COVID-19 Vaccines: When Will They Be Ready? Will They Work? Listen to Leading Expert Dr. Naor Bar-Zeev

Dr. Na or Bar - Zeev

[ M us ic ]

Female : 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 hea lthca re
of the future.

Well, this week Mark and Margaret speak with Dr. Naor Bar -
Zeev , Deputy Director of the International Vaccine Access
Center at the Johns Hopkins School of Public Health. Dr. Bar -
Zeev is collaborating with research scientists around the world
all wor king towards development of a viable vaccine for
COVID - 19. He talks about moving into phase three trials for
some leading candidates, and the huge challenge it will be to
get i t t o the marketplace.

Lori Robertson also checks in , Managing Editor of
FactChec k.org looks at m i sstatements spoken about health
policy in the public domain, separating the fa ke from the facts .
We end with a bright idea that's improving health and
wellbeing 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. You can also hear us by
asking Alexa to play the program . Now stay tuned for our
interview with Dr. Naor Bar - Zeev from Johns Hopkins
Bloomberg Sc hool of Public Health here on Conversations on
Health Care.

[Music]

Mark Masselli: We're speaking today with Dr. Naor Bar - Zeev , Deputy Director
of the International Vaccine Access Center at the Johns
Hopkins School of Public Health. He's a pediatric infect ious
disease physician and statistical epidemiologist whose
research has focused into how to maximize vaccine benefits
for low resource high mortality areas of the world. He recently
co - authored a piece in the British Journal, the Lancet on the
current rac e to develop a vaccine for COVID - 19.

Margaret Flinter: Dr. Bar - Zeev is a Principal Director on a number of research
protocols at the Bill and Melinda Gates Foundation and he's a
Founding Member of Immunizing Pregnant Women and
Infants Network . He l ed the V accines Research Group at the
Malawi - Liverpool - Wellcome Trust Clinical Research
Program me and was a member of Malawi's National
Immunization Technical Advisory Group . Dr. Bar - Zeev ,
welcome to Conversations on Health Care .

Dr. Na or Bar - Zeev

Dr. Naor Bar - Zeev: Thanks for havi ng me. Great to be here.

Mark Masselli: Dr. Bar - Zeev , I think it's fair to say that Johns Hopkins has
really been out in front of this pandemic, building a robust
scientifi c framework to address COVID - 19 . T he world obviously
is waiting with bated breath or any positive news about the
vaccine. In the recent Lancet article, you offered some
optimistic analysis of the phase one and two clinical trials of
drugs in the pipeline. But you also caution there may be some
potential roadblocks ahead, but I'm wondering if we could
start off what's involved in a phase one, phase two and phase
three vaccine development , a nd then if you could tell us why
you're both optimistic and concerned about the development
of the vaccine.

Dr. Naor Bar - Zeev: P hase one study looks at s afety in a small number of people,
and often tries to usually the first in human trial after some
animal work or other work in that precedes in. I t tries to
generate an immune response at varying doses. P hase t wo
similarly tries to get a little bit more de tail on the right dose of
an intervention , and again, looking at safety and usually in the
case of vaccines immunogenicity. In other words, does the
vaccine induce an immune response in the recipient? A phase
three trial is a whole order of magnitude diffe rent . It's a much
bigger trial and in the case of COVID - 19, it will be very much
bigger . I t looks to see whether the vaccination reduces the
infection itself , reduces the disease from infection and
infection. It is looking also at the immune response, but it's not
really worried about what the body does in terms of the
immunity, w orries about whether the vaccine actuall y
provides clinical protection .

Now there are lot of r easons to be optimistic . First of all, we've
seen a really big global effort , and ther e are many groups
around the world working simultaneously . There’s funding
that's available to drive that effort as well . W e're seeing a
broad range of vaccine candidates, which is really great
because many fail , and so having depth of field is important.
The initial findings are successful and have been good. But as
you say, there are hurdles to come. The key one is always with
any vaccine, but particularly now, the question of vaccine
safety is crucially important, and will need to be addressed in
ongoing studies. E ven once we have a vaccine, we need to
make sure that this distribution is equitable, that it's
affordable, and it comes at a reasonable cost , and all of these
are challenges yet to come.

