>> This next series
of sessions by Drs.
Slayton, Oliver and
Dooling, we're going to do
in the following manner.
So we're going to ask Dr.
Slayton to present the modeling,
excuse me, let me
take this mask off.
The modeling allocation
strategies.
Followed then by questions.
And then we will group the
work group interpretation
and prioritization and
work group next steps
in the next batch.
So let's begin with Dr. Slayton
and modeling allocation
strategies
for the initial COVID-19
vaccine supply.
Dr. Slayton, please go forward.
>> Good afternoon.
Thank you.
Next slide, please.
Today I'll be presenting on two
models that we've developed.
The first looks at a U.S.
population stratification.
And the second focuses
specifically
on nursing-home-related issues.
Next slide, please.
Before we dive into
the two models,
I'd like to outline
some considerations
for mathematical modeling.
Mathematical modeling is an
iterative process based upon the
best available data at the
time models are developed.
Models should be updated as
new data become available.
As sensitivity analyses also
enable a systematic exploration
of uncertainty.
We will describe some
initial sensitivity analyses
in today's presentation.
And our interest in
the committee's ideas
about additional sensitivity
analyses that may be beneficial.
Next slide, please.
We'll start with the U.S.
population stratification model.
Next slide.
I'll take a few minutes to walk
you through the methods first.
This model is a stratification
model based upon data
from the National
Health Interview Survey
from 2016 to 2018.
We take self-reported
data on age.
Race/ethnicity.
Occupation.
And medical condition.
The age groups employed in this
model are children zero to 17.
Adults 18 to 64.
And adults greater than
or equal to 65 years old.
Race and ethnicity groups
included non-Hispanic whites.
Non-Hispanic black.
Hispanic. And other.
Next slide, please.
We included a risk status
within each age group
that was a dichotomous variable.
Which represented
individuals having no high-risk
medical condition.
Or greater than or equal to one
high-risk medical condition.
These conditions came from
NHIS self-reported data.
And included obesity.
Chronic obstructive
pulmonary disease.
Chronic cancer.
Weak or failing kidney.
Chronic heart problems.
And chronic diabetes.
Additionally, we looked
at occupational groups.
With two priority
occupational groups assessed.
The first was healthcare
personnel.
Defined as any individual
working in a healthcare setting,
whether paid or unpaid.
And the second priority
occupational group included
essential workers.
Comprised of food supply.
Emergency services.
Utilities.
Critical financial services.
Government.
And education.
Next slide, please.
We modeled a scenario that
included a partial reopening
and social distancing measures.
This included school
contacts being reduced
by 70 percent from baseline.
And workplace contacts
being reduced by 50 percent
from baseline for all
individuals except healthcare
workers and essential workers.
In this initial analysis,
we looked at two sets
of vaccine efficacy assumptions
by age group per
two-dose course.
These are broad assumptions
and are not meant
to represent any
specific product.
The first analysis
evaluated a 70 percent VE
for persons 18 to 64.
And a 50 percent VE for persons
greater than or equal to 65.
And the second analysis
looked at an assumption
of 70 percent VE for all adults.
We assumed prior
immunity as stratified
by age and depicted here.
That was derived from
seroprevalence surveys
in Louisiana from
CDC's prior work.
Mortality included
unadjusted risk ratios by age.
Race/ethnicity.
And risk factors.
And were adjusted to model
strata using raking methods.
Next slide, please.
The model considered
the incremental
and relative impact
of vaccine courses.
And looked at contact
rates among the 72 strata
of the model based on age.
And location-specific
contact rates in home.
School. Workplaces.
And other.
We employed a deterministic
compartment modeling framework.
And assessed the estimated
incremental impact.
Which included both direct
and indirect benefits.
We assessed the impact on
population-wide incidence.
And derived our estimates
from the rates
of most probable
transmission among groups before
and after vaccination
or the dominant eigenvectors
of these matrices.
Next slide, please.
For our first analysis, where we
assumed VE was 70 percent among
adults 18 to 64 years old.
And 50 percent among
adults greater than
or equal to 65 years old.
You'll see the population-wide
decrease in rate
of COVID-19 infection
and COVID-19 deaths per 10
million vaccine courses.
You'll note that vaccinating
healthcare personnel.
Essential workers.
And individuals with underlying
condition resulted in reductions
in both infections and death.
Whereas, vaccinating individuals
greater than or equal
to 65 years old resulted
in smaller decreases
in COVID-19 infections.
And larger increases in
COVID-19 associated death.
Next slide, please.
In our second analysis,
we looked at VE
of 70 percent for all adults.
And saw a similar pattern.
Next slide, please.
Now we'll transition to looking
at the nursing-home-specific
model.
Next slide.
This model was parameterized
to represent a mean nursing
home set of characteristics
from an analysis of data
from the Centers for Medicare
and Medicaid Services.
This nursing home was
comprised of 87 residents.
With a mean length
of stay of 88 days.
And 41 healthcare
personnel who were assumed
to work daily in
eight-hour shifts.
We assumed that healthcare
personnel interacted at work
with other healthcare personnel.
And at-home and in
non-school settings
with others in the community.
Healthcare personnel
were assumed
to self-isolate on
symptom onset.
And prevalence of infection
among admitted nursing home
residents was assumed to follow
the community prevalence.
The first dose of vaccine in
these analyses was assumed
to be given before
the introduction
of infection into
a nursing home.
Next slide, please.
The product assumptions
for these analyses
included two doses
of vaccine given 28 days apart
with protection developing
14 days post-injection.
We evaluated a VE
variable of 70 percent.
50 percent.
And 30 percent among
patients 65 and older.
And we assumed that vaccination
does not attenuate severity nor
transmissibility of
breakthrough infection.
We assumed no waning of immunity
over the analysis time horizon.
Next slide, please.
This slide depicts a typical
outbreak in a nursing home
without the introduction
of vaccine.
Time and days is
depicted on the x-axis.
And prevalence of infection
is depicted on the y-axis.
We are providing separate
epidemiologic curves
for healthcare providers
in gold.
Residents in green.
And the community in gray.
Next slide, please.
When evaluating vaccine
with variable VE,
as shown on the x-axis here.
And grouped by vaccinating
either healthcare providers
on the left.
Or residents on the right.
We estimated that vaccinating
nursing home healthcare
providers results in greater
reduction in both infections
and deaths than vaccinating
nursing home residents.
This is even when assuming that
residents are at a higher risk
of severe disease and death due
to their older age and presence
of underlying medical condition.
Next slide, please.
In summary, from our two models
that we presented here today,
you'll see that vaccinating
healthcare personnel.
Essential workers.
Or adults with underlying
condition resulted in reductions
of COVID-19 infections
and death.
And vaccinating adults
greater than or equal
to 65 years old resulted in more
modest declines and infections.
And larger declines in death.
Vaccinating nursing home
healthcare personnel resulted
in greater reduction in
both infections and death
than vaccinating
nursing home residents.
Thank you.
>> Are there any questions?
Dr. Hunter.
>> Thanks for that presentation.
I'm wondering, will, with each
additional 10 million doses
of people vaccinated
according to this modeling.
Will that reduce infections
and deaths another 3
to 4 percent in a
linear fashion?
Or is there any reason
to suspect
that there'll be
increasing benefits?
Or, conversely, diminishing
returns
from vaccinating each
additional 10 million people?
>> So in our initial analyses,
we were considering the
first allocations of vaccines
that would become available.
Which follow, more or
less, linear pattern.
