2019–2020 Recommendations for Flu Prevention and Treatment in Children

By Adem Lewis / in , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , /

>>Good afternoon. I’m commander Ibad Khan and
I’m representing the clinician outreach and communication
activity, COCA, with the emergency risk
communication branch at the Centers for Disease
Control and Prevention. I’d like to welcome you
to today’s COCA call, 2019-2020 Recommendations
for Influenza Prevention and Treatment in Children: An
Update for Pediatric Providers. You may participate in today’s
presentation via webinar or you may download the
slides if you are unable to access the webinar. The PowerPoint slides in the
webinar link can be found in our COCA webpage at emergency.cdc.gov,
forward slash COCA. Again, the web address is
emergency.cdc.gov forward slash COCA. Free continuing education
is offered for this webinar. Instructions on how to earn
continuing education will be provided at the end of the call. In compliance with continuing
education requirements, CDC, our planners, our presenters
and their spouses, partners, wish to disclose they have
no financial interests or other relationships
with the manufacturers of commercial products, suppliers of commercial
services, or commercial supporters. Planners have reviewed content
to ensure there is no bias. Content will not include any
discussion of the unlabeled use of a product or product under
investigational use except for specific unapproved
uses of antivirals and influenza vaccine
recommended by CDC, AAP, and ACOG. CDC did not accept
commercial support for this continuing
education activity. After the speakers
have presented, you will have the
opportunity to ask questions. You may submit questions at any
time through the webinar system by clicking the Q and A button
at the bottom of your screen and then typing your question. For those who have
media questions, please contact CDC Media
Relations at 404 639 3286, or send an email
to [email protected] If you’re a patient,
please refer your questions to your healthcare provider. At the conclusion
of the session, the participants will be able
to accomplish the following: examine data from the 2018
to 2019 US influenza season to inform preparations for the
2019 to 2020 influenza season. Highlight key recommendations in the AAP influenza policy
statement, recommendations for prevention and control
influenza and children 2019 to 2020, and in the
CDC Advisory Committee on Immunization Practices
document prevention and control of seasonal influenza with
vaccines recommendations of the Advisory Committee
on Immunization Practices, United States 2019 to
2020 influenza season. And discuss recommendations for using influenza
antivirals in children. Now, we would like to
welcome our two presenters. Dr Fatimah Dawood and
Dr Flor Munoz. Dr Fatimah Dawood is a
medical epidemiologist in the influenza division at CDC
She completed her medical degree and pediatric residency at
Johns Hopkins University. During her tenure at CDC, Dr
Dawood has worked on analyses and studies in the United
States, Thailand, India, and Central America, focused
on describing the burden of influenza, identifying risk
factors for severe outcomes with influenza virus infection, evaluating influenza vaccine
efficacy and effectiveness, and evaluating the efficacy of
influenza antiviral medications. Dr Flor Muñoz is a pediatric
infectious disease specialist at Texas Children’s
Hospital in Houston, Texas. She is also a member
of the committee and infectious diseases of the
American Academy of Pediatrics as well as a committee on infectious diseases
representative on the influenza working
group of the ACIP. Thank you to both of our
presenters for joining us today. Dr Dawood, please proceed.>>Thanks very much. So for today’s presentation, I’ll be covering
three topic areas. I’ll start with a brief
overview of surveillance data from the last influenza
season, the 2018-19 season. Then review information on
CDC’s recommendations for use of influenza antiviral
medications. And third, provide an
update on the Advisory on Immunization Practices,
influenza recommendations for this coming season. Next slide, please. So, looking back on the
last influenza season, the 2018-19 season. This was a season considered
of moderate severity. When we compare it to
the previous season, the 2017-18 season, influenza-related
hospitalization rates were higher for adults but
similar for children and we saw activity begin
to increase in November and then peak around
mid February. This past season was a
record-breaking season in the sense that influenza
like-illness, or ILI, was actually above
baseline for 21 weeks, making it the longest
season in 10 years. And we saw two ways of influenza
A activity of similar magnitude but very little influenza
B. During the first part of the season, influenza A H1N1,
PDMO9 viruses predominated. And then starting
in mid-February, we saw predominance
of A H3N2 viruses for the remainder of the season. The majority of the circulating
H1 and B, Victorian B lineage, Yamagata B lineage viruses were
similar to the reference viruses that were in last
year’s influenza vaccine, but in contrast we
saw a fair amount of genetic diversity among
the circulating H3 viruses. And the majority of these
viruses were actually antigenically distinct
from the reference virus in last year’s vaccine. Next slide, please. So the next several slides
will show you data from some of CDC’s influenza surveillance
systems to illustrate the topics that I just mentioned
on the previous slide. So, this slide shows data from the CDC Influenza-like
Illness Network, or ILI Net, that collects data from
outpatient clinics. And the lines on the graph
show the past seven seasons, with this most recent season
shown in red with the triangles. On the y-axis we have the
percent of visits that were due to ILI or influenza-like illness and on the x-axis we
have calendar weeks. So for this last season,
ILI was associated with the moderate proportion of
visits reported to this network. The peak is lower than what
we saw in the previous season, the 2017-18 season,
but the number of weeks above baseline is prolonged
compared to other prior seasons. Next slide. This slide illustrates
the types of viruses that we saw circulating
last season. We have two graphs here. The bar graph, the bar
graph show the results of influenza positive tests
that were reported to CDC in the top graph by
US clinical labs, and then in the bottom graph
by public health laboratories. So if we start with
the top graph, most of the clinical
laboratories do not subtype the majority of specimens and
