> Welcome back everyone. We're ready to begin
the next session.">

    0:00

>> Welcome back everyone. We're ready to begin
the next session.

    0:05

So, this will be with Dr.
Dooling in the phased allocation

    0:11

of COVID-19 vaccines
presentation. Dr. Dooling, please.

> Thank you, Dr. Romero. Today, we will revisit
the phased allocation">

    0:17

>> Thank you, Dr. Romero. Today, we will revisit
the phased allocation

    0:23

of COVID-19 vaccines. Next slide. Once there's a vaccine
approved for use,

    0:31

there will likely be a period when there is insufficient
vaccine to meet demand. The objective for this
session is to select groups

    0:38

for COVID-19 vaccine allocation
in phase 1A, 1B, and 1C.

    0:44

Next slide. In the previous two
presentations, Dr. Oliver led us

    0:49

through the domains
of the evidence to recommendation framework. Those determinations will lead
to a decision on recommendations

    0:56

for any given vaccine. In order to answer
the policy question, which groups should
be recommended

    1:02

to received COVID-19
vaccine X during phase one, we will modify our
approach a little and focus

    1:08

on the science implementation
issues and ethical considerations that
inform this important question.

> As for the science pillar, the workgroup examined
COVID-19 vaccine, or sorry,">

    1:16

Next. >> As for the science pillar, the workgroup examined
COVID-19 vaccine, or sorry,

    1:21

COVID-19 disease burden as
well as the balance of benefits and harms in each group. Of course, details of the phase
three data will further inform

    1:29

this area when they
become available.

    1:35

Next. For implementation,
the workgroup took into consideration the
values of the target group

    1:41

and the feasibility
of implementation in each of the groups. Next. And finally, the
ethical principles.

    1:48

These were presented to ACIP
and supported by members at the last ACIP meeting.

    1:54

The principles aim to maximize
benefits and minimize harms, promote justice, mitigate
health inequalities, inequities,

    2:01

and promote transparency
throughout the vaccine policy process. Next. These three
pillars will be used

    2:11

to evaluate the proposed groups
for phase one vaccinations. These groups are
healthcare personnel,

    2:17

other essential workers
outside of healthcare, adults with high-risk
medical conditions, and adults who are
65 years and older.

    2:24

Recall that during the August
ACIP emergency meeting, ACIP members expressed support

    2:29

for vaccinating healthcare
personnel in phase 1A. Next. Now, let's take
a moment to review

    2:38

who these groups include. Healthcare personnel are
defined as essential workers,

    2:43

paid and unpaid, serving
in healthcare settings, who have the potential for
direct or indirect exposure

    2:49

to patients or infectious
materials. There are approximately 21
million healthcare personnel

    2:55

working in settings
such as hospitals, long-term care facilities,
outpatient settings, home healthcare, etc.
Essential workers are those

    3:03

that work outside of healthcare, continue critical
infrastructure, and maintain services and functions Americans
depend on daily.

    3:10

CISA within the Department of
Homeland Security is tasked with creating the list of
critical and essential workers

    3:16

that includes the listed sectors
here including healthcare. The guidance acknowledges
that workers

    3:24

who cannot perform duties
remotely and must work in close proximity to
others should be prioritized

    3:30

for mitigation measures. It also is important to
recognize that subcategories of essential workers maybe
prioritized differently

    3:38

in different jurisdictions
depending on local needs. The estimated population for
this group is 87 million,

    3:44

but it should be noted that
this is a very rough estimate and may be revised
as work placed evolve

    3:49

and find innovative ways
to protect their workers and allow work at a distance. Next are adults with medical
conditions the higher risk

    3:57

for severe COVID-19. The estimated population
for this group is over 100 million adults, and
the conditions that put people

    4:04

at risk are being
constantly refined according to the evidence and
updated on the CDC website.

    4:11

Finally, adults who
are 65 years of age and older are numbering
approximately 53 million.

    4:16

We can think of this group
as older adults living in the community and
those who are living

    4:22

in congregate settings. About three million
adults in the U.S. live in congregate setting such as
skilled nursing facilities,

    4:29

assisted living,
residential and HUD housing. The COVID-19 pandemic has taken
a tremendous toll on this group,

    4:36

and we will examine this
in greater detail later on in the presentation. Next. The next slide summarizes
the workgroup considerations

    4:47

supporting vaccinating
healthcare personnel in phase 1A.

    4:52

With respect to science,
as of November 21st, there have been more than 220,000 confirmed COVID-19
cases among healthcare personnel

    5:02

with 822 deaths. COVID-19 exposure that
occurs both inside

    5:07

and outside healthcare
settings results in absenteeism either
due to quarantine, infection, or illness.

    5:14

Vaccination has the potential to reduce healthcare
personnel absenteeism.

    5:19

Long-term care facility
modeling demonstrated more cases and death can be
averted at the facility

    5:25

by vaccinating staff compared
to vaccinating residents. Implementation considerations
support the selection

    5:32

of healthcare personnel as
acute care healthcare personnel routinely have high uptake
of influenza vaccine,

    5:40

which may predict high vaccine
acceptance of a COVID vaccine. Many acute care facilities have
the equipment and expertise

    5:49

to carry out large-scale
vaccination with a vaccine that requires ultra-cold
storage.

    5:54

From an ethical perspective,
vaccinating healthcare personnel with a safe and effective COVID
vaccine maximizes benefits

    6:01

by preserving healthcare
services essential to the COVID-19 response and
the overall healthcare system.

    6:08

Also, healthcare personnel
groups support equity as it is inclusive of all job
types in the healthcare setting,

    6:16

and the group is racially
and ethnically diverse. Next. Given ACIP's prior support
of early allocation of vaccine

    6:29

to healthcare personnel,
I'll now spend the remainder of the presentation focusing on the remaining
groups in phase one.

    6:35

We'll examine these
groups through the lens of science implementation
and ethics

    6:40

and highlight the
relevant differences. Next slide. First, let's look
at the science.

    6:49

Next. These are national
estimates of COVID-19 incidents of confirmed cases by age group.

    6:54

As you likely already know, COVID-19 incidence is
highest in young adults.

    7:00

Next. On the other hand, COVID mortality rates are
highest in older adults.

    7:08

You can see that the
national estimates of death per 100,000 population
rises steeply after age 55.

    7:15

Next. This figure
shows the proportion of COVID-associated hospitalized
patients who were admitted

    7:24

from a long-term care facility. More than 30% of
hospitalized patients aged 65

    7:30

to 74 were admitted from
a long-term care facility, and more than half of hospitalized COVID 19
patients 75 years of age

    7:38

and older were admitted from
a long-term care facility. Next. This table

    7:46

from a published paper
featuring COVID net data show that compared to people without
underlying medical conditions,

    7:55

adults with one or more
conditions were significantly more likely to be
hospitalized with COVID-19.

    8:01

That risk increased if a
person had multiple conditions. Older adults living in the
community were also more likely

    8:09

to be hospitalized for COVID
compared to younger adults. However, in this adjusted
analysis, the magnitude

    8:15

of association for older
age was smaller compared to having multiple
comorbidities.

    8:21

It should be noted
that persons living in long-term care were
excluded from this analysis.

    8:26

Next. In contrast to
the previous slide,

    8:34

among persons already
hospitalized for COVID-19, risk of in-hospital death
increased dramatically with age,

    8:41

and adjusted rate ratios ranging
from six to 11 in age groups that were 65 years
of age and older.

    8:49

Next slide. These data together
demonstrate that older adults

    8:55

in congregated settings are
disproportionately affected by COVID-19. Long-term care facility
residents and staff accounted

    9:01

for 6% of cases and 39%
of deaths in the U.S., despite the fact that long-term
care facility residents account

    9:08

for 1% of the U.S. population. The skilled nursing facility
population is approximately 1.3

    9:15

million and as of November 8th
had experienced almost half a million confirmed
and probable cases

    9:20

and more than 67,000 deaths. Assisted living facilities
are home

    9:26

to approximately 800,000
residents nationally, and although surveillance
is less systematic for this setting, states have
reported thousands of cases

    9:35

and deaths among
these residents. Next slide. Next, I'd like to
review modelling data

    9:44

that was presented to
the ACIP in October. The question was, what
is the potential impact

    9:50

of preventing COVID-19
infections and deaths of initially allocating vaccine
to one of the following groups

    9:56

after vaccinating healthcare
personnel in phase 1A. The analysis was updated with
a vaccine effectiveness input

    10:04

of 90% in younger
and older adults and to reflect our
current epidemiology.

    10:09

Full methods can be
reviewed at a ACIP website with the link provided. Next slide.

    10:15

The bars here represent
the population-wide averted infections after six
months from the beginning

    10:21

of the start of a
vaccine program. Using an infection-blocking
vaccine, in other words,

    10:27

assuming that there's no
asymptomatic infection or transmission among
vaccinated persons. Initially vaccinating high-risk
adults or essential workers

    10:36

in phase 1B averts approximately
1 to 3% more infections compared

    10:42

to targeting persons
65 and older. Next slide. Under the same timeline
and assumptions

    10:51

of vaccine performance, but instead considering
averted deaths, initially vaccinating
adults 65 and older

    10:59

in phase 1B averts approximately
0.5 to 2% more deaths compared

    11:04

to targeting high-risk
adults or essential workers. Next slide.

    11:10

Now, if we consider
the extreme scenario, whereby the vaccine does not
prevent asymptomatic infections

    11:17

or transmissions at all
and only prevents disease, the overall percent of a population-wide averted
deaths are much lower.

