FDA Advisory Committee Member Dr. Paul Offit on Vaccine Safety, Efficacy and Distribution

Dr. Paul Offit

[ Music ]

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 lthcare of the future.

This week Mark and Margaret speak with Dr. Paul Offit, v irology
expert, C o - C reator of the R otavirus V accine and D irector of the
Vaccine Education Center at Children's Hospital of Philadelphia. He's
also a member of the FDA Advisory Committee which recommended
emergency authorization of the Moderna and Pfizer COVID - 19
vaccines, which he calls a remarkable scientific achievement. He says
years of research led up to this moment and says it's imperative that
we scale up mass inoculations to bring this p andemic under control.

Lori Robertson also checks in, Managing Editor of F act C heck.org looks
at misstatements spoken about health policy in the public domain .
We end with a bright idea that's improving health and well - being in
everyday lives. If you have c omments, 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. Paul Offit here on
Conversations on Health Care.

[ Music ]

Mark Masselli: We’re speaking today with Dr. Paul Offit, Director of Vaccine
Education and Professor of Pediatrics in the Division of Infectious
Disease at the Children's Hospital of Philadelphia. H e's the M aurice
Hilleman, Professor of vaccinology at the Perelman School of
Medicine at the University of Pennsylvania and i s a member of the
FDA ’s Vaccine Advisory Committee, which recently gave emergency
approval for both the Pfizer and the Moderna vacc ine.

Margaret Flinter: Dr. Offit is an internationally recognized virology expert. He's the co -
developer of the rotavirus vaccine for which he received numerous
awards and distinctions. He's a founding advisory board member of
the Autism Science Foundatio n and the Foundation for Vaccine
Research . He's a member of the National Academy of Medicine, the
E ditor of the Publication Vaccines . Dr. Offit , we welcome you today to
Conversations on Health Care .

Dr. Paul Offit: Thanks for asking me.

Mark Masselli: I th ink the public knows the story of the virus . It's a year out now .
Global deaths are close to 2 million people, more than 350,000 deaths
in the United States and growing daily. W e're in the midst of a surge
upon a surge, a lots of troubling news , but I thin k there's really some
good news in the larger context of two vaccines have been approved.

Dr. Paul Offit

I think the whole vaccine development story needs to be told because
it's really just a remarkable accomplishment. While it took a year, it
really happened over a cou ple of decades that people have been
thinking about this. I know on one hand, there are lots of people who
were anxious about maybe the term Warp Speed . But this is science
at its best and I'm wondering if you could give us an overview of the
development s tory and why it's so vital to bring this pandemic under
control.

Dr. Paul Offit: It's a remarkable story. I mean, we only had this virus, the SARS - CoV - 2
virus in hand in January of 2020. That's when we knew the sequence
of the virus. W e knew which protein we were interested in . It’s that
protein that emanates from the surface of the viruses, so called spike
protein, that's the protein responsible for binding t w o cells , and
because we knew the sequence of the virus, we then knew that that
piece of M essenger RNA or mRNA that coded for that particular
protein.

T hen we proceeded to launch a novel vaccine strategy this mRNA
vaccine strategy, which although it had been really studied since for
about the last 15 years, this is going to be the first vaccine made usi ng
M essenger RNA technology . Within 11 months, we've done two large
clinical trials, 130 , 000 big which was the Moderna trial and then
44,000 for the Pfizer trial.

I mean, I think if you'd asked a thousand scientists on this globe,
whether in January of 202 0 they thought we would have a vaccine
that was 95% effective against disease including severe disease,
including people over 65 that would be available to the public by
November, I don't think you would have found one that would have
said that was possibl e. I think that part of it we've been amazingly
good at . T he reason it was f ast was , one , we spent the money . W e
spent $24 billion to basically take the risk out of it for pharmaceutical
companies. We mass produced the vaccine at risk not knowing
whether i t was worked or was safe.