As additional doses are assumed
to be part of the scenario,
you may deviate from
those linear trends.
And additional analyses
would need to be conducted
with better defined
parameters on expected VE
and seropositivity
among vaccinated
and unvaccinated individuals
to better discern those trends.
>> Thanks.
So you're just giving
us information
that we can incorporate
into a decision
about the initial vaccination.
But the other steps and
phases might need additional
information to guide
those, it sounds like?
Did I interpret what
you said correctly?
>> Yes, that's correct.
[ Multiple Speakers ]
>> Thank you very much.
>> To provide data to help
with the initial
allocation decisions.
>> Thank you.
>> Dr. Messonnier has a question
or comment.
>> Yeah, just to,
for clarification.
Rachel, always excellent
presentation.
You're looking at
this as the unit
of action being an
individual getting vaccinated.
You didn't model, for
example, if vaccination
of healthcare workers prevented
COVID from entering a facility.
And, therefore, would have
additional benefits beyond the
people that were vaccinated.
So I'm not exactly talking
about herd immunity.
But sort of you didn't
evaluate, again, for example,
somebody introduced it
into the nursing home.
If you could prevent that
person from getting sick, then,
in fact, there's an indirect
benefit for everybody else.
>> Sure. So our initial analysis
of nursing homes was
based upon the assumption
that there had not been
a prior importation
into that nursing home.
You're exactly right
that protecting nursing
home residents
from those importations,
which the models
and the epidemiological data
suggest are primarily coming
in through their healthcare
providers, is important.
And that further modeling
could be done to discern some
of the value that
you're describing there.
>> So if I can offer
comment to that also.
So while healthcare providers
are important sources
of introduction of COVID into
the nursing home environment.
Visitation is also
an important route.
It needs to be, and as an added
variable to this calculation.
So even protection of
nursing home residents
by protecting the healthcare
providers will still leave a
window open for those that
come from the public and visit.
So, Dr. Hunter, your
hand is still up.
Did you have a follow-up
question?
>> Sorry, I neglected to put
my hand down again, sorry.
>> No, no, no problem.
Just want to make sure.
Dr. Atmar.
>> Sorry, I had that mute.
Beautiful presentation.
Thank you.
I have two questions.
The first, I guess, I'll follow
up on the nursing home question.
Did you model if both,
what the results would be
or the incremental benefit
of vaccinating both healthcare
personnel and residents?
>> So it's a linear model.
So it would be additive for
the VE values that one assumes
for residents and healthcare
personnel respectively.
>> Okay, thank you.
I guess, and then
for the first model.
Did you do any sensitivity
analysis in terms
of what the effect would be
if there was higher
seroprevalence in the community?
>> Yes, we have evaluated
some different assumptions
about both the level
of mitigation.
And the prior seropositivity.
As you would expect, both of
these parameters are influential
in the absolute magnitude
of some of the results.
We did not include in this
iteration of the model any kind
of screening of individuals
prior to receiving a vaccine
to better represent
our understanding
of the current trials
and strategies
that are being considered.
But those are added features
that we could explore further
in this iterative process.
>> But you wouldn't, all the
absolute numbers might change?
You wouldn't expect the
relative amount of protection
to be different than
what you observed
with the seroprevalence
you measured or used?
>> I think over the
parameter space
that the current data
suggests that we're in,
the relative reductions
were relatively stable.
The longer the timeline for
vaccines to become available.
And the more that we deviate
from those initial assumptions,
both of prior seropositivities
and the level of mitigation
in the contact structure that
we've employed in the model,
the more we would
expect that to deviate.
>> Thank you.
>> Dr. Szilagyi.
>> Sorry, I was on mute.
Very nice presentation.
Sorry, about my echo.
I was wondering if you could
put the two analyses together?
And estimate what the
population-wide impact on death,
for example, would be
for a nursing home
vaccination program.
In Los Angeles, for example,
it's gotten less now,
about 40 to 50 percent of all
deaths were from individuals
in long-term care facilities.
And, you see what
I'm getting at?
>> Yes, so that's
a good question.
The nursing home model
did not include visitors
from the community, as a prior
questioner also described.
And because older adults, in the
best available data that we used
to develop these
models, have lower number
of contacts than younger adults.
And because nursing home
residents, in particular,
tend to stay in the
nursing homes.
So that distribution of
length of stay is bimodal
with short-stay and long-stay
nursing home residents.
The impact on the
broader community
of vaccinating the
residents, I would expect
to be relatively small.
The impact of vaccinating
the healthcare providers
who may work across multiple
nursing homes and tend
to be younger adults with
higher numbers of contacts
in the facilities and in
the communities would be
somewhat larger.
>> And my other question
was, would the prior data
about the very large
percentage of hospitalizations,
ICU deaths among individuals
with underlying conditions.
I guess I'm surprised
at the percentages.
This is Slide 10.
I'm surprised at
the percentages,
the population-wide decrease in
rate per 10 million courses was
so low in vaccinating
individuals
with underlying conditions
with a relatively
high VE of 70 percent.
>> So the deaths are, if
you're looking at Slide 10
of the population-wide
decrease in deaths
of vaccinating individuals
with underlying conditions
is somewhat larger.
Because those are more
of those direct effects
from vaccinating that age group.
The infection, which
also includes some
of the indirect effects
to a greater degree
because of the age
distribution of individuals
with underlying conditions
modeled.
And the assumptions
about the numbers
of contacts those
individuals have
with other folks are more
similar to the age structure.
And, therefore, the
reductions in infections
of vaccinating healthcare
personnel and essential workers.
>> Thank you.
>> Dr. Frey, excuse
me for jumping
over you to Dr. Szilagyi.
Dr. Frey, go forward.
>> Thank you.
Very nice presentation.
Thanks. I had a question
about the choice
or the assumption
of a 70 percent VE.
And I might have missed it.
But I was wondering
if you were also going
to consider a lesser
VE or 60 percent?
Or even 50 percent?
Not sure, and I might
be wrong about this.
But I'm not sure people have
completely decided what VE might
be an acceptable VE.
Although we would like to
see 70 percent or 80 percent.
But may not be that high.
And I was just wondering if
you had considered that or?
Thank you.
>> Yes, we've run this analysis
with VE values of 50 percent.
30 percent.
Though, in the interest
of time, did not show all
of those combinations here.
The general trends holds true,
looking at the differences
across the sort of first three
groups vaccinated compared
to the third.
So the absolute values
change as you would expect.
>> Dr. Maldonado.
>> Yes, sorry.
Yeah, so I was, had a question
about your indirect
effect assumptions.
So you may have mentioned this,
but does the indirect effect
assumptions vary by population?
And how did you decide how
to vary indirect effect size
in your different populations?
>> So those indirect
effects are all coming
in from the assumptions we made
about the contact structure.
We're using age-stratified
contact rates.
Which is a common
set of assumptions
that mechanistic modelers use.
And additionally, because we
were evaluating the occupational
groups of interest,
we added an assumption
that workplace contacts would
be reduced by 50 percent
from baseline for individuals
in all occupations
except healthcare
and essential workers.
Those workplace contacts are
one of four groups of contacts
that we included in the model.
The others were home.
Schools. And other settings.
>> Dr. Drees.
>> Yes, thank you.
Thank you for a great
presentation.
My question is about
your assumption
that healthcare workers
stop or they isolate as soon
as they become symptomatic.
I think our experience and many
others is that they continue
to work for at least a few
days, sometimes longer,
with the early symptoms
of COVID.
Sometimes because, you know,
often because those
symptoms are subtle
and are not recognized
as COVID until later.
