summary 2023 09 22 508

MEETING OF THE ADVISORY
COMMITTEE ON IMMUNIZATION
PRACTICES (ACIP)
SEPTEMBER 22 , 2023
MEETING SUMMARY
CONTENTS
FRIDAY: SEPTEMBER 22, 2023 .................................................................................................................. 2
WELCOME AND INTRODUCTIONS ........................................................................................................ 2
Call to Order/Roll Call ........................................................................................................................... 2
Announcements .................................................................................................................................... 2
MATERNAL/PEDIATRIC RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINES ................................ 3
Session Introduction .............................................................................................................................. 3
RSVpreF Vaccine Safety Surveillance in Pregnancy from the VSD ..................................................... 4
Maternal RSV Vaccine Safety Monitoring in VAERS and v -safesm....................................................... 8
An Economic Analysis of RSVpreF Mater nal Vaccination .................................................................. 10
Economics of Preventing RSV Disease among US Infants by Maternal Vaccination Prior to Birth ...13
EtR Framework Updates : Pfizer Maternal RSVpreF Vaccine.............................................................17
Updat
ed Clinical Considerations for Use of Both Nirsevimab and Pfizer RSVpreF Vaccine .............. 28
Implementation Considerations for Maternal RSV Vaccine ................................................................ 32
Vaccines for Childrens Resolution ...................................................................................................... 34
Pfizer Statement .................................................................................................................................. 36
Liaison Organization Statements ........................................................................................................ 37
ACIP Discussion Points, Observations, Suggestions for RSV Vaccine .............................................. 38
PUBLIC COMMENTS .............................................................................................................................. 47
Overview ............................................................................................................................................. 47
Public Comments ................................................................................................................................ 47
VOTES ..................................................................................................................................................... 49
Vote #1 RSV Maternal RSV Vaccine Recommendation ..................................................................... 49
Vote #2 VFC Resolution Maternal RSV Vaccine ................................................................................ 49
ADULT AND PEDIATRIC IMMUNIZATION SCHEDULE ADDENDUM .................................................. 52
Presentation ........................................................................................................................................ 52
Liaison Statements .............................................................................................................................. 54
CERTIFICATION ......................................................................................................................................... 58
ACIP MEMBERSHIP ROSTER .................................................................................................................. 59
ACRONYMS USED IN THIS DOCUMENT ................................................................................................. 68

  FRIDAY : SEPTEMBER 22 , 2023
WELCOME AND INTRODUCTIONS
Call to Order/Roll Call
Dr. Grace Lee (ACIP Chair) called to order and presided over the September 22, 2023
Advisory Committee on Immunization Practices (ACIP ) meeting. Dr. Lee conducted 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 2:30 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://w ww.regulations.gov using Docket Number ID CDC- 2023-00 76. 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.
2

 MATERNAL/PEDIATRIC RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINES
Session Introduction
Sarah S. Long, MD (Chair, Maternal/Pediatric RSV WG) reminded everyone that each year in
the United States (US) children less than 5 years of age, RSV is associated 100 to 300 deaths,1
50,000 to 80,000 hospitalizations,2 approximately 500,000 emergency department (ED) visits ,3
and about 1.5 million outpatient visits.3 RSV is the leading cause of hospitalization in US
infants .4 Most (68%) infants are infected in the first year of life and nearly all (97%) have been
infected by 2 years of age.5 Approximately 2% to 3% of young infants will be hospitalized for
RSV.6 RSV is the most common cause of lower respiratory tract infection (LRTI) in infants. The
highest RSV hospitalization rates occur in the first months of life and risk declines with
increasing age in early childhood.7 About 79% of children hospitalized with RSV under 2 years
of age had no underlying medical conditions,8 which is very important to keep in mind .
Topics of previous WG presentations to the ACIP regarding RSV prefusion F protein (RSV preF)
vaccine have included epidemiology and burden of RSV in infants ; virology and immunology of
RSV; safety and efficacy of RSVpreF; c ost-effectiveness analysis for RSVpreF (CDC model);
cost-effectiveness analysis for RSVpreF (comparison with the manufacturer model); Evidence to
Recommendations (EtR) framework for RSVpreF; and clinical considerations for RSVpreF .
On August 21, 2023, the Food and Drug Administration (FDA) approved Pfizer ’s RSV preF
vaccine for use in pregnant people for the prevention of lower risk for RSV lower respiratory
tract disease (LRTD) and severe LRTD in infants born and from birth to 6 months of age.9 The
vaccine is approved as a single- dose to begin at 32─ 36 weeks of gestation. In Phase 2b and
Phase 3 trials , vaccination was given during 24─ 36 weeks gestation . A numerical imbalance in
preterm births was observed in RSVpreF vaccine compared to placebo recipients in 2 clinical studies. Available data are insufficient to establish or exclude a causal relationship between
preterm birth and RSVpreF. Additionally, a numerical imbalance in hypertensive disorders of
pregnancy was observed in RSVpreF vaccine compared to placebo recipients. Starting dosing
at 32 weeks gestation can reduce the potential risk of and complications from preterm birth until
additional safety data are available. This avoids the risk of extremely preterm births, where there is substantive morbidity and mortality, and very preterm births. Similar vaccine efficacy (VE) in
32─36 weeks gestation compared to the overall study population. FDA has required the
manufacturer to conduct post -marketing studies to assess preterm birth and hypertensi ve
disorders of pregnancy, including pre- eclampsia.
1 Thompson et al, JAMA, 2003; and Hansen et al, JAMA Network Open, 2022
2 Hall et al, NEJM, 2009; and McLaughlin et al, J Infect Dis, 2022
3 Hall et al, NEJM, 2009
4 Suh et al. JID 2022
5 Glezen et al, Arch Dis Child, 1986
6 Hall et al, Pediatrics, 2013; Langley & Anderson, PIDJ, 2011; and CDC NVSN data
7 Hall et al, NEJM, 2009; and CDC NVSN data
8 Hall et al, NEJM, 2009
9 https://www.fda.gov/news- events/press -announcements/fda- approves -first-vaccine -pregnant -individuals -prevent -rsv-infants ;
https://www.fda.gov/media/171482/download?attachment; and https://www.fda.gov/media/171492/download?attachment
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   RSVpreF vaccine is one of two available preventive products for RSV in infants. On August 3, 2023, ACIP recommended nirsevimab for RSV prevention in infants . Infants aged <8 months
born during or entering their first RSV season are recommended to receive 1 dose of
nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5 kg). Children 8 ─19 months of age
who are at increased risk of severe RSV disease and en tering their second RSV season are
recommended to receive 1 dose of nirsevimab (200 mg) .
Both nirsevimab and maternal RSV vaccine provide passive immunity .
10 A person develops
active immunity from infection or vaccination, which triggers an immune respons e. Immunologic
memory provides prolonged protection that may be lifelong. Passive immunity is the transfer of
preformed antibody produced externally to provide protection to the recipient, such as from mother to baby through transplacental or breastmilk transfer; or through direct administration of
antibodies, such as i ntravenous immunoglobulin (IVIG) t herapy or monoclonal antibodies.
Passive immunity provides temporary protection that wanes with time.
This meeting included presentations on the following:
RSVpreF Vaccine Safety Surveillance in Pregnancy from The Vaccine Safety Datalink
(VSD)
Maternal RSV Vaccine Safety Monitoring in the Vaccine Adverse Event Reporting System
(VAERS) and v -safe
sm
An Economic Analy sis of RSVpreF Maternal Vaccination
Economics of Preventing RSV Disease among US Infants by Maternal Vaccination Prior to
Birth
EtR Framework Updates: Pfizer Maternal RSVpreF Vaccine Updated Clinical Considerations for Use of Both Nirsevimab and Pfizer RSVpreF V accine
Implementation Considerations for Maternal RSV Vaccine
Vaccines for Childrens Resolution
In closing, Dr. Long presented the Policy Question under consideration:
“Should Pfizer RSVpreF vaccine be recommended for pregnant people to be given during 32
through 36 weeks gestation to prevent RSV lower respiratory tract infection in infants?”
RSVpreF Vaccine Safety Surveillance in Pregnancy from the VSD
Malini DeSilva, MD, MPH (HealthPartners Institute) reminded everyone that the VSD is a
collaborative project between CDC ’s Immunization Safety Office (ISO) and integrat ed health
care organizations in the US. The VSD monitors the safety of vaccines used in the US through
real-world data of rare and serious events following vaccination. The project includes data on
approximatel y 15.5 million individuals across all sites annually, with approximately 115,000
annual live births. Data are organized using a common data model with standardized coding
systems. There are 13 VSD sites across the country that provide clinical, methodological, and data expertise, 11 of which provide data for the project .
10 https://www.cdc.gov/vaccines/vac -gen/immunity -types.htm
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  The VSD’s data structure is based on a distributed data model in which each VSD site creates
standardized data files used in multi- site studies. Each VSD site defines a cohort for inclusi on
based on enrollment in the site’ s health plan and/or care received at the VSD site. Once a
cohort has been defined, files for vaccine administrations, medical diagnoses, and procedures
from inpatient , outpatient, and ED visits and birth and death files are created. The dynamic
pregnancy episode files uses validated algorithms for identifying ongoing and completed
pregnancies. This file is updated weekly. Information in this file includes the pregnancy start
date, or last menstrual period (LMP), gestational age of the pregnancy, and pregnancy
outcomes when available. A mom baby linkage file allows for evaluation of infant outcomes
following prenatal vaccinations. Ancillary drug or laboratory files are available on an ad hoc
basis for specific studies . Automated data files are supplemented with chart reviews as needed.
The VSD has been evaluating the safety of vaccines administered during pregnancy for more
than 10 years. The RSV preF vaccine manufactured by Pfizer has been shown to be effective
against severe RSV -associated LRTIs in infants. RSV preF clinical trial data on safety in
pregnant persons identified injection site pain as the most common reactogenicity event and
identif ied an imbalance in preterm births in the vaccinated group. Most preterm births are late
preterm, meaning they occurred at 34 to less than 37 weeks gestation, and most occurred more
than 30 days after receipt of the RSVp reF vaccine. Preterm birth imbalance was most prominent
in a single country. Of note, GSK also was working on an RSV preF prenatal vaccine, but the
clinical trials halted due to an imbalance in preterm birth in the vaccinated population. The
etiology for preterm birth associated with RSV prenatal vaccine is unknown.
The goal of prenatal RSV vaccine surveillance is to evaluate the safety of RSV preF vaccine
administered during pregnancy in the VSD ’s large real -world population. Challenges are that as
vaccine uptake is unknown , which makes it difficult to provide any power estimates. Additionall y,
there may be healthy vaccin ee bias, meaning that healthier individuals or those with lower risk
pregnancies may be the first to be vaccinated. This is considered in the analyses and when
interpreting results. There is uncertainty regarding recommendations for RSVpreF use in
administration of this vaccine, which may impact who receives the vaccine. If persons at higher
risk for preterm delivery are recommended to receive RSV preF early in the vaccination window,
more preterm births may be identified the vaccinated group. Alternatively, these individuals may
be counseled to not receive the vaccine and wait to have their infant receive n irsevimab. The
timing of administration during pregnancy overlaps with Tdap recommendations and vaccine
administrations are also likely to overlap with influenza and COVID -19 vaccines.
To review the pregnancy outcomes and expected timing for the RSVp reF vaccine during
pregnancy , pregnancies are considered “ non-viable ” prior to 20 weeks gestation, “periviable”
from and from 20 through 26 weeks (e.g., meaning there is a reasonable chance of extra uterine
survival ), “preterm” if the pregnancy end s in a live birth before 37 weeks gestation, and “term” if
the pregnancy ends in a live birth at gestational age 37 weeks or thereafter . Intrauterine fetal
demise outcomes (IFDOs) include spontaneous abortions that can occur up to 20 weeks
gestational age, or a stillbirth that occurs at 20 weeks gestation or later. The yellow box in the
following diagram shows the time period during pregnancy when the RSV preF vaccine has
been approved for use. When considering pregnancy outcomes and the RSV preF vaccine, only
outcomes that are possible will be included. Spontaneous abortion is not a possible outcome
because of t he timing of vaccine and pregnancy :
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The primary approach for prenatal RSV preF surveillance will be through bimonthly surveillance.
Validated algorithms will be applied to electronic health data in the VSD population to identify
pregnant persons 16─ 49 years of age at ≥20 weeks gestation. Excluded pregnancies include
those that end in therapeutic abortion, multiple gestation pregnancies, and those with
insufficient information to determine the start date of the pregnancy. The exposure being
evaluated is RSV preF vaccination at or after 28 weeks gestation. This is to account for any
inaccuracies in gestational age estimation. Pregnant persons vaccinated with RSVpreF are
matched to pregnant persons unvaccinated 1:1 based on VSD site and gestational age at
vaccination. Propensity scores were created to account for confounding using readily available
variables (e.g., pregnant person’ s age, pregnancy start date, race, ethnicity , and medical
comorbidities ).
Adverse outcomes evaluated include a cute outcomes and pregnancy -related and birth
outcomes. These outcomes were chosen based on biologic plausibility and data from clinical
trials, as well as being used in prior vaccine safety studies. To identify these outcomes, an
algorithm will be used that wa s developed for other VSD safety surveillance work, which has
been modified for a pregnant population. The algorithm uses diagnoses associated with
outpatient , ED, and hospital encounters. Chart confirmation will be used for selected outcomes.
The pregnanc y-related and birth outcomes that will be evaluated include preeclampsia or
eclampsia based on International Classification of Diseases (ICD)- 10 codes, preterm birth
based on the gestational age at birth, and stillbirth identified from ICD -10 codes with c hart-
reviewed confirmation.
The next 2 tables show the acute outcomes that will be monitored following vaccination, the risk
window for which each outcome will be evaluated, and the VSD background rate per 10,000.
These background rates are based on data f rom COVID -19 studies using the rate in the
unvaccinated group. In the first table, the risk window for anaphylaxis is limited to the day of and
first day following vaccination and will be studied only in the vaccinated group. The next 3
outcomes (fever, malaise/ fatigue, and skin and soft tissue or local allergic reactions ) are limited
to 7 days following vaccination. All other outcomes listed alphabetically will be evaluated during
the 1─21 days and 1─ 42 days following vaccination. The second table is a continuation of the
first.
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The next table shows the pregnancy -related and birth outcomes that will be evaluated, the
outcome is listed in the left column, followed by the risk window during which each outcome will
be evaluated, and the number and percentage of vaccinated clinical trial participants who
experienced the outcome from the Phase 3 RSVpreF clinical trial. The outcomes that will be
evaluated are preeclampsia and eclampsia, preterm b irth, and stillbirth at 1─21 days and 1─42
days .
¥ RSVPreF Phase 3 clinical trial: Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants | NEJM
∆Preterm birth rate in high- income countries (Slide 23 Evidence to Recommendations Framework: (cdc.gov))
The risk window for preterm birth will vary based on the age of vaccination and will end up to 37
weeks gestation, given that births after 37 weeks gestation are considered term. The
percentages shown for the RSVp reF Phase 3 trial are based on all study participants for
preeclampsia and eclampsia and stillbirth. For preterm birth, the rate was used from high-
income countries since this seemed most applicable to the VSD population.
7

     For the analysis, risk ratios will be determined with corresponding 95% confidence intervals
using Poisson distribution with robust variance using a generalized estimating equation (GEE) .
Censoring within risk windows will be applied when an individual is no longer at risk for the
event, due to pregnancy outcomes that occur, or if an unvaccinated match is vaccinated.
Adjustments will be included for known confounders . If a preterm birth signal is detected, further
exploration into the etiology will be performed. A sensitivity analysis will be performed using
alternative matching strategies. Because the RSV preF vaccine is recommended for use during
the same time period when Tdap is recommended, an assessment we will be done to explore
whether it is possible to evaluate coadministration of Tdap and RSV preF.
In terms of an example timeline for the planned bimonthly surveillance, i f vaccination started in
October 2023 , the plan would be to capture 2 months of vaccinations followed by a 42- day
follow- up period and a 2- month data lag before pulling any data. The first data pull would be in
March 2024. Bimonthly surveillance would continue every 2 months.
Maternal RSV Vaccine Safety Monitoring in VAERS and v -safesm
Pedro L. Moro, MD , MPH (CDC/NCEZID) described maternal RSV vaccine safety monitoring in
VAERS and v -safesm. As a reminder, VAERS is a national passive surveillance system that is
the frontline surveillance system that monitors all licensed vaccines in the US. Created in 1990,
VAERS is co-managed by the CDC and FDA. A couple of the important s trengths of VAERS are
that it can rapidly detect safety signals and it can detect rare adverse events (AEs) . However,
one of its important limitations is that it is not designed to assess causality. VAERS is a
hypothesis -generating system that can identify potential vaccine safety concerns that can be
studied in more robust systems.
In terms of some of the approaches that can be used to analyze various data in pregnancy
reports , VAERS has been used for more than a decade as part of vaccine safety surveillance
for vaccines used in pregnancy (e.g., influenza, Tdap, COVID -19). One type of analysis that can
be performed using VAERS data is a descriptive analysis, which includes clinical review of
individual reports , aggregate descriptions of automated data (e.g., counts of reported AEs).11
Another is calculation of reporting rates for pregnancy outcomes if doses of RSV vaccine administered in pregnancy or vaccination coverage data are available. Regarding the statistical
analyses that may be done, historical approaches have included data mining to assess for
disproportionate reporting. This is under discussion for RSV vaccines.
The search for RSV pregnancy reports involves  a number of strategies . One strategy is to
search Medical Dictionary for Regulatory Activities (MedDRA) codes for the specific terms:
exposure during pregnancy, drug exposure during pregnancy, maternal exposure during
pregnancy.  Another approach is t o search for an affirmative answer to Question 8 that asks the
patient whether they were pregnant at the time of vaccination. In addition, a string search can
be done of text fields (e.g., symptoms, pre -existing illness, medical history ) for the term “preg .”
Medical records will be requested for all pregnancy reports, including serious and non -serious.
Clinicians will review these reports to confirm that they are pregnancy reports and to categorize
the main AE of interest.
11 Reported adverse events are coded using Medical Dictionary for Regulatory Activities terms ( https://www.meddra.org/ )
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   VAERS will conduct surveillance of adverse events of special interest (AESIs) after RSV
vaccination. Primary AESIs have been selected for historical , theoretical, or observed safety
concerns (i.e., in clinical trials) . VAERS will obtain medical records for all reports (serious12 and
non-serious) . CDC will review records and abstract clinically important information. AESIs may
be added to or removed from the list as appropriate. Secondary AESIs will be monitored via periodic (e.g., weekly) automated data tables, but the information will not be abstracted. If a secondary AESI is identified that is being reported frequently under suspicion of a safety
concern, that may be added to the primary AESI list. The current listing of primary and
secondary AESIs that will be monitored in VAERS for all RSV vaccines, including for reports
among pregnant persons, are as follows:
Pregnancy -specific  outcomes to be monitored in VAERS and abstracted after maternal RSV
vaccine include:
Premature/preterm birth
Stillbirth
Spontaneous abortion
Gestational diabetes
Preeclampsia/eclampsia/gestational hypertension
Birth defects
Maternal and infant deaths
Other selected adverse infant outcomes/AEs
Development of a new version of v-safesm began in Summer 2023. This system leverages the
existing CDC IT infrastructure and includes e- mail and text messaging options . The first use will
be for RSV vaccines received by persons ≥60 years of age in the Fall . Use for maternal RSV
vaccines is planned for later in the Fall. The v-safesm objectives are to: 1) characteriz e local and
systemic reactogenicity during day s 0─7 zero to seven after vaccination; 2) characterize health
impacts during a 6-week post -vaccination follow -up period; and 3) identify participants who
report medically -attended events after vaccination and encourage completion of  a VAERS
report.
12 Based on the Code of Federal Regulations if one of the following is reported: death, life-threatening illness, hospitalization or
prolongation of hospitalization, permanent disability, congenital anomaly or birth defect
9