We did a lot of the Phase III trials, I mean the government did that,
the companies didn't do that. That's why it was so fast , b ecause these
things were overlapping. Normally a company will do a Phase III trial
to see whether a va ccine works and safe , then they mass produce s .
They don’t mass produce it while they're doing the trials. That's the
way this work s .

Margaret Flinter: D r. Offit I wonder if I could ask you to do something for our listeners.
W e say things like mRNA or M esse nger RNA and it kind of rolls off our
tongue and we have an idea of what that means. But what we have
learned in talking with staff and people in our communities is they
hear genetic disruption , changes your DNA . I think the American
public has done an ama zing job of learning a lot of science throughout

Dr. Paul Offit

this pandemic. But maybe you could just take a minute or two,
explain to people how M essenger RNA technology actually works in
this situation in the body.

Dr. Paul Offit: Sure, so we all have M essenger RNA i n all of our cells. The DNA in the
nucleus of the cell makes M essenger RNA, which is then exported out
of the nucleus into the so called cytoplasm of the cell. There , it is
translated to a protein , so we all make proteins in our cells all the
time to maint ain life. T here's nothing novel about M essenger RNA as
far as our bodies are concerned . We have hundreds of thousands of
copies of M essenger RNA . The few copies that are introduced by this
vaccine are really fairly trivial compared to what we d eal with all the
time.

The question that comes up, and you're right , is will this genetically
altered ? I t's a gene , I mean, it's a small gene . Can it then enter the
nucleus and somehow transform DNA so that we would then , in some
way be harmed ? T hat can ’t happen, and here's why . First of all, the
M essenger RNA is in this little lipid droplet, which is then taken up
into the cell in the cytoplasm, then that little lipid droplets sort of
unc outh and then the M essenger RNA is naked messenger RNA is now
in the cytoplasm.

I n order for it to enter the nucleus, it needs to get past the nuclear
membrane, which means it needs an access signal, which it doesn't
have, therefore, it actually cannot possibly enter the nucleus . Even if
it entered the nucleus it’s RNA, it's not DNA . I t would have to be
reverse transcribed to be RNA and which requires the enzyme called
reverse transcriptase, which this vaccine also doesn’t have . Even if it
was reverse transcribed to DNA, it would have to be integrated into
the DNA which requires an enzy me called Integrase , which it also
doesn't have. It's not like the chances that it could affect our DNA are
small, the chances that it could affect our DNA is zero . You are more
likely to develop X - ray vision after getting this vaccine than having
your DNA altered .

Margaret Flinter: Great.

Mark Masselli: That is a great overview. I was just thinking about how you describe
this really, sort of moon launch effort that many governments around
the world including the United States playing incredible leader ship
role, invested $24 billion, engaged scientists around the world,
lowered barriers where they needed to be lowered. But I'm thinking
now about the distribution of it and it seems we developed a vaccine
for all 50 states, right , b ut we seem to have a state b y state maybe
local by local strategy on how we're going to distribute the vaccine.
Talk to us about this distribution model. Where's it failing? How could
it be improved? L ots of people are calling for seven days a week 24
hour vaccine centers . What's you r thought about it?

Dr. Paul Offit

Dr. Paul Offit: Right, I think in order to get this vaccine out th ere, we need to mass
produce it, mass distribute it, and mass administrate it , which
requires a public health infrastructure that we currently don't have .
We need to put that in place. What we should have done in
retrospect is when we were mass producing this vaccine at risk, we
also should have been basically coming up with a plan to mass
produce distribute and administer it at risk, meaning not knowing
whether we were go ing to have a vaccine . W e should have put that
plan in place then, because what we're talking about is something we
haven't done before, really, which is to say, mass administration,
meaning it's not like the flu vaccine where you walk into the
pharmacist or the retail pharmacist at your convenience . We need to
line people up and give them vaccine after vaccine after vaccine.