    11:26

Initially, vaccinating
adults 65 and older in phase 1B averts approximately
2 to 6.5% more deaths compared

    11:35

to targeting high-risk
adults or essential workers. Next slide. In summary, the workgroup
concluded that the differences

    11:45

between the three
strategies is minimal. Ethical principles and implementation
considerations may greatly

    11:51

contribute to the selection
of the optimal sequence in phase 1B and beyond. The largest impact
in averted deaths

    11:58

and infections is the timing of
vaccine introduction in relation to increases in COVID-19 cases.

    12:05

This really emphasizes the need to continue nonpharmaceutical
interventions such as wearing masks
and social distancing.

    12:12

This analysis will
continue to be updated as we have better information. The factors that will inform
interpretation of modelling

    12:21

as we go forward will
include estimates of vaccine effectiveness
in older adults

    12:26

and the vaccine's ability to prevent asymptomatic
infection in transmission. Next slide.

    12:34

So, in summary, the
workgroup felt that the COVID burden is high
throughout the population

    12:40

and that the differences between
sequencing strategies in terms of infections and deaths
prevented was small.

    12:48

Next slide. Now, let's look at the next
pillar, implementation.

    12:54

Next. These results depict
survey response of intent to receive a COVID-19
vaccine as of September.

    13:03

Note that this was prior to any
information publicly available

    13:09

about vaccine efficacy. Overall, 62% of survey
respondents indicated

    13:14

that they were either
absolutely certain, very likely, or somewhat likely to
get a COVID-19 vaccine

    13:19

when it became available. The proportion was
slightly higher for adults with high-risk medical
conditions compared to those

    13:26

without those medical conditions
and higher in adults 65 years and older compared
to younger adults.

    13:33

Next slide. In a Harris poll
conducted in August,

    13:39

survey respondents reported
the early allocation of COVID-19 vaccine to the
groups we have proposed

    13:46

for phase one with
the strongest support for healthcare workers
in seniors.

    13:52

Next slide.

    13:57

These are some of the feasibility
issues the workgroup took into consideration
for essential works.

    14:03

It will be challenging to reach
workers in rural locations, shift workers, those
with multiple jobs,

    14:10

or those working
in small cohorts. Jurisdictional approaches to overcome those challenges
include on-site occupational

    14:18

clinics, pharmacy delivery,
health department point of dispensing strike teams.

    14:24

Most jurisdictions have
an allocation micro plan, which includes prioritization
among nonhealthcare essential

    14:32

workers, and they're
prepared for the period during

    14:37

which vaccine supply is limited. For adults with high-risk
medical conditions,

    14:44

one of the biggest
challenges may be determination eligibility. Healthcare homes such
as provider offices

    14:50

or pharmacies could
be better suited to verify the underlying
medical conditions.

    14:55

Unfortunately, minimum size
of vaccine orders and storage and handling requirements
may preclude involvement

    15:01

of small clinics. For many, including adults 65
years and older, long distances

    15:08

to travel to central
clinics and the necessity of large high throughput
clinics may be challenging.

    15:14

It should be noted that a federal pharmacy program
has already been established to reach long-term
facility residents.

    15:21

Next slide. Values. So, ultimately, values,
consider it as a combination

    15:29

of intent to get the vaccine and
the values of the population. Increased from essential
workers to adults

    15:37

with high-risk medical
conditions to older adults. Feasibility was thought
to be slightly higher

    15:43

for essential workers and
older adult than those with high risk conditions. Next slide. Overall, the workgroup felt
implementation would be easiest

    15:54

among older adults. Next slide. Now, onto ethics.

    16:01

Next. This is an application
of the ethical principles

    16:06

to the three groups
we're discussing. The ACIP was introduced
to this application

    16:12

at the October meeting, and
additional details can be found in the MMWR publication,
which was published today,

    16:19

as Dr. Romero indicated
and referenced at the bottom of the slide. I'll highlight some of the text
on the slide, but please note

    16:26

that the darker green color
indicates stronger support for that ethical principle. For essential workers,
the workgroup noted

    16:33

that early vaccination of this
group would strongly support maximizing benefits
and minimizing harms,

    16:39

promote justice, and
mitigate health inequities. Vaccinating adults

    16:45

with high-risk medical
conditions moderately supported maximizing benefits
and promoting justice.

    16:51

There were concerns
that diagnosis of medical conditions
may favor those who already have
access to healthcare.

    16:57

The workgroup felt early
vaccination of adults 65 and older was strongly supported

    17:04

by maximizing benefits
and minimizing harms. There were concerns that
the racial and ethnic groups

    17:09

that have been
disproportionately affected by COVID so far are
underrepresented in this group.

    17:15

Next slide. This slide reflects, in the plus
system, the summary of the table

    17:21

that we just discussed. Next slide.

    17:30

And this slide reflects
the overall assessment of the three groups
considering science,

    17:36

implementation, and ethics. Next slide. As the workgroup took all
of this into consideration,

    17:47

and here you see the proposed
interim phase one sequence,

    17:53

which represents the
majority of workgroup opinion. As previously indicated,

    18:00

phase 1A would include
healthcare personnel. The workgroup also felt that
given the burden of disease,

    18:06

likely benefits, implementation, and ethics supported
the inclusion of long-term care facility
residents in phase 1A as well.

    18:15

The proposed phase 1B includes
essential workers such as those who work in the education
and childcare sector,

    18:23

food and agricultural,
utilities, police, firefighter, corrections officers, and those
who work in transportation.

    18:32

The proposed phase
1C includes adults

    18:38

with high-risk medical
conditions and adults 65 years and older. Next. This is an example

    18:44

of a schema depicting how the
phase one sequence might roll

    18:51

out over time. Two important things to
note here are that first

    18:56

that the phases will
likely overlap in time and it will not be
necessary to vaccinate 100%

    19:02

of one group before
moving onto the next. Second, that is more
vaccine supply is expected

    19:08

in later months, this will allow
broader and faster coverage. Next slide.

    19:15

Here are some additional
important workgroup considerations.

    19:22

The schema presented here
presents an interim phase one sequence allocation policy will
need to be dynamic and adapted

    19:32

as new information, such as
vaccine performance and supply and demand become clear.

    19:38

To that end, we will need gating
criteria to move expeditiously from one phase to the
next as demand saturates.

    19:46

The workgroup reinforced that reaching essential
workers may be challenging

    19:52

and will require jurisdictions
to identify critical sectors at risk and optimal
strategies to reach them.

    19:58

And it's important
to keep in mind that following vaccination
measures to stop the possible spread
of SARS-CoV-2, such as masks

    20:06

and social distancing,
will still be needed. And ultimately, this
interim allocation is a

    20:13

short-term measure. The U.S. government has
stated its commitment to making COVID-19 vaccines
available to all residents

    20:20

who want them as
soon as possible. So, that concludes
this presentation,

    20:27

and after following
ACIP discussion and at the prerogative of the
chairs, I'd like to come back

    20:34

and ask the ACIP members
for specific feedback on phase 1A, 1B, and 1C.

> Thank you very
much, Dr. Dooling, for that excellent presentation. So, we can open this up now
to questions and comments">

    20:45

>> Thank you very
much, Dr. Dooling, for that excellent presentation. So, we can open this up now
to questions and comments

    20:53

from the voting members
and then onto liaison. So, let me begin by
asking a question

    21:01

that is somewhat pessimistic. So, you've talked about gating
for moving from one phase

    21:09

to another as you
become saturated. What gating or will
gating be also applicable

    21:18

if there is reluctance
by a given group to accept the vaccine,
and at that point,

    21:27

will [inaudible] guidelines
for moving onto the next phase if we have significant
reluctance and acceptance

    21:35

of vaccine in a group? Over.

> Thank you, Dr. Romero. I'd like to say at this point
that one of the early principles">

    21:40

>> Thank you, Dr. Romero. I'd like to say at this point
that one of the early principles

    21:47

that the workgroup came up
with was the efficient delivery of vaccine to the
population amidst a pandemic,

    21:54

and that remains an
extremely important factor as we move forward. So, I think absolutely gating
criteria will need to take

    22:01

into account saturation of
demand for any given phase and to be able to move swiftly
and efficiently onto the next

    22:10

to make sure that we are
administering as much vaccine as the system will allow.

> Thank you very much. Any other comments
tailing onto that?">

    22:17

>> Thank you very much. Any other comments
tailing onto that?

> Thank you, Dr.
Romero, and thank you">

    22:23

Hearing none. Dr. Atmar, please. >> Thank you, Dr.
Romero, and thank you

    22:29

for a great presentation. I want to voice my concern
about moving persons

    22:38

in the long-term care
facilities up to phase 1A,

    22:43

and I guess I have three
main reasons for that,

    22:49

the first being that this
population is not a population that's been studied
in the vaccine trials.

    22:58

I recognize that they
have suffered some of the greatest burden, but
coming back to the science

    23:09

of it, we really are not
able to assess the balance of benefits and harms.

    23:15

So, that'll take me into
the next two issues, which is that we have no
efficacy data in this population

    23:23

because it hasn't been studied. We know from flu vaccine studies
that this population tends

    23:36

to have less efficacy of flu vaccine compared
to other persons.

    23:45

I'm gratified by the
high reported efficacy

    23:51

in the preliminary analyses
from the two companies that we're likely
to consider first,

    23:58

but we still really don't
know what the efficacy will be

    24:03

in this population and that
whether there, you know,

    24:08

based on the modeling studies, whether there might be
differential vaccine efficacy, and I think that
that's still likely.

