatrics in molecular virology and
microbiology at Baylor College of Medicine. And I would imagine that
at least once or twice a day, people are asking you what's going to

Dr. Peter Hotez

happen with schools? We're post the New Year's holiday , certainly
see ing huge spikes, there's discussions about whether school s should
close , stay open. Certainly seeing increases in numbers of
hospitalizations of kids, although probably associate d with just the
dramatic increase. What are you saying to school superintendents and
people there on the ground in Texas who want to know whether we
need to close schools again, and take the kind of draconian measures
that we did earl ier in the pandemic th at really thought we had moved
away from?

Dr. Peter Hotez: Well, and in fact I was just asked about the mayor of New York's
decision to keep schools open and I said, look, it's a choice between a
bad decision and a bad decision. There's no good decision he re. If you
go back to virtual learning, we know about the harmful effects over
the last two years on kids , on the mental health of kids and the
Surgeon General came up with his report at the end of the year . On
the other hand, trying to do this at the peak of a variant which is so
highly transmissible almost to the level of measles, it's, that's going to
be really, really tough to manage.

So is there a benefit to delaying the opening of schools another
couple of weeks and tacking it on in the summer treatin g almost like
two weeks of snow days. And as I say, I have a tremendous empathy
and sympathy for administrators making those tough decisions. And I
could argue it either way. And I think a lot of it has to do with the
wishes of the community and the school boards, and but either way,
it's going to be a very tough decision to make.

Mark Masselli: And another tough decision certainly for parents of young children,
right, still no vaccine on the horizon, or maybe there is one of the zero
to five birth to five years old. And this is particularly troublesome for
young people, the Omicron variant , maybe walk through some advice
for parents, what should they be watching out for, in terms of dealing
with a variant . I don't simply know what parents can do with childr en
in terms of who have no vaccine. But what's your best advice now for
parents?

Dr. Peter Hotez: But, you know, I think the key first of all is kids, five and up are eligible
to get vaccinated. And nationally, we're not doing very well,
vaccinating the 5 to 11 year olds, only about 15 to 20% of kids are
eligible are getting vaccinated. So I think there's room there, even
among the teenagers, we're not seeing good vaccination rates in the
northeast, a little better about 75%, but only about half that in the
south.

So I think maximizing out the use of vaccines for five and up is going
to be of paramount importance. And then for the little kids trying to
keep them safe and you know, under five years of age, I don't think
we'll have vaccines in the U.S. availab le anytime in the immediate

Dr. Peter Hotez

future. We're trying to do that now from India and globally with our
vaccine. So this is the reason for being conservative and, and trying to
make sure your kids wear masks in school so they're not bringing the
virus home to the family.

Margaret Flinter: Dr. Hotez , congratulations on the development of this new vaccine.
We'll be following its path from your lab to India and beyond. You can
follow Dr. Hotez ’s work by going to
bcm.edu/ NationalSchoolofTropicalMedicine or follow him on Twitter
at @PeterHotez . That's H - O - T - E - Z. Dr. Hotez. Thank you so much for
joining us once again on Conversations on Health Care . Good luck.

Dr. Peter Hotez: Thanks so much. And thanks for all your great work and all the best to
you .

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Mark Massel li: At Conversations on Health Care, we want our audience to be truly in
the know when it comes to the facts about health care reform and
policy. Lori Robertson is an award winning journalist and Managing
Editor of FactCheck.org, a nonpartisan, nonprofit c onsumer advocate
for voters that aim to reduce the level of deception in U.S. politics.
Lori, what have you got for us this week?

Lori Robertson : With the release of its pediatric COVID - 19 vaccine, Pfizer switched the
buffer used in its formulation to incr ease the stability of the product.
This allowed the vaccine to remain at refrigerator temperatures for
longer. The Food and Drug Administration okayed the change and the
change is also being made to some doses for teens and adults. Social
media posts howev er, have misleadingly suggested that the
ingredient swap is dangerous or was added to prevent heart attacks in
children. There 's no evidence to support that.

The ingredient in question is Tris or Trimethylamine , which is used as
a buffer in the children's vaccine and will soon be available in some
Adult and Teen formulations as well. A buffer keeps doses at the
correct pH , neither too acidic or too basic. The original iteration of
The Pfizer - BioNTech vaccine used phosphate buffered saline or PVS.
Pfizer and the FDA have said the switch was made to improve the
stability of its mRNA vaccine, which previously had to be kept ultra
cold for long term storage and lasted a month in a refrigerator once
th awed , the newer version can last in the fridge for up to 10 we eks.

Other experts back that up. Tris has safely been used in other vaccines
and other products. Less stringent cold chain requirements are
especially helpful for the pediatric vaccine, which is being
administered more in doctor ’ s offices. As for social me dia post claims
about Tr is being danger ous or a drug for heart attacks. In large
quantities Tr is can be used as a drug. But here as i n other vaccines

Dr. Peter Hotez

and medicines, the compound is present in only a very small amount
as an inactive ingredient to keep the v accine stable.