And so I would just be curious,
you know, I would assume
that that would accentuate
the value
of vaccinating healthcare
workers.
But I was wondering if there
was any plan to incorporate
that variable into a
sensitivity or other analysis?
Thank you.
>> So the initial model includes
healthcare workers coming
to work while infectious
if they're presymptomatic
or if they are asymptomatic.
And from the pandemic planning
scenarios, the current set
that are on CDC's website.
That asymptomatic group is about
40 percent of the population.
And so we do have healthcare
providers coming for some period
of time during their
presymptomatic phase.
And a substantial
minority of infections
who are asymptomatic
for the duration.
We can modify these
assumptions to show the impact,
which you're right,
would likely be larger
if we have healthcare
providers working
for a longer time
while infectious.
>> Are there any other questions
or comments from the work group?
I don't see any.
So thank you very,
very much miss,
Dr. Slayton for this
presentation
and for answering the questions.
Now we're going to go onto
the next two presentations.
Starting with Dr. Oliver on
work group interpretations.
>> Thanks and good afternoon.
Next slide.
So first for a quick
overview of COVID-19 vaccines
in human clinical trials.
Next slide.
This is a list of
vaccines in clinical trials
that are actively recruiting
in the United States.
We heard from Moderna
and Pfizer today.
And both are actively recruiting
for Phase 3 clinical trials.
Next slide.
These are the mRNA
or DNA vaccines
that are actively recruiting
outside of the United States.
Next slide.
These are the protein
subunit vaccines
that are actively
recruiting globally.
Novavax recently published Phase
1 data from Australia with plans
to begin Phase 2 studies in
the U.S. and Australia soon.
Next slide.
And these are the
viral vector vaccines
that are actively
recruiting globally.
The University
of Oxford/AstraZeneca vaccine
has begun Phase 3 trials outside
of the U.S. and has plans
to begin Phase 3
trials in the U.S. soon.
Next slide.
These are the inactivated
vaccines
that are actively
recruiting globally.
And there are several Phase 3
trials currently being conducted
in China.
Next slide.
So next I'll show the
work group interpretation
of the clinical trial data.
Next slide.
So information was
reviewed by the work group.
Including both Phase 1
immunogenicity and safety data
from the two mRNA vaccines.
And plans for Phase 3 studies
for both mRNA vaccines.
Next slide.
This slide shows
the immunogenicity
and safety data reviewed by the
work group for mRNA1273 vaccine.
Regarding immunogenicity
data, neutralizing
and binding antibodies
were measured
at seven days post-dose 2.
And responses were similar to
or exceeded a convalescent
sera comparison.
A Th1-biassed CD4 T-cell
response was noted.
And based on the Phase 1 data,
a dose of 100 micrograms
was selected
for the Phase 3 clinical trials.
Regarding safety data.
Local and systemic
symptoms were followed
for seven days post-vaccination.
Pain. Myalgia.
And fatigue were the most
common symptoms reported.
Reactogenicity symptoms were
higher after the second dose.
And no vaccine-related
SAEs were reported.
Next slide.
This slide shows
the immunogenicity
and biosafety data.
And safety data reviewed
by the work group
for the Pfzier/BioNTech vaccine.
Regarding the immunogenicity
data.
Neutralizing antibodies
were measured
at seven days post-dose 2.
And again the responses
were similar to
or exceeded the human
convalescent panel.
CD4 and CD8 T-cell
responses were demonstrated.
And a Th1 biassed CD4
response was found.
A 30-microgram dose of
the BNT162b2 was selected
for Phase 3 clinical trials.
Regarding the safety data.
Local and systemic symptoms were
followed after administration.
Fatigue. Headache.
And muscle pain were the most
common symptoms reported.
And reactogenicity symptoms were
lower in the older population.
Next slide.
Both companies reported
their plans
for Phase 3 clinical trials.
Both are currently enrolling
large Phase 3 efficacy trials
with goals of enrolling
around 30,000 individuals.
The primary efficacy end points
for both trials are symptomatic
virologically confirmed
COVID-19 disease.
And both vaccines are attempting
to enroll diverse populations.
Which includes racial
and ethnic diversity.
As well as age.
And underlying medical
conditions.
Next slide.
Both vaccine companies
discussed the current cold-chain
requirements for their
vaccine candidates.
mRNA1273 requires distribution
and storage at minus 20
with a round seven
days at 2 to 8 degrees.
And BNT162b2 requires
distribution and storage
at minus 70 with around 24
hours at 2 to 8 degrees.
These requirements
could be updated
as additional studies
are completed.
Next slide.
So overall, the work group
thought the Phase 1 data
from both mRNA vaccine
showed induction
of neutralizing antibodies
at seven days post-dose 2
that exceeded levels
in convalescent sera.
And the data from both mRNA
vaccines support advancing
to large-scale Phase
3 clinical trials
to assess safety and efficacy.
And the work group felt
that the diverse cold-chain
or ultra-low temperature
requirements could substantially
affect implementation efforts.
Next slide.
The work group had several
thoughts regarding the current
Phase 3 clinical trials.
First, they emphasized
the importance
of enrolling diverse
study participants.
They also emphasized
the need to allow
for sufficient time post-dose
2 to evaluate safety signals.
In addition to the
efficacy signals.
And there is a need to report
maternal and fetal outcomes
for women who become pregnant
during the clinical trials.
And it would be helpful
to evaluate the impact
on viral shedding
or transmission among
both symptomatic
asymptomatic populations.
Next slide.
The work group also had
thoughts regarding future
or additional studies.
First, regarding the need
to evaluate co-administration
of other vaccines.
Especially influenza vaccine.
As well as studies in
pregnant women and children
if the initial trials
are successful.
Next slide.
So next moving to the work group
interpretation of the epi data.
Next slide.
The work group reviewed COVID-19
epi among the U.S. population.
Epi among various
occupational settings.
And among individuals
at increased risk
for severe COVID disease.
Next, I'll highlight a few
of the important epi points
that influence the
work group discussions.
Next slide.
First, as a reminder,
the healthcare personnel
definition is very broad.
As essential workers who are
paid and unpaid persons serving
in healthcare settings who
have the potential for direct
or indirect exposure to patients
or infectious materials.
Next slide.
And this was presented
previously
as the hospitalized healthcare
personnel within COVID-NET,
demonstrating the broad
ranges of occupations
for infected healthcare
personnel.
Next slide.
This data presented previously
regarding the workforce
at long-term care facilities.
On the right is the graph
of cases among staff
at skilled nursing
facilities through mid-July.
Long-term care facilities
are disproportionally
lower-wage workers.
Nearly 40 percent are 50
years of age and older.
And nearly 80 percent are female
and a 1/4 are non-Hispanic
black persons.
Staff can be shared among
multiple facilities.
And in many instances COVID-19
activity increases among
long-term care facility staff
first and then the residents.
Next slide.
Next, highlighting
the data among workers
in food processing
and agricultural.
Among 14 states from April
to May, COVID was diagnosed
in 9 percent of workers at meat
and poultry processing plants.
And among cases with race
and ethnicity reported,
nearly 90 percent occurred among
racial or ethic minorities.
Outbreaks have been reported
in many food productions
and agricultural sectors.
And there are multiple factors
that increase a worker's risk.
With a few highlighted here.
Including prolonged
close workplace contact
with coworkers.
Shared transportation
or congregate housing.
And lack of paid sick leave.
Next slide.
In addition, the work group
reviewed data on workers
in correction and
detention facilities.