    24:16

And then it brings me
finally to safety concerns. Both of the vaccines
we're likely

    24:23

to consider first are
reactogenic, and in this case,

    24:29

I do mean reactogenic. And that reactogenicity in
this population often leads

    24:39

to additional evaluations,
trying to figure

    24:45

out whether there is some
intervening infections or other problem, and because we
haven't studied this population

    24:55

with the vaccine, we
don't know how much that can potentially affect
the outcomes in this group,

    25:05

and those of use who
see these patients in the hospital recognize

    25:11

that there are often medical
interventions that are done in the pursuit of a diagnosis,
of a change in clinical status,

    25:20

that in and of themselves
can lead to harm.

    25:25

And so, for all of these
reasons, I would be concerned about promoting this group
to 1A on a theoretical basis

    25:38

that maybe they'll get as much
benefit as other persons will.

> Thank you for those
comments, Dr. Atmar. Does anyone wish to add additional
comments in that line.">

    25:45

Over. >> Thank you for those
comments, Dr. Atmar. Does anyone wish to add additional
comments in that line.

> I do. I do too. >> Please do. Please do. >> I agree with Dr. Atmar,
and this is as a member">

    25:53

>> I do. I do too. >> Please do. Please do. >> I agree with Dr. Atmar,
and this is as a member

    26:01

of the COVID working group,
I've really struggled with this and actually have
struggled with putting into words some of my concerns.

    26:07

And Dr. Atmar has
said a lot of them. I think the one that's
hardest for me is that there is

    26:12

such a high mortality rate
in long-term care facilities. There will be a number
of patients

    26:21

who receive immunization for
COVID and will pass away,

    26:27

and it may be regardless
of the vaccine, and most likely will be
regardless of the vaccine,

    26:32

but early on, as we're
building confidence in this, we will not be able to show any
data to say that it was not due

    26:40

to the vaccine because
there's not been a randomized control trial. And I think you're going to
have a very striking backlash

    26:49

of my grandmother got the
vaccine, and she passed away. And they're not likely
to be related,

    26:56

but that will become
remembered and break some

    27:02

of the confidence
in the vaccine. I do think having a randomized
control trial, even if small,

    27:10

to show the safety would say
a lot about this vaccine.

    27:16

We can extrapolate that
there'll likely be some efficacy since it's so efficacious in
younger adults and older adults

    27:25

who are not in long-term
care facilities, but I do not think we can
extrapolate any safety data, and I think we're going
to need clear safety data

> It's Paul Hunter. Can I make a comment?">

    27:32

for the public. >> It's Paul Hunter. Can I make a comment?

> Yes, of course, you can. >> So, I think that Bob Atmar's">

    27:37

>> Yes, of course, you can. >> So, I think that Bob Atmar's

    27:43

and Kip Talbot's
comments are really great and I think well thought out.

    27:49

And I think I'm coming as usual from a more implementation
issue, having worked

    27:56

in nursing homes in
part of my career. And it's just going to be,
and in the logistical issues

    28:05

of you're coming through
and vaccinating the staff, and then you've got the vaccine
there, and you've got people

    28:13

who could benefit
from the vaccine. And if you skip over
them, that's going to be a difficult thing,
I think, for the staff

    28:21

to think about, because
they really care about their patients, and for
some of the family members, sort of the other
side of the coin

    28:28

of what Kip Talbot was
just talking about. So, but it doesn't, I mean, I
think that everything, you know,

    28:35

as a clinician, I
agree with everything that Bob and Kip just said. It's just that you got the
logistical efficiencies

    28:43

of bringing in a bunch
of vaccine into a venue, and why not vaccinate
people that, you know,

    28:49

you've got it all set
up and ready to go. It's an efficiency to
vaccinate a bunch of people

    28:55

who could benefit from it. Yeah, that's a real
implementation issue that I think we need
to keep in mind too.

> Thank you for
those thoughts, Paul. Anyone else wish to dovetail
onto this conversation.">

    29:01

So, that's all, thanks. >> Thank you for
those thoughts, Paul. Anyone else wish to dovetail
onto this conversation.

> Yeah. This is Grace Lee. >> Please. >> Thank you so much. I appreciate all the comments.">

    29:09

>> Yeah. This is Grace Lee. >> Please. >> Thank you so much. I appreciate all the comments.

    29:16

I think my struggle is is
that I'm not sure we're going to have much more
information by the time we get

    29:22

to phase 1C, for example. So, you could make the argument
similarly for, you know,

    29:28

adults 65 and older
with, you know, high-risk medical conditions that mortality may
be higher anyway.

    29:34

And so, I guess my concern
is is that while we wait for that data, you know,
I'm not sure at this point,

    29:43

giving at least what
we know today about the potential efficacy
and the safety profile

    29:48

of the vaccine that it would
necessarily dissuade me. I do think it's important
that we separate it out,

    29:53

all adults 65 and older from
the long-term care facility residents where their risk
for mortality is much higher.

    29:59

And I do think that there
is an opportunity for us to reduce that mortality. And I'm also, I think, along
the lines of Dr. Hunter,

    30:07

I tend to be a very practical
person in that it's hard to get back to some of
these locations, you know,

    30:13

from an infrastructure
standpoint to ensure vaccine
delivery of two doses first to healthcare personnel and then
to leave and then to come back

    30:22

in a later phase to
vaccinate all the residents. I do think it's a small enough
population that I, you know,

> Thank you for your
comments, Dr. Lee.">

    30:27

would be supportive of it. >> Thank you for your
comments, Dr. Lee.

> Yep. I'd like to respond
to Dr. Lee's comment. This is Dr. Atmar.">

    30:34

Anyone else who wishes to
add to this conversation? >> Yep. I'd like to respond
to Dr. Lee's comment. This is Dr. Atmar.

> Please do. >> So, I think what
we have between 1A and 1C is several weeks,
a few months' worth">

    30:40

>> Please do. >> So, I think what
we have between 1A and 1C is several weeks,
a few months' worth

    30:49

of additional safety data
in a much larger population to address some of the
concerns that Dr. Talbot raised.

    30:59

And the other piece is,

    31:06

well that's the main thing
I guess I wanted to say.

> I'll say this is [inaudible]. >> Yes, please go
forward, [inaudible]. >> So, I actually support
Grace Lee's position more.">

    31:12

Thanks. >> I'll say this is [inaudible]. >> Yes, please go
forward, [inaudible]. >> So, I actually support
Grace Lee's position more.

    31:22

I just think that it's a really
high-risk population and,

    31:29

you know, I think that,
you know, first of all, we need to ask the companies
to see what data they do have,

    31:36

because I'm not certain,
you know, I know that they were
vaccinating some over 65

    31:43

and over 85, so I think
we do need to see some of that data before we can
finally make a firm decision.

    31:50

But, it is such a
high-risk group that with appropriate
informed consent, I would be very hesitant
not to give it.

    32:00

Likewise, even within
the essential workers and the healthcare
professionals, I'll be upfront.

    32:09

I'm 66, and I'd rather give it to something much older
and sicker than me. And I just think that we have
to really think this closely,

    32:19

because I really think that
that's a very important group that ultimately needs it,

    32:25

including the healthcare
professionals who work in these long-term care
facilities and even consider

    32:31

for at least one of the
visitors who come, you know, one of the families who does
every day to visit or would

    32:40

like to come every day to visit. We think that's another
population that should be considered.

    32:46

If we're not going to
vaccinate that individual,

    32:54

who is in the long-term
care facility.

> Sorry, I didn't
unmute myself. Anyone else who wants
to add comment to this? >> Jose, this is Hank Bernstein.">

    33:02

>> Sorry, I didn't
unmute myself. Anyone else who wants
to add comment to this? >> Jose, this is Hank Bernstein.

> Please Hank, go ahead. >> I was, one question
I was wondering around this issue,
I happen to agree.">

    33:09

>> Please Hank, go ahead. >> I was, one question
I was wondering around this issue,
I happen to agree.

    33:15

I mean overall it's a
relatively small population of 3 million compared
with the larger numbers.

    33:24

But I also wondered if we were
to immunize all the staff,

    33:30

how many of them, if
it's not mandatory, how many of them would
actually take the vaccine

    33:37

or accepts the vaccine, and
if they, I'd feel different if I knew that all of
the healthcare personnel,

    33:46

providers working in the long-term care
facility were immunized,

    33:51

it might be a little bit
different, but I'm not convinced that all of them would
accept the vaccine.

    33:59

So, this high-risk population
would benefit and logistically, and as Dr. Hunter said,
it would be appropriate

    34:07

if you're there administering
it to everyone there, workers and residents alike.

> This is Sharon. >> Go ahead Sharon. >> I would like to also
make a comment in support">

    34:15

>> This is Sharon. >> Go ahead Sharon. >> I would like to also
make a comment in support

    34:22

of leaving the long-term
care facilities residents in phase 1A.

    34:27

I think Dr. Talbot's and Dr.
Atmar's comments are very well

    34:34

taken, and I don't think there's
really, you know, a solid,

    34:39

great answer to all these
questions we're trying to figure

    34:46

out one best way [inaudible]. One of the arguments made
for a wait and see approach

    34:55

for the long-term care
facility residents, but it may not work as well. But it might work well
enough to save some lives.

