The J&J Vaccine Delay: Brown University’s Dr. Ashish Jha Says Minimal Clot Risk Shouldn’t Inhibit Vaccine Uptake

This week hosts Mark Masselli and Margaret Flinter welcome Dr. Ashish Jha, Dean of the Brown University School of Public Health. Dr. Jha is a world renowned expert on pandemic preparedness and addresses concerns around the rare blood clot risk with the J&J vaccine, saying the brief pause in distribution is further evidence our scientific surveillance is working. He also talks about the impact of the pandemic to propel meaningful change in public health in the US, and the global health infrastructure as well.

Dr. Ashish Jha - 20210412JhaXM

[Music]
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, global health, and
the great minds who are shapi ng the hea lthcare of the future.

This week, Mark and Margaret speak with Dr. Ashish Jha, Dean of the
Brown University School of Public Health, a renowned expert on
pandemic preparedness. Dr. Jha examines the abundant caution by
the FDA and CDC in delaying the J&J COVID vaccines due to a very rare
risk of blood clots. Dr. Jha says the delay shouldn't impact vaccine
distribution but may amplify vaccine hesitancy. He also states people
who get COVID have a 95 times greater chance of deadly blood clot .

Lori R obertson also checks in, Managing Editor of FactCheck.org, looks
at misstatements spoken about health policy in the public domain,
separating the fake from the facts. We end with a bright idea that ’ s
improving health and well being in everyday lives.

If y ou have comments, pleas e email 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. Ashish Jha here on
Conversations on Health Care.

[Music]

Mark Masselli: We're speaking today with Dr. Ashish Jha , Dean of the School of Public
Health at Brown University. He's been advising national and
international entities on how best to respo nd to the COVID - 19
pandemic.

Margaret Flinter: Dr. Jha was the previous Director of the Harvard Global Health
Institute and Faculty at the Harvard School of Medicine and the T.H.
Chan School of Public Health. Dr. Jha , we welcome you back to
Conversations o n Health Care today.

Dr. Ashish Jha: Thank you for having me back.

Mark Masselli: Well, and there's just so much news that's breaking. We learned the
first thing on Tuesday this week that the CDC and the FDA
recommended a pause in the use of the Johnson & Johnson vaccines
due to possible links to really an extremely rare blood clot. Our own
organization, the Community Health Center , has administered about a
quarter of a million vaccines, but less than 2 to 3% of those were J&J ,
which I believe reflects the national percentages. There's also news
out today from an Oxford study linking the mRNA vaccines to similar

Dr. Ashish Jha - 20210412JhaXM

blood clot risk, which take on the abundance of caution by the FDA
and the CDC on the J & J delay, and also this breaking news on
Moderna and Pfizer b lood clot links as well.

Dr. Ashish Jha: Yeah, so a couple of things. I mean, first is, it's really important
remember how incredibly rare these things are, and we , the J&J
vaccine, we think, and we don't have all the details, we think it's
primarily in wo men 18 to 49 years of age, so women of childbearing
years, and even in that group, the risk is so exceedingly small, that
there's no question that for women who, let's say, may not have an
alternative, or it's really good, let's say it's the best option fo r them in
terms of vaccine, the benefits way outweigh the risks. And then the
question, of course, is for other groups, men, people over 50 , and
based on the data we have right now, and we're still collecting it, the
benefits way, way, way outweigh the ris ks. And this is in some ways,
not surprising. I mean, we didn't see any of this in the clinical trials of
tens of thousands of people. But once you start getting into events
that happen one in a million, you're not going to see it in a clinical
trial.

And the last point, I guess, I'll make is, we've just never done anything
like this. We've never vaccinated 125 million people in four months as
we have in the U . S . , and not with this level of close scrutiny. So it's not
surprising to see it. My sense is this kind of stuff happens all the time
with other vaccines with therapeutics, but we just have never paid
attention to it the same way.