In our hospital, we line up. I mean, we vaccinate 12 people every 30
minutes, we have four or five sites where we do that, and we'll
vaccinate thousands of people every week to get all of our employees
vaccinated. T hat's just one small example. But it's not easy to do that.
I mean, we have a big well resource hospital, which is a pediatric
hospital. A lthough we see certainly patients wi th COVID, we are not
overwhelmed by COVID b ecause we're a pediatric hospital. If you go
next door to the hospital the University of Pennsylvania, they're
overwhelmed by that, as are many of these hospitals. I t's hard for
them to shake loose the personnel.

I'll give you another example. I'm in the Commonwealth of
Pennsylvania and our Secretary of Health was trying to set this up .
She needs to work with the federal g overnment for how to set it up.
F or example, if she wants to give a vaccine in a sort of pharm acy poor
area where it ’ s sparsely populated, she needs to set up a center
where she's giving the vaccine much as you would have a testing
center. That requires money to do and it requires personnel to do it.
She needs to work with the federal government an d say, look here's
my plan , w hat do you think about my plan ? Here's how you need to
distribute this. Here's how many doses I think I can give a day. But you
need to do it in a manner that is sensible.

For example, when you see like, you know people standin g in line in
Florida for 13 hours who are over 65 years of age, that's not the way
to do it. You just have to schedule it in a sensible way. It's not easy.
This is not easy to do , a nd unfortunately we're a little late to get
around to doing it.

Margaret Fl inter: Well, thanks Dr. Offit for making that so clear. I'm glad to say the state
we're in is doing a pretty good job of getting these vaccine efforts
underway. But, we kind of climb ed the mountain on developing the
vaccine which , again, will be one of the great success stories of the
century and we're working hard on the distribution piece. Yet, o n the

Dr. Paul Offit

other side, we still are hearing a lot about vaccine hesitancy. Part of
why I asked you the earlier question . Let's just keep educating people
about what th is actually is.

I saw a figure that as many as 30% of clinicians, I think it was in New
York City, have declined to take the vaccine right away. This is hugely
concerning, from my point of view, but you've said you're not
worried, you think this is somewha t short term and as public
confidence in it grows and maybe as also people recognize, look, this
is in short supply and very valuable that people will put that hesitancy
aside and come forward . What are your thoughts on what's likely to
happen there? How l ong is that going to take ? I s that going to really
slow down our efforts, assuming we solve the distribution issue?

Dr. Paul Offit: I think most people who are concerned about this vaccine are
understandably concerned. I mean, here you have a vaccine that was
developed within a year, that's remarkably fast. It u sually takes 15 to
20 years . The work we did on the rotavirus vaccine took 26 years , s o
that's more typical. The language that is surrounding this vaccin e has
been a little frightening , Warp Speed, r ace for a vaccine, who's going
to be the first across the finish line , that's a little disconcerting , a nd
it's a novel technology. It's a scary virus, and it's a novel technology
and people tend to rate vaccines as possibly more dangerous . T he
more dangero us they see the disease , s o people will be more scared ,
for example , of an A nthrax vaccine or an Ebola vaccine than they will
of say like a mumps vaccine because they see those other diseases
being more frightening. I think that also is scary about this ba t
c oronavirus, that just came made its debut in the human population.

I think that's all fine. I think you should be skeptical of anything you
put into your body including vaccines. I consider myself a vaccine
skeptic. I think everybody who sits around the table at the FDA
Vaccine Advisory Committee meetings is as skep tic, show us the data.
But I think what people are concerned about the general population is
concerned is about safety. I don't think they think that we're lying to
them about efficacy. I thin k they believe it's effective. I just think they
are concerned whether it's safe. As more and more vaccines get out
there I think people will be more convincing .

The father of modern vaccines, a man named Maurice Hilleman, who I
was fortunate enough to kno w for 20 years, he was the primary either
inventor or developer of 9 of the 14 vaccines we gi ve to children. He
said it best. He said, “ I never breathe a sigh of relief until the first 3
million doses are out there . ” Well, they're out there , s o I think peo ple
can start to n ow breathe a sigh of relief that there's no serious rare
side effect.