Staff members can introduce the
virus through daily movements
between the facility
and the community.
And in an analysis of 16
U.S. prisons and jails,
more than half of the facilities
identified their first case
of COVID among staff members.
Next slide.
And, finally, the work group
reviewed data on adults
with increased risk for
severe COVID disease
that was presented
earlier today.
Accounting for the presence
of individual underlying
medical conditions,
higher hospitalization rates
were observed among adults 65
years of age and older.
In addition,
higher hospitalization rates
were observed for adults
with underlying medical
conditions, as shown here.
With obesity.
Chronic kidney disease.
Diabetes. And hypertension
as some
with the strongest association.
Next slide.
The work group also
had presentations
on modeling allocation
strategies
for the initial vaccine supply
that were just shown to ACIP.
Two different models were shown.
The overall population model
and a nursing home model.
Regarding the population
model, similar numbers
of infections were prevented
by vaccinating healthcare
personnel.
Essential workers.
And adults with underlying
medical conditions.
Vaccinating older adults
resulted in more modest declines
in infection, but
larger declines
in deaths compared
to the other groups.
But, overall, the
differences in impact
between vaccinating
different groups was small.
For the nursing home
model, more infections
and deaths were prevented
by vaccinating healthcare
personnel compared
to vaccinating nursing
home residents.
So, overall, the more
infections prevented now
through mitigation measures,
the more impact the vaccine
can have in the future.
Next slide.
Taking into account the
epidemiology and modeling data
that have been presented
over the past several months,
the work group discussed
several important points.
Many occupations deemed
essential workers are
at increased risk
of COVID-19 disease.
And the work group felt
that it's important
to consider these
individuals who are unable
to socially distance
or work from home.
Older adults, as well as adults
with underlying medical
conditions,
are also at increased risk
of severe COVID disease.
And the work group noted
that these groups are
not mutually exclusive.
That many essential
workers are also older
or have an underlying
medical condition.
Also putting them at risk
for severe COVID disease.
And in many instances cases
increased first among staff
in congregate settings.
Such as long-term
care facilities
or correction facilities.
And the work group
feels that it's possible
that some protection
could be provided
to these vulnerable population
by immunity among the
staff and workers.
Now we'll transition
to Dr. Dooling
who will discuss how the data
and work group thoughts can
inform further discussions
around allocation
and distribution
of the early vaccine doses.
>> Dr. Dooling, please.
>> Thank you.
Good afternoon, everyone.
Next slide.
First I'd like to
ground the presentation
in what the work group
envisions as the overall goals
of the COVID-19 vaccine program.
First, to ensure that we have
a safe and effective vaccine.
That the vaccine
reduces transmission.
Morbidity.
And mortality of
COVID-19 disease.
That the vaccine program
helps minimize disruption
to society and the economy.
Including maintaining
healthcare capacity.
And that we ensure equity
in vaccine allocation
and distribution.
Next. It's clear that
identifying groups
for allocation of initial
doses of vaccine is critical
for program planning
at this juncture.
I'd like to take
a moment to call
out at a high level all the
areas of the vaccine system
that will use this information.
For example, we can strengthen
vaccine distribution networks
to reach target groups.
And, of course, engage the
key partners and stakeholders
in order to accomplish that.
We need to develop state
and local micro-plans
to develop communication
strategies.
And, importantly, we
need to enhance systems
to rapidly monitor
vaccine safety.
Effectiveness.
And coverage.
Next. It's likely
that administration
of COVID-19 vaccine will
require a phased approach.
Once a vaccine is
approved for use,
there will likely be
insufficient vaccine
to meet demand at first.
There may also be
cold-chain storage
and handling requirements that
require specialized equipment
and high throughput at clinics.
Taken together, these call
for a highly targeted
administration
in the first phase.
In the second and third phases,
we anticipate sufficient supply
and a broadening of those
implementation strategies.
Next. However, today I'd like
to focus the ACIP members on,
attention on the first phase.
The period, projected
to be short, that may,
we may have limited
administration.
And, sorry, limited doses and
administration may be targeted.
How can we best achieve
the objectives
of the program during
this period?
Next slide.
To help your thinking
about this period,
here are some proposed scenarios
for planning in the
initial phase.
It should be noted
that these are not,
these do not represent
decisions,
but are rather a tool
to assist planning.
In the first scenario,
Vaccine A demonstrates safety
and efficacy.
And there could be 20 to
30 million doses available
by the end of December.
If such a product needed
to be shipped at 70 to 80,
minus 70 to minus
80 degrees Celsius.
And could be stored
for only 24 hours
at standard vaccine
refrigeration temperatures
of 2 to 8 degrees Celsius.
This scenario would
require shipping to large,
adequately equipped
administration sites
with high throughput.
In the second scenario,
Vaccine B demonstrates safety
and efficacy.
And there could be 15
million does available
by the end of December.
This vaccine could
be distributed
at minus 20 degrees Celsius.
And stored for seven days
at 2 to 8 degrees Celsius.
In scenario three,
both Vaccines A
and B demonstrate
safety and efficacy.
And doses would ramp
up with potentially 35
to 45 million doses available
by the end of December 2020.
Next slide.
Clearly the planning
needs are immense.
And CDC, state and
local jurisdictions all
over the country are
actively working on plans.
Although the implementation
details are not the focus
of this meeting, we can share
some of the CDC activities
to support implementation
planning.
Including micro-planning.
Critical populations focus.
Federal entity planning.
Development of IT tools.
Communication and
engagement materials.
Next slide.
Departing now from
implementation planning,
I'd like to recap previous ACIP
discussions regarding early
phase COVID-19 vaccination.
In June, ACIP expressed support
for identification of groups
for allocation of
initial vaccine
to aid implementation planning.
ACIP recognized the disparity
in COVID-19 vaccine impact
on minority race
and ethnic groups.
Essential workers.
And low-income families.
Also attention was called
to the need to build
on existing vaccine
infrastructure
to meet the challenges
of COVID-19 vaccination.
In June, sorry, in July,
ACIP expressed support
for healthcare personnel
and other essential workers
to receive initial
vaccine allocation.
Next slide.
The objective of today's
ACIP session is to focus
on the work group's
proposed groups
for early phase vaccination.
Those include healthcare
personnel.
Essential workers.
Persons with high-risk
medical conditions.
Individuals, older
adults over, 65 and older.
For each we will
describe the group.
Estimate the size of the group.
And then consider the
implementation challenges
for all.
We'd like to hear
members' considerations
for the sequence of the groups.
During the September
meeting of ACIP,
a vote on interim allocation
of initial doses is planned.
Next slide.
The first group I'd
like to highlight are
healthcare personnel.
They were discussed extensively
at the last ACIP meeting.
Healthcare personnel
are defined as paid
and unpaid persons serving
in healthcare settings
who have the potential for
direct or indirect exposure
to patients or infectious
material.
This includes persons
not directly involved
in patient care, but
potentially exposed
to infectious agents while
working in a healthcare setting.
The estimated population
for this group is 17
to 20 million people
in the United States.
This estimate comes from the
Bureau of Labor Statistics.
Although not exhaustive, some
examples include hospitals.
Long-term care facilities.
Which include assisted
living facilities as well
as skilled nursing facilities.
Outpatient.
Home healthcare.
Pharmacies.
EMS. And public health.
Next slide.
Also shown during the July
ACIP meeting, the composition
of healthcare workers
varies widely by setting.
As you can see here in the
comparison between hospitals
and skilled nursing facilities.
Next slide.