Margaret Flinter: Dr. Jha , vaccine hesitancy has been with us really from the first days
that there was a vaccine available even before it was available. But
there's a real concern that this is going to accelerate and increase that
resistance , that mistrust maybe of all vaccines. I'm not sure who did
the study of the show the 45% of all republicans say they're planning
to get the vaccine, but we see it in all groups, in our own patient
populations in our communities, just a fair amount of skepticism. I
think people have tried lots of different messaging, our approach i s,
usually just the facts, let's get the facts out there. Bu t what are you
hearing maybe from the communication experts and the social
science researchers on how we overcome this resistance to the
vaccine ? What's the best messaging strategy?

Dr. Ashish Jha: Yeah, the issues around vaccine confidence really are impo rtant and
obviously we're not going to be able to put this pandemic behind us if
a large proportion of people choose not to get vaccinated. My
personal view on this having talked to both communication experts
and sociologists and anthropologists is we real ly should begin by
trying to understand what's holding people back. What concerns do
they have? Because I don't know anybody who says I don't want to
protect myself, I don't want to protect my family. So clearly

Dr. Ashish Jha - 20210412JhaXM

something is holding them back and what is i t? And sometimes it
turns out is much more access and much more other issues. I've
talked to people who've done the surveys and find out in focus
groups, that part of the reason some workers are choosing not to
because they've heard that after your dose, y ou feel terrible for 24
hours, and they can't afford to take a day off. Well, that's not
classically the way we think about hesitancy, and so you got to com e
up with customized solutions.

I think there are some small proportion of people who just through
sheer amount of misinformation are going to be very resistant and
may take some time and effort , and there what you need is trusted
voices who can speak to people. But I really think we have got to solve
people's problems first . We've got to solve the acce ss problems , have
just to answer questions people have before we label them as anti -
vaxxers , and try to browbeat them into getting the vaccine.

Mark Masselli: Well, I want to pull the thread on your enough people need to get
vaccine vaccinated, and certain ly the supply chain issues loom large.
We heard a couple of weeks ago that the J&J production facility in
Maryland was contaminated, millions of doses were lost. But it said
the White House still says that it's on track for its 200 million vaccines
in the first 100 days of the Biden Administration . But some feel this
latest delay could affect the distribution down the line , and also we're
seeing vaccine nationalism is also an issue contributing to global
shortages. In this week, there was a consortium of fo rmer heads of
state and the Nobel laureates who asked the Biden Administration to
waive intellectual property rules for COVID vaccines. I wonder what
your thought is about this movement towards a people's vaccine
because we don't live in an island here. We n eed the whole world
vaccinated.

Dr. Ashish Jha: Yeah, absolu tely. This pandemic doesn't end if America gets
vaccinated, the pandemic ends when the world gets vaccinated . As
mind you that is a global pandemic. The problem is that building
vaccines is far more complicated than I think most people appreciate.
I don't think that the single biggest hold back of why we don't have
more vaccines is Intellectual Property . IP is a part of the conversation ,
it certainly needs to be and I'm very open to making IP muc h more
open. But it turns out making vaccines is fundamentally difficult stuff.
These are biologic agents , and so you can't just have some random
person just make vaccines and the J&J issue in that factory is a great
example of a company that actually had a lot of experience and still
made a mistake, and are causing a lot of contaminations. So you need
open IP, you need a ton of technical knowhow .

One of the major things that's holding companies back right now in
producing more vaccines is we're running ou t of raw materials, supply

Dr. Ashish Jha - 20210412JhaXM

chain issue s, that's got to get dealt with. IP alone won't solve that. So
you really need a concerted effort to address these issues, expand
manufacturing capacity, and then IP is going to be part of that
solution. How is that go ing to happen? It's going to require leadership
from the Biden Ministration . WHO can't do this by itsel f. I don't see
any other country stepping up in a way that the Biden Administration.
So I agree the Biden administration's got to do more, and a lot of u s
have been pushing them to do.

