Under the
current guidelines in 2007, there are no specific pregnancy
related recommendations for hepatitis A, post-exposure prophylaxis.
The workgroup discussed a number of issues relating to hepatitis A in pregnancy.
First, a study by Morrow, et al
in 2014 on hepatitis A vaccine safety during pregnancy
found no pattern of adverse events in pregnant women or their infants
following vaccination during pregnancy.
Second, the workgroup discussed
the review published in November of 2015 that found that generally infants
born to mothers with hepatitis A infection are healthy, with rare exceptions.
However, the review also found that while hepatitis A infection
during pregnancy is generally not associated with serious outcomes,
there is some association between infection and preterm labor,
placental eruption and premature rupture of membranes.
There does not appear to be an increased risk of mortality
for either the mother
or baby associated with hepatitis A infection during pregnancy.
And third
of note, the vaccination of pregnant women who have a specific risk
or who lack risk but want protection is included in the CDC
adult immunization schedule.
Under medical and other indications,
the work group perspective and included
that administration of Hep A vaccine during pregnancy is safe.
Risk of gestational complications exist if a pregnant woman
is infected with hepatitis A virus.
Vaccine provides long term protection.
IG administration in addition to vaccine can be considered
based on infection risk.
The summary of proposed recommendations for Hepatitis A Post-exposure
and international travel are shown here.
The changes just discussed are outlined
in red.
Okay, do we have questions for Dr.
Nelson?
Dr. Belongia.
This doesn't directly relate to the vote, but I'm curious.
You outlined some of the challenges of IG.
Is there any better technology
on the horizon? Are people looking at monoclonal antibodies in the future?
Are we likely to have some better options than IG?
or is that, are we stuck with IG for the long term?
Not that I'm aware of.
Dr. Lee So two questions.
One, for the 6 to 11 month old age group, are you recommending revaccination
after they return once they age into the appropriate category? Yes.
So they would still receive the two doses of vaccine after 12 months of age.
They would not be able to receive that first dose
until at least six months
after.
And then the second is related to the pregnancy question.
And I wonder if you have any estimates of the number needed to vaccinate
to prevent an adverse outcome of pregnancy due to hepatitis A infection?
I do not have that number.
Do you have an estimate of the number of women who might be prophylaxis?
Do we have a guesstimate?
Dr. Neuzil,
Kathy Neuzil, IDSA, I have some concern
and it may be confusion, but I'm worried if I have the confusion.
And others might have it with the caveat
for the measles issue.
You know, I travel and work all over the world.
We know that measles occurs in low resource and high resource places.
We know it's highly transmissible and outbreaks have occurred,
you know, because of transit through airports and in
at Disney World, for example, or Disneyland.
So, again, I just want to be sure that we want to have that exception.
And I think it will be very difficult to interpret from the practical standpoint.
The work group has discussed that.
And certainly it's something to consider if that exception
is needed.
Dr. Kimberlin.
Dr. Brady Yeah.
So kind of related to that.
I'm just wondering if the contraindication of giving the measles
mumps, rubella vaccine and the hepatitis A vaccine is based on data
suggesting either an increase in adverse events
or an impact on immunogenicity, or is that just
because there's no data that they can be given simultaneously?
So I think that there's some confusion about the measles language,
because I think sometimes what you had up on the slide
didn't exactly coalesce with what you were saying.
So can you just re summarize what cannot be given together
and what can be please?
I'll just verbally say it.
So, immunoglobulin. And
so hepatitis A immunoglobulin cannot be given concurrently
with MMR vaccine,
but the hepatitis A vaccine and MMR can be given together?
The vaccines can be. Yes. Okay.
So that makes a lot easier. Okay. Thank you.
Everybody get that because it was pretty confusing as we were going through it.
It took me a little bit to. But everyone's clear.
So it's it's it's this question
of being able to give the hepatitis A vaccine with MMR.
Yes. Can you just restate the current recommendation?
Sure, the current recommendation
Is that vaccine, hepatitis A vaccine
can be given to infants greater
than equal to 12 months of age.
Okay.
