>> We'll begin now with
meningococcal vaccines
with an introduction
by Dr. Stephens.
>> Thank you.
Again, I want to thank the ACIP
and CDC for the last four years
in terms of my service
on this committee.
So again, thank you very much.
Today we're going to be
focusing on serogroup B, MenB,
booster doses and
persons at risk
for serogroup B meningococcal
disease.
ACIP recommends a MenB
primary series for persons
at increased risk for serogroup
B meningococcal disease.
Booster doses are not
currently recommended
for persons at increased risk.
At the February 2019 meeting,
data was presented to ACIP
on the persistence of immune
response following MenB,
the MenB primary vaccination
series, immunogenicity safety
and persistence of the MenB
booster dose was also presented.
A grade evaluation evidence
of recommendation framework
for MenB booster
doses was presented
and the work group's
interpretation on policy options
for MenB booster doses.
So the group activities
subsequent
to that meeting have been a
review of the feedback provided
by ACIP, a discussion
of potential programmatic
challenges
for MenB booster doses,
specific updates proposed
to the CDC guidance, CDC
outbreak guidance related
to booster doses
implementation during outbreaks,
and there has been a development
of an updated ACIP statement
to harmonize existing
meningococcal vaccine
recommendations and potential
MenB booster recommendations
into a single document.
Are agenda today is to
summarize the immunogenicity
and safety data and review
grade, ETR and policy options
for MenB booster doses in
persons at increased risk.
Sarah Mbaeyi will present
that, and I want to thank Sarah
for all of her work and effort
in corralling, if you will,
the working group on
a number of occasions.
And also, she'll present
the updated ACIP statement
for meningococcal vaccination
in the United States.
So we will have two votes on
MenB booster doses and persons
at increased risk and a vote
on the updated ACIP
meningococcal vaccine statement.
And this is a list of the
working group members.
Again, I want to thank both
the members on the ACIP
and the other members for their
work in this area and also,
the CDC contributors to this.
And with that, I'll
introduce Sarah.
Thank you, Dr. Stephens.
And I also want to
sincerely thank Dr. Stephens
for his leadership
of this work group
over the last couple of years.
We've really enjoyed
having you as our chair.
Good morning.
Today I will be summarizing
data evaluated by the work group
to inform policy options
for serogroup B meningococcal
vaccine booster doses in persons
at increased risk for serogroup
B meningococcal disease.
At today's meeting I will
summarize information previously
presented to ACIP at
the February meeting.
This includes reviewing
the rationale
for serogroup B meningococcal
or MenB booster doses in persons
at increased risk for serogroup
B meningococcal disease,
summarize the work
group's interpretation
of the persistence of the
immune response following a MenB
primary series and
immunogenicity and persistence
of a MenB booster dose.
Summarize the grade and
ETR for MenB booster doses
in persons at increased risk.
And finally, review the
work group's considerations
for policy proposals related
to MenB booster doses.
Meningococcal disease
is a serious infection
that can progress rapidly.
One in ten patients die
despite antibiotic treatment,
and among survivors, one in
five have long-term sequelae.
The incidence of meningococcal
disease continues to decline
in the United States
with an incidence
of 0.11 cases per 100,000
population in 2017.
Serogroup B now accounts for
approximately 40% of all cases.
While incidence is low
in the United States,
certain individuals
are at increased risk
for serogroup B meningococcal
disease.
These include persons with
complement deficiencies,
complement inhibitor use,
anatomic or functional asplenia
and microbiologists
routinely exposed
to Neisseria meningitidis
isolates.
The magnitude of increased risk
in these individuals can
be up to 10,000-fold.
Based on the population
estimates for each group,
these individuals
comprise less than .1%
of the US population
aged at least ten years.
In addition, persons may
be at increased risk due
to a serogroup B
meningococcal disease outbreak.
During a college
outbreak, the magnitude
of increased risk is
approximately 165-fold
and is even higher in
freshman on-campus residents
and Greek life students.
Approximately 35,000
college students are
at increased risk annually
due to an outbreak.
In February 2015,
ACIP recommended
that persons aged 10 years
or older at increased risk
for serogroup B meningococcal
disease receive a MenB
primary series.
These groups are
also recommended
to receive quadrivalent
meningococcal conjugate
or MenACWY vaccination
with booster doses every
five years thereafter
for as long as risk remains.
In addition, in June
2015, ACIP recommended
that adolescents age 16 to
23 years may be vaccinated
with a MenB primary series based
on individual clinical
decision making
with a preferred age
of 16 to 18 years.
College students are
at increased risk
for serogroup B meningococcal
disease and outbreaks compared
to similarly aged young adults
who do not attend college.
Thirteen serogroup B
outbreaks have been reported
since 2013 to date.
In all of these outbreaks,
a MenB primary series
was implemented
as part of outbreak response.
Two of these outbreaks occurred
at a New Jersey university
during a three-year period.
During the first
outbreak in 2016,
MenB-FHbp vaccination
was recommended
for all undergraduates.
In the most recent outbreak
reported in February 2019,
MenB vaccination was
again recommended
to all undergraduates,
and for the first time,
booster vaccination was also
recommended for students
who completed a primary series
at least one year previously.
Thus, college students are the
primary group at increased risk
for serogroup B outbreaks
who may have received
a MenB primary series
as healthy adolescents.
Current MenB vaccination
coverage among adolescents is
low with approximately 15%
of 17-year-olds receiving
at least one dose in 2017,
though coverage has steadily
increased since licensure.
Additionally, several serogroup
B cases have been reported
in patients who received
MenB vaccination.
Of the five reported cases to
date, with any MenB vaccine,
three were fully
vaccinated with MenB-4C,
one was partially
vaccinated with MenB-4C,
and one was partially
vaccinated with MenB-FHbp.
Among those fully
vaccinated with MenB-4C,
two had known underlying
conditions
that may have increased their
risk for meningococcal disease,
and one was a young adult
with no known conditions.
The interval from last MenB dose
to disease onset ranged
from 5 to 26 months.
Preliminary analysis
on the strains showed
that potential protection
is dependent on just one
of four antigens in HBA,
and human serum bactericidal
activity, or HSBA,
results suggest that MenB-4C
likely confers limited
protection against
these strains.
No isolate was available
for the patient
who was partially vaccinated
with MenB-FHbp, and thus,
the strain could not
be analyzed further.
Information on these patients
is not sufficient to evaluate
or compare effectiveness
of MenB products.
In summary, although incidents
of serogroup B meningococcal
disease is low
in the United States, a small
group of individuals are
at substantially elevated risk.
ACIP recommended a MenB
primary series for persons
at increased risk
over four years ago.
Evidence presented to ACIP at
the February meeting suggest
that waning of immunity
occurs within one
to two years following
primary vaccination, and thus,
some vaccinated people may
no longer be protected.