    35:05

And also, the concern about
reactogenicity in the elders, I have to say, I share
those concerns very much,

    35:19

but you could also think
about adults in the 1C group

    35:26

who will also suffer from some of these same reactogenicity
issues and just the fact

    35:31

that they're older would
leave to more workup in those individuals
also, despite the fact

    35:38

that they're not in a
long-term care facility. They may also present to
their doctors with concerns

    35:43

that would lead to
further evaluation. Sorry. Thank you.

> Let me also add a
comment here, if I may, focusing on a little
differently than mortality.">

    35:50

>> Let me also add a
comment here, if I may, focusing on a little
differently than mortality.

    35:58

So, I can only comment,
all politics is local as Tip O'Neill used to say. So, my comments are from
the local point of view

    36:06

of the State of Arkansas. When we look at what
is occupying,

    36:12

coming into our hospital
ICUs and our beds, they are a substantial
number of patients

    36:18

from long-term care facilities. So, the impact of this vaccine
may not only be a decrease

    36:27

in mortality, but may
prevent an over burdening

    36:32

of our healthcare system that
we are most likely to encounter in the upcoming weeks.

    36:39

So, I just throw that
out as a consideration, and then I cut somebody
off, forgive me, please,

> Jose, this is Peter Szilagyi. >> Yes, Peter. >> I'm struggling
with this as well">

    36:45

whoever it was that
wanted to say something. >> Jose, this is Peter Szilagyi. >> Yes, Peter. >> I'm struggling
with this as well

    36:53

but am definitely
learning toward Dr. Hunter and Dr. Lee's point of view,
and I'm definitely not an expert

    36:59

at long-term care facilities. But it seems to me
that the efficacy issue

    37:06

with this relatively small
population of 3 million is not as important as the
safety question.

    37:13

And I definitely understand
the issues of reactogenicity, although I think what
I had heard earlier is

    37:19

that older adults have far
less reacted to these vaccines. But even if the vaccine
is somewhat effective,

    37:26

even if the healthcare
providers, most of them, they won't all be vaccinated
but many of them will.

    37:35

Other individuals are visiting
the long-term care facility residents and can easily
transmit SARS-CoV-2 to them.

    37:43

So, I'm definitely
leaning toward suggesting to include them. And one final point
is, as Bob said,

    37:49

because there's only a
couple months or a few months between phase 1A and
phase 1C potentially,

    37:56

I'm not sure we will have enough
safety data within a few months, even if trials can be
ramped up very quickly.

    38:04

I'm not sure we would
have enough safety data to really completely
reassure us. So, I think we're all dealing
with a limited level of evidence

    38:11

and these are just very
[inaudible] leaning toward keeping them in phase 1A.

> Thank you. Anyone else wish
to make a comment? >> [Inaudible] with AGS.">

    38:17

>> Thank you. Anyone else wish
to make a comment? >> [Inaudible] with AGS.

> Yes, please go ahead. And speak up a little bit,">

    38:22

Is that okay to comment
now, the liaisons? >> Yes, please go ahead. And speak up a little bit,

> All right. Is this better? >> Much.">

    38:27

because you're a little
[inaudible] on the sound. >> All right. Is this better? >> Much.

> Yeah, I'm representing
American Geriatric Society, and certainly we recognize the
important points that Dr. Atmar">

    38:32

>> Yeah, I'm representing
American Geriatric Society, and certainly we recognize the
important points that Dr. Atmar

    38:38

and Dr. Talbot raised and
certainly support research in long-term care
as we go along. But AGS does support
moving LTCF residents

    38:47

into phase 1A given
the devastating impact Kathleen mentioned. The potential benefits of the
vaccine have not been disproven,

    38:54

and the low numbers of long-term-care residents
has been pointed out and also the need for the
pragmatic delivery of vaccine

    39:01

to staff and residents
at the same time. I want to make a second
comment too that has to do

    39:06

with the entire phase one
sequence here, and that's to do with the fundamental
principle of aging

    39:13

that informs the sequence. And that principle is the rate
of aging and the accumulation

    39:18

of chronic conclusions varies
widely amongst individuals, which results in broad
heterogeneity of [inaudible].

    39:25

In other words, we become more
unlike each other the older we get. So, using an age cut point
alone is problematic,

    39:32

because it lungs well elders at
lowest for severe COVID together with sicker, vulnerable
older adults

    39:38

with multiple chronic
conditions, who are at much higher
risk for severe COVID. So, from AGS standpoint,

    39:43

65+ later on in the
sequence like 1C is okay. The trick is where
you put the sick or

    39:50

or more vulnerable individuals,
and of course they'll fall into the adults with
high-risk medical conditions.

> Thank you very much
for those comments.">

    39:55

And overall, the AGS is
okay with this sequence. Over >> Thank you very much
for those comments.

> Dr. Romero, this is Amanda. >> Yes. >> I was wondering if I could
ask, some of the ACIP members,">

    40:03

Anyone else [inaudible]. >> Dr. Romero, this is Amanda. >> Yes. >> I was wondering if I could
ask, some of the ACIP members,

    40:12

Dr. Talbot and Atmar and others and everyone has expressed
concern about potentially not,

    40:19

potentially about
events that happen in elderly long-term care
facility residents being

    40:28

connected potentially to
vaccine, and I was wondering if there was a large effort to
make sure that family members

    40:37

and long-term care
facility residents and the staff understood what
may happen and were educated

    40:46

around vaccines and
safety and understood

    40:51

that there were no data in this
group of frail, older adults.

    40:59

Would that alleviate some of
the concerns from those of you

    41:04

who are especially
concerned about safety?

> This is Dr. Atmar. I guess it would
because that would in part what you would be
doing in a clinical trial">

    41:13

>> This is Dr. Atmar. I guess it would
because that would in part what you would be
doing in a clinical trial

    41:22

if there was some organized
way to collect the information, which I think there
are plans for.

    41:30

Really, then, you're coming
back to the efficacy question

    41:36

and taking the gamble that this
population is going to benefit

    41:45

at some level that's going
to be higher than the groups

    41:50

that they're jumping
in front of. And I guess I would, you know,
come back and say that, yeah,

    42:01

the vaccine's been tested in the
elderly, and at least in some

    42:06

of the trials, immunogenicity
has been as good in the elderly,

    42:14

but these have been ambulatory
elderly and not the, you know, the [inaudible] age that
Dr. Schmader was talking

    42:24

about that's not just age based. So, I think it mitigates
some of the concerns,

    42:29

but it gets to the
feasibility question then, how well is that going to
be able to be accomplished?

> Does anyone wish to answer? Dr. [inaudible]. >> Yeah, I'll answer
in response to that.">

    42:39

Over. >> Does anyone wish to answer? Dr. [inaudible]. >> Yeah, I'll answer
in response to that.

    42:46

I think if you're talking about
consenting for this vaccine, then I think they would
get adequate information.

    42:53

I think just putting a sign
up would be inadequate.

> Does anyone else
wish to offer comment?">

    42:59

>> Does anyone else
wish to offer comment?

> Thanks. >> Amanda, do you
have any [inaudible]. >> No, thank you. This is helpful.">

    43:05

>> Thanks. >> Amanda, do you
have any [inaudible]. >> No, thank you. This is helpful.

> Thank you. >> We're just trying to make
sure that if a decision is made">

    43:10

>> Thank you. >> We're just trying to make
sure that if a decision is made

    43:15

to include long-term
care facility residents in this group, then we
do want to make sure

    43:21

that concerns are addressed
and that we have, you know, ways to mitigate some of the
potential risk in this group.

> Okay, thank you. >> Jose. It's Nancy. Can I ask a sort of a
semi change in topic">

    43:31

>> Okay, thank you. >> Jose. It's Nancy. Can I ask a sort of a
semi change in topic

> Yes, please do. And to so everybody else
who had their hand up,">

    43:37

but related topic question >> Yes, please do. And to so everybody else
who had their hand up,

> Yeah, so, part of what
I think we're all going">

    43:45

we will get to you. I promise. Keep going, please,
Dr. [inaudible]. >> Yeah, so, part of what
I think we're all going

    43:50

to be struggling
with is a desire to make these lovely lumping
categories versus the reality

    43:59

that the health department
and hospitals are going

    44:04

to be faced with, which is,
you know, you have 100 people, and you have less vaccine,
and you have to prioritize.

    44:12

And I think, and therefore, I know some of this
is frankly going to be beyond the
parsimoniousness

    44:19

of eventual ACIP discussions. However, it would
be really helpful to have a little more discussion

    44:26

around how you would
preferentially decide in terms of healthcare workers
with the following caveat.

    44:36

Based on what we hear
from Operation Warp Speed, their estimate is that we'll
have approximately 40 million

    44:43

doses of vaccine available
in December or enough vaccine to immunize about 20 million
people because it's two doses

    44:52

for each immunization. And then, on an ongoing
basis, month on month,

    44:57

have enough to immunize
approximately 25 million people. And so, I say that because
if you go to the other slide

    45:06

that Kathleen showed with the
lovely lumps that are sort of overlapping, it's okay, you
can keep it here, but it's not

    45:14

such a parsimonious
choice because it's people, and I guess it would really
be helpful to hear from ACIP

    45:20

when they were looking
at this categorization. Do they really mean every single
healthcare worker should get

    45:27

vaccinated before we move
onto another category, is the intention of the
healthcare worker category meant

    45:36

to be more the healthcare
workers that are at higher risk

    45:42

because they are,
because they're seeing higher-risk patients.

    45:49

And that links to me with
the question of where to put the long-term care
facilities because if you have

    45:55

to do all the healthcare
workers first, that changes when you can get to
long-term care facilities.

