summary 2023 08 03 508

MEETING OF THE ADVISORY
COMMITTEE ON IMMUNIZATION
PRACTICES (ACIP)
AUGUST 3, 2023
MEETING SUMMARY
CONTENTS
THURSDAY: AUGUST 3, 2023 .................................................................................................................... 2
WELCOME AND INTRODUCTIONS ...................................................................................... 2
Call to Order/Roll Call ......................................................................................................... 2
Announcements .................................................................................................................. 2
MATERNAL/PEDIATRIC RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINES ................ 4
Session Introduction ........................................................................................................... 4
Evidence to Recommendations (EtR) Framework: Nirsevimab Updates ............................. 5
Nirsevimab Implementation Considerations .......................................................................13
Proposed Clinical Consideration Updates for Nirsevimab ..................................................19
WG Considerations / Proposed Recommendations ...........................................................20
Vaccines for Children Resolution .......................................................................................26
PUBLIC COMMENTS ............................................................................................................27
VOTES ..................................................................................................................................30
Vote #1 RSV Maternal/ Pediatric Recommendations ..........................................................30
Vote #2 RSV Maternal/Pediatric Recommendations ..........................................................30
Vote #3: VFC Resolution: RSV Maternal/Pediatric .............................................................30
CERTIFICATION ......................................................................................................................................... 33
ACIP MEMBERSHIP ROSTER .................................................................................................................. 34
ACRONYMS USED IN THIS DOCUMENT ................................................................................................. 42

  THURSDAY : AUGUST 3 , 2023
WELCOME AND INTRODUCTIONS
Call to Order/Roll Call
Dr. Grace Lee (ACIP Chair) called to order and presided over the August 3, 2023 Advisory
Committee on Immunization Practices (ACIP ) meeting. Dr. Lee co nducted a roll call, which
established that a quorum was present. A list of Members, Ex Officios , and Liaison
Representatives is included in the appendixes at the end of this summary document. No
conflict s of interest (COIs) were identified.
Announcements
Dr. Melinda Wharton (ACIP Executive Secretary, CDC) noted that copies of the slides for the
meeting were available on the ACIP website and were made available through a ShareLink ™
file for ACIP Voting, Ex O fficios , and Liaisons Members . The ACIP is, at its heart, a public body.
Engagement with the public and transparency in all of its processes are vital to the committee’s
work. She indicated that there would be 1 oral public comment session during this meeting,
which was scheduled for 1:55 PM Eastern Time ( ET). To create a fair and more efficient
process, individuals interested in making an oral comment were asked to submit a request
online in advance of the meeting. Priority is given to these advance requests. If more people make requests than can be accommodated, a blind lottery is conducted to determine who the
speakers will be. Speakers selected in the lottery for this meeting were notified in advance of
the meeting. Members of the public also may submit written comments via
https://www.regulations.gov using Docket Number ID CDC- 2023-00 63. Information on the
written public comment process, including information on how to make a comment, can be
found on the ACIP website.
As noted in the ACIP Policies and Procedures manual, ACIP members agree to forgo
participation in certain activities related to vaccines during their tenure on the committee. For
certain other interests that potentially enhance a member’s expertise while serving on the
committee , CDC may issue limited COI waivers. Members who conduct vaccine clinical trials or
serve on data safety monitoring board s (DSMB s) may present to the committee on matters
related to those vaccines, but those members are prohibited from participating in committee
votes on issues related to those vaccines . Regarding other vaccines of the concerned company,
a member may participate in discussions with the provision that he/she abstains on all votes related to that company. ACIP members state any COIs at the beginning of each meeting.
Applications and nominations are being accepted for candidates to fill upcoming vacancies on
the committee. Detailed instructions for submissions of names for potential candidates to serve
as ACIP members are available on the ACIP website. The deadline for applications for ACIP
memb ership has been extended to September 1, 2023 for the 4-year term beginning in July
2024.
By way of introduction to the topic of the day’s meeting, Dr. Wharton b riefly reviewed 2 different
processes for immunization, passive and active. Passive immunization involves the transfer of
preformed antibody produced externally to provide protection to the recipient. Diphtheria
antitoxin is still manufactured in horses, but most products for passive immunization come from
human immune globulins . Some antibody products are made in cell culture systems. These
2

  antibodies can provide excellent protection, but that protection wanes over time because the
antibodies that are given only last so long. Transfer of maternal antibody across the placenta
that provides protection in early infancy is another example of passive immunization. In contrast, active immunization that occurs with traditional vaccines comes from the response of the
recipient ’s own immune system. Immu nological memory provides prolonged protection than
occurs with passive immunization and can be lifelong.
Advances in biotechnology offer the opportunity to prevent infectious diseases with long -acting
monoclonal antibodies (mAbs)
1 beyond what can be provided by traditional vaccines . When
used for passive immunization, these products can provide a level of protection similar to what
is observed with traditional vaccines, but for a limited period of time. They can be especially
valuable when full protection is needed without delay and when a traditional vaccine is not
available. For some indications, the protection provided by a long- acting monoclonal might be
“long enough” to provide protection during the risk period with a single dose for the duration of a
respiratory disease season, for a critical part of a pregnancy, or for the duration of travel.
CDC will prioritize for ACIP consideration of those long- acting mAbs for prevention of infectious
diseases that are: 1) expected to address conditions that result in a significant burden of
disease to the public's health; 2) are not expected, based on the characteristics of the product
itself, to present significant implementation issues for immunization providers (e.g., mode of
administration, storage and handling, and frequency of administration); and 3) are expected to
be priced at a level allowing for incorporation into immunization programs. She returned the floor to Dr. Lee who called upon Dr. John Farley to provide an overview from the Food and Drug Administration (FDA).
John Farley, MD, MPH (Director, CD ER/FDA) provided a few opening remarks on behalf of
the FDA. He reported that the FDA approved Biologics License Application ( BLA)- 761328 on
July 17, 2023 that licensed nirsevimab -alip injection with the trade name Beyfortus ™. The
indication was based on the data from adequate and well -controlled trials contained within the
BLA and reads as follows :
BEYFORTUS is a respiratory syncytial virus (RSV) F protein -directed fusion inhibitor
indicated for the prevention of RSV lower respiratory tract disease in:
• Neonates and infants born during or entering their first RSV season.
• Children up to 24 months of age who remain vulnerable to severe RSV disease
through their second RSV season.
The safety and efficacy of nirsevimab were supported by 3 clinical trials, Trials 03, 04, and 05.
The primary measure of efficacy was the incidence of medically -attended RSV lower respiratory
tract infection (MA-RSV LRTI ). It was evaluated during the 150 days after nirsevimab
administration. MA- RSV LRTI, the endpoint, included all healthcare provider (HCP) visits (e.g.,
physician office, urgent care, emergency room visits ) and hospitalizations for LRTD disease with
worsening clinical severity and a positive RSV test. Trial 03 included 1,453 preterm infants born at ≥29 weeks of gestational age up to <35 weeks of gestation who were born during or entering
their first RSV season. Of the preterm infants enrolled in the trial, 969 were randomized to a
single dose of nirsevimab and 484 were randomized to placebo. Nirsevimab reduced the risk of
MA-RSV LRTI by approximately 70% relative to placebo. The primary analysis group in Trial 04
1 https://www.who.int/images/default- source/departments/immunization- ivb/pdvac/who- monoclonal -
antibodies.jpg?sfvrsn=f0870999_3
3

 included 1,490 term and late preterm infants born at ≥35 weeks gestational age of whom 994
were randomized to a single dose of nirsevimab and 496 were randomized to placebo.
Nirsevimab reduced the risk of MA -RSV LRTI by approximately 75% relative to placebo in that
trial. Trial 05 was randomized, double- blind placebo- controlled multi- center trial in infants at high
risk for severe RSV disease. The trial enrolled 925 preterm infants as well as infants with
chronic lung disease (CLD) of prematurity or congenital heart disease (CHD) . These patients
were randomized 2:1 to receive n irsevimab or palivizumab by intramuscular ( IM) injection. The
efficacy of nirsevimab for prevention of MA -RSV LRTI in these high- risk patients during RSV
seasons 1 and 2 was extrapolated from efficacy in Trials 03 and 04 , with demonstration of
comparable serum nirsevimab exposures between the high- risk population in Trial 05 and the
Trials 03 and 04 populations.
FDA imposed 2 post-marketing requirements. One focused on monitoring the prevalence of
RSV variants , including the frequency of known n irsevimab resistance- associated substitutions
and the second requirement to phenotypically assess certain RSV- A and RSV -B substitutions.
The sponsor has agreed to a number of post -marketing commitments. These include
conducting the Harmony Study Extension that will evaluate antibody -dependent enhancement
of RSV disease, and conducting an observational US -based long- term study of infants eligible
to receive nirsevimab in their first year of life to assess the impact of RSV disease through Day
511 post -dosing. The FDA has determined that a pharmacovigilance strategy is necessary to
support coordinated monitoring and assessment of safety information from data sources across
both FDA and CDC. ACIP recommendations will be factored into the final pharmacovigilance
strategy as appropriate. The full details of this strategy will be finalized in a separate document
within 90 days of marketing approval, and this pharmacovigilance strategy may be modified as
safety information accumulates during the post-marketing period. Dr. Farley noted that FDA
Review Team members joined the meeting and were available to answer questions.
MATERNAL/PEDIATRIC RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINES
Session Introduction
Sarah S. Long, MD (Chai r, Maternal/Pediatric RSV WG) reminded everyone that p revious
Maternal/ Pediatric RSV WG presentations to the ACIP focused on nirsevimab, the long- acting
monoclonal antibody against RSV ; the epidemiology and burden of RSV in infants ; the virology
and immunology of RSV; the safety and efficacy of nirsevimab ; the cost effectiveness analysis
from a CDC model and a comparison with a manufacturer model; the Evidence to
Recommendation (EtR) Framework findings for nirsevimab ; and clinical considerations for
nirsevimab.
Dr. Long indicated that the sole focus of the presentations for this session would be on
nirsevimab because on June 8, 2023, the FDA Antimicrobial Drug Advisory Committee
(AMDAC) evaluated and voted on 2 questions :
1. Is the overall benefit -risk assessment favorable for the use of nirsevimab for the
prevention of RSV lower respiratory disease in neonates and infants born during or entering their first RSV season?
2. Is the overall benefit -risk assessment favorable for the use of nirsevimab for the
prevention of RSV lower respiratory tract disease in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season?
4

   The AMDAC voted 21 -0 in favor of the first question and 19 -2 in favor of the second question.
Many committee members recognized the need for guideline groups such as the American
Academy of Pediatrics ( AAP) and ACIP to provide additional recommendations on the use of
nirsevimab . As Dr. Farley noted earlier, the FDA approved nirsevimab on July 17, 2023 for the
prevention of RSV LRTD in neonates and infants born during or entering their first RSV season
and in children who remain vulnerable to severe RSV disease through their second RSV
season.
The agenda for this ACIP session included updated EtR Framework findings for nirsevimab,
nirsevimab implementation considerations, clinical considerations for nirsevimab,
Maternal/Pediatric RSV WG considerations and proposed recommendations and voting
language, and a Vaccines for Children (VFC) Resolution. Dr. Long concluded with the following
proposed ACIP voting language so that members could be thinking about it throughout the
presentations:
Infants aged <8 months born during or entering their first RSV season are recommended
to receive one dose of nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5 kg)
Children aged 8– 19 months who are at increased risk of severe RSV disease and
entering their second RSV season are recommended to receive one dose of nirse vimab
(200 mg)
Evidence to Recommendations (EtR) Framework: Nirsevimab Updates
Jefferson Jones, MD, MPH , FAAP, CDR, USPHS (CDC/NCIRD Co -lead, Maternal/Pediatric
RSV WG ) reiterated that the following 2 policy questions were considered by the Maternal /
Pediatric WG regarding nirsevimab:
1. Should one dose of nirsevimab be recommended for infants aged <8 months born during or
entering their first RSV season (50 mg for infants <5 kg and 100 mg for infants ≥5 kg)?
2. Should one dose of nirsevimab be recommended for children aged 8– 19 months who are at
increased risk of severe RSV disease and entering their second RSV season (200 mg)?
The rationale for inclusion of these age groups was that given an average RSV season of 4– 5
months, infants aged 8 months and children aged 20 months would be experiencing their
second and third RSV seasons, respectively.
As mentioned earlier, nirsevimab is a form of passive immunization against RSV . While it may
be referred to as “ immunization” during the presentations and discussion, it is passive
immunization. Nirsevimab does not provide active immunity. Active immunity results from
infection or vaccination, which triggers an immune response . Passive immunity is when a
person receives antibodies from an external source. Examples include antibodies transferred
from mother to baby through the placenta or breastmilk or direct administration of antibodies,
such as i ntravenous immunoglobulin (IVIG) therapy or monoclonal antibodies such as
nirsevimab.2
2 https://www.cdc.gov/vaccines/vac -gen/immunity -types.htm
5