so we have the data broken out by all A viruses
shown in yellow, and then all B viruses
shown in green. And we can see overall
there was a predominance of influenza A viruses with very
little detection of B viruses. And then when we look at the
bottom graph, this shows data from the Public Health
laboratories that do subtype out influenza A viruses and
also conduct a lineage testing for B viruses. And we can see that early in the
season, there was a predominance of A H1N1 viruses with
some H3 detection. And then as the season
progresses, the predominance switches
to A H3N2 predominance. And then lastly,
in the inset of the on the bottom graph we can see a
magnified view of the last weeks of this most recent season. And it illustrates that we have
seen some B Victoria detection over the summer months in
parts of the United States, specifically in some areas in
the southeastern United States. Next slide. So, this graph shows incidences of laboratory-confirmed
influenza associated hospitalizations. These are per 100,000
population. And these data are collected through CDC’s flu serve
net surveillance system. These data are presented
as cumulative rates, so we do expect the lines to
go up as you move from the left to the right of the graph. On the x-axis, again
we have weeks and on the y-axis now we have
rates per 100,000 population. The most recent season is shown,
the 2018-19 season is shown in green and also marked
with the red arrow. And you can see that in
this most recent season, the hospitalization rates
began to a bit earlier than prior seasons and the
overall cumulative rate for the season was 63.9
hospitalizations per 100,000. Next slide. So, this slide summarizes
mortality data in two graphs. On the left side we
have data on pneumonia and influenza mortality. These data are collected
by the National Center for Health Statistics
and they come largely from death certificate data. These are not lab,
necessarily laboratory-confirmed influenza cases. And the graph shows the
percent of all deaths reported that were due to pneumonia
influenza on the y-axis and then epidemiologic
weeks on the x-axis. And we can see the
2015 season onwards. So the most recent season,
again the 2018-19 season, is on the rightmost
part of the graph and we can see there’s
a moderate peak but it’s certainly not
as high as what we saw in the 2017-18 season. Then, if we turn to
the right-hand graph, we can see data here from CDC’s
pediatric influenza mortality surveillance system. Deaths of children
that are associated with the laboratory-confirmed
influenza have been reported to CDC since 2004. And so here these are
laboratory confirmed deaths and for this past
season, there were a total of 135 deaths reported. Next slide. This slide summarizes results
from a severity index that takes into consideration
outpatient visits, hospitalizations, and deaths. And the slide shows the
severity classification for 16 seasons going back
to the 2003-04 season and also includes the
2009-10 pandemic season when the H1N1 PM09
virus first emerged. So this past season
was considered to be a moderate severity
season, both overall and by age for children, adults,
and older adults. Next slide. On this slide, we have
preliminary burden estimates for this past season. For the 2018-19 season,
it was estimated that influenza resulted 37
to 43 million illnesses, 17 to 20 million medical visits, 500,000 to 650,000
flu hospitalizations, and roughly 36,000
to 61,000 deaths. These are preliminary
estimates and will be updated as additional data
become available. Next slide. So this is the last
surveillance slide that I’ll show in
my presentation. It shows a snapshot
of influenza detection in the southern hemisphere
for the past several months, which is their winter season. These bar graphs show results
of influenza-positive tests that are reported to the World
Health Organization flu net system for various regions
in the southern hemisphere. So we can see that detection
varies from region to region in the southern hemisphere. And some regions
saw a predominance of the H1N1 virus shown in the lightest blue color
whereas other regions saw predominance of the
H3N2 virus shown in the medium blue or teal bars. And some regions also saw some
lower level B virus detection. These data are informative
but it’s important to know that we cannot predict
necessarily what is going to happen in the north,
northern hemisphere based solely on these data. As we know, flu is
unpredictable. Next slide. Here are some links
to additional sources of surveillance data as we head
into this upcoming flu season. Typically beginning
in October we start to have more detailed reports as the US influenza activity
may start to pick up. The flu view website is a
particularly good resource to check back with periodically. It has weekly reports
during the flu season and then a component
called flu view interactive, which is an online application
where you can pull down data and look at it both by
different seasons as well as by different age groups. Next slide. So, now I’m going
to turn to a review of current influenza antiviral
treatment recommendations. For the most part, the recommendations this year
are unchanged from last season but I will mention a
newer antiviral drug that was licensed during
the last season a bit later in this talk. First, as a reminder, antiviral
treatment is recommended as early as possible for
any patient with confirmed or suspected influenza
in one of three groups. Those who are hospitalized,
those who have severe, complicated, or progressive
illness, and those who are at high risk for
flu complications. Next slide. So, let’s review who’s
considered at high-risk for influenza complications and for whom antiviral
treatment is recommended. The high-risk groups include
children who are younger than 2 years of age, adults 65
years of age and older, pregnant and postpartum women, children
18 years and younger who are on long-term aspirin
therapy, American Indians and Alaska Natives, people with
underlying medical conditions, and residents of nursing homes
and chronic care facilities. Next slide, please. The current recommendations
make a distinction between those for whom antiviral
treatment is recommended which are the three groups that
we talked about a few slides ago and are also as shown again
at the top of this slide. And then those for whom
antiviral treatment can be considered. Antiviral treatment
can be considered based on clinical judgment for any
previously healthy symptomatic outpatient who is not
part of a high-risk group and who has confirmed or
suspected influenza on the basis of clinical judgment, if the