Mark Masselli: What a remarkable career he had. We're speaking today with Dr. Paul
Offit, Director of the Vaccine Education Center, Professor of Pediatrics

Dr. Paul Offit

in the Divis ion of Infectious Disease at Children's Hospital of
Philadelphia, co - developer of rotavirus. He is a member of the FDA ’s
Vaccine Advisory Committee, which recently gave emergency
approval for both Pfizer and Moderna vaccines .

I was thinking about Margaret was talking about sort of public
confidence and building public confidence and there are going to be a
lot of things that sort of throw people off and have them worried , and
certainly one of them is the new COVID - 19 variant both in South
Africa and UK , and obviously here now in the United States. Y ou note
that the c oronavirus has a propensity for mutation. It's kind of
i nteresting to know that they've had the -- I assume that they've done
some work on th is variant already drawn blood from people who've
alre ady been tested. What do you know about its impact or is it just
one of those many things that we'll see along the way here of changes
that go on but do not impact the efficacy or the effectiveness of the
vaccine?

Dr. Paul Offit: I t’s an RNA virus, therefo re it will mutate when it reproduces itself by
definition . It will create variants by definition as all RNA viruses do.
The question is, does it functionally change ? Does that variant created
-- cause a -- do those mutational changes cause the virus to fun ction
differently? For example, does it caus e the virus to be more
contagious ? W hich appears to be true for this so called UK variant,
the B - 117 variant. Does it cause the virus to be more virulent,
meaning more likely to cause severe disease ? That doesn't appear to
be true for this.

T hen most importantly, the thing you would most worry about, has it
caused the virus to essentially escape recognition by an immune
responses induced by the vaccine ? That's not true for the UK variant.
T hen for the South Africa n variant and the Brazilian variant , they are
in the midst of doing those studies, but I frankly would be surprised
that this mutated away from the vaccine . I think , I mean, t here ’s --
here is two other RNA viruses as an example . Influenza is an RNA
virus. It mutates so much from one year to the next that natural
infection or immunization one year doesn't protect you the next year
hence the need for a yearly vaccine. Measles is an RNA virus. Measles
mutates all the time . Measles creates variants. Nonetheles s, we've
had a vaccine since 1963 and that virus has never escaped recognition
by the vaccine. A t least right now, this virus is looking more like
measles than it is influenza. I mean, we'll see . You should never make
predictions about this virus , I've lea rned . B ut at least for now it's all
reassuring .

Mark Masselli: Who's doing the research on this right now?

Dr. Paul Offit: A variety of groups across the globe.

Dr. Paul Offit

Margaret Flinter: Great. Dr. Offit , we’re, I think , inundated probably on a daily basis
with he adlines about COVID and about the vaccine testing seems to
have taken a little bit more of a backseat right now. But again, people
are getting so much information . I n the last week or so , I would say ,
one of the key things people are now aski ng is, wait we heard 100%,
two doses, two doses, two doses . We've just started hearing, maybe a
second dose is not as necessary , m aybe the strategy ought to be to
hold off on the second dose to get more doses out to people for that
first shot in the arm. I wonder if you could comment on that and also
a question that I started hearing more in clinical circles is, what about
children , d o we anticipate at some point including them in the
population that should be vaccinated? Maybe those two things the
one dose versus two, a nd what's the state of thinking right now
around kids ?

Dr. Paul Offit: T he second dose gives you a clear dramatic booster response to your
first shot . You have much higher titers the virus specific neutralizing
antibodies. All the studies that have been do ne looking to see
whether or not this vaccine works have been done with two dose s.
T he notion of giving a single dose and then waiting and hoping that
you'll get this the second dose soon enough is a terrible mistake. I
mean, it's born e of the notion that when they did these trials, when
Pfizer and Moderna did this trial, they gave one dose then if -- Pfizer
you waited about three weeks later, Moderna you waited four weeks
later to give the second dose. T here was a period of time where you
could look to see whether or not one dose was in any sense effect .

