October 2019 ACIP Meeting – Adult Immunization Schedule

>>Welcome back. We’ll begin our next topic, which is the Adult
Immunization Schedule, with Dr. Paul Hunter
giving the introduction. Paul, please?>>Hi, good morning. I’m Paul Hunter. I’m a family physician
from Wisconsin. I am here to talk about the
2020 Recommended Immunization Schedule for Adults, Aged 11
— 11 — 19 years and older. And Dr. Mark Freedman will be following up after me. These immunization
schedules are a tapestry woven from the threads of all the
individual recommendations that are voted on. And a quick way for clinicians
and patients and administrators, to see what individual
people need, and how to put all
the pieces together. That’s part of the reason
that we have so many people who are on our workgroup. There’s myself and Dr. Kevin
Ault who you heard from a little bit earlier, and
liaison and representatives from a very wide group of
people, of organizations, include — and consultants. And Dr. Mark Freedman is
now the work group lead, and replacing Dr. David
Kim who absconded off to Washington D.C. Also, you
can see that within the CDC, there are very, very many
contributors because we need to pull all those
threads together and I really appreciate
all of their contributions. The reason we’re talking about
the immunization schedule now, is we do this every
time this year. We need the ACI approval for
the proposed schedules necessary prior to the publication in
the MMWR in February of 2020, which is when it
comes out every year. I’ve already apologized in
advance to the nurse midwives for leaving out the M
on their abbreviation. The organizations that also
approved this proposed schedule prior to the publication
include the American College of Physicians, the American
Academy of Family Physicians, the American College of
Obstetrics and Gynecology, or is it Congress
now, I believe, and the American College
of Nurse Midwives. The new policy is
not established in the proposed schedules,
but we are trying to bring everything together,
and trying to make it look like it all agrees with each
other, as much as it can. And the annual schedules reflect
recommendations already approved by the ACIP. In addition to trying to
bring the threads together, we’re trying to harmonize
things between the child and adolescent schedule
and the adult schedules. They’ll be in our presentation,
Dr. Freeman’s presentation next, they’ll be edits to all
of the table there’s been and quite a large number
of votes we’ve had this year, as you might remember
from our last meeting which was a vote-a-thon. And so, we’ve had a
lot to put together. And there’s also some new colors that we’re going to
be talking about. There’s also content
changes to the notes. As the previous work
group chair said to me, “I was the king of footnotes.” Now, they’re not called
footnotes anymore. They’re just notes. So, I guess I’m just
the king of notes. So, we will have a
discussion and a vote after this too, in
separate parts. So, I am done, and we are
ready for Dr. Freeman.>>Thank you, Dr. Freedman.>>Hi, good morning everybody. So, the 2020 Adult Immunization
Schedule has been updated to reflect recommendations
published or voted upon since October of 2018. And these changes include Number
1, Hepatitis A vaccination for all persons with HIV who
are at least one year of age. Number 2, HPV vaccination for
all persons through Age 26. And shared clinical decision
making for persons age 27 through 45 years of age. Three, there’s updated
language for MMR vaccination in healthcare workers. Four, there’s language on the
shared clinical decision making for PCV 13 for immunocompetent
persons, age 65 years of age and older. Then there’s updated
meningococcal recommendations for Meningococcal B vaccine. Updated recommendations
for the use of TDAP. Anytime TD is indicated as was
discussed in a previous session, and clarification of
varicella vaccine indications for adults with HIV infection. So, what are the changes that impact multiple
portions of the schedule? They include updates to
the schedule graphics and edits throughout
the Notes section. And these changes were made to
reflect updated recommendations to improve harmonization
between the child and the adolescent schedule. And to clarify some language
from the previous schedule. Reading glasses are a new thing
for me, so they just went away. So, I’ll start with the cover
page of the adult schedule. On the cover page, there was
minor warning edits were added to the footnote
at the bottom. That’s highlighted
in the red box. And the updated language
highlights or clarifies the language that
there’s no need to restart or add doses to a
vaccine series if the — if there are extended
intervals between doses. Next, I’ll highlight
changes to Table 1 which is the recommended
Adult Immunization Schedule? This is a graphical
representation of Figure 1 — I’m
sorry, Table 1. The tetanus diphtheria and
pertussis row now reads that TD or TDAP as an option for
a booster every ten years. As I mentioned this
was discussed in the earlier session. The HPV row is now combined
into a single row for males and females reflecting
that HPV is now recommended for all adults, through
age 26 years of age. In addition, the blue color has
been added to the row indicating that HPV vaccination for persons
27 through 45 years of age, is now based on shared
clinical decision making. Within the pneumococcal
conjugate row, the box rating immunocompetent
persons 65 years of age and older, is now blue, indicating the updated
recommendation for vaccination in this group, is now based on
shared clinical decision-making. Within the meningococcal B
row, a blue box has been added for those 19 to 23 years of age,
who are not at increased risk for meningococcal disease, reflecting the updated
recommendation for vaccination in this group, is based on
shared clinical decision making. A blue footnote key has
been added indicating that the blue color indicates
the vaccine is recommended, based on shared clinical
decision making. And we made some minor updates
to the gray footnote key. The gray color now indicates that there is either no
recommendation/not applicable. Next, I’ll highlight
changes to Table 2 which is the Medical
Indications Schedule. Again, the tetanus, diphtheria,
and pertussis row now reads TD or TDAP, is an option any time a
tetanus booster is recommended. The HPV row has been combined
into a single row for both males and females, reflecting
that HPV is now recommended for all adults, through Age 26. In the Hepatitis A row, the box
for all persons living with HIV who are at least one year of
age, regardless of CD4 Count, is now yellow, reflecting
the new recommendation for this group. Lastly, the gray footnote has
been updated here as well. The key now says that the
gray color represents no recommendations/not applicable. There’s some content
edits to review in the Notes section
that I’ll go over. Within the Hepatitis A note,
under Special Situations, an expanded definition
of chronic liver disease, that is harmonized with
the Hepatitis B definition in the schedule, has been
added, as listed here. Additional indications
for vaccination were added for persons with HIV infection. And in settings for exposure,
as listed, in the slide. And lastly, clotting factor
disorders has been removed as an indication for
Hepatitis A vaccination. For HPV vaccination,
within the HPV note under Routine Vaccination,
you can see now that HPV vaccination’s
recommended for all adults through Age 26 years,
and it would be a two or three dose series, depending
on the age at initiation, or the underlying
medical condition. Under special situations for
persons Age 27 through 45 years of age, vaccination
may be considered, based on chart clinical decision
making, and this would be a two or three dose series,
again, as previously stated. Within the influenza note,
under Special Situations, language for when LAIV
is contraindicated, has been reformatted into
a bulleted list as shown, and this harmonizes
with the child schedule. Language for vaccinating
persons with the history of Guillain-Barre
Syndrome within six weeks of a previous dose