treatment can be initiated within 48 hours of
illness onset. Next slide. So for this season, there are
four FDA-approved antiviral medications that are recommended
for use in the United States. Three of these are
neuraminidase inhibitors and they include oseltamivir,
zanamivir, and peramivir. And the fourth is a newer
antiviral medication that was licensed last season. This is a cap dependent
endonucleus inhibitor called baloxavir. Next slide. This table summarizes
some of the differences between the four available
antiviral treatments. Oseltamivir and baloxavir are
both oral medications whereas zanamivir is administered
using a disc inhaler device. And peramivir is an
intravenous medication. Oseltamivir can be given
to anyone of any age, and that includes babies. Zanamivir is licensed
for treatment in people ages 7 and up. Another thing to note about
zanamivir it is, as is, since it is an inhaled
medication and has been associated
with bronchospasm and is not recommended
for anyone with underlying airway disease. Peramivir is approved for use
in children 2 years and up and baloxavir in
people 12 years and up. And then two of these drugs are
also approved and recommended for chemo prophylaxis. Those include oseltamivir
for children 3 months and up and then zanamivir for
children five years and up. Next slide. So, this slide gives
a bit more information on the newest antiviral
medication, baloxavir marboxil. As mentioned, this is a cap
dependent endonuclease inhibitor that acts through a new
mechanism of action compared to the neuraminidase
inhibitors, Baloxavir, blocks viral replication. It was approved by the
FDA during October of 2018 for the treatment of acute
uncomplicated influenza in patients who are 12
through 64 years of age. It is given as an
oral single dose and the dosage is
based on weight. So for persons 42 to
less than 80 kilograms, it’s one 40 milligram dose. And then for those 80
kilograms and over, it’s one 80 milligram dose. In clinical trials,
baloxavir was associated with a shorter time to
alleviation of symptoms compared to placebo and then
also associated with significantly more
rapid decline in viral load and shorter durations
of virus detection than oseltamivir or placebo. Similar to what we know about
the neuraminidase inhibitors, the greatest clinical benefit for baloxavir treatment
was seen with, when treatment was initiated
early after illness onset. And lastly, the emergence
of viral escape mutants with reduced susceptibility
has been seen in some clinical trials and
some small family clusters. So this is something
that’s important to continue to monitor. Next slide. So for this last
section of the talk, I’m going to review the
ACIP recommendations for influenza vaccination for the current season
the 2018-20, sorry. The 2019-2020 season. Next slide. For the most part,
the groups recommended for vaccination are
unchanged from last season. Routine annual influenza
vaccination is recommended for all persons 6
months of age and older who do not have a
contraindication to vaccination. While vaccination is recommended
for everyone in this age group, there are some for whom
it’s particularly important to get vaccinated and this
includes people who are 6 months and 8, 6 months of age and
older who are at increased risk of complications or severe
illness from influenza and contacts and caregivers
of children under the age of 5 years, persons 50
years of age and older, and people with medical
conditions that place them at higher risk for
influenza complications. Next slide. Next slide, please. So this slide summarizes the
groups that are considered at increased risk for influenza
complications and severe illness for the purposes of vaccination. And these groups
include children 6 months through 59 months of age as well as adults 50 years
of age and older. People with chronic
medical conditions or immunosuppressive conditions. Women who are or will
be pregnant during the influenza season. Children and adolescents
who are receiving aspirin or salicylate containing
medications that would place them at
risk for Reye’s syndrome after influenza virus infection. Residents of nursing homes and
other long-term care facilities. American Indians
and Alaska Natives. And persons who are
extremely obese with a body mass index
of 40 or greater. Next slide. For this upcoming season,
we do have a few updates to the recommendations. First there is an update
to the strain composition of the 2019-20 vaccine. And second, there are labeling
changes to two of the vaccines. Next slide. First, in terms of
the strain composition for the 2019-20 vaccine,
the trivalent vaccine which has three influenza
viruses represented will contain an A Brisbane-like H1N1 virus
and a Kansas-like H3N2 virus, and a B Colorado-like virus which represents the
Victoria lineage. Both the H1N1 and
H3N2 components of the vaccine are updated this
season compared to last season. Then, for the quadrivalent
viruses which have four influenza
viruses represented, these will contain
the same three viruses as in the trivalent vaccine
plus a B Phuket-like virus representing the
Yamagata lineage. It’s noteworthy that
all vaccines for the pediatric age group
this upcoming season are now quadrivalent. Next slide. The second change we’ll review
pertains to labeling changes for influenza vaccines
for young children 6 through 35 months of age. There are two changes. For Afluria quadrivalent, the
age indication has been expanded from approval for children 5
years and up to now approval for children 6 months and up. The dose volume for younger
children, that’s children 6 through 35 months
of age, is 0.25 mL. And for children 3 years of
age and older, it’s 0.5 mL. The second change pertains
to flu zone quadrivalent. For this upcoming season, the
dose volume for children 6 to 35 months of age has now been
expanded to include two options, either 0.25 mL or 0.5 mL. Previously only 0.25 mL was
approved for this age group. Next slide. This slide gives some brief
background about the use of influenza vaccines in
the youngest age group, children 6 through
35 months of age, as context for the labeling
changes that I mentioned on the previous slide. Historically, children in this
age group were recommended to receive 0.25 mL dose of
inactivated influenza vaccine. That’s half of the 0.5 mL
dose that’s recommended for older children and adults. And this recommendation came
about as a result of studies that had been conducted with whole virus inactivated
influenza vaccines, which showed a higher
rate of febrile reactions after vaccination
in this age group. But since roughly
2000, the 2000-2001, season whole virus inactivated