Margaret Flinter: Well, Dr. Bar - Zeev , you've been on the frontlines of vaccine

Dr. Na or Bar - Zeev

development for years and we really appreciate the focus that
you've had particularly on vulnerable sectors of a population
and pregnant women and children. But you have this unique
challenge of we've got to get to safety , and at the same time,
we know that people most affected by COVID - 19 have been
vulnerable, particularly members of some minority groups and
people with other coexisting chronic illnesses. M aybe you
could share with our listeners some of the unique challenges
that are encountered in t he developing of vaccine that will be
safe and will be safe for , in particular, those populations who
are really at most risk from the disease itself.

Dr. Naor Bar - Zeev: There are a number of challenges in developing a COVID - 19
vaccine , and partly they're related to generating protective
immunity. Given that we don't really even know yet what level
protective immunity is, we don't know how much antibody we
need to have in the body to prevent us getting infected. We've
seen from tria ls that t here’s good immune response and that's
great. We've also seen T - cell mediated or cellular mediated
response, and that's even better, and that's really reassuring,
but we'll have to see the phase threes really tell us. The other
challenging thing is that th e risk group as you've alluded to are
older adults , and older adults particularly older - older adults
have a phenomenon where they don't respond even in
logically as well as younger adults or indeed children. We call
that phenomenon immune s enescence.

D evel oping a vaccine that's particularly effective in older
adults can be quite challenging. It may require more than one
dose. It may require specific adju v ants or other formulations
that are unique for adults. At the moment, from the initial
studies, we can't say very much about adults. The phase
three ’s trials are going to include adults up to the age of 85 ,
specific groups around the country and elsewhere overseas
working on specific older adult vaccines and the re may be a
range of products out there in the end, so that other problems
are going to be generating long lasting immunity. We want
immunity to be there a year after vaccines and several years
after .

But underlying all of this beyond the vaccinology really is the
demographic question. Till now we've h ad a total of six people
of African descent in the Moderna trial and the OXI trial , for
example . They’re very preliminary trials, the numbers are
small anyway, but that's really a tin y number. T he phase three
trials are going to have to be in the tens of t housands and be
as inclusive as possible so that we can infer both safety and
efficacy in these population groups because the people who

Dr. Na or Bar - Zeev

want to receive the vaccine in the end want to know that it's
safe for them . W e won't know that unless they're in the
s tudies.

Mark Masselli: Well, let me pull the thread on that , we're heading into this
phase three, we might see -- I heard the number up to 30,000
people obviously the ability to reach out to a much broader
and diverse population . A s you just said, there's only a small
fraction of minorities being counted among the current
participants and those numbers were small. We happen to be
part of the initial IRB process for the A ll of US initiative at NIH.
Dr. Collins really set out to create a study that really
rep resented our whole country , and we here in the United
States have a very diverse populations as you know . I s there a
sort of a custodian of these phase threes that say, y ou're the
quarters you should be in , in terms of representation, or is
M oderna and oth ers allowed to sort of determine that on their
own?

Dr. Naor Bar - Zeev: Well, i t wi ll be up to the regulator s really. One of the
advantages of things being at , so called , warp speed, it's not so
nice to go and things warp speed because I think the
populatio n thinks that their cor ners are being cut, but they're
not. One of the advantages of doing things in a somewhat
more overlapping ways that in the routine co urse o f events ,
the company that wants to produce a product for the market
in those kinds of capital istic terms, if you like, goes off and
does its work and then gathers all the data and presents it to
an independent regulator to review . Here , because we want
things to be successful first time, we don't want to just send
companies back to the drawing boa rd because we as a society
can't afford to lose time .

Regulators are participating and not in the production of the
data , obviously , they need to retain independence. But they
are already laying out what trials really need to look like going
forward. P art of that comes from societal expectations. I think
scientists are just human beings . E ven though the methods
that we use is scientific, the questions that we ask are often
based not on science, but o n issues or on societal issues. T he
more we argue and the more we advocate for inclusive trials,
pragmatic trials, the more I think those will occur . Human
beings are not perfect specimens , and what we want are trials
that are pragmatic so that we can infer from those trials to
what the real world result will be . W e want a efficacy results
from trials that are much more closely reflective of what we
might expect in effectiveness. W e don’t -- the perfect
specimens in the trials, we want everybody in the trials.

