US COVID Response Has Failed By Not Scaling Up Home Testing: Harvard’s Michael Mina on Rapid Tests as Best Chance to Contain Outbreaks

Michael Mina

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 health care of the future.

This week Ma rk and Margaret speak with Dr. Michael Mina , Assistant
Professor of Epidemiology, Immunology, and Pathology at Harvard
School of Public Health in Harvard Medical School. He’s been a vocal
proponent since early in the pandemic on making cheap, rapid at -
home test available to all Americans which would have greatly
reduced the pandemic. Dr. Mina also is helping develop a global
immunological survey much like the national weather service to
better track disease outbreaks around the world.

Lori Robe rtson 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 wellbeing in everyday lives. If you hav e
comments please email us at [email protected] or find us on
Facebook, Twitter , Spotify 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 Harvard’s Dr. Michael Mina here on Conversations
on Health Care.

Mark Masselli : W e're speaking today with Dr. Michael Mina, Assistant Professor of
Epidemiology, Immunology a nd Pathology at the Harvard School of
Public Health in Harvard Medical School . He's a member of the Center
for Communicable Disease Dynamics at Harvard, and lead researcher
at the Human Immunomics Initiative .

Margaret Flinter: Dr. Min a has been advocating since early in the pandemic for the
deployment of a rapid testing infrastruct ure as a public health tool to
quickly contain COVID outbreaks and get this pandemic under control.
Dr. M ina w elcome to Conversations on Health Care .

Dr. Michael Mina: Thanks so much. I'm very happy to be here.

Mark Masselli: You know, the CDC just issued a recommendation on the booster
shots causing some commotion . T heir recommendation calls for
booster shots for those that are 65 and older a n d those 18 and older
who are working at higher risk professions or institutions. Y ou said we
should be less focusin g o n boosters, and more focused in on the
world's unvaccinated of which there are billions suggesting that one
shot to an unvaccinated person is worth a thousand boosters . I’m
wondering if you could just tell us more about that the ongoing threat
w ith so m uch of the world still unvaccinated

Dr. Michael Mina: I think it's important to realize that I have the luxury of being able to
discuss these things without actually having to deal with the

Michael Mina

practicality . T he practicality is that CDC is in a position where they're
focused on the United States. I am in a position where I rightly get to
focus on what's happening around the world. T his is really a tension, I
would say when you have a government that has their primary
operating principle is towards one country. But we are in a global
pandemic, how do you balance those things. I would say that,
arguably we have not figured out how to balance them.

In this pandemic a global aid is domestic defense . T he more we can
limit spread and limit the virus across the world, the better we're
going to be in the long run. But it's very hard to make that assessment
in real time. One unvaccinated person in a country where there are a
lot of cases right now, but not a lot of vaccines. Giving that one
unvaccinated p erson a vaccine i s likely to match the benefit that that
person would have in a nearly fully vaccinated community that it
would take thousands of booster doses . W e just have to look at the
infection fatality rate or giving it to a 12 year old for example . Y ou'd
have to vac cinate thousands and thousands of 12 year olds to have
the same benefit in terms of mortality protection.

T hese are really global ethical issues that are extraordinarily difficult
to manage without having an overarching equilibrating body that is
able to a llocate vaccines appropriately across the globe. But
unfortunately in this time, the wealthy continue to do what the
wealthy do, which is gain access first and even if it is unfortunately at
the expense indirectly of protecting other much more vulnerable
i ndividuals.

Margaret Flinter: Dr. M ina , you've been a pretty clear voice since early in the pandemic
calling for broad deployment of rapid COVID testing for all Americans.
Y ou've made the point that rapid testing is the tool that maybe helps
us end the pan demic without lockdowns or massive quarantines. But
as we hear about shortages of rapid tests and some of the public
health sites for testing not as readily available, maybe you could talk
to our listeners a little bit about kind of the medical approach to
testing using the more sensitive but the slower PCR tests with a more
delayed response time to rapid test is maybe the better public health
intervention.