influenza vaccines have not been used in the United States and
instead have been replaced with split virus and subunit
inactivated influenza vaccines. But the half dose
recommendation did remain, even after whole virus vaccine
was no longer being used. And in the recent influenza
seasons before the 2016-17 season, this youngest age group, the 6 through 35 month age
group, only had flu zone and then later flu
zone quadrivalent that was available
at the 0.25 mL dose. Next slide. As a result of recent
licensure changes, we now have more options
for this age group. There are four inactivated
influenza vaccines licensed for use now in 6
through 35 month olds. One thing that’s important
to be aware of though is that the dose volume differs for these vaccines
in this age group. So for children in this
age group, FluLaval and fluarix
quadrivalent are both licensed at 0.5 ml doses. Afluria quadrivalent is
licensed at 0.25 mL dose. And then as mentioned
previously, Fluzone quadrivalent is
now licensed to be used at either a 0.25 mL dose or 0.5
mL dose with no preference given to either dose volume. Because there’s several
different products available for this age group and the
dose volumes are different, it’s important to be
aware of these differences and administer the
appropriate dose. For children 3 years of age
and older and for older, and for adults, the dose
volume is 0.5 mL for all of the inactivated vaccines. Next slide. So, this is the last
slide in my presentation and includes some additional
CDC resources as we head into the upcoming flu season. This includes some links to
the influenza surveillance and vaccination coverage
data as well as to the ACIP influenza
vaccine recommendations that we reviewed today and
the antiviral treatment recommendations that
we reviewed. Thank you very much and I will
turn things over to Dr. Munoz for the second part
of the presentation.>>Thank you very much. My focus of this
presentation will be to present to you the recommendations for
influenza prevention in children from the American
Academy of Pediatrics. Next slide, please. The American Academy of
Pediatrics’ committee of infectious diseases is
the body that is in charge of reviewing the influenza
data on epidemiology, vaccines, and antivirals and then
providing the recommendations for prevention, diagnosis,
and treatment of influenza and children. As part of the information,
please be aware that in addition to the committee of
infectious diseases members which are voting
members and also liaisons to various different
organizations that deal with children in
the United States, there are various
committees, councils, sections, and even the board of
the AAP who participate in the development of
these recommendations. Next, next slide please. The recommendations are
available in different forms. So one of them is also the red
book and the red book online, and then there are updates
that are made in real time if you need to be
aware of these. Next slide, please. But the main publication that presents these
recommendations is put out in Pediatrics. And this is the actual
policy statement that was released early this
year on September 2nd, 2019, and the publication will be part of the Pediatrics Journal
October issue for your review. Next slide, please. The announcement of the release
of these recommendations came out in AAP News on
September 2nd as I mentioned and there is a link on
this announcement and also through the website for the
AAP to be able to have access to these recommendations
of the policy statement. Next slide, please. This is a summary of
the recommendations and the updates available
for the 2019-2020 season. And what you will see is
that the recommendations of the AAP are aligned the
CDC ACIP recommendations. As you have already heard, the IIV inactivated influenza
vaccine given as a shot and LAIV the live attenuated
influenza vaccine given as a nasal spray
are both recommended for children this season. Vaccines for children
this year are all going to be quadrivalent vaccines. This is the first
time this happens. And also as Dr Dawood
has mentioned, there are new formulations for
inactivated influenza vaccine for children 6 to
35 months of age. The AAP policies statement and recommendations also
provide guidance on dosing for influenza vaccine
in different age groups and mentions the new antiviral
medication for children. Next slide, please. So, in terms of who should be
vaccinated, this is very much in harmonized with ACIP
recommendations where you see that the AAP recommends
that everyone who is at least 6 months of age should
receive their influenza vaccine. The high-risk groups
for potential concerns of serious complications
from influenza are very much in concordance as well. Children less than 5
and people over 65 years of age are considered
at risk and those that have certain medical
conditions, in this case for Pediatrics we do
include neuromuscular disease and any child that also has
problems with swallowing that could result in aspiration
and complications for pneumonia. In addition to that, you
see the typical groups, patients with asthma chronic
lung or heart disease, immune suppression, patients
with metabolic diseases like diabetes and obesity
as well as pregnant women. We do make an emphasis of making
sure that household contacts and caregivers of
these children, especially if they have
high-risk conditions, are also vaccinated and
certainly health care personnel in order to protect
young children. Next slide, please. This is just this visual
summary of these populations at high risk and probably one
comment I should make now is that for the AAP
recommendations, the high-risk groups
for both vaccinations and antiviral treatment
are the same, with children under 5 being considered
at risk, noting that the ACIP
recommendations make an emphasis on those under 2, but this
is pretty concordant in terms of the rest of the
different populations at risk. Next slide, please. In addition to that, other comments regarding
the recommendations for 2019 and 2020 for the AAP is that the
vaccines that are appropriate for age and health status
of children should be used for this universal
influenza immunization and that any vaccine can be used
with no preference for one type or another type of vaccine. Similarly, the most
important change is the fact that this year the AAP
expresses no preferences for inactivated influenza
vaccine over the live influenza vaccine,
and we continue to focus on vaccination occurring before
the onset of influenza activity in the community in order
to ensure protection. This is going to be especially