Serogroup B outbreaks among
college students continue
to occur.
One university to-date
has implemented off label
and ACIP recommendations
for a booster dose.
Finally, no further data
on persistence following
a primary series
or booster dose are expected
from the manufacturers.
Additional data on MenB
effectiveness and duration
of protection in
adolescents and adults
or in US populations may
take years to generate.
Now I will review the work
group's interpretation
of the persistence of the
immune response following a MenB
primary series.
This figure summarizes
clinical trial data
for both a three-dose shown in
the purple and dark blue bars
and a two-dose shown
in light blue bars,
MenB FHbp primary series with
each panel representing data
from baseline or pre-vaccination
through 48 months
post-primary series for each
of the four test strains.
The work group's interpretation
is that antibodies wane
by 12 months following
completion
of a MenB FHBP primary series
and then remain stable for up
to four years in
healthy adolescents.
For MenB-4C, four
clinical trials,
each shown in a different
color, have been conducted
to assess immunogenicity
and persistence to each
of the four vaccine antigens
shown in the different panels
through seven and a half
years post-primary series.
Persistence following a MenB-4C
primary series was difficult
to generalize due to the
elevated baseline titers
in two studies, heterogenous
results by vaccine antigens,
different time points
assessed in different studies
and more limited
persistence data for NHBA
which contributes most to strain
coverage in the United States.
In light of this, the work
group's interpretation is
that antibodies wane
by two years following
the primary series
in healthy adolescents
and adults,
though they may wane earlier.
In addition, persistence
of MenB primary vaccination
against diverse serogroup
B strains,
including from college
outbreaks, has been assessed
in several observational
studies.
Variable patterns of short-term
persistence were observed
when measured up to 12
months post-vaccination.
In another recent study
to assess seroprevalence
at Princeton University
following the 2013 outbreak,
suboptimal short-term
immunogenicity followed
by substantial antibody waning
to the outbreak strain
was observed
in students vaccinated
with MenB-4C.
At two months post-vaccination,
61% of students had an HSBA
titer of at least one to four,
which declined at 24% by
20 months post-vaccination.
In summary, given the
variable rate of waning
between vaccine types
in between studies,
antibody persistence following
a MenB primary series was
difficult to generalize across
the two vaccine products.
It must also be noted that the
two vaccines are completely
different, and evaluations
of immunogenicity
and persistence were conducted
using different strains
and immunologic endpoints
and thus cannot be
directly compared.
However, the work
group felt that by one
to two years following
a MenB primary series,
booster vaccination is
indicated for persons
who remain at increased risk.
Next, I will review
immunogenicity and persistence
of a MenB booster dose.
Immunogenicity and persistence
of MenB-FHbp booster dose
administer four years
after completion of either a two
or three-dose primary series
demonstrates a robust immune
response at one month with
gradual waning and evidence
of persistence through 26
months post-booster dose.
Thus, the work group's
assessment is
that the immune response to a
MenB-FHbp booster dose persists
for at least two years
in healthy adolescents,
and given the gradual antibody
decay pattern, may last longer.
For MenB-4C, regardless
of timing since completion
of the primary series,
whether two, four or seven
and a half years, a robust
immune response was demonstrated
one month following
either a MenB-4C
or investigational
MenABCWY booster dose.
No studies assess persistence
of a MenB-4C booster dose.
However, following
a booster dose
with the investigational
MenABCWY vaccine,
which has the same MenB
component as MenB4C,
antibody persistence
was observed
through 12 months
post-booster for most antigens.
While there are no data
on immune persistence
following a MenB-4C booster dose
to inform the work
group interpretation,
the work group took into account
the demonstration of persistence
of an investigational MenABCWY
booster dose through 12 months,
as well as model data
presented by the manufacturer
at the February meeting
suggesting
that persistence is
likely several years.
To summarize a MenB booster
dose elicits a strong immune
response, and the
persistence appears to exceed
that of a MenB primary series.
Thus, the work group's
interpretation is
that antibody persistence of
a MenB booster dose is likely
at least two to three
years and maybe longer
in healthy adolescents
and adults.
Next, I will summarize the grade
and ETR for MenB booster doses
in persons at increased risk
for serogroup B meningococcal
disease.
Our overarching policy question
was, should persons vaccinated
with a MenB primary series
who remain at increased risk
for serogroup B meningococcal
disease receive a MenB
booster dose?
The population was persons
age ten years or older
at increased risk due to
specific underlying conditions
in microbiologists and persons
exposed during a serogroup B
meningococcal disease outbreak.
The intervention was
either a MenB-FHbp
or MenB-4C booster dose, and the
comparison was no booster dose.
Outcomes of interest related
to MenB booster doses were
identified by the work group,
though only data on
short-term immunogenicity,
persistence of the
immune response
and serious adverse
events were available.
For grade, we had a total
of four PICO questions,
two for each group at
increased risk and two
for each MenB vaccine.
First, I'll start with
persons at increased risk due
to underlying conditions
or microbiologists.
For both MenB-FHbp and
MenB-4C, the evidence type
across outcomes was a four,
indicating that the overall
certainty of evidence
in this population is very low.
The work group also reviewed
additional considerations
as part of the evidence to
recommendations framework.
Persons at increased risk due
to certain underlying
medical conditions
and microbiologists
comprise a small group
at substantially increased risk.
Thus, in this group, prevention
of serogroup B meningococcal
disease is an important concern.
However, immunogenicity to
MenB-4C is reduced in persons
with complement deficiency
or complement inhibitor use
compared to healthy controls.
And these persons may
be at increased risk
for meningococcal disease even
if they develop antibodies
following MenB vaccination.
Thus, in these persons,
the desirable effects
of vaccination may be
more limited compared
to others in the target group.
The undesirable effects
of booster vaccination are
expected to be minimal.
Safety of the MenB primary
series has been demonstrated
in several large evaluations in
healthy persons, though no data
on booster doses, included
repeated doses, are available
in persons with underlying
conditions.
In a survey, the
majority of pediatricians
and family physicians state they
would recommend a MenB primary
series for children at increased
risk demonstrating acceptance
of MenB vaccination,
though there is a disparity
by provider type which
may reflect levels
of awareness or feasibility.
There are no data on
cost effectiveness
in this population.
Thus, the work group's
interpretation is
that for this population
at increased risk,
serogroup B meningococcal
disease is a problem
of public health importance.
The desirable effects of a MenB
booster dose may vary in persons
with underlying conditions.
The undesirable effects
are likely minimal.
The intervention of a MenB
booster dose is favored,
but there is very low
certainty of the evidence.
The target population
may feel uncertain
that the desirable
effects are large relative
to undesirable effects, though
there is important uncertainty
in how much these persons
value the main outcomes.