  In terms of the PICO components for Policy Question #1 in this EtR analysis, the population
included infants aged <8 months born during or entering their first RSV season. The intervention
was nirsevimab (1 injection prior to the start of RSV season or at birth if born during the season,
50 mg if <5 kg or 100 mg if ≥5 kg) . The comparison was no nirsevimab prophylaxis. The
outcomes included MA- RSV-associated LRTI , RSV-associated LRTI with hospitalization, RSV-
associated LRTI with intensive care unit ( ICU) admission , RSV-associated death , all-cause
medically attended LRTI , all-cause LRTI -associated hospitalization, and serious adverse events
(SAEs). In terms of the EtR domains (e.g., Public Health Problem, Benefits and Harms, Values,
Acceptability, Feasibility, Resource Use, and Equity), the domains of Benefits and Harms,
Feasibility , and Resource Use included updates from what was presented during t he February
2023 ACIP meeting .
To review the first domain of the Public Health Problem, data from the National Respiratory and
Enteric Virus Surveillance System (NRE VSS)3, the primary source for monitoring RSV
seasonality in the US, showed that there was very limited RSV circulation until late Spring 2021
that was followed by a peak in activity in late Summer 2021 . Transmission continued throughout
the fall into December 2021. The most recent RSV season showed increasing RSV activity
startin g in late Summer 2022, with a peak in RSV transmission in October ─November 2022. To
summarize that, the 2022─ 2023 season began later than the 2021─ 2022 season but earlier
than pre- pandemic seasons. This suggests an incremental reversion to pre- pandemic
seasonality  with winter peaks and highlight s the uncertainty in when the next RSV season will
start.
In terms of epidemiology, RSV is the most common cause of hospitalization in US infants. The
highest RSV hospitalization rates are in the first months of life. The risk declines by month with
increasing age in infancy and early childhood. While p rematurity and other chronic diseases
increase the risk of RSV -associated hospitalization, most hospitalizations are in healthy term
infants. The WG felt that RSV -associated disease in infants born during or entering their first
RSV season is of public health importance.
Regarding the Benefits and H arms domain, there have been no updates to the GRADE
(Grading of Recommendation Assessment, Development and Evaluation) assessment of the
evidence presented in February 2023. However, some additional data were received from
pooled estimates combining Phase 2b and Phase 3 clinical trials estimate comparing the
nirsevimab arm to the placebo arm in addition to concerns in ter ms of the certainty of
assessment. T he estimated efficacy was 79% for MA-RSV LRTI , 80.6% for hospitalization , and
90% for ICU admission. No RSV -associated deaths were recorded, though this outcome could
not be evaluated. The estimated efficacy against all -cause medically attended LRTI was 34.8%
and against all- cause LRTI hospitalization was 44.9%. The risk ratio comparing SAEs in infants
receiving nirsevimab versus receiving placebo was 0.73.
In summary of GRADE for nirsevimab, there is high certainty that Nirsevimab is effective in
preventing medically attended RSV and RSV hospitalization. In addition to preventing all- cause
medically attended LRTI and LRTI hospitalization, there is moderate certainty that nirsevimab is
effect ive in protecting against RSV LRTI with ICU admission and that SAEs are not more
common in infants receiving nirsevimab compared with placebo. Additional safety data were
provided during the AMDAC meeting on nirsevimab4. The most commonly reported adverse
reactions (ARs) were injection site reactions (0.3% ) and rash ( 0.9% ). The FDA noted an
3 https://www.cdc.gov/mmwr/volumes/72/wr/mm7214a1.htm
4 https://www.fda.gov/advisory- committees/advisory -committee- calendar/june-8- 2023- meeting- antimicrobial -drugs -advisory -
committee- meeting- announcement -06082023
6

     imbalance in deaths between n irsevimab and the control arms but determined that the deaths
were unlikely to be related to nirsevimab.
The sponsor shared data from the ongoing Phase 3b study known as HARMONIE .5 The
HARMONIE study enrolled 8,058 infants. The age at enrollment was : 49% <3 months , 24% 3-5
months , and 28% ≥6 months . Of the infants, 85% were born at term and 50% were born during
the RSV season. This study is being conducted in France, the United Kingdom (UK), and
Germany. While these results are from August 8, 2022–February 28, 2023 , the study is
ongoing. The participants were randomized to n irsevimab or no injection, meaning the control
group was not given a placebo injection. The primary endpoint was RSV hospitalization, which
was a LRTI hospitalization with a positive RSV test. RSV tests were ordered by clinicians for patients with LRTI per the standard of care as opposed to systematically on all patients with
LRTI hospitalizations . Participants will be followed for at least 12 months after randomization. At
the end of the RSV season, the preliminary efficacy results were released, which were
presented during this session. These results were with a median post -randomization follow- up
time of 2.5 months. HARMONIE preliminary results reported an efficacy against RSV
hospitalization of 83% , 76% against severe disease (e.g., oxygen saturation below 90% and
oxygen given), and 58% against all-cause hospita lization with LRTI during the RSV season. For
safety, Grade 1 AEs were reported to be slightly higher in the nirsevimab arm (29%) versus the
no intervention arm (25%). The rate s of Grade 2 and Grade 3 AEs were similar between the
nirsevimab and control arm s. It is important to note that these results have not been peer -
reviewed or published in the scientific literature.
To summarize the Benefits and Harms domain, the overall GADE grade evidence rating was
moderate. The results were downgraded based on impr ecision for protection against ICU
admissions because of few recorded events and imprecision of SAEs because rare events are unlikely to be detected. The WG felt that the desirable anticipated effects of nirsevimab were
moderate to large, that the undesirable anticipated effects of nirsevimab were minimal to small,
and that the desirable effects outweighed the undesirable effects and favored n irsevimab over
no intervention.
The next domain is Values , for which no updates were available. In a survey of people currently
pregnant or pregnant within the last 12 months conducted by the CDC, the University of Iowa ,
and the Rand Corporation on RSV immunizations, only 33% of respondents thought their baby
“definitely ” or “probably would” get an RSV infection within 1 year after being born. Despite
being unsure or perceiving RSV risk to be low, respondents were worried that their baby would
need to be hospitalized if they got sick with RSV (mean response 4 of 5, with 5 being most
worried ). Of the respondents , 70% said they “definitely ” or “probably would” get an RSV
antibody injection for their baby if safe and effective. The WG determined that the target
population probably feels that the desirable effects are large relative to undesirable effects . The
WG varied in whether they felt there was important uncertainty about , or variability in , how much
people value the main outcomes.
5 Study not peer- reviewed and information provided directly by sponsor; https://www.cl inicaltrials.gov/study/NCT05437510
7

 The next domain is Acceptability with key stakeholders, for which no updates were available. In
a survey of US pediatric providers, over 85% agreed that parents need more information about
RSV, that immunization could help prevent RSV, and that immunization policy should ensure all
children get access.6 The American Academy of Pediatrics ( AAP) and the National Foundation
for Infectious (NFID) Disease Roundtable have stated the need for safe and effective RSV
prevention products.7 The WG felt that passive immunization with nirsevimab was or probably
was acceptable to key stakeholders.
Feasibility domain considerations were reviewed in the next presentation by Dr. Georgina
Peacock , but the WG felt that nirsevimab probably will be feasible to implement.
The R esource Use domain , the primary source of data was a cost -effectiveness analysis
performed by the University of Michigan. Since the cost- effectiveness analysis was presented to
ACIP in February 2023, the company provided an updated cost estimate of the product. The list
price was estimated to be $495 and the cost for the V FC program was estimated to be $395.
Assuming nirsevi mab is administered as 50% under the VFC and 50% under private insurance,
the average price was $445. This price was not final at the time of this session per the WG’s
understanding. Mortality assumptions were modified to include individuals at increased risk of
severe disease and savings from not using palivizumab to those recommended to receive it
were incorporated. Other inputs were unchanged from the previous model presented during the
February 23, 2023 ACIP meeting. The number needed to immunize with nirsevimab to prevent
1 health outcome was 17 for an outpatient visit, 18 for an ED visit, 128 for inpatient, 581 for ICU
admission, 24 per inpatient day, and 194 per ICU day. The cost per health event averted was
$2,662 per outpatient visit, $7,473 per ED visit, $19,909 per inpatient admission, $90,494 per
ICU admission, $3,687 per inpatient day, and $30,165 per ICU day. The updated base case
results of the cost -effectiveness analysis was $102,811 per quality adjusted life year saved. The
WG felt that n irsevimab is or probably is a reasonable and efficient use of resources . A full
presentation for this updated cost -effectiveness analysis was included in the extra slides.
The primary update to the Equity domain was that that if ACIP recommends use of nirsevimab,
ACIP also would vote on a VFC Resolution for nirsevimab. To summarize equity, national
studies of death certificates found higher rates among non- Hispanic Black children compared
with non- Hispanic White infants and children 1─4 years of age .8 ICU admission rates for RSV
among non -Hispanic Black infants <6 months of age were 1.2 to 1.6 times higher than among
non-Hispanic White infants.9 RSV hospitalization rates were 4 to 10 times higher among Alaska
Native and American Indian (AI/AN) children <24 months of age than the rate in the general
population.10 Studies of RSV hospitalization by race and ethnicity have differing results.11 The
WG felt that nirsevimab would increase health equity.
6 https://admin.allianceforpatientaccess.org/wp- content/uploads/2023/01/AfPA -and-NCfIH_The -Indirect -Impact -of-RSV_Survey -
Report_Jan- 2023.pdf
7 AAP COID BGC Pediatrics 2014 Aug;134(2):415- 20; and https://www.nfid.org/wp -content/uploads/2022/04/NFID -RSV-Call-to-
Action.pdf
8 Hansen J Infect Dis 2022 Aug 15;226(Suppl 2):S255-S266
9 Unpublished data from RSV -NET, CDC
10 Atwell Pediatrics 2023, e2022060435
11 Hall Pediatrics 2013 Aug;132(2):e341- 8; Hall NEJM 2009;360(6):588– 598; Iwane Pediatrics 2004 Jun;113(6):1758-64, findings
differed by age group; and Rha Pediatrics 2020 Jul;146(1):e20193611, findings differed by age group
8

 Displayed in this table are the WG’s judgments of the EtR Framework analysis for the first RSV
season indication:
The WG felt that the desirable consequences clearly outweigh the undesirable consequences in
most settings , with a minority opinion that the desirable consequences probably outweigh the
undesirable consequences. The WG recommended the intervention for all infants in their first
RSV season.
To review the EtR analysis for the second RSV indication, the population is chi ldren aged 8– 19
months who are at increased risk of severe RSV disease and who are entering their second
RSV season. The intervention was nirsevimab (200 mg [2 x 100 mg] injection near start of
second RSV season) and the comparison was no nirsevimab prophylaxis. The outcomes were
the same as those used for the first indication. Domains with updates unique to the second
season included the P ublic Health Problem and Resource Use.
For the P ublic Health Problem, the WG previously presented that they felt the risk groups to
receive nirsevimab f or the second RSV season could be based on the AAP recommendation for
palivizumab for a child’ s second RSV season.12 The WG assumed nirsevimab to be cost -saving
compared with palivizumab. The proposed recommendation to receive nirsevimab when
entering thei r second RSV season would include the following groups:
Children with CLD of prematurity if they require medical support (chronic corticosteroi d
t
herapy, diuretic therapy, or supplemental oxygen) during the 6- month period before t he
s
tart of the second RSV seas on
C
hildren with severe immunocompromis e
C
hildren with cystic fibrosis if manifestations of severe lung disease (previous hospitalizati on
f
or pulmonary exacerbation in the first year of life or abnormalities on chest imaging tha t
per
sist when stable) or weight for length <10th percentil e
12 American Academy of Pediatrics. Committee on Infectious Diseases [Respiratory Syncitial Virus.] In: Kimberlin DW, Barnett ED,
Lynfield R, Sawyer MH, eds. Red Book : 2021 Report of the Committee on Infectious Diseases. Itasca, IL: American Academy of
Pediatrics, 2021
9