    46:01

Jose, I hope that
question made sense. It did make sense, and I
will offer my opinions first

    46:08

and then let everybody
else gather their thoughts. So, I think that given the
limited amount of vaccine

    46:18

that it would be preferential to identify those healthcare
providers [inaudible].

    46:24

That includes those
individuals that are not in direct patient care
but have much to do

    46:32

with our ability
to see patients. So, for example, in the ED,
the housekeeping staff that has

    46:37

to turn that room around
very quickly in order to get the next person in.

    46:43

Those individuals at those
"front lines" be prioritized

    46:49

within the healthcare group. Now, it would be ideal
if we had enough vaccine

    46:55

or every healthcare worker
quickly and we can move quickly onto other groups, but
it doesn't look that way.

    47:02

And I think we need to look hard at our prioritization among the
healthcare personnel and begin

    47:09

to at least try to
identify those individuals at highest risk for
acquisition of the disease.

    47:16

And so, I'll stop there and open
it up to comments from others.

> Jose, this is Beth. Please Beth, Dr. Bell.">

    47:22

Please, who wishes to go next? >> Jose, this is Beth. Please Beth, Dr. Bell.

> Thank you. I think that this is a, what Nancy is raising
is an important point,">

    47:27

>> Thank you. I think that this is a, what Nancy is raising
is an important point,

    47:36

and I think it goes to what Dr.
Dooling was saying about demand and saturation of
demand and that we need

    47:44

to be moving expeditiously
in order to make sure that we make the best use

    47:50

of vaccine that's
available as we go forward. And, you know, given all of
the discussions we've had

    47:56

about hesitancy and the
data that we've seen about willingness to be
vaccinated, especially early on,

    48:03

I think as we think about
all of these groups, yes, there's the issues about
prioritization within groups

    48:10

and risk as Dr. Romero
has just been explaining. But there's also, you know,
the idea that not everybody,

    48:19

any group, for example, among
20 million healthcare workers, were not going to
have 100% coverage.

    48:25

And so, we need to think
of this, this process as a dynamic process where
as the demand is saturated,

    48:33

and the demand could
be for a subgroup of healthcare providers, but
as the demand is saturated,

    48:41

we're actually ready to
move on to the next group. And we don't wait until
we've achieved 100% coverage

    48:48

in any group. This, I think, is as I say,
is a very important principle,

    48:54

because at the end of the day,
I think we don't want to be in a situation where, you know,

    49:01

we're not using the vaccine
that's available to us as efficiently as possible.

> Thank you. Anyone else? >> This is Dr. Atmar. >> Please. >> So, I think there were
a couple of questions">

    49:08

>> Thank you. Anyone else? >> This is Dr. Atmar. >> Please. >> So, I think there were
a couple of questions

    49:18

or issues raised, and
one of those has to do with the availability
of the vaccine.

    49:24

I mean if there were 40 million
doses available in December, as some estimates have played,

    49:32

I mean that's almost
enough vaccine for all of the healthcare
personnel, and certainly

    49:38

by the time the second dose
is needed, they should be more

    49:44

than adequately covered. But at least in the institutions in which I've had the
opportunity to participate

    49:53

in planning, it doesn't
sound like those kinds

    49:58

of numbers are going to
be available, and so,

    50:04

some of the prioritization
that we've gone through has been just the same
kind that Dr. Romero discussed

    50:12

in terms of which
healthcare personnel would be targeted first. I guess it also raises
a question

    50:21

about as vaccine
is being allocated to different institutions
whether the second dose should

    50:33

be held for the individual who has already received
the first dose or used

    50:41

on the next healthcare
worker who might step up. And at least in some of our
planning, the assumption was

    50:48

that we would get vaccine to do
the second dose administration

    50:55

through a subsequent shipment. So, that might be something that could be addressed
through the FAQs.

> Thank you. Anyone else? >> [Inaudible] Jose.">

    51:01

Over. >> Thank you. Anyone else? >> [Inaudible] Jose.

    51:08

This is Pablo. I think that, you know, what
Nancy and what you brought up are critical because
unfortunately not all healthcare

    51:16

workers are equal in terms of
risk, and I do think that some of us, I know, in ID and
[inaudible] I have ample PPE,

    51:27

and some others may not,
in an emergency situation. So, I do think that within
institutions we're going to have

    51:33

to prioritize which
ones will get it. But I also agree that,
you know, we look for it

    51:40

with another supply coming in a
month, and we can vaccinate more up front rather than save
the subsequent dosing.

> Anyone else? >> This is Marcus [inaudible] with [inaudible]
health officials. I just wanted to
mention, we did have,">

    51:50

>> Anyone else? >> This is Marcus [inaudible] with [inaudible]
health officials. I just wanted to
mention, we did have,

    51:57

we've had several conversations
about this with the leaders of state public health
departments,

    52:02

actually the last one on Friday that was queued up
by Dr. Messonnier. But, you know, I just wanted
to sort of raise the issues

    52:10

that I think amongst state
public health officials, there is pretty strong support

    52:16

for vaccinating healthcare
workers, and although there was some
discussion around, you know,

    52:22

maybe some more than others, I
do think there's the fact that, you know, healthcare workers,
you know, not only are

    52:29

in contact with lots of people,
but they're also in contact with people who are
very vulnerable, and that maybe makes
them a little different

    52:35

from other essential workers. And then they are also a very
important part of the response

    52:40

as far as taking care of
people and being the ones to vaccinate other people. So, those were the themes that
were raised in the conversation

    52:48

that we had, and I think
that's the one place that there was a pretty
strong perspective

> Thank you for those
comments Dr. [inaudible].">

    52:53

from our constituency. >> Thank you for those
comments Dr. [inaudible].

> Hi. This is Molly
Howell with the Association">

    53:00

Next, anyone else? >> Hi. This is Molly
Howell with the Association

    53:05

of Immunization Managers. I just wanted to echo
a lot of the comments about logistically
vaccinating staff and residents

    53:15

at the same time,
being much easier. I also feel like going
to a long-term care

    53:20

to vaccinate staff will
lead to higher uptake versus expecting staff to come

    53:26

to a mass vaccination
clinic held offsite. I'm wondering if
there are any plans

    53:32

to update the modelling data
that was presented in August to potentially look
at what it would mean

    53:40

with a higher efficacy rate
in the elderly population and if consideration
for uptake of staff,

    53:47

especially if we're
expecting between 40 and 60% of long-term care staff
to accept the vaccine,

    53:53

how much of an impact
that will make on whether or not residents
should be vaccinated. I also just wanted to mention
that the discussion earlier

    54:03

around people who have been
recently infected with COVID or prior positives, if that
may impact this somewhat.

    54:11

I think a lot of
long-term care staff and residents have
already had COVID,

    54:16

and I think that could also
inform some decision making in allocation if you're looking
at potentially delaying people

    54:24

who were recently
positive for COVID-19.

> Thank you very much. Are there any other comments
along this line before I return">

    54:30

>> Thank you very much. Are there any other comments
along this line before I return

> Yeah, this is
Hank, again, Jose. Did I hear that some were,
that there was a discussion">

    54:37

to the queue? >> Yeah, this is
Hank, again, Jose. Did I hear that some were,
that there was a discussion

    54:48

that people we're going
to be prioritizing within healthcare personnel who
gets vaccine and who doesn't or?

    54:57

Because I thought by definition
they were paid and unpaid, serving in healthcare
settings, and they're essential

    55:05

for the COVID response and
also at high risk of exposure.

    55:10

So, I just wanted to
make sure I didn't hear that there were going
to be prioritization

> Dr. Bernstein,
this is Amanda.">

    55:16

within the healthcare
personnel group. >> Dr. Bernstein,
this is Amanda.

    55:21

I can clarify. What we were talking about is that given the very
limited number

    55:27

of doses likely coming available
like in week one and week two and week three after a
vaccine authorization,

    55:36

not all healthcare workers will
be able to be offered vaccine at the exact same time.

    55:41

So, it's self-allocating
but from a, you know, we're talking a difference,
at the very local

    55:48

and hospital setting,
who do you, you know, how do you arrange your staff
over the course of a couple

> Yeah, just for, you know,">

    55:54

of weeks, for example,
does that make sense? >> Yeah, just for, you know,

> Actually, this is Grace Lee.">

    55:59

for practical logistical
concerns, sure. >> Actually, this is Grace Lee.

    56:05

If I could extend that a little
bit or comment on that comment, which is to say that I do
think, you know, well, at least,

    56:13

the intent that I'm
thinking about is that early allocation is
for what I'm going to call "essential workers" who
need to be in the workplace.

    56:20

And that those who are able
to work remotely as part of their job function, as
long as even next summer,

    56:27

perhaps should not be at
the front of the line, even if they are considered
healthcare personnel. So, some of our healthcare
workers will qualify technically

    56:35

in 1C but might not be actually
in the workplace interacting

    56:40

with patients or other staff. And so, I do think that the
allocation piece is not only

    56:46

just for the first few weeks,
but it's thinking about it from a public health and
community standpoint.

    56:52

If we have healthcare workers
who are able to work remotely until next spring or summer. I think, you know, we should
be vaccinating and moving

    56:59

onto phase 1B and perhaps 1C
and then capturing the rest of our healthcare
workforce that way.

    57:05

I don't think we should actually
have the gating criteria be set at 100%.

    57:10

I actually think we're going
to need that flexibility because we don't know exactly
what the supply will look like in early weeks.