A MenB booster dose is probably
acceptable to key stakeholders,
though it is uncertain whether
the intervention is a reasonable
and efficient allocation
of resources
or is feasible to implement.
Thus, the majority of
the workers were in favor
of proposing MenB booster
doses in this population.
Next, I will review
grade and ETR for persons
at increased risk due
to a serogroup meningococcal
disease outbreak.
For MenB FHbp, the evidence
type across outcomes was a four,
indicating that the
overall certainty
of evidence is very low.
For MenB-4C, the evidence
type was a three or four
across outcomes depending
on study design,
indicating that the overall
certainty of evidence is low.
The work group also reviewed
other considerations as part
of the evidence
to recommendations
framework for this population.
Seven percent of
serogroup B cases
in the United States
are outbreak-related,
and college students are
disproportionately affected.
Limited data are available
on effectiveness and duration
of protection in
adolescents and adults,
and no data are available
in US populations.
Following mass vaccination with
MenB-4C in a region of Quebec,
Canada experiencing
increased rates of disease,
the vaccine was estimated to
be 79% effective in persons
under the age of 20 years up
to four years post-vaccination,
though the confidence
intervals were very wide.
However, an additional factor is
that the evidence
to-date suggests no impact
of MenB vaccines on
meningococcal carriage,
thus herd immunity is unlikely.
As a safety of a MenB primary
series has been demonstrated
through multiple evaluations
following mass vaccination
during outbreaks,
the harms are likely
to be minimal for
a booster dose.
The work group also
reviewed factors specific
to college outbreaks.
All 13 universities that
experienced outbreaks
since MenB vaccines became
available implemented MenB
primary series indicating
acceptance
of MenB vaccine to stakeholders.
Though first dose
coverage varied widely
which may reflect values,
feasibility or other factors,
additionally one university
to-date has implemented a
booster dose even in the absence
of ACIP recommendation
reflecting acceptance
of this intervention.
MenB mass vaccination
during college outbreaks is
resource-intensive,
though it's estimated
to be more cost effective
than universal vaccination
of all students at
college entry.
Outbreaks require
intensive coordination,
significant human resources
and action among
multiple stakeholders
to efficiently respond
within a short time.
MenB booster doses may create
additional complexities,
though colleges have already
demonstrated feasibility
of conducting mass vaccination
under very challenging
circumstances.
Indeed, additional
challenges related
to booster dose implementation
were noted
at the New Jersey University,
including additional
communication
and logistical challenges
related in part to the lack
of an ACIP recommendation
as well as challenges
in determining booster dose
eligibility, for example,
if a primary series
was completed
in which product was used.
Thus, the work group's
interpretation is
that for this population
at risk during an outbreak,
serogroup B meningococcal
disease is a problem
of public health importance.
The desirable effects of a
MenB booster dose may be large
with minimal undesirable
effects.
The intervention of a MenB
booster dose is favored,
but there is very low
certainty of the evidence.
The target population may feel
that the desirable
effects are large relative
to undesirable effects, and
there is probably variability
in how much these persons
valued the main outcomes.
We consider that
the intervention
of a MenB booster dose is
acceptable to key stakeholders,
a reasonable and efficient
allocation of resources
and feasible to implement.
Therefore, the work group is
in favor of a MenB booster dose
for persons at increased risk
during a serogroup B outbreak.
Next, I will summarize the
work group's deliberation
for MenB booster
dose policy options
and persons at increased risk.
To summarize the work group
review data I just presented
on the persistence of the
immune response following a MenB
primary series, immunogenicity
persistence and safety
of a MenB booster dose
and results from the grade
and ETR evaluations,
the majority
of work group members agreed
upon the need for and timing
of MenB booster doses.
A small minority felt there
was insufficient evidence
on the safety and efficacy
of MenB booster doses
to inform policy options.
The following slides represent
the views of the majority
of work group members.
In summary, the work group feels
that MenB booster
vaccinations is necessary
to sustain protection in persons
who remain at increased risk.
The work group suggests that a
MenB booster dose is indicated
at one year following completion
of the primary series.
Greater persistence is
expected after the booster dose
and thus a longer interval
for repeat booster
doses may be considered.
Given the serious nature
of meningococcal disease,
the work group feels that
the potential benefits
of MenB booster vaccination
outweigh potential risks
in this population.
As with MenB primary
vaccination,
challenges in the implementation
of MenB booster doses
are anticipated,
but the work group feels
that the potential benefits
of booster vaccination justify
the additional implementation
efforts that will be needed.
Thus, the work group proposes
that ACIP recommend
MenB booster vaccination
in persons aged ten years
or older at increased risk
for serogroup B meningococcal
disease
who previously completed
a MenB primary series.
This recommendation does
not apply to persons
who previously completed
a MenB primary series
as an adolescent based
on individual clinical
decision making and who are not
at increased risk for serogroup
B meningococcal disease.
For persons with
complement deficiency,
complement inhibitor use,
asplenia or microbiologists,
a MenB booster dose is
recommended one year following
completion of a MenB
primary series followed
by booster doses every two
to three years thereafter
for as long as risk remains.
For persons determined by
public health officials to be
at increased risk
during an outbreak,
a one-time MenB booster dose
is recommended if it has been
at least one year
since completion
of a MenB primary series.
A booster dose interval
of at least six months
may be considered
by public health
officials depending
on the specific outbreak,
vaccination strategy
and projected duration
of the elevated risk.
ACIP will be asked to vote
on the policy proposal
for MenB booster doses in
persons at increased risk
for serogroup B meningococcal
disease.
In advance of this afternoon's
vote, we would like to ask
for any additional feedback on
the work group's policy proposal
for MenB booster doses.
>> Open for comment, questions
from the voting members.
Dr. Atmar.
>> Could you remind us of the
basis for the original approval
in terms of the MenB vaccine.
I mean we're making
recommendations here based
on immunogenicity and safety.
And the original recommendations
were made also based
on immunogenicity,
as best I can tell,
from the meningococcal
vaccine recommendations.
Is that correct?
>> That's correct.
Immunogenicity data for
both vaccines was reviewed
when making the recommendation
for persons at increased risk,
as well as for adolescents
who are not at increased risk.
We don't have any vaccine
effectiveness data or duration
of protection estimates
that inform that policy.
>> And then my other
question relates
to a cost effectiveness
assessment that's,
I understand what was done for
the original recommendation
and what the extra cost
and benefit would be
for a booster recommendation.
>> We did not conduct a formal
cost effectiveness evaluation,
because these recommendations
are really
for a very small group of
individuals at increased risk.
This is, we are not considering
booster recommendations
for adolescents who are
not at increased risk,
which is a much broader
population.
We attempted to look at
some of this, but we found
that there was such wide variety
in the assumptions we
would have to make.