 To evaluate the evidence if other risk groups should be considered for a recommendation, CDC
conducted 2 analyses, a systematic review of the literature and an analysis of the M arket Scan
national claims database. The systematic review included any studies that compared RSV
hospitalization rates among children with risk factors to a healthy control among children 6─ 24
months of age . Among 3,825 abstracts reviewed, 6 studies were identified. CLD, CHD, and
neuromuscular  disease (NMD) were analyzed in these studies. These studies indicated an
increased risk of hospitalization for these risk factors. No studies evaluating other risk factors
were identified.
Given the limited evidence available in the systematic review, CDC conducted an analysis of the
Market Scan national claims database for select risk factors for severe RSV disease during the
second RSV season using data from 2015─2021. Using International Classification of Diseases
(ICD)- 9 and ICD-10 codes, children were identified with and without selected conditions (e.g.,
CLD, CHD, Down syndrome, NMD, pulmonary malformations, immunodeficiency, cystic fibrosis)
and children who were hospitalized with RSV. The rates of RSV hospitalization among children
with a chronic condition were compared to children without any of these chronic conditions .
Increased rates of hospitalization were seen for all conditions. It is important to note that a
primary limitation in this study is that RSV testing may be more common for children with risk
conditions , inflating RSV -specific hospitalization rates.
Several prior studies have documented increased incidence of RSV hospitalizations among
AI/AN children.13 One study found that rates of RSV hospitalization in AI/AN children were 4 to
10 times the average rates of US children overall aged 12─ 23 months as determined from the
New Vaccine Surveillance Network (NVSN) .14 These studies have been conducted in specific
populations and may not be broadly representative of the risk in all AI/AN children. Findings of
these studies do not separate environmental, sociocultural, or other factors that may increase severe disease risk. And some AI/AN communities are also in remote areas that can make
transportati on of children with severe RSV to an appropriate health care setting more
challenging.
15
To summarize the Public Health Problem domain, the WG group felt that evidence for RSV
burden among children 8 ─19 months entering their second RSV season with specific risk
conditions is limited. The WG felt that n irsevimab should be recommended to the same groups
the AAP recommends for palivizumab for the second RSV season. The WG also felt that
nirsevimab should be recommended to AN /AI children entering their second RSV season. In
addition, the WG felt that RSV disease among children who are at high risk of severe disease16
in their second RSV season was of public health importance.
13 Atwell 2023 Pediat rics 2023 Jul 14;e2022060435; Karron et al. J Infect Dis 1999; Holman et al. Pediatrics 2004; Lowther et al. J
Ped Infect Dis 2000
14 Atwell 2023 Pediatrics 2023 Jul 14;e2022060435
15 American Academy of Pediatrics. Committee on Infectious Diseases [Respirat ory Syncytial Virus.] In: Kimberlin DW, Barnett ED,
Lynfield R, Sawyer MH, eds. Red Book: 2021 Report of the Committee on Infectious Diseases. Itasca, IL: American Academy of
Pediatrics, 2021.
16 For groups recommended to receive palivizumab in their second RSV season by the American Academy of Pediatrics and
American Indian and Alaska Native children
10

   Moving to the Benefits and Harms domain, a pharmacokinetic trial17 was conducted that
randomized children at risk of severe RSV disease to palivizumab or nirsevimab. In the second
RSV season, 220 participants received n irsevimab and 42 received palivizumab. Among those
who received nirsevimab, 2 pharmacokinetic endpoints have been reported. The Day 150
nirsevimab concentration s compared with the Phase 3 Prevention of Medically Attended Lower
Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term
Infants (MELODY) efficacy trial among late preterm and term infants that showed efficacy. The
proportion of participants who had an area under the curve (AUC) nirsevimab concentration
above a target based on the efficacy trial data in term and preterm infants of 12.8 mg day/ml.
Among recipients of nirsevimab, Day 150 concentrations were higher in the high- risk infants
who received 200 mg in the second RSV season (Trial 05 ) that infants who received 50 mg (if
<5kg) or 100 mg (if >5kg) in P hase 3 MELODY trial ( Trial 04) . For the other pharmacokinetic
endpoint among recipients of nirsevimab in the second RSV season, most had an AUC
nirsevimab concentration above the target threshold. Among infants with CLD and CHD, 97.7%
and 100% respectively had concentrations above that target threshold. For safety, no AEs were
judged to be related to nirsevimab or palivizumab in the second RSV season follow -up period.18
In summary of GRADE for the second RSV season, nirsevimab may be effective in preventing
MA-RSV LRTI, but with low cert ainty. The prevalence of SAEs was not significantly different in
the intervention group or control group, but the certainty of evidence was very low. No data were
available for other outcomes. Overall, the evidence rating was very low certainty (Type 4). T his
was downgraded on indirectness because of the use of pharmacokinetic data as a surrogate for
efficacy , the population did not include children who match the proposed indication outside of
CLD and CHD, the study was small in size, and no placebo group was included for a comparison. For groups recommended to receive palivizumab in their second RSV season by
the AAP and AI /AN children, the WG felt that the desirable anticipated effects were moderate,
the undesirable anticipated effects were minimal, and the desirable effects outweighed the undesirable effects and favored n irsevimab over no intervention.
No additional data were available for the domains of Values or Acceptability specific to high- risk
populations in their second RSV season. The WG determined that for groups recommended to
receive palivizumab in their second RSV season by the AAP and AI /AN children, the target
population probably feels that the desirable effects are large relative to undesirable eff ects. The
WG also felt that there probably was not important uncertainty or variability in how much people
valued the main outcomes. The WG felt that prevention with nirsevimab was, or probably was,
acceptable to the key stakeholders. For feasibility, an additional visit to a provider might be
needed for administration of nirsevimab prior to the beginning of the second RSV season. The
WG felt that n irsevimab was probably feasible to implement among children 8─ 19 months of
age at increased risk of severe RSV disease entering their second RSV season for groups
recommended to receive palivizumab in their second RSV season by the AAP and AI/AN
children.
17 Domachowske J, Madhi SA, Simões EAF, Atanasova V, Cabañas F, Furuno K, et al. Safety of nirsevimab for RSV in infants with
heart or lung disease or prematurity. New England Journal of Medicine. 2023;386(9): 892–894. doi:10.1056/NEJMc2112186
18 Source: FDA briefing document for Antimicrobial Drugs Advisory Committee June 8, 2023 meeting
11

    For the Resource Use domain, the inputs were updated similar to the cost -effectiveness
analysis for the first RSV season indication. As presented in February 2023, theoretical groups
of children with increased risk were created with 2, 4, 6, and 10 times higher risk than the
general population 8─ 19 months as of October for beginning of RSV season. Compared w ith
February, 2 scenarios were created to account for th e uncertainty in mortality in this group. As
previously presented, the incidence of RSV -associated hospitalization and incidence per
hospitalization were increased. For the other scenario, the incidence of RSV -associated
hospitalization was increased. However, the mortality per hospitalization was not changed
because of lack of evidence. No increases were made to the incidence of outpatient and ED
visits, healthcare costs, or quality adjusted life year s (QALY) lost with RSV disease for these
increased risk groups due to lack of data.19 The cost was updated to $890 for nirsevimab per
child based on 2 times the $445 per dose assumed in the first season analysis to account
for the 200 mg injections needed. Baseline mortality estimates were modified to include high-
risk individuals and other inputs were unchanged similar to the first season model. This table
displays the updated results :
The WG felt that nirsevimab use among children 8─ 19 months of age entering their second
RSV season who are at increased risk of severe disease is probably a reasonable and efficient
allocation of resources. Like all domains, this assumes increased risk of severe disease refers
to groups recommended to receive palivizumab in their second RSV season by the AAP and
also including AI /AN children.
For the E quity domain, no updated information is available. As previously presented, equity
issues differ by chronic condition among infants and young children. AI/AN children have
reported higher hospitalization incidence rates than the general population during their second RSV season. Non-Hispanic Black and Hispanic populations have higher reported rates of
preterm birth than non -Hispanic White populations. The WG felt that n irsevimab use probably
would increase health equity.
19 Same assumption as previous model presented at February 23, 2023 ACIP meet ing
12

  Displayed in this table are the WG’s judgments of the EtR Framework analysis for children at
high risk entering their second RSV season :
After reviewing the totality of the data presented during this session and acknowledging
uncertainties around the aspects of the data, the WG felt that the desirable consequences
probably outweigh the undesirable consequences in most settings, with a minor ity opinion that
desirable consequences clearly outweigh the undesirable consequences. The WG proposed to ACIP to recommend the intervention for groups recommended to receive palivizumab in their
second RSV season by the AAP and for AI/AN children.
Nirse vimab Implementation Considerations
Georgina Peacock, MD, MPH, FAAP (CDC/NCIRD) briefly reviewed some of the many
implementation considerations related to nirsevimab , such as the definition of “vaccine,” c ost,
storage and handling, h ospital dosing, o utpatient dosing, c oding and Immunization Information
Systems (IISs), timing of vaccination, second y ear vaccinations , vaccine administration , safety
reporting, and v accine confidence and demand . There are some mitigation strategies and CDC
is exploring ot hers internally and with its partners in the field.
One issue that has arisen is the definition of “vaccine. ” There is no statutory definition of
“vaccine” in the statute for the VFC program (section 1928 of the Social Security Act) .
20 There
also is no st atutory definition of “vaccine” in the Affordable Care Act (ACA) (section 2713 of PHS
Act),21 or its implementing regulations, which has a provision that mandates coverage of
vaccine recommendations included on CDC ’’s immunization schedules. Therefore, CDC has
determined that nirsevimab is eligible for inclusion in the Childhood Immunization Schedule and
the VFC. It is important to note that some states do have different definitions of “vaccine ” in their
state statutes , which may affect the state purchase of vaccine in universal purchase states.
However, it does not affect the use of federally purchased vaccine in states.
20 https://www.ssa.gov/OP_Home/ssact/title19/1928.htm
21 https://www.federalregister.gov/documents/2015/07/14/2015- 17076/coverage- of-certain- preventive- services- under- the-affordable-
care-act
13

   Nirsevimab is a costly product. If nirsevimab is recommended by ACIP, it will be covered by
insurance and included in the VFC program. It is important to make sure that there is equitable
access to nirsevimab . The cost of n irsevimab is a potential implementation barrier, particularly
for outpatient settings or ambulatory practices. In the provider agreement for VFC providers ,
there is a provision that if a practice has both public and private payers, they must carry stock .
Recognizing that this may be challenging for some practices , CDC is working through some
potential short -term solutions that could be implemented during the ramp -up of inclusion of
nirsevimab in the VFC program.
This product is similar to other routine vaccines for children in terms of storage, handling, and
administration. Nirsevimab is administered as an intramuscular (IM) injection using a single -
dose pr e-filled syringe and can be administered simultaneously with other childhood vaccines.
Dosing is weight -based (50 mg if <5 kg; 100 mg if ≥5 kg; 200 mg (2x100 mg) for high- risk
children entering second RSV season). S torage and handling are similar to other routine
vaccines. Nirsevimab is stored in a refrigerator at 2-80 C and may be kept at room temperature
(20-250 C) for up to 8 hours .
There have been some questions about scope of practice issues . Different jurisdictions or states
may have different scope of practice statutes related to who can administer injectable therapeutics versus vaccines. CDC conducted a scan of different state statutes or laws to
determine who is allowed to administer therapeutics. It appears that in most states, medical
assistants who frequently do administer vaccines also will be able to deliver injection drugs.
While there is some variability, this does not appear to be major issue related to scope of
practice.
There have been conversations about where doses will be given and the age of the infant .
Approximately 10% of birthing hospitals participate in the VFC program. There has been a
suggestion that if nirsevimab were to be given in the hospital, this would be s imilar to what is
done with hepatitis B vaccine. Hepatitis B vaccine is bundled into a payment model for newborn
care. It is important to note that hepatitis B vaccine costs approximately $13 to $16 a dose.
22 If
nirsevimab were to be included in a bundled payment model, it may take time for that to be put
into practice. Regardless of where the dose is given, it is critical to ensure that documentation of
nirsevimab administration and all parties involved are sent to the primary care provider (PCP).
There are some potential challenges with n irsevi mab being entered into IISs since it is a
therapeutic versus a vaccine. Comprehensive maternal- neonatal records will become even
more critical if maternal RSV vaccine is licensed and recommended and will adds to the need
for communication between maternal records, hospital records, and ambulatory settings or
primary care offices. Regarding outpatient administration, communication from the birthing
hospital is extremely important related to this product. CDC also recognize s that an initial
investment by pedi atricians who are unsure on the demand for this product may create some
challenges . Historically, there has been a lag in insurance payment s for new products.
Because of the uniqueness of this product, there is a n eed to consider different coding
requirem ents. The initial meeting and American Medical Association ( AMA ) decision pertaining
to Current Procedural Terminology (CPT) codes classified n irsevimab as a drug or a
therapeutic. That means that currently, it is associated with an administration code that does not
include a counseling component and is not eligible for a standalone counseling component.
CDC understands that there are efforts underway potentially to propose a unique code for thi s
22 https://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine- management/price- list/index.html
14