true for those young children that need two doses
and for those children, we do want to make sure that
vaccination is offered as soon as the vaccine becomes available and that complete vaccination
is ideally achieved by the end of October for every child. We also recognize
that it is difficult to sometimes achieve this goal of vaccinating the
end of October. Therefore, vaccination should
continue to be offered as long and as influenza is
circulating in the community to provide protection. Next slide, please. I would like to focus a
little bit on the change in the recommendation
for IIV and LAIV and give you a little bit about
the background on how this, this decision was made. The AAP news in March
provided the first notice of the AAP change in this
recommendation expressing no preference of IIV over
LAIV for this season and this is the publication
that we put out. Next slide, please. The rationale for this change in recommendation
included a revision of data by the committee of
infectious diseases of the AAP during the
spring meeting of 2019. And this is the data that
was available at the time that was reviewed
by the committee. This included the preliminary
vaccine effectiveness data against medically attended
influenza in the United States, which was preliminary
at the time. We also looked at preliminary
vaccine effectiveness data for the live influenza vaccine
outside of the United States because the live vaccine
was being utilized mostly in other countries. And any other final vaccine
effectiveness that was available for the previous
season, 2017-18, outside of the United
States for the LAIV. Importantly, the
committee also noted that no additional vaccine
effectiveness data would be available until the end of
the 2018-19 influenza season, which as you’ve heard was
a very prolonged season and therefore it was important
to try to provide some guidance to providers regarding
the utilization of the influenza vaccines
for the upcoming season at the time they were going
to be preparing their orders for obtaining influenza
vaccine for their practices. It was also noted by the
committee that it was important to provide harmonization of
recommendations with ACIP which continue to express no
preference between IIV and LAIV for the past season and no plans to make any changing
those recommendations for the upcoming
2019 to 20 season. It’s important to
note as well though that the committee
would continue to review any vaccine
effectiveness data that becomes available and that
recommendations could be revised based on any additional
new information. Next slide, please. I just wanted to show you
with this table a little bit of the historical progression of
the changes in recommendation. So, here you have in the first
column the different years starting with 2013-14
season which is the year where the live quadrivalent
influenza vaccine was introduced in the United States. And those three years from 2013
to 2016, you see that both ACIP and AAP recommended both
vaccines, the inactivated and the live vaccine,
with no preference of one over the other. But during this period of time
is where there was a report, there were reports coming
from CDC surveillance data that the effectiveness
of the live vaccine against the H1N1 virus
was inadequate and lacking for most of these years. Therefore, 2016-17
and 17-18 seasons, LAIV was not recommended by ACIP
or AAP during those two years. 2018-19 is the season we just
finished and as you can see, this is where we had a
little bit of difference in the recommendation where although both vaccines
would be able to be utilized, AAP did express a preference for
the inactivated vaccine given as a shot with the
LAIV given to children who would not otherwise
receive their influenza vaccine. The majority of the vaccine
utilized in the United States in that season was the shot, the
inactivated influenza vaccine. And then again this year you
see again the harmonization and concordance of the
recommendations utilizing both, with no preference and all
vaccines being quadrivalent. The next slide is
going to show you, you can pass the
next slide, please. Just a summary of some of the
data that was available prior to the decision of not using
the live vaccine, showing mostly that the problem was with the A
H1N1 pandemic influenza strain where the LAIV provided no
effectiveness in children in various studies, including
full studies in the US and in a meta-analysis
that, that was done for the different seasons that occurred during
that period of time. It also showed that IIV
was better than the LAIV for all age groups in the
United States and unfortunately, there were no US data
on vaccine effectiveness for the live vaccine since 2015, simply because there
was no circulation of the H1N1 strain during
that period of time. But there was a change in the
formulation of the vaccine so that the H1N1 strain was
changed to an A Slovenia strain to try to address the issue
of the lack of effectiveness of the H1N1 strain
existing in the vaccine. And this updated
formulation of the vaccine of LAIV 4 was utilized
since 2017-18 season in other countries such as
the UK, Finland, and Canada. For H3N2 and for the B strains, the vaccines were relatively
equivalent except maybe for some small groups. For example, the 2 and 4 year
olds where the IIV was better for H3N2 but for B strains in some reports maybe LAIV
had an advantage over IIV, although that was
not significant. The next slide, if you
can please past that one, shows you the US vaccine
effectiveness data for 2018-19 which is the season that just
passed including all vaccine types, noting that most
of the vaccine utilized in the United States was
the inactivated vaccine. And this is preliminary data
but it shows you overall that you can see
against any influenza. So influenza A or B viruses,
for various age groups, the adjusted vaccine
effectiveness which is the column before
last, varies quite significantly and there was really very
low vaccine effectiveness in children for 9 to 17 years of
age with a confidence interval that crossed zero at minus 22 to
27, indicating actually a lack of effectiveness of the
vaccine that we used last year for 9 to 17 year olds. If you see the contrast
with that is the 6 month to 8 year old children,
49% vaccine effectiveness with a positive confidence
interval. So, the vaccine seemed to work
better for the younger children. Next slide, please. When you look at this table
which might be a little busy but let me walk you through it. This is also looking at the United States
adjusted vaccine efficacy for children specifically, and I
have put there for you the year in the first column and