   An Economic Analysis of RSVpreF Maternal Vaccination
David W. Hutton, PhD, MS (University of Michigan) provided some updates since his June
2023 presentation to the ACIP to report the findings of an additional vaccine efficacy scenario,
additional timing scenarios for which the vaccine might be administered in specific months of the
year, a gestation scenario from 32─36 weeks,  and an updated cost per vaccine dose scenario.
The initial efficacy scenario has not changed,13 with sigmoid downward sloping efficacy during
the 6 months, using the average efficacy during these periods based on average 6 months
efficacy. Hospitalization efficacy was based on hospitalization efficacy from the trial and efficacy
against outpatient visits was based on efficacy and medically -attended LRTIs . A scenario also
was evaluated with flat efficacy during those 6 months, and then back down to 0 efficacy after
that. In both of the last 2 scenarios, 0 efficacy was assumed after 6 months. The new scenario
is more optimistic, with slightly higher efficacy in the first 6 months. The efficacy against
hospitalization in this scenario was based on efficacy against severe -medically attended RSV
LRTI observed in the trial , which was slightly than the efficacy used in the base-case. In this
optimistic scenario, it was assumed that there is declining efficacy for months 6─9.
In the initial base- case, RSV preF given year -round was evaluated. The new scenarios assessed
cost- effectiveness if RSV preF is given during specific months of the year and if RSVpreF is
administered in specific ranges of months throughout the year : April- February , May-February ,
June- February , August -January , September -January , and September -December . Another
change was a scenario in which the mother was vaccinated from the beginning of week 32
through the end of week 36 of the pregnancy , which is a narrower range than was used in the
trial but is what the FDA has settled on. In the new scenario, it was assumed that the vaccine
must be given within 2 weeks before birth for the vaccine to confer protection. It was assumed
that for a baby born within 2 weeks of administration, the re would be no efficacy of the vaccine.
If it is assumed that for 100 pregnant persons, 50 intend to vaccinate, 48 actually get vaccinated
because 2 might give birth before that, and 3 of the 48 would be vaccinated within 2 weeks of
delivery —that would res ult in 45 being vaccinated in time (e.g., within 2 weeks before delivery) .
In June, Dr. Hutton presented numbers based on 1000 births. During this session, he present ed
the results based on the entire US birth cohort per year assuming 50% uptake of the RSVpreF
vaccine across the first RSV season. Another major update for this scenario is a cost of $295
per dose. That is an increase from the $200 per dose estimate used in June, which is a
significant increase in the price per dose. In terms of the results,  the number needed to
vaccinate (NNV) to avoid an outpatient visit (40), an ED visit (115), an inpatient stay (242), an
ICU admission (1100), an inpatient day (45), or an intensive care unit ( ICU) day (367) was very
similar to what was shown in June. It was about 4% higher because of the later timing of
vaccination in weeks 32 ─36 due to slightly more people being vaccinated within 2 weeks of
birth. But basically, this is very similar to what was reported in June.
In the updated scenario, the total cost were higher due to evaluating a larger cohort of 3.66
million births, assuming 50% intended uptake in RSVpreF group. The intervention cost is higher
relatively -speaking because the vaccine price per dose increased by just under 50% from the
previous scenario. The cost per event averted also was higher than show n in June because the
price per dose is a little bit less than 50% higher than what was assumed in June. For example,
the cost to avert an inpatient stay would be about $68,000 per inpatient stay averted. The
13 Kampmann et al 2023
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  incremental cost-effectiveness ratio (ICER) in the updated scenario is now about $400,000 per
quality -adjusted life year (QALY) gained. This is driven primarily by the increased cost of the
vaccine dose compared to the cost used in June.
Looking at sensitivity analyses showing how various changes in the assumptions will change
the ICER, the rankings of which parameters are most important are similar to those seen in
June. Prematurity potentially can increase the ICER dramatically , though hopefully that is less
likely with later administration of RSVpreF . The QALY impacts of RSV also are likely to have
large impact on the ICER . The vaccine price is an important driver of cost -effectiveness. The
cost of inpatient care also can have a large impact on the cost -effectiveness of vaccination. VE
also can have a large impact on cost-effectiveness . One of the scenarios was varying how VE
was modeled. When flat efficacy was assumed, the ICER was about $365,000 per QALY
gained. The updated scenario used a m ore optimistic higher and longer efficacy. The ICER
under this scenario was about $286,000 per QALY gained.
In a sensitivity analysis varying efficacy, hospitalization cost, and mortality the base cost was
$11,000 per hospitalization. Varying the hospitalization cost from the base cost to higher costs,
the cost -effectiveness ratio would decrease as hospitalization costs increase. With a more
optimistic VE (e.g., higher and longer efficacy ) the cost- benefit ratio would decrease as well.
With m ore deadly RSV, there would be a 1% risk of dying in the hospital instead of 0.1%. The
cost per vaccine dose also can have a major impact on cost -effectiveness. With a base-case
price of $295 per dose, the cost per QALY is close to $400,000 . If the vaccine cost per dose
was lower, the ICER would decrease as well.
Everything just show n was assuming the vaccine is given year -round. Now looking by month
and by specific ranges of months to determine the cost- effectiveness ratio if RSVpreF is given in
a particular month of the year, it is important to remember that RSV is seasonal and there are
many infections in the wintertime. If RSVpreF is given right before wintertime so that it has 6
months of efficacy during that peak, the cost of that administration would decrease dramatically .
For instance, if RSVpreF is given during any month between February ─July, the cost -benefit
ratio would be over $500,000 per QALY. If given during October ─November, the cost -
effectiveness ratio would range from approximately $111,000 to $115,000 per QALY. The cost
of administration could be dramatically lower if RSVpreF is given right before the peak of the
RSV season. Looking at ranges of months and recalling that the base -case was about $400,000
per QALY if given year-round,  if it was given during the range of September ─December, the
ICER would be approximately $141,000 per QALY.
To summarize, the limitations of this updated analysis are similar to the ones reported in June.
The model structure does not include risk groups or dynamic transmission. Given that this is a
new vaccine, the impact of the vaccine on transmission and indirect effects is unknow. Inputs
also are still uncertain with respect to RSVpreF costs , QALYs lost , impact URTIs , and
prematurity. All of these scenarios assumed that no infants will be receiving nirsevimab.
RSVpreF may improve RSV outcomes, but it also will increase costs. RSVpreF has the potential
to be cost -effective , but the results are sensitive to a wide variety of assumptions, including r ate
of prematurity ; cost per dose (~ $65,000─$68,000/QALY) ; hospitalization costs ( cost-
saving─$440,000/QALY) ; efficacy (~ $280,000─$680,000/QALY); QALYs lost
(~$100,000─$800,000/QALY) ; and m onth of administration (~ $110,000─ Millions/QALY) .
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   Looki
ng now at the economics of the combined use of Pfizer maternal RSVpreF vaccine and
nirsevimab , ACIP recommended the use of nirsevimab On August 3, 2023. This raises the
following questions about how to think about combinations of RSVpreF and nirsevimab :
If it is known that RSVpreF has been administered to the pregnan t person in time, how cost -
effective is it also to provide nirsevimab to the infant ?
If it is known that the infant definitely will receive nirsevimab, how cost -effective is it to
provide RSVpreF to the pregnant person?
In terms of updates since the June ACIP meeting, the assumption was made in the updated
analysis that RSVpreF would be administered in weeks 32─36. Because of this, the assumption
also was made that the infant is full- term and there would be no need for palivizumab for any
newborns considered in this analysis. The updated analysis also considered some higher risk
populations and assumed that they were not premature. In addition, the new timing of RSVpreF
administration was considered. There is no evidence of efficacy with the combined use of these
products. Therefore, the assumption was made that efficacy would be equal to the highest of
nirsevimab or RSVpreF, which is higher. That is, efficacy would not be higher than from the
most effective product and there would be no combined synergistic efficacy. That is the same
assumption that was made in June.
Assuming administration of nirsevimab at birth to the infant of someone who received RSVpreF ,
nirsevimab would provide additional efficacy on top of what RSVpreF would provide. If the baby
was born in August, they would have some RSVpreF efficacy. If nirsevimab was given on top of
that in October, there would be an increase in efficacy. A s a reminder, peak infections are
typically in the December ─February timeframe, and additional efficacy would be desired during
that peak timeframe.
To highlight the incremental benefit of adding nirsevimab on top of RSVpreF for infants of
persons vaccinated with RSVpreF during pregnancy at least 2 weeks prior to delivery , there
would be a higher risk or increased multiplier on the risk of hospitalization. There would be no
change in outpatient incidence, ED inciden ce, costs per outcome, or QALY per outcome.
Looking at the incremental benefit of adding nirsevimab on top of RSVpreF by m onth and risk if
nirsevimab is given at birth during October ─March compared to a baby born in
April─September who would not be given nirsevimab at birth but would receive it at the start of
the RSV season in October or November , the incremental cost-effectiveness of adding
nirsevimab looks better if given to babies born in April, May, June, July, August, and September.
If given at the beginning of the season in October and November, the cost- effectiveness ratios
would be much lower. The ICERs are much higher for infants who are at 3-, 6-, and 10 -times
higher risk of hospitalization. That is, it is much more valuable to give them nirsevimab on top of
RSVpreF .
Particularly for babies born in the summer, giving nirsevimab at the beginning of the season
would result in an ICER $150,000 per QALY gained and lower . For potentially higher risk
individual s born during the season, the ICERs for n irsevimab given at birth might look good for
higher risk populations. Assuming that nirsevimab is given to all infants born year -round to
vaccinated mothers, the NNV to avoid an inpatient visit for an average risk child would be over
200 infants to avoid 1 inpatient visit. Adding nirsevimab to all infants born year -round to
vaccinated mot hers would be quite expensive for people at average risk at $400,000 per QALY .
Providing nirsevimab to infants at 6 times the risk born to vaccinated mothers would be about
$40,000 per QALY gained and might be cost -effective .
12

 In a scenario of giving nirsevimab in October ─November to babies born in April─ September,
rather than at birth, born to mothers who received RSVpreF at least 2 weeks prior to delivery,
the NNV was similar but slightly lower than if giving n irsevimab year -round. It would be more
cost- effective to provide nirsevimab to infants born since April─ September at the beginning of
the RSV season at about $300,000 per QALY for infants at the lowest risk and about $200,000
per QALY for infants at 3-, 6-, and 10- times higher risk. In a scenario of adding nirsevimab
during the season for infants born October─March to mothers who received RSVpreF at least 2
weeks prior to delivery, the NNV would be higher because they already would have a lot of
RSVpreF protection during that time period. The ICER would be $600,000 per QALY if given to
average risk babies. That is, it would be less cost -effective to give these babies nirsevimab on
top of their RSVpreF protection.
Regarding the incremental benefit of adding n irsevimab on top of a baby’s RSVpreF protection,
there is some additional benefit beyond RSVpreF protection. The ICERs are high, but could be
lower for higher -risk populations, particularly born if they are born off -peak. In terms of the
incremental benefit of adding RSVpreF on top of nirsevimab if it is known the infant will be
receiving nirsevimab, the ICERs are very high. Similar to what was seen previously, this scenario would be over $10 million per QALY for many months of the year . The best month of
the year would be April, although the ICER still would be $2.4 million per QALY gained if
nirsevimab was given to babies whose mothers received RSVpreF at least 2 weeks prior to
delivery . The incremental benefit of adding RSVpreF on top of nirsevimab would be very
marg inal beyond nirsevimab protection and the ICERs would be extremely high.
In summary of scenarios involving combinations of RSVpreF on top of nirsevimab, a limitation is
that there are no efficacy data on these combined products. Therefore, these scenarios are all
based on assumptions about what the efficacy might be. Nirsevimab may add additional
protection on top of RSVpreF , particularly for high -risk infants . Adding RSVpreF on top of
Nirsevimab would add marginal effectiveness at a very high cost in the general population.
Economics of Preventing RSV Disease among US Infants by Maternal Vaccination Prior
to Birth
Ismael R. Ortega- Sanchez, PhD (CDC/NCIRD) summarize d the key elements and findings of
2 economic studies , the Pfizer Model and the University of Michigan- CDC ( UM-CDC) M odel,
focused on the economics of preventing RSV disease among US infants by maternal
vaccination prior to birth. In the last 8 to 9 months, the 2 models were updated several times. In
this summary, Dr. Ortega -Sanchez focused only on the vaccine so there was no discussion
about the last component of Dr. Hutton’s presentation regarding nirsevimab . For full disclosure,
Dr. Ortega -Sanchez indicated that he has been part of the team conducting the CDC model.
The starting point of the 2 economic models was the policy question regarding potential
recommendations for the use of RSV vaccine in pregnant mothers , “Should Pfizer RSVpreF
vaccine be recommended for pregnant mothers to be given during 32 through 36 weeks
gestation to prevent RSV lower respiratory tract infection in infants?” To consider the economics
of the policy question is to consider simultaneously the health benefits and costs of vaccination,
namely, “Is vaccinating pregnant mothers prior to birth to protect infants against RSV ’s cost -
effective?” To address this question, the 2 models used the same comparator , unvaccinated
mothers and the standard of care (SoC) for infants. They focused on analyzing the cost -
effectiveness of vaccinating pregnant mothers 32 ─36 weeks of gestation ≥2 or more weeks
prior to the birth with RSV preF vaccine compared to no vaccine.
13

     The policy question has important implications for 2 groups of elements . The comparison of the
2 economic models focus es on the appropriateness of the modeling approach selected; the
inputs for RSV disease burden, RSVpreF, VE, and costs ; and how the strength and influence of
the assumptions on the outcomes. The 2 models followed similar designs. Both used a static
analytical decision- making approach , relied on sensitivity analys es and probabilistic simulation,
model ed a hypothetical cohort of all pregnant mothers in the US year-round, selected a
timeframe of the first year after birth, accounted for loss of income associated with temporary
productivity loss and the loss of premature RSV -associated infant mortality. Once the modeling
study was set, the 2 models were fed by different types of input data, including clinical,
epidemiological, economic, QALY, vaccine characteristics, health care resource utilization
(HCRU) and cost, and indirect costs . Across models, the source and specific values and
assumptions of these parameters have some overlaps, but there were marked differences as
well. The boxes below list the standard outcomes estimated and reported by the 2 models :
Dr. Ortega -Sanchez emphasized that once the models are built this way, it is necessary to work
in reverse in order to go first with the outcomes and then analyze what happens with the inputs.
The base case estimate for vaccinating pregnant mothers in the vaccination window of 32 ─36
weeks gestational age year-round would be approximately $400,000 per QALY gained when
vaccine costs are $295 per dose. Additionally, the CDC model reports cost per specific type of
health outcome prevented and the NNV to prevent hospitalization , ED visits, outpatient visits,
and deaths associated with RSV LRTI . the base case estimate for maternal vaccination in the
vaccination window of 32─36 weeks gestational age year -round would be approximately
$85,000 per QALY gained when vaccine cost is $295 per dose. The Pfizer cost per QALY is
supported wit h its probabilistic sensitivity analysis (PSA) when simultaneously providing the
input and variables in the model. Most of the simulations included in the base case were
somewhat costly, but with gains in QALY. Approximately 65% of the simulations in the P fizer
model had a cost -effectiveness ratio that was less than $100,000 per QALY . Even though both
models assumed the same vaccine cost per dose, vaccination window of 32─ 36 weeks of
gestational age, and year-round vaccination administration, the CDC results costs per QALY
were still much higher than those of Pfizer. Specifically, the CDC estimates of the cost per
QALY and the cost per hospitalization of births were about 5 times higher than those of Pfiz er
and about 10 times higher for the cost per death prevented. The CDC model report ed a 65%
14