    product that would include counseling and storage and handling components. Again, there may
be potential challenges in recording the doses in IISs.
This graphic depicts the complexity of the steps involved in paring systems for administering a
newly authorized vaccine across the US , which illustrates that there are numerous processes
and partners involved and that it takes time:
To further detail IISs and vaccine forecasting considerations, coding of nirsevimab as a
therapeutic instead of a vaccine could create challenges with internal provider ordering,
provision of a vaccine record, and interoperability and data exchange with electronic health
records (EHRs) and IISs. In addition, there are some forecasting issues related to Clinical
Decision Support (CDS) systems for immunizations. The dosage is determined by weight , but
CDS systems do not have access to patient weight. This could create challenges with
forecasting doses. Second season recommendations also may be challenging. In addition, CDS
systems are unable to take into account maternal vaccination history for forecasting of infant
nirsevimab immunization.
Special considerations also add complexity. Timing of vaccination is based on RSV season.
Tropical climates may have different or unpredictable seasonality when compared with most of
the continental US (CONUS) . There also is variability in different localities. For example,
seasonality in Alaska is less predictable and of longer duration. For those who are going to
receive a second dose, high- risk populations must be defined and palivizumab
recommendations must be clarified in the setting of nirsevimab availability.
Reporting of AEs is more complicated for nirsevimab than other immunizations being classified
as a therapeutic versus a vaccine. If nirsevimab is administered alone , suspected AEs are
reported to MedWatch. If nirsevimab is administered simultaneously with any vaccine,
suspected AEs are reported to the Vaccine Adverse Event Reporting System (VAERS) and
additional reporting to MedWatch will not be needed.
In terms of introduction of nirsevimab in the context of coming out of a pandemic during which
there have been many conversations about vaccine confidence and demand, it is not clear
whether physicians and the public will accept this new product and/or what the demand would
be. In addition, this is occurring at the same time as commercialization of COVID -19 vaccine
and seasonal influenza vaccine administration. Vaccine hesitancy and the need for counseling
15

  are anticipated regarding all vaccines and products. In addition, there have been efforts to
weaken school immunization requirements and expand vaccine exemptions at the state level.
This also feeds into vaccine confidence and demand issues.
In conclusion, this summarizes just some of the potential issues with implementation of
nirsevimab . The risks during this season’s rollout include timing of availability of doses, provider
hesitancy, and uptake. The recommendations will be complex with regard to hospital versus outpatient administration and seasonality and timing. Lessons learned with respect to hepatitis
A and B should be considered. In addition, there may be unintended consequences. Therefore,
it is important that all partners involved in this are thinking through potential implementation
issues moving forward to ensure that the product has good uptake and infants are protected.
Discussion Points
Dr. Poehling requested that the FDA or the vaccine manufacturer share the list price and
bounds in the most recent iteration. B ecause there is availability of the product in 2 formulations
(e.g., 50 mg and 100 mg) she asked for confirmation that they both would be priced the same in
order to ensure that infants can receive the appropriate dosing without an additional cost
concern.  Another potential concern that Dr. Peacock raised regarding the CPT code defining
nirsevimab as a drug or therapeutic. While the ACA covers vaccines, there are a lot of private
insurance plans that have high deductibles. This raised a concern about whether large co -pays
could be anticipate d for many families .
Dr. Ritch ey responded that Sanofi Vaccines is committed to making Beyfortus ™ successful and
cost- effective for all infants entering their first RSV season. Consistent with the analysis shared
by ACI P and the WG, a ssuming an all -infant recommendation and inclusion in the VFC program
to ensure access for those infants, Sanofi Vaccines’ pricing will be cost- effective with a
commercial list price of $495 and a lower VFC price of $395 to reflect that volume that is
purchased through the program. The 50 mg and 100 mg formulations would be $495, which
means that 2 doses given for 200 mg would be $990. In terms of private insurance and the potential for high co- pays, Dr. Peacock reached out to
billing expert s and reported that nirsevimab would be covered under the ACA as an
immunization with no co -pay if it is recommended by the ACIP .
Dr. Talbot asked whether the AMA would reconsider its classification of nirsevimab as a drug
and therapeutic. When the term “drug and therapeutic” is used, patients are going to think that
this is a treatment for RSV rather than a prevention. This will make educating families much
more difficult. As a member of the WG, Ms. Stinchfield (NAPNAP) thanked Dr. Peacock for outlining the
significant implementation challenges discussed with the WG . Coming from the private sector
hospital and clinic setting s, she encouraged all of her colleagues across the US to use Dr.
Peacock’s very detailed presentation as a template f or the work that needs to be done and
starting now with the patient education, staff education, storage and handling, electronic medical
records (EMRs), et cetera . The numerous considerations for implementation should not be
barriers. They are just going to take some work beginning immediately .
Dr. Hopkins (NFID) emphasized that addressing potential issues around collaboration and
communication would be critical to do as soon as possible with regard to this product and for
RSV prevention in infants in general.
16

     Regarding the cost -effectiveness results for children 8─19 months of age, Dr. Cieslak (CSTE)
said he was surprised to see that the WG thought the costs were reasonable. He asked Dr.
Jones to explain the risk category for the base case scenario and the rationale for apparently
upping that 10-fold in the sensitivity analysis.
Dr. Jones indicated that the baseline risk was based on those who would be entering their
second RSV season in October who would be 8─19 months of age per NVSN rate s for the
general population. Because the analysis was considering those at increased risk and there was
a lack of data on what the hospitalization rate would be for these increased risks, theoretical risk
groups were created to estimate what the rates may be. This was the reason the WG did not
expand beyond those who already were recommended to receive palivizumab. Instead using
palivizumab as a 5-dose monthly monoclonal antibody product for those who are recommended
to receive palivizumab , switching them to nirsevimab would be assumed to be a cost-saving in
that scenario. That is the scenario the WG interpreted as being a reasonable allocation of
resources.
Dr. Loehr asked Dr. Jones to clarify if Slide 55 was saying that some people have a higher risk
but there are no data. He asked for clarification about whether there were any data on the
children who received palivizumab to give them a sense of how much more likely they are to be
in the hospital than the average 12 -month -old or 18- month -old. He agreed that switching to
nirsevimab would be very expensive if the increased risk is not significant.
Dr. Jones responded that the lack of data on the increased incidence rate of hospitalization or
other health outcomes for those at increased risk is most concerning. Based on the lack of data
in a review of the evidence, the AAP recommends palivizumab only in the second season for a
fairly select group. The WG reviewed that paper and did the systematic review, and found a
very limited set of data that show ed an increased risk of 2, 4, and 4 times the risk. The
Market Scan analysis show ed higher prevalence ratios of hospitalization, but the WG had
considerable concern about whether those represent the truth or if those are inflated due to
RSV testing of high- risk populations versus the general population. Given the lack of data, the
WG did not have confidence in what the rates would be.
Dr. Loehr agreed that if nirsevimab is on the immunization schedule, it will get covered without
co-pay under the ACA. However, he reiterated something he has brought up many times. This
will take time. He just had to research this for a presentation and confirmed that insurance
companies have 1 year after approval and until the following plan year. If ACIP approv ed a
product in February 2023, insurance plans would have until February of 2024 to cover it without
cost. If the ACIP approved nirsevimab during this meeting, it could be 18 months before it would
be covered. There are insurance companies that would begin covering it immediately upon
approval of the ACIP’s recommendation by the CDC director. He encouraged insurance
colleagues to simply adopt that policy because it is in the best interest of patients and
communities.
Dr. Lee invited Dr. Grubb from America’s Health Insurance Plans (AHIP) to comment on this,
recognizing that there is heterogeneity by health plan.
From a state health department point of view, Ms. Bahta highlight ed that bundling as has been
done with hepatitis B may be a challenge going forward with only 10% of hospitals enrolled in
the VFC program. It would be a major onboarding project to get state programs enrolled in the
17

 VFC program. There also would be major challenges in practically implementing screening for
eligibility.
Dr. Daley expressed appreciation for the additional thought and care the WG put into including
AI/AN populations in terms of second season dosage. Given the data that were presented on 4
to 10 times the hospitalization rate during the second season, the argument is compelling.
However, he wondered about the aspects of acceptability and feasibility whether there are any
data to speak to the ability to implement that as a strategy. Dr. Jones indicated that while they do not have any specific data points, they have be en in
discussions with colleagues from the Indian Health Service (IHS) and CDC ’s Office of Tribal
Affairs and Strategic Alliances (OTASA) that works with the agency’s tribal partners and are
continuing to receive feedback. These clinical considerations are being proposed and a VFC
vote was planned during this meeting, but there are always opportunities to receive more
feedback. Dr. Clark (IHS) reported that the IHS is in the process of evaluating the logistical implications of
this recommendation for the IHS system of care, including federal, tribal, and urban programs.
This is a high priority given the increased risk to the IHS’s patient population.
Dr. Poehling emphasized that as Dr. Peacock mentioned in her presentation, careful thought
must be given to the potential for an RSV vaccine recommendation for pregnant persons. This
would be the first time that a vaccine given to a pregnant person would make a modification
necessary in the vaccines that person’s child receive s. This has major implications for IISs and
in terms of avoiding record scatter and duplication of efforts.
Dr. Lee pointed out that this is a new era with regard to thinking about prevention more broadly.
In terms of innovation, this is an important step forward for prevention activities . However,
implementation does take time and there are a lot of complexities with regard to this type of
product.  This is one of the first products the ACIP is considering in this way . Everyone must
work together to consider how to set up implementation in systems across various settings .
While this is going to be difficult in the short -term, this product will open up many more
opportunities and will have major benefit s in the long- term. Recognizing that the numbers would
be small, she asked whether there are any data on immunocompromised populations to
understand whether at 150 days , the level of immunity is durable.
Dr. Jones indicated that the company had a small safety trial in an immunocompromised
population and called upon Sanofi Vaccines to comment further.
Dr. Christian Felter , Sanofi, reported that the immunocompromised study is ongoing. While
there are no additional data at this point, the pharmacokinetics of nirsevimab is consistent
across populations. Significant differences have not been observed in any populations. It is
known that the duration of protection lasts at least 50 days and there are signals that it may last
longer than that.
Ms. Rebecca Coyle (AIRA ) pointed out that Dr. Peaccock did a fabulous job of outlining many of
the challenges for IISs. About 80% of the data come from EHRs and pharmacy systems , which
is a very heterogeneous group of systems. She cautioned that there will be challenges with
EHRs in terms of how quickly EHRs can adopt this and enter it into their systems to be able to
send it to an IIS.
18

 Proposed Clinical Consideration Updates for Nirsevimab
Jefferson Jones, MD, MPH , FAAP, CDR, USPHS (CDC/NCIRD Co -lead, Maternal/Pediatric
RSV WG ) reviewed proposed clinical consideration updates for nirsevim ab. For the timing of
nirsevimab, providers should target administration in the first week of life for infants born shortly
before the start of the RSV season for infants <8 months of age and shortly before the start of
the RSV season for children 8─19 months of age who are at increased risk of severe RSV
disease. While the optimal timing for nirsevimab administration is shortly before the season, it
may be given at any time during the RSV season for age -eligible infants and children who have
not yet received a dose. Based on pre- pandemic patterns, this means nirsevimab could be
administered in most of the continental US from October through the end of March.
Because the timing of the onset , peak , and decline of RSV activity may vary by jurisdiction,
providers can adjust administration schedules based on local epidemiology. For infants born
shortly before or during the RSV season, nirsevimab should be administered within 1 week of
birth. Administration can be during the birth hospitalizat ion or in the outpatient setting. Infants
with prolonged birth hospitalizations due to prematurity or other causes should receive
nirsevimab shortly before or promptly after discharge. Tropical climates may have seasonality
that differs from most of the continental US or that is unpredictable. This may include Southern
Florida, Hawaii, Guam, Puerto Rico, the US Virgin Islands (USVI) , and the U S-affiliated Pacific
Islands. In Alaska, RSV seasonality is less predictable, and the duration of RSV seasons is
often  longer than the national average. Providers in these jurisdictions should consult state,
local, or territorial guidance on the timing of nirsevimab administration .
In accordance with CDC's general best practices for immunizations, simultaneous administration of nirsevimab with age -appropriate vaccines is recommended. In clinical trials,
when nirsevimab was given concomitantly with routine childhood vaccines, the safety and
reactogenicity profile of the co- administered regimen was similar to the childhood vaccines
given alone.
23 When co -administered, nirsevimab is not expected to interfere with the immune
response to other childhood immunizations.24
Children 8–19 months of age are recommended to receive nirsevimab when entering their
second RSV season because of increased risk of severe disease. This includes children with CLD of prematurity who required medical support (chronic corticosteroid therapy, diuretic
therapy, or supplemental oxygen) any time during the 6- month period before the start of the
second RSV season ; children with severe immunocompromise; children with cystic fibrosis with
manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in
the first year of life or abnormalities on chest imaging that persist when stable) or weight -for-
length <10
th percentile;  and AI/AN children.
Nirsevimab is recommended for infants <8 months of age born during or entering their first RSV
season, including those recommended to received palivizumab by the AAP .25 Nirsevim ab is
recommended for children 8─ 19 months of age with increased risk of severe RSV disease and
entering their second RSV season, including those recommended to receive palivizumab by
23 https://www.accessdata.fda.gov/spl/data/2 f08fa60- f674- 432d- 801b- 1f9514bd9b39/2f08fa60-f674- 432d- 801b- 1f9514bd9b39.xml
24 Espocito Front Immunol. 2021 Aug 11;12:708939
25 American Academy of Pediatrics. Committee on Infectious Diseases [Respiratory Syncytial Virus.] In: Kimberlin DW, Barnett ED,
Lynfield R, Sawyer MH, eds. Red Book: 2021 Report of the Committee on Infectious Diseases. Itasca, IL: American Academy of
Pediatrics,  2021.
19

