Recommendations for Prevention and Control of Influenza in Children, 2021-2022
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TECHNICAL REPORT
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Recommendations for Prevention and
Control of Influenza in Children,
2021–2022
COMMITTEE ON INFECTIOUS DISEASES
This technical report accompanies the recommendations of the abstract
American Academy of Pediatrics for the routine use of the influenza
vaccine and antiviral medications in the prevention and treatment of
influenza in children during the 2021–2022 season. Influenza
vaccination is an important intervention to protect vulnerable
populations and reduce the burden of respiratory illnesses during
circulation of severe acute respiratory syndrome coronavirus 2, which
is expected to continue during this influenza season. In this technical
report, we summarize recent influenza seasons, morbidity and
mortality in children, vaccine effectiveness, vaccination coverage, and
American Academy of Pediatrics, Itasca, Illinois
detailed guidance on storage, administration, and implementation. We
also provide background on inactivated and live attenuated influenza This document is copyrighted and is property of the American
Academy of Pediatrics and its Board of Directors. All authors have
vaccine recommendations, vaccination during pregnancy and filed conflict of interest statements with the American Academy of
breastfeeding, diagnostic testing, and antiviral medications for Pediatrics. Any conflicts have been resolved through a process
approved by the Board of Directors. The American Academy of
treatment and chemoprophylaxis. Pediatrics has neither solicited nor accepted any commercial
involvement in the development of the content of this publication.
Technical reports from the American Academy of Pediatrics benefit
from expertise and resources of liaisons and internal (AAP) and
external reviewers. However, technical reports from the American
INTRODUCTION Academy of Pediatrics may not reflect the views of the liaisons or
This technical report accompanies the recommendations of the the organizations or government agencies that they represent.
American Academy of Pediatrics (AAP) for the routine use of influenza The guidance in this report does not indicate an exclusive course
of treatment or serve as a standard of medical care. Variations,
vaccine and antiviral medications in the prevention and treatment of taking into account individual circumstances, may be appropriate.
influenza in children during the 2021–2022 season.1 All technical reports from the American Academy of Pediatrics
automatically expire 5 years after publication unless reaffirmed,
revised, or retired at or before that time.
DOI: https://doi.org/10.1542/peds.2021-053745
SUMMARY OF RECENT INFLUENZA SEASONS IN THE UNITED STATES
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
2017–2018, 2018–2019, and 2019–2020 Influenza Seasons Copyright © 2021 by the American Academy of Pediatrics
The 2017–2018 influenza season was the first season classified as a
high-severity season for all age groups, with high levels of outpatient
clinic and emergency department visits for influenzalike illness, high To cite: AAP Committee on Infectious Diseases
Recommendations for Prevention and Control of Influenza in
rates of influenza-related hospitalization, and high mortality.2–4 Children, 2021–2022. Pediatrics. 2021;148(4):e2021053745
Influenza A (H3N2) predominated early, followed by a second wave of
PEDIATRICS Volume 148, number 4, October 2021:e2021053745 FROM THE AMERICAN ACADEMY OF PEDIATRICSinfluenza B/Yamagata from March past decade, with elevated levels of A(H3N2) this season, despite
2018 onward. Although influenzalike illness activity for a achieving the highest vaccination
hospitalization rates for children did total duration of 21 consecutive coverage reported in the last decade
not exceed those reported during weeks (compared with an average in children (62.6% overall) (Table 1,
the 2009 pandemic, they did surpass duration of 16 weeks).5 Variations Fig 1).5,6
rates reported in previous high- in circulating strains affected
severity A(H3N2)-predominant vaccine efficacy. Influenza The 2018–2019 season was of
seasons. Excluding the 2009 A(H1N1)pdm09 viruses moderate severity, with similar
pandemic, the 188 pediatric deaths predominated from October to mid- hospitalization rates in children as
reported during the 2017–2018 February, and influenza A(H3N2) during the 2017–2018 season (71
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season (approximately half of which viruses were identified more per 100 000 among children 0–4
occurred in otherwise healthy frequently from February to May. years old and 20.4 per 100 000
children) were the highest reported Influenza B (B/Victoria lineage among children 5–17 years old),
since influenza-associated pediatric predominant) represented which were higher than those
mortality became a nationally approximately 5% of circulating observed in previous seasons from
notifiable condition in 2004.2–4 strains. Most characterized influenza 2013–2014 to 2016–2017.5 Among
Among pediatric deaths of children A(H3N2) viruses were antigenically 1132 children hospitalized with
6 months and older who were distinct from the A(H3N2) influenza and for whom data were
eligible for vaccination and for component of the 2018–2019 available, 55% had at least 1
whom vaccination status was vaccine. The vaccine’s A(H3N2) underlying medical condition; the
known, approximately 80% had not virus belonged to subclade 3C.2a1. most commonly reported underlying
received the influenza vaccine Cocirculation of multiple genetically conditions were asthma or reactive
during the 2017–2018 season.2 diverse subclades of A(H3N2) was airway disease (26%), neurologic
Influenza vaccine effectiveness (VE) documented. Circulating viruses disorders (15.6%), and obesity
for the 2017–2018 season in identified belonged to subclade (11.6%).7 A total of 144 influenza-
children is shown in Table 1.3 3C.2a1 or clade 3C.3a, with 3C.3a associated pediatric deaths were
viruses accounting for >70% of the reported.