Dr. Michael Mina: E arly on in this pandemic, we focused on the PCR test in general
because that was - - it's a very easy thing to develop , a PCR test. We
need to know the sequence of the virus and then within a day or so
we can have a well working PCR test. But the PCR test was pretty
readily recognized that PCR is not the best approach if our goal is one
of public health. W hat I mean by that is for public health, we're not
interested in asking i s this person symptom due to an infection that
they had two weeks ago? That's for a physician to answer. A physician
does not have to think about the 99.9999% of pe ople that are not

Michael Mina

passing through their office.

But in public health, we have to think about the system, we have to
think about how do we reduce transmission of this virus across the
community. T o do that a rapid test is what we need, because a rapid
test will indicate if you are currently infectious, and they're extremely
accurate for doing that. If you're infectious with this virus and a risk
for spreading the virus to other people, then these simple rapid tests
are going to turn positive.

There's been so much confusion about is it less accurate or more
accurate. I n many ways, it is actually the more accurate test for that
specific question. W hat happened early in this pandemic is we
medicalize the approach . I t felt like our approach to tackling this
pande mic, this global health emergency was trying to tackle it at an
individual medical basis, one person at a time. Y ou will never claw
back a pandemic one person at a time , you have to deal with the
pandemic and then the medical issues resolved themselves if you stop
the spread. But what happened was we started regulating these tools
as medical devices, which put the FDA actually in an impossible
position of trying to say, o kay, we need to take a test that is highly
accurate to ask if you are infectious and co mpare it to a PCR tests
that's highly accurate to ask, d o you have any remnants of viral RNA
even if you were infectious for weeks ago, so they're very, very
different things.

I like to liken it to a security system at an airport is a bit like having 1%
o f all people who are going through the -- into an airport, we're only
shuttling 1% of them through the security screens. Meanwhile, 99% of
the people are just not getting screened at all. T his is the difference
w hat we found, obviously years ago with airpor t screening is we can't
do that , we actually have to have a 100% of the people walking
through metal detectors, even if they're not the most sensitive to
detect the m. V ery last little charge metal you might have in you, they
are doing the exact job that we need them to do amongst the most
number of people as possible , a nd that's what rapid tests are
extremely good at doing.

Mark Masselli: I t seems that President Biden's gotten religion about scaling up the
production of rapid tests and really trying to driv e that price point
down. He's planning to deploy them , I know we're going to receive
th em here at Community Health Centers , but also s afety n et providers
across the country, really making sure the underserved population are
able to have access to it. But t here are some real concerns about the
lack of supply. I'm wondering if you could talk to us about the hurdles
that remain whether the current administration's efforts are going far
enough .

Dr. Michael Mina: Well, at the moment, they are not going far enoug h. But I do believe

Michael Mina

that they are trying . T he President's COVID - 19 action plan that he
announced the other day was a massive step in the right direction.
W hat happens with these types of plans is he comes out and says
we're going to get 280 million tests , t hat's a pretty mediocre number
of tests when you have a country of 330 million. When we need tests
to help us in our everyday lives, we need more than one test p er
person per year. What it was, was a recognition that these tests are
extremely important to our overall efforts to battle this virus.

I think where the administration has had difficulty is understanding
actually what is the true bottleneck in terms of Americans having
access . T hey've been trying . W hen I spoke with the Trump
A dministration a nd ea rlier during the transition with the Biden
A dministration, the response that I got quite often was, this sounds
like a great idea. Frankly, we don't have any supply to actually make a
robust plan for the country , s o that's kind of where the conversation
al ways ended.

W hat we can do is we can recognize so why is the US so behind our
European counterparts to get this test? It's not because the test don't
exist. It's not because we need to scale up a few companies more
because they're the only companies that c an make these tests. It's
because we have evaluated these tests all wrong. It has created a
bottleneck in terms of which companies have actually been able to
pass through the FDA gauntlet to get authorization.

