CDC Director Rochelle Walensky on COVID Fall Booster Details

Rochelle Walensky

M arianne O’Hare : Welcome to Conversations on Health Care . This week we
welcome Dr. Rochelle Walensky , Director of the Center for
Disease Control and Prevention on a recent announcement of
a sha ke up of the agency to address failures in the pandemic.

Dr. Roc helle Walensky: So the strategy now is to tailor vaccine for giving us the largest
breadth of response.

Marianne O’Hare: Lori Robertson joins us from Fact C heck .org a nd we end with a
bright idea improving health and wellbeing and everyday lives.
Now, here a re your hosts, Mark Mas s elli and Margaret Flinter.

Mark Masselli: CDC director, Dr. Rochelle Walensky , recently said , “ To be
frank, we are responsible for some pretty dramatic and pretty
(inaudible 00:00:38) mistakes during COVID from testing to
data to co mmunications . It's the agency's responsibility to
learn from those lessons and do better. ”

Margaret Flinter: Dr. Walensky has an ambitious plan to reset the CDC . A nd . of
course, it can't be happening soon enough as we are facing
new hurdles. She ’s been in the post since 2021 , and we always
appreciate he r taking time to speak with us.

Mark Masselli: Yeah, thank you so much Dr. Walensky for being a guest again
on Conversations on Health Care .

Dr. Rochelle Walensky: Always delighted to be with y ou. Thanks for having me.

Mark Masselli: Yeah, we're experiencing a BA.5 outbreak as we talk with you.
Soon , you and your colleagues will announce the decision on
new COVID B ooster shots . I ’m wonder ing if you could share
with our listeners the process that you'll take to review the
data to make sure that it's safe and secure for the American
public.

Dr. Rochelle Walensky: Yeah, well, maybe first I will say we have now given over 600
million doses of this vaccine in this country , s o we have an
extraordinary safety profile probably unlike any we've seen
with any vaccine in history. W hat will happen over the next
several weeks is Pfizer and Moderna have put forward
applications for this new b ooster for the fall a Bivalent
b ooster , which is part prototype the original str ain a nd p art
BA.5. As they do so , the FDA ’s Advisory Committee will review
those data, the FDA will authorize that should the FDA make
the decision to authorize that vaccine . T hen it'll come to our
Advisory Committee on Immunization Practices a nd then I will
pu t forward a recommendation for its use. T hat is the process
in the weeks ahead and looking forward to being able to
execute on t hat based on the conversations.

Rochelle Walensky

Margaret Flinter: Well, you have questions flying at you every day at CDC, and
certainly one of the big ones seems to be the opinions about
when's the best possible time to get a COVID b ooster shot ?
S hould somebody get it as soon as possible , when they --
when and if they become approved , o r should they wait until
cases rise in the fall and winter, a s we've seen in the earlier
winters of the pandemic in order to maximize immunity when
it's really needed ? Is that part of CDCs role to o to weigh in on
timing and try and educate the public as to what is maximally
effective for them?

Dr. Rochelle Walensky: Yeah, one of the things I will say is as we've rolled out our
guidance we have been --- for our vaccination , we have been --
- the data on what these vaccines are good at and doing has
changed over time. Right now we know specifically with the
Omicron vari ant , w hile they are good at preventing infections,
they are very good , exceptionally good , at preventing severe
disease and death . I n fact, even to this day as we have over
350 deaths a day still, with this BA.5 variant as you noted, the
people who are see ing most at risk of severe disease and
death continue to be those who are unvaccinated or under
vaccinated .

I've always said there is no bad time to become up - to - date on
your COVID checks. If you haven't gotten a b ooster in the year
of -- calendar year of 2 022, and you're eligible for a b oost er ,
there's no bad time to get one . We are going to be reviewing
data on these updated b oosters , as I mentioned coming soon .
B ut if you are in a place where you feel like you're at high risk
of severe disease, if you're over the age of 50, if you're
especially over the age of 65 and there's a lot of infection in
your community, you may want to go ahead and not wait for
that b ooster . The information from that b ooster , get the one
that is available to you now and then w e’ ll have further
recommendations about when you can get an updated
b ooster in the fall.

What I really want to avoid is somebody who was waiting two
weeks and happened to get severely ill in that interim period
of time when they could have avoided that by gett ing the
p rototype b ooster now . M y party line is never a bad time to
get a booster if you're eligible. If you get one today, and you
should if you're eligible , that doesn't necessarily mean you
won't have a recommendation for another o ne in the fall.