The 2018–2019 influenza season A(H3N2) viruses in the United
was the longest-lasting season States. This likely contributed to an The 2019–2020 influenza season
reported in the United States in the overall lower VE against influenza was unusual and complicated by the
TABLE 1 Adjusted VE in Children in the United States, by Season, as Reported by the CDC, US Influenza VE Network
2017–2018 H3N2 and B/Yamagata, 2018–2019 H1N1 and H3N2, 2019–2020 B/Victoria and H1N1,
Influenza Type and Age Group VE% (95% CI) VE% (95% CI) VE% (95% CI)
Influenza A and B
Overall all ages 38 (31 to 43) 29 (21 to 35) 39 (32 to 44)
6 mo to 8 y 68 (55 to 77) 48 (37 to 58) 34 (19 to 46)
9–17 y 32 (16 to 44) 7 (−20 to 28) 40 (22 to 53)
Influenza A(H1N1)pdm09
Overall all ages 62 (50 to 71) 44 (37 to 51) 30 (21 to 39)
6 mo to 8 y 87 (71 to 95) 59 (47 to 69) 23 (−3 to 42)
9–17 y 70 (46 to 67) 24 (−18 to 51) 29 (−7 to 52)
Influenza A(H3N2)
Overall all ages 22 (12 to 31) 9 (−4 to 20) NA
6 mo to 8 y 54 (33 to 69) 24 (1 to 42) NA
9–17 y 18 (−6 to 36) 3 (−30 to 28) NA
Influenza B/Victoria
Overall all ages 76 (45 to 89) Not reported 45 (37 to 52)
6 mo to 8 y Not reported Not reported 39 (20 to 54)
9–17 y Note reported Not reported 43 (23 to 58)
Influenza B/Yamagata
Overall all ages 48 (39 to 55) Not reported NA
6 mo to 8 y 77 (49 to 90) Not reported NA
9–17 y 28 (1 to 48) Not reported NA
VE is estimated as 100% × (1 − odds ratio [ratio of the odds of being vaccinated among outpatients with influenza-positive test results on the CDC’s real-time reverse transcripta-
se–polymerase chain reaction to the odds of being vaccinated among outpatients with influenza-negative test results]); odds ratios were estimated by using logistic regression.
Adjusted for study site, age group, sex, race and/or ethnicity, self-rated general health, number of days from illness onset to enrollment, and month of illness using logistic regres-
sion. NA, not applicable.
2 FROM THE AMERICAN ACADEMY OF PEDIATRICSDownloaded from http://publications.aap.org/pediatrics/article-pdf/148/4/e2021053745/1197842/peds_2021053745.pdf by guest on 20 November 2021
FIGURE 1 Influenza vaccination coverage in children 6 months to 17 years of age in the United States, 2010–2020. Error bars represent 95% CIs around the
estimates. Adapted from Centers for Disease Control and Prevention. Flu vaccination coverage, United States, 2019–20 influenza season. Available
at: https://www.cdc.gov/flu/fluvaxview/coverage-1920estimates.htm#ref10. Accessed July 12, 2021; and National Immunization Survey-Flu (NIS-Flu)
(https://www.cdc.gov/vaccines/imzmanagers/nis/about.html).
emergence of the severe acute 2019–2020 vaccine. During this the highest hospitalization rates in
respiratory syndrome coronavirus 2 season, the predominant A(H3N2) children, 68.2 per 100 000
(SARS-CoV-2) pandemic in early circulating clade was 3C.2a, subclade population overall, were reported
2020. Influenza activity began early 3C.2a1, with cocirculation of a small this season. The first peak of activity
in October 2019, continuing through proportion of 3C.3a, in contrast to occurred in early January, likely
mid-March 2020, with an abrupt the 2018–2019 season, when 3C.3a associated with influenza B
decline after the implementation of strains predominated. Estimates of circulation; the second peak
social distancing measures for the effectiveness of the 2019–2020 occurred in February, when
mitigation of the SARS-CoV-2 seasonal influenza vaccines against influenza A(H1N1)pdm09 became
pandemic. Although influenza medically attended influenza illness predominant; and the third peak in
B/Victoria viruses predominated from the US Flu VE Network are March was associated with
early in the season, influenza shown in Table 1.8 Susceptibility to cocirculation of influenza and SARS-
A(H1N1)pdm09 viruses were the available antiviral agents remained CoV-2. The CDC now has a separate
most predominant circulating strain. greater than 99% for all circulating surveillance report for novel
Influenza A(H3N2) and the B/ strains, but 0.5% of A(H1N1)pdm09 coronavirus disease 2019
Yamagata lineage represented isolates tested by the Centers for (COVID-19)–like illness.10 The
approximately 4.1% and 0.8% of Disease Control and Prevention cumulative influenza hospitalization
circulating strains, respectively. A (CDC) exhibited substantially rates per 100 000 population were
majority of characterized influenza reduced inhibition to oseltamivir 92.3 among children 0 to 4 years
A(H1N1)pdm09 (82.5%) and and peramivir. Reduced old and 23.5 among children 5 to 17
influenza B/Victoria (59.7%) viruses susceptibility to baloxavir has not years old. Hospitalization rates in
were antigenically similar to the been reported in the United States children 0 to 4 years old were
viruses included in the 2019–2020 to date.9 higher than those seen for this age
influenza vaccine. Less than half group during the 2009 influenza
(46.5%) of influenza A(H3N2) The 2019–2020 season was of pandemic, higher than the rate in
viruses were antigenically similar to moderate severity, although 3 peaks adults 50 to 64 years old this season
the A(H3N2) component of the of influenzalike illness activity and (89.4 per 100 000), and the highest
PEDIATRICS Volume 148, number 4, October 2021 3on record for this age group. Among vaccination, and 7 had received 1 COVID-19 mortality observed this
children hospitalized with influenza of 2 ACIP-recommended doses). season was attributable primarily to
and for whom data were available, COVID-19 and not influenza. No
48.6% had no recorded underlying 2020–2021 Influenza Season influenza-associated pediatric deaths
condition and 42.9% had at least 1 The 2020–2021 influenza season were identified from this past
underlying medical condition; the was substantially and unusually season. One influenza-associated
most commonly reported underlying mild, likely because of the pediatric death that occurred in
conditions were asthma or reactive circulation of SARS-CoV-2 and the January 2020 was reported during
airway disease (22.1%), neurologic implementation of pandemic the 2020–2021 season.
disorders (17.5%), and obesity mitigation measures. The circulation
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(12%). of influenza viruses was low, INFLUENZA MORBIDITY AND
without a typical seasonal peak. MORTALITY IN CHILDREN
There were 199 laboratory- From September 2020 to May 22, Influenza viruses are a common
confirmed influenza-associated 2021,TABLE 2 People at High Risk of Influenza Complications Children
children 5 to 17 years of age and be appropriate for a given patient, i. all vaccines: B/Phuket/
43% among children 6 months to 4 and vaccination should not be 3073/2013-like virus (B/
years of age.18 delayed to obtain a specific product. Yamagata/16/88 lineage)
(unchanged).