You can't really blame the FDA, they've been a sked to do one thing
which is authorized medical devices. U nfortunately, because the US
doesn't have a regulatory framework for public health tools, all of
these powerful public health tools had to go through the FDA ’s
bottleneck of medical devices and mos t of them not bec ause they're
inferior technologies, b ut because the companies didn't know how to
set up their clinical trials to kind of skew the participants the right
way .

I have not been able to gain authorization , s o there's actually a very
simple sol ution. T hat solution is for the President to use executive
action to do something very simple, which is to state that the tools
used for public health testing will be designated as public health tools .
W hat that would do is it takes the onus off of the FDA , and it places
the burden on the CDC or the NIH to figure out how to authorize
these appropriately as transmission indicating tools, not tools to tell
you that you have any RNA from a previous infection. But the tool
that tells you now in real time that y ou are infectious, if the CDC takes
it over, then they can use the right metrics to evaluate these tools,
they can say we just need the tools that will detect people who are
infectious . T hen we can also even look to Europe and say, what are
our trusted all ies , a nd if they've had good experience for a number of

Michael Mina

months with certain tests, then immediately overnight we could say,
we are going to see to review and enable those companies to come
into the United States as well. We could triple our access to tests
literally overnight, and all it takes is a re - designation, that's very
sensible.

Margaret Flinter: That’s such a clear call to action, and maybe less clear is what should
we be doing in the nation's schools? I understand more than a million
children had b een diagnosed with COVID . In the past week, we've
certainly seen younger children being sicker than we saw pre - Delta
V ariant. Y et school systems seem to be really struggling. Should they
be testing all kids? How do we avoid hopefully the kind of extended
q uarantines and lockdowns that we had before? What is your public
health perspective on testing for COVID in the schools, at least in
areas where the pandemic is really running rampant?

Dr. Michael Mina: I mean, there's nothing more important, I think, in a society than
making sure that we're giving children the foundation that they need
to succeed . T aking a year away from peers away from school, we
don't have any idea actually what the damage is going to be. W e need
to stop quarantining students . A lot of s chools have relied on PCR
testing, even when they're taking three days to return. The test that
comes back three days later is just not stopping transmission and
particular ly with Delta . W e keep putting a lot of energy into these PCR
tests, largely because we haven't had the rapid tests available.

If you have an outbreak in your school, you can stop the outbreak
very, very fast, deploy rapid test , have them in people's homes. I f you
have cases start to emerge in your school, have all of the students use
a t est each morning for five days to keep kids in school, without
needing to stay home just because Johnny in their classroom was
found to be infectious. These tools are 95% sensitive to detect people
who are currently infectious, and nearly 100% sensitive to detect the
super spreaders which are really the problems in school . I f you're
really interested in stopping spread , these are 95 to 100%. W e can
deploy these at scale across schools s o Johnny in the classroom is
found to be infected, instead of telling al l 25 of those children to go
home for 10 days. That's an information problem.

We closed down society last year, purely because of an information
problem. But with rapid tests, we actually have a tool that solves this
inflammation problem. So have kids use them before they go to
school. A lot of people say well, how do you know that they actually
used it? Well, we actually have software and we have verification
programs that enable it. Companies like eM ed have worked with the
CDC and Abbott to create platfor ms that allow you -- allow a proctor
to actually watch that , yes little Johnny did do his test today a nd he
gets a real laboratory pass. T he result goes to the public health

Michael Mina

authorities , s o it allows us to also keep the epidemiological data
flowing. W e sho uld really be using all of these different tools to keep
kids in school a nd frankly to stop outbreaks .

W e've been focusing on masks, but we should also recognize that
masks don't do a whole lot in a classroom because they're all pulling
down their mask all the time , a nd this is a highly response virus . B ut a
rapid test before school will be like a 95% reduction in risk that you're
walking and spreading. I would urge the CDC to o to really start
creating guidance for each individual sector of society, whether it's
schools, businesses, vaccinate or test we have to really have a hard
conversation about why that program was created by the P resident
because vaccines aren't stopping transmission. It's a hospitalization
staffing too. W e just have to redefine what it is we're even trying to
do here and I think we absolutely can.