Dr. Na or Bar - Zeev

The All of Us example that you g ave, that’s a great ex ample of
the breadth of data that are required. I think i f you want to
understand the data are useful in a couple of ways. First of all,
obviously, they tell us what we can know , but they only tell us
those things if we measure them . [ I naudible 00:10:04] t hat
data can tell us what we don't yet know, and where we need
to try to look . I think that those gaps are important when it
comes to developi ng trials.

Vaccine trials are a bit different to clinical trials , and I think the
general public isn't aware of th ese things. But a clinical trial,
let's imagine a new treatment for cancer , w ell I need to go to
patients who have cancer, they're already sick , and perhaps
they'd be willing to tolerate some degree of risk to cure their
cancer with a potential cure . A v ac cine trial isn't like that,
vaccine trial is given to healthy people , and it's given
potentially with the view that it would be given to all the
target population , all people , in order to prevent a condition ,
not to cure an existing condition. T he bar of s afety has to be
much, much higher. I mean, we really have to demonstrate
safety in vaccine trials even more than in usual therapeutic
clinical trials.

As in all trials, particularly here, the individual who is
participating the trial has to be fully inform ed and has to
consent. That's the foundation of ethical conduct of trials , and
that implies trust, and it implies openness , and the reason for
that is that yo u need voluntary participation. I mean, I think
the A ll of U s thin g is fantastic. But it's not eno ugh just to go to
communities and observe them. We need communities to be
participating in the trial. It's not just with the company that
makes the product. Now this is a different kettle of fish. We
need all of humanity to come together and participate in these
activities so that we can have a vaccine for their communities
as soon as possible.

Margaret Flinter: Well, Dr. Bar - Zeev , I wonder if you could comment on another
-- I think a concern that we've had that maybe there's other
crises in the making here , and that is that we saw the
tremendous drop off in people getting primary care at all and
with a real drop off in childhood immunizations over this
course of time. That's really gone on for about five months
now , and we have the flu season coming up , rig ht. Now we're
telling other people avoid crowds and avoid putting yourself in
places where you can't social distance , and yet we have the
huge potential for the risk of people are not getting the
influenza vaccine . I'm really curious have you seen any spik es
or crises? How are we going to message to this for the fall to

Dr. Na or Bar - Zeev

get people to come and get that flu vaccine even when we're
telling people avoid crowds?

Dr. Naor Bar - Zeev: Sure. L ook, there are good data already available from around
the world. I mean, i n the US in the first quarter of 2020 at least
some states have reported a reduction in childhood
vaccination coverage of over 20%. In a n analysis World Health
Organization conducted showed that at least in 68 countries,
which covered about 400 million und er five children, and
coverage reduced between 15 % to 50% in some settings , and
that's work that was done here at Johns Hopkins , so t hese are
real crises. They don't want to even wait till we have another
measles crisis or [audio cut] the fact that we have low
coverage is a crisis . It’s not just children who are at risk of
reduced childhood vaccination rates , it's the rest of us. We've
seen adult cases of measles occurring a year ago when we
have the measles outbreak because of redu ction in childhood
vaccin ation.

C olleagues of mine from around the world are telling me
stories that people that they know are being turned away from
accessing healthcare when they're about to birth a baby
because of lockdowns and whatever, let alone with a mother
seeking to vacci nate her child. The key issue is that we really
have to ensure access to everybody. This really is an
opportunity to build the systems , rebuild the vaccine systems
in a way that's robust and flexible, adaptive and responsive to
community needs , to family n eeds .

I've seen in places around the world that vaccinators really
make a big effort to reach every child . It's like they go far in
the back of a bike but then they have to carry the bike on the
back to cross the mud or in the Pacific where people are
addi ng little dinghies going across from island to island. T hat
kind of flexibility and outreach has to happen even in high
income settings. We need to value what vaccines are.