  AAP. Per the FDA label, children who have received nirsevimab should not receive palivizumab
for the same RSV season.26
In terms of precautions and contraindications, providers administering nirsevimab should follow
ACIP ’s general practice guidelines for immunization. Nirsevimab should not be administered to
persons with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a
product component. As mentioned in an earlier presentation, AEs after administration of
nirsevimab without co -administration with any vaccine can be reported to M edWatch online at
www.fda.gov/medwatch or by phone at 1 -800-FDA-1088. AEs or suspected AEs events
following co -administration of nirsevimab with any vaccine should be reported t o the VAERS
and additional reporting of the same AE to MedWatch is not needed.
WG Considerations / Proposed Recommendations
Jefferson Jones, MD, MPH , FAAP, CDR, USPHS (CDC/NCIRD Co -lead, Maternal/Pediatric
RSV WG ) summarized WG considerations and presented the proposed recommendations. In
terms of safety monitoring for nirsevimab , FDA will monitor safety reports submitted by patients,
providers , and the manufacturer to the FDA Adverse Event Reporting System (FAERS) and
VAERS. FDA will monitor other data sources, including the scientific literature, the applicant ’s
periodic safety reports, ongoing clinical studies, and potential other sources (e.g., medical billing
and EHRs) . CDC will monitor reports submitted to VAE RS that involve simultaneous
administration of nirsevimab with childhood vaccines and also will monitor the safety of
nirsevimab in the Vaccine Safety Datalink (VSD). CDC will leverage existing vaccine
effectiveness platforms. The NVSN is an active surveillance system for acute respiratory
infection (ARI) at 7 pediatric medical centers that can assess effectiveness against outpatient
and ED visits and hospitalizations. This platform can capture nirsevimab receipt through parent
interviews, medical record reviews at the primary care provider and birth hospital, and through
state IIS s. Virtual SARS- CoV-2, Influenza, or other Respiratory Viruses Network (VISION ) is a
multi- site EHR- based network that can assess effectiveness against ED and urgent care vi sits,
hospitalization, and critical illness. Nirsevimab effectiveness analyses will be limited to
integrated healthcare system sites that will have more complete capture of nirsevimab receipt
through IIS linkage and claims data. CDC will monitor nirsevimab effectiveness throughout the
season, but end- of-season estimates likely will be the most accurate. The power to estimate
effectiveness depends on n irsevimab uptake and RSV incidence.
RSV genomic surveillance also will be important. Mutations resulting in nirsevimab resistance
have been rarely reported.27 Sanofi and AstraZeneca are sponsoring INFORM -RSV, a global
genomic surveillance study in children less than 5 years, to monitor evolution of RSV strains, F-
protein antigenic sites, and their relationships with clinical features of RSV disease.28 CDC is
planning genomic surveillance of pediatric and adult RSV specimens, including whole genomic
surveillance. This s urveillance will monitor for changes in the F- protein that might result in
nirsevimab resistance.
For the indication for infants <8 months of age born during or entering the RSV season, the WG
found that nirsevimab is safe and effective in reducing the risk of RSV disease, including
hospitalization due to RSV. The WG shared the concerns as outlined in the presentation by Dr.
Peacock on implementation considerations. The WG felt that the use of nirsevimab would be a
reasonable and efficient allocation of resources, but many WG members prefer a lower cost per
26 https://www.accessdata.fda.gov/spl/data/2f08fa60- f674- 432d- 801b- 1f9514bd9b39/2f08fa60-f674- 432d- 801b- 1f9514bd9b39.xml
27 Ahani et al. Nat Comm 2023 14:4347; and Wilkins et al. Lancet Infect Dis 2023; 23: 856– 66
28 Tabor 2020 Dec 17;59(1):e01828 -20
20

   dose. The WG felt that there were limited efficacy and safety data for the indication for children
8─19 months of who had increased risk of severe RSV disease and were entering their second
RSV season. Additionally, there were limited data on the burden of severe disease in the
second RSV season for children with chronic conditions. Therefore, the WG supported the
recommendation of nirsevimab being given to children 8─19 months of age entering their
second RSV season for those who are recommended for palivizumab by the AAP in their
second RSV season and for AI /AN children as described in clinical considerations. The
following is the proposed ACIP voting language:
Infants aged <8 months born during or entering their first RSV season are recommended
to receive one dose of nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5 kg)
Children aged 8– 19 months who are at increased risk of severe RSV disease and
entering their second RSV season are rec ommended to receive one dose of nirsevimab
(200 mg)
Discussion Points
Referring to Slide 5, Dr. Loehr requested clarification that nirsevimab will not interfere with
measles, mumps, and rubella (MMR) and varicella vaccines . In general, there are
considerations for immunoglobulins and live vaccines. In addition, he asked for clarification
about when to start nirsevimab .
Dr. Jones replied that the WG had a presentation and discussion on this. The data are fairly
limited on nirsevimab bein g co- administered with vaccines and immunogenicity. Per discussions
with expert input from CDC immunologists, the risk appear s to be low . Per the FDA label and
CDC’ s general best practices for immunization, the WG felt it appropriate to recommend co -
admini stration of nirsevimab for age- appropriate vaccines.
Dr. Natalie Thornburg emphasized that there are not a lot of data on co-administration of
monoclonal antibody prophylaxis with childhood immunization, given that they are not yet widely used. There are some data for infants who have received palivizumab, with no indication that
they interfere with vaccine responses. Most of the data that are available for co -administration of
vaccines or inhibition of vaccines deal with live -attenuated vaccines. Obviously, this product is
not a vaccine. It is a passive immunization product for which the mechanisms of inhibitions are
not relevant.
In terms of when to start nirsevimab, Dr. Jones reiterated that the trials showed an efficacy of
150 days and that there were some data suggesting that efficacy may last longer than 150 days.
It is important to try to time administration between October through March, which is shortly
before the RSV season. Dr. Poehling request ed input from FDA or Dr. Shimabukuro about how they would collaborate
with the FAERS and VAERS systems in terms of ensuring that everything is captured and there
is a complete picture .
Dr. S himabukuro responded that first and foremost, CDC work s closely w ith FDA to monitor
vaccine safety. For n irsevimab, CDC has worked closely with the Center for Drug Evaluation
and Research (CDER), the Center for Biologics and Research (CBER), and NCIRD to develop
a comprehensive monitoring approach. As mentioned, the home for possible AEs involving
21

 nirsevimab will be the FDA ’s FAERS system . Reports involving nirsevimab and other vaccines
will be sent to VAERS. There is a process for addressing mis -routed reports.
Dr. Poehling stressed that the cost per dose was weighing heavily on her. While she understood
that these have been expensive studies and the company’s process needs to compensate for
that work, she remained concerned about equity. Hospitals will have 1 week to administer this
and there will be a cost differential for a baby born in July versus one born in October.
Therefore, it seemed prudent to have private practices administer it versus the hospital. Also
exacerbating this issue is the rural -urban differential in that locations in rural Am erica would not
have access to this.
Dr. Sanchez emphasized that if nothing else was learned from COVID -19, it was that no one
knows when the RSV seasons will start this year. Continued monitoring of local epidemiology
will help to understand when the opt imal time will be to start administering nirsevimab. In terms
of implementation issues, this is a new medication that will be given to every infant <8 months of
age. However, the benefit will be huge. The main issue for him is whether they will be able to
get a supply for the coming season. Those who have been administering palivizumab really
want nirsevimab. While there will be issues of implementation, he does not think they will be
insurmountable.
Dr. Talbot expressed concern about nirsevimab being referred to interchangeably as a drug and
therapeutic even though ACIP is treating it as a vaccine. For the purpose of monitoring,
considerable effort needs to be made to term this one way to prevent some of the co mplications
that will occur .
Dr. Daley noted that he had received some detailed questions from colleagues, such as whether
it would be considered an administration error if a child who is 8.5 months old and is not in a
high- risk group presents in December during a bad RSV season and receives nirsevimab. He
also stressed the importance of communication to providers about what to say when parents
ask whether nirsevimab is a vaccine. He feels like those conversations are going to come up
thousands of times, and it would help providers to be able to answer this question in a
transparent, honest, and succinct way.
Dr. Jones indicated that the current recommendation is that n irsevimab is recommended for
children less than 8 months of age. Having high- risk condit ions is an exception. Children 8–19
months who are at increased risk of severe RSV disease and entering their second RSV season
are recommended to receive one 200 mg dose of nirsevimab . CDC is working on education and
other materials to help providers and webinars and updated websites are planned for the near
future.
Based on the available evidence, Ms. McNally requested more information about whether there
is any reason to believe that there would be harm to an infant if there was maternal vaccination
and nirsevimab was given to the infant. In addition, she asked whether a Vaccine Information
Statement (VIS) sheet would be provided to parents of infants receiving nirsevimab and what
the adjudication mechanism would be for claims of potential injury from nirsevimab.
Dr. Jones noted that questions referring to maternal vaccine are generally deferred pending
FDA licensure of a maternal vaccine. Maternal antibody from infection is certainly present in
infants, and nirsevimab was likely given to infants born to mothers who were infected recently or
during pregnancy. The consensus is that there is not thought to be any risk from that.
22

 Dr. Peacock indicated that there would be something similar to VIS sheet s. Because nirsevimab
is not a vaccine, the sheet will be called something else but will look similar.
Dr. Grimes from the Health Resources and Services Administration (HRSA) indicated that for
vaccines, the criteria for coverage is typically for routinely administered vaccines and
adjudication is through the national Vaccine Injury Compensation Program (VICP) . That is when
a vaccine has been recommended by CDC for routine administration to children or pregnant
women, subject to an excise tax by federal law, and added to the Vaccine Injury Table by the
Secretary of HHS. The Vaccine Act that governs the VICP does not define “vaccine. ” Of those 3
criteria are met, there is potential route for coverage within the VICP. The VICP and VFC
programs are separate. Inclusion in the VFC would not trigger i nclusion in the VICP or vice
versa.
Dr. Lee praised the work that CDC is doing with AHIP , but expressed concern about the
financing of prevention. While nirsevimab is a fantastic product that has not been available
previously and that has many benefits in terms of the durability of protection compared to other
antibody products that have been used previously for high-risk children, there are challenges in
the ambulatory setting. Pediatricians , family p ractice doctors, and birthing hospitals essentially
have been asked to pay upfront for the cost of products, including vaccines , and then hope for
adequate reimbursement. Pediatricians and family practitioners in small practices will be
bearing the brunt the upfront cost and potentially losing money to be able to deliver these
preventive interventions. In terms of thinking about more innovative strategies for prevention,
she put out a general plea for reconsideration of where the risk will occur. The high c ost is a
burden and disincentive for getting people to do the right thing. Dr. Lee emphasized the critical
importance of aligning incentives and securing the ability to ensure adequate reimbursement,
even at -cost reimbursement .
Dr. Grubb (AHIP) stressed that while activities would depend upon what the ACIP recommends ,
compliance issues would be very similar to compliance issues for any other vaccine. She noted
that other members of AHIP had joined the meeting, and they would take the input back to AHIP. Th is is going to involve a multi -layered response because there are many questions with
regard to issues, such as coding. AHIP looks forward to working with CDC and ACIP on these issues.
Dr. Kotton stressed that because nirsevimab is passive immunization, there could be issues
entering administration into the immunization record and other places . For instance, it was
difficult to get Evusheld into the immunization records in Epic .
Dr. Jones replied that CDC is aware of this issue and continues to work with national and
internal partners to address it.
Dr. Poehling said that while she liked the voting language that was presented and recognized
that it was time- limited, ACIP was in a difficult position because FDA was currently reviewing a
maternal vaccine. The way she interpreted the language was that if the maternal vaccine is
subsequently approved, both nirsevimab and the maternal vaccine would be given. She
stressed that she was not ready to make that decision during this meeting and request ed input
on the WG’s thoughts about how they thought the ACIP should address this. For example, would ACIP have to meet again to vote on maternal vaccine.
Dr. Jones reiterated that the WG would revisit the recommendation at such time that a maternal
vacci ne is licensed by FDA.
23