    57:17

And, you know, this is where
I think closed partnership with our public health
colleagues will be critically important to make sure that we
are not trying to vaccinate 100%

    57:25

of our healthcare
workforce if some proportion of our workforce
can work from home.

> Before we continue on
with more comments on that, there's a piece of information
that was just given to me that I want to throw out there
for everyone's consideration.">

    57:31

>> Before we continue on
with more comments on that, there's a piece of information
that was just given to me that I want to throw out there
for everyone's consideration.

    57:39

So, I was just informed that 30% of all long-term care facilities
residents turn over at 30 days,

    57:47

which means that we would
have to be revaccinating in those populations every 30
days or so in order to keep

    57:54

up with that change
in new population. So, I'll see if anybody else
has any other comments they want

> Yeah. This is Pablo. I just want to absolutely
agree with Grace's comments.">

    58:03

to offer. >> Yeah. This is Pablo. I just want to absolutely
agree with Grace's comments.

> This is Jeff Duchin. >> Yes, Jeff.">

    58:10

I agree with her completely. >> This is Jeff Duchin. >> Yes, Jeff.

> I'd also -- thank you. I'd like to emphasize from my
local public health perspective">

    58:16

>> I'd also -- thank you. I'd like to emphasize from my
local public health perspective

    58:21

how important it is
to have clear guidance on this prioritization
business because we, you know,

    58:29

all first shipments
of vaccine will go to large healthcare systems that
have the appropriate storage

    58:36

for these, ultra cold, and they
may want to vaccinate everyone

    58:42

in their facility,
tertiary care centers, yet we know that the risk
is highest in the community

    58:48

at the long-term facility level. That's where most of our healthcare workers
are becoming infected.

    58:54

So, I think for equity
purposes and for allocation and decision making, we need
to have rather, I think,

    59:02

specific guidance
that's consistent. And in the same vein,
you know, when we talk

    59:09

about long-term care facilities
and healthcare workers in the same tier, we would

    59:17

like to know how do we allocate
the supply that we're getting between those two sectors?

> Thank you. So, we have to move on. We have several things
else to talk about.">

    59:25

Over. >> Thank you. So, we have to move on. We have several things
else to talk about.

    59:32

Does anybody have a pressing
need to make a comment on this before I turn
back to the queue?

    59:41

Okay. So, let me go to queue,
and then I'm going to ask you to keep your comments
fairly succinct.

    59:47

We won't ask for
followup commentary to the question or comment.

    59:54

We'll just move through the
queue as we have in the past. So, Dr. Zahn, you're
top of the queue please.

    1:00:08

Okay. We can come back to
you if your hand is still up. Dr. Kimberlin, I
see your hand is up.

> Yes, it's a clarifying
question. I'd like to confirm
that the people who work">

    1:00:13

>> Yes, it's a clarifying
question. I'd like to confirm
that the people who work

    1:00:21

in long-term care facilities are
considered healthcare workers and therefore qualify
under phase 1A.

    1:00:28

I'm talking specifically of
people who bring the laundry into the facilities,
who carry trays of food

    1:00:36

into residents' rooms
and so forth. I'm not talking about
the nurses. I think they're considered
healthcare workers pretty

    1:00:42

much outright. How about everyone else working
in the facility regardless of what the decision is

    1:00:47

about whether long-term care
facilities residents are considered phase 1A or not.

> Thank you -- >> Dr. Dooling do
you want [inaudible]. >> Yes, please. The response to that is yes.">

    1:00:53

>> Thank you -- >> Dr. Dooling do
you want [inaudible]. >> Yes, please. The response to that is yes.

    1:00:59

All workers working in a
long-term care facility, which would be considered
a healthcare facility are

> And so they will be in phase
1A no matter what the decision">

    1:01:04

considered healthcare personnel. >> And so they will be in phase
1A no matter what the decision

> That's correct. They are considered
healthcare personnel.">

    1:01:11

is about long-term care
facility residents. >> That's correct. They are considered
healthcare personnel.

> Thank you. >> Thank you for that question. Dr. Rockwell.">

    1:01:17

>> Thank you. >> Thank you for that question. Dr. Rockwell.

> Hi. Thank you. I actually have been
holding off on my comment because Dr. Nancy Messonnier
started off my thread of thought">

    1:01:23

>> Hi. Thank you. I actually have been
holding off on my comment because Dr. Nancy Messonnier
started off my thread of thought

    1:01:32

in that I'm hoping for a
little more guidance in terms of phase 1A assuming
insufficient vaccine supply

    1:01:41

to get through phase 1A before
it is expected to start phase 1B

    1:01:46

in that perhaps healthcare
personnel who have high-risk
medical conditions

    1:01:52

and who are older
may be prioritized over others given
limited supply.

> Thank you. Ms. McNally, please. >> Thank you.">

    1:01:59

Over. >> Thank you. Ms. McNally, please. >> Thank you.

    1:02:05

I'm just wondering
about acceptability for long-term care facilities
residents, and I'm looking

    1:02:11

at slides 25 and
26 and wondering if that population
was contemplated.

    1:02:17

So, that would be Hall,
Hull, and let's see, the intent to receive COVID-19
vaccine September 2020.

> Thank you. So, this survey reached out
to individuals and stratified">

    1:02:30

>> Thank you. So, this survey reached out
to individuals and stratified

    1:02:36

by age less than 65 years
old and older than 65, and I do not believe
there was an attempt

    1:02:42

to make a separate group
consisting of persons who reside in long-term care facilities.

> Thank you. Dr. Whitley-Williams, please.">

    1:02:51

>> Thank you. Dr. Whitley-Williams, please.

> Thank you, Dr. Romero. I just wanted to
comment on the fact that by vaccinating
healthcare workers">

    1:02:57

>> Thank you, Dr. Romero. I just wanted to
comment on the fact that by vaccinating
healthcare workers

    1:03:04

in long-term care facilities
just to make note that some of those workers also
live in communities

    1:03:10

where COVID is of higher risk. So, indeed, getting them
vaccinated does help,

    1:03:16

hopefully will help and protect
them from becoming infected and going home and spreading
it more within the community.

    1:03:25

And it's true also
for the hospitals and vaccinating both essential,
all healthcare workers,

    1:03:35

whether they're in
housekeeping or dietary or on the healthcare side.

> Thank you. Dr. Eckert, please. >> Thank you.">

    1:03:41

>> Thank you. Dr. Eckert, please. >> Thank you.

    1:03:47

On behalf of the American
College of Obstetrics and Gynecology, I'd just
like to raise the point

    1:03:52

that since the allocation plans
do not mention pregnant women or lactating women,
many of whom will be

    1:03:58

in the tier one allocation
groups, how can this special
population be addressed?

> Thank you. Dr. Eckert.">

    1:04:03

Thank you. >> Thank you. Dr. Eckert.

> That was just me. I'll take my hand down. >> That's fine, thank you.">

    1:04:12

Okay. >> That was just me. I'll take my hand down. >> That's fine, thank you.

> Yes, Carol Hayes with
the American College of Nurse Midwives.">

    1:04:17

Dr. Hayes. >> Yes, Carol Hayes with
the American College of Nurse Midwives.

    1:04:22

So, I'm curious if the American
Hospital Association has been brought into these conversations
about the percent of employees

    1:04:30

of healthcare systems
and hospitals that are considered providing
direct patient care compared

    1:04:36

to the employees of health
systems and hospitals that are not provide, or, you
know, as everyone has mentioned,

    1:04:44

you know, housekeepers and the
dietary delivering the trays. But I feel like there's a
tremendous number of people

    1:04:50

that work in health systems
that are not providing care, and it might be easy
for them to come

    1:04:56

up with a policy dovetailing
with all of this conversation about how hospitals can go
about prioritizing which members

    1:05:04

of healthcare professionals and
employees of essential workers within the hospital need
to be vaccinated first.

> Thank you. Dr. Fryhofer, did I jump you? I'm sorry, is that, did
I skip you just now?">

    1:05:10

>> Thank you. Dr. Fryhofer, did I jump you? I'm sorry, is that, did
I skip you just now?

> Yes, you did skip
me, but you're forgiven. >> Are you up? Yes. I'm very sorry. I'm very sorry. >> Okay. Sandra Fryhofer,
American Medical Association.">

    1:05:15

>> Yes, you did skip
me, but you're forgiven. >> Are you up? Yes. I'm very sorry. I'm very sorry. >> Okay. Sandra Fryhofer,
American Medical Association.

    1:05:22

I really appreciated Dr.
Sanchez's comments about access to PPE and just a reminder

    1:05:29

that there are many
small community practices that are seeing patients
that are on the front line

    1:05:34

that don't have access
to protective equipment. A lot of, if you go online to
try to order this from some

    1:05:42

of the companies like
McKesson and Henry Schein, they allocated their N95
mask to the hospital.

    1:05:48

Small practices can't
get them a lot of times, and small practices have
had to resort to, you know,

    1:05:54

having small opportunities
to get in a group purchasing
sort of thing.

    1:06:00

So, it can be very
difficult for small practices

    1:06:05

to keep their staff protected. And remember that, you
know, 40 to 50% of patients

    1:06:12

with COVID are asymptomatic. So, even if patients say
they're not having symptoms

    1:06:18

or they don't have
a fever, you know, they're still putting
our employees at risk.