In terms of the question about flu, I think it's a great
opportunity to have a dres s rehearsal for COVID vaccine. If we
b uild the right kind of mechanisms to reach all older adults
with vaccines and make -- flu vaccines, I mean, before the
coming winter and make them available and engage with
communities to make that happen, we can learn a lot from
that. We can learn how we can engage with the communities,
we can learn how we can reach optimally older adults, and
that would be great lessons to then implement when it comes
to the availability of COVID - 19 vaccine .

Mark Masselli: We're speak ing today with Dr. Naor Bar - Zeev , Director of the

Dr. Na or Bar - Zeev

International Vaccine Access Center at the Johns Hopkins
School of Public Health. He recently co - authored a piece in the
British Journal, the Lancet on the current race to develop a
vaccine for COVID - 19. Yo u know Dr. Bar - Zeev , you and your
colleagues at Johns Hopkins recently held a press event
addressing the race to a vaccine, which you feel could be ready
for some kind of deployment next year. But you say the
federal state and local governments must start acting now to
really to develop a comprehensive strategy to prepare the
public and the need to participate on the COVID - 19
vaccination.

I think we also have some of the challenges for a much larger
movement that seems to be growing about pe ople who are
opp osed to vaccine . B ut we're still seeing a very disjointed
message out of the White House on some of the basics use of
mask , trying to make sure they're talking about proven
remedies versus unproven remedies. What kind of messaging
would you recommend for t he government's to really be
conducted right now to prepare the public for really a very
important campaign that's going to go on trying to control the
pandemic?

Dr. Naor Bar - Zeev: Look, I think it's important to remember that we're seeing a
brand new , and we're learning a huge amount very quickly.
What we're actually seeing is science unfolding , mainly
blossoming in real time . With [ inaudible 00:16:01] glorious
uncertainties , w e don't know everything in science and that's
good , t hat's what science is about , i t's about exploring the
unknown. Our obligation is to provide as best available data,
the best cutting edge science to the population as quickly and
definitively as we can, but also humbly to admit what we don't
know and to be prepared to change course if new evidence
emerges. Hydroxychloroquine example which perhaps you
were alluding to or others, is a good one. I mean, we thought
that -- there was some suggestion, there was some evidence,
and then the evidence was undone , and so the messagin g was
chang ed, and that's okay.

The public maybe feels uncomfortable about that because
people in our society, we live in this kind of a post -- w ell, let
me just say like this , tha t people put a lot of sto ne on what
science has to say, and science seems to be the do ing of some
kind of objective truth , and that's not the case. Science is just
human beings exploring the unknown. I think as long as we a re
clear about that, but messages have to be empathic and they
have to be real, with their feet on the ground , t hey hav e to
know what communities are feeling. They shouldn't be

Dr. Na or Bar - Zeev

patronizing. They shouldn't pontificate. It's especially true for
vaccine safety , just saying vaccines are safe , and the saying
that vaccines are safe doesn't make them safe . The evidence
that vacci nes are safe is hard one, and it's challenging to get
and it takes a lot of effort and dilig ence.

I think the best way to speak to people is to be frank, open,
honest, listen as much as you speak, speak with people not to
or at people, and listen to their concerns . If people have
concerns about vaccine safety , so do I . I don't want to give an
unsafe vaccine my aging mother , I want to be able to give her
a safe vaccine . Now we're all in the same boat, the scientific
community, the vaccine community and the g eneral
community , and I think that that's the foundation in which we
would need to discuss with people rather than message at
people .

Margaret Flinter: Well, let me as k you to address an other what I just see as
enormous challenge . W e've never had anything in my lifetime
that I can remember that we've said we would want to get this
to every person on the planet or as close to that as we can .
N ow we’re talking about a manufacturing process of just like
enormous proportions , and now we're talking about a
logis tics, if you will, operation of enormous proportions . I
appreciate the point about using our flu clinic this year as a
kind of a dress rehearsal. But this is on a factor a few hundred
times larger. I'm really curious at the center at Johns Hopkins,
is ther e somebody in charge of scenario planning, thinking
about just the scale of what we are all going to try and
accomplish when a vaccine becomes available?