Dr. Kawsar Talaat, an infectious disease physician and vaccine
scientist at the Johns Hopkins Bloomberg School of Public Health, told
us the infinitesimal amount of Tris in vaccines has absolutely nothing
to do with the much larger volumes a nd higher concentrations of Tris
being given to people who are having heart attacks. The Pfizer -
BioNTech COVID - 19 vaccine is not known to increase the risk of a
heart attack in any population. Instead, the cardiac concern that has
been identified for the t wo mRNA vaccines is an increased risk of
myocarditis, or inflammation of the heart muscle, and pericarditis in
inflammation of the lining surrounding the heart, particularly in young
men. But these adverse events are rare and as a buffer Tris would not
be expected to modify the risk in either direction. And that’s my fact
check for this week. I'm Lori Robertson, Managing Editor of
FactCheck.org.

Margaret Flinter: F act C heck.org is committed to factual accuracy from the country's
major political players and i s a project of the Annenberg Public Policy
Center at the University of Pennsylvania. If you have a fact that you'd
like checked, e - mail us at www.chcradio.com . We'll have
FactCheck.org’s Lori Robertson check it out for you here on
Conversations on Health Care.

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Margaret Flinter: Each week Conversations highlights a bright idea about how to make
wellness a part of our communities and everyday lives.

Daniel a Tudor , had a revelation a few years ago waking up on the cold
floor of a jail cell, she could ask for help for her drug and alcohol
addiction or she could die. She chose the former . T u dor then
launch ed not only on her own recovery journey, but on a broader
quest to develop tools that c ould help all people gr appling with
addiction recovery to avoid relapse, which is so common, especially in
the early days of sobriety, she realized that there needed to be more
readily accessible tools for those in recovery to stay connected to
their treatment goals. Beyond the 12 step meetings and the talk
therapy sessions,

Daniel a Tudor : I am in long term recovery. And I went through a four - week inpatient
treatment program, where at the end of that four week program, all I
received was a piece of paper that listed an enormous a mount of
things I'm supposed to do on a daily and weekly basis for the rest of
my life to stay in recovery. And I knew that building something on our
cell phones that are with us 24/7 regardless of where you're from and
who you are, would be a way to bridg e that gap and keep people
accountable through an app to those activities.

Dr. Peter Hotez

Margaret Flinter: So she founded WEConnect a relapse prevention on the go mobile
application that can be downloaded on a smartphone. The platform is
designed to keep people e ngaged in their recovery plan u sing daily
reminders and a reward system for when you perform the tasks that
are essential to recovery.

Daniel a Tudor : The individual along with the support of our certified peer recovery
support specialists are able to input those activities into the app. And
when it comes time for that activity to start, you simply check into it.
You see at the top of the app, how you're earning your incentives.
And by the way, this incentive program is based on evidence based
research called conti ngency management. So it's actually proven to
show that it keeps people accountable to their recovery plans or their
care plans. The way that we've digitized it in the immediacy of that
incentive, keeps people accountable to checking into those activities
on the go.

Margaret Flinter: And the digital platform also allows everyone who's connected to the
person's health care ecosystem to see in real time activities that are
enhancing recovery. And also when one might be at higher risk for
relapse.

Daniel a Tudo r : We have trained peer recovery support specialist all across the
country. And they get to leverage a tool that we developed called a
data dashboard, where they can see in an instance if someone needs
additional support or outreach, and that is built thro ugh the app with
keeping them accountable to those activities and the peer having
insights on how they're staying accountable to those activities in real
time. So it really allows for this connection of support 24/7 and
visibility so that when someone need s that added support, you know,
not days or weeks go by which is without this program is what
happens, but rather gives insight and gives the option for connection
in real time .

Margaret Flinter: Since the pandemic hit Tu d or says the WEC onnect platform has been
a lifeline for those in recovery. Those now often cut off from meetings
and in - person sessions during the shutdown.

Daniel a Tudor : Actually , when the pandemic hit, immediately, my heart went out for
Wow, none of us have support meetings to go to any more in - person .
So we immediately stood up with a set of partners, these mutual aid
meetings that are online that are led by certified peers. And within
just a couple months, over 200,000 people joined from all states and
several countries .

Margaret Flinte r: WE Connect , a downloadable app designed by people in recovery for
people in recovery, to help maintain sobriety with a support system in
the palm of their hand, keeping them on track with health goals,
staying connected to a care team and avoiding relaps e. Now that's a

Dr. Peter Hotez
bright idea.
[ Music ]
Mark Masselli: You've been listening to Conversations on Health Care. I'm Mark
Masselli.
Margaret Flinter: And I'm Margaret Flinter.
Mark Masselli: Peace and Health.
Margaret Flinter: Conversations on Health Care is rec orded at WESU at Wesleyan
University, streaming live at www.chcradio.com , iTunes, or wherever
you listen to Podcasts. If you have comments, please e - mail us at
chcradio@chc1. com , or find us on Facebook or Twitter. We love
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Health Center.
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