Next, let's take a look
at essential workers other
than healthcare personnel.
CISA, within the Department
of Homeland Security,
is tasked with creating a list
of workers who are essential
to continue critical
infrastructure
and maintain services
and functions Americans
depend on daily.
CISA has recently revised
their list in the context
of the evolving demands of
the workplace during COVID-19.
The guidance acknowledges
that workers
who cannot perform their
duties remotely and must work
in close proximity to
others should be prioritized
for mitigation measures.
It's also important to
recognize that subcategories
of essential workers may
be prioritized differently
in different jurisdictions,
depending on local needs.
The estimated population
for this group is approximately
70 to 80 million people.
But it should be noted this
is a very rough estimate.
And may be revised
as workplaces evolve
and we find innovative
ways to protect workers.
Although not exhaustive,
some examples include workers
in industries such as
food and agriculture.
Transportation.
Education.
Energy. Water and wastewater.
And law enforcement.
Next slide.
It's worth noting that
healthcare personnel
and essential worker composition
by race and ethnicity is similar
to the overall U.S. population,
according to self-reported data
from the National
Health Interview Survey.
Next slide.
Despite representation of black
and Hispanic essential workers
that is similar to the overall
population, a recent study
from Utah demonstrated
that Hispanic
and nonwhite workers
accounted for 73 percent
of workplace outbreaks.
Outbreak-associated
COVID-19 cases.
The vertical axis you see here
shows the industry sectors
that have experienced
workplace outbreaks.
The dark blue marker shows the
baseline industry percentage
of Hispanic and nonwhite
workers.
The light blue marker
shows the percentage
of COVID outbreak workers who
are Hispanic and nonwhite.
As you can see, in
every industry Hispanic
and nonwhite workers have been
disproportionally affected
by workplace outbreaks.
Next slide.
Next, I'd like to highlight
adults with medical conditions
at higher risk for
severe COVID-19.
Earlier today you saw details
of the epidemiologic
risks associated
with these conditions.
A systematic review
indicates people of any age
with the following conditions
listed alphabetically are
at increased risk for severe
illness from COVID-19.
The estimated population
for this group is
over 100 million adults.
This is a rough estimate and
may change as we gain evidence
about the conditions
which confer risk.
From a nationally representative
survey called BRFS,
the percentage of
adult population
with selected medical conditions
was estimated at 30 percent,
31 percent with obesity.
11 percent with diabetes.
7 percent with chronic
obstructive pulmonary disease.
7 percent with heart condition.
And 3 percent with
chronic kidney disease.
These are not mutually
exclusive.
Next slide.
In the final group I'll
highlight is adults
who are 65 years
of age and older.
As you can see, the
population pyramid here is
in the millions of persons.
And the overall group
is estimated
at approximately 53 million
by 2019 U.S. Census estimates.
This accounts for
approximately 16 percent
of the U.S. population.
Of note, approximately 3
million persons currently live
in long-term care facilities.
Next slide.
The proportion of the population
with COVID-19 high-risk medical
conditions is 33 percent among
younger adults.
And 39 percent among
older adults according
to self-reported data
from the National Health
Interview Survey.
Next. So to summarize.
These groups are
clearly overlapping.
There is significant
heterogeneity
between them and within them.
And we are talking
about a lot of people.
This accounts for more
than half of U.S. adults.
Therefore, there may be a need
for additional sub-grouping.
Next slide.
Now I'd like to transition
to work group considerations.
Specifically work group
thoughts on epidemiology.
Feasibility.
Equity and ethics.
Next slide.
The work group has
considered feasibility,
including the implementation
challenges and implications
for distribution
of initial vaccine.
The following points
summarize their input.
A COVID-19 vaccine that requires
distribution and storage
at minus 20 followed by
seven days maximum at 2
to 8 degrees Celsius will
require diligent vaccine
management to minimize waste.
The storage, distribution
and handling requirements
of a minus 70 vaccine will
make it very difficult
for community clinics and
local pharmacies to store
and administer such a vaccine.
Ultimately, this will
necessitate most vaccine be
administered at centralized
sites
with adequate equipment
and high throughput.
Vaccine healthcare personnel,
vaccinating healthcare personnel
at centralized sites with
high throughput is the best
allocation of initial supply.
Next slide.
Workers at long-term care
facilities remain a priority
among healthcare personnel.
And achieving high
coverage is important.
And may be resource intensive.
Mass vaccination clinics
will be difficult to conduct
in the setting of
social distancing.
Healthcare homes, such as
provider offices or pharmacies,
could be better suited
to provide vaccination
if recommendations are based
on individual risk factors.
Such as age or underlying
medical conditions.
The work group also
noted challenges
to equitable vaccine
administration.
These include, but are not
certainly not limited to,
reaching people in rural areas.
Reaching racial and
ethnic minorities.
And reaching people with
limited access to vaccines.
Next slide.
Clearly as we consider groups
for interim prioritization
of initial vaccine supply,
there are many unknowns.
First, we don't yet know
the vaccine performance,
the magnitude or the
benefits and potential risks.
And importantly, if the vaccines
are efficacious in older adults.
We don't yet know if there
will be multiple vaccines
with different profiles.
We don't know yet the
pathway to approval.
Whether that should be an
emergency use authorization
or full licensure.
We don't yet know the timing
of vaccine availability,
nor do we know the
number of doses available.
Or the rate of scale-up.
And although we are
working with unknowns
and incomplete information, the
work group remains committed
to moving forward to help
ACIP lay the groundwork
for evidence-informed
COVID-19 vaccine policy.
Next slide.
Next slide.
To that end, I'll outline the
next steps for the work group.
And then, sorry, back one side.
I apologize.
To that end I'll outline the
next steps for the work group.
And then return to
questions for the ACIP.
The next steps are to
review clinical trial data
for candidate vaccines,
as they become available.
Namely, the safety data.
Including plans
for post-approval
vaccine surveillance.
As well as immunogenicity
and efficacy data.
To review the epidemiologic data
for risk of COVID-19 disease
and severity by race
and ethnicity.
And you'll see that at
the next ACIP meeting.
Review results of focus groups
and other public engagement
regarding COVID-19 vaccines.
And also to review
equity frameworks
for allocating vaccine.
Next slide.
And in that vein, authors at the
Johns Hopkins Bloomberg School
of Public Health recently
released an interim framework
for COVID-19 vaccine allocation
and distribution in
the United States.
I'd like to specifically
call out that Tier 1 groups
within their framework
are described
as those most essential
in sustaining the
ongoing COVID-19 response.
Those at increased risk for
severe illness and death.
Plus their caregivers.
And those most essential to
maintain core society functions.
The work group will be
considering this framework
as well as that which
is forthcoming
from the National
Academy of Science,
Engineering and Medicine.
Next slide.
We now have some
questions for ACIP input.
Given the information
presented thus far,
including the epidemiology.
The values.
Acceptability.
Feasibility that
you've heard about.
Do you agree that initial doses
of COVID-19 vaccine
should be allocated
to healthcare personnel?
I'll pause there before going
on to the next question.
>> We'll open it up to
question, to comments, please.
Dr. Maldonado, I see
that your hand is up.
Must be a left over.
Sorry, thank you.
Dr. Atmar.
>> Thank you.
So I have a question,
and then I'll try
and answer your first question.
My question is, has the work
group considered regional
distribution of vaccine
based on or guided
by local prevalence of disease?
You know, based on where
the virus is circulating?
Where it's been more
or less controlled
through other public health
interventions being guided
by epidemiologic information?