Margaret Flinter: Well, maybe I'll take this moment to take our eyes off just the
pandemic for a second and note for all of our listeners, that your
research over many years is f ocused on how to improve health care
quality ov erall, along with, of course, always thinking about
controlling costs. we had this moment where we think maybe some of
the lessons that we're learning during the pandemic as well as from
the pandemic, they may inform what we can do going forward and
Biden Administration has recommended quite a bit of improvements
and investments that might help improve health care quality,
accessibility , availability down the road, whether that's Telehealth or
increased access, addressing disparities, what lasting changes do you
think we might see? And do you have any optimism that there will be
improvements overall to our whole public health infrastructure as
well as our sort of personal healthcare system?

Dr. Ashish Jha: Yeah, it's a great question. I'm actually very optimi stic about the
longer term effects of this horrible pandemic on some of those things.
So, on the public health side, I think we're going to see much more
investment in the public health infrastructure, substantial
improvements in the data infr astructure or the public health
infrastructure especially around IT is really quite abysmal , quite
primitive, it needs substantial investments . Think about things like the
HITECH Act, which had these huge investments in hospitals and
physicians, not on the public healt h side, that's coming , much more of
a building up of the public health workforce . On the healthcare side,
some of the stuff I think is clear . We’re going to have the kind of rules
that are going to stabilize the Affordable Care Act, I think we're going
to improve access to insurance that way. But I also think that there's
going to be a lot of efforts around improving the payment system. A
lot of these innovations that happened as a result of the pandemic are
here to stay . Certainly telemedicine is one of th em. But you're going
to see other ways that we're going to be starting to think about how
to deliver care. Pandemics change things. They're so profound t hat
people don't go back to pre - pandemic life in the same way. And I
think th ere's an opportunity here to re - envision our healthcare
system, the payment models, the delivery systems, and say, w hat do
we want coming out of this pandemic? And I think what we want is
more access, lower cost, higher quality, and I thi nk that's going to be
possible.

Dr. Ashish Jha - 20210412JhaXM

Mark Massell i: We're speaking today with Dr. Ashish Jha, Dean of the School of Public
Health at Brown University. Dr. Jha , when you joined us a year ago,
you were starting your new role at Brown University wondering
whether you were going to be remote or in person. Bu t now we're
looking ahead to the fall semester of 2021. And a number of colleges
will be requiring vaccinations. I'm not sure about Brown but Wesleyan
here in Connecticut declared that it was requiring students outside of
some with medical exceptions . And also, we're seeing many
businesses, sports franchises in some countries requiring proof of
vaccines. And I'm wondering what your thoughts are on vaccine
passports and the role they may play in this sort of new normal that
we're about to enter . Also hearing some talk , I think the head of Pfizer
announced today and I think Dr. Fauci, might as well have said that,
there's a booster in our horizon. What are you seeing?

Dr. Ashish Jha: Yeah , so Brown University was one of the first actually after Rutgers,
Rutger s was the first university to announce requiring vaccinations,
and Brown was second. We did this a couple of weeks ago. We did it
because when we were planning the fall and spri ng of next year and
said, w hat do we want? We wanted classes back normal, we wa nted
sports back, we wanted theater and arts back, we wanted dorms and
kind of the classic college experience , and then we said, how do we
make all that safe for people. And there's really only one way to do it,
to make it truly safe and that was to ensure that everybody was
vaccinated. And therefore, Brown is going to require that all students
be vaccinated. We're working on policies around faculty and staff , a
little more tricky but no question that we can do it for students and
we will and I think it's g ood for students.