  


    higher NNV to prevent hospitalization and 300% higher in the number needed to prevent an
RSV-associated death. The first takeaway for the committee is that both models agree that
maternal vaccination will be relatively costly, but it also will prevent LRTI and hospitalization and
will save QALY s among infants and caregivers.
To understand these persistent discrepancies in the UM -CDC model and the Pfizer model , an
effort was made to i dentify the sources of these differences. The CDC model’s 1 -way sensitivity
analysis ranked the most influential input variables. The probability of prematurity ranks first,
followed by RSV QALYs lost , disease -specific inpatient cost, and VE against hospitalization. In
a similar fashion, Pfizer also report ed one -way sensitivity analy ses. T he most influential
variables were VE , followed by medical costs for hospitalization, vaccine duration of protection
when truncated at 6 months, and the case fatality rate among hospitalized infants with RSV
LRTI. Except for RSV hospitalization risk and seasonality and vaccine- associated AEs, the
other elements identified in the Pfizer and UM -CDC models included, which were explored
further :
Vaccine efficacy Duration of protection and waning RSV Case fatality rate
Medical cost of RSV hospitalization, ED and Outpatient care QALYs lost by patients and caregivers
First, 2 elements that did not explain these differences were the risk of hospitalization and RSV
seasonality as input data used in both model s were practically the same. Specifically, the risk of
RSV hospitalization data used in both models was based on laborator y-confirmed RSV -
associated hospitalization by age in months from the New Vaccine Surveillance Network
(NVSN). This includes only RSV cases that manifests as LRTI. Therefore, unlike the uncertainty
in RSV hospitalization that was a question for discussion for older adults, it is not what could
explain the difference in outcomes in infants . Likewise, RSV seasonality was based on data
from the National Respiratory and Enteric Virus Surveillance System (NREVSS) . The 2 main
explanatory factors turn out to be VE and case definition. Although both models use the same
source for VE,
14 which reports the data from the P hase 3 clinical trials from Pfizer , each model
picked different data points from this source mainly because none of the Pfizer Phase 2
endpoint definitions overlap ideally with a case definition used by the US burden data. For
hospitalizations, the CDC model used average VE over months 0─6 reported by RSV LRTI
hospitalization, with an average value of 56.8%. The Pfizer model used VE for severe RS V-
positive MA -LTRI as a proxy for VE against RSV -LRTI requiring hospitalization, and efficacy
against RSV -positive MA -LRTI was used as a proxy for VE against RSV -LRTI treated in the ED.
VE for late preterm infants was assumed to be 83.3% of corresponding values for full- term
infants.
This also will help to understand the duration of protection. Although assessing the difference
about the initial VE is important, it is more about the assumption of performance over time. In
the Pfizer model, the linear assumption was based on 4 data endpoints reported from Phase 3
data until 180 days after vaccinat ion, or the equivalent of 6 months, followed by the assumed
impact from the 6th to the 9th month. That is discriminated by a full -term versus late -term. The
CDC model use d a 6-month efficacy against hospitalization or MA RSV-associated RTI. The
duration of protection reached 0 at 6 months . They noted a higher level of uncertainty of the
14 Kampmann et al New England Journal of Medicine. 2023 Apr
15

  waning assumption beyond available Phase 2 data. The CDC model trie d to minimize this
uncert ainty impact  on its outcomes. Therefore, there was no effectiveness after the 6th month.
Although the base- case case fatality rate s for hospitalization were basically the same in both
models, the distinction is that Pfizer inputs used a higher case fatality rate for late preterms
using mortality rates for all pre- terms. Therefore, the same rate included for extremely early,
early , and late preterms were used as the dominator for the case fatality rate for all preterms.
Regarding medical costs, the input values using the Pfizer model were 2 times higher for
hospitalization to about 4 times higher for ED and outpatient visits than the ranges used by the
CDC model to reach the average cost value using. While the source of t he CDC model is a
publicly available meta- analysis review of many publications. The source of the Pfizer model is
reported as data on file and not yet available for examination. The committee members should
bear in mind that the higher the input values , the lower the ICER would be, or the equivalent,
the more cost -effective the vaccination program would be.
Cost-effective analysis programs should include not only the cost of vaccines or vaccine
administration, but also the risk of vaccine- associated AEs and associated costs. Using data
reported from the Pfizer P hase 3 trial , both models included the rate of injection site reactions
and associated costs, including the cost of outpatient visits. The difference was when dealing
with hypothetical serious adverse events ( SAEs ) or when considering the incremental risk of
prematurity . The potential increased risk of AEs considered in the CDC model, when modeled in
the base case or as a potential scenario could influence the ICERs and significantly increas e
the cost of the intervention.
In terms of the QALY impact of RSV outcomes in both patients and caregivers , the point
estimates scores used in both models were the same for the caregivers. The difference was in
the patient scores, which were somewhat higher in the CDC model. The second difference was
that the CDC model also relied on ranges from each of these scores, which allowed for the
analysis and sensitivity analysis of the impact of them. Unlike CDC, the Pfizer model consider ed
only the point estimate f or the base case without viability, and as a consequence quality loss
was not identified as an influential variable in the Pfizer model .
Up to this point, the comparisons focus ed on the inputs used in the models. The idea at this
point was to determine how sizeable differences in cost per QALY could be explained from
outcomes estimated using different input values and assumptions. One way to cross -validate
the models is to see if one model could imitate the other by selecting some input values and
assumptions. Looking at the cost per QALY for selected scenarios using a CDC model focusing
on combining Scenarios A (c ost of RSV -LRTI hospitalization: $20,000 or $50,000) and B ( UM-
CDC model with same VE duration of protection as Pfizer) that included price, medical costs,
and assumptions of duration of protection, the specific impact on the cost per QALY drops to
$234,000 per QALY. That is still 2 times higher than the cost per QALY reported by Pfizer. Two
other important scenarios reported were Scenario E with a potential increase in the risk of
prematurity in 1% or 2% points, which could range from about $900,000 if it is only 1% point
increase in the risk of prematurity to more than $1.3 million per QALY if it is a 2% point incr ease
in the risk of prematurity. Scenario F deals with the timing of vaccination. CDC is the only model
that present ed timing of vaccination. Vaccinating mothers with births in September ─January
would provide a cost per QALY of less than $200,000 as opposed to February ─July, which will
be in the millions per QALY.
16

  By the same token, Pfizer attempted to replicate the CDC outcomes by sequentially using CDC
inputs and assumptions. For Scenario A, the cost per QALY estimate with selected CDC inputs
and the cost per QALY value were close to what was reported by CDC at approximately 85%.
Scenario A was $343,000 per QALY in the Pfizer model , which was very close to the $400,000
per QALY reported by CDC. When Pfizer used its own model with some of the select ed CDC
inputs and returned most of its own inputs and assumptions piece- by-piece and cumulatively ,
Pfizer return ed to his initial VE. It returned to the duration of protection and medical costs that
Pfizer used and to approximately $83,000 per QALY, which is basically the same one that was
reported by them in the base case scenario. Since they were able to replicate some of the
analys es, it seems that the inputs and the assumptions that are being used in the models are
crucial.
In terms of limitations, the factors not considered may result in overestimating the ICER, under -
estimating the cost -effectiveness of maternal vaccination, by both models. In the base case,
both models assumed no protection against upper respiratory tract infection (URTI), no benefits
of vaccination for vaccinated pregnant mothers, and no out -of-pocket costs accrued by
caregivers during an infant RSV illness. Neither model included RSV-related costs incurred after
discharge from RSV -associated hospitalization or ED department v isits, such as p roductivity
losses incurred by caregivers after discharge. Both models assumed no indirect effects of
vaccination (e.g., no protection against RSV transmission among unvaccinated people).
In conclusion, difference s in key inputs among the Pfizer and CDC models explain differences in
the results. Among the key differences are initial VE and assumptions about protection waning,
medical cost data, QALYs associated with RSV LRTI outcomes for patients and caregivers, and
vaccine- related AEs. In addition, the CDC model identified 2 important factors that could drive
the results and make the difference—hy pothetically severe v accine- associated AEs and timing
of vaccination for RSV when it targeted to specific periods in the RSV season. In terms of the
base case in both models, maternal vaccination would significantly reduce RSV disease burden
and disease costs in infants. Data from clinical trials used in both models support the reduction
in RSV disease and associated costs. However, the economic value of vaccinating pregnant
people to protect infants could increase costs. Reasonable vaccine price and duration of
protection, combined with careful design of seasonal interventions , will determine the cost -
effectiveness value of routine vaccination of pregnant people during the 32─ 36 weeks of
gestational age.
EtR Framework Updates: Pfizer Maternal RSVpreF Vaccine
Katherine E. Fleming -Dutra, MD (CDC/NCIRD) presented EtR Framework updates for the
Pfizer Maternal RSVpreF vaccine. She reminded everyone that the policy question before the
ACIP was, “Should Pfizer RSVpreF vaccine be recommended for pregnant people to be given
during 32 through 36 weeks gestation to prevent RSV lower respiratory tract infection in
infants ?” Notably, the dosing window represented a change from the policy question discussed
during the June ACIP meeting. The reason for this change was because On August 21, 2023,15
FDA approved the Pfizer RSVpreF vaccine for use in pregnant people as a single dose to be
given at 32 through 36 weeks gestation. In the Phase 2b and 3 trials, vaccination was given
during 24 through 36 weeks gestation. The change was made to avoid the risk of extremely
preterm births where there is substantive morbidity and mortality and very preterm birt h. FDA
considered that the benefit of vaccine efficacy when the Pfizer RSVpreF vaccine is administered
15 https://www.fda.gov/news- events/press -announcements/fda- approves -first-vaccine- pregnant -individuals -prevent -rsv-infants ; and
https://www.fda.gov/media/168185/download
17

   between 32 and 36 weeks outweighed the risk of vaccination, including the potential risk of
preterm birth and hypertensive disorders of pregnancy. Throughout the presentation, these
were denoted as the approved dosing interval (32 –36 weeks gestation) and the trial dosing
interval (24– 36 weeks gestation) . In terms of the PICO question, the intervention was updated
to reflect the approved dosing interval at 32─36 weeks gestation. Otherwise, the population,
comparison, and outcomes remained the same.
In terms of the Public Health Problem domain, RSV infection is the leading cause of
hospitalization in US infants. Most (68%) infants are infected in the first year of life and nearly all
(97%) by age 2.16 Approximately 2% to 3% of young infants will be hospitalized for RSV.17 RSV
is a common cause of LRTI in infants. The highest RSV hospitalization rates occur in the first
months of life, all young infants are at risk, and risk declines with increasing age in early
childhood.18 Approximately 79% of children hospitalized with RSV who are less than 2 years of
age had no underlying medical conditions.19 The WG agree unanimously that RSV among
infants is of public health importance .
Moving to the Benefits and H arms domain, the WG had data for all 11 outcomes for the Grading
of Recommendation Assessment, Development and Evaluation ( GRADE ) for this analysis . Data
were available from 2 trials, Pfizer ’s Phase 3 trial and an earlier Phase 2b trial in pregnant
people. In terms of how these data were used for GRADE and the benefits and harms domain
overall, there were data from both trials on the dosing interval and from the FDA approved
dosing interval. The number of maternal participants by vaccine and placebo arms in the Phase
2b and Phase 3 are shown in this table:
*For phase 2b trial and phase 3 trial safety set, number of maternal participants are listed. For phase 3 trial efficacy set, number of
infants participants are listed.
1 Data provided by Pfizer
2 Kampmann et al. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants -PubMed (nih.gov)
3 Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Briefing Document -FDA
In both phases, less than half of the maternal participants receive the intervention in the
approved dosing interval, meaning that the power to assess safety and efficacy was reduced.
Therefore, for GRADE , the outcomes as assessed in the full trial population with the trial dosing
interval of 24 ─36 weeks were used consistent with the trial design. The post-hoc analysis using
data from the approved interval was used as supplemental data. To summarize the effect,
estimates , and concerns in uncertainty of the assessment for the benefits for this vaccine
assessed at 0─180 days of life, VE against medically attended RSV -associated LRTI in infants
was 51%, and efficacy against hospitalization for RSV -associated LRTI in infants was 56.8%.
16 Suh et al. JID 2022
17 Hall et al, Pediatrics, 2013; Langley & Anderson, PIDJ, 2011; and CDC NVSN data
18 Hall et al, Pediatrics, 2013; and CDC NVSN data
19 Hall et al, Pediatrics, 2013
18

  Additional data received since June included the important outcomes of ICU admission for RSV
hospitalization in infants with an efficacy of 42.9% , and mechanical ventilation with an efficacy of
100%. Both estimates had very wide confidence intervals, and thus the certainty assessments
were downgraded due to very serious concerns for imprecision. Additionally, there are now data
for all -cause hospitalization for LRTI with an efficacy of 28.9%, with a confidence interval that
crossed the null. Therefore, the certainty assessment was downgraded for seri ous concern for
imprecision.
Regarding the certainty of assessments for harms, changes from June included the
downgrading of 3 outcomes (e.g., SAEs in pregnant people, SAEs in infants, and preterm birth)
for serious concerns about indirectness due to the difference in the trial dosing interval
compared to the approved dosing interval. This was done because 55% of the Phase 3 trial
population and 62% of the Phase 2b trial populations did not receive vaccine doses during the
approved dosing interval. There is likely less opportunity for SAEs during pregnancy to occur ,
including preterm birth , when dosing starts at 32 weeks gestation as compared to 24 weeks
gestation. In particular, the risk of preterm birth likely would be lower with dosing starting at 32
weeks than with a dosing window that starts at 24 weeks gestation.
Overall, the summary of GRADE showed that the Pfizer RSV maternal vaccine is effective in
preventing medically attended RSV -associated LRTI in infants with high certainty in the
evidence. This vaccine may be effective in preventing hospitalization for RSV -associated LRTI
in infants , with moderate cert ainty. The vaccine may be effective in preventing ICU admission
for RSV hospitalization in infants , with low certainty. The vaccine may be effective in preventing
mechanical ventilation for RSV hospitalization in infants , with low certainty. The vaccine is not
effective in preventing all -cause medically attended LRTI in infants , with moderate certainty. The
vaccine may be effective in preventing all -cause hospitalization for LRTI in infants , with
moderate certainty. SAEs in pregnant people were balanced between the vaccine and placebo
groups, with low certainty. Reactogenicity in pregnant people was balanced between vaccine
and placebo groups , with moderate certainty. SAEs in infants were balanced between the
vaccine and placebo groups , with low certainty . Preterm births were unbalanced between the
vaccine and placebo groups , with very low certainty in the evidence. This result ed in an overall
evidence type of “Very Low.” In GRADE , the overall evidence type is driven by the lowest quality
of evidence for critical outcomes, and here was driven by the evidence rating for the critical
harm of preterm birth being very low. Comparing the effect estimates for benefits for each of the GRADE outcomes from the full
Phase 3 trial using the pre- specified trial dosing interval (24–36 weeks gestation) and the
efficacy estimates for the same outcomes from the Phase 3 trial limited to participants who
received doses during the approved dosing interval (32–36 weeks gestation) , the point
estimates were relatively similar for each of the outcomes. The confidence intervals were much
wider when limited to the approved dosing interval, which is to be expected given the smaller
number of participants who received vaccination in the approved dosing interval.
The Phase 3 efficacy against severe medically attended RSV -associated LRTI was a co -primary
trial endpoint but was not included in GRADE . The reason for this is that this outcome was not
included by the WG as an a priori critical or important outcome for vaccine policy decisions.
However, the WG felt that this was important to present as part of the supplemental data in the
EtR F ramework. Shown here side- by-side are the Pfizer definitions of severe medically -
attended RSV LRTI on the left and medically attended RSV LRTI on the right, which was
included by the WG as a critical outcome for GRADE . The differences in these two definitions
are highlighted in blue:
19

   Pfizer Trial Definition WG Definition
Severe medically -attended RSV -associated LRTI*
required at least 1 of the following signs/ symptoms:
− Fast breathing (respiratory rate ≥70 (<2 month of
age [60 days]) or ≥60 (≥2 to 12 months of age)
breaths per minute
− SpO2 measured in room air <93%
− High -flow nasal cannula or mechanical
− Ventilation
− ICU admission for >4 hours
− Unresponsive/unconscious Medically -attended RSV -associated LRTI* required at
least 1 of the following signs/symptoms:
− Fast breathing: respiratory rate ≥60 (<2 months of
age [60 days]) or ≥50 (≥2 to 12 months of age)
breaths per minute
− SpO2 measured in room air <95%
− Chest wall indrawing
*Medically attended visit includes inpatient and outpatient encounters. Additionally, definition also required RT -PCR or nucleic acid amplification (NAAT) test
positive for RSV. Blue text denotes differences between the two definitions. SpO2= Peripheral capillary oxygen saturation
1.Kampmann et al. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants -PubMed (nih.gov)
2.Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Briefing Document -FDA
In terms of VE against severe medically -attended RSV LRTI in the trial dosing interval and the
approved interval, at 0─ 180 days after birth efficacy was 69.4% in the full interval and 76.5% in
the approved interval. It is important to note t hat not all of the 81 infants who met the severe
RSV definition within 0─180 days after birth were hospitalized, n or did all infants who were
hospitalized for RSV meet the severe definition. Comparison for estimates from the full Phase 3
trial dosing interval to the approved dosing interval, the point estimates for relative risk were
similar but the confidence intervals were wider. Specifically for preterm birth, the relative risk in
the vaccinated group compared to the placebo group using the full trial dosing interval was 1.20
with a 95% confidence interval of 0.99 to 1.46. The relative risk with the approved dosing
interval was 1.15 (0.82, 1.61) with a wider confidence interval consistent with decreased power
to detect this outcome. The confidence intervals were overlapping between the 2 estimates.
As a reminder, the WG chose preterm birth as a critical outcome because a trial for a similar
GSK maternal RSV vaccine,20 also a stabilized prefusion F- protein vaccine, was halted due to
an imbalance of preterm births , with higher numbers in the vaccine compared to the placebo
group. In that trial, there also was an imbalance in neonatal deaths, which was determined to be
a consequence of the preterm birth imbalance. The imbalance in preterm births was seen in
low- and middle- income countries (RR: 1.57, 95% CI: 1.17, 2.10), but not high- income countries
(RR: 1.04, 95% CI: 0.68, 1.58). The imbalance was observed from April ─December 2021, but
not consistently after December 2021. The reason for the imbalance in preterm births in the trial
remains unclear.
To describe the Pfizer RSVpreF vaccine P hase 3 trial data comparing the trial versus the
approved dosing interval in more detail, in the full trial with the trial dosing interval, 5.7% of
births were preterm in the vaccinated group compared to 4.7% in the placebo group. When
dosing is limited to the approved interval, 4.2% of births in the vaccine arm compared to 3.7% in
the placebo arm were preterm, showing that the rate of preterm birth decreased as there was
less opportunity to be born preterm . Also, the imbalance between the vaccine and placebo
groups narrowed with the approved dosing interval. In terms of low birth weight (≤2500 grams )
and neonatal jaundice, low birthweight and neonatal jaundice were both more common in the
full trial population in the vaccinated group compared to placebo group. However, the
confidence intervals between tho se 2 groups overlapped and the differences were not
significant. When limited to the approved dosing interval, 4.1% of infants in the vaccine arm had
low birth weight compared to 3.4% in the placebo group. Neonatal jaundice was slightly less
20 https://www.fda.gov/media/165621/download
20

    common among the vaccinated group compared to the placebo, but the confidence intervals overlapped.
During the June ACIP meeting, ACIP members requested additional data regarding the Pfizer
maternal RSV vaccine, including the rate of preterm birth by calendar month of birth, birth by
week of gestational age, percent of births that were preterm by country, and adverse pregnan cy
outcomes. Enrollment in the Pfizer Phase 3 trial started in June 2020. The earliest births in the
trial were inevitably preterm , so the rate was high in both the vaccine and placebo groups. For
Pfizer, the imbalance was more prominent during August ─Dece mber  2021 and then again in
April─May of 2022.
21 As a reminder, the GSK imbalance was present in April ─December 2021.
Looking at preterm birth rates by calendar time in the approved dosing interval, preterm birth was less common overall and the temporal patterns were less clear.
Additionally, ACIP requested a histogram on the number of births by week of gestational age
from the full Phase 3 trial with the trial dosing interval (24–36 weeks gestation), shown here with
the vaccine arm in blue and the placebo arm in gray :
The next histogram shows preterm births only (<37 weeks gestation), which illustrates that the
imbalance in preterm birth begins at 33 weeks gestation:
21 Data source: Pfizer response to ACIP, unpublished data, July 2023
21