>> Right. I'll answer
that before you go
on to your response
to our first question.
But the work group has
considered that to some extent.
And also discussion of
outbreak, vaccine allocation
in an outbreak setting.
And some of the factors that
were discussed included the fact
that all of the early
vaccines candidates
in development are two doses.
Thus the amount of protection
that's conferred before the
second several weeks following
the second dose administration
is unknown.
So the timing may
not be adequate
to really combat
active outbreaks.
The second is, you know, there
are still unknowns with regard
to the, what the
underlying seroprevalence
of any jurisdiction
will be at the time.
And, ultimately, how
long-lasting that protection is
that we're testing by way
of seroprevalence studies.
So those are just some of the
factors that have been brought
up in that context when we think
about allocation
differential by disease rates.
>> Thank you.
So to a certain degree,
I'm worried that my answer
and the answers of many on the
panel may seem self-serving
since we're all healthcare
personnel.
You know, it's hard based
on the risk stratification
that you gave to pick
one group over another.
And it really sounds like
the guiding principle may be
the implementation.
And I would agree that the
healthcare industry is probably
in a better position to handle
and distribute the vaccine
to healthcare personnel in
that, in those circumstances
that you outlined should it be
one of the candidate vaccines
that has those difficult
cold-chain issues to address.
Over.
>> Dr. Cohn, please.
>> Thanks.
This is Dr. Cohn.
I just want to add to Dr.
Dooling's presentation
and Dr. Atmar's comment.
That, when you look
at the number of doses
that may be available early,
in that very early
constrained period.
We would propose that you would
actually half those numbers
of individuals that
should be vaccinated.
Because of the short
timeline between doses one
and two being 21 and 28 days.
If doses are being
released, we want to make sure
that individuals
receive both doses.
And we don't vaccinate
more broadly
and then not have doses made
available the following month,
for example, to provide people
second doses in those windows.
So there's some additional
considerations
around the total
number of individuals
that may be vaccinated
over time as well.
>> Dr. Szilagyi.
>> Yeah, thank you.
And, Dr. Dooling, thank you,
as always, for a wonderful,
wonderfully clear presentation.
I'll go out on a limb as well.
And I was going to go where
Dr. Atmar was in terms
of both somewhat of a dilemma
about feeling self-serving
because we're healthcare
personnel.
But really focusing on
implementation issues
in addition to the cold-chain.
I mean, I'm struggling with,
I don't really know how many
doses there really will be.
And, Dr. Cohn, I understand
the issue about the two doses.
But if there will only
be 20 million doses,
then how would we allocate
vaccine within the other groups,
which are much larger?
You know, 100 million 50
million, 60, 80 million.
Secondly, I do think
that there is a challenge
with confidence in this vaccine.
Because of a number
of different reasons
that we have all discussed.
And even greater,
there's some evidence now
that very high-risk populations,
including some minority
populations,
may have more concerns
about the future vaccine
than other populations.
My sense, as healthcare
personnel,
although I've been
hearing anecdotes
about concerns about
the vaccine.
My sense is that the uptake
among healthcare personnel would
be much higher.
And so that could start kind
of a nice process toward
increasing confidence toward the
vaccine if we get it ourselves.
And if the proportion
of healthcare personnel
who are vaccinated is very high.
Particularly, when
there's an issue of concern
about confidence in the vaccine,
kind of doing it ourselves
is a very good demonstration,
I think, for the
rest of the country.
And the other point I was going
to make is back to the point
about how many doses
there might be.
I'm almost wondering
whether we may need to think
about prioritizing
within these conditions
if there are fewer doses.
In other words, the circle of
available doses is much smaller
than the circles that
are on this slide.
Thank you.
>> So I'll take this
opportunity for my comments.
And I think they echo those
which have already been stated.
The issue that stands out
most in my mind is the issue
of storage transmission
of the vaccine.
These requirements
for ultra-cold storage
and transmission.
In a state like mine,
which is primarily rural,
this poses a significant
problem.
It without a doubt means that
we're going to have to focus
on healthcare personnel
initially.
And to really reach
other populations,
our high-risk essential
workers, such as meat packers.
Agricultural workers.
They may have to wait until
we have a more stable vaccine
that can be transmit, can
transport it and deliver it more
or less at room temperature.
So I see that as
a big issue here.
One that is maybe
out of our control
because of the vaccines
that are available.
I also think that there should
be some degree of flexibility
in determining these
risk groups based
on the limited supply
within each state.
So my risk group assessment, and
I'm just using me as a person.
I mean, our risk group
assessment may be a little bit
different than that of the
work group or the ACIP.
So there should be
allowed some flexibility
in that area, I think, overall.
Not to vary significantly,
but that there should
be some flexibility.
Lastly, two comments.
The issue of lab personnel.
Whether they, not
specifically in the hospital,
but in commercial laboratories
that are carrying
forward the diagnostics
of COVID disease, of COVID.
We as public health
officials suffer greatly
when we cannot have rapid
turnaround of diagnostic tests.
Either because of
supply or because
of personnel not able
to process those.
My public health lab, if it
suffered a significant hit
from COVID, would be a
major blow to our effort
of COVID detection
and containment mitigation
within the state.
So I think it's very
important that within
that healthcare group, you
include not just laboratorians
within the hospital system, but
public health and commercial.
And, lastly, the issue
of public health workers.
So public health workers
are essential to my state
in controlling mitigation
of outbreaks.
We send them out
into the community
to find these individuals.
Test these individuals.
Make recommendations.
And, unfortunately,
I have had several
of my public health
employees become infected.
So I would like to
put that out there.
Champion that cause also.
>> And this is Dr. Cohn.
I just want to provide
a clarifying statement
on behalf of Dr. Romero.
He's speaking in his new role
as the State Health Officer
for the State of Arkansas.
So he's now officially a member
of the public health community.
>> And I thank the public health
community for taking me in.
Thank you.
Doctor, sorry, Ms. Bahta.
>> It certainly seems
clear that in some
of the modeling there is benefit
both to the healthcare community
and the population
that they care for,
especially in long-term
care facilities,
by vaccinating those
healthcare workers.
And as I thought about this,
I read through the
Johns Hopkins document.
It seems that we really
need to be able to continue
to provide care to
our broader population
who will require
hospitalization.
And without having
a huge compromise
of our healthcare population.
I know in Minnesota we saw many
of our long-term care facilities
healthcare workers ill
with COVID-19 in the spring.
And a lot of it was
because of lack of PPE.
But that seems to be, going
to be, as far as I understand,
a persistent issue of obtaining
adequate amounts of PPE
for our healthcare workers.
And so in that respect, I can
really support an allocation
to our healthcare personnel.
>> Dr. Lee.
>> Thanks so much.
Sorry, there's an echo still.
Thank you.
For summarizing the
work group perspective,
it's been a really
challenging set
of discussions for
so many reasons.
I did want to maybe
state that, first of all,
I do think that the
sort of distinction
between where we want to
be in six to nine months
versus where we are today
is really important.
In part because, of course,
benefit risk balance is going
to be critical to all
of our decision-making.
Within the first, you know,
weeks of vaccines
being available,
implementation considerations
are going to be huge.
And do you agree that given
the current vaccine candidates
that we think, you know,
hope might come forward
on the earlier side.
That it would make sense
for us to really make sure
that we're reducing the
complexity of implementation
as much as is feasible.
The more complex we make it up
front, the harder it's going
to be for us to then
scale-up quickly.