  Dr. Lee confirmed that the ACIP would have to convene again to vote on a maternal RSV
vaccine and discuss any implications related to the use of n irsevimab at that time.
Dr. Fryhofer (AMA) said that speaking as a practicing physici an, she applauded the WG’s
recommendation to include giving a dose of nirsevimab to AI/AN children in their second RSV
season. Based on the presentations, the rate of RSV hospitalization for these children is 4 to 10
times that of the general population. It also is known that the maternal mortality rates for their
mothers are over twice as high as rates for white women. ACIP and p racticing physicians often
hear about VAERS, but are not as familiar with FAERS . She was relieved to hear that CDC and
FDA work so closely together to make sure that any reported concerns will be made available
to the appropriate agency. In terms of CPT coding, she attended a meeting earlier in the year as
AMA Board Chair of the AMA CPT Advisory Committee . The nuances discussed throughout the
day in the ACIP meeting between vaccines and passive immunizations like nirsevimab have
been anticipated and the issues are already being discussed. And as pointed out in Dr.
Peacock's presentation, the issue about it not being eligible for standalone counseling is an
important one that she will share with the AMA Advisory Committee.
Dr. Whitley -Williams (NMA) applauded the WG and presenters for their careful considerations
and deliberations. She noted that she just returned from the national meeting of the National
Medical Association (NMA) , which is comprised predominantly of African -American physicians.
The presentations during that meeting included a talk on RSV vaccines and another on nirsevimab , which were well-received. In attendance w ere pediatricians , physicians ,
academicians , and inner city and rural providers . Concerns were raised about how nirsevimab
would be recorded and that registries may not be available in the rural areas. She urged that
any communications emphasize the importance of the first of nirsevimab being given in the
hospital prior to discharge, particularly in rural areas where nirsevimab may not be included as
part of the armamentarium of medications. Also important is clear communication that this is a
biologic not a vaccine.
Dr. Loehr said he was looking forward to 2 years from now when this was all in the past. This is
a spectacular advancement that is going to help families and offices and keep children out of
the hospital that will be covered by insurance 2 years from now and all implementation activities
will be in place. While there will be growing pains, he emphasized that they should not lose sight
of how important this advancement is. With regard to the vote language in front of the ACIP , he
favored the first proposal completely. He was wrestling with the second proposal, given that it
would be a very expensive proposal recommendation with a lot of extrapolations. However, he
thought it would promote equity. While he had not decided yet how he would vote, he wanted to
express his hesitation about the second proposal.
In terms of the second proposal, Dr. Long pointed out that the groups who are part of the AAP
recommendations are already receiving p alivizumab, which wou ld be much more expensive
than nirsevimab . The only expansion of the group would be to include AI/AN children who are at
6 to 10 times higher risk for severe disease and hospitalization than the general population. The WG thinks that this would be a very small group of children of about 1% of the population of
children 8─19 months. These children already are costing a lot of money because of
palivizumab and there are not sufficient data to say that the indication for passive protection
should be removed for those who are already receiving palivizumab.
24

          Dr. Jones added that the second indication is expected to be cost -saving for children who
currently are recommended by AAP to receive palivizumab. A nother consideration for the AI/AN
Children is that there are many geographic areas where children who get severe RSV require
emergency air transport to receive appropriate medical care, which was another consideration
of the WG .
Ms. Howell indicated that she was representing the Association of Immunization Managers
(AIM) , which is a membership association comprised of the 64 federally -funded state, territorial,
and city health agencies that administer immunization programs at the local level that administer
the V FC locally and oversee the implementation of IISs. As a group, AIM has been anticipating
nirsevimab availability for a while and has been looking forward to planning assumptions and
collaborating with CDC and others to overcome the challenges regarding implementation. She
pointed out that there is a fee cap in the VFC for the administration of vaccines that are included
in the VFC, and asked whether the fee cap also would apply to nirsevimab even though it is
being classified as a drug and not a vaccine.
Ms. Hance, Centers for Medicare and Medicaid Services ( CMS ) indicated that because
nirsevimab would be administered under the VFC program, the vaccine administration fee
ceiling would have to apply. She explained that the ceiling is the amount a state Medicaid
agency can reimburse a provider, and that a state Medicaid agency has the flexibility to set the
rate up to that ceiling.
Dr. Poehling mad e a motion to approve the ACIP voting language as presented, which Dr.
Sanchez seconded. Dr. Hopkins (NFID) commented that the National Foundation for Infectious Diseases (NFID) has
posted a number of educational materials on RSV and that following the actions of the ACIP on
nirsevimab, they will continue to provide educational materials supporting providers , patients ,
and families going forward. Dr. Lee asked whether there is a minimum interval for children who might be eligible in their
second RSV season, such as a child who is born at the end of season one but who a
practitioner wants to protect through season two .
Dr. Jones responded that there is no minimal interval. Based on pre- pandemic seasonality,
high- risk infant s born at the end of March would be a little over 6 months before the beginning of
October when the second RSV season would start.
In terms of equity, Dr. Daley pointed out that there is a risk of making health equity worse or
increasing inequity with a new product that has so many challenges. While there appears to be a great opportunity to improve health equity with nirsevimab, it is extremely important to
consider those who are coming from a more disadvantaged situation, such as living in a rural area of the country. Regarding implementation, he asked Dr. Peacock to speak to how the ACIP
could help with some of the challenges she raised in her presentation and whether there were
any other issues the committee should discuss during this public session.
Dr. O ’Leary, Pediatric Infectious Diseases Society (PIDS), noted that many of the PIDS
concerns were addressed during this session and expressed excitement about the potential to
prevent many hospitalizations. PIDS is workin g internally and with its partners in the federal,
state , and local governments to focus on the issue of equity as this product is rolled out. AAP
25

   also is working on potential implementation issues and barriers, including communications and
crafting implem entation guidance for its partners.
Dr. Peacock expressed appreciation for all of the comments and the recognition that
implementation is going to be challenging. It is important to remember that this is a new and very exciting product , and this is going to be a transitionary season. She captured a list of
important issues raised related to insurance, coding, equity, et cetera. The VFC is an example
of a program that has successfully addressed health equity issues over the last 30 years. It
provides access not only to children who are on Medicaid, but also children who are under -
insured or uninsured and AI/AN children. All of these considerations are very important, and it
will be necessary to work hand- in-hand with vaccine providers, physicians, nurses, health
departments, and others who are involved to ensure that as much access as possible is
provided during the initial implementation and moving forward. It appears that this season may
be different from the last couple of years. As a reminder, hepatitis B began with a different
recommendation and eventually became given regularly in hospitals. In the near -term with the
rollout, more nirsevimab may be given in the o utpatient setting. It is important to take a step
back and appreciate that this is an amazing time in terms of RSV.
Vaccines for Children Resolution
Jeannie Santoli, MD, MPH (CDC/NCIRD) explained that the purpose of this resolution was to
add the monoclonal antibody preparation n irsevimab for infants to prevent RSV disease to the
VFC program. The first eligible group is infants <8 months of age born during or entering their
first RSV season. The second eligible group is children 8─19 months of age as noted in Table 1
who are at increased risk of severe RSV disease and entering their second RSV season. Table
1 describes children at increased risk of severe RSV disease and Table 2 explains the
recommended immunization schedule and dosage intervals .
For recommended dosage, readers are referred to the product package insert. For
contraindications and p recautions , readers are referred to the package inserts available at:
https://www.accessdata.fda.gov/spl/data/2f08fa60 -f674-432d- 801b -1f9514bd9b39/2f08fa60-
f674- 432d -801b- 1f9514bd9b39.xml .
The following standard statement regarding updates based on published documents also is included in the resolution:
[If an ACIP recommendation or notice regarding RSV prevention is published within 6 months
following this resolution, the relevant language above (except in the eligible groups sections) will be replaced with the language in the recommendation and incorporated by reference to the
publication URL.]
Discussion Points
Referring to Slide 10, Dr. Daley suggested working on the wording of the timing. While he
thought they knew what was intended, it could be clearer.
Dr. Kotton’s requested further clarification of what was meant by “ children with severe
immunocompromised” meant and asked whether further definitions would be provided.
Dr. Jones replied that initially, specific examples were included. However, there was concern
that if the recommendations were overly prescriptive, it may miss others who would qualify.
26

  Dr. Long added that those caring for immunocompromised patients are the best ones to make
these decisions.
Dr. Kotton advocated for clinicians to have some type of guidance, but then leave a more open
clause like, “ as well as other children deemed to be severely immunocompromised by their care
team.”  She stressed that clinicians have been clamoring for fairly specific guidance from the
CDC regarding immunization recommendations, as it can be hard to fully understand what the
recommendations mean. From her perspective, further guidance could be useful. Outstanding
guidance was provided by the CDC during the COVID -19 pandemic regarding the definition of
who is moderately to severely immunocompromised, which she thought changed the field for
the better. She suggested including additional input.
Dr. Lee agreed that it would be extremely beneficial to have at least some “big picture” guidance
on that in the C linical Considerations .
Ms. Goode (APhA) requested clarification on the second vote language about whether someone
receiving a dose in the first season before 8 months of age should receive a second dose in the
second season .
Dr. Jones clarified the recommendations were independent,  with the second pertaining to
children at increased risk. The FDA label specif ies that those who received palivizumab in their
first RSV season can receive n irsevimab in their second RSV season. There are no
disqualifications for the second RSV season related to what did or did not happen in the first
RSV season.
Dr. Long stressed that this was somewhat confusing, but the WG wanted to be sure not to use
the words “second dose” so that the recommendation would not be misinterpreted as 2 doses
being needed.
Dr. Poehling made a motion to accept the VFC R esolution as proposed with the clarification in
the table as noted during the discussion. Dr. Sanchez seconded the motion.
PUBLIC COMMENTS
Overview
The floor was opened for public comment on August 3, 2023 at 2:00 PM ET. Given that many
more individuals registered to make oral public comments than could be accommodated during
this meeting, selection was made randomly via a lottery. Dr. Lee provided a gentle reminder that
the ACIP appreciates diverse viewpoints that are respectful in nature and issue- focused rather
than comments directed at individuals. The comments made during the meeting are included in this document. Members of the public also were invited to submit written public comments to
ACIP through the Federal eRulemaking Portal under Docket Number ID CDC -2023- 0063. Visit
http://www.regulations.gov for access to the docket or to submit comments or read background
documents and commen ts received.
27

     Public Comments
Ms. Susan Hepworth
National Coalition for Infant Health
Thank you so much and thank you for this opportunity to make these comments on behalf of the
National Coalition for Infant Health . We are made up of more than 200 professional, clinical,
community health, and family support organizations —all with the focus of improving the lives of
all infants and their families. I just first want to thank the committee for prioritizing this review of
this immunization. I know the committee has undertaken so much over the last few years
throughout the public health emergency, so we appreciate your prioritizing this review among
what I know are many other competing priorities. We are incredibly pleased and want to thank
you for voting in favor of the VFC resolution. This is a huge step toward ensuring equitable
access a nd reducing the burden of RSV. I would like to make one additional comment and that
is the coalition ’s strong support of equitable and timely access to this prevention in hospitals,
birthing centers, and provider settings. I know this was something that was included in a recent
letter from the American Academy of Pediatrics as well. With strong, clear guidance and
recommendations from the CDC for babies to receive this new immunization prior to being
discharged from the hospital, all babies will have the opportunity to be immunized and protected
before they even leave the hospital setting. I think this measure is what is truly going to ensure
equitable access for all infants, and it is also going to ensure a major reduction in the burden of
RSV. As has been spoken about in prior meetings, the burden of RSV is multifaceted. It is not
just medical, but it is emotional, and it is financial for families as well. With clear guidance, I
think we will be able to ensure that we will not have further existing health disparities. I just want
to thank you all for what you do to protect and improve the health and safety of our nation’s
infants and childr en. Thank you for the opportunity to give these comments.
Laura Burns Transplant Recipients and Immunocompromised Patient Advocacy Group
My name is Laura Burns and I represent TRAIPAG, Transplant Recipient and
Immunocompromised Patient Advocacy Group. Being immunocompromised and vulnerable to
disease, we have a deep sense of kinship with the infants so vulnerable to RSV. We urge you to protect these children and to recommend nirsevimab for RSV prevention. It has been approved
by the FDA and, with your vote, it will be covered by insurance as required under the ACA. But
insurance only covers about 50% of babies, so ACIP members, we intrigue you to resolve that
nirsevimab be added to the Vaccines for Children program so that all babies can be protected.
Nirsevimab would be the first passive immunization product to be included in the CDC
Immunization Schedule, but we think that there is little distinction to be made between active
and passive immunization. The key is what prevents disease. Indeed, Congress sees it this
way, too. Under 26 USC 4132, the term "vaccine" means “any substance designed to be
administered to a human being for the prevention of one or more diseases.” Nirsevimab fits that
bill. Looking to the future, TRAIPAG anticipates you will be faced with a similar decision greatly
affecting our health. Our group represents people of all ages, from people with blood cancers,
autoimmune diseases, organ transplants. Since most of us have low or no response to vaccines, in all fairness, we need alternative preventions. A number of monoclonal antibodies,
for example, are in development for the prevention of COVID: Invivyd, AstraZeneca
SUPERNOVA 3152. Also, antivirals. If one or more of them “passes muster” with the FDA, we
hope that ACP will show the same deliberative care for vulnerable adults that you’re showing
today for infants and that you recommend passive immunizations when they work. This in turn would guarantee that insurance will cover it. Likewise, as there is no vaccines for adults
28