Dr. Naor Bar - Zeev: There's not going to be one solution that's suitable for all
locations . The detail has to be focused ground up not planning
from the top. W e have to be listening to what people want
and understanding how countries prioritize. For example, the
COVAX Facility which is a combination of CEPI which is
pandemic preparedness organization, GAVI which is remedies
to deliver vaccines globally, and the WHO conducted 136
country consultations just now finished to really understand
where countries are at , what their planning requirements are.
It's one thing to give a country a whole bunch of doses, bu t it's
quite another if they don't have the cultur e and capacity , I
mean where am I going to store my vaccines ?

Wh en new vaccines were introduced in 2011, and 2012 , f or
example, in Malawi, there was a lot of very pro active planning
by the Ministry of Healt h to their very great credit, they
thought about this very carefully in advance, and they built the

Dr. Na or Bar - Zeev

culture and capacity right through system to accommodate
just the storage of the physical vaccine. T hat has all happened
in advance. There's no point having a vaccine and then not
being able to d eliver it. Wh at we're doing here at Johns
Hopkins and the International Vaccine Access Center is
developing the tools that countries can use that that the
National Immunization Technical Advisory Groups can use to
imp lement and to plan f or implementation and delivery.

Every country will have different priorities , there needs to be
block parties as mentioned around safety and around
financing, there's going to be ethical questions about which
population and subpopulatio ns should we prioritize first .
There are questions about demand and hesitancy , and how do
we address those things . Again , I can try to deliver, but if the
population doesn't want to receive, then I need to address
that in advance. A ll of these things are f acets of sort of a
complex matrix, a Rubik's c ube, if you like, that every country
has to think about implement and evaluate . Just as an example
for, let's say healthcare workers in the United States, the y’ re
probably will be in the first round prioritize . That probably
could be vaccinated through their places of work.

Older adults, as I said before, we need to think about the
infrastructure for delivery. But think about people with
comorbid conditions. How do we even identify them? Maybe
there's a diabetes registry or whatever, but how do we identify
everybody who's obese or everybody who's got high blood
pressure? How do we reach them? These are very complex .
T he question of resistance or hesitancy , a gain, we need to
address that right at the outset throug h the whole process
with inclusion, openness, honesty . I mean, the large bulk of
people in the middle who share my vaccine safety concerns ,
not extremists, but normal people who have reasonable
concerns, and they need to be engaged in the process in orde r
to be successful in delivery.

We are hopeful that some of these new vaccine products and
vaccine platforms are scalable. We'll get through those
hurdles, they're not insurmountable . It’s good to know that
some of these companies that are investing at risk [ inaudible
00:21:29] with not knowing that the vaccine be definitively
efficacious, and are investing the infrastructure that's required
to produce these vaccines to massive scale, billions of doses.

Mark Masselli: Dr. Bar - Zeev , we've been fortunate to hav e a number of
thought leaders who have joined us recently Dr. Eric Topol and
Dr. Zeke Emanuel . I t seems to be some unanimity on one

Dr. Na or Bar - Zeev

hand, the lack of federal leadership in this really incredible
time of crisis, the muzzling of the CDC that ’s been going on.
But they also marvel at the accelerated level of scientific
collaboration that's occurring really all over the globe. A s you
sort of look at all the investment that's going in, what are their
collateral discoveries might be hastened or unleashed because
o f this real ly massive scientific endeavor.

Dr. Naor Bar - Zeev: Yeah, look, I mean, there's always reasons to be optimistic,
and especially now there are many reasons . I think the science
is cutting edge. We've shown ourselves as a community ,
scientific comm unity , that we can really band together and
move things forward. The vaccine platforms that are being
developed and novel, obviously, we need to demonstrate their
safety and effectiveness. But they're not just novel, but
potentially adaptable for the futur e and that's really important
because this isn't going to be our last pandemic. We're
fortunate that this is a very infectious pandemic, but with a
relatively modest mortality, if we were to combine in 50 years
from now or in 15 years from now a c oronaviru s pandemic
with the infectivity of this one and the mortality of the MERS
one that happened in 2012, th at would be medieval like
plague all over again.