So I do think that I am
supportive of this idea
of prioritizing populations
where we can actually implement
the vaccine, assuming, again,
excellent benefit risk
balance in our favor.
I had one question which
is, I wonder if anyone
on the phone would
be able to comment
on other potential
vaccine candidates
that were mentioned early on?
I'm thinking specifically there
were two that were supposed
to initiate trials later on.
What the timing of
that might be?
Just because I think
that could be helpful
for our decision-making
early on as well.
And I think they were Novavax
and the Oxford vaccine.
Maybe I'll stop there
for a second.
And I think I have
one more comment.
>> This is Kathleen Dooling.
I can respond that we are
in communication with all
of the companies that are,
have plans to enroll candidates
and do clinical trials
in the United States.
And the work group
will hear from them.
And then, subsequently, they
will have an opportunity
to present to the ACIP.
>> You had another
comment, Dr. Lee?
>> Yeah, thank you.
Just really quickly.
Thinking about the fact
that Dr. Szilagyi mentioned.
That, if we do have a really
limited supply of vaccine
in the early weeks, it
will behove us to make sure
that we're using data to
drive decision-making.
Obviously, we want flexibility
at the local level to make sure
that each local area
understands the epidemiology
of their disease.
And is getting it to those
workers that really seem
to have a high risk of exposure.
And that will different
by, you know, region.
Or by sort of local context.
So I think, you know, providing
the guidance around this.
And yet allowing and ensuring
that people are using data
to drive that decision-making
will be really important for us.
Thank you.
>> Dr. Hunter.
>> Thanks I just want to
start by saying that I really,
I want to thank all
the speakers today.
And over the four years
that I've been on the ACIP.
For serving up just on a
silver platter the kind
of information we voting
members need to give input.
So I just want to be very
appreciative of that.
I agree that starting
with healthcare personnel
will prevent a large number
of infections and deaths.
And much, you know, more
than other priorities groups.
So that makes sense
starting with them.
I think that implementation
issues
like vaccinating healthcare
personnel being able to be done
at facilities that
are most likely
to implement the specialized
storage and handling is a plus
from an implementation
point of view.
In addition, I have some
personal things that I'd
like to advocate for from my
perspective as a clinician
and a public health person.
Welcome to public health, Jose.
And that's, first one of
those is, I think in order
to promote vaccine
confidence, I would advocate
for ACIP policy statements
that encourage vaccination
to be voluntary.
And not a condition
of employment.
I would also support
policy statements
that allow some flexibility
in interpreting eligibility
for vaccination at the point of
administration or registration.
Especially as vaccine
supplies increase.
Obviously, early on
that's going to be,
going to be need to be tight.
But I think that we need to
prepare from the beginning
for that transition
between those first
of the three phases outside of
the red circle into the time
when we're going to have
more, hopefully, vaccine.
So that's my comments.
And thanks again for all
the wonderful information.
>> Thanks, Dr. Atmar.
This is Amanda.
I just want to build
off of your one comment.
And remind the committee
members that,
while many healthcare
workers will be able
to be vaccinated with, more
easily given that they are
at healthcare facilities.
There are a number of
healthcare workers who work
at long-term care facilities
or other, and in other places
that we will still have to
ensure access to vaccination.
If, indeed, that
is the first group.
Going back to Dr.
Slayton's presentation.
Clearly long-term care facility
staff will be an important group
as well.
Dr. Lee, Dr. Romero had
to step out for a moment.
So I'm going to take
over, Dr. Lee.
>> I apologize.
>> Dr. Hunter.
Oh, we're.
Ms. McNally.
>> Yes, thank you.
Speaking as the consumer
representative
for really the reasons
that have been discussed.
And, in particular,
the risk associated
with healthcare personnel
and COVID-19.
The implementation
that's been discussed,
as well as the potential
for safety managering.
I also would express
support for prioritization
to healthcare personnel.
>> Dr. Drees.
>> Yes, I just wanted to
comment on the comment
from a few minutes ago
about making the vaccine.
[ Inaudible Comment ]
Vaccine as a condition,
is required for employment
and there's an adverse effect.
That is automatically
covered by workers comp.
Whereas, if it's an
optional vaccine,
it is not necessarily covered.
Although an institution
can choose to cover that.
So that we just might
want to think through kind
of the language around that.
And making sure that
any adverse effects
that do happen are covered.
Thank you.
>> Dr. Atmar, I saw
your hand was up.
Did you want?
[ Multiple Speakers ]
>> It's, I took it down.
I put it up again.
I wanted to reply to
Dr. Hunter's comment
about not making it mandatory.
I don't know about other states,
but here in the state of Texas,
there is a law that
basically says
that healthcare practitioners,
personnel need to take
or be vaccinated against
vaccine-preventable diseases
with, you know, a
few exceptions.
So we may make suggestions.
But some of this is going to
be guided by local laws and,
you know, other considerations.
>> Dr. Cohn.
>> I just wanted to add to that.
Just wanted to remind everybody
that under an emergency
use authorization, an EUA,
vaccines are not
allowed to be mandatory.
So early in this
vaccination phase,
individuals will
have to be consented.
And they won't be
able to be mandated.
>> We didn't clarify
whether this was going to be
under EUA or licensure.
That was an open question.
So, but thanks for
that clarification.
>> I don't want to
cut off discussion,
but we do have other questions.
I have two people on the, that
want to ask or make a comment.
Dr. Bell first.
Followed by Dr. Hunter.
>> That's okay.
I'll wait till we're
about to wrap up.
>> Thank you, Dr. Bell.
Dr. Hunter.
>> Yes, just a quick
clarification
of my previous comments.
I didn't suggest that, I
guess, what I was suggesting is
that our ACIP recommendations
are sort of a base.
Sort of like a federal law
where you can, you have a base
of the minimum that you can do.
And then local or state can
do more with a federal law.
And I sort of see that the
same way, in my opinion,
about how to deal
with, you know,
requiring it for employment.
Which is we're not, we wouldn't
say that we're, you know,
saying it has to be
required for employment.
But that, you know,
that would, you know,
could be a consideration
that you could require
for employment.
And here's, in the guidance,
you know, here's some advantages
and disadvantages of that,
I guess, is the way I was,
just to give a little more
nuance to my previous comments.
Thanks.
>> Thank you, all.
So we'll move on now
to the next question.
Dr. Dooling.
>> The second question
for ACIP members is
if vaccine supply
remains constrained due
to either vaccine or
distribution limitations.
Do you agree with vaccinating
essential workers next,
as supply permits?
>> Dr. Hunter, your hand is up.
Is it left over from
the previous question?
>> Yep, still left over.
>> Dr. Bernstein.
>> Maybe you can
remind me when you were,
in discussing the modeling
allocation strategies.
And you talked about different
assumptions regarding VE.
How was acceptance of vaccine
by these specific
populations factored in?
If we were talking
healthcare personnel were we,
did we look at it at
75 percent acceptance?
50 percent acceptance?
25 percent acceptance?
And the same with the other
groups in building confidence
into that is very important.
>> I can speak to
my understanding
of the modeling results.
And if Dr. Slayton's
on the line,
she can correct me if I'm wrong.
But the models did not
factor in partial acceptance.
They modeled X number
of doses going entirely
to certain groups.
And then let the model
results play out.
>> As I would expect it,
each of these populations,
the percentage of individuals
that would accept these
vaccines could be quite variable
by population as well
as geographically.
>> Dr. Atmar.
>> I'll bite, and I will
agree with the assessment
that essential workers
would be the next target
to basically help maintain
society's infrastructure.