the different strains to break it up by strains. H1N1, H3N2 B and any
influenza at the end for the different age
groups as mentioned, and you see that the overall
data that I mentioned is at the end of the column with
about 49 percent effectiveness for the younger children
6 months to 8 years, and no effectiveness for
the older children 7, 9, 9 to 17 years of age with 6% BE. When you break it
down by strains, you see that we do not
have really much data on B but certainly for H1N1 and
H3N2, the younger children seem to have effectiveness but
not the older children. Interestingly, as you know,
the H3N2 strain had changed over time and we had seen a
lower effectiveness actually for all age groups for H3N2 because the strain was
very different from that, that was circulating, I’m
sorry, was very different from the vaccine strain. And I showed you there the 17-18
and 16-17 data because again, those were the 2 years
where were using mostly IIV and you see that
for the most part, the vaccine was effective
except for 2017-18 for the again older children
9 to 17 where we started to see the decrease
effectiveness against the H3N2 strain. And then lastly,
the 2015-16 season where you have the
breakdown between the IIV where it’s 60% effectiveness
and LAIV 5% effectiveness, actually no effectiveness, if you see the negative
confidence interval>Which was the year, again,
that we saw no effectiveness, especially against H1N1,
leading to the discontinuation of the recommendation to use. Next slide, please. So I just again, to
give you the background, in addition to that data,
the committee looked at any other data that was
published regarding estimates of BE 2018-19. Coming from other countries where again it would be
utilization of both LAIV and IIV and of those, Canada, Hong Kong, and Australia did not report
specific data for LAIV but they had overall a
positive vaccine effectiveness as preliminary data. And then in Europe, the UK
had provided the vaccine effectiveness of LAIV
specifically for children of 87% with a positive confidence
interval against the H1N1 strain. So these were encouraging data. The next slide is
going to just break it down for you a little bit more
with that data of that 87% for H1N1, although the overall
efficacy was interestingly negative already. Nevertheless, in terms of the
decision-making for allowing or not having a preference if
I would say for IIV over LAIV, this year was mostly
based on again the fact that overall the effectiveness
for H1N1 as you can see here for the two years, 17-18, 18-19
provided by other countries, especially UK where they were
utilizing it, had been addressed by the change in
formulation or it looked like it had been addressed
for H1N1 specifically, yet we still had, you know,
really already concerns for both IIV and LAIV
with H3N2 strains. And it was thought that
both vaccines would be performing similarly. Next slide, please. So we can talk a little
bit more about that at the question session,
but I just wanted to share with you a table that lists
the different vaccines that are available for
children in 2019 and 20. And you can see, as
mentioned before, they are all quadrivalent
vaccine. Most of the vaccines
are egg based and you have there the four
products that are available with different formulations
and presentations. And then indication where most of these vaccines are now
recommended and available and indicated for 6
months of age and older. Noting that the 0.25 has
half of the antigen content than the 0.5, which
is 15 micrograms. There’s one cell culture
based vaccine available for children 4 years
of age and older and we have the live attenuated
vaccine which is available and recommended for children
2 years of age and older. Next slide, please. As Dr Dawood mentioned,
over the last year since 2018 there have been
new vaccine formulations that have been licensed and so
these are the ones that we have for children 6 to 35 months
of age, where you have at least three options
of prefilled vac– , prefilled syringes of 0.5 mLs
and then that’s the Fluarix, Flulaval, and Fluzone. And then you have two options,
Afluria and Fluzone of 0.25 mL. Based on clinical studies
that looked at the 0.25 versus 0.5 mL formulations and
demonstrated equivalent efficacy and no increase in
reactogenicity, any of these formulations
can be used at the volumes that are indicated, and the
AAP expresses no preference. The next slide shows you
an updated figure that, that has the number
of vaccine doses that are recommended
for children. And these are broken
up now in two columns. The column to your right is
going to be the children, I’m sorry, yeah, the
children 9 to 17 years of age who we know need only one dose
of influenza vaccine regardless of their previous
vaccination history. And that is at the 0.5 mL. The columns to your left are
showing you the children 6 months through 18 years of age where the recommendations
have not changed. If the children have
received two doses or more of any influenza vaccine
before July 1st 2019, then they only should
get one dose of influenza vaccine this year. But if the answer to
this question is no, then they need two doses of influenza vaccine
given four weeks apart. One clarification that
was added is that we need to administer two doses
based on the age at receipt of the first dose of the influenza vaccine
during the season, so children who receive their
first dose before their 9 birthday and need two doses
should still receive the two doses even if they turn 9 years
old during the same season. The next two slides are going
to show you just briefly, if you can move to
the next slide, please the contraindications. This is coming from the
MMWR document and basically for the inactivated and
the cell-based vaccines, the contraindications are
related to allergic reactions with precautions being
especially Guillain Barre syndrome after vaccine receipt
and also any severe illness with that, with or
without fever. And the next table, next
slide, is just showing you that for LAIV, there are more
contraindications just again because it’s not a vaccine
for children under 2. It’s not a vaccine for
children who are not healthy, so those who might have
asthma or their lung disease or immune suppression or other
chronic diseases should get the inactivated vaccine
and not the LAIV. Same thing for those who
are pregnant or those who are already on treatment. Next slide is going to show
you mostly just a reminder about the egg allergy. This has not changed and
basically based on many data, the recommendation for
not needing to worry about egg allergy because it
does not increase the risk of anaphylactic reaction and