W e need vaccine platforms that can be developed quickly and
rapidly and adapt to new emerging threats , a nd that's
happening right now and that will become norm al going
forward. The other opportunity is to heal ourselves as a
society as we build better health systems, responsive health
systems and inclusive health systems. More than a science it's
our ability to gather together with all of our differences and all
of our divisions to really celebrate the division . T hose divisions
are just all many parts of the unified whole that we’re healing
and strengthening in response to this pandemic.

Margaret Flinter: We' ve been speaking today with Dr. Naor Bar - Zeev , the
Deputy Director of the International Vaccine Access Center at
the Johns Hopkins School of Public Health . Learn more about
their important work on COVID - 19 by going to
www.jhsph.edu/IVAC or go to www.jhsph.edu/covid - 19 . Dr.
Bar - Zeev , we want to thank you for your commitment to
advancing this vit al area of scientific discovery and for
providing a sober but , I think , optim istic voice in this ongoing
crisis and for joining us today on Conversations on Health
Care .

Dr. Naor Bar - Zeev: Thanks so much for having me.

[Music]

Dr. Na or Bar - Zeev

Mark Masselli: At Conversations on Health Care, we want our audience to be
truly in the know when it comes to the facts about healthcare
reform and policy. Lori Robertson is an award winning
journalist and Managing Editor of FactCheck.org, a
nonpartisan, nonprofit consumer advocate for voters that aim
to reduce the level of deception in US p olitics. Lori, what have
you got for us this week?

Lori Robertson: New York Governor Andrew Cuomo made the over the top
claim that if the Trump Administration , “ had done its job, the
virus wouldn't come here, ” meaning New York. Cuomo
pointed to a study that suggested governm ent officials could
have better mitigated the spread of the Coronavirus in New
York City, but it didn't say they could have stopped it. Cuomo
made his comments in a July 16 CNN interview . The governor
referred to a study by the Centers for Disease Control and
Prevention in saying , “ Trump is to blame for the virus coming
to New York, ” and that's what the CDC just said.

The study found that genome sequencing of positive
Coronavirus cases in New York City mostly resembled
sequences in Europe, but the US govern ment's travel
restrictions on Europe were implemented too late to mitigate
the introduction of the virus. Those restrictions were
th th
implemented on March 13 . By March 15 community
transmission was widespread, but the CDC didn't say that
Trump is to blame for the c oronavirus coming to New York or
that the federal government could have stopped the virus
from coming to New York as Cuomo suggest.

As we've written before, the research on international travel
limitations shows they can delay the path of the spre ad of
diseases, but do little to contain them. The CDC report used
specimens collected by the New York City Department of
st th
Health and Mental Hygiene from March 1 through the 20 at
six hospital emergency rooms from patients with influenza like
symptoms, who had tested negative for influenza. Of the 544
specimens , the CDC found 36 tested positive for the
Coronavirus . The CDC then use d genetic sequencing and found
the positive specimen mostly resembled the genetic
sequences of the virus circulating in Europ e.

The study suggests the virus spreading in New York City in
March largely wasn't affected by the federal government's
restrictions on travel from China, which were implemented on
nd
February 2 . Limited testing availability and strict testing
criteria harm ed the ability to detect cases and slow the spread ,
t he report further said . That’s my fact check for this week . I'm

Dr. Na or Bar - Zeev

Lori Robertson, Managing Editor of FactCheck .org.

[Music]

Margaret Flinter: FactCheck.org is committed to factual accuracy from the
country 's major political players and is 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.or g's Lori
Robertson check it out for you here on Conversations on
Health Care.

[Music]

Margaret Flinter: Each week Conversations highlights a bright idea about how to
make wellness a part of our communities and everyday lives.
September is suicide preventio n month, and it's a particular
interest to the Veterans Administration. An estimated 22
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Margaret Flinter: According to Dr. Caitlin Thompson, Deputy Director of VA
Suicide Prevention Program , it takes only a moment and just
one small act can start them down the path to getting the
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even if they're not registered with the VA or enrolled in VA
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a nd individuals to find ways of offering support to getting

Dr. Na or Bar - Zeev
veterans to help they need before it's too late. Now that's a
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.
Female : Conversations on Health Care is recorded at WESU at
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