I have a high schooler, but I think, when she goes off to college, I
would feel much more comfortable sending her to a college where
everybody, all the students were vaccinated. So I think that's going to
be really important. The issue o f vaccine passports has gotten a few
different issues kind of muddled. Why people worry about the
government issuing passports ? Passports usually come from the
government . I see this as much more kind of vaccine certificates that
private companies are goin g to be giving out . It's going to be a private
sector set of initiatives, and really meeting a private sector need. You
know, I've been hearing from theaters who say, w ell, how do we
make sure that our theater is safe, so that you can imagine the
audience if you've been to a Broadway show a lot of them are like
super packed in together . How do you pack that many people in, who
are going to sit together for two, three hours, and if you'd like them to
not have to wear a mask and be quiet for three hours, ther e's only
one way to do it.

I mean, there's a couple of ways you can do a lot of testing, but the
easiest way is to make sure everybody's vaccinated. Well, you're going

Dr. Ashish Jha - 20210412JhaXM

to have to find some way to authenticate them. Private players want
vaccine certificate s. Therefore, private companies will figure out how
to give them vaccine certificates. And the role of government in my
mind should be to just ensure these things are authentic , they’re
secure, and they're private . So that that information then let's say
i sn’t then turned around and sold to somebody for marketing
purposes. There are some protections, patient protections that are
important part of that. I am fine with the government playing that
role. I don't think the government should be issuing certificat es. I
don't think they will in the United States. In other countries where the
government plays a bigger role you can imagine them doing it. I think
this is a private sector. It's a contract between individuals and sellers
of services that say I want to on ly vaccinated people coming in and
enjoying this. I don't know that the government can stop or should
stop.

Margaret Flinter: I think I was momentarily thinking about a Broadway theater. That
would be a great thing to be able to do again, but you know, it is
springtime and here in New England our thoughts become optimistic.
We've made progress and yet we look around the country and we're
still seeing areas of surge. Our friends in Michigan certainly have been
dealing with a very difficult surge. I am really curious what your
feeling is at this point with all we know 15 months down the road, is it
still the time to have shutdowns? Should our other strategies, mask
wearing and social distancing suffice? Can people handle more
shutdowns economically even from a mental health perspective?
What's your thought is as we look around the country and probably
we'll still see some more surges coming o ver the summer and fall
months.

Dr. Ashish Jha: Yeah, so a couple of thoughts. One is, I'm hopeful that we're going to
be done with surges by the time we get to the summer, we may get a
little bump back again in the fall. But certainly, here we are in mid
April and the next month or so remains tenuous in a lot of places. And
that's because we have two sets of competing force s ha ppening at the
same time. The B 117 variant and other variants are driving cases up.
And vaccines are driving cases down. And it really is a race between
these two things, and the country overall is pretty flat.

Michigan, unfortunately, is on the wrong side of that race where the
B117 it's just a little further ahead, and it's causing these huge spikes.
I am pretty optimistic that by the time we get to mid May, these
things will be dramatically down, that case numbers will start coming
down. Certainly b y the end of May, by Memorial Day, you should see
case numbers way down. All of this is contingent on a lot more
vaccinations, which is all contingent on people having confidence in
vaccines. If we end up with 40% of adults, 50% of adults unvaccinated,
the n we have a problem, then you're going to see more outbreaks,

Dr. Ashish Jha - 20210412JhaXM

and we're going to get into the summer months with things not
looking great. But if people have confidence in vaccines, and we get
into 65 % 70% of adults, ideally more vaccinated, it really w ill make a
dramatic difference.

Mark Masselli: Well, I was just thinking, as you were saying about competing forces,
certainly ideology is playing your role as one of those competing
forces . We see a stark difference between Democrats and
Republicans in terms of their openness. I am wondering what's the
best way to approach this . I’ve been talking a long time, we got to get
away from the politics and back to the science on that. But I think
there's an ideological divide in terms of what's the science telling u s
wondering what your thoughts about because we have to get to those
larger numbers to really achieve whatever it's called herd immunity,
or however you want to define it.