In the case of Pfizer, it was about 52% effective for a few weeks . I n
the case of Moderna it was about 80% for a few weeks, but you don't
know if it's effective for six weeks or two months. But you do know
this, you know that that second dose gives you a huge boost er
response , and you know that that second dose induces so called T
cells, which suggests you're going to have more immunological
memory and therefore longer live protection. Y ou know that you only
have tested to see whether this vaccine works by giving a two dose
vaccine. I mean, everybody knows trial has got a second dose. G iving
one dose and then hoping you can get that second dose soon enough
is a mistake, because I think it disrupts the program . You're not sure
when you're going to get the second dose. If a few months goes by
and your immunity fades and you're again at risk of disease, you're
going to have a lot of people out there who think they're somewhat
protected when they’re not, it's a mi stake.

The other thing that's been raised which I think is equally a mistake is
the notion of two half dose s. That was born e of the so called Phase II
trials, which are immunogenicity trials where you look at the immune
response induced by the vaccine, in this case the Moderna vaccine .
The Moderna vaccine is a 100 micrograms of dose one , a 100

Dr. Paul Offit

micrograms of dose two, but in those immunogenicity trials you saw
that for the 50 microgram dose, there was an immune response
which was to some extent comparable to the 100 microgram dose.
P eople have raised the notion, well okay let's just give half a dose.
First of all we haven't tested half a dose to see whether it works. But
more importantly, it assumes that that immune response you're
seeing correlates with prot ection. You don't know that. If you knew
that was true, we wouldn't need to do Phase III trials to see whether
something works.

I'd say half the vaccines that are currently being given to infants and
young children don't have a clear immunological correlat e for
protection. W hen Moderna and Pfizer were asked at those FDA
Vaccine Advisory Committee meetings, do you have an immunological
correlate? Can you say those people who broke through , meaning got
the vaccine and still got disease , did they have a lesser immune
response? They don't know that yet. I think the notion of using
immunity to say , okay we can correlate that with protection is a bad
idea.

In terms of children, children need to be vaccinated. I think that any
virus that cause suffer, be hospitaliz ed and occasionally die, the
children need to be vaccinated. I mean, there are obviously a very
small percentage of the deaths in this country, very, very small. But
nonetheless, they can develop inflammation of blood vessels, and jus t
sort of multi system disease. They need to be -- w e have a hospital
which has a nu mber of children with the virus, infected with the virus
in our hospital now . B ut you can't just say, o kay, this worked in adults,
we'll just do the same thing in children. You need to test in c hildren.
Th ose studies are now being done.

Margaret Flinter: Great.

Mark Masselli: I wonder if you could give us sort of a waterfront overview of vaccine
development in terms of what's next. We've had Pfizer and Moderna.
We've got AstraZeneca. We've got ot her groups in various parts of the
world, the Chinese, the Indians have developed vaccines, what's it
look like from you? T hen maybe sort of an insider look on the FDA
advisory panel, when do you get information on, you start to receive
it sort of general through collegial contacts . I know that there's a
formal process that the pharmacy itself, the developers will put the
whole package together, but how are you keeping abreast of it?
W hat's it look like that we might see over the next six months?

Dr. Paul O ffit: Right. Well, just to answer the second part of that question first. We
as FDA advisory committee meeting members will see the data on
these vaccines when the company submitted for approval through
emergency use authorization . They have essentially a packet that's 80
to a 100 page long, here's our submission for approval through UA

Dr. Paul Offit

[PH] . T hen the FDA goes through all the clinical data and then they
also give us a second document. Usually, a couple weeks in advance
of our meetings is how we come to know about it.

There are other vaccines out there . The Chinese have an inactivated
vaccine, take the virus, grow it up and activate it with a chemical. It' s
the same way we get the polio, an a ctivated polio vaccine, rabies
vaccine, hepatitis A vaccine . It is a well worn technology . They claim
79% efficacy . It would be nice if they actually publish those data so
the rest of the world can look at instead of dealing in this kind of
science by press release age .

The Russians have a vaccine which is a replication de fective human
adenovirus five, followed by replication defective human
adenoviruses type 26, which is the same strategy actually that second
part that Johnson & Johnson is using to make their vaccine. The
Russians claim 94% efficacy. It would be nice to se e those data at
some point .