There was such a range in
our estimated numbers needed
to vaccinate based on
uncertainty around the level
of increased risk, etcetera,
the population size, etcetera,
that the numbers really
weren't very meaningful,
which is why I haven't
even presented those.
>> Can you remind us of
the total estimate size
of the population that
you're talking about?
Not, I guess, both for increased
risk and also the average number
of college students that are
vaccinated during an outbreak --
>> Sure. It is, let me go back.
>> Slide seven.
>> Slide seven, please.
Yes, so it's a little
under 300,000.
And the college students
are about 35,000.
So that's taken into
the estimate.
These are, I should point
out, these are estimates too.
If you take, for example, those
with complement deficiency,
the top line, the
majority of people
who have complement
deficiency are not aware
of their deficiency.
Often people will find out
after their first episode
of meningococcal disease
or another infection
or if they have family
members with it.
>> Dr. Maldonado.
>> Yeah, thank you.
That was a nice presentation.
As, since this is a booster
recommendation, and I think,
as you know, pediatricians are
somewhat concerned about how
to counsel families given
the very low risk of disease.
I think that in addition to
giving incidents, I would hope
that maybe there would be
actual numbers of cases,
because that helps
the pediatrician.
For example, looking at the
2017 surveillance data from CDC,
there's a total in
all ages of 134 cases
of MenB disease in the US.
And so I think it would
help a pediatrician
to counsel the family given the
level of risk in that age group.
>> That would be helpful.
Thanks. Thank you.
>> Dr. Stephens.
>> So just to respond
to Dr. Atmar's question.
The license of the B vaccines
is based on immunogenicity,
require a lot of protection
as this sero assay,
and that's been a standard
for a number of years
for most meningococcal vaccines.
I do think, to comment
on another question is the
complement inhibitor issue.
I think that even though we
are recommending vaccination
and booster vaccination
in this group,
we still haven't particularly
solved this problem in terms
of the seriousness, and
we've presented data
on that in the past.
But this is, as was
pointed out, a small group
that we're recommending
boosters for at this point.
>> Dr. Hunter.
>> Yeah, I was wondering if
our college health and NACCHO
and ASTHO liaisons can
comment on the following issue
that if there's an outbreak
on a college campus, whether,
how much the booster
recommendation would help
in the implementation of a
response to that in that you may
or may not need to ask before
you vaccinate what their
history is.
And if you don't have a
reliable vaccination history,
whether that would be helpful.
>> Can we ask ACHA
behind you also?
>> Yeah, this isn't even ACHA.
I think you've pointed
out something
that we've thought
about, but there's likely
in an outbreak situation the
access to vaccine information
on which, if they had MenB
before the students are unlikely
to know which ones they
have, and it depends
on the recordkeeping and
the ease of recordkeeping.
I mean if you have all the
students' immunization quickly
available in an electronic
record, that's one thing.
But it's not, that's not the,
that's not a general practice.
So I think we would be
using, my assumption is
that a campus would
use the vaccine
that was most readily available,
administer that as widely
as possible in situations
where someone was aware
of the vaccine they
had had before,
if they'd had two doses
before, we would, you know,
make every attempt to
use that same vaccine.
The speed of the response
seems to be more important
at that point and when
you're in that situation.
>> So for NACCHO
Society, I think yeah,
it's a good point, Paul.
I think it depends on
the size of population
that you're trying to reach.
You know, if you have 30 people
that you potentially expose,
it's really different than if
you're talking 3,000 people.
I think that either
way, you know,
if you say that there's been
a meninge event and you need
to vaccinate a very
large number of people,
even if you're saying we
just want to get people
who have never been
vaccinated before, either way,
I think there's a real potential
for missing, for giving,
you know, there's
no recommendation.
You're still going
to give extra doses
because there've been
people who vaccinated
that didn't realize then
they got vaccinated.
So I think that on balance,
I think that this is
definitely helpful.
I think this clarifies
the question.
I think it's an obvious question
that begs, hey, you know,
we know that after a couple
of years your immunity
really wanes and, you know,
to me it's an obvious
question and obvious concern
and there's potentially
utility to it.
I think there is
an issue in terms
of getting everybody's
vaccination status right
and over-vaccinating.
I think that looks like you can
go down to six months or more,
you know, or after, which
makes, you know, a better chance
that people will
remember what they got
within the last six
months at least.
So, I think there is an issue
and concern you described.
But I think on balance,
I think this is something
that public health will
welcome the recommendation of.
>> Dr. Messonnier.
>> Yeah, I wanted to ask a
question of the working group.
So, I really appreciate the
systematic way you worked
through the issue and
the desire to fill a hole
in our recommendations,
which I think makes,
tries to provide helpful
guidance to clinicians.
These groups appear different
than the outbreak settings are
in groups that have
a more lifetime risk.
And I understand the limitations
of the available data
but also the desire to provide
recommendations beyond the
single booster dose.
And I just wanted to
ask the working group
if they could comment
separately on reassuring us
that they don't have
concerns about safety.
I mean, I know we don't really
know about effectiveness
of repeat vaccination
after even, you know,
a second, a first booster.
But if you could just
comment on the safety issue.
>> I think that from a safety
standpoint, and we did look
at those data, and that
there isn't a major concern
around safety of booster doses.
I think there is, based on
the data that was emphasized,
that this is a memory-inducing
vaccine
and therefore a booster dose
should provide significantly
longer protection than the
original priming series.
But we don't have
data to support that,
but I think that is
the, that's the message
from the limited data
that's available.
Sarah may want to also comment.
>> Dr. Ault.
>> Just in follow up then,
if this recommendation were
to go forward, I think it
would be important for those
at a lifetime risk to
generate those data
because it may well be that
the interval can be longer
as more doses have
been delivered.
>> Dr. Echez.
>> So, I was thinking as
I was looking through it,
and I was thinking, this
includes the 100,000
of the people that have
sickle cell disease that as
into have functional asplenia.
And so your recommendation
is that they are going
to receive these every two
to three years for life.
And it seems like we
really don't have the data
that shows effectiveness.
Now, do we actually have
the safety data beyond one
booster dose.
So I would just keep wondering
on what foundation we are going
to make that recommendation that
individuals who have sickle cell
who have functional
asplenia should be immunized
with the primary series and
receive immunization every two
to three years for life.
>> Go ahead, Dr. Stephens.
>> So yeah, I think, I think
you raised an obvious dilemma,
how we know this vaccine does
work in terms of efficacy.
It does prevent disease
in high risk groups
and in those individuals
with functional asplenia,
the risk is significant.
So, you weigh the, we use things
like prophylactic penicillin
in some of these individuals
for other increased risk.
That is, you know, for
lengthy periods of time.
So I think my response is
that yes, I would believe
that a booster could help
protect these individuals.
How often you give that
booster is the question that's
on the table.
How long do we continue to
make these recommendations
in this particular group?