of influenza vaccine, now reads that these persons
generally should not be vaccinated unless the
vaccination benefits outweigh the risks for those
at higher risk for severe complications
of influenza. Within the measles,
mumps, and rubella note, under Special Situations, language for healthcare
personnel has been clarified with separate bullets. The first bullet for those
born in 1957 or later, with no evidence of immunity
to measles, mumps, or rubella. And then a separate bullet
for those born before 1957, with no evidence
to — of immunity. Within the meningococcal
note, under Special Situations for Meningococcal B, we added
the new complement inhibitor, Ravulizumab to the list of
indications for vaccination. And added guidance for a
Meningococcal B booster dose, one year after primary series
completion, and then also to revaccinate those persons
every two to three years if they have ongoing risk to
reflect the new recommendations. And we added updated
recommendations for adolescents and young adults, who
are not at increased risk for meningococcal disease,
to be vaccinated based on shared clinical
decision making, as listed on the slide here. Within the pneumococcal note,
under Routine Vaccination, immunocompetent adults
65 years of age or older, should receive one dose of the polysaccharide
or PPSV23 vaccine. One dose of the pneumococcal
conjugate vaccine, or PCV13 is recommended based on
shared clinical decision making. So, the order has been
changed to read PPSV23 first. However, the spacing of
vaccines has not been changed, and is listed on the slide. Within the tetanus,
diphtheria, pertussis note, under Routine Vaccination, for those who previously
did not receive TDAP, at or after 11 years of
age, the recommendations to administer one dose
TDAP, then administer TD or TDAP every ten years. Under Special Situations
for those who previously did not receive
primary vaccination series for tetanus, diphtheria,
or pertussis, administer at least one dose of
TDAP, followed by one dose TD or TDAP, at least four
weeks after the TDAP. And then administer another dose
of TD or TDAP 6 to 12 months after the last TD or TDAP dose. Again, TDAP can be
substituted for any TD dose, but it’s still preferred
as the first dose. And then, additional language
to indicate that TD or TDAP, can be used every
ten years thereafter. Also, the information
for these of TD or TDAP as tetanus prophylaxis,
the link has been updated. Within the varicella note,
under Special Situations, for persons with HIV
infection with CD4 counts of at least 200 cells per
microliter, with no evidence of immunity, vaccination
may be considered, and it would be two doses,
administered three months apart. And that’s just a clarification
of the previous language. So, that’s all I have. We are now open for discussion. Thank you.>>So, the adult
immunization schedule is open for discussion and questions. Just a note, that the suggested
changes for diphtheria do not go into effect on — TDAP,
sorry, do not go into effect until the vote this
afternoon, if it is approved. Any questions or comments
from the near table? Dr. Bernstein?>>Can you go to Slide 26? It’s 2 — I was wondering
whether the bolded text, whether it previously did not
receive primary vaccinations series for tetanus, diphtheria, or pertussis rather
than end pertussis? Unless that’s saying
the same thing?>>Let me see. Check what I have
in the fold outs.>>Thank you. Anything else? Yes, Ms. McNally.>>I would just like to thank
you for the additional color to the schedule, as
I think that it adds to the clarity for consumers.>>So–>>Back to– .>>-sorry for the — for
Dr. Bernstein’s question. The language does
use the word “and.” I will verify whether that
should be “and” or “or.” I’ll check with Dr. Havers.>>Dr. Lee.>>So, first, I want
to thank the work group for taking what turns out
to be a very complex set of recommendations and
trying to distill it, because I think now it’s
becoming clear to me that the adult immunization
schedule is becoming increasingly complex. So, you did a really
amazing job. So, thank you for that. One of the things that
I’m challenged by and — so, would completely agree
with all the recommendations, but I’m still struggling
a little bit with the implementation
challenges. And partly, it’s
not so much Table 1. It’s really Table 2 for me. Thinking about if
I’m a provider, who predominantly sees
end stage renal disease or I might only see
chronic liver disease patients, how do we help our
subspecialists who might be seeing these
populations more frequently than we do, to help to vaccinate and make sure these
individuals are up to date? I don’t have a good answer,
but I wanted to raise that the complexity — the complexity of the schedule
itself and trying to distill it in such a simple way, it’s still
complicated to interpret it. Going across, I really
appreciate the notes because I think from a
vaccine specific standpoint, it’s clear what the
recommendations are. But I think from a
population standpoint, it becomes a little
confusing for subspecialists who are caring for these
populations, and I really want to figure out how we
can partner with them to best protect these
populations.>>Thank you for those comments. Questions. Anybody else? Yes, Dr. Sanchez?>>It’s more of a question. With the inactivated flu — with
the LAIV the [inaudible] in the cochlear implant population, can you comment on that?>>I’m sorry, I didn’t
hear your question.>>So, one of the — it
said cochlear implants, that it was a precaution
or not to be used?>>I’m sorry. Can you repeat the question?>>LAIV must not be
used cochlear implants, and I was just wondering where
— what’s the date on data?>>Can you ask your question into the microphone,
because–?>>So, Dr. Sanchez is
asking a question about LAIV and it’s used in
individuals or recommendation that it not be used in
individuals with LAIV. This has been a topic of
discussion on the past, but if you could please
offer a comment on that?>>Dr. Robinson’s
going to answer that?>>Yes, go ahead please.>>Hi, yes. So, there are some conditions
outlined in the influenza notes that are not technically
contraindications or precautions, but there’s
a lack of data on the use of that vaccines in
persons with that condition. And I believe cochlear
implants is one of those groups that fall into that paragraph. So, we specifically use
the language in the note, that these are situations under
which, I believe it’s like, under which LAIV
should not be used, and we don’t turn
them contraindications or precautions, because they are
not labeled contraindications or precautions, but
the data is not clear for the use in those
populations.>>Thank you very much. Dr. Atmar.>>I had similar concerns
about some of the other groups, the asplenia and in
the guidance from — that was published earlier this
year, it notes that I guess, IDSA has made recommendations
about some of these risk groups and that ACIP was gathering
further information, but it says contraindicated,
and rather than precaution. And I’m bothered
by that, I guess.>>So, just to clarify,
the language that will be in the schedule is
on the slide here. LAIV should not be used. I used the term contraindication
in my discussion which was sort of misuse of that word. I should have said “Situations where it’s not recommended
to be used.” It’s not listed as a
specific contraindication.>>And so, I know on the table,
it appears as red, which was why for the legend in the
table, for the red, particularly you’ll
notice its in child and adolescence schedule,
it says, “Contraindication or should not be used,”
because we did not want to introduce a new color to
represent, “Should not be used.” So, we have — and we
can make sure of that, we added it into the
adult schedule as well. So, we’re specific that
the color represents both of those scenarios.>>It’s Dr.– .>>Is this a continuation
of your first question?>>A continuation.>>Go ahead, Dr. Atmar.>>So, in fact the guidance in the flu recommendations does
not say it should not be used. It notes that there have been
concerns raised by other groups, but it does not say,
“Should not be used.”>>Dr. Kroger, do you