   Looking at a histogram of births by gestational age limited to participants who received doses
during the approved interval (32– 36 weeks gestation) , the imbalance is less prominent and is
only clearly present at 36 weeks :
The ACIP also requested the percent of preterm births by country in the Phase 3 trial.
Importantly, the US data was the single largest country contributing to the trial and accounted
for just under half of all trial participants. In the full trial dosing interval of 24 ─36 weeks in the
US, 5.7% of births in the vaccine arm were pre- term compared to 5.3% in the placebo arm.
However, in the approved dosing interval in the US, the direction of this imbalance reversed with
4% of births in the vaccine arm being preterm compared to 4.4% in the placebo arm.
The ACIP also requested data on adverse pregnancy outcomes. Looking at select pregnancy -
related SAEs occurring at any time after vaccination up to 6 months after delivery for the full
Phase 3 trial population,22 maternal SAEs occurred in 16.2% of the vaccine arm compared to
15.2% of the placebo arm , with overlapping confidence intervals. FDA is requiring post -
marketing studies to assess hypertensive disorders of pregnancy, including pre -eclampsia. In
the full trial population, pre-eclampsia occurred in 1.8% of the vaccine recipients versus 1.4% of
the placebo recipients. Gestational hypertension occurred in 1.1% of vaccine recipients and 1%
of placebo recipients. Hypertension occurred in 0.4% of vaccine recipients and 0.2% of placebo
recipients.
Another consideration of interest is inflammatory neurologic events.23 The Pfizer maternal RSV
vaccine is the same formulation and dose approved for use in adults ≥60 years of age . Within
the trials for this product, a potential safety signal of inflammatory neurologic events was
identified among adults ≥60 years of age. A total of 3 cases of interest were recorded among
20,255 investigational vaccine recipients ≥60 years of age and no cases were observed among
placebo recipients. The details of these cases were discussed during the June ACIP meeting
during the session on RSV vaccines in older adults. As a reminder, these cases included 1 case
of Guillain -Barré Syndrome (GBS), 1 case of Miller Fisher syndrome (MFS; a GBS variant ), and
1 case of undifferentiated motor -sensory axonal polyneuropathy with worsening of pre- existing
22 Table 3 ABRYSVO package insert Package Insert -ABRYSVO (STN 125768) (fda.gov); Includes all SAEs from vaccination to 6
months post -delivery (up to approximately 10 months, depending on the gestational age at the time of vaccination). In the phase
3 RCT, eclampsia occurred in 5 participants (3 in the RSVpreF group and 2 in the placebo group) and HELLP syndrome occurred
in 5 participants (2 in the RSVpreF group and 3 in the placebo group).
23 Melgar et al. Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on
Immunization Practices — United States, 2023 | MMWR (cdc.gov)
22

   symptoms. No GBS or other demyelinating events were reported in the Phase 2 or 3 trials
among pregnant people.24 The background rate GBS syndrome in pregnant people is much
lower than that among older adults.25 In the VSD during 2004─2015, there were 2 cases of G BS
in pregnant people with an incidence rate of 2.8 per million person years.26
In summary of the Benefits and Harms domain, the WG felt that this is an efficacious vaccine
that can prevent RSV LRTI in young infants. However, there was no consensus among the WG
regarding the clinical importance of the preterm birth imbalance observed in the clinical trials.
WG members found several points concerning preterm birth. Although not statistically
significant, an imbalance in preterm births was seen in the full trial population. The trial was
powered for efficacy outcomes and was not designed or powered to detect a 20% increase in
preterm birth. There may have been less precise dating of gestational age in some sites and
countries in the trial, but there is no reason that this should bias towards a preterm birth
imbalance among vaccinated compared to placebo recipients. The pre -term birth signal in the
GSK maternal RSV vaccine trial, which also is a stabilized prefusion F- protein vaccine, added to
the WG’s concern.
WG members also found several aspects of the data to be reassuring regarding the preterm
birth imbalance. When using the full trial dosing interval, most preterm births (60%) were more
than 30 days after vaccination. T here is no known biologic mechanism for vaccines to cause
preterm birth, particularly more than 30 days after vaccination. When assessed among those
vaccinated during the approved dosing interval of 32─ 36 weeks, data on preterm birth were
reassuring to the WG. Specifically, the imbalance in preterm birth was still present but lessened.
Most infants born preterm in the vaccine group were born at 36 weeks. In the US, which was the
single largest contributing country in the trial, the imbalance in preterm births reversed from the
trial dosing interval (trial dosing interval: 5.7% in vaccine vs. 5.3% in placebo recipients ;
approved dosing interval: 4.0% in vaccine vs. 4.4% in placebo recipients ). Overall, the majority
of the WG members felt that the approved dosing interval of 32─ 36 weeks gestation could
reduce the potential risk of preterm birth and the potential for complications from preterm birth,
both by preventing preterm birth and because babies born late preterm are less likely to have
complications from preterm birth. This was their major safety concern.
When asked how substantial the desirable anticipated effects are of the Pfizer maternal RSV
vaccine for the critical and important outcomes, the WG was split between “Large” and
“Moderate, ” with a narrow majority choosing “Large. ” When asked how substantial the
undesirable effects are of the Pfizer maternal RSV RSVpreF vaccine for the critical and
important outcomes, the WG responded that they were “S mall. ” When asked about the balance
of desirable and undesirable effects, the WG determined that the balance favored the
intervention of the Pfizer maternal RSVpreF vaccine.
24 https://www.fda.gov/media/168185/download
25 Myers TR, McCarthy NL, Panagiotakopoulos L, Omer SB. Estimation of the Incidence of Guillain- Barré Syndrome During
Pregnancy in the United States. Open Forum Infect Dis. 2019 Mar 15;6(3):ofz071. doi: 10.1093/ofid/ofz071; and Sejvar JJ,
Baughman AL, Wise M, Morgan O. Population Incidence of Guillain- Barré Syndrome: A Systematic Review and Meta- Analysis.
Neuroepidemiology 2011;36:123– 133
26 Myers TR, McCarthy NL, Panagiotakopoulos L, Omer SB. Estimation of the Incidence of Guillain- Barré Syndrome During
Pregnancy in the United States. Open Forum Infect Dis. 2019 Mar 15;6(3):ofz071. doi: 10.1093/ofid/ofz071
23

   Moving to the Values domain, the results of a values survey of pregnant and recently pregnant
people conducted during December 2022─ January 2023 conducted by the University of Iowa,
RAND, and the CDC were presented during the June ACIP meeting. Among the respondents,
68% had knowledge of RSV prior to taking the survey and 61% of respondents said they
“definitely ” or “probably ” would get an RSV vaccine while pregnant. Among those who did not
respond that they “definitel y” would get an RSV vaccine while pregnant, safety concerns, lack of
RSV knowledge, and concerns about vaccination causing or intensifying RSV infection were the
top reasons for not wanting an RSV vaccine during pregnancy.27 It also is important to look at
the uptake of other vaccines in pregnancy. In the US, coverage for recommended vaccines
among pregnant people decreased during the pandemic and varies by race and ethnicity.28
TDAP vaccination coverage was 53.5% in the 2020─2021 season and 45.8% in the 2021─2022 season. Rates of TDAP coverage were higher in White, non-Hispanic women than among
Black, non-Hispanic  women during the 2020─2021 and 2021─2022 seasons.
When asked whether the WG felt that pregnant people feel the desirable effects are large
relative to the undesirable effects , the answered “probably yes. ” When asked if there is
important uncertainty about , or variability in, how much pregnant people value the main
outcomes , the WG was evenly split between “ probably important uncertainty or variability ” and
“probably not important uncertainty or variability. ”
There were limited data to inform the Acceptability domain and no updates since the June ACIP
meeting. A study in England
29 assessed support of an RSV vaccine among maternity health
care professionals (HCP) , specifically obstetricians and midwives . If the vaccine was routinely
recommended , 47% of responders said they “ definitely ” would recommend the vaccine, 34%
“likely ” would support a routinely recommended RSV vacci ne, 14% were “not sure,” 4% said
“unlikely,” and 0.5% said “very unlikely .” When asked i f RSV prevention with the Pfizer maternal
RSV vaccine was acceptable to key stakeholders, the majority of the WG answered “yes” and a
minority answer ed “probably yes. ”
In terms of the F easibility domain, the storage and handling requirements, the vaccine is
supplied as single 0.5 mL dose or as a 5- pack or 10- pack of single- dose kits . Reconstitution is
required, with  a single dose vial of lyophilized powder and reconstitution supplies included in the
kits. The p roduct should be refrigerated (2° –8°C) in the original container and protected from
light. After reconstitution, the product should be administered within 4 hour s and otherwise
discarded.30 Additionally, most pregnant patients receive Tdap vaccine in an obstetrician’ s or
midwife ’s office. Therefore, it is likely that pregnant patients also most often would receive RSV
vaccine at their prenatal care provider ’s offi ce.31
27 CDC and University of Iowa/RAND survey, unpublished
28 Flu, Tdap, and COVID -19 Vaccination Coverage Among Pregnant Women – United States, April 2022 | FluVaxView | Seasonal
Influenza (Flu) | CDC; https://www.cdc.gov/flu/fluva xview/pregnant -women- apr2022.htm
29 Wilcox CR, Calvert A, Metz J, et al. Attitudes of Pregnant Women and Healthcare Professionals Toward Clinical Trials and
Routine Implementation of Antenatal Vaccination Against Respiratory Syncytial Virus: A Multicenter Questionnaire Study. The
Pediatric Infectious Disease Journal. 2019 Sept;38(9):944- 951. DOI: 10.1097/INF.0000000000002384.
30 Package Insert -ABRY SVO (STN 125769/26) (fda.gov)
31 https://www.cdc.gov/flu/fluvaxview/pregnant -women- apr2022.htm
24

  Another important consideration for feasibility is simultaneous administration of RSV vaccine
with other vaccines in pregnant people. Pregnant people potentially may be eligible to receive
RSV, T dap, COVID -19, and influenza vaccines during the same visit. There are limited data
regarding simultaneous administration, but there was a Pfizer study32 in healthy non- pregnant
women 18─49 years of age on simultaneous administration of Tdap and Pfizer RSV vaccine
that found decreased immune response to pertussis components, meaning that the non-
inferiority criteria were not met. However, given the lack of correlates of protection for pertussis,
it is unclear how this might impact protection against pertussis from maternal Tdap when
simultaneously administered with RSV vaccine. Tdap is recommended every pregnancy,
preferably during the early part of gestational weeks 27─ 36,33 which means that Tdap preferably
would be given before 32 weeks and RSV vaccine would be given at or after 32 weeks.
However, in MarketScan data from 2018─2021,34 about half of captured Tdap doses were given
before 32 weeks gestation.
Another important consideration is that RSV vaccine is 1 of 2 available preventive products for
RSV in infants. Either RSV vaccination during pregnancy or nirsevimab administration for the
infant after birth can be used to prevent RSV disease in infants. The WG felt strongly that both
products are not needed for most infants. The pregnant person and their prenatal care provider
will need to make the decision during pregnancy regarding which RSV prevention product to
use. Many prenatal care providers may not have time to discuss options for RSV prevention
with their patients. In addition, prena tal care providers may not feel equipped to discuss
nirsevimab since this product will be given to the infant after birth.
Regarding the timing of RSV vaccine dosing during the calendar year, RSV vaccine dosing
could be implemented for pregnant people as a seasonal campaign or year-round.  The WG
unanimously supported the use of a seasonal dosing strategy for maternal RSV vaccine
because this would maximize cost -effectiveness , maximize the benefits for infants, and target
RSV vaccine dosing to inf ants who will be in the first months of life during the RSV season.
Importantly, nirsevimab is available for infants who are born out of season for whom maternal
vaccine protection would have waned by RSV season. The WG supported seasonal dosing
beginning in September and going through January in most of the continental US based on
typical pre -pandemic seasonality. This aligns with implementation of influenza vaccine and
would simplify implementation for prenatal care providers. The WG felt that jurisdictions in which
RSV seasonality differs from most of the continental US should have flexibility regarding start and stop of administration of RSV vaccine in pregnant people. These jurisdictions include
Alaska and jurisdictions with tropical climates (e.g., parts of Florida, Puerto Rico, US Virgin
Islands, Hawaii, Guam, and US -affiliated Pacific Islands ).
When asked whether the Pfizer maternal RSV vaccine is feasible to implement , the majority of
the WG answered “yes” and a substantial minority answered “probably yes. ”
32 Peterson et al. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F Vaccine When CoadministeredWith a
Tetanus, Diphtheria, and Acellular Pertussis Vaccine.The Journal of Infectious Diseases. 2022 June 15; 225(12): 2077– 2086. doi:
10.1093/infdis/jiab505
33 CDC, https://www.cdc.gov/vaccines/vpd/dtap- tdap- td/hcp/recommendations.html
34 MarketScan data, 2018- 2021
25

   Regarding the R esource Use Domain, the ACIP heard presentations earlier from D rs. Hutton
and Ortega -Sanchez on economic analyses. Dr. Hutton showed scenarios for cost -effectiveness
by months of RSV vaccine dosing during the calendar year. The base case was about $400,000
per QALY. If the months of dosing were limited to target dosing to pregnant people whose
infants would be in the first months of life during the RSV season, the ICER decreased and the
cost- effectiveness improved. Importantl y, the ICER would be $167,000 per QALY is dosing is
provided during the September ─January timeframe. The WG interpretation was that while RSV
vaccine may improve outcomes, it also would increase costs. The base case model showed an
icer of about $400,000 p er QALY and assumed year -round dosing of this vaccine and typical
RSV seasonality in most of the continental US. The WG felt that this vaccine would not be cost -
effective under the base case conditions. However, cost -effectiveness would be improved by
using a seasonal dosing strategy during September ─January in most of the continental US.
Thus, the WG unanimously supported the use of a seasonal dosing strategy.
When asked whether Pfizer maternal vaccine use would be a reasonable and efficient allocation
of resources , a substantial majority of the WG answered “ probably yes ” and a substantial
minority answered “yes.” It is important to note that the WG responses were based on seasonal
dosing for RSV vaccine specifically during September ─January in most of the continental US.
Data for the final domain of Equity have been presented before. National studies of death
certificates found higher rates of RSV -associated deaths among non- Hispanic Black children
compared with non -Hispanic White infants in children 1-4 years of age.35 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.36 In one study, RSV hospitalization rates were 4 to 10 times
higher among Alaska Native and American Indian (AI/AN) children <24 months than the rate in
the general population.37 However, it is important to note that the study was limited to specific
populations and might not be broadly representative of risk in all A I/AN children.
Regarding Medicaid coverage for pregnant people and vaccines during pregnancy , by federal
law, all states provide Medicaid coverage for pregnancy -related services to pregnant women
with income levels up to 138% of the federal poverty level.38 In 2021, 41% of mothers had
Medicaid at the time of birth,39 making Medicaid the largest payer for maternity care in the US. If
recommended, ACIP would vote on a Vaccines for Children (VFC) resolution for the vaccine for
pregnant people < 19 years of age. B eginning on October 1, 2023, when the Inflation Reduction
Act of 2022 (IRA) provisions become effective, state Medicaid agencies will be required to
recover vaccines and their administration without cost -sharing for nearly all adult beneficiaries
covered under traditional Medicaid, if the CDC recommendations apply. Regarding other
insurance coverage, meaning commercial insurance for vaccines during pregnancy under the Affordable Care Act (ACA) and its implementing regulations, ACIP recommendations that have
been adopted by CDC and are listed on CDC’s I mmunization Schedules generally are required
to be covered by group health plans and health insurance issuers without any cost -sharing
requirements.
35 Hansen et al. The Use of Death Certificate Data to Characterize Mortality Associated With Respiratory Syncytial Virus,
Unspecified Bronchiolitis, and Influenza in the United States, 1999- 2018 J Infect Dis. 2022 Aug 15;226(Supplement 2): S255–
S266.
36 Unpublished data from RSV -NET, CDC.
37 Atwell et al. RSV Among American Indian and Alaska Native Children: 2019 to 2020 Pediatrics. 2023 Aug 1;152(2):e2022060435
38 https://www.kff.org/womens -health- policy/issue -brief/medicaid- coverage- for-women/
39 https://www.medicaid.gov/sites/default/files/2023- 04/beneficiary -profile -2023.pdf
26

     When asked what the impact of the Pfizer maternal RSV vaccine on health equity would be , the
WG’s answers ranged and there was no clear majority . The most common answer among the
WG was “probably increased, ” the second most common was “probably no impact, ” and the
third most common was “increased. ”
In summar y, regarding the use of the Pfizer maternal RSV vaccine to prevent RSV in infants ,
the WG judged this is an important public health problem, the desirable anticipated effects are
large, the undesirable anticipated effects are small, the balance of desirable and undesirable
effects favor the intervention, and that the target population probably feels the desirable effects
are large relative to the undesirable effects. Half of the WG chose that there is probably
important uncertainty or variability in how patients value the outcome, and half chose there is
probably not important uncertainty or variability. The WG judged that the intervention is
acceptable to key stakeholders , is feasible to implement, and is probably a reasonable and
efficient allocation of resources with seasonal dosing. The WG had varied answers as to
whether the intervention would increase health equity, ranging from probably no impact to increased health equity. The majority of the WG felt that the desirable consequences probably
outweigh the undesirable consequences in most settings, and a substantial minority felt that the
desirable consequences clearly outweigh the undesirable consequences in most settings. The
majority opinion was in favor of recommending the Pfizer maternal RSV vaccine, and there was
a minority opinion to recommend the intervention based on shared clinical decision- making.
To summarize the WG’s considerations overall, for benefits and harms, the majority of the WG
was supportive of the intervention with the Pfizer maternal RSV vaccine for pregnant people
with the approved dosing interval of 32─ 36 weeks gestation. They found the data on preterm
births, when assessed among those vaccinated during the approved interval, to be reassuring.
They felt the approved dosing interval of 32─ 36 weeks gestation would reduce the potential risk
of preterm birth and the potential for complications from preterm birth, which was their major
safety concern. All WG members endorsed the importance of post -introduction vaccine safety
monitoring. The WG unanimously supported the use of a seasonal dosing strategy, which would
maximize benefits and cost -effectiveness. The WG supported that RSV vaccine dosing should
occur during September ─January in most of the continental US and felt that jurisdictions in
which RSV seasonality differs from most of the continental US should have flexibility regarding
start and stop of administration of RSV vaccine in pregnant people.
The WG also considered the implications of RSV vaccine being 1 of 2 available preventive
products for RSV in infants. The WG expressed that pregnant people should have options for
RSV prevention, given that nirsevimab may not be readily available in all settings. In addition,
pregnant people and their providers may have preferences regarding these 2 products. The WG
also stated that pregnant people should be made aware that they either could receive RSV
vaccine during pregnancy or that nirsevimab could be given to the infant, but that most infants
would not need both. The WG expressed that pregnant people should be informed regarding
the risks and benefits of both products before making a decision.
The WG had extensive discussions regarding a full recommendation versus a shared clinical
decision- making recommendation. Most WG members support a full recommendation. They felt
the approved dosing interval would reduce the potential risk of , and complications from , preterm
birth. They stress ed the importance of clear vaccine recommendations and noted that providers
who will help pregnant people decide which product to receive generally have less familiarity
with the data than ACIP does. They expressed that shared clinical decision- making
recommendations can be confusing, hard to implement for providers , can lead to lower vaccine
confidence and uptake of vaccine, and potentially could influence support for the vaccine in
27

  lower -and middle- income countries where nirsevimab may not be available. A minority of WG
members supported a recommendation with shared clinical decision- making. They noted that
without shared clinical decision- making, a full recommendation could result in some providers
recommending RSV vaccine during pregnancy without discussing with pregnant patients that
nirsevimab is an option. They cited the potential risk for preterm birth and neuroinflammatory
events and cited that the same vaccine is recommended under shared clinical decision- making
for adults ≥60 years and older. It is important to note that ACIP generally makes shared clinical
decision- making recommendations when individuals may benefit from vaccination, but broad
vaccination of people in that group is unlikely to have population- level impacts. As discussed
during the June ACIP meeting, the WG noted that currently there are no data available on the
efficacy of the first lifetime dose during subsequent pregnancies, or the safety of additional
doses given in subsequent pregnancies. The WG felt that it was too early to decide whether
additional doses should be given in subsequent pregnancies due to the lack of data, that
additional data are needed to inform whether additional doses in subsequent pregnancies would
be indicated, and that recommendations can be updated in the future.
With all of th is in mind, the proposed voting language put forward for a potential vote during this
meeting was as follows:
“Maternal RSV vaccine is recommended for pregnant people during 32 through 36 weeks
gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in
infants.”
Updated Clinical Considerations for Use of Both Nirsevimab and Pfizer RSVpreF Vaccine
Jefferson Jones MD, MPH, FAAP, CDR USPHS (CDC/NCIRD) discussed the updated clinical
considerations for the use of maternal RSVpreF vaccine and nirsevimab. Beginning with the
proposed clinical considerations for use of the maternal RSV vaccine, as Dr. Fleming -Dutra
reviewed, the WG discussion points that shaped these considerations included that as
proposed, the maternal RSV vaccine would be recommended for pregnant people during 32─ 36
weeks gestation with seasonal administration or during September ─January in most of the
continental US in jurisdictions with seasonality that differs from most of the continental states,
including Alaska and jurisdictions with tropical climates (e.g., parts of Florida, Hawaii, Puerto
Rico, Guam, US Virgin Islands, and the US- affiliated Pacific Islands ). In those jurisdictions,
providers would follow state, local, or territorial guidance on the timing of administration. The
maternal RSVpreF vaccine may be administered simultaneously with other eligible
vaccinations.40
Before reviewing the clinical considerations for use of both the maternal RSV vaccine and
nirsevimab, Dr. Jones summarize d the considerations of the WG. He first discussed 2 groups of
infants born to vaccinated mothers who were previously considered for nirsevimab during the
June ACIP meeti ng, preterm infants and infants born outside of the RSV season. As proposed
regarding infants born prematurely, the maternal RSV vaccine recommendation is for
administration beginning at 32 weeks gestation. F rom the time of maternal vaccination, 14 or
more days are likely needed for development and transplacental transfer of maternal antibodies
to protect the infant and nirsevimab is recommended for infants born within 14 days of
vaccination. The earliest an infant can be born and hav e maternal vaccine- induced protection is
40 https://www.cdc.gov/vaccines/hcp/acip -recs/general -recs/index.html
28