Historically, up to 80% of influenza- All 2021–2022 seasonal influenza 2. Trivalent vaccines do not include
associated pediatric deaths have vaccines will be quadrivalent and the B/Yamagata component (not
occurred in unvaccinated children 6 contain the same influenza strains available in United States).
months and older. Influenza as recommended by the World
vaccination is associated with Health Organization (WHO) and Inactivated Influenza Vaccine
reduced risk of laboratory- the US Food and Drug For the 2021–2022 season, all
confirmed influenza-related
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Administration’s (FDA’s) Vaccines licensed inactivated influenza
pediatric death.19 In one case-cohort and Related Biological Products vaccines (IIVs) for children and
analysis comparing vaccination Advisory Committee for the adults in the United States are
uptake in laboratory-confirmed Northern Hemisphere.22 Both quadrivalent vaccines, with specific
influenza-associated pediatric deaths influenza A(H1N1) and A(H3N2) age indications for available
to estimated vaccination coverage components are different in this formulations (Table 3). Among
among pediatric cohorts in the season’s vaccine. The B vaccines available for children, 4 are
United States from 2010 to 2014, components are unchanged. The egg based (seed strains grown in
Flannery et al19 found that only influenza A strains may be eggs) and 1 is cell culture based
26% of children had received the different for egg-based versus cell- (seed strains grown in Madin-Darby
vaccine before illness onset, or recombinant-based vaccines on canine kidney cells). All inactivated
compared to an average vaccination the basis of their optimal egg-based vaccines (Afluria
coverage of 48%. Overall VE against characteristics for each platform, Quadrivalent, Fluarix Quadrivalent,
influenza-associated death in but all are matched to the strains Flulaval Quadrivalent, and Fluzone
children was 65% (95% CI, 54% to expected to circulate in the Quadrivalent) are licensed for
74%). More than half of children in 2021–2022 season. children 6 months and older and are
this study who died of influenza had available in single-dose, thimerosal-
$1 underlying medical condition 1. Quadrivalent vaccines contain the free, prefilled syringes. The only
associated with increased risk of following: pediatric cell culture–based vaccine
severe influenza-related a. influenza A(H1N1) component: (Flucelvax Quadrivalent) is now
complications; only 1 in 3 of these i. egg-based vaccines: A/ licensed for children 2 years and
at-risk children had been Victoria/2570/2019 older.23 The extension of the age
vaccinated; yet VE against death in (H1N1) pdm09-like virus indication down from 4 years to 2
children with underlying conditions (new this season); and years of age in March 2021 was
was 51% (95% CI, 31% to 67%). ii. cell- or recombinant-based based on data from a randomized
Similarly, influenza vaccination vaccines: A/Wisconsin/ double-blind clinical efficacy study
reduces by three-quarters the risk of 588/2019 (H1N1) pdm09- conducted among children 2 to 18
severe life-threatening laboratory- like virus (new this years of age over 3 seasons (2017 in
confirmed influenza in children season); the Southern Hemisphere and
requiring admission to the ICU.20 b. influenza A(H3N2) component: 2017–2018 and 2018–2019 in the
The influenza virus type might also i. egg-based vaccines: A/ Northern Hemisphere), in which
affect the severity of disease. In a Cambodia/e0826360/2020 Flucelvax Quadrivalent
study of hospitalizations for (H3N2)-like virus (new this demonstrated efficacy against
influenza A versus B, the odds of season); and laboratory-confirmed influenza
mortality were significantly greater ii. cell- or recombinant-based illness of 54.6% (95% CI, 45.7% to
with influenza B than with influenza vaccines: A/Cambodia/ 62.1%), compared with a control
A and were not entirely explained e0826360/2020 (H3N2)- vaccine (meningococcal serogroup
by underlying health conditions.21 like virus (new this season); ACWY conjugate vaccine).24
c. B/Victoria component:
SEASONAL INFLUENZA VACCINES i. all vaccines: B/Washington/ A quadrivalent recombinant
The seasonal influenza vaccines 02/2019-like virus (B/ baculovirus-expressed
licensed for children and adults for Victoria/2/87 lineage) hemagglutinin influenza vaccine
the 2021–2022 season are shown in (unchanged); and (quadrivalent recombinant influenza
Table 3. More than one product may d. B/Yamagata component: vaccine [RIV4]) (Flublok
6 FROM THE AMERICAN ACADEMY OF PEDIATRICSTABLE 3 Recommended Seasonal Influenza Vaccines for Different Age Groups: United States, 2021–2022 Influenza Season
Presentation and Hemagglutinin Antigen Thimerosal Mercury
Content (IIVs and RIV4) or Virus Count Content,
Vaccine Trade Name (Manufacturer) Age Group (LAIV4) per Dose for Each Antigen μg Hg/0.5-mL Dose CPT Code
Quadrivalent standard dose: egg-
based vaccines
IIV4 Afluria Quadrivalent (Seqirus) 6–35 mo 0.25-mL prefilled syringe (7.5 μg/0.25 mL) 0 90685
— ≥36 mo 0.5-mL prefilled syringe (15 μg/0.5 mL) 0 90686
— ≥6 mo 5.0-mL multidose viala (15 μg/0.5 mL) 24.5 90687
IIV4 Fluarix Quadrivalent ≥6 mo 0.5-mL prefilled syringe (15 μg/0.5 mL) 0 90686
(GlaxoSmithKline)
IIV4 FluLaval Quadrivalent ≥6 mo 0.5-mL prefilled syringe (15 μg/0.5 mL) 0 90686
(GlaxoSmithKline)
IIV4 Fluzone Quadrivalent (Sanofi ≥6 mo 0.5-mL prefilled syringe (15 μg/0.5 mL) 0 90686
Pasteur) (0.25 mL no longer available)
PEDIATRICS Volume 148, number 4, October 2021
— ≥6 mo 0.5-mL single-dose vial (15 μg/0.5 mL) 0 90686
— ≥6 mo 5.0-mL multidose viala (15 μg/0.5 mL) 25 90687
Quadrivalent standard dose: cell
culture–based vaccines
ccIIV4 Flucelvax Quadrivalent (Seqirus) ≥2 y 0.5-mL prefilled syringe (15 μg/0.5 mL) 0 90674
— ≥2 y 5.0 mL multidose viala (15 μg/0.5 mL) 25 90756
Quadrivalent standard dose: egg-
based with adjuvant vaccines
aIIV4 MF-59 adjuvanted Fluad Quadrivalent (Seqirus) ≥65 y 0.5-mL prefilled syringe (15 μg/0.5 mL) 0 90653
Quadrivalent high dose: egg-
based vaccine
IIV4 Fluzone High-Dose Quadrivalent ≥65 y 0.7-mL prefilled syringe (60 μg/0.7 mL) 0 90662
(Sanofi Pasteur)
Recombinant vaccine
RIV4 Flublok Quadrivalent (Sanofi ≥18 y 0.5-mL prefilled syringe (45 μg/0.5 mL) 0 90682
Pasteur)
Live attenuated vaccine
LAIV4 FluMist Quadrivalent 2–49 y 0.2-mL prefilled intranasal sprayer (virus 0 90672
(AstraZeneca) dose: 10 6.5–7.5 FFU/0.2 mL)
Adapted from Grohskopf LA, Alyanak E, Ferdinands JM, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices—United States, 2021–22 influenza season.