want to [inaudible] for comment?>>Yes. Andrew Kroger, CDC,
Communication Education Branch. Conditions that are
contraindications also should not be used. They are labeled specifically
as contraindications. Pregnancy is another one,
specifically with LAIV. So, it does make sense that
both conditions are listed on the schedule. But we can double check with
influenza subject matter experts to make sure that
our list is complete.>>What does it say
on the flu statement?>>Go ahead, doctor.>>So, for the flu statement,
pregnancy is a contraindication, and cochlear implant is
— should not be used.>>Dr. Messonnier.>>Would it help if we changed
the notes so that it’s clearer which of these things are
contraindications and which of them are — should
not be used? Is that what you’re asking for? More precision in the language? I’m not sure sort of specifically you know,
what direction to go.>>Should not be administered.>>Dr. Talbot, then
Dr. Hunter, and then Dr. Baker. Dr. Talbot?>>I’m going to be right on
your line, so you’re okay. So, I think the concern is that
there are healthcare workers who refuse to get needles. And LAIV is a major way that many hospitals
vaccinate healthcare workers. So, if they have any of these that we don’t have enough
data on, or it’s a precaution, and you put a big, red box, there’s no Occ Health
that’s going to give LAIV to that person who’s
a healthcare worker. So, I think an orange
box would be the answer.>>Dr. Messonnier.>>So, your issue is not — I mean, your issue is how
we’re translating what’s in the flu statement
into this table, and that the red
color is a problem. We probably can’t use orange
because orange is precautions, which actually also doesn’t
really reflect the same thing as what they’re saying. So, I think if we follow this
line, we need another color. Is that — I mean, is
that where we’re going? I’m just trying to
translate this directly.>>Yes, I mean we could
do something similar. Like we could do orange with the
dots, or something like that, so that it’s not a new color, but it does add that
it’s different.>>Again, this is adding to
the complexity of the reading of this document, and yes, I
just say that as chair here. I think I’m reflecting what a
lot of us are thinking about it. That not all this
information can be transmitted through the table alone. That the notes are an
integral part of this. So, Dr. Hunter, your comment?>>Yes, I was just making sure
that we were talking about how to translate what’s
already written in something we voted on, into
what it looks like on the paper, rather than trying to go back to change what the
actual recommendation is. And I got that clarified. We’re on the right track.>>Dr. Baker, if you would?>>I think I heard
somebody say the IDSA agrees with contraindication
for cochlear implants. I am unaware that that is true, and I agree with
the conversation that — that’s being had. I’m not going to tell
you how to do it, but a contraindication should
be an immune compromised person, and we assume pregnant women
are that fine, fine, fine, for live vaccines because
of the theoretical risk. But for cochlear implants, or
even asplenia for flu vaccine, I think we need to — if
there’s contraindication, it should be contraindication. Otherwise, it should be
a precaution, with dots, or whatever you do, but I think
it would really send the wrong message, and we should make
whatever the current 2020 statement for flu vaccine, should be consistent
with the table.>>Dr. Sanchez?>>And I just want to agree
with that because to me, “Should not be used,”
is a contraindication and I just — it makes no sense. If we don’t have the
data, that’s something that should be stated
rather than in.>>Dr. Messinee?>>I just want to go back
to what Dr. Hunter said. This is about translating what
you all have already voted on, into a statement and Dr.
Bernstein just gave me the specific table which perhaps
we can get for you all because in the flu
statement, Table 2, under LAIV there’s a column
that says, “Contraindications and conditions for which
use is not recommended,” and that’s exactly what it says. And so, if you want to change
those things from conditions for which vaccine is not
recommended, we would need to go back and revote on the
flu statement, which is not up for consideration today. So, we can do that, but you
kind of can’t do that today, because you can’t change
it from a precaution — from a condition for which
vaccines should not be used, to a precaution in the schedule.>>It does. It says–>>-cochlear implant?>>Use your microphone please?>>There’s a variety
of conditions for which it says this, right? So, maybe again, as a point of
order, perhaps we could pause, get this language sort of
around so folks can see it and then maybe they could
compare that with this? Because not everybody’s looking
at the same thing that we are.>>Very good. Dr. Weber?>>I heard both on the first
slide and in this discussion, people using the term,
“healthcare workers and healthcare personnel,”
interchangeably. So, we feel strongly that the
correct term is healthcare personnel because we need
to remember that students and volunteers are not
workers, and we do believe in protecting them as well. So, — and the ACIP in
general has adopted that term of healthcare personnel.>>Thank you. Dr. Lee?>>Thank you. Just to address Dr. Messinee’s
comments, I’m wondering if we could change the red
box to say, “Contraindicated or Not Recommended,” because
that’s what you have down below, but maybe just having that “or not recommended,”
would help with that? That’s just one suggestion. The second is, I
struggle a little bit, and I understand the
rationale why, but flipping between Tables 1 and 2, which
I imagine some people will do, there’s — it’s clear that
the yellow are universally recommended vaccines by
age group, or by condition, but the purple, because
it’s the same color, it gets a little confusing
if you’re trying to go back and forth between the
two, because you realize, it’s a risk-based condition or a
high-risk condition in Table 1, and then Table 2, it’s an
additional risk-based condition for purple, in Table 2. And so, I worry that some
people might go back and forth, and it might take them a
second to realize that you have to have, for example — if you
have end stage renal disease, and diabetes, that
you would default to the yellow, if
that makes sense. So, that’s my other question. And then, the third point of
clarification and I don’t know if this goes against
basic principles for how to develop this table,
but on the — with the adult pneumococcal
vaccine recommendations, they are some of the more
complex ones, I will admit. And I realize that
unlike the other vaccines, we do recommend this in series. So, the PCV13 plus PPSV23
for people at high risk, or PPSV23 if you have
a risk condition. And I’m wondering if it helps
to clarify those two options? So, instead of just having
PCV, having PCV13 plus PPSV23 for one line, and then
PPSV23 for the second line. Because it is a little
confusing I think, to the average practitioner.>>Thank you for those thoughts. Anyone else with
comment that I missed? Dr. Hunter and then
Dr. Messinee.>>So, I’m just trying to
figure out, Grace, are you — so, you’re not saying on PCV
that you’d add a third line? You would just change the
second line to a combination. That’s a very interesting idea. If I could go back to
your previous comment about specialists looking down
the — vertically on Table 2, I would be very happy
if they were doing that, and that they were — the specialists were
vaccinating more than they are. And if they were looking at
this schedule, in general. I think that the
overwhelming majority of people who have specialist indications,
are getting their vaccines in primary care and
public health settings. And I think that —
that’s a struggle, that we who do education
of clinicians reach and it’s not a — it’s a systemic issue
from my understanding, of the limited understanding
I have of it, in that it’s very hard
to carry vaccines. Just ask people who do
it in private practice. And when that’s not the
majority of what you do, it’s hard for a specialist