   34 weeks gestation. This means that all infants born at <34 weeks gestation will be
recommended to receive nirsevimab.41
Regarding infants born outside of the RSV season, protection from maternal vaccination may
begin to wane after 3 or more months. For example, this has been seen with the influenza and
COVID -19 vaccines .42 WG members initially were concerned that some infants born outside of
the RSV season and born to vaccinated mothers may benefit from nirsevimab in order to boost protection when entering the RSV season. However, because maternal RSV vaccine
administration is now proposed to be recommended during September ─January, most infants of
vaccinated mothers will be born during the RSV during October ─March . Mothers of infants born
outside of the RSV season during April ─September will not have been vaccinated, and
nirsevimab will be recommended for these infants.
Other WG considerations regarding the use of both maternal RSV vaccine and nirsevimab
included that there are 2 products available to protect infants from RSV LRTI . For infants born to
vaccinated mothers , the addition of nirsevimab may provide incremental protection, but there
are no efficacy data on the use of nirsevimab in infants born to vaccinated mothers, so this is
unknown. There also are no safety data on the use of nirsevimab in infants born to vaccinated
mothers , but nirsevimab trials included infants with maternal infection- induced antibodies and
the risk is likely minimal. The WG felt that for most infants, administering both products is not
needed and would not be a reasonable and efficient allocation of resources based on the cost -
effectiveness analysis presented earlier in the day. Of note, documentation of maternal
vaccination status may not be available to the infant ’s HCP.
Most WG members felt that pregnant people should be aware that both maternal vaccination
and nirsevimab are options when deciding whether to be vaccinated. However, HCP of
pregnant people may not have the time or feel equipped to discuss nirsevimab when
counseling. The WG felt that in rare situations, flexibility is needed for providers to be able to
administer nirsevimab when it is clinically warranted for infants born to vaccinated mothers.
Examples include conditions in pregnant people resulting in an inadequate immune response to
vaccine or decrease in transplacental antibody transfer.
43 Also, infants who have undergone
cardiopulmonary bypass leading to a loss of maternal antibodies44 and infants with su fficiently
increased risk for severe disease to warrant nirsevimab because of the potential increased benefit.
The following are the proposed clinical considerations for the use of the maternal RSV vaccine
and nirsevimab :
Either maternal vaccination or use of nirsevimab in the infant is recommended to prevent
RSV LRTI , but administration of both products is not needed for most infants.
Health care providers of pregnant people should provide information on both products and
consider patient preferences when determining whether to vaccinate the pregnant patient or
to not vaccinate and rely on administration of nirsevimab to the infant after birth.
41 https://www.cdc.gov/vaccines/pregnancy/vacc- during- after.html
42 Kampmann NEJM 2023; Nunes F1000Res 2018;and Zerbo Nat Commun 2023.
43 Palmerira Clin Dev Immunol 2012
44 Feltes J Pediatr 2003
29

   It is important to note that both products are safe and effective in preventing RSV LRTIs in
infants. The following displays potential information that could be shared with patients on the
relative risks and benefits of a maternal RSV vaccine and nirsevimab:
Relative benefits of maternal vaccination include that a maternal vaccine provides protection
immediately after birth, when infants are at the highest risk for severe RSV disease. A maternal
vaccine may be more resistant to virus mutation compared w ith monoclonal antibodies,
although RSV does not mutate rapidly. While both products require an injection, use of a
maternal vaccine avoids injection of the infant. Relative risks of maternal RSV vaccination
include that maternal vaccine- induced protection is reduced if fewer vaccine- induced antibodies
are produced or are transferred from the mother to the baby (e.g., mother immunocompromised
or the infant is born soon after vaccination. There is a potential risk of preterm birth , but
administration at 32─ 36 weeks reduces this risk.
The relative benefits of nirsevimab include studies of antibody levels suggest ing that protection
from nirsevimab might wane more slowly. Administration of nirsevimab can provide antibodies directly if an infant receives less antibodies from the mother. Since nirsevimab is provided after
birth, there are no risk of adverse pregnancy outcomes. Relative risks of nirsevimab include that
there may be potential limited availability of nirsevimab during the 2023─2024 RSV season. In
the setting of a maternal vaccine, nirsevimab would be recommended for infants <8 months of
age born during or entering their first RSV season if the mother did not receive the RSV vaccine
or it is unknown if the mother received an RSV vaccine or mother was vaccinated, but the infant
was born <14 days after vaccination. Nirsevimab is not needed for most infants born ≥14 days
after maternal vaccination.
Nirsevimab can be considered in circumstances when the mother has received RSV vaccine
≥14 days prior to birth . Nirsevimab can be considered in rare circumstances, per the c linical
judgment of the HCP , the potential incremental benefit of administration is warranted. One
example is infants born to pregnant people who may not mount an adequate immune response
to vaccination (e.g., people with immunocompromising conditions ) or have conditions
associated with reduced transplacental antibody transfer (e.g., people living with HIV
infection).
45 Other examples include infants who have gone undergone cardiopulmonary
bypass, leading to a loss of maternal antibodies46 or infants with substantial increased risk for
45 Palmerira Clin Dev Immunol 2012
46 Feltes J Pediatr 2003
30

  severe RSV disease (e.g., hemodynamically significant congenital heart disease or ICU
admission requiring oxygen at discharge ). Recommendations for nirsevimab can be
summarized in the following algorithm .
Nirsevimab is recommended to all infants aged <8 months on the day of administration who
meet all 3 of the following criteria :
Details on timing, including special situations and flexibility, are described in the footnotes:
These were previously presented during the August ACIP meeting under nirsevimab and
described in the published nirsevimab recommendation in the Morbidity and Mortality Weekly
Report (MMWR ).
31

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   Implementation Considerations for Maternal RSV Vaccine
Georgina Peacock, MD, MPH (CDC/NCIRD) presented m aternal RSV vaccine implementation
Considerations , including the following:
Vaccine storage, handling, and administration
Cost of vaccine
Insurance coverage
Supply and availability
Complexity of immunization schedule
Vaccine demand and coverage in pregnant people Obstetric and pediatric provider roles in vaccination decisions
Immunization information systems
Communication challenges
For Pfizer RSV vaccine storage, handling, and administration, the overall clinical implementation
is similar to other vaccines. It is stored at 2◦ to 8◦ C and administered as a single dose through
an intramuscular ( IM) route. Additional steps are required for dilution, including reconstitution of
the lyophilized antigen component with the sterile water diluent component.
47 The proposed
recommendations to ACIP allow for simultaneous administration with other recommended
vaccines,  and there is som e consideration that increasing the number of vaccines could lead to
limited storage space.
There has been a lot of conversation already about cost of the vaccine at $295 a dose for the
Pfizer RSV compared to Tdap that is approximately $46 to $52.48 This cost is lower than the
infant nirsevimab cost of $495 for the private sector cost. Reimbursement and cost recovery
challenges already have been identified by providers and practices as implementation barrier s
for maternal immunization. Among providers, f inancial concerns are a leading barrier to
maternal immunization.49
Related to insurance coverage, most pregnant people are covered by some form of private
payer or Medicaid. About 52% of pregnant people have private insurance, 41% have Medicaid,
and about 4% are likely uninsured and are considered “ self-pay.”50 If recommended, ACIP
would vote on a V FC resolution for maternal RSV vaccine in people aged <19 years . For people
≥19 years of age, there would be limited availability through the 317 program in jurisdictions. In
terms of i nsurance coverage for infant nirsevimab , the ACIP already recommended nirsevimab
as a routine immunization. Therefore, it will be covered under the ACA without cost -sharing by
the patient starting in the effective plan year .51 Anecdotally, plans are starting to let people know
that they will start covering nirsevimab when it becomes available in the coming weeks.
Nirsevimab is included in the V FC program for eligible children, so about 50% of children in the
US will be able to access nirsevimab at no cost.
47 https://www.fda.gov/media/168889/download?attachment
48 Current CDC Vaccine Price List | CDC
49 https://www.sciencedirect.com/science/article/abs/pii/S0749379717306396#f0010
50 https://www.cdc.gov/nchs/products/databriefs/db468.htm
51 https://www.law.cornell.edu/uscode/text/42/300gg- 13
32

   With regard to supply and availability of maternal RSV vaccine and nirsevimab during the 2023–
2024 RSV season , there are no anticipated supply/demand mismatches . Because the Pfizer
maternal RSV vaccine is the same product in use for adults ≥60 years of age, availability is
expected shortly after ACIP recommendations. Nirsevimab likely will be available in late
September or early October . There were some conversations during the last ACIP meeting
about delivery in birthing hospitals versus outpatient settings. Efforts are underway to increase
the number of birthing hospitals that will administer nirsevimab , particularly under the VFC
program.
It is important to point out the increas ing complexity of the maternal immunization schedule as
illustrated in this figure:
The maternal immunization schedule is increasingly complex in terms of d ifferent timing of
vaccines based on the season and/or gestational age, with seasonal timing varying in some
locations. In addition, there is a limited window for RSV vaccine administration. The willingness
of pregnant people to accept multiple vaccines in pregnancy also is unclear. In a survey of
pregnant people, approximately 12% said they would accept no vaccines and about 49% said
they would accept 1 or 2 vaccines .52 Uptake of vaccines among pregnant people has declined
and disparities persist.53
Important decisions will need to be made regarding w hether to administer maternal RSV
vaccine or infant nirsevimab. Studies continue to demonstrate that HCPs are pregnant people’s
most trust ed source of information on vaccines, and that provider recommendation is a strong
predictor of vaccination.54 However, one survey show ed that two- thirds of obstetricians did not
feel comfortable providing information about routine childhood immunizations or that that was
their role.55 In terms of pediatric provider roles in immunization decisions, recommendations for
nirsevimab that are contingent upon knowledge of maternal vaccination status could be challenging if the pediatric provider does not receive the maternal record. Verbal report s of
vaccines received during pregnancy may not be reliable.
56 Therefore, pediatric providers may
need to make decisions on nirsevimab administration without having complete information on maternal vaccination status.
52 CDC and University of Iowa/RAND survey, unpublished
53 https://www.cdc.gov/flu/fluvaxview/pregnant -women- apr2022.htm
54 Lutz C, et al. Understanding barriers and predictors of maternal immunization: Identifying gaps through an exploratory literature
review. Vaccine 36 (2018): 7445- 7455
55 https://link.springer.com/article/10.1007/s10995-011- 0936-0
56 https://www.cdc.gov/mmwr/volumes/66/wr/mm6641a3.htm
33

 


 Moreover, s tate Immunization Information System s (IISs) vary in what they capture related to
adult immunization. Pregnancy status is not identified in IIS, though potentially RSV vaccine
administrations in adult women <age 60 years of age could be used as a proxy for RSV vaccine
administration. There is not a way currently to link maternal and infant i mmunization records in
IISs, so it is not possible through these systems at this point to use that to forecast whether
infant nirsevimab immunization is needed. In some state policies, there is not an ability for
pediatric providers to review adult records or records of individuals who are not their patients.
As always in immunization implementation, there are some communication challenges. This
includes use of t erms like “vaccine” for the maternal product versus “immunization” for the infant
product . Conveying potential risks and benefits of each approach and helping the pregnant
person make an informed decision, including the potential but undetermined risk of preterm birth
with maternal immunization, is going to take time for providers. D iscussing financial implications
with a patient in a setting of uncertainty related to coverage in the first year of implementation
may be challenging.
A lot of work is being done at CDC to address communication activities. There has been
formative research and message testing, including with focus groups and in- depth interviews to
help inform the ultimate communication activities that will be done for the public. There have
been surveys of parents of young children and also pregnant and recen tly pregnant people.
With that information, patient and provider education materials are being developed. There also
are some partnerships with HCP organizations and organizations that serve pregnant people.
There also is an intention to utilize social media across all of CDC’ s platforms.
Vaccines for Childrens Resolution
Jeanne Santoli, MD, MPH (CDC/NCIRD) indicated that the purpose of this resolution was to: 1)
add an RSV vaccine for pregnant people aged <19 years to the program ; and 2) update the
language regarding the recommended vaccine schedule for nirsevimab to take into account
RSV vaccine for use during pregnancy. The eligible groups include pregnant people aged <19
years. The recommended vaccination schedule and intervals included the language that was
reviewed during this session:
During 32 through 36 weeks gestation, with seasonal administration. This would be during September through January in most of the continental United States. In jurisdictions with
seasonality that differs from most of the continental Unites States (e.g., those with tropical
climates, Alaska), providers should follow state, local, or territorial guidance on timing of administration.
Either RSV vaccination during pregnancy at 32 through 36 weeks gestation or nirsevimab administration for infants age <8 months shortly before or during the RSV seasons is
recommended to prevent RSV lower respiratory tract infection, but both products are not
indicated for most infants.
Recommended DosageRefer to product package inserts.
Contraindications and Precautions
Contraindications can be found in the package inserts available at:
https://www.fda.gov/media/168889/download?attachment
34

 

     For t
he nirsevimab component, the only change was that now there are 2 components to the
eligible gr oups:
Infants aged <8 months born during or entering their first RSV season
Children aged 8- 19 months as noted in Table 1 who are at increased risk of severe RSV
disease and entering their second RSV season
No changes were made to the Table 1:
Language was added to Table 2 for the first season stating, “whose mother’s receipt of RSV
vaccine is unknown or who was born within 14 days of maternal vaccination” and the rest of the resolution is the way it appeared in August 2023 :
This recommended vaccination schedule and intervals language also has been added and there
is some language in each component of the resolution that refers to the other components:
“For most infants aged infants aged <8 months born during or entering their first RSV season
whose mother received an RSV vaccine 14 or more days prior to birth, nirsevimab is not
needed. Nirsevimab can be considered in rare circumstances when, per the clinical judgment of
the healthcare provider, the potential incremental benefit of administration is warranted. ”
35

 The recommended dosage, contraindications and precautions, and standard documents
statement about ACIP recommendations or notices within 6 months remained unchanged:
Recommended Dosage
Refer to product package inserts.
Contraindications and Precautions
Contraindications and Precautions can be found in the package inserts available at:
https://www.accessdata.fda.gov/spl/data/2f08fa60 -f674-432d- 801b -1f9514bd9b39/2f08fa60-
f674- 432d -801b- 1f9514bd9b39.xml
[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] .
Pfizer Statement
Luis Jodar, MD (Chief Medical Officer , Vaccines & Antivirals, Pfizer) thanked the ACIP for
the opportunity to speak. Pfizer is excited about the recent FDA approval of the maternal
indication for RSV vaccine, ABRYSVO ™. Last Fall, the US experienced a triple epidemic of
RSV, influenza, and COVID -19 infections , making national headlines. With the threat of another
triple epidemic, having multiple options for RSV prevention for infants will be more important
than ever. As shown in the from the data on efficacy in the randomized controlled trial s (RTCs) ,
the maternal RSV vaccine provides infants with a high degree of protection against RSV immediately from birth when infants are at highest risk for severe disease and maintains this
protection for at least 180 days. This is even more important when considering equity. Medicaid recipients miss or cancel a substantial proportion of their well -child visits in the first 6 months of
life, with only 25% attending all recommended well -child visits. In contrast, more than 90% of
Medicaid mothers attend at least 1 visit prior to delivery . With an estimated 41% of pregnant
individuals on Medicaid, maternal immunization provides a secure, stable, and equitable
approach to RSV prevention for newborns.
Regarding the concern raised about an imbalance in pre -term birth s, the totality of the data
supports a favorable benefit -risk profile for maternal vaccination as supported by the external
Data Monitoring Committee ( DMC ), the FDA’s Vaccines and Related Biological Products
Advisory Committee (VRBPAC), and FDA licensure. The US indication of 32─36 weeks is
reassuring about the potential risk of preterm birth. Pfizer has committed to 4 post-licensure
pharmacovigilance studies. The safety surveillance systems in place through Pfizer’s post -
marketing commitments, a long with the CDC and FDA systems presented during this meeting,
are sensitive, timely, powerful , and can detect any safety signals should any arise. Pfizer want s
to assure the committee that a robust supply of vaccine is already available to providers and is
ready to be implemented through existing vaccine programs. The RSV season is already
starting and, for the first time, there potentially could be 2 important routinely recommended
options for RSV prevention for infants. Pregnant persons now will be able to have an informed
discussion with their obstetricians and other maternal health providers, as they do for all
routinely recommended maternal vaccines , and make an informed decision on which option is
best for them and their baby. Dr. Jodar emphasized that the RSV vaccine would be a lower cost
option and overall could result in a lower budget impact for the US healthcare system. Pfizer
thanked ACIP and the WG for their careful deliberations and dedication to preventing infectious
diseases.
36