Mark M asselli: Well, that's great Dr. Walensky . Just one more question on this
because there are other scientists that say the government is
moving too fast and they believe the existing vaccines provide

Rochelle Walensky

strong protection against severe disease . S ome say the new
b ooster raises questions because it involves studies on mice
instead of humans. I'm wondering if we could give you a
chance to respond to those criticisms.

Dr. Rochelle Walensky: Yeah, and maybe this goes back to the safety of those
vaccines, which we kno w based on hundreds of millions of
people who have received them are extraordinarily safe. As we
have updated these b ooster shots for the fall, the data that we
a re looking at is related to very, very small changes in the
mRNA sequence, and really shouldn' t impact safety at all.
We're not expecting it will impact safety .

T here's always a question here of being too slow versus too
fast . I think one of the challenges is if we wait for those data to
emerge in human data, not just mice data, in human data, we
w ill be using what I would consider to be a potentially
outdated vaccine . M aybe it's best , and I believe it is best , to
use a vaccine that's tailored for the variant that we have right
now. W e do know that the variant -- over 88% of the
sequences that we're seeing right now are BA.5 , over 98% are
either BA.4 or BA.5 .

T he strategy now is to tailor vaccine for giving us the largest
breadth of response, ideally one that would have less waning
over time , and that is by targeting what I would say is the most
prox imal variant, the one that we have closest to us, which is
BA.4 and BA.5 . I believe there's significant upsides to doing
that with this updated Bivalent Vaccine , and very little
downside in doing so. W hile we -- I have heard those critics
before , but I act ually think in a time of we could either be too
slow or too fast , I really would love to be ahead of this variant
this season.

Margaret Flinter: Well, August is wrapping up , Labor Day is right ahead of us ,
and we understand that f ederal officials are prepa ring for a
Labor Day kickoff f or b ooster vaccine campaign . We saw plan
online to talks about leveraging partnerships and engaging
trusted messengers, which really was the foundation of so
much of what we did in the communities , I think , throughout
the coun try over these last two years. But still, we've hit walls
around getting everybody to be vaccinated even with the
primary series and pure as you've noted with the b ooster
doses . Is there anything new, dare I say radical or new
different , you feel that ther e's element to the approach that
you're going to take that may really capture pe ople's attention
at this point?

Dr. Rochelle Walensky: Yeah, I think, first of all we ’ve recognize d that we need to have

Rochelle Walensky

ease in messaging . We really need to have people unders tand
the communications of who should get what when , and so
that is certainly something that is high on our mind. I don't
want to get ahead of when , this is actually going to happen
when we'll hear from the FDA, when we'll hear from the ACIP,
but what I wi ll say is time and time again, we've learned that
we can make the recommendations, but it's you the trusted
messengers, the people who work with folks who trusted all
day every day on the ground who have been the reliable go to
through not just COVID - 19 , b ut through prior health
challenges , through prior health care, you are the people who
can deliver those messages for us and who we will continue to
rely upon. One group also that I think is going to be critically
important is our children. We do have vacci ne now for even
our youngest d own to six months old. Yet the uptake of that
has been slow . A s we get our children back to school, we do
really want to send a message that we know how we can keep
them safe.

We've seen incredible safety benchmarks from even down to
the youngest , and we'll continue to relay those data as well s o
people know that they can rely on the safety of these vaccines .
When it comes to our children , COVID - 19 during the pandemic
has been one of the top five killers of our children and in the
age demographic under the age of 18 and the number one
infectious cause of death during the pandemic.

Mark Masselli: In addition to the internal review that you initiated, the
General Accounting Office will soon release a report on CDC
that is expected to be very tough. What do you think the GAO
report will show? In the interest of transparency, will you be
able to release the entire contents of your own study that you
initiated?

Dr. Rochelle Walensky: Yeah, so I can't actually speak to the GAO report p rior to it
being public. But I can certainly speak to our review , and
maybe I'll just say that we took on two parallel processes. We
took on a process that was led by Jim Macrae that really
looked at our COVID - 19 response, how do we operate during a
pandem ic, if you will, and what are our -- what did we do well,
and what are some of the challenges that we had and how can
we learn the lessons of our response in our everyday
operations at CDC.

We also wanted to take at the same time a review of our just
basel ine systems, processes, policies, that may not incentivize
people to work in the optimal way that they do ., and so we
took on both of those reviews . W e engaged in over 170

Rochelle Walensky

interviews with key stakeholders, both within the agency ,
within our response, but t hen importantly outside the agency,
government officials, prior CDC d irectors, other public health
leaders to really understand their perspective . These are key
stakeholders who understand CDC , utilize CDC , depend on
CDC . In both of those processes we've s ynthesized a lot of the
work that we have ahead and those will become public in the
week ahead.