to keep that in mind. And I think that those of us in
primary care, it’s what we do. So, I hear what you’re saying
about the vertical part of things, but I don’t
see a quick way of doing that right now, personally.>>Dr. Messinee?>>Thank you. You know, one of the things
that we’ve tried to work on in the past couple
of years within ACIP, is to differentiate your role
from the role of the people who need to implement
these recommendations. And some of you, because of
your jobs, cross those lines because you’re also
implementing. I think the schedule is a place
where we see this tension, because you all are trying to
fit the schedule into a way that gets towards
implementation, and we completely
appreciate all the feedback. I’m not sure that we
can arbitrate this around the schedule itself, but we completely
recognize this complexity, and the schedule is
getting more complex. Decision making is
getting more complex. And we at CDC and all of
our implementation partners around the room, need to
get more sophisticated at providing the tools
that clinicians need, so that it makes it easy for
them to do the right thing. That being said, one of
the tensions about some of the things that you’re
asking us, is that on one hand, you want us to simplify the
schedule, but on the other hand, some of the things that you’re
asking us to do are going to make it more complex. So, a specific question maybe
before we get to a vote kind of thing is, we could add to the
box that says “Contraindicated,” the same language that’s
on the footnote, that says, “Contraindicated or
Not Recommended.” It would make the words
in that box squishier, but if you want us to
do that and you think that that’s a better conveyance
of what you mean, we’ll do it. But I guess it just would be
helpful to hear if folks agree with the direction that Grace is
going in, that Kip brought up, that that word,
“Contraindicated,” is going to be such an impediment
to clinicians, that it’s worth the
extra complexity to add more words into the box. Because again, we could do it. I just — I’m not sure where
you all are going with this.>>So, let me add
comment to that which is, sitting on the child/adolescent
immunization, workgroup and previous chair of it, we
were tasked with stripping it to make it as compact
as possible. And we spent a period of time, and are still spending a
period of time, to do that. Now, you’re asking us to expand
it again, and fill the void that we have created by
cutting down on the verbiage. So, keep that in mind. It’s not — you can’t
have it both ways. You have to make a
decision of what you want. So, go ahead. So, I believe Dr. Lee and
then Dr. Frey and then Dr. Atmar — but Dr. Lee.>>Okay. You never thought
the colors were going to cause so much controversy,
but here we go. I actually — well,
I won’t comment on the other point you brought
up, but I guess I just want to make the general statement
that I think that as we continue to delve into more complex
recommendations over time, and this just — it just — it
used to be simpler 15 years ago, and now it just feels like
every recommendation we make, it’s not easy. And we especially
make it difficult for our implantation partners. So, I take your point
about the distinction between recommendations
and implementation. I will say though that I think that there are many missed
opportunities we have because sometimes for some of these high-risk
populations we’re delving into, our subspecialists
are actually — have multiple points of contact
with them, that I think our — they don’t actually
necessarily see primary care, and sometimes there’s
also a reluctance, if there’s not a good
understanding of where they are in their course of their
disease, and I’ll bring up congenital heart disease
as one of the challenges. That these kids can
go under vaccinated for a long period of time. So, I think just in
general, as we start to move into this more complex era, I
would push us to start to think about how we can avoid those
missed opportunities and part of that relates to the
implementation section of our evidenced to
recommendation framework. But I completely hear
your point, Dr. Messinee.>>Dr. Fry?>>I’m going to pass. I think I just answered
my own question.>>Dr. Atmar?>>I think the issue —
I’m not asking for it to be more complicated. I think the issue
is the disagreement as to what the recommendations
actually say as it relates to LAIV. And you know, I looked
at the table. I looked at the text
of the recommendations. And some of these
groups, they’re — the actual language says,
“Because there are no data, we recommend RIV4 or
IV, for these patients.” It doesn’t say it’s not
indicated specifically. And you know, as was —
Dr. Talbot brought up, there might be some
circumstances where an injection may not
be desired by the recipient. And it is an option, and there’s
not — it’s not a safety issue.>>I’m sorry, Dr. Hunter please?>>So, I’d just like to
reiterate at my understanding and experience, subspecialists
are not caring vaccines in their practices, and are
generally not vaccinating.>>That’s not true. So, speaking as a subspecialist,
I will tell you that every child that shows up in our clinic,
has an extensive review of their immunizations based on the state health immunization
record, and those vaccines that are deficient or are
available for that child at that age, are given. So, I can say that at
least for my subspecialty, I have Grace nodding her head, we do look at this
very carefully.>>Our next person is
Dr. Middleman. Please?>>Middleman from Society for
LS in Health and Medicine. I don’t usually look
at the adult schedule, so I want to make that
clear from the beginning, but in Table 1, if this is
really, truly harmonized with the way that the child
and adolescent schedule works, for me it’s very difficult to understand how an annual flu
vaccine that should be given to everyone, is the same
color as a measles, mumps, rubella vaccine which is
essentially what we would consider in child
and adolescence, a catch-up vaccine
recommendation. So, for me, the fact that
there’s no distinction between what we should be giving
on a routine basis to adults, versus what we’re
giving for somebody who perhaps hasn’t had a
vaccine or lacks documentation of a vaccine, is
really problematic. And really does separate
the use of this from the use of the child and
adolescent schedule. And so, I think that it would
be important to go through and really rethink the use
of the colors and the legends at the bottom, because if
you also look at Table 2, you’ll note that the
bottom purple says, “Recommended Vaccination
for Adults with an Additional Risk Factor.” Does that mean an additional
risk factor to diabetes, if you’re looking at
diabetes, or does it mean with that risk factor? So, the way the legends
work and the colors work, I think could be clarified.>>So, I’ll just respond to
— you know, we — this is — this comes up every couple
of years as many of you who have been here
for a long time know, and I think that that’s — these
are all really good points. I think it can be hard sometimes
when we’re only talking about this in October,
to then decide on the schedule for
the next year. And so, one of the
things we can think about doing next year is talking
about some of these issues in prior meetings, so that
these can be more discussed and resolved prior
to the next schedule. And that’s definitely something
we can move forward with.>>Yes, an excellent
suggestion. Dr. Bell.>>Thank you. I just wanted to go back to
this question, this tension between increasing complexity, missed opportunities,
and simplification. And just make the obvious
point that what we’re looking at here is a piece of paper, and while it’s important
we you know — you know that the piece of
paper is very important, it hangs up all over the
place on the bulletin boards, it just occurs to me that as —
on somebody’s phone or tablet, there are many more
opportunities to make our message clearer,
and avoid missed opportunities. And perhaps, you know,
one of the things for the future might
be some ways to more explicitly
direct people to tools that can reflect this