MMWR Recomm Rep. 2021;70(5):1–28. The implementation guidance on supply, pricing, payment, CPT coding, and liability issues can be found at www.aapredbook.org/implementation. aIIV4, quadrivalent adjuvanted inactivated influenza
vaccine; ccIIV4, quadrivalent cell culture–based inactivated influenza vaccine; CPT, Current Procedural Terminology; FFU, fluorescent focus unit; —, not applicable.
a
For vaccines that include a multidose vial presentation, a maximum of 10 doses can be drawn from a multidose vial.
7
Downloaded from http://publications.aap.org/pediatrics/article-pdf/148/4/e2021053745/1197842/peds_2021053745.pdf by guest on 20 November 2021Quadrivalent) is licensed only for Only the 0.5-mL Fluzone prefilled appetite, fatigue, muscle aches,
people 18 years and older. A high- syringe will be available this season. headache, arthralgia, and
dose quadrivalent inactivated In addition, 2 other vaccines, Fluarix gastrointestinal tract symptoms.
influenza vaccine (IIV4) (Fluzone Quadrivalent29 and FluLaval
High-Dose Quadrivalent) containing Quadrivalent,30 are licensed at a 0.5- IIVs can be administered
4 times the amount of antigen for mL dose in children 6 to 35 months concomitantly with other inactivated
each virus strain compared with the of age. These 2 vaccines do not have or live vaccines.32–36 The influenza
standard-dose vaccines is licensed a 0.25-mL dose formulation. Afluria vaccine may be administered
only for people 65 years and older. Quadrivalent is the only pediatric simultaneously or at any time before
The quadrivalent MF-59 adjuvanted vaccine that has a 0.25-mL or after administration of the
currently available COVID-19
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inactivated vaccine (Fluad presentation for children 6 to 35
Quadrivalent) was licensed for months of age. Afluria 0.5 mL is vaccines.37 In general, although data
people 65 years and older in licensed for children 3 years and are not available for concomitant
February 2020.23 Adjuvants may be older only.31 administration of COVID-19 with
included in a vaccine to elicit a more other vaccines in children, extensive
robust immune response, which Given that different formulations of experience with non-COVID-19
IIV for children 6 to 35 months of vaccines has demonstrated that
could lead to a reduction in the
age are available, care should be immunogenicity and adverse event
number of doses required for
taken to administer the profiles are generally similar when
children. In one pediatric study, the
appropriate volume and dose for vaccines are administered
relative vaccine efficacy of an MF-59
each product. In each instance, the simultaneously as when they are
adjuvanted influenza vaccine was
recommended volume may be administered alone. Furthermore,
significantly greater than that of a
administered from an appropriate concomitant administration with the
nonadjuvanted vaccine in the 6- to
prefilled syringe, a single-dose vial, influenza vaccine is being evaluated
23-month age group.25 Adjuvanted
or a multidose vial, as supplied by in adults (unpublished observations
seasonal influenza vaccines are not
the manufacturer. For vaccines presented at ACIP Influenza
licensed for children in the United
that include a multidose vial Workgroup meeting, February 2,
States.
presentation, a maximum of 10 2021), and data in children are
doses can be drawn from a anticipated to inform
Children 36 months (3 years) and
multidose vial. Importantly, dose recommendations. Given that it is
older can receive any age-
volume is different from the unknown whether reactogenicity of
appropriate licensed IIV,
number of doses needed to COVID-19 vaccines will be increased
administered at a 0.5-mL dose
complete vaccination. Children 6 with coadministration of the
containing 15 lg of hemagglutinin
months to 8 years of age who influenza vaccine, the reactogenicity
(HA) from each strain. Children 6 to
require 2 doses of the vaccine for profile of the vaccines should be
35 months of age may receive any
the 2021–2022 season should considered, and providers should
age-appropriate licensed IIV without
receive 2 separate doses at the consult the most current ACIP and
preference for one product over
recommended dose volume AAP guidance regarding
another. Several vaccines have been
specified for each product. coadministration of COVID-19
licensed for children 6 to 35 months vaccines with influenza vaccines.38
of age since 2017 (Table 3). All are IIVs are well tolerated in Overall, the benefits of timely
quadrivalent, but the dose volume, children and can be used in vaccination with same-day
and therefore the antigen content, healthy children as well as those administration of IIV and other
may vary among different IIV with underlying chronic medical recommended vaccines outweigh
products. In addition to a 0.25-mL conditions. CDC best practice the risk of potential reactogenicity
(7.5 lg of HA per vaccine virus) guidelines should be followed for in children.
Fluzone Quadrivalent vaccine, a 0.5- administration (https://www.cdc.