    1:06:23

And I also wanted
to echo the emphasis on making sure our essential
workers are covered because,

    1:06:31

you know, the people
that bring in the food, that prepare our food,
that do all these things

    1:06:36

that help our nation work,
they can't stay home. They can't telework, and
we've got to make sure

> Dr. Fryhofer, this is Amanda. I think you segued perfectly
into the next question">

    1:06:43

that they're protected. >> Dr. Fryhofer, this is Amanda. I think you segued perfectly
into the next question

> Yeah, so that's, let me
just make sure, really quick,">

    1:06:50

that we want to address, Dr.
Romero, do you want to -- >> Yeah, so that's, let me
just make sure, really quick,

> Yeah, can you hear me? >> Yes. >> Okay. Sorry for
[inaudible] before.">

    1:06:58

Dr. Zahn, your hand is still up. >> Yeah, can you hear me? >> Yes. >> Okay. Sorry for
[inaudible] before.

    1:07:03

So, yeah, I mean just from a local public
health standpoint I wanted to again agree with both Dr.
Hunter and you, Dr. Romero,

    1:07:13

and Dr. Duchin have
said on a couple points. One is that we really
need guidance in terms

    1:07:18

of exactly how this
vaccine is supposed to be allocated,
even on the 1A level. What we're going
to get, I presume,

    1:07:25

whenever we have a situation
like this, you ask for hospitals or healthcare systems how
much vaccine you want,

    1:07:31

they ask for as much as they
possibly can, and they say, well, I'm going to
ask for the moon. It's up to local public health
to give us what they can.

    1:07:38

We really need guidance
and clarity as to what we can tell them
they really ought to be asking.

    1:07:44

That's one comment. And another, you
know, just to mention, follow up on what Dr. Hunter
had said regarding vaccination

    1:07:50

of long-term care settings to
start out with staff and then

    1:07:55

to go back again to
residents would be difficult, and I'd also just say in
terms of the conversation with long-term care facilities,

    1:08:02

if we don't vaccinate
the residents, then the impression there
is we're using the staff,

    1:08:07

we're going to vaccinate
the staff, we're going to make
sure they're protected, but also to protect
the residents. I think we all are
operating under the impression

    1:08:15

that at the beginning all of us can decide whether we
think it's appropriate for us to receive the vaccine
or not, and it just feels

    1:08:22

like that conversation
with the staff to begin with to say we're not going
to vaccinate your residents. We're at the highest
risk, but we want you all

    1:08:30

to get vaccinated, and a
lot of reason we want you to be vaccinated
is to protect them, that becomes a very complicated
conversation to my mind

    1:08:37

from local public health
when you're talking to these providers
when there's going to be understandable hesitancy
at the beginning as to who wants

> Thank you. >> Thanks [inaudible]. >> Thank you. Dr. Hayes, your hand
is still up.">

    1:08:44

to get the vaccine
and who doesn't. >> Thank you. >> Thanks [inaudible]. >> Thank you. Dr. Hayes, your hand
is still up.

> I apologize. I'll take my hand down.">

    1:08:49

I just want to make sure that
you have your chance to speak. >> I apologize. I'll take my hand down.

> No, nothing to apologize for. I want to make sure
everybody gets a chance. Ms. McNally, you too? >> My apologies.">

    1:08:55

>> No, nothing to apologize for. I want to make sure
everybody gets a chance. Ms. McNally, you too? >> My apologies.

> No apology necessary. Okay. So, we'd like to move onto
the next question, which is,">

    1:09:04

I'll take it down. >> No apology necessary. Okay. So, we'd like to move onto
the next question, which is,

    1:09:10

could you discuss the same
issue of prioritization

    1:09:15

between essential workers
versus high risk adults, older individuals, and
older individuals in 1B.

    1:09:22

And either Amanda or Dr.
[inaudible] or Dr. Dooling want to add further clarification
of that question

> Yeah, Dr. Romero, I'll
let Dr. Dooling speak after,">

    1:09:28

or is that good enough? >> Yeah, Dr. Romero, I'll
let Dr. Dooling speak after,

    1:09:34

but I do want to just let
everybody know that we are, this has been, this is
an amazing conversation.

    1:09:41

We need to start our public
comment period at 4:40, and we would like to hear from
each ACIP member before we do.

    1:09:49

So, we only have
about 10 minutes to have this conversation. So, we'd really like for people
to speak in a focused way

    1:09:58

to answer this question,
and please email us if you have additional input. Dr. Dooling.

> [Inaudible] ACIP
members [inaudible]. >> Yes. Thank you.">

    1:10:04

>> [Inaudible] ACIP
members [inaudible]. >> Yes. Thank you.

    1:10:09

So, we'd like to hear
from ACIP members now about the following
three questions. First, do members agree
with healthcare personnel

    1:10:16

and long-term care facilities
residents in phase 1A? Do you agree with
essential works,

    1:10:23

nonhealthcare, in phase 1B. And finally, do you agree with adults high risk medical
conditions and adults 65 years

    1:10:32

and older in phase 1C? I'll return to the chairs now.

> Okay. We're open for comment. >> Yep. Specifically on
two, do ACIP members agree">

    1:10:38

>> Okay. We're open for comment. >> Yep. Specifically on
two, do ACIP members agree

    1:10:45

with essential workers
in phase 1B?

> Dr. Szilagyi. >> Hi. Thank you. Just very briefly, I do agree">

    1:10:53

>> Dr. Szilagyi. >> Hi. Thank you. Just very briefly, I do agree

    1:11:00

with essential workers
in phase 1B. Having thought about this a
lot, I agree that the science

    1:11:08

and the implementation,
there's some pros and cons with each group, but they're
relatively similar, and to me,

    1:11:15

the issue of ethics is very
significant, very important for this country and clearly
favors the essential workers

    1:11:24

group because of the high
proportion of minority and low income and low
education workers among the

> Thank you.">

    1:11:31

essential workers. So, I do agree with this. Thank you. >> Thank you.

> I just want to echo
what DR. Szilagyi said.">

    1:11:36

Ms. Bahta. >> I just want to echo
what DR. Szilagyi said.

    1:11:43

This is where we can
really elevate the issue of health equity, and having
been working in our response

    1:11:54

where we see an intersection
between essential workers and their community is

> Thank you.">

    1:12:00

where we've seen the
greatest amount of disease. >> Thank you.

    1:12:05

Dr. Poehling.

    1:12:14

All right, thank you. So, first of all, I'm going
to agree, the importance

    1:12:20

of the nonpharmaceutical
measures even during this allocation is really
important to highlight.

    1:12:26

We also appreciate the focus
on maximizing benefits for all. The challenge is how to best
allocate vaccinations among all

    1:12:36

groups who would benefit until
it is so widely available. The science implementation

    1:12:41

and ethics conversations have
been very important, and to me,

    1:12:47

the maximize the benefit
[inaudible] mitigate inequities

    1:12:52

is very important. And so, I would agree with
the long-term care facilities

> Thank you.">

    1:12:57

residents in 1A. I agree with essential workers. Over. >> Thank you.

> Thank you.">

    1:13:03

Thank you. Dr. Bell. >> Thank you.

    1:13:09

I want to also agree with
having the essential workers b

    1:13:15

in phase 1B. I think that, you know,
the initial rollout of this vaccination
program will set the tone,

    1:13:23

and I think if we're
serious about valuing equity that we need to have
that baked in the early

    1:13:29

on in the vaccination program. I think that as others
have said,

    1:13:35

these essential workers are out
there putting themselves at risk to allow the rest of us to
socially distance and etc.

    1:13:45

And they come from [inaudible]. They live in disadvantaged
communities.

    1:13:51

And recognizing that
not all of them may want to be vaccinated at this stage.

    1:13:57

We need to provide them
with the opportunity early

    1:14:02

on in the process. And so, for those reasons, I think that this is an
important message to be sending,

    1:14:11

and you know, so that
we need to do that. Certainly, you know, we
will continue to evaluate

    1:14:22

as things develop, but I think that to begin a vaccination
program with a very strong
statement about equity,

    1:14:28

especially given modelling
results that don't show that there's a huge
difference in terms

    1:14:35

of science among the three
groups, is extremely important.

    1:14:41

While I have the floor and
to sort of move things along, I'll also add in
terms of phase 1A,

    1:14:47

I really appreciate the
concerns that having been raised about including long-term care
facility residents in phase 1A,

    1:14:56

but I do think on balance that
it's a reasonable thing to do. It that while we can imagine
that vaccine efficacy,

    1:15:04

we'll be considerably
lower in this population, if we're starting at such
high vaccine efficacy,

    1:15:11

I think it's reasonable
to suppose that there will be
some efficacy,

    1:15:18

and given the mortality and the
impact on the healthcare system from the number of nursing home
residents that have been dying,

> Thank you.">

    1:15:26

I think on balance
it makes sense to include hem in phase 1A. >> Thank you.

    1:15:32

Just a second here
while I check my list. Dr. Hunter, forgive me.

> Paul Hunter. I strongly agree with all
three phases, 1A, B, C,">

    1:15:38

Go ahead. >> Paul Hunter. I strongly agree with all
three phases, 1A, B, C,

    1:15:47

and especially the principles
and the topics that went into forming how that was done.

    1:15:54

The process is really
excellent, especially, you know, putting safety and
efficacy first

    1:16:01

and then the implementation
and the ethics equity issues. I think the point, one
additional thing I wanted

    1:16:07

to say was that that process
may need to be repeated over

    1:16:15

and over again at state and
local and even, you know, smaller planning levels,

    1:16:23

and as much as that process
could be put into guidance

    1:16:29

that would be helpful and
clear to folks at those levels, the better as far
as I'm concerned.

