>> Thanks, everyone.
We will now reconvene the ACIP meeting
and specifically the vote and the discussion section.
So let me ask -- so we are going to actually switch the order
of the votes compared to the agenda.
So we will do the zoster vote first and then we'll move
to the pneumococcal vote.
So if you could please put up the zoster vote.
Before we move to the vote, I wanted to ask Dr. Anderson just
to respond to an earlier question from Ms. McNally
as well as just read a clarification of the rewording
of the recommendation, which is exactly the same.
But just wanted to make sure
that that was fully clear and stated.
>> Great. Thank you, Dr. Lee.
Yes, we just wanted to follow-up
on the question regarding vaccine coadministration just
to clarify.
I note from our colleagues
that there is an ongoing study that'll be looking
at coadministration of Shingrix and Fluad and then Shingrix
and Fluzone in individuals 65 and up.
The caveat is that it's not a study
in immunocompromised patients.
So there is some safety study activity there.
And that's an ongoing study over the next couple
of flu seasons that's enrolling.
And then just to also reiterate as we've talked
about in the past that, you know, we will continue
to monitor any safety issues and the usual systems
like Vare and VSD [phonetic].
>> Thank you.
Could you please put up the slide with the vote language?
Dr. Anderson, would you like to read the recommendation
for vote?
>> Yes. We received an email just commenting on the order
of the wording, so we went ahead and made that change,
just to make sure that this is clearly worded.
So two doses of zoster vaccine are recommended
for the prevention of herpes zoster and its complications
in adults age 19 years and older who are
or will be immunodeficient or immunosuppressed due
to disease or therapy.
So just a slight rewording to make that a clearer statement.
>> Thank you, Dr. Anderson.
I want to just confirm whether the committee has any additional
questions or if the committee would be ready to vote.
Okay, I'm not seeing any hands raised,
so I will assume the committee's ready to vote
on the motion on the table.
ACPI members, I'm going to ask you to please state your name,
whether you have a conflict of interest, and then your vote
for the proposed recommendation listed here
on the zoster vaccine.
And I'm supposed to remind everybody
to put their video on, including me.
I cannot find my video.
Okay.
All right, terrific.
I believe we have the numbers up.
May I confirm?
For the vote.
Okay, terrific.
So we will begin.
And as a reminder, it's your name,
whether you have any conflicts, and then your vote
for the proposed recommendation.
And I will start with Dr. Poehling.
>> Poehling.
No conflicts.
Yes.
>> Thank you.
Dr. Sanchez.
>> Sanchez.
No conflict.
Yes.
>> Thank you.
Dr. Talbot.
>> Talbot.
No conflict.
Yes.
>> Thank you.
Dr. Ault.
>> Ault. No conflicts.
Yes.
>> Thank you.
Ms. Bahta?
>> Bahta. No conflicts.
Yes.
>> Thank you.
Dr. Bell.
>> Bell. No conflicts.
Yes.
>> Thank you.
Dr. Brooks.
>> Oliver Brooks.
No conflicts.
Yes.
>> Thank you.
Dr. Chen.
>> Chen. No conflicts.
Yes.
>> Thank you.
Dr. Cineas.
>> Sybil Cineas.
No conflicts.
Yes.
>> Thank you.
Dr. Daley.
>> Matt Daley.
No conflicts.
Yes.
>> Thank you.
Dr. Kotton.
>> Camille Cotton.
No conflicts.
Yes.
>> Thank you.
Dr. Loehr.
>> Loehr. No conflicts.
Yes.
>> Thank you.
Dr. Long.
>> Sarah Long.
No conflict.
Yes.
>> Thank you.
Ms. McNally.
>> McNally.
No conflict.
Yes.
>> Thank you.
And Lee, no conflicts, yes.
So proposed recommendation now passes, 15 yeses, zero nos.
Any other questions or comments, Dr. Wharton?
Okay. Thank you very much.
Oh, actually before I move on, I wanted to ask
if any individuals, an ACIP members,
would like to make a comment
or provide any further explanation for their vote?
I just wanted to give the opportunity.
You do not have to take it
if you don't want to say anything else.
Okay, I don't see any hands raised,
so very little controversy on this one.
So thank you very much to our ACIP members.
And we are going to move next to the pneumococcal vote.
Are we good to proceed?
Okay. Let's get that vote up on the screen for everyone to see.
As a reminder, this is the proposed age-based
recommendation vote.