mL formulation of Fluzone gov/vaccines/hcp/acip-recs/ Thimerosal-containing vaccines are
Quadrivalent containing 15 lg of HA general-recs/). The most common not associated with an increased
per vaccine virus per dose was injection site adverse reactions risk of autism spectrum disorder in
licensed in January 2019 after these after administration of IIV in chil- children. Thimerosal from vaccines
2 formulations were shown to have dren are injection site pain, red- has not been linked to any
comparable safety and ness, and swelling. The most neurologic condition. The AAP
immunogenicity in a single common systemic adverse events supports the current WHO
randomized multicenter study.26–28 are drowsiness, irritability, loss of recommendations for use of
8 FROM THE AMERICAN ACADEMY OF PEDIATRICSthimerosal as a preservative in children during the 2016–2017 and reviewed available data on influenza
multiuse vials in the global vaccine 2017–2018 seasons, given concerns epidemiology and VE for the
supply.39 Despite the lack of about its effectiveness against 2018–2019 season and agreed that
evidence of harm, some states have A(H1N1)pdm09. For the 2017–2018 harmonizing recommendations
legislation restricting the use of season, a new A(H1N1)pdm09-like between the AAP and CDC for the
vaccines that contain even trace virus strain (A/Slovenia/2903/ use of LAIVs in the 2019–2020
amounts of thimerosal. The benefits 2015) was included in the LAIV4, season was appropriate. After the
of protecting children against the replacing the previous A/Bolivia/ February 2020 ACIP meeting, the
known risks of influenza are clear. 559/2013 strain. A study conducted AAP Committee on Infectious
Therefore, to the extent permitted by the LAIV4 manufacturer Diseases reviewed available
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by state law, children should receive evaluated viral shedding and epidemiological and effectiveness
any available formulation of IIVs immunogenicity associated with the data for the previous and current
rather than delaying vaccination LAIV4 formulation containing the seasons to inform recommendations
while waiting for reduced new A(H1N1) pdm09-like virus for the 2020–2021 season. Despite
thimerosal-content or thimerosal- among US children 24 to 48 months the early circulation of
free vaccines. IIV formulations that of age.41 Shedding and A(H1N1)pdm09 during the
are free of even trace amounts of immunogenicity data suggested that 2018–2019 season and its
thimerosal are widely available the new influenza A(H1N1)pdm09- predominance during the
(Table 3). like virus included in its latest 2019–2020 season, low use of the
formulation had improved LAIV4 in the US population has
Live Attenuated (Intranasal) replicative fitness over previous limited the evaluation of product-
Influenza Vaccine LAIV4 influenza A(H1N1)pdm09-like specific VE, and no additional US
The intranasal live attenuated virus strains, resulting in an data on VE for the LAIV4 are
influenza vaccine (LAIV) was initially improved immune response available. Although the proportion of
licensed in the United States in 2003 comparable to that of the LAIV3 the LAIV used for vaccination is
for people 5 to 49 years of age as a available before the 2009 pandemic. unknown, interim overall VE (not
trivalent formulation (trivalent live Shedding and replicative fitness are specific to a type of vaccine) for the
attenuated influenza vaccine [LAIV3]), not known to correlate with efficacy, 2019–2020 influenza season showed
and the approved age group was and no published effectiveness reassuring protection in children
extended to 2 years of age in 2007. estimates for this revised against circulating influenza A and B
The quadrivalent formulation formulation of the vaccine against strains (Table 1).42 Furthermore,
(quadrivalent live attenuated influenza A(H1N1)pdm09 viruses influenza vaccine coverage rates in
influenza vaccine [LAIV4]), licensed in were available before the start of children were stable until the
2012, was first available during the the 2018–2019 influenza season COVID-19 pandemic.6 In European
2013–2014 influenza season, because influenza A(H3N2) and surveillance networks where
replacing the LAIV3. influenza B viruses predominated uninterrupted use of the LAIV has
during the 2017–2018 Northern continued from the 2016–2017 to
The CDC conducted a systematic Hemisphere season. Therefore, for the 2019–2020 seasons, the United
review of published studies the 2018–2019 influenza season, the Kingdom was the only country to
evaluating the effectiveness of the AAP recommended the IIV4 or report final VE against medically
LAIV3 and LAIV4 in children from trivalent inactivated influenza attended influenza for the
the 2010–2011 to the 2016–2017 vaccine as the primary choice for 2018–2019 season. In children 2 to
influenza seasons, including data influenza vaccination in children, 17 years of age, the reported VE
from US and European studies.40 with LAIV4 use reserved for was 49.9% (95% CI, 14.3% to
The data suggested that the children who would not otherwise 78.0%) for A(H1N1)pdm09 and
effectiveness of the LAIV3 or LAIV4 receive an influenza vaccine and for 27.1% (95% CI, 130.5% to 77%)
for the influenza A(H1N1)pdm09 whom LAIV use was appropriate for for A(H3N2).43 The final adjusted VE
strain was lower than that of the IIV age (2 years and older) and health in the United States (where mostly
in children 2 to 17 years of age. The status (ie, healthy, without any the IIV was used) for 2018–2019
LAIV was similarly effective against underlying chronic medical against A(H1N1)pdm09 was 59%
influenza B and A/H3N2 strains in condition). (95% CI, 47% to 69%) for children
some age groups compared with the 6 months to 8 years of age but only
IIV. The LAIV was not recommended In February 2019, the AAP 24% (95% CI, 18% to 51%) for
by the CDC or AAP for use in Committee on Infectious Diseases children 9 to 17 years of age. The
PEDIATRICS Volume 148, number 4, October 2021 9reported US VE was 24% (95% CI, vaccines is separated by a 4-week determine if future receipt of the
1% to 42%) in children 6 months to interval from LAIV4 vaccination. vaccine is appropriate.
8 years of age and 3% (95%
CI, 30% to 28%) in children 9 to LAIV and Immunocompromised Minor illnesses, with or without
17 years of age for A(H3N2).44 Hosts fever, are not contraindications to
Direct comparisons cannot be made The IIV is the vaccine of choice for the use of influenza vaccines,
given differences in reporting of VE anyone in close contact with a including among children with mild
for various age groups. Other subset of severely upper respiratory infection
countries that use the LAIV (Canada, immunocompromised people (ie, symptoms or allergic rhinitis. In
Finland) have not reported LAIV4- those requiring a protected children with a moderate to severe
febrile illness (eg, high fever, active
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specific VE in the past several environment). The IIV is preferred
seasons. Small case numbers and over the LAIV for contacts of infection, requiring hospitalization),
low LAIV use may also limit severely immunocompromised on the basis of the judgment of the
accurate VE calculations in these people because of a theoretical risk clinician, vaccination should be
countries. In general, as long as use of infection attributable to LAIV deferred until resolution of the
of the LAIV is low relative to the IIV, illness. Children with confirmed
strains in an immunocompromised
it will be difficult to estimate LAIV COVID-19 can receive the influenza
contact of an LAIV-immunized
VE accurately. Furthermore, vaccine when the acute illness has
person. Available data indicate a low
important variability in VE against resolved and/or illness is mild.
risk of transmission of the virus
all strains is reported for both the Children with an amount of nasal
from both children and adults
IIV and LAIV. congestion that would notably
vaccinated with the LAIV. Health
impede vaccine delivery into the
Influenza VE varies from season to care personnel (HCP) immunized nasopharyngeal mucosa should have
season and is affected by many with the LAIV may continue to work the LAIV deferred until resolution or
factors, including age and health in most units of a hospital, including may receive the IIV.