kind of complexity, without us tying ourselves into
knots, and standing on our heads when we’re looking at
this piece of paper.>>Thank you, Dr. Bell. Dr. Goldman.>>Thank you. So, when I approach
these things, I look at both the public
health aspect of it, as well as the individual
practitioner. And for those of us in
individual private practice, who want to vaccinate patients, we’re going to learn
the schedule. We’re going to know the
schedule, understand what we do. So, we want to from the
public health perspective, make it as easy as possible, but we can’t let the perfect
be the enemy of the good. We need to know that those who
want to vaccinate and engage in a vaccine program, are
going to learn the schedule. I find this very useful. I think for you know,
after the learning curve, it’s easy to read. It’s digestible. We know what we’re doing for
those of us who are vaccinating, and I think it’s good the way
it is, because those who want to learn it, will learn it. As far as private practice,
primary care versus specialists, again, it goes back to you
know, the public health and a system approach,
versus the individual. You know, I’m not finding that my nephrologists
are vaccinating, but the dialysis centers are. So, it comes down to a question
of what systems are in place. The health system will
learn it and vaccinate from the specialty perspective, but not necessarily the
individual specialists. So, you know, for the bottom
line, those of us who engage in a vaccine program, are
going to learn the schedule. I think it is going to
be a learning curve. We can’t just spoon
feed everyone. They have to be able to
understand to digest it, and I think this, after
years of experience with it, is very digestible and I really
like the way it’s laid out.>>Thank you. Dr. Fryhofer.>>Sandra Fryhofer for American
Medical Association speaking as a practicing physician. I want to compliment the work
group on all the time that went into coming up with
this schedule. And the way I look at this
is the table is something — the schedule is something
to draw you in. It’s like, as you said, a
one-page, sort of cheat sheet. It’s not the end all. You go to the notes. After the notes, you go to
the full recommendation. So, that information is there. If you add too much
writing on that schedule, people are just going to not
even go there, and we’re going to defeat the purpose. And as Jason mentioned, he’s
also a practicing physician. You know, there are lots of
people that are taking care of the patient that
are immunizing, just a plug for everyone to
please put their immunizations into the immunization
schedule, so everyone can be on the same page and know
what our patients do need. And back to Dr. Middleman’s
comment, about the — when she mentioned
the flu shot, MMR. I still have patients that come
in that didn’t get vaccinated with MMR, and I have
mainly an adult practice. So, I think having it in
yellow, it’s just a reminder that this is something
important that people need. But I’m with you. Everyone six months and older
needs flu shot every year. And Dr. Atmar, I agree with you. We need to get those details
about the LAIV worked out. As a practicing doc,
I don’t want to — we have standing orders for
flu vaccination in my office. I do not want to give a
patient the wrong vaccine and have a problem. But we would — I
as a practicing doc, would really appreciate
clarification on that. I don’t think that this
schedule today is the time to do it though.>>Thank you very much
for those comments. Dr. Bernstein?>>Yes, I just wanted
to echo and remember that the adult schedule
and the child and adolescent schedule
are trying to translate the actual policy. They are not creating policy. And so, to echo what Dr.
Atmar said, it is important that whatever language,
contraindications, or precautions, around
LAIV for example, we should use what the
language that’s specifically in the current flu policy, and we’ll make sure
that that happens. That’s very important. As a minor thing, can you
go to Slide 24 please? So, I am not an adult doctor,
but for me, the top part says, “65 and older, one
dose is recommended, one dose at 13 is recommended, on shared clinical
decision making.” For me, I think it’s important that that third bullet actually
be the first bullet rather than say that if both are to be administered,
give the PCV13 first. I think first you should say, “They shouldn’t be
administered at the same visit. And they need to
be a year apart. And blah. The PCV13
should be given first.” That’s my simplification.>>Thank you. Thank you. Dr. Messinee?>>Yes, trying to
move us forward, it sounds like the biggest
tension is around the language of the LAIV, and I don’t see the
flu workgroup chair in the room, so Jessica, can you please
call them and get them here? And let us, while we’re in
between, check the language and make sure that we
can justify the way that it is specifically,
because I just feel like we don’t have the
right people in the room. My second question is, to
the question of the schedule, can you go back to your Table 2? So, you know, one
of the things we try to do is harmonize the
child to an adult schedule, and in thinking about
this question of where the word
contraindicated on this schedule,
is disconcerting, I look to see what the
childhood schedule said. And it turns out that in the
childhood schedule, Table 3, there aren’t any words. The justification is perhaps that these groups didn’t
completely harmonize, or maybe it’s also that the
childhood schedule actually, Table 3, is a little more
— the boxes are smaller, so they didn’t have space. But would you guys prefer
that we took the words off of this one, because it
would be then harmonized and maybe it would give us more
of a chance to direct people to look at the actual
language underneath, which makes a clearer case for
— that it’s contraindicated or not recommended, and maybe
we’ll even switch the order of that so it starts
with not recommended. So, would that help? Okay.>>Dr. Talbot?>>Yes, it would help a lot. And as long as it’s truly
contraindicated if it’s red.>>Thank you. Are there any other
comments, questions? Dr. Hunter?>>I would recommend that we
keep in the text in the yellow and purple boxes however, because that prevents people
having to go to the notes.>>Okay. So, yes Dr. Hunter?>>I would wonder if we
could, before we vote on this later this afternoon, see all those changes
and review them? Yes, like we used to do?>>Sorry. Do — taking
that forward, will there be enough time
to have those changes made?>>We could also change this
vote to tomorrow morning if they need additional time.>>That may be a
better idea, I think, if we postponed the vote
till tomorrow morning. Do we need a motion for that
or just leave it the way it is?>>I just feel more comfortable
if we actually were voting on what we could actually see.>>Yes, I think that’s right. Then the committee can
actually take a look at what the product will be. Okay, very good. So now, hopefully, we’ll move
on to the less contentious, gentler childhood
immunization schedule with–>>We have the childhood first.>>-right. With an introduction
by Dr. Bernstein.>>It’s easier living
in a child’s world. So, I plan to give a brief
introduction for the 2020 Child and Adolescent Immunization
Schedule workgroup. The workgroup has
four ACIP members. Besides myself, Dr. Kathy Poehling, Dr. Jose Romero, and Dr. Peter Szilagyi. I would like to acknowledge our
multiple liaison representatives who are listed on the
left slide of this slide. They’re incredibly helpful, as
are our workgroup consultants and our CDC lead,
Candace Robinson who again, makes us look good. And here are the multiple people that we should acknowledge
our multiple CDC contributors, and all of them really
help us tremendously in making this schedule easy
to use at point of care, which is the purpose for
putting this schedule together. But now, I’d like
to take a pause. I’d like to make a pause,
and I wanted to thank and congratulate
Dr. Ray Strikas. We want to recognize one
of our CDC contributors, Dr. Ray Strikas, who is
retiring later this year. In his over 30-year career, Dr.