And I will ask if Dr. Kobayashi would be willing to read
that vote for the committee to vote on.
>> Adults 65 years of age or older
who have not previously received a pneumococcal conjugate vaccine
or whose previous vaccination history is unknown should
receive a pneumococcal conjugate vaccine,
either PCB 20 or PCB 15.
If PCB 15 is used, this should be followed
by a dose of PPSV 23.
>> Thank you.
And we'll start with Ms. Bahta.
>> Bahta. No conflict.
Yes.
>> Thank you.
Dr. Bell.
>> Bell. No conflicts.
Yes.
>> Thank you.
Dr. Brooks.
>> Oliver Brooks.
No conflicts.
Yes.
>> Thank you.
Dr. Chen.
>> Chen. No conflicts.
Yes.
>> Thank you.
Dr. Cineas.
>> Cineas.
No conflicts.
Yes.
>> Thank you.
Dr. Daley.
>> Matt Daley.
No conflicts.
Yes.
>> Thank you.
Dr. Kotton.
>> Camille Kotton.
No conflicts.
Yes.
>> Thank you.
Dr. Loehr.
>> Loehr. No conflicts.
Yes.
>> Thank you.
Dr. Long.
>> Sarah Long.
No conflict.
Yes.
>> Thank you.
Ms. McNally.
>> McNally.
No conflict.
Yes.
>> Thank you.
Dr. Poehling.
>> Poehling.
No conflicts.
Yes.
>> Thank you.
Dr. Sanchez.
>> Sanchez.
No conflict.
Yes.
>> Thank you.
Dr. Talbot.
>> Talbot.
No conflicts.
Yes.
>> Thank you.
Dr. Ault.
>> Ault. No conflicts.
Yes.
>> Thank you.
And Lee, no conflicts, yes.
So proposed age-based recommendation passes,
15 yeses, zero nos.
And we'll confirm.
And I'll actually ask if we should take the next vote
and then offer a time for discussion?
Okay, that sounds great.
All right, so we will then move
on to the proposed risk-based recommendation.
Dr. Kobayashi, would you be willing to read
through the risk-based recommendation?
>> Yes. Adults age 19 to 64 years of age
with certain underlying medical conditions or other risk factors
who have not previously received a pneumococcal conjugate vaccine
or whose previous vaccination history is unknown should
receive a pneumococcal conjugate vaccine,
either PCB 20 or PCB 15.
If PCB 15 is used, this should be followed by a dose of PPSV.
>> Thank you very much.
Any questions or clarifications needed before we proceed
with the vote?
Okay, I see no hands raised, so we'll move on to the vote.
And this time I will start with Dr. Sanchez.
>> Sanchez.
No conflict.
Yes.
>> Thank you.
Dr. Talbot.
>> Talbot.
No conflicts.
Yes.
>> Thank you.
Dr. Ault.
>> Ault. No conflicts.
Yes.
>> Thank you.
Ms. Bahta.
>> Bahta. No conflicts.
Yes.
>> Thank you.
Dr. Bell.
>> Bell. No conflicts.
Yes.
>> Thank you.
Dr. Brooks.
>> Oliver Brooks.
No conflicts.
Yes.
>> Thank you.
Dr. Chen.
>> Chen. No conflicts.
Yes.
>> Thank you.
Dr. Cineas.
>> Cineas.
No conflicts.
Yes.
>> Thank you.
Dr. Daley.
>> Matt Daley.
No conflicts.
Yes.
>> Thank you.
Dr. Kotton.
>> Kotton.
No conflicts.
Yes.
>> Thank you.
Dr. Loehr.
>> Loehr. No conflicts.
Yes.
>> Thank you.
Dr. Long.
>> Sarah Long.
No conflicts.
Yes.
>> Thank you.
Ms. McNally.
>> McNally.
No conflicts.
Yes.
>> Thank you.
Dr. Poehling.
>> Poehling.
No conflicts.
Yes.
>> Thank you.
And Lee, no conflicts, yes.
And this proposed risk-based recommendation now passes
with 15 yeses and zero nos.
Thank you very much to our committee members.
I would like to again offer the opportunity if individuals would
like to comment on their vote or make any additional comments
for us to open up the floor to our committee members.
Dr. Brooks.
>> Yes. Though I voted yes, I do have some concerns
that the disparities in outcomes related to pneumococcal disease,
invasive pneumococcal disease,
may not be totally addressed by our/my vote.