 program yet, the CDC should include whichever preventions work, active or passive, in both the
bridge access and the VFC programs. This will ensure equity and that everyone, child or adult,
will have affordable access to life- saving immunizations at least through 2024. Thinking back, I
want you to know that Evusheld was a godsend for us and for our families and friends who got to be with us. So was REGEN -COV for post -exposure prophylaxis (PEP) before that.
Unfortunately, not all of us had access. With commercialization, equitable access is an even
larger issue, but one you should tackle. If you will indulge me for just a few seconds, Dr. Lee, we
were truly heartened by your comments today earlier about how groundbreaking this step is and
how it opens up new avenues for preventing disease in the immunocompromised. While it may
be initially complicated, it will be well worth working through those issues. Thank you and thank
you all very, very much for all you do. We urge you to vote “yes” on all of these.
Claire Hannan
Executive Director
Association of Immunization Managers
Good afternoon and thank you for the opportunity to comment on the potential implementation
of the RSV monoclonal antibody, nirsevimab. We are excited that this groundbreaking opportunity to protect infants from RSV. I’m Claire Hannan, Executive Director of the
Association of Immunization Managers , or AIM. AIM is a membership association whose
members direct the immunization programs in the 64 federally -funded state, territorial, and local
health agencies. In partnerships with CDC, these jurisdictions administer the Vaccines for
Children , or VFC , program and work to assure protection of the population through vaccination.
Last week, we polled jurisdictions about their ability to incorporate nir sevimab into their
programs, including the Vaccines for Children program, and you’ ve discussed this mightily today
already . Among respondents, 52% report that their immunization information systems can
document nirsevimab, 22% cannot , and 26% report that it is unknown. Reported challenges
include lack of funding for the IIS vendor and lack of information on coding. 68% report that their
IIS can be used for ordering nirsevimab in the VFC program, 14% that their IIS cannot be used,
and 18% report unknown. Additional time and funding were the cited barriers to incorporate into
IIS ordering applications. Additional challenges cited in the poll include the lack of participation
of birthing hospitals in the VFC program, concern about data exchange between electronic
health records and IIS, and lack of adequate time and guidance to prepare. The poll
demonstrates that time and funding are needed to incorporate this new product into VFC and
other existing programs. However, the jurisdictions have not received guidance or assumptions
to prepare for potential recommendation, such as the information needed to incorporate
nirsevimab into VFC ordering applications and packaging and storage information. Jurisdictions
have not been able to hold discussions with CDC or IIS vendors to address challenges with
coding and tracking. What is most concerning to the incorporation of this potentially life -saving
product into existing childhood programs is that jurisdictions have suffered an average loss of
20% in funding for their IIS due to rescission of COVID funds. ACIP is holding this s pecial
meeting in August in order to vote on this life- saving product in time for the upcoming flu and
RSV season. However, jurisdictions responsible for implementation have not been involved in
the planning discussions. The lack of federal communication to and coordination with jurisdiction
immunization programs continues to impact the ability of immunization program managers to roll
out new and important products with maximum impact. They cannot be expected to deploy
critical products such as nirsevimab without the information and time needed to execute these
programs. We urge our federal partners to find ways to work with jurisdictions and provide
planning assumptions earlier in the process and to share critical information as it becomes
available. Thank you so much for the opportunity to comment today.
29

 VOTES
Dr. Grace Lee (ACIP Chair) pointed out that while the votes for the recommendations were
moved and seconded together, the ACIP would vote on each proposed recommendation and
the VFC Resolution separately:
Vote #1 RSV Maternal/Pediatric Recommendations
Infants aged <8 months born during or entering their first RSV season are recommended to
receive one dose of nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5 kg).
Vote #2 RSV Maternal/Pediatric Recommendations
Children aged 8– 19 months who are at increased risk of severe RSV disease and entering their
second RSV season are recommended to receive one dose of nirsevimab (200 mg).
Vote #3: VFC Resolution: RSV Maternal/Pediatric
Approve the Vaccines for Children (VFC) Resolution for nirsevimab.
Motion/Vote #1 RSV Maternal/Pediatric
Dr. Poehling made a motion to amend the proposed Vote #1 recommendation stating , “Infants
aged <8 months born during or entering their first RSV season are recommended to receive one
dose of nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5 kg). Dr. Sanchez
seconded the motion. No COIs were declared. The motion carried with 10 affirmative votes, 0
negative votes, and 0 abstentions. The disposition of the vote was as follows:
10 Favored: Bahta, Chen, Daley, Lee, Loehr, Long, McNally, Poehling, Sanchez, Talbot
0 Opposed: N/A
0 Abstained: N/A
Motion/Vote #2 RSV Maternal/Pediatric
Dr. Poehling made a motion to amend the proposed Vote #2 recommendation stating , “Children
aged 8–19 months who are at increased risk of severe RSV disease and entering their second
RSV season are recommended to receive one dose of nirsevimab (200 mg). ” Dr. Sanchez
seconded the motion. No COIs were declared. The motion carried with 10 affirmative votes, 0
negative votes, and 0 abstentions. The disposition of the vote was as follows:
10 Favored: Bahta, Chen, Daley, Lee, Loehr, Long, McNally, Poehling, Sanchez, Talbot
0 Opposed: N/A
0 Abstained: N/A
30

 Motion/Vote #3: VFC Resolution RSV Maternal/Pediatric
Dr. Poehling made a motion to amend the proposed Vote #3 recommendation for the VFC
Resolution stating , “Approve the Vaccines for Children (VFC) Resolution for nirsevimab. ” Dr.
Sanchez seconded the motion. No COIs were declared. The motion carried with 11 affirmative
votes, 0 negative votes, and 0 abstentions. The disposition of the vote was as follows:
11 Favored: Bahta, Chen, Daley, Kotton, Lee, Loehr, Long, McNally, Poehling, Sanchez,
Talbot
0 Opposed: N/A
0 Abstained: N/A
Discussion Points
Dr. Talbot expressed her excitement about nirsevimab, which she thinks will be incredible and
life-changing. She emphasized that as had been pointed out , there are a lot of logistics to work
out. Dr. Long recognized the remarkable, committed work of the WG who engaged in many
discussions about all of the issues raised during this meeting. She felt that the WG thoroughly
dealt with what they could based on the available data and their best assumptions for the
unknowns. This is a milestone in that it is the first antibody protection against the remark ably
high remaining burden of disease in children, so parents should be relieved that they will not
have to be concerned about the likelihood that their children could be hospitalized with RSV
disease. As with every breakthrough, there is the feeling of responsibility and the burden that
this is the firs t time an antibody will be administered universally. All of the safeguards are in
place and there have been no signals of AEs within the small trials that were conducted. The
WG also does not believe there is any biologic plausibility that there will be any interference with
any immunization or live virus vaccine. The WG was extraordinar ily disappoint ed w ith the price-
setting of the manufacturer and wanted to assure the ACIP and public that should a maternal
vaccine be licensed, the WG will address the cost issue of that product as well.
Dr. Sanchez agreed that this is great and exciting news for a product that everyone has been
eagerly awaiting. There has been considerable experience with palivizumab, which has to be
given monthly and has high costs as wel l. Practitioners have been waiting to be able to give
safe and effective protection to every baby and this is fantastic news. While this is just the first
step, it is an extremely important step in the right direction for the major public health problem of
RSV.
Dr. Lee echoed all of the comments regarding what an amazing milestone this is, emphasized
the importance of continuing to monitor ongoing effectiveness and safety, and pointed out the
importance of the ACIP hearing updated presentations in the future to demonstrate that there is follow- up on these specific areas and the impact of implementation on equity. While she
recognized that implementation is not necessarily the purview of the ACIP, how nirsevimab use
gets implemented and its impact on equity may impact how the ACIP rethink s recommendations
in the future. She expressed gratitude to the CDC team, the FDA team, the WG, and everyone
else who has done a phenomenal job steering this through and getting this product to market.
31

  Dr. Daley thank CDC colleagues for their work on getting the ACIP to the point at which they
could vote on a VFC Resolution for nirsevimab. He suspected that it was not an easy
undertaking. He emphasized that the f olks within CDC are tremendously devoted to public
health and have been doing everything they could to make this happen. He recalled that during
the February 2023 ACIP meeting, this looked somewhat more daunting, yet now they had voted
on the recommendations and the VFC Resolution . He expressed gratitude to those who saw
this as so important to include this in the VFC Program in order to provide the maximum public
health benefit for RSV.
Dr. Romero added his thanks to the members of the ACIP and the WG for all of the deliberation
and work they all put into this effort. This marked a historic event and he thought they would be able to look back in a short period of time and see what a major impact this vote has had on the
health and well -being of children in the US. He said he thought this would mark one of the major
accomplishments of the ACIP, for which he congratulated the committee.
32

  CERTIFICATION
Upon reviewing the foregoing version of the August 3, 2023 ACIP meeting minutes, Dr. Grace
Lee, ACIP Chair, certified that to the best of her knowledge, they are accurate and complete.
Her original, signed certification is on file with the Management Analysis and Services Office
(MASO) of CDC.
33

  ACIP MEMBERSHIP ROSTE R
CHAIR
LEE, Grace M, MD, MPH
Associate Chief Medical Officer for Practice Innovation Lucile Packard Children’s Hospital
Professor of Pediatrics, Stanford University School of Medicine
Stanford, CA
Term: 8/4/2021 – 6/30/2023
EXECUTIVE SECRETARY
WHARTON, Melinda, MD, MPH
National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention
Atlanta, GA
MEMBERS
BAHTA, Lynn, RN, MPH, CPH
Immunization Program Clinical Consultant
Infectious Disease, Epidemiology, Prevention & Control Division
Minnesota Department of Health Saint Paul, Minnesota
Term: 7/1/2019 – 6/30/2023
CHEN, Wilbur H, MD, MS, FACP, FIDSA
Professor of Medicine
Center for Vaccine Development and Global Heal th
University of Maryland School of Medicine Baltimore, MD
Term: 12/23/2020 – 6/30/2024
DALEY, Matthew F, MD Senior Investigator
Institute for Health Research, Kaiser Permanente Colorado
Associate Professor of Pediatrics University of Colorado School of Medicine
Aurora, CO
Term: 1/4/2021 – 6/30/2024
KOTTON, Camille Nelson, MD, FIDSA, FAST
Clinical Director, Transplant and Immunocompromised Host Infectious Diseases
Infectious Diseases Division, Massachusetts General Hospital
Associate Professor of Medicine, Harvard Medical School
Boston, MA Term: 12/23/2020 – 6/30/2024
34

  LOEHR, Jamie, MD, FAAFP
Owner, Cayuga Family Medicine Ithaca, New York
Term: 7/26/2021 – 6/30/2025
LONG, S arah S, MD
Professor of Pediatrics
Drexel University College of Medicine Section of Infectious Diseases
St. Christopher’s Hospital for Children
Philadelphia, Pennsylvania
Term: 12/24/2020 – 6/30/2024
MCNALLY, Veronica V, JD
President and CEO Franny
Strong Foundation
West Bloomfield, Michigan Term: 10/31/2018 – 6/30/2022
POEHLING, Katherine A, MD, MPH
Professor of Pediatrics and Epidemiology and Prevention Director, Pediatric Population Health Department of Pediatrics
Wake Forest School of Medicine Winston- Salem, NC
Term: 7/1/2019 – 6/30/2023
SÁNCHEZ, Pablo J, MD Professor of Pediatrics
The Ohio State University – Nationwide Children’s Hospital
Divisions of Neonatal- Perinatal Medicine and Pediatric Infectious Diseases
Director, Clinical & Translational Research (Neonatology) Center for Perinatal Research
The Research Institute at Nationwide Children's Hospital Columbus, Ohio
Term: 7/1/2019 – 6/30/2023
TALBOT, Helen Keipp, MD
Associate Professor of Medicine Vanderbilt University
Nashville, TN Term: 10/29/2018 – 6/30/2022
35