Strikas has had the opportunity to work on many different
subject areas. Lucky for us, he has worked with
this ACIP for the last 7 years. During this time, he served
as CDC lead for the Child and Adolescent Immunization
Schedule for two years, was a contributing member of
the adult immunization schedule, zoster and pneumococcal
workgroups, and briefly served as Acting ACIP Secretariat. Dr. Strikas, it has been
great working with you, and we wish you the best in
your retirement going forward. [ Applause ]>>So, I’d like to as
chair, exercise a point of personal privilege. So, I had the privilege of
learning of Dr. Strikas in 1986, when I was a
fellow in the laboratory of a polio virologist. And Dr. Strikas’ original
first paper out of the CDC, has stood the test of time. This report was a 14-year
survey of polio virus and nonpolio enteroviruses
by the CDC. It characterized the
epidemiology both temporarily and geographically enteroviral
infections on the United States. It served and still serves
today, as the reference point for this particular topic,
and is cited over in many, many articles, both in my
articles and other articles, and is a major, I
think contribution to the epidemiology
of this disease. It’s very germane
today in the face of the acute VAFM epidemic we’re
having or [inaudible] right now. So again, thank you Ray
for everything you’ve done. Thank you for the work
that you’ve contributed. We are — we really
appreciate it. You can have left
a lasting legacy. Next slide, please?>>Thanks again, Ray, and
we do wish you the best. So, returning back to the
child and adolescent schedule, I would like to remind
you that I need to go forward on the slides. So, I’d like to remind you that
the committee and the audience, why we present the schedule
for a vote every fall. The ACIP’s approval is necessary
prior to the publication of the schedule in February
of the following year. ACIP approval is necessary
before we have our partners AP, AAFP, ACOG, and ACNM, review
and approve this schedule. Of note, this is the first year
that the ACNM will be listed as an approving organization
for the child and adolescent schedule, and we
welcome them and their input. Finally, no one policy is
established by this schedule. Rather, it reflects a summary
or ACIP recommendations. That’s very important
to keep in mind. With the adolescent — child
and adolescent schedule, there are multiple edits to all
the tables, and content changes or clarifying edits for multiple
notes, have been included. Dr. Robinson will
discuss the proposed edits for this 2020 schedule. These edits are intended to incorporate ACIP
recommendations, and MMWR publications, that have
occurred since October of 2018. And improve the readability
and utility of this schedule into language that is
easy to use at point of care by the busy provider. The following presentation
will highlight proposed edits to Table 1, Table 2, and Table
3, as well as content changes and clarifying edits
for multiple notes as listed on this slide. This session will
conclude with a discussion of the proposed edits, followed
by a vote on the adult schedule and the child and adolescent
schedule as in the agenda. I’ll now ask Dr. Robinson
to take us through each of the proposed edits
in the schedule.>>Good morning, everyone. This is a list of ACIP
votes relevant to the Child and Adolescent Schedule that
have occurred since October of 2018, that meeting
at the ACIP. Content edits based on recent
votes for Hepatitis A, Men B, and pending votes for TDAP
vaccines, were discussed by the workgroup
and incorporated into the presentation today. And clarifying edits
for the influenza note, were also incorporated
into the proposed schedule. In addition, edits were
made to the tables and notes of other vaccines as
needed for clarity. On the cover page,
the American College of Nurse Midwives has been added
as an approving organization for the Child and Adolescent
Immunization Schedule, as mentioned by Dr. Bernstein. Within Table 1, this
is the proposed Table 1 for the 2020 immunization
schedule. In the Hepatitis A row, the
bar representing vaccination for those 2 through 18 years
of age, has been changed from a split purple and green
bar, to a solid green bar. This denotes the recommendation for routine catch Hepatitis
A catch-up vaccination, for all children and adolescents
through 18 years of age. The Men B row has been moved
down in the table to appear just above the — sorry, the Men ACWY
row has moved down in the table to appear just above
the Men B row. Within the legend, the
text for the blue box and gray boxes have been edited. The blue box text now
reads Recommended based on shared clinical
decision making. And for the gray box, the
phrase “Not Applicable,” has been added to the text. And this harmonizes this text
between the adult and child and adolescent schedules. This is the proposed
2020 Table 2. There is one minor
edit for this table. ACWY has been added
next to the appearance of the words Meningococcal
in this table, and that is to clarify that these catch-up
recommendations are for Men ACWY vaccines only,
and not for Men B vaccines. I will now review the relevant
edits to the notes section. Oh, sorry. I will now discuss Table 3. Within Table 3, the Hepatitis
A bar has been changed to all yellow, and
that is to denote that vaccination is recommended
for all person irrespective of their medical conditions. The Men ACWY row, has also
been moved in this table to mirror the move into Table 1. Additionally, the box in the
pregnancy row, has been changed from purple to yellow. This is to indicate that
pregnancy is not a reason to withhold vaccination
in an adolescent and routine vaccination
should be administered if indicated for pregnant women. Lastly, on this table, the text
“Not Applicable” has been added to the gray box, for consistency
with the Table 1 text. Now, I will review the relevant
edits to the notes section. Within the DTAP note,
language has been edited to clarify the circumstances
under which the fifth dose of DTAP is not needed. The addition of the highlighted
language is also harmonized with similar language that
appears in other notes with similar vaccine
catch-up guidance, including the polio note. Within the Hib note, a bullet
has been added to clarify that catch-up vaccination
is not needed for previously unvaccinated