Margaret Flinter: Well, we certainly know Jim Macrae well from the Community
Health Center world. We’re glad to see tha t he was working on
that review, but we h ad --- .

Dr. Rochelle Walensky: And a dear colleague.

Margaret Flinter: Yeah, dear colleague . W e had the opportunity recently to
speak with one of your predecessors, Dr. Tom Frieden who I
thought had an interesting idea . He suggested that it would be
a good idea for you to hold a press conference. I think he even
said it hour long press conference, if I'm not mistaken, with all
of the CDC experts to discuss boosters, the new school
guidelines and any other questions that would help us towards
this goal of mo re transparency and perhaps more engagement
of the public. Would you be open to that kind of press
conference? Do you think it might accomplish some good in
terms of giving people a chance to really hear from you and
your colleagues directly?

Dr. Rochelle Walensky: Yeah, one of the things that we learned through this review
from both Jim and our own review is that there was a hunger
for more contact with our subject matter experts , discussion
with our subject matter experts, press conferences with health
re porters so that they could ask s sort of nitty - gritty health
related questions rather than sort of just made overall p ress
reporters. W e've taken that to heart . Y ou have probably seen
through our monkeypox response we ’ve have had many more
press conferences in that regard. We have done more with
regard to and did one when we released our COVID - 19
guidance. C ertainly something that is on the table , and as part
of really learning from what we have from the review itself is
that we have been engaging in more an d more of these press
conferences with subject matter expertise at CDC.

Mark Masselli: I think one thing that the public may not know is that while
CDC receives a good amount of money, it doesn't have a lot of
flexibility in that expenditure. L et's say you could go to Capitol
Hill and make anything happen , w hat's the one wish you'd
want the budget gods to grant you right now?

Rochelle Walensky

Dr. Rochelle Walensky: Well, I can't synthesize it down to one wish, but I will give you
maybe top two or three. One , is we really ne ed sustainable
longitudinal budget lines that don't wax and wane from crisis
to crisis . The infrastructure in public health, our core
capabilities, our workforce, our laboratory, our data systems,
we need a sustainable investment that I would say is diseas e
agnostic , o ne that doesn't necessarily wax and wane as we
talked about . W e are now looking at how we can utilize COVID
dollars to help monkeypox resource efforts. T hose are the
kinds of things that I think are really challenging, and it needs
to be susta inable. It can't be borrowing from a prior challenge ,
s o that I think would be one big one, again, disease agnostic,
sustainable resources.

The other is that there are challenges in this review s pecifically
we identified challenges that didn't allow us to be as nimble as
we otherwise might have wanted, didn't allow us to see a full
scope of everything that we wanted. T here are of course
challenges related to our data authorities. We wait for data to
come in from our state and local jurisdictions, our partne rs,
but we can' t compel those data to come in, so we can't always
see where all the cases of monkeypox are or where all of the
vaccines are or the ethnic and racial diversity of who has been
vaccinated. We can't compare those . Now those data are
starting t o come in as you've probably seen .

We have challenges with the Paperwork Reduction Act and the
delays that we have in setting up studies because of the
Paperwork Reduction Act . Challenges related to our human
resource authorities, how quickly we can hire , h ow quickly we
can deploy even during a pandemic . S ome of these are -- the ir
nitty - gritty authorities w ho are kind of in the weeds here, but
they have really hampered our ability to be nimble in a time
where it was so important to be nimble.

Margaret Flint er: Well, I think in many ways you've answered the question that
was on the tip of my t ime , but I'm going to ask you to expand
upon that a little bit a nyway . C ertainly, we did learn a lot
wherever you w ere , in health care or just wherever you were,
during COVID. T hen monke y pox appeared on our horizon
unexpectedly, I would say from our perspective . We ran into
some of the same issues around getting access to testing the
vaccine shortage issues and some confusing messages I think
as we tried to explain to peo ple different strategies for
stretching the vaccine supply. How do you think we're doing
with monkeypox across the country and really taking the
learning from previous experiences and getting it out there ,
particularly , I think , in terms of education, vacc ines and

Rochelle Walensky

testing?