I agree with Dr. Atmar
that we need more data
on repeated boosters
to your question.
>> And just to chime in on this
sickle cell question a little
bit more.
The reason that they're
considered,
I mean a big reason why
they're considered a risk group
for meningococcal
disease in general is
that if they do get it,
they have extremely high case
fatality rates, you know, 60%,
70% of people can get an
overwhelming post, you know,
splenectomy infection.
And so I do think
it is important
to consider them
I this population.
>> Just a follow up.
I mean I do understand
why this needs to be done.
I'm just wondering how
we are going to represent
in the recommendation that this
is the recommendation we are
making with limited
available data.
That's really, so just to
make sure that we are hoping,
and that's something
I think ACIP could
and the manufacturer could
come into which is to make sure
that we do collect this data.
You know, what happens
usually is
that after this start this data.
So if you, there was a way
to make the recommendation
that we will overlook, the ACIP
will review this recommendation
in five years.
A way to kind of put in place
some data collection of safety.
>> Dr. Whitney Williams,
did you?
No, okay, sorry.
Forgive me.
>> I was wondering if it
would be interesting to look
at this vaccination strategy
as an added value above
and beyond chemoprophylaxis.
I mean following the
comment, I think people
on [inaudible] are
having, there were thoughts
about giving them prophylaxis
because the meningococcal
disease was non-vaccine type.
So how much more do you
add by boosting with MenB?
And the other question that I
had was for microbiologists,
I am one, whether or not I
want the vaccine every two
to three years, I'm not sure.
But so that study is
a study from 2005.
Do you think that the process
in the lab is now safer working
with biosafety level
two and above?
And is that risk still the same?
I just find that this
recommendation is very heavy
in terms of boosting.
>> Yeah, I think these are
issues that we've really tried
to understand on the work
group a little bit better.
I think we recognize
that every two
to three years this is
a pretty short interval.
But the work group, and
even when this was brought
to ACIP several years
ago initially felt
that we didn't have
the data to say
that we could wait five years.
The data is just not there.
People will be left unprotected.
I do agree we have
some gaps in our data.
You know, we don't have
more refined estimates among
microbiologists since
that paper.
Like Dr. Stephens mentions,
there's still a lot of issues
to be worked out with people
taking complement inhibitors
and how much vaccination
actually protects them.
But I think the work group
felt that we know that they're
at exceptionally high risk,
and there is a possibility
of benefit in these groups, so
we should continue recommending
that in the primary series
but also booster
vaccination in this group.
>> Dr. Mesonye.
>> Yeah, I just wanted
to point out two things.
One is, you know, we do have a
routine cycle now with a review
of these recommendations
every five years.
And so that will
happen routinely.
ACIP is certainly
welcome to include
in their statement language
directing CDC to, you know,
try to find ways
to evaluate this.
I would say that it
would be difficult
to have a standalone study.
So what we would be looking
to see is if that in any
of these groups there
are existing studies
where folks are, for
example, drawing blood
from patients with sickle cell.
Because it would
be more efficient
for us to try to add on.
So we'll look for collaborators
who actually have clinical care
of these patient populations
to see if there's a way to,
you know, answer some
of your questions.
And I'm saying it here
because perhaps somebody
in our larger community
might, for example,
know of a researcher whose
working on sickle cell disease
and be able to connect us with
somebody that would help us
to answer these questions.
>> Dr. Bernstein.
>> I struggle a little bit
with, since these vaccine,
two vaccines are
not interchangeable,
I struggle a little bit calling
it a booster if we really
in that population of college
students during an outbreak
that we do not know what
product they received.
Are we really doing a service
in giving them a single dose
of vaccine, since one of the
two products is a zero one
month schedule?
Should we be extending our
recommendation for those
that have not received MenB
vaccine in college or before
or we don't know and can't find
out which product they had?
>> The work group did
discuss that in depth.
I think that is a major
feasibility concern
that we have.
I think we really
want to emphasize,
I mean the ACIP recommendation
would be
that to use the same product
that the doses are
not interchangeable,
our vaccine products are not
interchangeable, just as it is
for primary series vaccination.
We recognize that that's a
challenge during an outbreak.
We've attempted to review the
work group potential guidance
for our CDC's outbreak
guidance document, understanding
that we're not always
going to get it right.
But that we do feel that these
students should be offered the
chance to get a booster
vaccination.
And Rutgers presented, sorry,
the New Jersey University
presented to us
about their experience.
And it does sound like
that was a challenge.
But they overall felt that
that was something they could
work with.
>> Dr. Hunter.
>> Yeah, just to
respond to that.
I'm looking at this and
correct me if I'm wrong.
But that the booster
recommendation gives more
flexibility rather than
limiting the direction of,
you know, an outbreak response.
So that, you know, at
least if you find out later
that you vaccinated
somebody a second time,
you didn't do something that
was against a recommendation.
>> Dr. Fryhofer.
>> Sandra Fryhofer,
American Medical Association.
As a practicing physician,
I've had difficulty figuring
out which of the vaccines
my patients have received.
It's not indicated on our
GRITS registry, and oftentimes,
I have to call the pharmacy
or call the pediatrician,
which can be quite cumbersome.
So, just a shout out to
include the specifics
on the registries and the notes.
>> Dr. Even.
>> Yeah, I was just
going to add that I think
with the general lack of a broad
recommendation for all college,
entering college students to
get them meningitis B vaccine,
I mean having it be a
clinical decision making
in the low uptake at
this point of MenB.
I mean we would understand
that we have some
who have had previous doses,
but I think we'd be looking
at it more like this is the
outbreak, initial outbreak dose
so that the booster might
be the flexibility for those
who had already had some,
at some point in the past,
but I think we'd
be thinking it more
like this is the
outbreak dose that we're
under recommendation to give.
>> Any other comments,
questions?
Okay, since we're going
to have to vote on this
in the afternoon, could I
have the wording proposed
for the vote on the screen?
>> Yes, that's slide 53.
>> Okay. So, do members feel
comfortable making a motion
at this time?
And if so, then can I have
somebody make the motion?
>> So I --
>> Dr. Stephens.
>> Moving that ACIP recommends
MenB booster vaccinations
in persons aged greater
than or equal to ten years
at increased risk for serogroup
B meningococcal disease
who previously completed
a MenB primary series.
>> Motion second.
Do you have a counter?
>> I don't know what he's doing.
>> He's already motioned.
So you have a countermotion?
Then we'll carry
your countermotion.
>> I, just listening to the
conversation, I'm struggling
with the fact that we have
a great deal of uncertainty
and acknowledge that we
still have to make a decision
in the face of that uncertainty.
So I'm comfortable with
that component of it.
I strongly do feel
that there should be,
I don't know what
the equivalent is
of like a post-marketing
commitment
or requirement specific to
this area, but something
like that in this area.