  EX OFFICIO MEMBERS
Centers for Medicare and Medicaid Services (CMS)
HANCE, Mary Beth
Senior Policy Advisor Division of Quality, Evaluations and Health Outcomes
Children and Adults Health Programs Group
Center for Medicaid, CHIP and Survey & Certification Centers
for Medicare and Medicaid Services
Baltimore, MD
Food and Drug Administr ation (FDA)
FINK, Doran, MD, PhD
Deputy Director, Clinical, Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration Silver Spring, MD
Health Resources and Services Administration (HRSA)RUBIN, Mary, MD Chief Medical Officer
Division of Injury Compensation Programs
Rockville, MD
Indian Health Service (IHS)
CLARK, Matthew, MD, FAAP, FACP
Physician
Chair, IHS National Pharmacy & Therapeutics Committee
Durango, CO
Office of Infectious Disease and HIV/AIDS Policy (OIDP)
KIM, David, MD, MA
Director, Division of Vaccines, OIDP
Office of the Assistant Secretary for Health Department of Health and Human Services
Washington, DC
National Institutes of Health (NIH)
BEIGEL, John, MD
Associate Director for Clinical Research
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, MD
36

  LIAISON REPRESENTATIVES
American Academy of Family Physicians (AAFP)
ROCKWELL, Pamela G, DO
Associate Professor, Department of Family Medicine, University of Michigan Medical School
Medical Director, Dominos Farms Family Medicine
Ann Arbor, MI
American Academy of Pediatrics (AAP)
MALDONADO, Yvonne, MD
Senior Associate Dean for Faculty Development and Diversity
Professor of Pediatrics and Health Research and Policy
Chief, Division of Pediatric Infectious Diseases Stanford University School of Medicine
Stanford, CA
American Academy of Pediatrics (AA P)
Red Book Editor
KIMBERLIN, David, MD
Professor of Pediatrics
Division of Pediatric Infectious Diseases The University of Alabama at Birmingham School of Medicine
Birmingham, AL
American Academy of Physician Assistants (AAPA)LÉGER, Marie -Michèl e, MPH, PA -C
Senior Director, Clinical and Health Affairs American Academy of Physician Assistants
Alexandria, VA
American College Health Association (ACHA)CHAI, Thevy S., MD
Director of Medical Services
Campus Health Services
University of North Carolina at Chapel Hill Chapel Hill,
NC
American College Health Association (ACHA) (alternate)
MCMULLEN, Sharon, RN, MPH, FACHA Assistant Vice President of Student & Campus Life for Health and Wellbeing Cornell Health Ithaca, NY
American College of Nurse Midwives (ACNM)HAYES, Carol E., CNM, MN, MPH Lead Clinician
Clinical Quality Compliance and Management
Planned Parenthood Southeast  Atlanta, GA
37

  American College of Nurse Midwives (ACNM) (alternate)
MEHARRY, Pamela M., PHD, CNM
Midwifery Educator, Human Resources for Health
In partnership with University of Rwanda and University of Illinois, Chicago
American College of Obstetricians and Gynec ologists (ACOG)
ECKERT, Linda O, MD, FACOG
Professor, Department of Obstetrics & Gynecology
Adjunct Professor, Department of Global Health University of Washington
Seattle, WA
American College of Physicians (ACP)
GOLDMAN, Jason M , MD, FACP
Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic University, Boca Raton, Florida
Private Practice
Coral Springs, FL
American Geriatrics Society (AGS)
SCHMADER, Kenneth, MD Professor of Medicine- Geriatrics Geriatrics
Division Chief Duke University and Durham VA Medical Centers
Durham, NC
America’s Health Insurance Plans (AHIP)
GLUCKMAN, Robert A, MD, MACP Chief Medical Officer, Providence Health Plans
Beaverton, OR
American Immunization Registry Association (AIRA)
COYLE, Rebecca, MSEd
Executive Director, AIRA
Washington, DC
American Medical Association (AMA)
FRYHOFER, Sandra Adamson, MD
Adjunct Associate Professor of Medicine Emory
University School of Medicine
Atlanta, GA
American Nurses Association (ANA)
RITTLE, Charles (Chad), DNP, MPH, RN Assistant
Professor, Nursing Faculty Chatham University, School of Health Sciences
Pittsbu rgh, PA
38

 American Osteopathic Association (AOA)
GROGG, Stanley E, DO
Associate Dean/Professor of Pediatrics
Oklahoma State University -Center for Health Sciences
Tulsa, OK
American Pharmacists Association (APhA)
HOGUE, Michael D., PharmD, FAPhA, FNAP
Dean and Professor of Loma Linda University School of Pharmacy Director, Center for Interprofessional Education & Practice Loma Linda, CA
Association of Immunization Managers (AIM)
HOWELL, Molly, MPH
Immunization Program Manager North Dakota Department of Health
Bismarck, ND
Association for Prevention Teaching and Research (APTR)
ZIMMERMAN, Richard, MD, MPH
Professor
University of Pittsburgh School of Medicine
Department of Family Medicine and Clinical Epidemiology Pittsburgh, PA
Association of State and Territorial Health Officials (ASTHO)SHAH, Nirav D, MD, JD Director
Maine Center for Disease Control and Prevention
Augusta, ME
Biotechnology Industry Organization (BIO)
ARTHUR, Phyllis A, MBA
Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy Washington, DC
Council of State and Territorial Epidemiologists (CSTE)
HAHN, Christine, MD
State Epidemiologist
Office of Epidemiology, Food Protection and Immunization Idaho
Department of Health and Welfare Boise, ID
Council of State and Territorial Epidemiologists (CSTE) (alternate)
LETT, Susan, MD, MPH Medical Director, Immunization Program
Division of Epidemiology and Immunization
Massachusetts Department of Public Health
Boston, MA
39

  Canadian National Advisory Committee on Immunization (NACI)
DEEKS, Shelley, MD, MHSc, FRCPC, FAFPHM
Deputy Chief Medical Officer of Health, Department of Health and Wellness, Nova Scotia
Associate Professor, Dalla Lana School of Public Health, University of Toronto
Chair, National Advisory Committee on Immunization
Halifax, Nova Scotia
Infectious Diseases Society of America (IDSA)
BAKER, Carol J., MD
Professor of Pediatrics
Molecular Virology and Microbiology Baylor College of Medicine
Houston, TX
International Society for Travel Medicine (ISTM)
BARNETT, Elizabeth D, MD Professo r of
Pediatrics Boston University School of Medicine Boston, MA
National Association of County and City Health Officials (NACCHO)
ZAHN, Matthew, MD
Medical Director, Epidemiology
Orange County Health Care Agency
Santa Ana, CA
National Associa tion of County and City Health Officials (NACCHO) (alternate)
DUCHIN, Jeffrey, MD
Health Officer and Chief, Communicable Disease
Epidemiology and Immunization Section Public Health - Seattle and King County
Professor in Medicine  Division of Allergy and Infectious Diseases
University of Washington School of Medicine and School of Public Health
Seattle, WA
National Association of Pediatric Nurse Practitioners (NAPNAP)
STINCHFIELD, Patricia A, RN, MS, CPNP
Director Infectious Disease/Immunology/Infection Control
Children's Hospitals and Clinics of Minnesota
St. Paul, MN
National Foundation for Infectious Diseases (NFID)
SCHAFFNER, William, MD
Chairman, Department of Preventive Medicine
Vanderbilt University School of Medicine
Nashville, TN
40

  National Foundation for Infectious Diseases (NFID) (alternate)
DALTON, Marla, PE, CAE
Executive Director & CEO
National Foundation for Infectious Diseases (NFID)
Bethesda, MD
National Medical Association (NMA)
WHITLEY -WILLIAMS, Patricia, MD Professor and Chair
University of Medicine and Dentistry of New Jersey Robert Wood
Johnson Medical School
New Brunswick , NJ
Pediatric Infectious Diseases Society (PIDS)
O’LEARY, Sean, MD, MPH Associate Professor of Pediatrics
Pediatric Infectious Diseases
General Academic Pediatrics
Children’s Hospital Colorado
University of Colorado School of Medicine
Pediatric Infectious Diseases Society (PIDS) (alternate)
SAWYER, Mark H, MD Professor of Clinical Pediatrics University of California, San Diego School of Medicine
San Diego, CA
Pharmaceutical Research and Manufacturers of America (PhRMA)ROBERT SON, Corey, MD, MPH
Senior Director, US Medical, Sanofi Pasteur
Swiftwater, PA
Society for Adolescent Health and Medicine (SAHM)
MIDDLEMAN, Amy B, MD, MSEd, MPH
Professor of Pediatrics
Chief, Section of Adolescent Medicine
University of Oklahoma Health Sciences Center
Oklahoma City, OK
Society for Healthcare Epidemiology of America (SHEA)DREES, Marci, MD, MS
Chief Infection Prevention Officer & Hospital Epidemiologist
ChristianaCare Wilmington, DE
Associate Professor of Medicine
Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA
41
42

  ACRONYMS USED IN  THIS  DOCUMENT
AAFP American Academy of Family Physicians
AAP American Academy of Pediatrics
ACA Affordable Care Act
ACHA American College Health Association
ACIP Advisory Committee on Immunization Practices
ACOG American College of Obstetricians and Gynecologists
ACP American College of Physicians
AE Adverse Event
AHIP America’s Health Insurance Plans
AI/AN American Indian/Alaskan Native
AIM Association of Immunization Managers
AIRA American Immunization Registry Association
AMA American Medical Association
AMDAC Antimicrobial Drug Advisory Committee
AOA American Osteopathic Association
APhA American Pharmacists Association
AR Adverse Reaction
ARI Acute Respiratory Illness
ASTHO Association of State and Territorial Health Officers
AUC Area Under the Curve
BLA Biologics License Application
CDC Centers for Disease Control and Prevention
CDER Center for Drug Evaluation and Research
CDS Clinical Decision Support
CHD Chronic Heart Disease
CLD Chronic Lung Disease
CMS Center for Medicare and Medicaid Services
COI Conflict of Interest
CONUS Continental United States
CPT Current Procedural Terminology
CSTE Council of State and Territorial Epidemiologists
DFO Designated Federal Official
DoD Department of Defense
DSMB Data Safety Monitoring Board
ED Emergency Department
EHRs Electronic Health Records
EMR Electronic Medical Record
ET Eastern Time
EtR Evidence to Recommendation
FAERS FDA Adverse Event Reporting System
FDA Food and Drug Administration
GRADE Grading of Recommendation Assessment, Development and Evaluation
HARMONIE Hospitalized RSV Monoclonal Antibody Prevention
HCP Healthcare Personnel / Providers
HHS (Department of) Health and Human Services

   HRSA Health Resources and Services Administration
ICU Intensive Care Unit
IDSA Infectious Disease Society of America
IHS Indian Health Service
IIS Immunization Information System
IM Intramuscular
IT Information Technology
IVIG Intravenous Immunoglobulin Therapy
LRTD Lower Respiratory Tract Disease
LRTI Lower Respiratory Tract Illness
MA-RSV LRTI Medically -Attended RSV Lower Respiratory Tract Infection
MASO Management Analysis and Services Office
MELODY Prevention of Medically Attended Lower Respiratory Tract Infection Due to
Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants
mAbs Monoclonal Antibodies
MMWR Morbidity and Mortality Weekly Report
NACCHO National Association of County and City Health Officials
NACI National Advisory Committee on Immunization Canada
NAPNAP National Association of Pediatric Nurse Practitioners
NCEZID National Center for Emerging and Zoono tic Infectious Diseases
NCIRD National Center for Immunization and Respiratory Diseases
NFID National Foundation for Infectious Diseases
NIAID National Institute of Allergy and Infectious Diseases
NIH National Institutes of Health
NMA National Medical Association
NMD Neuromuscular Disease
NVAC National Vaccine Advisory Committee
NVPO National Vaccine Program Office
NVSN New Vaccine Surveillance Network
OIDP Office of Infectious Disease and HIV/AIDS Policy
OTASA Office of Tribal Affairs and Strategic Alliances
PCP Primary Care Provider/Practitioner
PCR Polymerase Chain Reaction
PEP Post-Exposure Prophylaxis
PHAC Public Health Agency Canada
PICO Population, Intervention, Comparison, Outcomes
PIDS Pediatric Infectious Disease Society
QALY Quality -Adjusted Life Year
RCT Randomized Controlled Trial
SAB Spontaneous Abortion
SAE Serious Adverse Event
SAHM Society for Adolescent Health and Medicine
SHEA Society for Healthcare Epidemiology of America
SME Subject Matter Expert
UK United Kingdom
US United States
USG United States Government
USVI US Virgin Islands
VAERS Vaccine Adverse Event Reporting System
43

 VE Vaccine Efficacy
VE Vaccine Effectiveness
VFC Vaccines For Children
VICP National Vaccine Injury Compensation Program
VIS Vaccine Information Statement
VISION Virtual SARS -CoV-2, Influenza, or Other Respiratory Viruses Network
VSD Vaccine Safety Datalink
WG Work Group
44

Summary: MEETING OF THE ADVISORY  COMMITTEE ON IMMUNIZATION  PRACTICES (ACIP)  AUGUST 3, 2023  MEETING SUMMARY  CONTENTS   THURSDAY: AUGUST 3, 2023 .................................................................................................................... 2  WELCOME AND INTRODUCTIONS ...................................................................................... 2  Call to Order/Roll Call…