  Liaison Organi zation Statements
Brenna Hughes, MD, MSc, FACOG (ACOG) thanked the leadership of ACIP and the WG on
behalf of the American College of Obstetricians and Gynecologists (ACOG) for their
collaboration on this topic and for inviting ACOG to share its position and expert opinions
regarding the maternal RSV vaccine. It is critical that the O B-GYN voice be considered
particularly as implementation considerations are discussed. ACOG remains unequivocally
supportive of a full recommendation for maternal RSV vaccine for pregnant individuals. This
RSV vaccine is efficacio us and could decrease the risk of severe disease in many infants. While
nirsevimab is clearly highly efficacious, it may not be available or may not be preferred by a
parent or health care facility as the primary intervention. Therefore, ACOG believes it i s critical
to ensure that pregnant individuals can access this RSV vaccine to give their newborns
protection after birth. As a practicing obstetrician and member of the RSV Vaccine W G, Dr.
Hughes has reviewed these data extensively, along with the other ex perts on the WG , and has
discussed these data with ACOG experts and leadership. They have evaluated all of the
available data regarding the risk of premature delivery, and currently consider this outcome to
be a theoretical risk , with the benefits of vaccination outweighing the hypothetical risk of AEs.
Therefore, ACOG feels that this vaccine should be recommended. Finally, ACOG continues to
encourage the collection of additional data to inform future policy considerations, and look s
forward to collaborating with the CDC and other organizations to ensure optimal implementation of strategies to decrease the burden of RSV disease in infants.
Carol Hayes, CNM, MN, MPH, FACNM (ACNM) provided comments on behalf of the American
College of Nurse Midwiv es (ACNM), the largest professional association representing certified
nurse midwives and certified midwives in the US. ACNM sets the standard for excellence in
midwifery education and practice in the US and strengthens the capacity of midwives in
developing countries. ACNM members are primary care and sexual and reproductive health
providers for people throughout their lifespans , with a special emphasis on pregnancy,
childbirth, gynecological, and reproductive health. ACNM has participated actively in the ACIP and the CDC Task F orce on Maternal Immunizations and regularly update s and encourages
members to recommend the 3 standard maternal immunizations throughout a shared decision-
making model. The midwifery model of care puts women and pregnant people at the center of
care and encourages members to share scientific evidence on choice surrounding
immunizations so that pregnant families can make the best decisions for themselves. After
reviewing the evidence on the safety and efficacy of the maternal vaccine, as well as the
incidence of RSV cases in newborns and infants, ACNM strongly recommends that ACIP
support the availability of this vaccine to all pregnant people from 32─ 36 weeks of gestation.
ACNM believes that pregnant individuals should be informed of the benefits and the risks of
maternal RSV vaccine, and the vaccine should be available to those who choose it without any
barrier to access, such as cost , referral , or approval by a third party. Given the rise and the
prevalence of RSV cases among newborns, ACNM believes that pregnant people should be
able to access a vaccine that is proven to prevent LRTD and severe LRTD caused by RSV in
infants from birth to 6 months of age.
37

   ACIP Discussion Points, Observations, Suggestions for RSV Vaccine
Following Presentations by Dr. DeSilva and Dr. More
• ACIP expressed gratitude to Drs. DeSilva and More for sharing the proactive plans to
monitor RSV vaccines.
• In terms of an inquiry about how pregnancies with multiple gestations (e. g., twins,
triplets, et cetera) would be monitored since they have a risk for being preterm , Dr.
DeSilva indicated that multiple gestations will be excluded from the initial planned
evaluation. However, a more c omprehensive end-of-season evaluation is being planned
and consideration will be given to how to account for multiple gestation births .
• In response to a request about a status update on how the v-safesm monitoring of RSV
vaccines received by persons ≥60 years of age is going, Dr. Anne H ause from the v -
safesm program indicated that the new version of v-safesm is still in the final stages of
development, with a launch planned in Fall 2023 for RSV vaccines among older adults
and anticipated for maternal RSV later in Fall 2023. Dr. Shimabukuro added that while
they have received a small number of reports for the older adult population, no unusual or unexpected patterns have been seen at this point.
• Regarding whether any “back of the envelope” calculations have been done yet using different assumptions for uptake to understand what would be expected in terms of accrual of pregnancies in the VSD, Dr. DeSilva indicated that there is uncertainty about
vaccine uptake, and they are awaiting recommendations for use, but it is anticipated that
they will be well- powered to detect significant differences in preterm birth within 6
months of vaccine eligibility. Additionally, there are plans to perform some preterm and stillbirth surveillance that will be separate from this plan by monthly surveillance that
would only be descriptive, but it would be limited to the vaccinated population and can
be performed somewhat more quickly. These results lack a control population, so this
would not statistical comparisons.
• In terms of whether there would be monitoring of infant pertussis infection in the first 2 months of age given the lower pertussis antibodies with simultaneous vaccination with
an RSVpreF vaccine and Tdap for which the clinical significance is unknown, Dr.
DeSilva indicated that the VSD focuses on safety and not necessarily effectiveness of
vaccines. vaccine effectiveness. There are other groups within the agency who have
plans in place to study post -licensure effectiveness of maternal RSV vaccine.
• Regarding whether there is a systematic way to capture illnesses other than RSV or
concomitant illnesses that occur during pregnancy that could increase risk of outcomes
of interest, Dr. DeSilva replied that they will be capturing medically -attended events. If an
illness rises to the level of seeking medical attention, there could be some information about concomitant infection with RSV or other infections that are not RSV. This would be
dependent on how the provider codes what they are seeing. Consideration can be given
to how some additional covariates potentially could be included, such as diagnosed respiratory illnesses —especially if testing is involved.
• Regarding a comment that it would be beneficial to capture respiratory illnesses other than or concomitant with RSV and coadministration of vaccines among pregnant people,
Dr. Moro indicated that VAERS will capture other vaccines received at the time of vaccination with RSV.
• A lesson learned from COVID -19 vaccines is that when vaccines were received in public
settings (e.g., pharmacy, grocery store), people often were not informed about v-safe
sm
and no paperwork was provided. It would be beneficial for the v-safesm team to
implement a campaign with the chain pharmacies, grocery stores, the American College
of Obstetricians and Gynecologists (ACOG ), and the American College of Nurse-
38

 Midwives (ACNM) to promote v-safesm. It is an incredibly valuable tool for monitoring
side effects .
Following Presentation by Dr. Hutton and Dr. Ortega -Sanchez
• It is clear that the cost of the vaccine is a very important determinant in terms of cost -
effectiveness, but RSV is a prevalent and costly disease. With that in mind, Pfizer was
given the opportunity to speak to whether $295 was going to be the or if there would be
any decrease in cost.
• Donna Altenpohl , Pfizer , confirmed that the original price was $295 per dose for both the
maternal and older adult indications and that the Pfizer vaccine is the same product and
formulation for both indications. The product has one National Drug Code ( NDC) and
one Current Procedural Terminology (CPT) code for reimbursement, which Pfizer took
into consideration. Pfizer’s pricing strategy is guided by the value that their innovation
brings to patients and society, with the goal of achieving the broadest possible access
for patients. Based on the results of the Pfizer cost -effectiveness analysis, they priced
their vaccine to be both cost -effective and reflect the value that it will bring to helping
prevent RSV for older adults and infants. As they shared with the ACIP WG, the RSV maternal  vaccine will be a lower cost option and could result in a lower budget impact to
the US healthcare system .
• The expense of this vaccine is very disappointing, particularly in the context of making a recommendation for all pregnant people to receive the vaccine. It would be beneficial for the ACIP to know the cost of this vaccine to countries outside of the US to understand
whether it is overpriced in the US or if the price is standardized throughout the world.
• Donna Altenpohl , Pfizer, indicated that they have a tiered pricing strategy outside the US
that allows the price to be contingent upon the affordability of each individual country. As they are beginning to launch the RSV maternal vaccine, the pricing will be decided at
that point. Given that Pfizer has not confirmed all of its pricing, it would be inappropriate
to try to comment or speculate on that at this point beyond saying that they have not
finalized the price depending on whether there is separate pricing for the older adult
indication and the maternal vaccination. The global pricing strategy is tiered based on
the affordability of each and every country, with the goal of making sure there is affordable access for all eligible patients.
• Slides 6 and 7 in Dr. Hutton’s presentation show the difference in waning between 1, 6, and 9 months. Since maternal antibodies fade away by 6 months, it was not clear which
of the 2 slides was a more realistic representation of efficacy and whether there would
still be antibodies between 6 and 9 months or a dramatic decrease at 6 months. There
are maternal antibody data for other illnesses.
• Dr. Hutton replied that during their conversations, they thought 6 months was a
conservative assumption and that there are a lot of data to suggest that antibodies would be gone after that. Because that is not known for certain, they had a couple of different scenarios.
• Referring to Slide 15 in his presentation, Dr. Ortega- Sanchez added that the 2
assumptions about duration of protection were shown side -by-side. The pink shaded
area in each model denotes a higher level of uncertainty of the waning assumption beyond available Phase 3 data. There are no data that that support whatever the
vaccine efficacy to say that there will be some protection. The CDC model assumed a
more conservative assumption to minimize the uncertainty about whatever vaccine protection will be received after 6 months.
39

  • To the point about other maternal antibody data, Dr. Fleming Dutra confirmed that there
are data from other vaccines (e.g., Tdap, influenza, and COVID vaccines) that indicate
that post -maternal effectiveness of these other vaccines usually has waned by 6 months.
• It is important to understand that while maternal antibodies can persist in the infant as late as 18 months, the protective level of antibody is the issue. With other vaccines, the antibody level is significantly reduced after 3 to 6 months. Although some antibodies can
be detected, the levels probably are too low to be considered efficacious for whatever
disease one is trying to prevent.
• Dr. Jessica Atwell, Pfizer, provided more context regarding the data that inform antibody persistence in infants beyond 6 months. In addition to the data from Pfizer’s Phase 3
clinical trial, they also have data from their Phase 2b study that measured antibody
persistence in infants out to 6 months and compared those levels between infants born to vaccinated individuals and unvaccinated individuals. They were significantly higher
among infants born to vaccinated individuals compared to infants born to women who
received placebo in the Phase 2b trial. They used the half -life of antibody decay from
those data to then extend the potential antibody persistence beyond the 6- month time
point. That modeling, which was shared with the WG, showed persistence even beyond 9 months out to 12 months. Because there is no correlative of protection for RSV, it is it
is difficult to make direct assumptions about how those antibody levels may translate,
but certainly Pfizer has data to support persistence in infants beyond 6 months, which
were critical for informing th e assumption about persistence of antibodies and potential
benefit. If a pregnant person r eceived RSVpreF 3 weeks before delivery, the practitioner
would have to weigh the question of what the additional value would be of adding
nirsevimab on top of that. If it is known the infant will definitely receive nirsevimab, it would be reasonable to consider the value of adding RSV preF on top of that.
• Regarding an inquiry about whether, with the information about the monoclonal antibody and the vaccine on top of that having some benefit but at a very costly rate, there ever
would be a scenario in which monoclonal antibody could not be given to infants and
there would have to be reliance on mother ’s immunization, there is no known
contraindication to giving both. Dr. Hutton said it would be a reasonable intuitive
assumption that there would be some added incremental benefit. Dr. Long added that it was very perceptive for ACIP members to be asking these questions, and that later
presentations would later “thread the needed” pertaining to what circumstances would
allow a physician to give nirsevimab after a pregnant person has been properly
immunized.
• Hearing that the cost per QALY for RSVpreF is about $400,000 at a dose of $295 per
dose and recalling that during the August 3, 2023 ACIP meeting the cost per QALY for
nirsevimab was $100,000 at a cost of $495 per dose , the difference was unclear.
• Dr. Hutton responded that there is a lot going on. The major element in the simulation
modeling of nirsevimab is that efficacy is slightly better at the beginning, so slightly higher efficacy is one difference. Another difference is that nirsevimab can be given at
the peak of the RSV season. An infant born in April, May, June, or July would be given
nirsevimab to have peak efficacy during the season. Those are a couple of the factors
that affect the differences in the cost -effectiveness of nirsevimab versus what was
shown regarding RSVpreF during this session. The cost- effectiveness of RSVpreF looks
much better when it is given right before the peak of the RSV season when it will confer
the highest levels of efficacy.
• Regarding an observation that there did not seem to be a comparison of the cost of
either the pregnant person receiving maternal vaccine or the baby receiving nirsevimab, Dr. Long indicated that there are no head- to-head comparisons because these are
40

   standalone products that have been assessed. The recommendation for a possible vote
during this meeting pertained on to the vaccine product. However, that did not preclude
the possibility of occasional unusual situations in which a vaccine would be given before
delivery followed by nirsevimab after delivery. Dr. Jones added that the base case
scenario of giving the vaccine alone is the cost -effectiveness when not giving nirsevimab
on top of it. E ssentially, it was being presented as if either RSVpreF or nirsevimab was
given.
• In terms of an inquiry about projected uptake rates, Dr. Hutton responded that the UM-
CDC model assumed 50% uptake. A nice round number like 50% typically suggests that
it is an assumption. There are limited data about uptake at this point beyond the surveys
that have asked people about their intent, which suggests that 50% might be a
reasonable assumption. Given the anticipated implementation challenges, Dr. Long
thought 50% uptake would be optimistic for the vaccine this year.
• In an ideal world, it seemed that the precision public health approach of considering seasonality would be the best -case scenario. However, there are issues of the
complexity of implementation in terms of such tight timing, the cost and burden on teams
who are trying to deliver the vaccine in a precise manner, and so forth—even if that
precision might lead to a better investment in health overall .
• ACIP members continued to struggle with the cost of RSVpreF vaccine. While they
acknowledged and understand that the studies were expensive and Pfizer needs to
recoup their costs, $295 per dose is a hard cost to swallow. It is known that the higher the price of a vaccine, the higher the disparities.
Following Presentations by Dr. Fleming- Dutra,  Dr. Jones, Dr. Peacock
• To set the stage for this discussion session, Dr. Long made a few comments on the underpinnings of the WG considerations and recommendations for ACIP’s consideration. The WG was very concerned about the imbalance in prematurity, especially in the
shadow of the GSK vaccine that was not pursued. The WG likely would not have come
to consensus on a non -suffixed recommendation for 24─36 weeks. “Non- suffixed”
meaning with shared clinical decision- making. The data on vaccination at 32─36 weeks
gestation, coupled with the information that the prematurity that occurred in the trials was an average of 4 plus weeks after immunization was not associated with reactogenicity at
the time of immunization, made the WG more sanguine with 32─36 weeks gestation.
They thanked the FDA for making that restriction and not having the WG have to do that as a first potential restriction. The second restriction of the seasonal administration,
although this is not terribly popular, goes with the influenza season. That also, for most of WG, was based on a safety consideration. Given the potential risk of prematurity,
year-round administration may not benefit the infants born in April ─September. That was
the reason for that restriction. Regarding cost in terms of the base case, she did not
think the WG would have come to consensus for a recommendation. It was only the
seasonal use that, while it may be somewhat off -putting to some, that was the only way
in which this could get down to a QALY that was acceptable in their minds or similar to
other vaccine or preventions that allowed the WG the ability to present a non- suffixed
recommendation to the ACIP. In addition, there are no head- to-head trials of these
products or of safety. The WG thought that there would be mitigation of the potential risk
of prematurity, et cetera. In terms of how ACIP considers the WG’s very restricted
suggestions for the use of nirsevimab after the receipt of appropriately timed vaccine,
that the ACIP takes into consideration that these are both “antibody paint ” and that the
“antibody paint ” will wear off. They do not change the epidemiology of RSV disease and
the goal is not to prevent RSV infections in every individual. This can only r educe the
41

  morbid consequences of RSV by a certain degree. Pediatricians and others already
have already expressed concerned about the cut -points for nirsevimab and the vaccine.
The cut -points are based on data. Because this is not a vaccine that will chang e the
epidemiology, prevent herd, provide long -term protection, the cost must be acceptable
as possible because these are extraordinarily and probably unreasonably priced
products. The WG would say , “Bring on the competition to bring the costs down in the
US.”
• Dr. Talbot said she thought this might be the most complicated vaccine recommendation
for young adults that ACIP has had in a long time. She is worried about the complication
of the time period. While influenza and COVID vaccines are given during that season,
they are given to everybody regardless of where they are in their pregnancy. She also is
concerned that in the adult world if someone gets the same vaccine twice, the same
vaccine may be paid for twice. That is, if a mother has gotten the RSV vaccine but is confused because she received 4 vaccines, 2 vaccines, or 3 vaccines and the
pediatrician is left in a position to give the child the antibody, someone is going to have
to pay because that is double- dipping since ACIP would be recommending one or the
other. She wondered what the benefit would be of this vaccine if every child would be
given antibody.
• Dr. Long emphasized that it is always good to have 2 products . It is not known what
manufacturing will be like in the future or if after the first year of use, one or the other
would make them more hesitant to use one or the other.
• Dr. Poehling said that in speaking to parents who have recently given birth, some would
prefer to take a vaccine rather than have their child get a shot. She also has had cases
recently, including one in which the father of the child had a significant bleeding disorder,
who did not want the child to have any sticks for any reasons because it would be
unknown at that point whether the child was going to have a bleeding disorder. There
will be multiple cases like that. T here is a lot of complexity . Clearly document ing the
information so that everybody knows what has and has not been received is going to be
extraordinarily important. It also builds upon what has been said repeatedly during
previous meetings that having an immunization registry for all is desperately needed.
She recalled that Dr. Peacock ’s presentation showed that 52% of persons who are
pregnant have private insurance, 41% have Medicaid, and 4% are self -pay. She thought
they needed to dive deeper into this. The ACA states that private insurance has to cover
the vaccine, but that is not immediately. She wondered whether there are any data on
how many private insurances are paying for the RSV vaccine for adults ≥60 years of
age.
• Dr. Grubb (AHIP) said that while she did not have those data readily available, she
would try to obtain the information for the ACIP.
• Dr. Poehling emphasized the importance of the people listening to understand that there is a delay before insurance companies actually pay for the vaccine. In addition, it was her understanding the 317 funds recently have been decreased, which could impact
individuals 18─19 years of age who do not fall under Medicaid or the VFC program.
• Dr. Peacock confirmed that while the 317 funds have not decreased, the re is limited
availability of funds since there are more vaccines that potentially could be paid for
uninsured adults through this program. For context, 317 program funds are allocated t o
all immunization awardees so that they can purchase some vaccine. Typically, this
program is used for uninsured adults , sometimes fills in gaps related to children, and
also is used for outbreak funds.
42