Although there seems to be evidence related to hypertension
or obesity not being at higher risk
for invasive pneumococcal disease, I believe I'd
like to see it and then theoretically revisit the
underlying conditions at some time in the near future.
>> Thank you for that comment.
Dr. Talbot.
>> I just want to point out one fact.
We really gave the age 65 not for scientific reasons
but because that was the age chosen
for Social Security and Medicare.
In 1935, the reason why 65 was chosen was
that the average life expectancy of a man was
about 60 and a woman 64.
So it's not a very scientific way for us to move forward
with adult immunization.
It made sense at one time,
but I think going forward we really need
to be more science-based when we look at our adult immunizations
and really reevaluate what's the correct age
that we can vaccinate to improve healthcare
in our adults and older adults.
Thank you.
>> Thank you.
Dr. Kotton.
>> Similar to the request from my colleague, Dr. Brooks,
I would like to make sure that we accumulate clinical data,
because we are making a recommendation
for immunocompromised and other at-risk patient largely
on immunogenicity.
And so I think that we really need to monitor this situation
and make sure that we continue
to see robust clinical protection
as well as immunologic data.
Thank you.
>> Thank you.
Dr. Loehr.
>> I'd like to thank the pneumococcal workgroup
for all their hard work.
It was a very difficult process getting all this data corralled
and present it in a way that was -- made sense for us to vote on.
I want to give them a great shout-out.
I also would like to remind everyone that we want
to revisit this in five to seven years
after the children have received the vaccinations and see
if this recommendation is still necessary at that time.
Thank you.
>> Thank you.
Dr. Long.
>> Yes, I'd just like to point out it is increasingly important
for those who take care of adults who will
or will not be impacted by this decision,
if there is invasive pneumococcal disease,
that those isolates be saved and sent for serotyping.
Because this is not a completely preventable disease.
And we know that in immunocompromised patients
specifically, the likelihood
that they have non-vaccine serotypes
of invasive disease is quite high.
So that our clinical observations --
which are so important of what we are seeing --
and how that is or isn't covered
by the vaccine will only be relevant if we have serotyping
of those isolates -- something that's much less likely
to be done.
>> Thank you, Dr. Long.
Dr. Daley.
>> So two quick comments.
One is I just want to thank my colleagues on the NCIP.
You know, I think every time one of you speaks,
I learn something new or have a new perspective on things.
The other thing is that I think sometimes we feel
like once we've made a vote or a decision the work ends,
but really I would say now that the work just continues.
And everything that my colleagues have mentioned are
all things that we now need to monitor very closely.
And I would add another, which is coverage in 50
to 64-year-olds with chronic medical conditions, right.
We need to monitor that closely to see
if this is achieving our goal.
So, you know, the work continues and let's just keep adding
on to the things that we need to carefully monitor.
Thanks, all.
>> Thank you.
And I wanted to just add an additional comment.
And I was confirming with my CDC colleagues in the room
about what Dr. Daley had just mentioned
and what others had just mentioned starting
with Dr. Brooks, that we need to continue to review the data
on effectiveness and not just immunogenicity.
That we need to monitor access
and potential disparities carefully over time.
And that this is a dynamic decision-making process
and we need to reconsider these decisions when the time comes.
I also just want to state that at some point
in the future it may make sense for us to lower that age group.
But given the data we had today, I felt very comfortable
with the decision that we made on the age-based
and risk-based thresholds that we had.
Are there any other comments or final points individuals would
like to make regarding this particular vote?
Okay, I see no.
>> This is all -- one quick comment.
>> Sure.
>> I again want to underscore how impressive the work
from the workgroup was.
Last time this was presented, it was all over the place.
It was not their fault.
I spoke to them directly and saw how difficult this was.
The fact that they were able to distill it down to
where we took those two votes and they were both unanimous --
there's some trepidation and some concern.
I really want them to understand how deeply I believe the whole
committee appreciates what they did,
especially underscored Dr. Kobayashi.
>> Thank you.
Thank you very much.
And we really appreciate those --
you ending with those comments, Dr. Brooks.
I want to thank Dr. Kobayashi, Dr. Poehling, Dr. Anderson,
Dr. Kotton for taking us through the votes today.
And thank you again to all of our speakers, members,
and liaisons for the robust discussion.
Is there any further business or any objections
to adjourning today's meeting from any members?
I'm looking at Dr. Wharton.
Okay, hearing none, today's ACIP meeting is now adjourned.
We look forward to seeing you all again tomorrow.