Dr. Rochelle Walensky: Yeah, I mean, I think it's interesting to think about what are
the parallels a nd what are the differences with these two
outbreaks, or in one pandemic, one outbreak . Certainly, one of
the things that I think is very similar is though we knew a lot
about monkeypox by virtue of the fact that we had been
studying at the CDC for decades, which I think really helped us
jumpstart things. Most of the American public did not know
about monkeypox , and most clinicians did not know about
monkeypox , s o we were scientifically more attuned and knew
more about monkeypox , but we needed to educate America,
all of America, what is this disease? What should you be on
the lookout for? How is it transmitted ? T hat was a huge heavy
lift ear ly on as this outbreak was taking hold.

The testing component was different. We again, we had a test
for this . W e had sequences published within days of finding
the first case that were on our website -- published sequences
as well , actually they were on o ur website within days, so that
people c ould easily find them. We scaled up our laboratory
testing . W e we re talking to commercial labs within days of
that first test to be able to scale up laboratory testing , but we
ha d to educate America that not everyone can walk in and get
a monkeypox test, you actually need to have a rash in order to
be able to get a test. T hen we needed to work closely with our
state and local health departments as to how and who should
be able to send those monkeypox tests and how can we make
sure that we're getting the right people to get those tests and
get those results back faster.

One of the challenges that we've had at CDC is again ho w slow
the data were to come in . How slow we were to receive data
from our local jurisdictions t o be able to then feed it back to
the American people and back to our local jurisdictions , a nd
that is not -- this is a partnership with the local jurisdictions
that we are fostering . O ne of the things we’ve learned from
their review is how much we need to work more closely with
our local jurisdictions and our partners in those ways . B ut we
need to have data systems that allow fluid flow of those data .

We were getting case reports, in some cases by e - mail , and
some cases by Excel, and in some cases by Cloud, that's not a
productive way to be able to import our data. T hat's really one
of the core public health infrastructures that I think we need
to bolster in the years ahead to make sure that our data
systems can receive those data fluidl y so we can feed them
back out.

Rochelle Walensky

Mark Masselli: So important data unite s us, anecdotes divide us, s o having
that information is so important. Let me ask you about
because I think we're all sorting out Dr. Fauci's upcoming
departure from government service , w hat that will mean .
You’ve worked with him, he's a friend . W hat's the -- maybe
share with us a little bit about his departure , b ut what's the
biggest piece of advice he's given you through the years?

Dr. Rochelle Walensky: Maybe what I will just say is I have had the great gi ft and
fortune of knowing Dr. Fauci for about 20 / 25 years . H e has
been a mentor to me, he has been a colleague to me and I've
had the great gift of working with him closely over the last
year and a half. He's a giant public servant. He has incredible
exper tise and incredible wisdom . Maybe what I will just say is I
wish him the very best of luck in his exciting next chapter,
which is I'm understanding not retirement, but just the next
chapter . I'm really thrilled for him and wish him only the very
best.

Marg aret Flinter: He a r , he a r. And Dr. Walensky , many thanks for your time
today , and thank you for our audience for being here. You can
learn more about so many things and learn more about
Conversations on Health Care by signing up for our e - mail
updates at www.chcradio.com . Dr. Walensky thank you so
much for taking the time to share your thoughts with us.

Dr. Rochelle Walensky: Always good to be with you. Thanks for having me .

[MUSIC]

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

Lori Robertson: Numerous studies have found that COVID - 19 vaccination is
safe during pregnancy and doesn't raise the risk of
miscarriage. Results from the Pfizer - BioNTech clinical trial are
consistent with those findings. In the trial for the Pfizer COVID -
19 vaccine there were just three spontaneous abortions or
miscarriages reported among 50 participants who became
pregnant and received the vaccine during the trial. The
miscarriage rate was normal and wasn't more than the rate
among those who received the placebo.

Estimates vary but miscarriage before 20 weeks is common

Rochelle Walensky

and occurs in some 10% to 20% of known pregnancies. But a
false claim has been spreading through social media that
during Pfizer's main clinical trial 44% of the pregnant women
who were vaccinated miscarried . T hat's wrong. Th e statistic
comes from a faulty tally of miscarriages that counted each
miscarriage twice and included miscarriages fro m people in
the placebo group.

The claim originates from a post on the DailyClout, a website
run by Naomi Wolf and author and former Democratic
consultant who is trafficked in conspiracy theories. The August
12 p ost is no longer on that website , but as we often find,
once a claim is made it can take on a life of its own on other
websites or in social media post. The post claimed that
according to a Pfizer document that was made public through
a Freedom of Information Act request, there were 22
instances of miscarriage out of the 50 subjects in the trial, who
reported pregnancy after the first dose of the vaccine. But
there are only 11 unique miscarriages listed in the Pfizer
document. Each miscarriage was counted twice because they
appear in two different ta bles. And those 11 miscarriages are
for all participants, vaccine and placebo recipients combined.