Because I do feel like
additional effectiveness
and safety data are needed,
including with the interchange
of the different
products if that happens
in an outbreak setting.
But the countermotion I
wanted to put on the table was
to consider shared
clinical decision making,
which I know is not going to
be a favorite in this room.
But the reason I
say that is probably
because of Dr. Quach's comments
about are we making a blanket
recommendation in the face
of uncertainty versus
a recommendation
that allows people to
use their judgment.
There are some populations
for which I feel more strongly
about it and others where
I feel like it's less clear
to me what the right answer is.
And we're mixing
them all together.
So I'm struggling with it.
So that was a very long
motion, and I apologize.
But the motion is whether
to consider shared clinical
decision making for populations
who remain at increased risk
of which I think they are
a heterogenous population.
>> Do you have another motion?
>> No, I didn't have a motion.
I wanted to support it, but I
wanted to ask if there was a,
can you make a, or can
you support a motion
with a condition?
>> Yeah, an amendment.
>> So with an amendment.
So what I was considering
was, you know,
I agree that we don't have
all the data that we need.
But I think we have enough
data to make a recommendation
if we also commit to
collecting the data.
So I was thinking to
support the proposal
but with a recommendation.
But attached to it that
if we have enough people,
we have 100,000 people with
sickle cell, for example,
that we actually collect
this data in a way
that is not left hanging.
So when you support it you
can make that amendment.
>> So you're amendment
to the motion is
to Dr. Stephens motion.
Is that correct?
>> Yes. To say I support that
with this amendment [inaudible].
>> Okay. So, we have two
motions on the table.
At this time, then,
I think we should go
with Dr. Stephens
motion as chair
of the work group
for seconding, right.
We have to --
>> I'm confused about,
I mean usually recommendations
don't have the language
that Dr. Eche included.
That's sort of part of
the paragraph, right.
So that could be
included regardless
of the recommendation language.
I was just trying to reply
to that before you --
>> That's good.
Very good.
So, we'll have a second
if the motion is seconded,
then it will be carried
forward to a vote.
If it is not seconded, then we
would more to Dr. Lee's motion
for seconding and then
carry forward to a vote.
Eche do you have
another question.
>> No, so I will second it.
I'm just saying, I
was just asking you.
So I want to be able to do
is to say that I second it
to move forward but
that we include,
I really do think we should
include that data collection.
>> Now comments.
So, Dr. Atmar.
>> So can I request that over
the lunch, less than hour now,
that a counterproposal
reflecting Dr. Lee's
recommendation be drawn
up so that in the event
that this is voted down,
we can look at the counter,
maybe we can even look
at it before we vote
to help us guide our
decision on the first vote.
>> I think, yes, that would
have been something I would have
suggested, but I
think we can do that.
Dr. Talbot.
>> I feel like I missed
something really big,
but this recommendation
doesn't say when to do this.
>> Or how.
>> Or how often.
So, is it a year after they
finish their primary series?
Is it two years?
Is it as soon as they
finish their primary series?
>> That was on the table
on the prior slide.
Do you want to pull that up?
>> Yeah, that's better.
Okay, thank you.
>> So I just want to clarify
from a procedural perspective.
So Eche has put an
amendment on the table.
Technically, if that amendment
is seconded, then we would need
to vote on the amendment
and then vote
after the public comment
on the proposed amendment.
I think Dr. Mesonye's comment
that we can incorporate
that language not included in
the policy is also an option
But I just wanted to make sure
that there was nobody who wanted
to second that amendment.
>> So I need clarification
of that.
Because I thought that by
your statement you were saying
to include it in the statement.
>> No, I'm sorry.
I guess what I'm saying is,
you know, we have really worked
over the past, especially
the past five years,
to make the recommendations
very clearly a recommendation
around vaccination and not
to have other language.
Because I think, you know, and
my guess, I mean many years ago,
the recommendation
language was so complicated
that folks really felt like it
was difficult to understand.
And so we've really
tried to get to a place
where your recommendations are
clearly ACIP recommends give
a vaccine.
You don't give the
vaccine clinical guidance.
But that the language that
Dr. Eche said could be part
of that whole paragraph
where we lead
up to the actual
recommendation and, you know,
eventually you guys will see
a statement and it can be
in there regardless, therefore,
of actually including it
in the thing that you vote on.
Does that make sense?
>> Great. Thank you very much.
So are there any
other comments from --
>> Yeah, we're just a
little confused back here.
The shared decision
making potential amendment,
is this just for persons at
increased risk for meningitis?
Or is this across the, because
we do have some concerns
about shared decision
making in an outbreak.
I mean that's going to be
challenging for those of us
who deal with outbreaks.
It's different than
an individual,
but maybe we're misunderstanding
back here.
>> Yes, it is shared, and we'll
come back with that after lunch.
Okay, so more comments.
>> I just want to
comment in support
of the original recommendation
in that the reason
that a routine recommendation
is important for boosters
for these individuals
at increased risk is
that there's no question
that they need frequent,
they need boosting in order to
be protected against hepatitis,
sorry, wrong work group,
meningococcal B disease,
whatever the disease is.
And so there's really no
question that they do,
if they wish to be
protected, then, and they are
at increased risk, they need to
be boosted and the best evidence
that we have is two
to three years later,
I think ongoing information
is important to collect
to understand if, you know,
that is forever, if we're able
to stretch that out as
more data become available.
But I think that that's
the reason that it needs
to be a clear guidance
that if you're in one
of these increased
risk categories,
it's a recommendation.
It's not a requirement.
People choose all the
time not to get vaccines
that are recommended for them.
And they can certainly do that.
But for protection, they need
to be, they need to booster.
>> Can I just clarify,
I just want to respond.
Is that okay?
My response was I was not
talking about outbreaks.
I was talking about
the first population.
Thank you.
>> Dr. Stephens.
>> So, I was going to
make the same comment
that I think shared decision
making is very difficult
in this setting where
you have obvious risk.
Interpretation would
potentially be different.
I mean these are
individuals with ongoing risk
that is not going to
necessarily change.
And to be soft, if you will,
in terms of a recommendation,
I think is a mistake.
So that's --
>> Eche had a comment,
and then --
>> Well, I just wanted to
put on record that I do think
that this is, that where
shared decision is really going
to help guide what we do.
That if we are going to make
this recommendation based
on the data we have, recognizing
even the limitation of the data,
that we should make that
recommendation and be able
to get the data that will
guide us when we review.
>> Dr. Fryhofer.
>> Sandra Fryhofer,
American Medical Association.
I'm speaking as a
practicing physician.
You have to think about
who's giving these vaccines.
I mean it's people in,
you know, private offices.
They're, you know,
public health people.
They don't have the expertise
that you do around that table.
And believe it or not, when
ACIP makes a recommendation,
it's not a law.