children who have history of egg allergies can received
the influenza vaccines with no special precautions
compared to any other vaccines. Only those that might have
severe allergy could have, you know, administration
in places where they have the
ability to manage those. The next slide is a reminder
regarding the options to improve influenza
vaccination in Pediatrics, making sure that it’s
easily accessible and having the opportunity
for either walk-ins or vaccination clinics, extended
hours, and taking advantage of even discharge
from hospital stays where vaccination is possible. As you can see, standing
orders and making sure that the vaccine is going to
be given to not just a child but parents and other
individuals that are in their contact is important. Next slide. The AAP recommendations also
have a brief comment regarding the diagnosis of influenza and
in this one, you basically need to note that there are
many options and most of the diagnosis is
now made through PCR. And we do need to consider
the influenza activity in the community in
order to be testing. The next slide as part of the
document and is just a reminder of the different types of
influenza diagnostic tests with again molecular-based
assays being a lot more sensitive and more rapid to be
able to give you a diagnosis. The next slide, please, is
a table that reminds you about the presentation,
a clinical presentation of influenza in children where you can have not just a
respiratory symptoms with fever and cough but also
gastrointestinal symptoms which are more prominent
in children than adults. And the next slide shows you
a number of complications that we do worry
about in children, not just influenza
pneumonia in and of itself which is the classic pneumonia
presentation in the context of systemic illness but
secondary bacterial infections that could occur
after influenza, particularly staph
aureus pneumococcus and, and group A strep. We also have exacerbations
of chronic lung disease but encephalopathies,
myositis, myocarditis and sepsis-like syndrome
could be a complication. And certainly if you look
at the next slide please. The children under 5 during
the period of influenza are of course well known to have
increased medical visits in the clinics and the emergency
departments during the season and young children,
especially those under 2, have increased risk
of hospitalization. We also have potentially
increased mortality in this age group due to
these secondary infections and therefore treatment
is recommended. The next slide I am
going to just skip because Dr Dawood
already presented that so this is just a reminder
again that as far as we know, most of the children
who have mortality from influenza unfortunately
are previously healthy so at least 50% based on
recent data, and the majority, almost 80%, had not
been vaccinated. These are young children
of a mean age of 7 years and you can see from infants
to 17 years of age can succumb from influenza, therefore the
importance of vaccinations. The next slide is
just going to point out two important references
regarding the ability of influenza vaccine to
protect against severe influenza with hospitalization as
a surrogate and death. So the first study shows that
vaccinated children had 74 or 82% less likelihood
to be admitted to the intensive care unit
for influenza compared to unvaccinated, but those
who needed two doses needed to have the two doses
to be protected. One single dose for children who need two doses
was not protective. And that in terms of death,
again 65% vaccine effectiveness against mortality in
children 6 months to 17 years, years old in the
second study and I would like to remind everybody to
tell their, their parents, their patients, that we
also have this benefit of influenza vaccination. Even if children do get the
flu, they could have decrease in these complications
and mortality. And then the next slide
please is just the summary. Dr Dawood already presented this
to you but just to point out, this table is also available in the AAP recommendations
regarding the antivirals. And the next slide confirms the
same recommendations harmonized with CDC that are not changed
from the previous year. We need to treat patients
who are hospitalized those with severe influenza
progressive disease or those with high-risk conditions and
consider treatment for those who have influenza based on
clinical decision making. I will then next move to the
next slide please just again to point out that the
high-risk groups are the same for treatment and
for vaccination. And this list is the same
as you have with the CDC. And the conclusions for the
next slide are just a summary that you can have a handy,
again about our recommendations for no preference and that all
vaccines can be utilized based on their stated indication. The new formulations
for the young children, the dosing recommendations and
their high-risk groups that need to be immunized, the importance
to vaccinate by end of October and through the season,
no egg allergy concerns. And the next and final slide and gives you the
neuraminidase inhibitors and endonucleus inhibitor
recommendations and, which are available for
treatment and prophylaxis. And thank you for that. I will finish with that
with my last slide. I appreciate the opportunity
to speak with you today.>>Thank you so much
Dr Dawood and Dr Munoz. We will now go into
our Q&A session. Please remember you may
submit your questions through the webinar system
by clicking the Q & A button at the bottom of your screen
and then typing your question. Our first question is
regarding the recommendation to have healthcare
professionals be vaccinated. The question asks when do you
recommend hospital workers get their flu shots?>>Dr Munoz, would you
like me to take this one?>>Yes, sure.>>Great. This is
Fatima Dawood speaking. The recommendation is that all
people get the influenza vaccine by the end of October,
taking into consideration that we don’t always know when flu activity will
begin and/or peak. So the key message
is get vaccinated by the end of October.>>Thank you. The next question asks
is there a prediction that this year may be unusually
dangerous or prolonged?>>So this is Fatima
Dawood again. I can, I can take that one. So it’s always hard to predict
what flu season is going to look like. I showed some data from
the southern hemisphere, but we really can’t necessarily
predict from what we saw in the southern hemisphere
what we’re going to see this upcoming flu season. So again, the key
message is get vaccinated. It’s the best way to protect
ourselves and our patients from influenza and we’ll