Mark Masselli: We're speaking today with Dr. Michael M ina , Assistant Professor at
Epidemiology, Immunology a nd Pathology at the Harvard School of
Public Health in the Harvard Medical School. H e's a member of the
Center for Communicable Disease Dynamics , and a lead re searcher at
the Human Immunomics I nitiative.

Dr. Min a , your team at Harvard has been applying multiple disciplines
to really develop a new surveillance system for monitoring outbrea ks .
How do we do a better job of data mining and surveillance? What's
the larger strategy that goes all the way down to the local public
health organization that they can utilize as well ?

Dr. Michael Mina: I'm really glad you're asking this because there i s a major difference
between public health surveillance and public health mitigation
strategies. Surveillance is to give the public health authorities an idea
of what's going on so that they can then act. But public health testing
and screening is actually the action. T here are two different things ,
a nd I think we have tools actually that we have not really deployed for
pandemic preparedness in the future that can actually allow us to
discover new pandemics before they really take off using the immune
syste m , using new tools that allow us to profile millions of blood
samples very rapidly for all sorts of viruses to look for the immune
signatures of a novel outbreak . W hat I would like to see developed as
a global immune observatory to really tie laboratories across the
globe together for true pandemic surveillance.

But coming back closer to home, we have a lot of different options for
this pandemic. For example, a lot of people think that we are just
bee n testing purgatory . I don't want us to just be testing f orever . I
want us to be testing strategically. T o do that we need to have good
surveillance systems at local levels . W e can do what some schools
have done which is deploys sort of testing a fraction of students once
a week, it's just enough to be able to i dentify if there's an outbreak

Michael Mina

that's sort of emerging. But we also have really, really powerful tools
in wastewater surveillance, which you can actually do quite easily in
many locations. Y ou could say, as long as there's no massive cases
going on communi ty, we're going to just do passive wastewater
surveillance for viral RNA. I f you start to detect viral RNA in the
wastewater, then you know that there's cases and then you can turn
back on the individual level testing.

I call this s ort of dynamic testing a pproach i s it doesn't just have to be
that everyone tests themselves once a week, no matter what, stop
the testing, when cases really start to pick up, then you can scale up
the testing. T he only way to really do that, to have this sort of
dynamic fluctuat ing amount of testing is to have people have these
rapid tests at home, because then you're distributing the effort of
turning them on and off, you're not having to deal with a lot of big
logistical chains of hiring nurses. Y ou're just allowing the public to do
what the public should be doing in a public health emergency, which
is participate in public health, even from their own homes. I would
like to see us really have dynamic testing, combined with localized
surveillance programs that can enable schools to move forward in a
very tolerable way.

Margaret Flinter: W ell , Dr. Mina that is a really helpful public health perspective. I
wonder if I could turn our focus just for a minute to some of the
people in the middle of this pandemic , a nd that's the health c are
workforce that's been at the heart of trying to respond and care for
people. I think 3600 health care workers died from COVID l ast year, a
disproportionate impact on people of color and yet application for
people coming into health care, at least in m edicine and nursing,
where there's some good data is up . I t seems like there's been a
renewed call to service perhaps that people were experiencing . B ut
from where you sit, how should we be thinking about maybe revising
training and curriculum to meet the needs of our world going
forward? How should we be preparing them maybe a little bit
differently ?

Dr. Michael Mina: W e should recognize where our deficiencies are in our medical
training. But also in our public health training, w e talk a lot about
health c are, but in the midst of a pandemic, actually, the health
professionals, they are the boots on the ground for the sick people.
But dealing with a pandemic actually doesn't really require health
care i nterestingly enough, it requires engineering , it require s a lot of
different sciences. Actually, health care is almost like the end of that
line, it should be the last thing because if you're seeing somebody in a
health care setting, that means we've failed up front with the public
health bit.

One of the things that I wish that we could do, because it's hard in

Michael Mina

high school and college for students to really get engaged with public
health, we should be building graduate schools that are much more
robust around public health that is almost equivalent to medical
sc hool . W e have master's programs , b ut we don't really have a real
profession of public health in the way that we have an industrial
complex of medicine. M aybe many, many physicians actually find
themselves wanting to do public health. But ultimately, the wa y that
we train students is so medicalized that it doesn't tie together.