Over.
>> Dr. Poehling.
>> All right, thank you.
I wanted to add to
this conversation.
Because I do agree that the
data that has been presented
to date highlights
the importance
of covering the healthcare
personnel followed
by the essential workers.
And the implementation is really
a important component of things.
Because the more that is
reliably in the population
with full protection,
meaning both doses.
And so the micro-planning
and all that going
on is really essential.
Because implementation in cold
storage will remain an important
part of this consideration.
>> Dr. Sanchez.
>> Sorry, on mute.
I agree to a point.
But I think that the high-risk
medical conditions really,
I mean, so in other
words, that would be next.
And I don't know if maybe
within the essential workers
prioritizing first high
medical conditions.
Because, obviously,
it's a huge number
that the vaccine may not
be available for all.
But I, you know, the high-risk
medical conditions are
associated with more
severe disease and death.
And I think that
we need to make,
to prioritize some
of that as well.
>> Thank you.
Dr. Szilagyi.
>> Sorry, I was on mute.
I'm struggling with this one.
The size of essential
workers is about the same
as the older population.
And would, essential workers,
if the model is correct
that we saw before, would be,
would save, far fewer deaths.
But they're essential workers.
And that's critical
for societal operation.
So I'm kind of struggling with
all of these three circles.
Which is obviously why
you asked us to comment.
I do want to point out that
with minorities having
substantially higher risks
from COVID and morbidity
and death from COVID.
And many of them being
essential workers.
I think, as well as many
of them having high-risk
medical conditions.
I think in a sense targeting
essential workers targets a very
high minority population
that is obviously essential
because of their occupation.
So I could certainly
go along with this.
But I'm struggling.
And I'd love, and I can't
remember what the overlap is
between essential workers and
high-risk medical conditions.
Is, does it look
like these circles?
Or there a greater overlap?
I also think it would be
potentially possibly easier
to administer the vaccine
with the cold-chain,
especially if there are sort
of mobile vans or other ways
of getting to the
essential workers.
Thank you.
>> Dr. Frey.
>> Thank you.
I had a quick comment.
Really more of a question.
I mean, so far I agree with both
of these groups of
being prioritized.
But I think there has to be
a strategy within the groups
to prioritize people within
the group, each these groups.
But my question is, and I think
Dr. Lee eluded to this earlier.
Who makes the decision
about how many doses go
to a particular region or state?
And then, within that region
and/or state, who distributes
or will prioritize who's
supposed to get vaccine?
In other words, does the
federal government say, okay,
Region 1 gets X number of doses?
And, Region 1, you figure out
who is, in that region and going
to receive those doses?
How does this allocation occur
on who's going to be vaccinated?
>> So Dr. Mazonyay
would offer comment.
>> Yeah, thank you.
It's a really important issue.
And my response is not as
succinct as I like to give ACIP
when they ask these
hard questions.
I think that that's still an
issue that is under discussion.
And there is a complicated
interplay between the question
of prioritization
and allocation.
In other words, one might
want general information
about the question you posed
before you make decisions
about prioritization.
But we think that the way
this is going to go is that,
once we have ACIP's
recommendations
around prioritization.
And once we have
more information
about the specific
characteristics
of the conditions of
use of the vaccine.
The federal government will
be in a better position
to make allocation decisions.
And from a CDC perspective,
we're working
up the technical specifications
that would go with a variety
of potential scenarios.
What I would also
say is that for folks
who have been through H1N1.
Which is very different, but
has certainly similarities.
I hear some of the
same sentiment
that Dr. Romero echoed
earlier in this session.
Which is to ask us not
to try to over-engineer.
And to leave space for state
and local health departments
to do some, leave state
and local health departments
some flexibility to deal
with their own local situations.
And so we definitely
have heard that input.
And we'll try to take it into
account in our proposals.
>> Thank you.
>> So unless there is
substantial objection
by the voting members, I'd
like to take two more persons
for questions or comments.
And then move onto the
public comment session.
So if you have objection,
raise your hand.
And in the meantime, Dr.
Lee, please go forward.
>> Thank you.
I'll try to be quick.
You know, with regard
to number two,
I'm also struggling with it.
It's hard to make this
decision yet until, you know.
It's assuming that the
implementation considerations
that we know about
today are going
to be the same four
weeks from now.
So I just want to acknowledge
that I think, you know,
deciding, you know, whether
it's essential workers or those
with high-risk medical
conditions,
to me is really challenging.
And I think we'll just have to
see where we are in a few weeks
with regard to understanding
more
about implementation challenges.
And, again, getting a sense
of which vaccine candidates
might be the most likely
to come forward initially.
I did want to say that the,
within the groups there is,
you know, obviously, and Dr.
Mazonyay alluded to this.
The ability to acknowledge
that there are differential
risks among even low-wage
workers within the
healthcare delivery system.
Those with high-risk
medical conditions and age.
But that kind of guidance, even
within a particular category,
I think should not impair
implementation efforts.
And we do need to acknowledge
that risk-based recommendations
are always more challenging
to implement, you know,
COVID notwithstanding,
in universal recommendations.
So I think providing enough
information that local teams
who are doing the vaccinating
can actually make sure
that they are maximizing
the impact.
But also not cons
training them so much
that they're not getting
the vaccine out there.
I think that's the balance
we'll need to strike.
Thank you.
>> Dr. Talbot.
>> Yes. I just want
to remind everyone
that we're in a weird time.
And that we have people who
still have to go to work
and put themselves at risk.
And there are many with
high-risk conditions
that can work from home.
But there are many with
high-risk conditions
who are essential workers and
who are putting their lives
on the line to keep
our society running.
And so I think it's absolutely
critical that we continue
to think about the essential
workers for many reasons.
One is because they are of,
many are of lower
socioeconomic status.
Many have high-risk conditions,
and they are unable
to work from home.
So I think that's the key.
As vaccine becomes
available in huge quantities,
then we can talk
about the people
who have the luxury
of staying at home.
And I think along
those lines, too,
is we won't have enough vaccine
or everyone in the healthcare
and then everyone who's
an essential worker.
But I think you also have
to remember not everyone's
going to want the vaccine.
We have the opportunity to
offer it to these first.
But not everyone's
going it take it up.
And maybe, too, with
a limited supply,
some people will be more
motivated to get it.
I think, as for the
freezer comments.
There are some amazingly
talented and innovative people
in our health departments and,
at the CDC in public health.
And I think they will come up
with incredible ways to get
to our essential workers.
So I don't want that
to limit us.
I think we should
continue to think
about our essential workers.
And then just get
really creative.
Over.
>> So it's getting
time that we move on.
But in deference to the chair
of the work group committee,
Dr. Bell, would you please
offer the final comment
in this session.
>> Thank you, Dr. Romero.
And that's what I wanted to do.
I just want to thank all of
my colleagues on the ACIP
for such thoughtful and
helpful feedback to what's
on the work group as we
move forward in an effort
to make interim recommendations
[inaudible] purposes.
Which is clearly
going to be pivotal
to any successful
vaccination program
with all of the moving parts.
All of the uncertainties.
I, as I said, I just
want to thank people.
And I've been struck by how
much the ACIP members have stuck
with the guiding principles.
And, as I say, also provided us
with some feedback
and food for thought.
So that we can work
through these issues further
between now and our
next meeting.
So thank you to everyone.
>> Thank you all, work group,
for having offered those
comments that were thoughtful.
Insightful.
And will guide us in
future discussions.
And thank all of the CDC work
team that has put this together.