children, age 16 months and older, not at high
risk of Hib disease. Within the Hepatitis A note,
a bullet has been added to the catch-up vaccination
section to reflect the recommendation
for routine catch-up vaccination of all children and adolescents
2 through 18 years of age, who were not previously
vaccinated with Hepatitis A vaccine. Additionally, the special
situation section has been removed, as all persons through
18 years of age are recommended to receive vaccination
irrespective of other conditions. Within the Hepatitis B note, a special situation
section has been added. This section outlines the groups for whom revaccination
may be recommended, and refers to the Hepatitis
B ACIP recommendations for additional details. The influenza note
has been reformatted to more clearly present the
recommendations for children who are recommended to receive
two doses of influenza vaccine and which children are
recommended to receive one dose of influenza vaccine
in a particular season. We will put a pause in this
language for the LAIV note. Within the special situations
section of the Men ACWY note, the term Complement Inhibitor
Use, will now be used where relevant to refer to
all medications in the class of medications such as
eculizumab and ravulizumab. Also, information has
been added to this section which outlines the
recommendations for adolescent vaccination
of children who received Men ACWY
prior to age 10 years. The sub-bullets outline the
recommendations for children in whom booster doses
are not recommended, and those in whom booster
doses are recommended. Within the Men B notes, a reference to the
MMWR publication for the booster dose
recommendations for meningococcal B
vaccine, has been added. This harmonizes the presence of similar recommendations
in the Men ACWY note. The inactivated polio virus
vaccination note has been renamed polio virus vaccination, as the note also contains
information regarding OPV. The note will be moved to the
appropriate alphabetical place within the notes section. In addition, detailed
information regarding which doses of OPV can count
as TOPV, has been added. Within the TDAP note, or TDAP
has been added as a placeholder, as a vaccine option
for booster doses. This is of course pending
vote by ACIP and same for the adult language, it will
be included if voted on by ACIP. Finally, clinical guidance
for children who receive TDAP or DTAP between 7 to 10 years of
age, has been added to the note, as mentioned in the earlier
TDAP section, by Dr. Havers. And at this time, we’ll open up this presentation
for discussion.>>Thank you, Dr. Robinson. Members of the voting committee,
do you have any comments? Do you have any comments,
Dr. Bernstein? I’m sorry. Forgive me. I was looking at you.>>We’re interchangeable
primary care physicians. So, if I’m — yes, too weird.>>Forgive me.>>I’m just looking at the adult
immunization schedule and seeing that pregnancy Men ACWY is
purple, and you’re changing that box in the child
schedule from purple to yellow?>>Yes, so for children, we
have a routine recommendation for Men ACWY, at adolescent age. And so, in those instances, pregnancy would not
be considered a reason to withhold the vaccination. However, for adults, there is no
routine Men ACWY recommendation. It is all indications based, which is why there’s
purple [inaudible].>>So, you want to — you
want to make it yellow, so you make sure they — that
the routine one gets done.>>Yes.>>I see. Thank you.>>Dr. Poehling.>>Thank you for
this presentation. I really liked in Table 3, how you put the Mening
ACWY and B together. My question is, would it be
possible to put Hepatitis A and B together in this table?>>So, oops, wrong way. So, I will note that for Table
— the order of Table 3 is based on the order of Table 1. And the reason why
we have Men — not Men B, Hepatitis B
and Hepatitis A separated, is that the goal was to kind
of have this progression in the yellow boxes, from the
first recommended vaccine, and then down through
to the adolescent, so you could follow
along from left to right.>>Okay.>>So, that’s why we have
it, although certainly if persons are passionate, we
can consider moving Hepatitis B. But that’s why we
have it that way.>>Thank you.>>Dr. Talbot?>>Mine’s going to
be very similar to Dr. Poehling.
because I would have on Table 3, put TDAP right under DTAP,
just so that you know, when you change, based
on the medical condition. But I guess it’ll
mess up Table 1.>>Dr. Bell?>>At the risk of getting
thrown out of the room here, just going back to Grace’s
point about the difficulty in the adult schedule
on Table 2, the people with the conditions? I know that there are
lines, longitudinal lines down on Table 3, and I’m
just wondering if we could do that in the adult schedule? At least then, you could look down your column a
little bit more easily.>>Thank you for
that suggestion.>>[Inaudible] take
that to the [inaudible]. I’m getting the thumbs
up from Dr. Freedman.>>Dr. Eckert.>>Yes, I wanted to ask about the shared
clinical decision making for HPV vaccine for 9-year olds?>>So, for — on Table 1, originally when we introduced
a box for 9 to 10-year olds, we just introduced a purple box
which was the recommendation for a high-risk child which of
course, as we know, for HPV, those who are — have been
victims of sexual abuse or assault are definitely
recommended to receive it at 9 to 10. However, we got feedback
that that didn’t — it also made it seem like you
could not use it routinely in 9-year olds, which
the HPV notes are clear that you can start the series
at Age 9, if indicated. So, this box was placed to
denote that you don’t have to have that high-risk
indication to start it at Age 9, but that’s how we got the
blue for that to denote that you can start it,
which is consistent with the ACIP recommendation.>>Dr. Lee?>>Just for simplicity,
it would be great to think about other opportunities for harmonizing the
adult and childhood. And for me, it’s just
the bottom boxes. And it doesn’t really matter
to me which direction, but I was noticing the
wording is slightly different for the different —
for the same color across the childhood and adults. So, if it would be okay to
do that, that’d be terrific. Thank you.>>Yes, we can certainly
look at how to best harmonize that while keeping the intent
the — as it should be for both.>>Dr. Kimberlin.>>David Kimberlin, A.A.P.