We tell people that they understand public health, but actually they
don't . T hey never actually practice it. I would love to see for example,
medical education include rotations in pu blic health agencies. Our
physicians are some of the brightest people in this country and but to
not funnel them as many who would want to into these things where
instead of you're dealing with one patient at a time you're dealing
with populations . I would love to see rotations really start pushing on
that. CDC is actually has a little bit of that there's actually residency
programs for public health, but they're pretty limited.

I do think we have to be really careful after this year . W hile we're
seeing a b ig increase in people wanting to go into professions that
have been engaged with the pandemic, at the same time we're seeing
the people who have actually been engaged with the pandemic, who
are already professionals burning out at unprecedented rates. H ow
we tackle that I think, is really going to be crucial to make sure that
we are not -- we're not setting students up to see mentors who are
burning out and then choose to run away from it.

This country in particular has a tremendous amount of money and
reso urces , a nd I don't feel that we deploy it well enough . L ike just
what residents get paid, for example, has barely increased in years ,
a nd so that causes people to move away from things like public
health, because it doesn't pay very well and move towards
n eurosurgery. Why don't we pay people who go to the CDC like we
pay doctors ? W e should be paying people commensurate with the
work they're doing , a nd public health generally tends to be pretty
darn secondary.

Mark Masselli: I hate to say that there's a silv er lining to this dark cloud, we've seen
the advance of the mRNA vaccine. What are you seeing out there that
maybe past the pandemic itself in terms of the exploration that's
going on with these new platforms ?

Dr. Michael Mina: I don't think it's bad at al l to say you hate to say that there's a silver
lining , a nd there are so many silver linings to this absolute travesty
that we've been dealing with . T he technology that is getting
developed during this pandemic has literally been accelerated
anywhere from 2 to 10 years, as a result of the need and urgency.
mRNA vaccines are an amazing advancement that have kind of been

Michael Mina

trickling out for a while . Y ears ago, I was working a bit with M o derna
on their Zika vaccine. Now what we're seeing is the world has seen
the power of these tools in a profound way. T hese are going to be the
tools as we move into the future that are going to enable us to
harness the immune system to battle cancer, really a pretty early
stage in our understanding of how to coerce this powerful s ystem w e
all have inside of us our immunity to fight things like cancer.

I believe very firmly that in the next coming years we're going to start
seeing mRNA vaccines that are going to be personalized to your
cancer to actually help us fight it off. We're also going to see moving
away from the vaccine industry but towards sort of testing and all this
telehealth because people couldn't move around during the
pandemic, we saw this massive acceleration of physicians and
telehealth companies getting on board to say, l ook, you don't have to
spend a half of a day to go to a doctor just to talk with them for 30
minutes, you can actually do it from your home quite well. T his has
really changed people's view of what is possible in healthcare.

Now, we're also seeing t hings like RADx with the NIH really accelerate
the development of new technologies for diagnostics across the
board. T he need to go into a doctor's office on a regular basis is going
to change. We're going to be talking to our doctors through
telemedicine . W e're going to have tools at our disposal to either join
into drug trials from our home or just to be able to monitor ourselves
on a more regular basis and be able to really get preventative health
care as a part of our society. It's things that we can't even imagine
what their use is going to be , b ut it is absolutely going to make , I
think , the average Americans interaction with what is currently an
extraordinarily strained health care system much more manageable.

Margaret Flinter: We've been speaking tod ay with Dr. Michael Mina, Assistant
Professor of Epidemiology, Immunology a nd Pathology at the Harvard
School of Public Health an d Harvard Medical School. Dr. Mina, we
want to thank you for your commitment throughout this pandemic, to
helping to educate th e public to advance the science of public health
and interventions that will save lives. T hank you so much for joining
us today on C onversations on H ealth C are.

Dr. Michael Mina: Thanks so much for having me.