> Thank you. We can come back around if
people have additional comments">

    1:16:36

Thank you. >> Thank you. We can come back around if
people have additional comments

    1:16:41

about this next part. But you've also been asked to make comments
regarding the thoughts

    1:16:47

of prioritizing the essential
workforce over high risk,

    1:16:53

over individuals with
high-risk medical conditions. So, if you can comment
on that also.

> Me? No, I think that's --">

    1:16:59

OH, never mind [inaudible] >> Me? No, I think that's --

> Go ahead, Doctor. >> I think -- this
is Paul Hunter. I strongly agree with
that for equity reasons.">

    1:17:04

>> Go ahead, Doctor. >> I think -- this
is Paul Hunter. I strongly agree with
that for equity reasons.

> Thank you very much. I'm getting cross messages here.">

    1:17:11

Thanks. >> Thank you very much. I'm getting cross messages here.

> Thank you. Was the list of people
that went into 1B decided">

    1:17:16

Too many messages at one time. Dr. Ault, forgive me, go ahead. >> Thank you. Was the list of people
that went into 1B decided

    1:17:25

in the previous pandemic? I think we discussed that
several meetings ago, and I don't remember how we came
up with that list of people.

> Hello. This is Dr. Dooling.">

    1:17:32

Basically, I mean thinking
is have we missed anybody? >> Hello. This is Dr. Dooling.

    1:17:39

The list of essential
workers is determined by CISA, which is an agency within the
Department of Homeland Security.

    1:17:46

It is long, and it is detailed, and any given jurisdiction
may choose to prioritize some

    1:17:53

over others, and some essential
worker classes may not be relevant in every jurisdiction.

> You did mention
that previously,">

    1:17:58

So, it is a list for the
country, which may need to be adapted locally. >> You did mention
that previously,

> Dr. Bernstein. >> I just wanted to comment and
agree with the majority here">

    1:18:06

but I didn't know
what CISA meant. So, thank you. >> Dr. Bernstein. >> I just wanted to comment and
agree with the majority here

    1:18:16

that with essential
workers being in phase 1B,

    1:18:21

I think equity is a priority to
protect vulnerable populations.

    1:18:27

It was even added as a
domain to the evidence to recommendations framework.

    1:18:34

I think these workers
are essential. They're fundamental to
our response to COVID,

    1:18:41

and they're at risk
because they work in close proximity to others.

    1:18:46

And so, I totally
agree that they belong in that group to be vaccinated.

> Thank you. So, I will agree with everything
that has been said previously.">

    1:18:54

>> Thank you. So, I will agree with everything
that has been said previously.

    1:19:00

I also agree with
the stratification of phase 1B essential workers. Now, for the sake
of saving time,

    1:19:08

I won't make any
additional comments. But what I would like is
for any of the liaisons

> And Dr. Romero, I
think we have a couple">

    1:19:15

to please offer comment
at this time. >> And Dr. Romero, I
think we have a couple

    1:19:22

of other ACIP members who
haven't spoken as well. So, if any ACIP members
who haven't spoken and want

    1:19:29

to express an opinion
and/or liaisons, please raise your hand.

> Thank you. Let me go to Dr. Howell, please.">

    1:19:36

>> Thank you. Let me go to Dr. Howell, please.

> Hi. Molly Howell, Association
of Immunization Managers. I was just wondering, on slide
13, it looks like the death rate">

    1:19:42

>> Hi. Molly Howell, Association
of Immunization Managers. I was just wondering, on slide
13, it looks like the death rate

    1:19:51

or the mortality
rate among those 80 and older is significantly
greater than even the 65 to 79.

    1:19:58

So, and I don't know what
percent are in long-term care versus not, so I'm
just wondering

    1:20:03

if there's been any thought
to stratifying the 65 and older age group
or changing the age

    1:20:10

for that age group at all.

> Thank you for that question. Dr. Szilagyi, your hand is up. Did you wish to make
another comment?">

    1:20:16

>> Thank you for that question. Dr. Szilagyi, your hand is up. Did you wish to make
another comment?

    1:20:23

No, I didn't. I'm sorry. Okay. I'm just making sure
that nobody is being missed. Dr. Atmar.

> Well, I'm responding to Dr.
Cohn's request that respond">

    1:20:28

do you wish to make
another comment? >> Well, I'm responding to Dr.
Cohn's request that respond

    1:20:36

to two, and I support
essential workers over adults

    1:20:42

with high-risk medical
conditions for the reasons that have been addressed
already.

    1:20:48

In addition, the
ability of these workers to mitigate their risks of
potential exposure due to going

    1:20:56

to work is less than persons
that are currently in 1C.

> Thank you. Dr. Gluckman.">

    1:21:05

Over. >> Thank you. Dr. Gluckman.

> Thank you. I also just wanted to
reiterate, number one, given the very high
mortality rate of the elderly">

    1:21:11

>> Thank you. I also just wanted to
reiterate, number one, given the very high
mortality rate of the elderly

    1:21:19

in long-term care facilities, it
seems reasonable to provide them with the opportunity to
benefit from vaccine.

    1:21:25

I want to applaud the
entire conversation today around the emphasis on equity
and identifying that the racial,

    1:21:34

ethnic, and low-income
disparities and the impact of COVID warrants prioritization
of essential workers,

    1:21:40

and I am hopeful that as
we think about the adults with high-risks conditions
and adults over 65

    1:21:47

that we also recognize the
racial and ethnic disparities and the risks to those
populations as well

> Thank you for contribution.">

    1:21:53

and thank you for a
robust discussion today. >> Thank you for contribution.

> Thank you. I mean I think it's important
that we all put our thoughts">

    1:21:58

Dr. Frey. >> Thank you. I mean I think it's important
that we all put our thoughts

    1:22:08

out there on the table so we can
take [inaudible] of the group. I have to say that I agree
with what has been said

    1:22:14

by many of my colleagues. I do believe that phase 1B
essential workers should be

    1:22:22

in group 1B, and I don't
have anything else other

    1:22:27

than to say that, you know,
these decisions are difficult. There's no perfect solution, and
it will be up to the local areas

    1:22:37

to the final prioritization about groups [inaudible],
within groups.

> Thank you. Are there any other
comments from the liaisons">

    1:22:42

Thank you. >> Thank you. Are there any other
comments from the liaisons

    1:22:49

or from the voting members? I'm not seeing -- Ms. McNally?

> Dr. Romero, I would add that
I agree with this prioritization from the consumer perspective,
echoing all of the sentiments">

    1:22:58

>> Dr. Romero, I would add that
I agree with this prioritization from the consumer perspective,
echoing all of the sentiments

> Thank you very much. Anyone else?">

    1:23:04

that have been expressed
by those in support. >> Thank you very much. Anyone else?

    1:23:10

I don't want to cut anybody off
that wishes to make a comment.

    1:23:15

Okay. I'm not seeing any hands. Dr. Dooling, Drs. Cohn and Messonnier, have
we addressed the questions?

> No. Thank you very much.">

    1:23:24

Do you need more
information from us? >> No. Thank you very much.

    1:23:30

I'd like to thank all the
ACIP members, liaisons, for giving great feedback. Thank you.

> Thank you. And let me say the same. This has been an outstanding
and robust discussion.">

    1:23:36

>> Thank you. And let me say the same. This has been an outstanding
and robust discussion.

> Yeah. Dr. Romero,
Dr. Messonnier would">

    1:23:44

Do we have time for a
break, Dr. [inaudible]. >> Yeah. Dr. Romero,
Dr. Messonnier would

    1:23:52

like to make a comment
before we break, and then we can actually
break at 4:30.

    1:23:58

Thank you, everyone, for, I apologize if I made
you guys speed talk,

    1:24:03

but thank you very much. We will start, Dr. Messonnier
wants to make a comment,

> Thank you, Dr. Cohn.">

    1:24:08

and then we can break until 4:40
for the public comment period. >> Thank you, Dr. Cohn.

    1:24:16

I just wanted to take
a minute to be sure to thank the ACIP members,
the ex officio members,

    1:24:22

and the liaisons for today's
meeting but also in general

    1:24:27

for their dedication to ACIP,
which we've clearly seen in their commitment
to this process.

    1:24:34

There are many things that
we're not sure of, but one thing that I am sure of
is my trust in ACIP.

    1:24:41

The process and the members,
the diligence and passion of the members for what they do.

    1:24:47

You have several really huge
decisions in front of you,

    1:24:54

the first being the
recommendation for a vaccine and the second being
the really complicated

    1:25:01

and difficult discussion
that we were just having around early prioritization

    1:25:06

when there is limited
quantities of vaccine. I think as someone just said,

    1:25:13

there aren't any
perfect decisions, and I know this is
something that most

    1:25:18

of you didn't anticipate
doing, making these kind of huge decisions in
the midst of a pandemic.

    1:25:25

But I also know that in the
past ACIP has made many good recommendations that we at CDC
have relied on for many years,

    1:25:34

and I trust you and
I trust the process to help us make the
correct decisions now.

    1:25:41

So, thank you for
everything that you're doing and for what you'll continue
to do to support CDC,

> Thank you for those
comments, Dr. Messonnier.">

    1:25:46

the government, and
the public, thank you. >> Thank you for those
comments, Dr. Messonnier.

    1:25:54

They're greatly appreciated. Then I think at this time we'll
break and come back as stated

    1:26:02

by Dr. Cohn in approximately
15 minutes. Thank you.