I realize it can be done across the entire table, but
to channel Larry Pickering, the dash meaning whether it’s to
or through that particular year that follows the dash,
can be confusing. And so, maybe a statement
at some point in this document saying that a
dash is inclusive of the year that follows the dash,
might be helpful.>>So, we do have in the
additional information section, a bullet that says, “A
dash should be interpreted as through.” We have that present in the
additional information section, but we can expand upon
that bullet if needed.>>You may not need to
expand on it at all, but it did — I did
not notice it. Thank you.>>Thanks.>>Any other comments
or questions? Dr. O’Leary.>>Yes, I just want to
go back to the point about shared clinical decision
making for HPV vaccine. I’m not sure what the right way
to do that is, but you know, we seem to be going down
this slippery slope of more and more shared clinical
decision making, but in all the other
cases, it’s something that was voted upon at ACIP. In this case, you know, AAP recommends vaccination
at this age. CDC sort of recommends
vaccination, but it wasn’t specifically
in the language that it’s shared
clinical decision making. So again, I don’t know what
the best way to do that is, but in my mind, you know,
yellow is almost better than shared clinical
decision making.>>Thank you for those comments. Dr. Bernstein.>>So, along those
lines, Dr. O’Leary, I mean I think that’s
a discussion and I think that’s going
to perhaps be revisited at some time, and different
groups have different recommendations around
HPV vaccine. Again, this schedule is — we’re creating the
schedule not to make policy. Just what’s current
recommendations from ACIP. And so, actually the addition of the blue area is really
allowed to, and to point out to people that
it is an opportunity to give the HPV vaccine
at an earlier age. But it is not a yellow
recommendation, and that’s not the current
policy from ACIP as a routine. The one other thing, the
one other comment I wanted to make is, with the child
and adolescent schedule, some of the notes that we
have, rather than include a lot of text, we’ve included
the links to the text. And that might be helpful
in the adult schedule, because there seems to be
an awful lot of narrative in the notes, in
the adult schedule. And I think some of that
could be abbreviated by giving the links, which is
what we tried to do in the child and adolescent schedule.>>Dr. Cohn.>>I apologize. I did want to acknowledge
though that we are trying to be consistent with just
having the blue acknowledge where we specifically voted for
shared clinical decision making. There’s other parts in the
schedule where it says, you may do this, or you
may do that from prior to implementing the
ATR framework. And so, we should
go back and think about what’s the
most consistent color for that specific
recommendation.>>Go ahead. I’m sorry.>>Yes, I mean, those of you who
don’t know, this is the chair of the flu — the CDC
lead of the flu workgroup, but I asked her to come and
answer the question of what — how we consider cochlear
implants, because it wasn’t really clear
to me that we all understood. So, Lisa, do you want
to talk about that?>>Thank you. The short answer is
that cochlear implants and persistent CSF oropharyngeal
cavity communications are considered what we call,
a Do Not Recommend, which equals contraindication. Several years back,
it became apparent that we have really only two
labeled contraindications for LAIV use that are
in the package insert, which are salicylate
and aspirin use and severe hypersensitivity,
or anaphylaxis. But yet, for a number of years,
we’ve had other conditions for which we said,
“Don’t use it.” And it was suggested to us
after several back and forths with other groups,
that we should say — have a concise table with a
column that is contraindications which also includes conditions
in which should not be used. Immunocompromised conditions
are included in there. That column does not
specifically list under any immunocompromising
conditions the cochlear implants and the persistent CSF
communications, however, it is noted in the text. I believe for next season, one thing that we can do is add
those two things specifically to the table. We do consider them
a breach of immunity, and that is why they’re
in the Do Not Recommend.>>Thank you for
that clarification.>>Dr. Fryhofer.>>I have a question
about the suggestion that more white lines be
put on the adult schedule. And the question is, when we
look at the child schedule, it says, “One dose,
one dose, one dose.” But on the adult schedule,
it’s more — we’re not — they’re just having
to get kind of one. So, I’m not sure if that
would make it easier or more complicated. I want things to be easy.>>Thank you. Anyone else that I
might have missed? Dr. Coyle.>>Not to belabor the point on
HPV but I was trying to look through the recommendations
just to make sure I understood where the shared clinical
decision-making piece is, and I don’t see anything
in the recommendations, and I’m hopeful somebody
can point me to where that was actually called out.>>For HPV, in the recs, it
does not specifically say, “Share clinical decision
making.” It just says, “You can
start vaccination at Age 9.”>>Dr. Kimberlin — oh.>>So, wouldn’t that be
indicated by yellow then? Because I think [inaudible] the
range of — well, it can be?>>Well, I’m seeing some mixed.>>Sorry.>>We can certainly have
an internal discussion here with the subject matter
expert, and our ACIP members, and determine what’s the
best color for that box.>>So, just to remind everyone,
I think the plan now is going to be all of these comments
are going to be considered and incorporated, and then
we’ll reschedule the vote for not right after
lunch, but you’ll see all of this before you have to
make a motion for a vote.>>Dr. [inaudible].>>David Kimberlin, A.A.P. This
is going to show my ignorance, but a question to follow
up on the CSF communication or leakage following
cochlear implantation, is that a permanent leakage? It seems like they’d
be dying right and left of bacterial meningitis
if that was the case?>>Cochlear implant and persistent CSF
communications are described as two separate things. Not necessarily a CSF leak
following a cochlear implant, if I understand the
question correctly. But the, “Do Not Recommend,” specifies persistent CSF
oropharyngeal communications.>>Oh, cochlear implant
[inaudible].>>Dr. Grohskopf — sorry.>>So, that — does a cochlear
implant yield, always yield, those persistent
CSF communications, I guess is my question?>>Well, can I just say
that I just looked it up. The incidence of CSF leak in cochlear implantation
is reported to be between 1 and 5% in large case series. So, I guess, are you just
worried that these could be 1 to 5% of the kids with
cochlear implants.>>Before you answer
that question, let me just add one
more thing to that. So, in a recent discussion with
RENT specialists at our center, I was told that this question of
the leak and associated problems with the CSF, were
more closely associated with the original types of cochlear implants
that were used. And that this is not
so much a problem today as it was in the past. So, and now, Dr. Grohskopf.>>Dr. Sanchez wants to
say something before.>>Thank you.>>With regard to that.>>Yes, exactly. No, I want to echo that because
it has been with the original, and no longer with
the current ones. But I — I think that
needs to be stated clearly, because I personally don’t
see it as a contraindication. And do not recommend or do
not use is a contraindication that — and if it’s because
we don’t have the data, maybe that’s what
should be stated, rather than that it
should not be used.>>Dr. [inaudible], please?>>Thank you. The — for those two conditions
specifically actually, there’s a paragraph in
the guidance that notes that there is a lack of data
for those two conditions. And that because we have
other vaccines available, that is the reason for
it not being recommended. The workgroup did review this — these two topics several
years back and at the time, the thinking was that there
simply just wasn’t enough data to move on. And again, we have
alternative vaccines. So, that was the logic for that. But at this point, this is
something, that you know, we had been planning to
take back to the workgroup and to assess whether
more data were available.>>Thank you. Any other comments or is there
anybody that I left off the list that wanted to make a comment? Alright, then we’ll
close the discussion and comment at this time. If there are no objections,
from the committee, then we’d like to take
a ten-minute break, before entering public comment. We will have public comment for the immunization
schedules today. Both immunization
scheduled voting will be move till tomorrow. We will vote on the pertussis
vaccine issues today, after lunch.

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