So this is the six month to 12 month
period that we're talking about.
Go ahead, Dr. Walter.
I tend to agree with Kathy.
I think for practical purposes, for that 6 to 12 month age range
for the practitioner who has both of these vaccines
in their office to try and figure out where a measles endemic area is
and where there's an outbreak, it's really going to be difficult.
So, you know, why are we making that distinction?
We can certainly consider,
you know, the vote without that distinction.
Dr. Romero, do you want to clarify that?
No. I mean, I was about to say we can certainly move that off.
But the group considered it to be something to discuss for the ACIP
I mean, I think if it is causing a lot of confusion and it did
I mean, the language did, I have to admit
we did discuss it and afterwards it seemed prudent to leave it in.
But it is causing a lot of this, a lot of confusion.
Then we can remove that and still leave it as using vaccine.
Dr. Atmar,
I want to come back to the post-exposure
recommendation for the 40 to 50 year age group.
So it appeared to me from the data that were presented
that the immunogenicity in the 40 to 50 year age
group is inferior to that of younger age
groups and and not as inferior as over 50,
but with an
incubation period of 2 to 6 weeks for hepatitis A,
having more than 20% of people
between in that age group, 40 to 50
not have a quote unquote protective level of antibody.
I guess it's a little bit concerning to me.
And I wonder whether or not the work group considered
just removing the preferential recommendation for IG
in that age group and making either.
I mean, currently vaccine is really
has a secondary role but either being
possibilities if if the implementation is such
considered to be such a problem, I, I guess I'm
you know we don't really have data to say whether it's going
to be equally efficacious and we're not likely to get any.
And so
I just am a little bothered by the inferior immunogenicity in,
in that age group.
I mean that was listed as a consideration for over 50.
And I think it's
still a consideration for the 40 to 50 based on the data
presented.
Thank you.
Dr. Moore.
Thank you.
I think I think the intent of the workgroup in leaving in the comments
about IG for that 6 to 11 month group was and I certainly think
it would be much simpler to say vaccine just give both vaccines routinely,
but in some cases it's still acceptable to give IG if the clinician
and the family prefer to administer IG, but only in situations
where they're going to places where measles has been eliminated.
So I think it was meant to not say that a and a medically appropriate product
that can protect against hepatitis
A should no longer be used under any circumstances.
We didn't want to go that far,
but I certainly think it could be some more simply stated
that both vaccines should be used for MMR and hepatitis A in that age group.
If there is a clinical decision about IG, it is
it will protect against hepatitis A in that age group.
But there are stronger considerations
around measles protection that should be borne in mind.
Dr. Massoud Yeah, thank you.
I have a question about this 6 to 12 month old or 612 month old age group.
Do you know how many infants there are in this category
that we're wondering about that would be in the category of needing vaccination?
And also, where are they getting seen?
Because I think this clinical decision making looks different.
If it's a average pediatrician who's trying to interpret this versus,
for example, somebody who specialty has travel medicine, who is probably much
more aware of what we mean when we say
measles, endemic countries.
I'm not aware
of the number of infants that this affects, but I'm
my understanding is that the majority of these infants
at that age range would be seen at the general pediatrician.
Ms.. Pellegrini,
I'd like to know if the work group talked at all about the nature of exposure
for persons over 40 and stratifying based on that.
It sounds, if I'm understanding, right,
like the IG is providing short term protection for a few months,
and that would perhaps be most appropriate for, say, a foodborne
exposure, which is going to be hopefully a one time episode.
However, if you're homeless or an IV drug user,
that's probably going to be a long term
ongoing exposure where the vaccine might be more appropriate.
Did the workgroup consider breaking things down that way?
So the the the guidance
that would be accompanying this discusses the risk.
So if the person is of a high falls into one of the hepatitis
A vaccine, risk groups such aS I'm assuming I.V.
drug use, they would get the vaccine
and then it could be the addition of immunoglobulin,
particularly if they're immunocompromised
or have chronic liver disease.
The 90 day, 30 days
after vaccination is about
90% or more zero protection.