  • Ms. Hance (CMS) confirmed that Medicaid will cover t he vaccine for adults who have
Medicaid who are covered under a CDC ACIP recommendation. That coverage is
separate from the 317 program.
• Dr. Sanchez said he favored a shared clinical decision- making recommendation
because there are 2 options that need to be discussed with the pregnant individual. The
first would be by her obstetrician who will need to discuss vaccination at 32─36 weeks
gestation, but also will need to discuss that the other option is nirsevimab. Pediatricians who will be taking care of the infants would have to tell the mother the baby cannot get
nirsevimab if she chose to receive the RSVpreF vaccine. Regardless of whether those
discussions are easy or hard, they must be had. With that in mind, he asked whether
there would be an option to vote on shared clinical decision- making.
• Dr. Lee requested that the team display the proposed vote language. She said that in
her opinion, every recommendation should be a shared decision similar to all medical
care that clinicians provide. To her, the distinction about the recommendation was not
about whether the process occurred. It was more about a universal recommendation
versus more of a selective recommendation. Even a full recommendation would not
mean that this discussion should not happen. In fact, this discussion should occur with every pregnant person to make sure that they are aware of the options. She did not think
that a shared clinical decision- making recommendation would change that. She noted
that while there always is an opportunity to amend proposed voting language, she would
like to focus on the displayed proposed language from the WG to make sure everyone
had an opportunity to comment.
• Ms. Bah ta agreed that the feasibility of having 2 products that would be given at 2
different times to 2 different audiences would be challenging. Colleagues in her own health department are struggling with how to implement nirsevimab and how to reconcile
that if the RSVpreF vaccine also is recommended. She also cautioned that because
RSVpreF is being implemented among older adults and the vaccine is very costly, there could be competition over a limited supply and/or limited availability if maternal vaccine
is recommended. Given that there were 2 wonderful options, it was extremely difficult not
to be supportive of the recommendation as proposed. While she supported it and agreed that every vaccine provided to patients should be explained, she wanted to highlight her
concern about the feasibility of implementation.
• Dr. Loehr strongly supported the seasonal nature of the recommendation. He noted that one insurance company that typically has been slow to implement recommendations is
covering nirsevimab effective immediately, and he expressed gratitude to all of the
insurance companies that are doing likewise in order to get it administered within this
season. He asked whether the WG considered adding a sentence stating that this
recommendation is for pregnant persons not intending for their infants to receive
nirsevimab, or if there was a reason not to include such language. For instance, if he
knows an infant will receive nirsevimab, he would not recommend maternal RSV
vaccine.
• Dr. Poehling noted that one insurance in North Carolina has agreed to pay for nirsevimab in the outpatient setting. They are still awaiting word on the inpatient setting.
She continues to remain concerned about the cost and who is going to cover it.
• Dr. Long responded that including that language might be a tacit implication that ACIP
might not prefer this vaccine. At this point this year, not knowing more than what they do
about efficacy and safety, they probably would not want to do this. She agreed with others that while it did not rise to the level of a policy decision, this absolutely should be
a shared decision between a doctor and patient. That is best addressed in the clinical
considerations. If anyone was wondering why in the world a decision ever would be
43

 made to withhold nirsevimab or give the vaccine on top of the plan for nirsevimab, they
occur at different times in the pregnancy and there may be compelling reasons. For
example, if it was identified in utero that a baby had significant congenital heart disease
and no safety issues had been identified, she would want to save that person for
nirsevimab and not risk any potential AEs by giving the vaccine during pregnancy. While
she favored the spirit of Dr. Loehr’s suggestion, she did not favor including it in the language per se.
• Dr. Sanchez suggested that there could be another angle. For example, a fetus diagnosed with severe congenital heart disease or other malformation may stay in the
neonatal intensive care unit (NICU) for an extended period of time. While every effort is
made to prevent RSV infection in the NICU, it does occur. If nirsevimab is not going to be given until discharge, this could be a compelling reason to vaccinate the pregnant
person to ensure that the baby benefits from maternal antibody at least through the time of discharge. In any case, they have recommended that nirsevimab be given irrespective
of whether the mother was vaccinated. He thought that should be kept as a clinical
consideration.
• Dr. Long expressed gratitude to Dr. Sanchez for raising this issue and stressed that he
has been instrumental in helping the WG understand all aspects, especially of
perinatology. However, she did not think monoclonal antibody or anything else should be
given in the NICU to protect infants in the nurser y. Infection control should do that. If
infection control fails, then monoclonal antibody can be given. She also thought protection from maternal antibody could be long gone before an infant with severe congenital heart disease was discharged from the NICU .
• Dr. Sanchez clarified that he was not suggesting giving nirsevimab to infants in the NICU until the time of discharge and agreed that infection prevention and control is preferable.
However, some infections do occur. His thinking was that if a term baby had maternal
antibodies, at least for the first several weeks before they have their surgery or bypass,
that it might also be beneficial, and the risk should be low because of infection
prevention practices.
• Dr. Kotton expressed her support for the proposed recommendation language as
presented. She thought it was easy to understand and that it is imperative for the public to clearly understand what the ACIP is recommending. Shared clinical decision- making
has been very confusing, so she would not support that.
• Regarding the shared clinical decision- making comments, Dr. Hughes (ACOG)
emphasized that obstetricians are highly experienced with and routinely perform counseling for all patients who receive vaccines, and this would be no different. She
agreed with Dr. Long’s assertion that for this reason, the recommendation did not rise to
the level of shared decision- making policy and she would support the full
recommendation on behalf of ACOG.
• Dr. Talbot pointed out that it seemed this recommendation was telling their obstetric
colleagues that all pregnant persons should receive the RSVpreF vaccine between
32─36 weeks and unless the fetus has a condition , and the infant then could not get
monoclonal antibody if the pregnant person was vaccinated. If a pregnant person was
32─36 weeks near the end of the RSV season, it was not clear what this would mean for
the infant in terms of qualifying for monoclonal antibody.
• Dr. Jones clarified that there was voting language and the clinical considerations. The
WG discussed all of this at length and there were some differing opinions among the
WG members. The majority felt that the voting language proposed for the vaccine would
be appropriate. The voting language for the vaccine was to convey that either product is
recommended and administration of both is not needed. The decision of which option to
44

 choose should occur at the time when deciding whether to vaccinate the pregnant
person.
• Dr. Long added that if the pregnant person chooses the vaccine, then the practitioner would indicate that at birth, the baby would not need nirsevimab except in rare
instances. It is true that the mother has a choice, but it is merely a choice like choosing different colored shoes with different heights of heels. Some will choose to protect their
infant by vaccinating themselves, and others will choose for their baby to have
nirsevimab. Given the anticipation that this season will be messy in terms of who
receives what and who pays for what, whether there are risks, and what the
effectiveness of these products will be , the WG wanted to offer the best possible
accommodations .
• Dr. Jones confirmed that all of the details that should occur in discussions with patients
would be covered in the clinical considerations and emphasized in the suite of educational materials, the MMWR , the Vaccine Information Statement (VIS), et cetera.
This includes specification of the rare situations in which there are insufficient antibodies
either because they were not produced after vaccination in a pregnant person or there is
decreased transplacental transfer. For those who will have potential waning of
antibodies and waning protection by the time RSV season peaks, because the
recommendat ion would be from September─January and infants would be born to those
mothers during the RSV season.
• With regard to the vote, Dr. Lee said she believes this is a good vaccine product with a
favorable benefit -risk balance, particularly with the efforts to mitigate potential risks. This
is an excellent option to protect infants from hospitalization. If there was not a
monoclonal antibody available such as nirsevimab, she thought the cost- effectiveness
conversation might have been slightly different. In terms of the struggle with cost -
effectiveness, which always is an important domain, the decision is sensitive to this
domain.  The intervention itself and maternal vaccine development in general are
incredibly important investments with regard to future directions with the US vaccination
programs as a country . She wanted to recognize that cost -effectiveness is about the
value of the vaccine and the value of the investment. The proposed vote the WG asked
the ACIP to consider in terms of seasonal dosing of RSV vaccine seemed extremely helpful to ensure that they are making the investment as worthwhile as possible. The
cost- effectiveness ratio is still high -ish, recognizing that they do not have an explicit
threshold by any means. This will be one of the more expensive interventions the ACIP
has recommended,  so she wanted to call out that seasonal dosing is a way to at least
get into a more reasonable range. Recalling an earlier conversation, she said she
thought the ACIP’s role is only to comment on the value of this vaccine in the US. As
they learned during COVID, having products available such as these RSV vaccines or
passive immunization become more available to low -and middle- income countries that
might not otherwise have access is som ething they need to consider. She encouraged
their manufacturing sector colleagues to consider how such innovative products can be
made available in countries at an affordable price, recognizing that each country is
different, but also recognizing that there is a greater responsibility from a public health
perspective.
• Dr. Sanchez said he thought one of the problems was that it was impossible to consider
this vaccine in isolation, because the fact is, there is another product. Unfortunately, there is not a head- to-head trial comparison of the 2 products with respect to either
efficacy or effectiveness. Discussions must be had with the pregnant person because there are options, and each medical decision should be shared decision- making. There
should be a lot of education about both products.
45

  • Dr. Loehr said he wanted to go on record that he believes an infant receiving nirsevimab
is better based on the evidence that it has better efficacy. It also is more cost -effective.
Therefore, he did not want it to be an equal representation. He recognized that they
were not going to make a preferential  statement and that a lot more data would
accumulate over the next couple of years to determine in the long- run which is better. He
doubted they ever would have head -to-head information. If he was presenting this to a
pregnant person , he would recommend giving nirsevimab to their child if that is what
they wanted. If not, then the vaccine would be another option. This is just a small nuance.
• Dr. Sanchez emphasized that to him, the signal for prematurity was a major concern for him and the WG. The FDA did help with this issue by approving vaccine administration
at 32─36 weeks gestation. Nevertheless, mothers should be made aware that this needs
to be monitored and there will be post -licensure and post -recommendation surveillance.
• Dr. Bell emphasized that one complication is going to be that the pregnant person is
likely going to be seeing a different doctor during pregnancy than the doctor who will be
taking care of their child. Tools must be made available quickly to physicians, which is
something the partners and professional organizations can help to facilitate. It is difficult to make a choice without all of the tools.
• Dr. Talbot emphasized that her feeling was that this would be incredibly complicated. There is a great option that can be given to children, which will protect more children and
that is more cost -effective. The vaccine seems like an incredibly complicated, way out of
the atmosphere expensive option that would not result in much benefit and would
increase confusion in terms of whether the pregnant person received vaccine or
received it and then delivered too early. She did not believe this would improve care and
would make providing care more difficult. If they simply say the child should receive the
monoclonal, the recommendation would be a very simple and cost -effective mechanism.
With an adult immunization registry in every state, using this mechanism may put
children at risk and/or leave the parent stuck with a $500 bill because only one method
would be paid for.
• Dr. Poehling emphasized that as a newborn provider, she evaluates the charts of the moms and babies. It may not be easy, but it is definitely doable.
• Dr. Hughes (ACOG) emphasized that it is absolutely routine for obstetricians to collaborate with their pediatric colleagues to review maternal charts. It is done every day
regarding testing like hepatitis B testing. Those results are always communicat ed. While
ACOG recognizes that there are some complexit ies to ensuring that the charts are
complete related to receipt of vaccine, it is quite doable. Also acknowledging the fact that
this is fairly complex , ACOG and its colleagues at the Society for Maternal Fetal
Medicine, plan to partner with other entities like AAP, AAFP, and ACNM to ensure that
there is a solid implementation strategy to assure that these challenges are met.
• Dr. Poehling made a motion to approve the language as presented, which Dr. Loehr
seconded.
Following Dr. Santoli’s Presentation
• For Table 1, it was suggested that the additional language be revised to read, “whose mother did not receive the vaccine, whose mother’s vaccine status is unknown, or who
was born within 14 days of maternal vaccine.”
• Dr. Santoli indicated that the language could be updated for clarity.
46

    PUBLIC COMMENTS
Overview
The floor was opened for public comment on September 22, 2023 at 2:30 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- 0076.  Visit http://www.regulations.gov for access to the docket or to submit comments or
read background documents and comments received.
Public Comments
Mr. Paul Hennessy
Individual
Hi. I was supposed to comment at the meeting on the 12th, but I think only 1 person spoke
during public comments. So, I definitely urge you to look into that issue. I know there are a lot of
commenters who didn’ t get to speak. But, yeah, I ’m here to talk about the future of vaccine
rollouts, not just RSV, but COVID as well. You know, I thank the ACIP for approving those 3
vaccine options last week. But a once-a- year shot does not go far enough, considering
protection wanes after about 5 months and there’ s multiple waves of COVID per year. COVID is
not the flu, so a shot schedule like the flu just isn’ t working. A once -a-year vaccine just isn ’t
enough to protect us from a virus that fuses brain cells, causes blood clots, is linked to diabetes,
dementia, and more. Furthermore, COVID and RSV are airborne illnesses , so the vaccine- only
approach doesn’ t properly reduce transmission as much as it can. You know, clean- air tech and
masking must be encouraged along with vaccines and even required in places like medical
settings. Pediatric approval for the Novavax COVID vaccine is also needed as soon as possible.
You know, I definitely appreciate that the RNA has been approved, but children, like adults, deserve the choice. Novavax was shown to wane less quickly than mRNA and offer broad
immunity against variants. Successive doses actually enhance protection as well as offer some
upper respiratory protection. Children deserve this excellent choice as well. Finally, just going
forward, I ’d definitely like to urge ACIP to approve vaccines before surges . That includes both
COVID and RSV. Moderna ’s and Pfizer ’s COVID vaccines were ready, and I believe submitted
a number of months ago , but it took until September to get approval. It ’s so important to approve
both COVID and RSV vaccines before the school year so children are protected going to
school. Thank you.
Jane Hull, PT, MPH
TRAIPAG
I’m Jane Kaplan H ull I’m speaking on behalf of TRAIPAG, which is a patient advocacy group
whose members are transplant recipients and/or are immunocompromised. We strongly urge
the committee to recommend the RSV maternal vaccine and to add it to the Vaccines for
Children Program so as to immunize the child through the mother. Our TRAIPAG Advocacy
Group commends the committee for placing the mAb, nirsevimab, not sure I ’m saying that right,
on the Vaccines for Children Program and taking the groundbreaking step of recommending
47

  passive immunization, which ensures that it will be covered . We u rge the committee to do
likewise if and when a monoclonal antibody or antiviral prophylaxis against COVID is authorized
by the FDA. This would be especially crucial to the population of immunocompromised people
who do not respond to vaccines and will greatly benefit from effective vaccine or prophylactic
treatments that can both save lives and improve quality of lives for those affected. We would
also hope that the committee in future deliberations recommend the RSV vaccines, not just for
the 60 and over, but give access to the RSV vaccines for those who are immunocompromised
or high risk and those living or working with vulnerable populations. Thank you for giving me the
opportunity to speak.
Dr. Roselie Bright, ScD
COBID Safe Maryland
Hi. Good afternoon. I’m Roselie Bright. I have a Doctor of Science in Epidemiology and had a
30-year career as a Federal Medical Product Epidemiologist. For meaningful consideration of
public input, the substantive materials for CDC Advisory Committee meetings, the slides, whit e
papers, et cetera, should be available to the public for at least a week before the meetings to allow adequate time for thoughtful, in- depth public review and comment. People who have
already signed up for comment should be notified the same day the materials become available.
The oral public comment session needs to be expanded to at least an hour and occur before
motions and votes. RSV vaccines have been approved by the FDA for older adults and infants a
month ago. The one under consideration today was also approved by FDA for pregnant people and infants. I support expanding the use of RSV vaccines and have several points regarding the
specific RSV vaccine under consideration and RSV vaccines in general : 1) for non- pregnant
adults, the RSV vaccine has been approved for people 60 years old and over. I urge the
sponsors to quickly study the usefulness of the [ inaudible] all people at high- risk from RSV and
all people in professions and situations that often interact with people who are at high risk of RSV, that is, health care workers, patients and visitors, and childcare and school staff and
children, etc. ; 2) RSV infections have risen significantly year over year during the COVID -19
pandemic. If the rise is due to immune damage from COVID -19, the potential benefit of offering
the [inaudible] ; 3) Three, RSV circulation is seasonal, typically starting during the fall and
peaking in the winter. The peak RSV hospitalization season has been moving to earlier in the calendar year in the specific surveillance areas of the US. Please offer the RSV vaccine in the
summer to prevent the surges that have recently been starting in September ; 4) because getting
the RSV vaccine is recommended for a narrow window of pregnancy, 32 to 36 weeks of
gestation, availability for pregnant people needs to be speedy to help as many pregnant people
as possible this fall ; 5) RSV vaccine efficacy wanes. That’s fine for pregnancy and infancy.
However, please consider recommending that pregnant people should be revaccinated during each subsequent pregnancy. In addition, older adults should be offered semiannual
vaccinations ; and 6) RSV is part of the trio of airborne viruses that CDC is already campaigning
about. While the COVID -19, influenza, and RSV vaccines reduce the risk and severity of
infection, they don’ t entirely eliminate infections and some people should not take them. I ask
CDC and the vaccine sponsors to include other precautions against airborne viruses in your
public messages, including N95 or higher quality masks, otherwise known as respirators, and
air cleaners with h igh-efficiency p articulate air (HEPA ) filters and fresh air ventilation [inaudible]
especially if those that vulnerable patients must attend as staff or clients, including health care
facilities, schools, and prisons. Thank you for this opportunity to comment.
48

  VOTES
Dr. Grace Lee (ACIP Chair) requested that the language for the votes be displayed for the
recommendation and VFC votes.
Vote #1 RSV Maternal RSV Vaccine Recommendation
Maternal RSV vaccine is recommended for pregnant people during 32 through 36 weeks
gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in
infants.
Motion/Vote #1 Maternal RSV Vaccine
Dr. Poehling made a motion to approve the proposed Vote #1 recommendation stating ,
“Maternal RSV vaccine is recommended for pregnant people during 32 through 36 weeks
gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in
infants. ” Dr. Loehr seconded the motion. No COIs were declared. The motion carried with 11
affirmative votes, 1 negative votes, and 0 abstentions. The disposition of the vote was as
follows:
11 Favored: Bahta, Chen, Daley, Lee, Loehr, Long, McNally, Poehling, Sanchez
1 Opposed: Talbot
0 Abstained: N/A
Vote #2 VFC Resolution Maternal RSV Vaccine
Approve the Vaccines for Children (VFC) resolution for RSV maternal vaccine.
Motion/Vote #2: VFC Resolution Maternal RSV Vaccine
Dr. Loehr made a motion to approve the proposed Vote # 2 recommendation for the VFC
Resolution stating , “Approve the Vaccines for Children (VFC) Resolution for RSV maternal
vaccine. ” Dr. Poehling seconded the motion. No COIs were declared. The motion carried with
11 affirmative votes, 1 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
1 Opposed: Talbot
0 Abstained: N/A
49