status of the recipient, influenza the NICU and general oncology
type and subtype, existing immunity ward, using standard infection- A precaution for vaccination is a
from previous infection or control techniques. As a condition in a recipient that might
vaccination, and degree of antigenic precautionary measure, people increase the risk or seriousness of a
match between vaccine and recently vaccinated with the LAIV possible vaccine-related adverse
circulating virus strains. It is should restrict contact with severely reaction. A precaution also may exist
possible that VE also differs among immunocompromised patients for 7 for conditions that might
individual vaccine products; days after immunization, although compromise the ability of the host
however, product-specific there have been no reports of LAIV to develop immunity after
comparative effectiveness data are transmission from a vaccinated vaccination. Vaccination may be
lacking for most vaccines. Additional person to an immunocompromised recommended in the presence of a
experience over multiple influenza person. In the theoretical scenario in precaution if the benefit of
seasons will help to determine which symptomatic LAIV infection protection from the vaccine
optimal use of the available vaccine develops in an outweighs the potential risks.
formulations in children. The AAP immunocompromised host, LAIV
will continue to monitor annual A history of Guillain-Barre syndrome
strains are susceptible to antiviral
influenza surveillance and VE (GBS) after influenza vaccination is
medications.
reports to update influenza vaccine considered a precaution for the
recommendations if necessary. administration of influenza vaccines.
INFLUENZA VACCINE GBS is rare, especially in children,
CONTRAINDICATIONS AND and there is a lack of evidence on
The most commonly reported
PRECAUTIONS
reactions of the LAIV4 in children risk of GBS after influenza
are runny nose or nasal congestion, Anaphylactic and severe allergic vaccination in children. Nonetheless,
headache, decreased activity or reactions to any influenza vaccine regardless of age, a history of GBS
lethargy, and sore throat. The LAIV4 are contraindications to vaccination.outweigh the risks for certain close contacts and caregivers of immunization. It is not necessary to
people who have a history of GBS those who are severely immuno- inquire about an egg allergy before
(particularly if not associated with compromised and require a pro- the administration of any influenza
previous influenza vaccination) and tected environment; vaccine, including on screening
who also are at high risk for severe children and adolescents receiv- forms. Routine prevaccination
complications from influenza. ing aspirin or salicylate-contain- questions regarding anaphylaxis
ing medications; after receipt of any vaccine are
Specific precautions for the LAIV children who have received other appropriate. Standard vaccination
include a diagnosis of asthma in live-virus vaccines within the pre- practice for all vaccines in children
children 5 years and older and the vious 4 weeks (except for the rota- should include the ability to respond
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presence of certain chronic virus vaccine); however, the LAIV to rare acute hypersensitivity
underlying medical conditions, can be administered on the same
reactions. Children who have had a
including metabolic disease, day with other live-virus vaccines
previous allergic reaction to the
diabetes mellitus, other chronic if necessary;
influenza vaccine should be
disorders of the pulmonary or children taking an influenza anti-
evaluated by an allergist to
cardiovascular systems, renal viral medication until 48 hours
determine if future receipt of the
dysfunction, or hemoglobinopathies. (oseltamivir, zanamivir), 5 days
vaccine is appropriate.
Because the safety of the LAIV has (peramivir), or 2 weeks (baloxa-
not been definitively established in vir) after stopping the influenza
these situations, the IIV should be antiviral therapy; if a child INFLUENZA VACCINES DURING
considered, and vaccination should recently received the LAIV but PREGNANCY AND BREASTFEEDING
not be delayed in these high-risk has an influenza illness for which The influenza vaccine is
groups. People who should not antiviral agents are appropriate, recommended by the ACIP, the
receive the LAIV are listed below. the antiviral agents should be
American College of Obstetrics and
given; if antiviral agents are nec-
Gynecology, and the American
People in whom the LAIV is essary for treatment within 2
Academy of Family Physicians for all
contraindicated include the weeks of LAIV immunization,
women during any trimester of
following: reimmunization or administra-
gestation for the protection of
tion of IIV is indicated because of
mothers against influenza and its
children younger than 2 years; the potential effects of antiviral
complications.23,47 Substantial
children 2 to 4 years of age with medications on LAIV replication
and immunogenicity; and evidence has accumulated regarding
a diagnosis of asthma or a his-
pregnant women. the efficacy of maternal influenza
tory of recurrent wheezing or a
immunization in preventing
medically attended wheezing epi-
laboratory-confirmed influenza
sode in the previous 12 months INFLUENZA VACCINES AND EGG
because of the potential for ALLERGY disease and its complications in
increased wheezing after immu- both mothers and their infants in
There is strong evidence that
nization; in this age range, many the first 2 to 6 months of life.47–52
individuals with egg allergies can
children have a history of wheez- Pregnant women who are
safely receive the influenza vaccine
ing with respiratory tract ill- immunized against influenza at any
without any additional precautions
nesses and are eventually time during their pregnancy provide
beyond those recommended for any
diagnosed with asthma; vaccine.45,46 The presence of an egg protection to their infants during
children with cochlear implants allergy in an individual is not a their first 6 months of life, when
or active cerebrospinal fluid contraindication to receive the IIV they are too young to receive the
leaks; or LAIV. Vaccine recipients with egg influenza vaccine themselves,
children who have a known or allergies are at no greater risk for a through transplacental passage of
suspected primary or acquired systemic allergic reaction than those antibodies.49–57 Infants born to
immunodeficiency or who are without egg allergies. Therefore, women who receive influenza
receiving immunosuppressive precautions, such as choice of a vaccination during pregnancy have
or immunomodulatory particular vaccine, special been shown to have a risk reduction
therapies; observation periods, or restriction of of up to 72% (95% CI, 39% to 87%)
children with anatomic or func- administration to particular medical for laboratory-confirmed influenza
tional asplenia, including from settings, are not warranted and hospitalization in the first few
sickle cell disease; constitute an unnecessary barrier to months of life.55
PEDIATRICS Volume 148, number 4, October 2021 11It is safe to administer the IIV to association between receipt of the maternal-or-infant-illnesses/
pregnant women during any IIV containing H1N1pdm09 and risk influenza.html and at https://www.