There is shared decision making
that goes on with that patient
and the person providing the
immunization and offering it.
And we need specific guidance.
I mean, I think the shared
decision making is a little bit
of a copout.
>> Dr. Hunter.
>> I'm not against the shared
decision making possibility
for the high risk groups.
But I'm just wondering, if
I understand it correctly,
that the currently, the
initial recommendation
for vaccinating these high
risk groups is a routine
recommendation and is
not individual decision.
Okay, so if we went
with a shared decision
making fore the booster,
then that would be
routine for the initial
and shared decision
for the, okay.
I just want to make sure
I understood it correctly.
>> Yeah. Yes, yes, I was
going to say you're next.
>> I'm actually going to
withdraw my proposal, because,
but I will say this, but I want
clarification on two things.
>> Your proposal or your motion?
>> My motion.
Sorry. But I'm hoping for
clarification on two things.
So number one, in terms
of microbiologists,
and the reason I'm thinking
about this is probably
because if this becomes a
recommendation, then I think
that that might become
a requirement
for healthcare workers in that
setting to receive that vaccine.
And if they opt out, if they opt
out, there might be a, you know,
a potential consequence.
So just thinking about that,
is there really a, is there,
What Dr. Quach said,
is she still here?
Oh, okay. Well, what she
had said about, you know,
have we really changed
the way we practice?
And has the risk changed at all?
And thinking about
that, I'm realizing
that we don't often
know what an isolate is
when it comes in the door.
So it's, like I think
that enhanced protection
actually still makes sense.
Because in the known setting,
it's a different thing.
But I the unknown
where you're working
up an isolate I think
that's different.
So, that takes care
of that question.
And then the other is specific
to the asplenia population.
And then the balance of
prophylaxis and vaccination.
And we would not stop
prophylaxis, you know,
in those patients who
have ongoing asplenia
for multiple reasons, some
of which could be sickle cell
but it could be due to
a variety of reasons.
So, I just want to
make sure that again,
we think about the
ongoing safety of that
and the benefit risk
balance for that population.
No challenges at all
with people who have,
[inaudible] who already are at
extremely high risk for MenB
or meningococcal disease
in general as well
as the other chronic
complement deficiencies
for chronic disease issues.
>> So personal note,
just anecdotally,
that scenario you pointed
out clearly happened at
or hospital very, very
recently where the isolate,
you don't know that you're
working up, you have no idea
that that's going to be
the case, and it turns
out to be major exposure.
Dr. Stephens and
then Dr. Maldonado.
>> Yeah, I do think the SAVAR
[phonetic] study that was done
in 2005 probably
needs to be updated.
I think the point that
we are now looking
at safety issues more
effectively maybe meningococcal
microbiology laboratories
for meninge,
but the point is you
don't know sometimes.
And some other cultures are
still done without the kind
of protection that
you would need.
So it's the unknowns that I
think are the big concerns.
But I do think that
to all of our points
that more data is
probably indicated
to look, again, look at risk.
>> Right, I mean
David's looking at me
because that SAVAR
study was mine.
So, right.
I also think that the
relevant thing here is
that the SAVAR study was done
at the time if you look back
at the epi curve
that Sarah showed
when meninge rates were
higher, and so we were able
to demonstrate an increased
risk, the absolute risk now is
so much lower that it's going
to be much more difficult
to actually identify whether
or not there's still a
substantive risk associated
with laboratory exposures.
But the problem is, of course,
it's an occupational
health hazard,
and I think that it would
be difficult unless there's
concrete data saying
that they're not at risk,
to take it away because
of exactly these kind
of incidents which, I
mean this partly started
when there was an incident at
Emory university that, you know,
was tragic and, you know,
preventable because
there was a vaccine.
>> Dr. Maldonado.
>> I have a question.
I guess I'm a little
confused now.
So, I think when
Dr. Hunter mentioned
that this is a routine
recommendation.
Oh, it is on.
Sorry, that it is a
routine recommendation.
Are you talking about,
anyway, my understanding is
that the meningococcal B vaccine
is a shared decision making
vaccine, not a routine
vaccine, right?
>> You are correct on it.
This is for the high
risk people.
>> Right.
>> So we have a routine
recommendation for persons
who are at increased risk.
These groups that Dr. Mbaeyi
has been talking about.
And that is the only group
which we are considering for --
>> I just want to clarify this,
because we've gotten many,
I've gotten lots of emails from
our members from the academy.
And they're concerned because
they say does this mean we have
to start vaccinating everybody
because we're afraid
they might be?
So I'm just, you know,
we've talked about this.
So I think we just
need to make it clear
that the vaccine itself is
not routinely recommended.
The booster is recommended,
is going to be, you're going
to vote on whether it's
routinely recommended for people
who have already
been vaccinated.
But the, but they're
starting to ask,
does this mean we're
now going to have
to do the primary series too
where that's a shared
decision making responsibility.
>> Dr. Kimberlin.
>> No I'm confused,
and I'm with her.
Put to the next slide, please,
the vote number one slide.
Okay, does that include
college students?
>> Yes.
>> Okay, thank you.
>> So just to clarify,
this is only for people
who are identified at
being at increased risk
for meningococcal disease.
We did include some
language which we would put
in our information, sorry --
>> But your table, I'm
sorry to interrupt,
but your table does
talk about outbreak,
which is college
students and that's why --
>> Can we state the
recommendation language
over lunch?
How about if we, I think the
problem is that your language
that you put up for a vote
proposal is not, is probably,
you simplified it too much.
And so how about over lunch -
>> Separating it.
>> we fix it and then
come back after lunch.
>> That'd be great.
And I assume that since
it says vote number one
that means there's
a vote number two?
>> There's another vote.
>> Will I see that
language before lunch?
>> Yeah. So, if we're
going to, so we may need
to have re-motions done because
you're going to wordsmith
that motion at this time.
So I -
>> Do an amendment.
>> Yeah, I would propose, if
that's okay with you, Amanda,
and with Dr. Mesonye, that we
work on the wording of this.
We come back again and then make
a motion if Dr., if Eche wants
to add his amendment,
we add the amendment.
Then have a second of that
and we'll move forward.
>> Will you ask Dr. Stephens
to withdraw his motion.
>> Yeah.
>> Can I ask the CDC leads
go back and write language
that includes as background
what Dr. Eche asked,
which would clearly be part
of what we would be saying
and show us that as well as the
actual recommendation language.
>> So, I'm going to ask Dr.
Stephens first and then Eche
to withdraw, if you're willing
to withdraw your motion.
And then have it
reconsidered after lunch.
Will you consider
that, Dr. Stephens?
>> Sure.
>> Dr. Eche.
>> Yes.
>> Okay, both motions
have been withdrawn.
We're now going to
take a 45-minute break,
right and be back here at --
>> So just to clarify
for everybody.