       Discussion Points : Voting Members
Dr. Poehling emphasized what an exciting day this was because throughout her career, RSV
has been a difficult disease, given that there have been no options beyond supportive care
treatment. There were over 1.5 million outpatient visits, over half a billion ED visits, and 58 ,000
to 80,000 RSV hospitalizations last year, which was a dramatic example. The vast majority,
almost 80% , of children less than 2 years of age have no underlying conditions. There is nothing
simple about this RSV vaccine or nirsevimab, but they both offer hopes. They have done this
before with COVID vaccine. She think s that if everybody is willing to chip in and do their part ,
this is feasible and will improve the well -being of many families throughout the nation.
Dr. Bell said she wanted to take advantage of her gray -haired status and reflect for a moment
on the issue of complicated recommendations for which implementation is unclear and there are
a lot of challenges. To Dr. Lee’s point earlier that in looking back over the decades, these types
of recommendations have provided opportunities for innovation, availability of options, and
improvements over the longer term even if the beginning is extremely bumpy . This is another
example that perhaps will lead to improvements in physician education, patient decision-
making, communication between the obstetrical and pediatric worlds, and addressing
disparities. Even though ACIP members may be feeling at the moment that this is very
complicated and will be difficult to implement, in the longer term it will result in new options that
will improve children’s health.
Dr. Sanchez agreed completely. He thought the discussions throughout the day had been
extremely helpful because he certainly has struggled with his decision throughout the time that
he has been on the RSV WG. He has fluctuated back and forth, but thought the day’s
discussions steered him clearly through the amazing work that has been done. There are
challenges and complexities, but there are options for mother s and HCPs . Physicians also have
personal preferences that are part of the physician- patient discussion. He thought the options
were great. Pediatricians , infectious disease specialist s, and neonatologist s have to prevent
serious RSV disease in babies. He thought it was fantastic that they had achieved this vote , as
well as the nirsevimab vote. He could not have imagined better options for infants and children ,
which is what they have been striving for —especially for high- risk babies. He urged more
discussions with obstetricians, mothers ’ healthcare provider s, and pediatric family practices.
Just like they need to know the mother ’s syphilis, HIV, and hepatitis B status, they also will need
to know whether the mother received the RSV vaccine. Hopefully, this will ultimately improve
care and communication with obstetric providers.
Dr. Brooks said he was reflecting back on the days when they thought PCV discussions were
complex . Yes, RSV has been very complex. However, they likely are going to have more
complex decisions to make moving forward. Dovetailing on what Dr. Sanchez said, one of the
things that struck him was that a large number of obstetricians feel uncomfortable with
discussing vaccine decisions. Looking at the schedule, there are 4 vaccines that theoretically
could be available or needed for a pregnant person (RSV, COVID, influenza, and Tdap)
between October through March. That is half of the year —a significant amount of time where
there are going to be some really interesting discussions. They need to lean on the American
College of Obstetricians and Gynecologists (ACOG ) to work with their members to feel more
comfortable with these discussions. To him, one of the benefits is a fundamental concept of
vaccination, which is that generally speaking, the ideal is for a person to get vaccinated at the
earliest opportunity or the concept of immediate protection. The earliest opportunity would be
before the mother deliver s. People’s situations may change. Someone might leave the country,
50

   their insurance status may change, t heir perspective on protection of a child from RSV may
change, et cetera. It is very important to get them vaccinated as soon as possible.
Notwithstanding Dr. Loehr ’s statement that nirsevimab seems to be a more efficacious and cost -
effective , it is excell ent to have this option of the vaccine for the pregnant person prior to the
birth of the child.
Ms. McNally said she struggled with this recommendation for the reason that she does not know
what the counseling looks like for the mother who asks her obstetrician if she should get this
vaccine and the mother who ask s the child’ s pediatrician what she should do. Because of that,
she agreed with Dr. Lee that the stakeholder medical associations could get together and
prepare a statement about this issue. She thought that would be immensely helpful for the
consumer. She also observed that it seemed like the ACIP had discussed shared clinical
decision- making recommendations a lot more lately. That gives her a certain level of discomfort
as a consumer because while she believes there is a place for shared clinical decision- making,
it makes her n ervous that there could be some baseline assumptions about the knowledge that
consumers have for risk of disease. She wondered whether there is a way to talk about best
practices to revisit the idea of shared clinical decision- making in order to help ACIP arrive at
better decisions of the future regarding vaccine recommendations.
Dr. Talbot reiterated how important it is that medical societies work on this process. The
pneumococcal vaccines have been complicated for years and had to be written out of the
infectious disease boards because they were too complicated. She worries that this has created
another very complicated recommendation. W hat happened with pneumococcus was low
immunization rates. She implored every society to talk. There needs to be massive education
and it has to be better than what was done for pneumococcus. Dr. Kotton said that while she appreciated how complicated the decision- making was through all
of this, she was excited to see that they were at a time in which there is a shared clinical
decision- making recommendation for adults ≥60 years of age, an RSV vaccine for pregnant
people, and monoclonal antibodies for infants. This is a horrible disease for many, especially
immunocompromised persons. She is cautiously optimistic that there will be diminished rates of
disease in multiple communities that hopefully will result in decreased transmissions to
vulnerable populations. This is an exciting time in the medical world, and she is excited to see
what things will look like with multiple protective vaccines for many different populations. Dr. Long said that she was outrageously grateful for the ACIP to think this through again with
the WG . She could not add up all of the hours that they have struggled with this. She
appreciated everyone’s comments and thought this was the right decision to make. They w ill
see, through what may be a very messy year, whether one rises to a preference over the other
and hopefully that both will become less expensive.
Discussion Points: Liaisons
Patsy Stinchfield (NAPNAP) commented that during the 20 years she has been participating in
the ACIP, this has got to be one of the more complex decisions that has been before this
committee . As a member of the RSV WG, she acknowledged the phenomenal work they did .
There were intense deliberations during the WG meetings, and the presentations and
conversation during the meeting were very good in terms of highlighting the difference of
opinion and complexities. Having listened to so many of these conversations over the years ,
she agreed that this is complex and challenging. However, it was one of those times when they
needed to focus on the policy questions before them . Is it safe? Is it effective? Is it feasible?
51

 
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



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   They did not get to ask whether it is easy, but they know it is not going to be easy? What will
happen is that practice will follow ACIP policy , and the committee will re-review , discuss, and
measure in the future. The practice barriers are what they need to be working on at this time.
The clinician is the linchpin and is the one who is going to be discussing the options  available.
They will need to be prepared for their own educational needs, attending the Clinician Outreach
and Communication Activity (COCA) calls, listening to National Foundation for Infectious
Diseases (NFID ) webinars, and making sure they are prepa red to share this with families. She
very much agreed with Dr. Lee’s observation about the quality improvements and that they
cannot wait until they have all of the technical , financial , and other reimbursements in place
when they have a very good product before them . They must make sure that they are
communicating with their peers and parents alike, taking the barriers into consideration but not
letting the barrier s stop them from advancing a very good product.
ADULT AND PEDIATRIC IMMUNI ZATION SCHEDULE ADDENDUM
Presentation
Sarah Schillie, MD, MPH, MBA, CAPT USPHS discussed the addition of an addendum to the
immunization schedules . As a reminder, the immunization schedules are published on an
annual basis, typically every February.57 There are two separate schedules , the Child and
Adolescent Immunization S chedule that covers birth through 18 years of age and the Adult
Immunization S chedule that covers ≥19 years of age. There are multiple sections in each of
these schedules that summarize the approved ACIP policy, including the Cover Page, Tables
that contain graphic rows of recommendations, Notes, and an A ppendix. The schedules are
published in 3 formats: PDF, webpage, and app. The 9 professional organizations listed here
partner with CDC to approve the schedules, and some of these professional organizations
publish the schedules :
American College of Physicians ( www.acponline.org )
American Academy of Family Physicians ( www.aafp.org )
American College of Obstetricians and Gynecologists ( www.acog.org )
American College of Nurse- Midwives ( www.midwife.org )
American Academy of Physician Associates ( www.aapa.org )
American Pharmacists Association ( www.pharmacist.com )
Society for Healthcare Epidemiology of America ( www.shea -online.or g)
American Academy of Pediatrics ( www.aap.org )
National Association of Pediatric Nurse Practitioners ( www.napnap.org )
Traditionally, the schedules are published in February each year, but the publication process
starts in October with the ACIP vote. In November and December, professional organizations
approve the schedule. In December and January, the draft s are developed and cleared for the
MMWR reports and Annals of Internal Medicine report for the adult schedule. In February, the
schedules are published along with the accompanying MMWR Notice to Readers and Annals of
Internal Medicine report. The timeliness of schedule publication has several important
implications. First, some insurers link vaccine reimbursement to the vaccine listed on the
immunization schedules. Second, the ability of certain HCP to administer immunizations also is
related to the schedule. For example, some states link pharmacist s’ immunization authority to
the schedule. Third , HCP knowledge and practices are related to the immunization
57 www.cdc.gov/vaccines/schedules/index.html
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  recommendations.  For example, if a HCP is referring to a schedule that is several months old,
they may not be aware of the most recent ACIP recommendations.
The ACA addresses immunization coverage and is interpreted by CMS. According to the ACA,
insurers must provide coverage for and must not impose cost -sharing restrictions for
immunizations that have a routine recommendation and that are listed on the immunization
schedules of the CDC. Of note, the AC A does not specify the layout of the immunization
schedule. Legally, CDC has discretion regarding the design of the immunization schedules. The
entire document constitutes the schedule, not just the graphic bars or the tables.
CDC takes a 3-pronged approach to address schedule timeliness. The immediate strategy
consists of the addition of addenda to help bring the schedule up -to-date. The short -term
strategy involves publication of the entirety of the schedule shortly after the October ACIP vote.
The longer -term strategy is to consider sustainable approaches to ensure the schedules remain
dynamic and responsive, and to engage partners in the planning process. Regarding the
addition of the addenda to the 2023 immunization schedules, the addenda will contain ACIP
recommendations that occurred after the 2023 schedule was published. The plan was to
release the 2023 immunization schedules with the addenda the week following this meeting.
With this addition, all ACIP recommendations will formally be part of the CDC Immunization
Schedules.
To describe the changes related to adding the addenda to the schedules, a red bar will be added to the top of the cover page to refer users to the addendum. A fifth step, also referring
users to the addendum, will be added to the steps of to how to use the document. Any new
vaccine recommendations will be added to the table on the cover sheet. Here is the addendum for the Adult Immunization Schedule,  which consists of 1 page and includes vaccines for which
recent recommendations have been made, a synopsis of those recommendations, and the
effective date of the recommendation:
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   The addendum for the Pediatric Schedule is similar. It also is also 1 page, and is depicted here :
In summary, the release of the 2023 Immunization Schedules with the Addenda is anticipated
during the week following this meeting. This will formally incorporate all ACIP recommendations
into the 2023 CDC Immunization Schedules. There are also plans for short -and long- term
sustainable strategies to address schedule timeliness and will ensure partner engagement with
this process.
Liaison Statements
Jason Goldman , MD, FACP (ACP) provided a statement on behalf of the ACP. The American
College of Physicians, with over 160, 000 members and the largest single specialty medicine
organization representing all internal medicine specialists, greatly appreciates the work of the
CDC and the Advisory Committee on Immunization Practices, especially the willingness to work
with the vaccine schedule. The ACP understands the challenges of analyzing copious amounts
of data to put forth the best evidence- based recommendations. However, there is a need for
timely updates to the vaccine schedule so that practicing physicians can have guidance in implementing those guidelines. Obviously, one of those challenges is the delay created between
approval by the committee, sign- off by the CDC director, and final publication of the schedule.
The ACA allows insurance companies to have up to a year to cover these life- saving vaccines ,
but many will start that year at final publication and not at approval by the commi ttee. It is
imperative that the schedule be updated, approved, and published as quickly as possible to
avoid unnecessary delays in implementation. The ACP appreciates the willingness of the CDC
to expedite this process. The lack of insurance coverage creates unnecessary barriers to
access to care and further exacerbates healthcare disparities as uninsured and underinsured
patients will not have access to these vaccines. The ACP also strongly agrees with the need for
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    a Vaccine for Adults program to address those gaps in coverage so patients can get the
vaccines they need. Finally, the ACP would ask the vaccine manufacturers to provide vaccines
fairly and equitably without preferential distribution to large systems and non- physician entities
so that the physicians can vaccinate patients in their offices in a timely manner. Specifically, the
delays in distribution of influenza vaccines this season to many physician offices has created
hardships for patients and decreased access to care. Once again, the ACP is supportive of the
good work of the committee and look s forward to continued collaboration to advance health
equity and access to life- saving vaccines.
Sean O'Leary, MD, MPH (AAP) provided a statement on behalf of the AAP. The immunization
delivery system is complex, with many interrelated parts that need to work together to ensure
that the nation’ s children can receive timely and equitable access to vaccines. This is
particularly true when new vaccines are recommended by the Advisory Committee on Immunization Practices. Once the ACIP makes a recommendation for a new vaccine and the
CDC director signs off on the recommendation, this prompts a series of steps that are critical to ensuring smooth and equitable rollout. The publication of official CDC recommendations is an
essential step in this process. As an example, consider the PCV20 vaccine, the pneumococcal
conjugate vaccine, which was recommended by the ACIP during its June meeting. AAP
members have recently reported that some VFC programs are providing only PCV20 and that
some vaccine- buying groups are directing people to use this vaccine over other pneumococcal
vaccines. However, this is problematic because a lack of formal recommendations in an
updated immunization schedule or publication in MMWR is leading to payment denials for
PCV20, as well as delays in TRICARE coverage for children in military families. Timely updates
to the immunization schedule would provide pediatricians with an authoritative source for the
latest immunization recommendations, which is invaluable at the point -of-care to maximize
every opportunity to vaccinate. The American Academy of Pediatrics strongly supports the
efforts of the CDC to update the immunization schedule on an as -needed and timely basis.
Jean- Venable “Kelly” Goode, PharmD, BCPS, FAPhA, FCCP (APhA) provided a statement
on behalf of the nation’ s 330,000 pharmacists for the American Pharmacist Association. APhA
is pleased to provide supportive comments on the importance of timely updates to the vaccine
schedules. APHA, representing the profession of pharmacy, is honored to be one of the
organizations granted the opportunity to review and indicate support of the adult vaccine
schedule. Over the past 20- plus years, pharmacists and their teams have protected the public
from vaccine -preventable diseases by recommending and administering vaccines, most notably
of late, administering well over half the COVID -19 vaccines during the pandemic. APhA
recommends updating the schedules as recommendations and clinical guidance are approved by ACIP. It is important for policy and patient access to vaccines. An example is the RSV
vaccine. ACIP voted on the recommendations in June for the vaccine to be administered as
soon as vaccine becomes available and throughout the RSV season. However, currently, it will
not be on the vaccine schedule until February. States regulate vaccine administration by
pharmacists and pharmacy personnel. Several states require that vaccines must be on the
CDC/ ACIP  recommended schedule for pharmac ists or pharmacy personnel administration. The
gap means that many thousands of patients will not have access to the RSV vaccine until
February if the schedule updates are not accelerated. Given the number of patients who receive
their vaccines from a pharmacy team member, especially those in rural and medically underserved areas, it is imperative that the vaccine schedules be updated as new vaccines
become available and recommended by CDC ACIP. Therefore, AP hA strongly supports timely
updates to the vaccine schedule for newly recommended vaccines to facilitate access to
vaccination by pharmacists and pharmacy team members , and that payers be strongly informed
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  that they do not need to wait for publishing of the MMWR for the updated schedule to begin
coverage for the ACIP recommended vaccines.
Pamela Rockwell , DO (AAFP) provided a statement on behalf of the AAFP . Family physicians
provide care for people of all ages from birth through end of life, including care for those who
are pregnant. AAFP feels strongly that timely updates to the vaccination schedules are
extremely important to allow family physicians and other health care professionals determine
who is due for vaccination and quickly. Many of the newly updated recommendations are scattered throu ghout CDC web pages and not easily accessed. As we enter the fall respiratory
season, many family physicians have expressed disappointment that updates on several
vaccines, including influenza, pneumococcal, RSV, and COVID -19, are not easily accessible on
the Harmonized Child, Adolescent, and Adult Vaccination 2023 schedule. It was encouraging to
hear from Dr. Schillie about the addendum to be added to the immunization schedules next
week. To summarize, AAFP encourages continuous and additional timely updates to the
schedules as new vaccine recommendations are added or amended, as these are essential to ensure continued prevention of disease and improve public health through vaccination.
Robert H. Hopkins, Jr., MD (Medical Director, NFID) provided an update on behalf of the
National Foundation for Infectious Diseases. NFID thanked the ACIP for its ongoing work to
ensure the availability of safe and effective vaccines and monoclonal antibodies to help protect
the most vulnerable individuals from RS V, and f or the addition of the ACIP schedule and plans
to continue to update these schedules in the future to avoid some of the challenges with reimbursement and coverage. RSV impacts individuals of all ages, including premature infants and infants younger than 6 months. Each year in the US, RSV is estimated to cause more than
2 million outpatient visits ; 58,000 to 80,000 hospitalizations ; and 100 to 300 deaths among
children under 5 years of age. While immunizing pregnant women will be a tremendous step
toward RSV pr evention, healthcare professionals will continue to need clear guidance and
education to inform their decisions with patients and parents about the use of vaccines in
pregnant women and/or nirsevimab in infants. NFID is committed to collaborating with CDC and
partners in educating healthcare professionals and the public to help facilitate the effective use of these active and passive tools in RSV prevention. The low uptake among pregnant women of
vaccines to prevent influenza and COVID -19 underscores the importance of building confidence
in all recommended vaccines. As partners in protecting public health, we must focus on using all
available tools to prevent RSV and protect those most at risk. For 50 years, NFID has been
dedicated to educating and engaging the public, communities, and healthcare professionals
about infectious diseases across the lifespan. NFID commends the tireless efforts of ACIP in
guiding US immunization policy and stands ready to support the work of ACIP and CDC, which
is instru mental in saving lives and protecting public health.
Patsy Stinchfield RN, MS, CPNP (NAPNAP) provided a statement on behalf of NAPNAP, the
National Association of Pediatric Nurse Practitioners to add her v oice to so many of the other
association colleagues to say how important the updated schedule is. It is our tool. It is an
outline. It is not all of the details, but it is critical for us to practice. Also, the great work that we
have had with our RSV vaccines and products will make that schedule even more important. On
behalf of pediatrics, we all know that RSV, in that in the infant age group as well as the older
age group, can be a devastating disease. Today is a very, very great day in the pre
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Summary: MEETING OF THE ADVISORY  COMMITTEE ON IMMUNIZATION  PRACTICES (ACIP)  SEPTEMBER 22 , 2023  MEETING SUMMARY  CONTENTS   FRIDAY: SEPTEMBER 22, 2023 .................................................................................................................. 2  WELCOME AND INTRODUCTIONS ........................................................................................................ 2  Call to Order/Roll Call…