trimester of gestation and post of spontaneous abortion when an cdc.gov/flu/professionals/
partum. Any licensed, recommended, H1N1pdm09-containing vaccine had infectioncontrol/peri-post-settings.
and age-appropriate influenza also been received the previous htm. Breastfeeding should be
vaccine may be used, although season.64 A follow-up study encouraged even if the mother or
experience with the use of the RIV4 conducted by the same investigators infant has influenza illness. The
in pregnant women is limited. The with a larger population and mother should pump and feed
LAIV is contraindicated during stricter outcome measures did not expressed milk if she or her infant is
pregnancy. Data on the safety of show this association and further too sick to breastfeed. If the breast-
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influenza vaccination at any time supported the safety of the feeding mother requires antiviral
during pregnancy continues to influenza vaccine during agents, treatment with oral oselta-
support the safety of influenza pregnancy.65 mivir is preferred. The CDC does not
immunization during recommend use of baloxavir for
pregnancy.47,49–54,58 In a 5-year Women in the postpartum period treatment of pregnant women or
retrospective cohort study from who did not receive influenza breastfeeding mothers. There are no
2003 to 2008 with more than vaccination during pregnancy should available efficacy or safety data in
10 000 women, influenza be encouraged to discuss receiving pregnant women, and there are no
vaccination in the first trimester the influenza vaccine before available data on the presence of
discharge from the hospital with baloxavir in human milk, the effects
was not associated with an increase
their obstetrician, family physician, on the breastfed infant, or the
in the rates of major congenital
nurse midwife, or other trusted
malformations.59 Similarly, a effects on milk production.
provider. Women who traditionally
systematic review and meta-analysis
experience barriers to preventive
of studies of congenital anomalies VACCINE STORAGE AND
care (eg, women who do not qualify
after vaccination during pregnancy, ADMINISTRATION
for Medicaid) should be offered
including data from 15 studies (14 The AAP storage and handling tip
vaccination before hospital
cohort studies and 1 case-control sheet provides resources for
discharge or offered information in
study), did not show any association practices to develop comprehensive
their preferred language about free
between congenital defects and vaccine management protocols to
vaccine clinics. Vaccination during
influenza vaccination in any keep the temperature for vaccine
breastfeeding is safe for mothers
trimester, including the first storage constant during a power
and their infants.
trimester of gestation.60 failure or other disaster.67 The AAP
Assessments of any association with Breastfeeding is strongly recommends the development of a
influenza vaccination and preterm recommended to protect infants written disaster plan for all practice
birth and infants small for against influenza viruses by settings. During the COVID-19
gestational age have yielded activating innate antiviral pandemic, the AAP recommends
inconsistent results, with most mechanisms, specifically type 1 that influenza vaccine
studies reporting a protective effect interferons. Human milk from administration follow CDC guidance
or no association against these mothers vaccinated during the third for administration of immunizations
outcomes.61,62 The authors of a trimester also contains higher levels (https://www.cdc.gov/vaccines/
cohort study from the Vaccines and of influenza-specific immunoglobulin pandemic-guidance/index.html).
Medications in Pregnancy A.66 Greater exclusivity of Vaccination in the medical home is
Surveillance System of vaccine breastfeeding in the first 6 months ideal to ensure that pediatric
exposure during the 2010–2011 to of life decreases the episodes of patients receive other vaccinations
2013–2014 influenza seasons found respiratory illness with fever in and routine care in a timely man-
no significant association of infants of vaccinated mothers. For ner and receive catch-up immuni-
spontaneous abortion with influenza infants born to mothers with zations if delays have occurred
vaccine exposure in the first confirmed influenza illness at because of the pandemic. In gen-
trimester or within the first 20 delivery, breastfeeding is eral, infection-prevention measures
weeks’ gestation.63 One encouraged, and guidance on should be in place for all patient
observational Vaccine Safety breastfeeding practices can be found encounters, including screening for
Datalink study conducted during the at https://www.cdc.gov/ symptoms, physical distancing,
2010–2011 and 2011–2012 breastfeeding/breastfeeding- respiratory and hand hygiene, and
influenza seasons indicated an special-circumstances/ surface decontamination. In
12 FROM THE AMERICAN ACADEMY OF PEDIATRICSaddition to standard precautions LAIV onset of the influenza season.
and hand hygiene, during the The cold-adapted, temperature- Children who require only 1 dose of
COVID-19 pandemic, it is recom- sensitive LAIV4 formulation is the influenza vaccine should also
mended that vaccine administra- shipped and stored at 2 C to 8 C ideally be vaccinated by the end of
tors wear a surgical face mask (not (35 F–46 F) and administered October. Recent data in adults
N95 or respirator) at all times and intranasally in a prefilled single-use suggest that early vaccination (July
eye protection if the level of com- sprayer containing 0.2 mL of the or August) might be associated with
munity spread is moderate or ele- vaccine. A removable dose-divider suboptimal immunity before the end
vated.68 Administration of the LAIV clip is attached to the sprayer to of the influenza season, and the CDC
intranasally is not an aerosol-gen- facilitate administration of 0.1 mL now discourages vaccination in the
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erating procedure; however, vac- separately into each nostril. If the summer months, particularly among
cine administrators are advised to child sneezes immediately after older adults.37
wear gloves when administering administration, the dose should not
be repeated. Although the evidence is limited in
the LAIV given the potential for
children, recent reports raise the
contact with respiratory secretions.