Dr., Ashish Jha: Yeah, I'm always reminded that Republicans and Democrats actually
w ant the same thing, right. They want to protect themselves, their
families, their communities, because it turns out Republicans and
Democrats are all human beings and those are things that we all
want. So the question is, why are some people more hesitant than
others? And there are a lot of issues. It's about what information
ecosystem you live in, what's the information you are being fed?
There's a tribalism element here of people were --- Democrats were a
lot more skeptical during the Trump period and that split . I find that
very unfortunate. I mean, I'm glad that Democrats started feeling
better about the vaccine but I'm sad that the Republican s started
feeling worse. And I'm also reminded that the latest polling, a
majority of Republicans still want the va ccine even though it's lower
than it is. So my take on this is, you know, I spen d a lot of time on
media, I spend a good amount of it on conservative media. And I try
to address people's concerns. I try to hear what's on their minds,
what's holding people back and I try to address it.

I think that's ultimately the way to win this battle, is to win the hearts
and minds of people by understanding what's holding them back and
sharing information in a way that they understand. I'm also very clear
that I can be one messenger, but I'm not going to be the most
effective. And so we need messengers from communities where there
is a lot of lack of confidence to speak up about the importance of
these things. And that's political, religious, civil society leaders.

Marg aret Flinter: We've been speaking today with Dr. Ashish Jha , Dean of the School of
Public Health at Brown University. Learn more about his vitally
important work by going to brown.ed u/academics/ public health or
follow his expert analysis on Twitter @a shish kjha. Dr. Jha, we want to
thank you for being a beacon of light throughout this pandemic for
offering guidance on the way forward. And thank you so much for

Dr. Ashish Jha - 20210412JhaXM

joining us once again on Conversations on Health Care .

Dr. Ashish Jha: Thank you for having me back . I really enjoyed it and hope that we
can have another conversation again, as this pandemic gets into the
rearview mirror.

Margaret Flinter: Absolutely , thank you so much.

Mark Masselli: That’s where we want to see it. Yeah, thanks so much. Take care.

Dr. Ashish Jha: Take care. Bye bye.

[Music]

Mark Masselli: 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 Managin g
Editor of FactCheck.org, a nonpartisan, nonprofit consumer 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 : Social media posts repeatedly misuse unverified data from the
vaccine adverse event reporting system to falsely claim that COVID - 19
vaccines are dangerous and even lethal, but the government database
is not designed to determine if vaccines cause health problems.
Nearly 200 million vaccine doses had been adminis tered in the United
States by mid April. Most of those who have reported side effects
have said they were minor such as pain or swelling at the injection
site , headaches, ch ills or fever. Some people have no side effects at
all. And a small number two to f ive people per million vaccinated have
reported a severe allergic reaction called anaphylaxis, which normally
occurs within a half an hour of being vaccinated. Yet over and over
websites and social media posts improperly cite unverified raw data
from the v accine adverse event reporting system or VAERS as
evidence that the approved COVID - 19 vaccines cause widespread
complications.

VAERS is an alert system managed by the CDC and FDA to detect
pos sible safety issues in vaccines. Anyone can submit a report of a n
event to VAERS e ven if it's not clear that a vaccine caused the
problem. All reports are accepted into the database without
determining whether the event was caused by a particular vaccine. As
the various website warns any report submitted to the databas e, “ is
not documentation that a vaccine caused the event. ” The main goal of
the database is to serve as a signaling system for adverse reactions or
events that were not detected during the clinical trials or before a
vaccine entered the market. Patients , p arents and caregivers are
encouraged to report any important health problem after vaccination,
even if they're not sure if it was a result of the vaccine. These reports
create a public national database that allows government scientists

Dr. Ashish Jha - 20210412JhaXM

and others to rapid ly detect unusual and unexpected patterns that
later can be analyzed. It's one of the monitoring systems that enable d
the agencies to detect six cases of a very rare blood clot that led the
agencies to pause the use of the Johnson and Johnson vaccine. Whil e
they review those reports. More than 7 million doses of the J&J
vaccine have been administered. 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 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.org’s Lori Robertson check it out for you here on
Conversations on Health Care.