Johnson & Johnson ha ve been rolling quiet . The hope is that by the
end of this month we will see those data , but to date I don't know.
AstraZeneca is currently doing a study in the United States , a two
dose trial in the United S tates. W hen that trial is completed, we will
see those data but I can tell you that we ’re not crazy about what's
going on in England where they sort of -- the way they did in England
was they had -- they did studies in England with their vaccine, which is
a replication defective simian adenovirus given as two dos es. In the
UK, they had sort of -- between the UK and Brazil they had two
different dosing strategies, full dose, full dose versus half dose, full
dose . T hey had two different intervals, one was a m onth and other
was up to three months later . T hey had two different placebo groups ,
and t hen they tried to combine all that into one thing and say, okay
it's 70% effective. You can't do it that way. That's not the way you do
i t.

I think we'll wait for a tr ial in the United States to see whether this
vaccine is what you hope it would be , b ecause the more vaccines the
merrier. I mean, I think part of the burden of trying to get a lot of
people vaccinated is right now you only have two vaccine companies
that a re making it . When we vaccinate with flu in the United States
every year there are many companies that make a flu vaccine.

Mark Masselli: I want to slip in one additional question here before we wrap up. W e
have the efficacy side during the trial and then we have the
effectiveness about how does it impact all of us . How are you keeping
abreast of its effectiveness? What's the process s o as we get to
millions and millions of Americans over periods of time, we actually
are measuring that , h ow's that process b eing managed?

Dr. Paul Offit

Dr. Paul Offit: Hopefully, the CDC is doing those studies. I mean, it’s the same way .
I t's the so called wedge studies , t he way the Ebola vaccine trials work.
I n other words, when there was the Ebola outbreak in West Africa,
and there were a couple of vaccines that were then introduced into
West Africa, those weren't prospective placebo controlled trials
where they got a permission to either have you get vaccine o r placebo
because Ebola was a killer. W hat that was, that trial was , was a wedge
trial. Y ou just introduced the vaccine, knowing not everybody is going
to get it all at once , and then you can retrospectively see who got it
and who didn't as you move along and what the effectiveness was .
But that's a really good point. The efficacy tria ls are done under v ery
highly regulated conditions . F or vaccine , f or example, like Pfizer's
vaccine, which has pretty restrictive storage and handling and
guidelines in terms of once the vaccines is in a refrigera tor it only has
five days. Once it's recons tituted, you only have six hours. I mean that
in the real world that might play out a little differently than it does
during the trial.

Margaret Flinter: We've been speaking today with Dr. Paul Offit, Director of the Vaccine
Education Center and Professor of Pediatrics in the Division of
Infectious Diseases at the Children's Hospital of Philadelphia. He's also
a member of the FDA Vaccine Advisory Committee . Learn more about
his work and access his extensive writing on the subject of vaccines at
www.paul - offit.com . Follow him on Twitter @ DrPaul Offit. Dr. Offit ,
thank you so much for your groundbreaking work on rotavirus and
other vaccines, for your commitment to science and sci entific
discovery, for being a voice of reason and expertise in these very
challenging times . Thank you so much for joining us today on
Conversations on Health Care .

Dr. Paul Offit: Thank you for asking me.

[ Music ]

Mark Masselli: At Conversations on Health Care we want our audience to be truly i n
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: As Coron avirus cases spiked in December s tates began vaccinating
individuals throughout the United States. Let's look at how the
vaccines are being administered and what we know about their
safety. So far, the Food and Drug Administration has authorized two
vaccines, one from Pfizer and BioNTech and another from Moderna.
Both require two doses and had an efficacy of 94% or higher in clinical
trials. The federal government is distributin g doses to states and other
jurisdictions based on population. States can make their own

Dr. Paul Offit

decisions on prioritization, but most are following guidance from the
Centers for Disease Control and Prevention's Advisory Committee on
Immunization Practices, which concluded that the first vaccines
should go to the nation's 21 million healthcare personnel and 3
million residents of long term care facilities.