possibility that early vaccination
Gloves used for intranasal or intra- TIMING OF VACCINATION AND
DURATION OF PROTECTION might contribute to reduced
muscular vaccine administration
protection later in the influenza
should be changed with every Although peak influenza activity in
season.69–80 In these studies, VE
patient. Gowns are not required. the United States tends to occur
decreased within a single influenza
from January to March, influenza
season, and this decrease was
can circulate from early fall
correlated with increasing time after
(October) to late spring (May), with
IIVs vaccination. However, this decay in
one or more disease peaks. This
IIVs for intramuscular injection are VE was not consistent across
pattern of circulation was
shipped and stored at 2 C to 8 C different age groups and varied by
substantially altered during the
(36 F–46 F); vaccines that are season and virus subtypes. In some
COVID-19 pandemic. Predicting the
studies, waning VE was more
inadvertently frozen should not be onset and duration or the severity of
evident among older adults and
used. These vaccines are the influenza season with accuracy
younger children72,74 and with
administered intramuscularly into is impossible. It is also challenging
influenza A(H3N2) viruses more
the anterolateral thigh of infants and to balance public health strategies
than influenza A(H1N1) or B
young children and into the deltoid needed to achieve high vaccination
viruses.73,76,78 A multiseason
muscle of older children and adults. coverage with achieving optimal
analysis from the US Flu VE
Given that various IIVs are available, individual immunity for protection
against influenza at the peak of Network found that VE declined by
careful attention should be paid to
seasonal activity, knowing that the approximately 7% per month for
ensure that each product is used
duration of immunity after influenza A (H3N2) and influenza B
according to its approved age
vaccination can wane over time. and by 6% to 11% per month for
indication, dosing, and volume of influenza A (H1N1)pdm09 in
administration (Table 3). A 0.5-mL Initiation of influenza vaccination
before influenza is circulating in the individuals 9 years and older.71 VE
unit dose of any IIV should not be remained greater than 0 for at least
community and continuing to
split into 2 separate 0.25-mL doses. 5 to 6 months after vaccination. A
vaccinate throughout the influenza
If a lower dose than recommended more recent study of children older
season are important components of
is inadvertently administered to a than 2 years also found evidence of
an effective influenza vaccination
child 36 months or older (eg, 0.25 declining VE, with an odds ratio
strategy.
mL), an additional 0.25-mL dose increasing approximately 16% with
should be administered to provide a Complete influenza vaccination by each additional 28 days from
full dose of 0.5 mL as soon as the end of October is recommended vaccine administration.77 Another
possible. The total number of full by the CDC and AAP. Children who study evaluating VE from the
doses appropriate for age should be need 2 doses of the vaccine should 2011–2012 to the 2013–2014
administered. If a child is receive their first dose as soon as influenza seasons demonstrated
inadvertently vaccinated with a possible when the vaccine becomes 54% to 67% protection from 0 to
formulation only approved for available, to allow sufficient time for 180 days after vaccination.75 Finally,
adults, the dose should be counted receipt of the second dose $4 a multiseason study in Europe from
as valid. weeks after the first, before the 2011–2012 to 2014–2015 showed a
PEDIATRICS Volume 148, number 4, October 2021 13steady decline in VE down to 0% coding, and liability issues; these practice-specific Web sites, or social
protection by 111 days after documents can be found at https:// media platforms); creating walk-in
vaccination.76 www.aap.org/en/patient-care- influenza vaccination clinics;
pages-in-progress/influenza/ extending hours beyond routine
Further evaluation is needed before managing-influenzavaccination- times during peak vaccination
any policy change in timing of in-your-practice/. The committee periods; administering the influenza
influenza administration in children supports adequate payment from vaccine during both well-child
is made. An early onset of the public and private payers for the examinations and sick visits as well
influenza season is a concern when vaccine product and administration as in hospitalized patients, especially
considering delaying vaccination. in the pediatric population. Informa- those at high risk of influenza
Until there are definitive data
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tion on preparing your practice to complications, before hospital
demonstrating waning immunity administerinfluenza vaccines during discharge (unless medically
influences VE in children, the COVID-19 pandemic can be contraindicated); implementing
administration of the influenza found at https://services.aap.org/ standing orders for influenza
vaccine should not be delayed to a en/pages/2019-novel- vaccination; considering how to
later date because this increases the coronaviruscovid-19-infections/ immunize parents, adult caregivers,
likelihood of missing influenza help-for-pediatricians/ and siblings (see risk management
vaccination altogether.81 Providers preparing-for-flu-season/. HCP, guidance associated with adult
may continue to offer vaccination as influenza campaign organizers, and immunizations in ref 85) at the
long as influenza is circulating and public health agencies are encour- same time as children; and working
until June 30 of each year, when the aged to collaborate to develop with other institutions (eg, schools,
seasonal influenza vaccine expires, improved strategies for planning, child care programs, local public
because the duration of influenza distribution, communication, and health departments, and religious
circulation is unpredictable. administration of vaccines. For organizations) or alternative care
Furthermore, a person may example, pediatricians can play a sites, such as pharmacies and
experience more than 1 influenza key role in educating and assisting hospital emergency departments, to
infection during a given season early childhood education centers expand venues for administering the
because of the various cocirculating and schools in educating parents on vaccine. If a child receives the
strains. Although influenza activity the importance of influenza immuni- influenza vaccine outside his or her
in the United States is typically low zation. Resources for effective com- medical home, such as at a
during the summer, influenza cases munication and messaging pharmacy, retail-based clinic, or
and outbreaks can occur, strategies, including promoting vac- another practice setting, appropriate
particularly among international cinations and providing resources documentation of vaccination should
travelers, who may be exposed to for pediatricians to communicate be provided to the patient to be
influenza year-round, depending on
with patients, families, and the com- shared with his or her medical
the destination.
munities they serve, are available on home and entered into the state or
the AAP Web site (https://services. regional immunization information
VACCINE IMPLEMENTATION aap.org/en/news-room/ system (ie, registry).
The AAP Partnership for Policy campaigns-and-toolkits/
Implementation has developed a immunizations and https://www. Concerted efforts among the
series of definitions using accepted aap.org/en-us/advocacy-and- aforementioned groups, plus vaccine
health information technology policy/aap-health-initiatives/ manufacturers, distributors, and
standards to assist in the immunizations/Influenza- payers, are necessary to prioritize
implementation of vaccine Implementation-Guidance/Pages/ distribution appropriately to the
recommendations in computer Patient-Family-and-Community. primary care office setting and
systems and quality measurement aspx). patient-centered medical home
efforts. This document is available at before other venues, especially
https://www.aap.org/enus/ Pediatricians and other pediatric when vaccine supplies are delayed
professional-resources/ health care providers should plan to or limited. Payers should eliminate
quality-improvement/ make the influenza vaccine easily remaining patient responsibility cost
Pages/Partnership-for-Policy- accessible for all children. Examples barriers to the influenza vaccine
Implementation.aspx. In addition, include sending alerts to families where they still exist. Similar efforts
the AAP has developed implementa- that vaccine is available (eg, e-mails, should be made to eliminate the
tion guidance on supply, payment, texts, letters, patient portals, vaccine supply discrepancy between
14 FROM THE AMERICAN ACADEMY OF PEDIATRICSYou can also read