[Music]

Mark Masselli: At C onversations in H eal th C are, we want our audience to be truly in
the know when it comes to the facts about health care reform and
policy . Lori Robertson is an award winning journalist and Managing
Editor of F act C heck.org, a nonpartisan, nonprofit consumer advocate
for voters that aim to reduce the level of deception in US politics. L ori ,
what if you got for us this week,

Michael Mina

Lori Robertson: How do people who have not been vaccinated against COVID - 19 pose
a risk to people who have been vaccinated ? An unvaccinated person
who is infe cted with COVID - 19 poses a much greater risk to others
who are also unvaccinated, but vaccines are not 100% of e ffective, so
there is a chance that an unvaccinated person could infect a
vaccinated person, particularly the vulnerable. Although all of the
va ccines approved and authorized for use in the United States are
effective at preventing symptomatic disease, so called b reakthrough
cases of COVID 19 after vaccination are to be expected, perhaps even
more so now because of the more contagious Delta V arian t of the
virus .

A September analysis by the Centers for Disease Control and
Prevention said that since the introduction of Delta , vaccine
effectiveness against hospitalization ranged from 75% to 95% and
effectiveness against infection range from 39% to 84% . Wh ile the
chance is much lower for vaccinated individuals, they can still contract
the virus and even have a severe case. In particular
immunocompromised people who already have moderately to
severely weakened immune systems are vulnerable. That's why th e
Food and Drug Administration authorized a third dose of the mRNA
vaccines for certain immunocompromised people.

Also, studies show vaccine effectiveness against infection and milder
forms of the illness wanes over time, and the elderly can experience a
d ecreased immune response due to aging. The CDC and FDA recently
recommended a booster shot of the Pfizer vaccine for those aged 65
and older as well as other groups at increased risk.

More unvaccinated people in a population also leads to more virus
transm ission. Johns Hopkins University E pidemiologist David D owdy
told us that when transmission rates increase , the risk for everyone
goes up. Still, the risk of getting COVID - 19 is higher for the
unvaccinated. A CDC study found that due to the Delta V ariant, t he
unvaccinated were nearly five times more likely to become infected
about 10 times more likely to require hospitalization, and almost 11
times more likely to die from COVID - 19 th a n fully vaccinated
individuals. T hat's my fact check for this week. I'm Lau rie Robertson,
Managing Editor of F act C heck.org

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 hav e a fact that you’d
like checked, email us at 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

Michael Mina

we llness a part of our communities and everyday lives. Stanford
based bioengineer Manu P rakash has a simple goal. He wants to
create a portable medical lab small enough to fit in a backpack, and
he's already developed a tool that fits the bill. While sitting under a
tree in Uganda, he noticed that the local medical clinics door was
propped open by an expensive centrifuge machine, one that was
reliant on electricity now broken and no longer in use.

He wondered how could he create a portable centrifuge that wou ld
be inexpensive to make and easy to replace? His inspiration came
from a simple childhood toy, the whirl i gig, a toy that functions by
pulling two ends of a string threaded through a round object like a
button.

Manu Prakash: W e spent a significant portion of this time truly understanding the
mathematical face space for how you can convert linear motion into
rotational motion. There's some beautiful mathematics hidden inside
this object.

Margaret Flinter: H e took this simple toy idea to another level creati ng a human power
centrifuge made from simple components, paper, twine and plastic.
All together each paperfuge , as he calls it , can be constructed in under
two minutes and cost only 20 cents . Y et remarkably, it works
extremely efficiently.

Manu Prakash: Wi th this set of principles, we're able to essentially make a centrifuge
that spins all the way to 120,000 RPM . W e can separate and pull out
malaria parasites from blood. This is a tool that requires no electricity,
no infrastructure . Y ou can carry them arou nd in your pockets f or a
price point of 20 cents

Margaret Flinter: T he paperfuge , a cheap but highly effective feel to for clinicians
providing a portable solution to diagnostic challenges creating a
quicker pathway to diagnosis and treatment. 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 .

[Music]

Female : 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 email us at
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Michael Mina
Health Center .