The next prioritized groups include those 75 years of age and older
and frontline essential workers. Following that are people between
the ages of 65 and 74 , a nyone younger who has a high risk medical
condition, and additional essential workers. All of this means vaccine
doses are unlikely to become available to the general public for
several more months. As for s ide effects, trial data show that many
people experience pain at the site of injection, fatigue, joint or muscle
pain, headache, chills, or fever. These reactions are more likely after
the second dose given several weeks after the first and more commo n
and severe in younger people.

After the rollout of the Pfizer BioNTech vaccine, several individuals in
Alaska and Britain had serious allergic reactions following receipt of
the shot , a lthough all has now recovered . S ome allergic reactions are
to be expected with any vaccine, although these are typically very
rare . The CDC is also investigating and has advised that anyone who
has previously experienced anaphylaxis be monitored for a half hour
after getting the shot. Everyone else should be monitored for 15
min utes . All administration sites will be set up to treat allergic
reactions.

4.8 million vaccine doses had been given in the US as of the morning
th
of January 5 . As for anaphylaxis, the CDC said there had been 21
reported cases among the first 1.9 million do ses administered . Both
shots are mRNA vaccines and while no mRNA vaccine has ever
received FDA approval before this type of vaccine has been studied
for years . That's my fact check for this week. I'm Lori Robertson,
Managing Editor of FactCheck.org.

Margar et 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.org'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. People living
in Sub - Saharan Africa have tougher odds at overcoming diseases. T he
problem is not just the lack of access to healthcare providers but once
someone is diagnosed with an illness, access to vital life saving

Dr. Paul Offit

medicine is out of reach for many who are sick simply because they
can't afford them.

Gregory Rockson: Africa has some of the highest drug prices in the world, simply
because it's a free price in the market. Y ou can take a single medicine
and two p harmacies next to each other will sell that same drug at
widely different prices.

Margaret Flinter: Gregory Ro ckson is the founder of mPharma , a nonprofit organization
that is seeking to address inequities in drug prices in Africa, and the
supply chain tha t often puts these life saving drugs out of reach of the
people who need them. mP harma operates in four African countries .
It decided to tackle the problem by redirecting the supply chain that
forces small independent pharmacies and clinics to source their own
drugs and help offers these entities a chance to outsource their
procurement for pharmaceuticals .

Gregory Rockson: We realized that if we could begin to bring together all these
independent pharmacies and remove the pressure that they have to
face in sourcing their own drugs, we can begin to address the issue of
medicine availability and affordability.

Margaret Flinter: Rockson says they help ed improve the drug procurement supply chain
by collecting data on actual drug sales, which allows healthcare
en tities to avoid over or under stocking. I t reduces their vulnerability
to fraud and corruption, which sadly is rampant in direct supply chains
in parts of the world.

Gregory Rockson: The beautiful thing about the service that we offer them is that not
only are we taking ownership of the supply chain, we're also providing
the financing to purchase the inventory. We offer them a simple value
proposition , pay only when you dispense the drug to the patient.
Beyond having the parts available we actively help the m manage their
inventory.

Margaret Flinter: Rockson says another important benefit more affordable drug
supplies help clinicians better manage patient outcomes. mP harma
was a 2019 recipient of the School Foun dation's Entrepreneurship
Award.

Gregory Rockson : With our focus on bringing down the cost of drugs tha t there wi ll be a
systemic change that even other actors will be forced to reduce their
prices .

Margaret Flinter: mPharma a nonprofit entity that utilizes reliable data on drug usage
eliminates fraud a nd waste in the drug supply chains, makes life
saving medications more readily available to some of the world's most
vulnerable people, improves outcomes and saves money. Now that's
a bright idea .

Dr. Paul Offit
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Mark Masselli: You've been listening to Conversatio ns on Health Care. I'm Mark
Masselli.
Margaret Flinter: And I'm Margaret Flinter.
Mark Masselli: Peace and Health
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