We at FactCheck.org cross checked the information with a
document that shows whether a participant was assigned to
the placebo or vaccine group. We found tha t three of the 11
miscarriages were among vaccine recipients. The remaining
eight miscarriages were in the placebo group, which also
reported one induced abortion . T he 44% statistic is false. Since
the Pfizer trial, other studies have looked at vaccination and
pregnancy. Victoria Male , a lecturer in Reproductive
Immunology at Imperial College London has been tracking this
research. She told us that none of the eight studies looking at
miscarriage found an increased rate of miscarriage associated
with COVID - 19 vaccination. Those studies included nearly
72,000 people who we re vaccinated during pregnancy. T hat's
my fact check for this week. I'm Lori Robertson, Managing
Editor of FactCheck.org.

[ Music ]

Marianne O’Hare: FactCheck.org is committed to factual accur acy 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 w e'll have FactCheck.org’s Lori
Robertson check it out for you here on Conversations on Health Care.

Rochelle Walensky

Mark Masselli: Each week Conversations highlights a bright idea about how to
make wellness a part of our communities and everyday lives.
Over the past few decad es kids have been getting less and less
physical activity throughout the school day and as budgets
have been tightened, and achievement requirements of
increased Phys Ed has become less prevalent in many schools .
T he University of Michigan researchers want ed to find a
creative and effective solution that would increase kids
movement and increasing sedentary lifestyles without
disrupting the school day .

Dr. Rebecca Hasson : We looked at the scientific literature in terms of prolonged
sitting , and they have de monstrated that if you just do two
minutes of activity, a small burst ,. get up do some movements,
sit back down activity and that small of a dose can have
dramatic improvements on health , on cognition , on learning.
W e decided to develop an intervention , a program , that would
allow children to get these small burst of activity throughout
the day.

Mark Masselli: Dr. Rebecca Hasson is Principal Investigator for InPACT ,
interrupting of prolonged s itting with activity . She wanted to
find out if just two to three minutes short burst of physical
activity five times a day would impact the kids ’ cumulative
movement. The research showed that kids of all shapes and
body types found that program easy to participate in.

Dr. Rebecca Hasson : We typically see in PE or reces s lower participation in girls
compared to boys , but in classroom activity breaks you
actually see similar rates of participation, if not higher rates of
participation in girls compared to boys. We also saw that for
children who are carrying a few extra po unds that those
children also were exercising at a high intensity . Even children
with asthma , they were even able to do the activity breaks at a
higher extent than the children without asthma.

Mark Masselli: Dr. Hasson , a kinesiologist said they wanted to design the
intervention that would be easy for teachers to adopt and
manage , s o they created videos designed to get kids moving
quickly . T hen allow them to quickly eas e back into their
learning mode.

Dr. Rebecca Hasson : We created a compendium of 200 activ ity breaks that are just
three minutes long. T he teachers had a variety of different
types of activities, whether it was jumping jacks, leapfrogs,
something that will get their heart rate in the target heart
zones . W e got a lot of positive responses, parti cularly for the
videos from the teachers, because it was really easy to
implement.

Rochelle Walensky

Mark Masselli: Kids burned on average about 150 more calories per day, and
at the end of the week, had accrued a significant amount of
physical activity.

Dr. Rebecca Hasson : The kids when they left the laboratory, when they went home,
they still continued to be physically active. We had these little
accelerometers , they measure movement at the hip and so it
tells us how many calories were the kids burning away from
the labora tory and how much physical activity were they
getting .

Mark Masselli: A low cost easily adoptable fitness intervention for kids,
allowing short burst of physical activity throughout the school
day, enhancing fitness, empowering kids to move more ,
positivel y impacting the learning experience. Now that's a
bright idea.

[ Music ]

Mark Masselli: I’m Mark Masselli .

Margaret Flinter: And I'm Margaret Flinter .

Mark Masselli : P eace and health .

Marianne O’Hare : Conversations on Health Care is recorded in the Knowledge
and Technology Center Studios in Middletown, Connecticut,
and is brought to you by the Community Health Center now
celebrating 50 years of providing quality care to the
underserved where health care is a right not a privilege ,
www.chc1.com and www.chcradio.com .