[ Music ]

Mark Masselli: Each week Conversations highlights a bright idea about how to make
wellness a part of our communities and everyday lives. Charles
Slaught er [PH] learned the value of entrepreneurship from an early
age first as a paper boy growing up in Connecticut, then with a bicycle
repair business, he started at Yale. Later he took the passion globally
as a field organizer for a micro finance company, Tr ickle - up . Then
came his first successful venture TravelSmith a $100 million online
clothing supply company for serious global travelers. But his travels
also showed him another stark reality, the number of children dying in
third world countries from treat able diseases due to lack of access to
basic medicine.

Charles Slaughter : On average, in the countries we work somewhere between 50 and
100 out of a 1000 kids w ho fail to reach their fifth year . There's only
three or four sort of major causes of this , diar rheal disease, malaria,
and pneumonia. What is shocking is that all of those things can be
addressed at extremely low cost. But the barrier is effectively
delivering what we know works.

Mark Masselli: He wondered how we could put the power of healing in th e hands of
villagers themselves. And he realized the successful model already
existed

Charles Slaughter : The challenge is how can we reinvigorate this idea of door - to - door
healthcare make it both more impactful and financially viable in
places where financ ial resources are extremely unlimited? I'm
thinking about that I go, Wait a minute, hold the phone, isn't there a
business model that excels at that, and you start to think about
Amway, and Avon and Tupperware. Further research, I actually went
out and en rolled as an Avon Lady and learn t, and tried to learn it from
the inside.

Dr. Ashish Jha - 20210412JhaXM

Mark Masselli: After training as an Avon Lady himself, h e founded Living Goods, a
company that sells not makeup, but life saving essentials like drugs to
treat malaria, and diarrhea and solar light.

Charles Slaughter: In a sense, what Living Go o ds does is quite simple. We recruit, train
and support networks of community health promoters, who go door -
to - door every day teaching families how to improve their health and
wealth, and then making a living by selling high impact health
products like simple treatments for malaria and diarrhea, healthy
fortified foods, high efficiency cook stoves, solar lights, and water
filters.

Mark Masselli: Sales associates go from home to home, in their v illages, not just
selling the goods, but teaching the families in the entire community
how to use these life saving essentials.

Charles Slaughter: Every agent works as an entrepreneur. Under the Living Goods brand.
We typically partner very closely with th e local government. So where
we operate, we are the Government's Community Health Army. And
now perhaps most importantly, they get a smartphone. And that
smartphone has a Living Goods designed application on it that can
help them with a guided diagnosis of childhood diseases that enables
them to register and support pregnant women and reminds them to
follow up with those customers.

Mark Masselli: There are now Living Good s sale associates serving the needs of some
5 million residents through Sub Saharan Afr ica. And the results are
quite impressive. In some cases, infant and child mortality is down
25% in the commun ities being served.

Charles Slaughter: I think within 10 years time, it's possible that every community who
needs a community health worker can ha ve one to make sure that
that kid doesn't die of malari a or pneumonia or something else
ridiculously simple that they needn’t die of.

Mark Masselli: Living Goods, a simple grassroots business model, facilitating the
distribution of low cost, life saving ma terials to families living in low
resource areas.

Female: Most of the health centers are very fa r . And these mothers, these
fathers do not have access to these health centers. But with the Living
Goods, we are always there for them. Anytime they come acros s you ,
y ou are ready, you have the med ication, you give the treatment.

Mark Masselli: Generating income while saving lives and improving the health of
communities as well. Now that's a bright idea.

[ Music ]

Mark Masselli: You've been listening to Conversat ions on Health Care. I'm Mark

Dr. Ashish Jha - 20210412JhaXM
Masselli.
Margaret Flinter: And I'm Margaret Flinter.
Mark Masselli: Peace and Health.
Margaret Flinter: Conversations on Health Care is recorded 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
[email protected] , or find us on Facebook or Twitter. We love
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