be continuing to monitor through the season,
check back on flu view as the season progresses
to get updates.>>Thank you. Our next question asks
what are recommendations for oseltamivir use
in premature infants?>>I think I can take
that one, if that’s okay. This is Flor Muñoz. So, premature infants
can receive oseltamivir and this is based on their
chronological age post birth. And actually there is a table
with recommendations for dosing that includes term
infants and preterm infants in the AAP policy statement
and also in a separate document that recommends antivirals,
I believe from, from CDC. But basically yes,
you can utilize, you can use oseltamivir
in premature babies. It’s just the dosing might
be a little bit different which is weight adjusting.>>Thank you. Can you please address
if it’s appropriate to administer a flu shot and
an allergy shot on the same day or if there’s a minimal
interval you recommend?>>So let me, let me
try to address that one. I guess allergy shots
would be specific for certain allergic conditions and they would not
necessarily interfere with the vaccination
with influenza. In general, I have not seen
any specific recommendations indicating that you
cannot give them at the same time the inactivated
influenza vaccine should not be affected by allergy shots.>>Thank you. The next question asks if you could please
reiterate the recommendations by the agency and AAP for intranasal live
attenuated influenza vaccine?>>Sure, so this Fatima Dawood. I can start that one and
then Dr Munoz may want to add to what I say. The live attenuated
influenza vaccine or LAIV is recommended
this season is one of several vaccine options. There’s no preference per the
ACIP recommendations for whether to give LAIV or IIV,
inactivated vaccine as long as an individual doesn’t have
a contraindication to LAIV. And just as a reminder to
everyone, LAIV is licensed for persons 2 through
49 years of age. People who should not
receive LAIV per the ACIP recommendations include
children 2 to 4 years of age who have been diagnosed with
asthma had a wheezing episode in the last 12 months, anyone
who’s immunocompromised or close contacts and caregivers
of immunocompromised persons, pregnant women, and anyone who’s
had an antiviral medication in the past 48 hours.>>And I can, this
is Flor Munoz. I would also speak for
the AAP recommendations which are harmonized with
the ACIP recommendations. And for this year, both
IIV and LAIV can be used in children with no preference.>>Thank you. Can you please also comment
or address on the possibility of waning immunity if
the flu season starts? Later I suppose the
inquirer is wondering if you would recommend
revaccination in a high-risk population
in such a scenario.>>I can start and again
Dr Dawood can also comment. But at this time there is no
recommendation for a second dose or revaccination except
for the children less than 8 years of age. So 6 months to 8 years
who are receiving vaccine for the first time or who
are incompletely vaccinated in the previous seasons. So, the question of waning
immunity I know has been discussed over time and
there are, is quite a bit of work being done
in that arena. But the data are not
indicating that it’s necessary to delay the vaccination or to
give a second dose at this time. Especially in children, the
data is very, very scarce.>>This is Fatima Dawood. .I can just add to that, that Dr
Munoz’s uses comments cover the CDC recommendations as well. There is no recommendation to revaccinate even high-risk
populations at the present time. The data on waning
immunity really are mixed and we have a lot more
to learn about that area. But as of now, the
recommendation is as I mentioned earlier get
vaccinated by the end of October to be well covered for
whenever the season does begin.>>Thank you. And our last question
asks how do you counsel or recommend clinicians to
consult families who are worried about the effectiveness
of the influenza vaccine.>>This is Fatima Dawood. I can, I can start with that one
and Dr Munoz may want to add. So I think the key message for
families is that the best way to protect our children,
our families, ourselves from influenza is
through getting vaccinated. And as Dr Munoz showed in her
talk, there is a large body of data now that shows that
the vaccine is effective when the vaccine viruses and circulating viruses
are well-matched. Influenza vaccines can
reduce the risk of getting by about a half and then there
are now also studies that show that flu vaccines can reduce
the risk of getting hospitalized with influenza, requiring
intensive care, and even death. So there’s lots of data to
support that vaccines work and they are our best
protection against the flu.>>And this is Flor Munoz. I would concur 100%
with that statement. It’s important to let parents
know that the flu vaccine, despite its variability
and effectiveness over time which is inherent to the fact that different strains circulate
year-to-year and that the match and the effectiveness of
the vaccine varies by age, health status, and
other factors, that it is the best method
we have to prevent influenza and its complications,
not just influenza. So even if someone does develop
the flu after vaccination, you do have a very good
chance of having protection against most severe influenza
hospitalization and death, especially those at high risk. So please vaccinate.>>Thank you for that. If we were not able to
get to your questions, please send your
questions to [email protected] On behalf of COCA, I would
like to thank everyone for joining us today,
with a special thank you to our presenters Dr Fatima
Dawood and Dr Flor Munoz. The recording of this call and
the transcript will be posted within the next few
days to the COCA website at emergency.cdc.gov/coca. Again, that web address
is emergency.cdc.gov/coca. All continuing education for
COCA calls are issued online through TCE online,
the CDC training and continuing education online
system at www.CDC.gov/tceonline. Those who participated in
today’s COCA call and would like to receive continuing
education should complete the online evaluation by October 29,
2019 and use course code WC2922. Those who will review the
call on demand and would like to receive continuing
education should complete the online evaluation
between October 29 2019 and October 29 2021. And you score, score WD2922. Please join us for our next
COCA call that will be held on Thursday October 24
at 2:00 p.m. Eastern, and the topic will be new
interim guidance related to enhanced barrier
precautions in nursing homes to prevent the spread of
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