So the concern is is really in that
that 15 day window, while that immune response
is is increasing.
Dr. Moore,
in response to this, from a programmatic standpoint,
I think one of the major considerations around IG is that most
health departments don't have it readily available, most clinicians don't.
And time is of the essence in these situations.
When we find people who have been exposed, it's often
right at the end of that 14 day window when we actually track them down.
And the intent here is to ensure that the clinician gives
what is readily available immediately, which is the vaccine.
And then if they need to scramble to get that IG
because they need to provide more assurance,
they can do that, but they haven't wasted time saying, well,
come back when I get the IG, let's get that vaccine in them.
Today and then figure out what we need to do.
And that's something that I think will help us programmatically
provide more efficient protection to more people who need post-exposure
prophylaxis, who otherwise might miss the window
of opportunity for protection at all.
Dr. Rosen
Yeah, I mean, as part of the workgroup, I think another one of the considerations
when you're describing the nature of the exposure,
you know, the one biggest issue local public health runs into is an awful
lot of these exposure events are foodborne exposure situations.
And so in that scenario of very often to begin,
you don't know how many exposures you have and you may have
people who are in the hundreds or even in the thousands.
And in general terms, the risk of that sort of exposure
is a lot lower than someone who is a household contact of someone.
And so, you know, I'll admit, in terms of the driver of this age groups,
to me, a local public health driver is, you know, if you have 1000 people
who have been exposed and several hundred of them are in older age group,
you're just not going to be able to get a hold of immune globulin very often.
And so, you know, having vaccine at least is the option really, you know, really
is, you know, something that's a lot more practical and deserves consideration.
So that's that's at least one of the thoughts here.
Thank you, Dr.
Kimberlin.
David Kimberlin, AP Red book
seeking clarification.
The middle row that says healthy persons greater than 50 years of age.
The data on one of your earlier slides on seroconversion at
15 days was 50 through 59 years.
And a second row of greater than or equal to 60 years.
Should that be greater than or equal to 50 years of age?
Or do you literally mean a 51 year old and older?
So currently
the recommendation is for including age 40,
so would be 41 to 50
and then 51
through 50 and then 51 and up even though the earlier slide
was showing 50 through 59 year olds.
It's the dash that's the issue.
Yeah. So
I guess it would be
depend on
what makes the most sense in terms of understanding.
I think since right now the recommendation is up through age 40
and then the next increment would be 41 through 50
and then the next increment after that would be a 51 through 60.
So greater than 50 years.
Dr. Messonnier,
I was going to ask Dr.
Ward maybe to make a comment about the intent of these recommendations.
Yeah, what we're trying to think is, as some of the comments already reflect
where these changes reflect, that vaccine does afford protection
at any age for a sizable proportion of the population,
but that in some situations for the older group
that's at the highest risk for severe Hepatitis A immunoglobulin is appropriate,
but it's sort of depends on the situation and that's where the provider
guidance comes into play to help you help providers
to understand when IG is really the most indicated versus
some of these other exposures where a vaccine is more practical.
Thank you.
Dr. Romero.
So given the confusion and the suggestions that were made,
it may be more appropriate to take this back to the work group.
Smith words together and make the recommendations
a little clearer for everybody and bring it back in June.
That's what I would propose.
So any objection to that from the committee?
Okay.
Any further comments for the work group to take back?
I do just want to make the comment that we have two individuals
signed up for public comment prior to this vote.
But since we're not taking a vote on this issue, I would like to put those
two public comments to the end of the day with the rest of the general
public comments. Dr. Stevens.
I just did this for information for the working group.
I would Second, Dr.
Atmar Concerned about the reduced immunogenicity in the 40 to 50 age group
as a as a guideline, and that will be one of the things we look at.
Again.
Okay.
Thank you very much.
This has been a great discussion. And I think that,
you know, there's no great urgency about taking this vote today.
So I think Dr.
Ramirez of request is is well taken.
I think we will go ahead and take a break.
We're actually 15 minutes early, So could I ask the people be back at 10:15
from the break so that we can then start the influenza session?
Thank you.