We're going to take
a 45-minute break.
We're going to be
back here at 1:30.
We were supposed to have the
public comment period at 1:30,
but the public comment
period will happen
after this session is complete.
>> Okay, so we'll begin
the afternoon session.
I'm going to ask
Sarah to go back up.
Dr. Mbaeyi to go back up.
And we're going to have a motion
on the language for the votes
for the meningococcal vaccines.
So there are, right now
there are two motions?
>> Now, we withdrew
all the motions.
>> Right, no, no, no
but there are going
to be two votes on this.
Okay, so why don't
we have the first --
>> Let's have Sarah just --
>> Sarah, go ahead.
>> Thank you.
So just before we start with
the motions, I just wanted
to quickly remind everyone what
the current recommendations are
for MenB vaccines.
So, ACIP recommends that persons
aged at least ten years who are
at increased risk for serogroup
B disease receive a MenB
primary series.
That's a routine recommendation
for everybody in this group
at increased risk,
which is listed below.
In June 2015, ACIP recommended
that adolescents age 16
to 23 years may be vaccinated
with a MenB primary series based
on individual clinical
decision making.
So for these groups of
adolescents who are not
at an increased risk, this
is a clinical decision
making recommendation.
So now I'm going to go through
the revised language for a vote.
For persons aged
at least ten years
with complement deficiency,
complement inhibitor use,
asplenia or microbiologists,
ACIP recommends a MenB
booster dose one year following
completion of a MenB
primary series followed
by MenB booster doses every
two to three years thereafter
for as long as increased
risk remains.
For persons aged at least
ten years determined
by public health officials to be
at increased risk
during an outbreak,
ACIP recommends a one-time
booster dose if it has been
at least one year
since completion
of a MenB primary series.
A booster dose interval
of at least six months
may be considered
by public health
officials depending
on the specific outbreak,
vaccination strategy
and projected duration
of elevated risk.
And then we've included some
additional guidance based
on the feedback received.
These recommendations
do not apply to persons
who previously completed
a MenB primary series
as an adolescent based
on individual clinical
decision making and who are not
at increased risk for serogroup
B meningococcal disease.
MenB vaccines are
not interchangeable.
The same product must
be used for all doses.
And collection of safety
and effectiveness data
for repeated booster doses
of MenB vaccine in persons
at increased risk for serogroup
meningococcal disease is needed
for the ongoing evaluation
of these recommendations
by the ACIP meningococcal
vaccine's work group.
>> I'm sorry to interrupt,
but would you just take
out work group, because it's
by ACIP, not work group.
>> Okay.
>> All right.
Are there any questions,
comments from the
voting members?
Dr. Szilagyi.
>> Yeah, this is
very clear now to me.
Much, much better.
>> Okay. From the
liaison members,
do they have any comments?
Okay. None being.
I just want to make
sure going around.
I can't see everybody, so I want
to make sure I'm
not missing, yes.
There's a thumbs up.
>> We think that's much clearer.
Thank you very much.
>> Like I said, I can't see
everybody, so I'm just sort
of bobbing and weaving here.
Okay, so, I will need a
motion for this proposed vote.
Dr. Stephens.
>> I make such a motion based
on the language outlined
on the slide.
>> Okay. May I have
a second to this?
>> I will second Dr.
Stephens' motion.
>> Thank you, Dr. Lee.
So rather than other, any
other comments or questions.
All right, rather than read
the whole thing all over again,
you have it in front of you.
>> We're not voting right now.
>> But we're going to move
it to the vote, right.
So it's carried.
We're going to move it
forward for vote, right, okay.
>> Sarah has one
more presentation.
>> We have --
>> No, no, no, no, no.
>> No, no, no, no, no.
>> Just to clarify, there's one
brief additional presentation
on the statement before
we move to public comment.
>> Right.
>> Yeah. Sarah.
>> Okay, so now I'll review
the updated ACIP statement
for meningococcal vaccination
in the United States.
The last statement
was published in 2013
and included ACIP
recommendations
for quadrivalent
meningococcal conjugate
or MenACWY vaccination.
Since this time, five policy
notes related to MenACWY
and recently licensed MenB
vaccines have been published.
In 2019, an updated
statement was developed
to consolidate all existing
ACIP recommendations for MenACWY
and MenB vaccines in
a single document.
In addition, if ACIP votes today
to recommend MenB booster doses
in persons at increased risk,
these recommendations will
be included in the document.
The objectives of the
updated statement are
to describe the background
in meningococcal disease,
epidemiology and risk groups,
provide updated information
on currently licensed
and available vaccines,
describe the process undertaken
and rational used in support
of ACIP recommendations and
provide ACIP recommendations
and guidance for use of
meningococcal vaccines.
We conducted a systematic
review of the literature related
to safety immunogenicity
and effectiveness of MenACWY
and MenB vaccines
in the age groups
in whom the vaccines
are licensed.
We consolidated and
clarified existing MenACWY
and MenB recommendations
and drafted preliminary MenB
booster recommendations.
The draft statement was
shared with work group members
and ACIP voting members
to provide an opportunity
for feedback prior
to today's meeting.
We included information
on the four vaccines
that are currently
licensed and available
in the United States two
MenACWY and two MenB vaccines.
Additionally, two
vaccine products included
in the previous ACIP statement
are no longer available
in the United States.
Polysaccharide meningococcal
vaccine and a combined hib
and meningococcal
serogroup C and Y vaccine.
Thus detailed information
and recommendations related
to these two vaccines
are not included
in the updated statement.
We included all recommendations
for the currently licensed
MenACWY and MenB vaccines,
starting from MenACWY
introduction in 2005
through preliminary MenB booster
dose recommendations in 2019.
Key changes in the updated
statement include a compilation
of all existing MenACWY
and MenB recommendations,
as well as the proposed
new recommendation
for MenB booster doses
in a single document.
The previous category B language
for MenB primary vaccination
in adolescents will be updated
to ACIP recommends a
MenB primary series
for individuals age
16 to 23 years based
on shared clinical
decision making.
In addition, the appendices with
guidance for chemoprophylaxis
of close contacts and management
of outbreaks are no longer part
of the ACIP statement.
Guidance for these aspects
of public health
management are included
in CDC guidance documents.
Thus, today's vote consists
of affirming the
updated statement related
to meningococcal vaccination
in the United States.
>> Are there any comments,
questions from the
voting members?
The liaisons?
All right.
May I have a motion
for this vote?
Dr. Stephens.
>> So I move that ACIP
affirms the updated statement
of meningococcal
vaccination recommendation,
so the advisor committee
on immunization practices.
>> We have a second, Dr. Frey.
>> I second Dr. Stephens'
motion.
>> Any discussion or questions?
Okay, this will be voted
upon this afternoon.
