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 Maternal 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

Updated 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
2

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

conflicts 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 ShareLinkTM

file for ACIP Voting, Ex Officios, 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://www.regulations.gov using Docket Number ID CDC-2023-0076. 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 boards (DSMBs) 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.
3

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 (RSVpreF) 

vaccine have included epidemiology and burden of RSV in infants; virology and immunology of 

RSV; safety and efficacy of RSVpreF; cost-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 RSVpreF

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 hypertensive 

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
4

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 entering 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 response. 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 intravenous immunoglobulin (IVIG) therapy 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-safesm

❑ An Economic Analysis 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 Vaccine

❑ 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 integrated 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 

approximately 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
5

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 inclusion 

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 RSVpreF vaccine manufactured by Pfizer has been shown to be effective

against severe RSV-associated LRTIs in infants. RSVpreF clinical trial data on safety in

pregnant persons identified injection site pain as the most common reactogenicity event and 

identified 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 RSVpreF vaccine. Preterm birth imbalance was most prominent 

in a single country. Of note, GSK also was working on an RSVpreF 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 RSVpreF 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. Additionally,

there may be healthy vaccinee 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 RSVpreF 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 nirsevimab. 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 RSVpreF 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 ends 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 RSVpreF vaccine has

been approved for use. When considering pregnancy outcomes and the RSVpreF vaccine, only 

outcomes that are possible will be included. Spontaneous abortion is not a possible outcome

because of the timing of vaccine and pregnancy:
6

The primary approach for prenatal RSVpreF 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 RSVpreF 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 acute 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 was 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 pregnancy-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 chartreviewed 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 from 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.
7

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 birth, 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 RSVpreF Phase 3 trial are based on all study participants for 

preeclampsia and eclampsia and stillbirth. For preterm birth, the rate was used from highincome countries since this seemed most applicable to the VSD population.
8

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 RSVpreF 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 RSVpreF.

In terms of an example timeline for the planned bimonthly surveillance, if 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 strengths 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 to 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/)
9

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) characterize local and 

systemic reactogenicity during days 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
10

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, RSVpreF given year-round was evaluated. The new scenarios assessed 

cost-effectiveness if RSVpreF 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, there 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 result 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 presented 

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 shown 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
11

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 more 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 more 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 shown 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 costeffectiveness 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 rate 

of prematurity; cost per dose (~$65,000─$68,000/QALY); hospitalization costs (costsaving─$440,000/QALY); efficacy (~$280,000─$680,000/QALY); QALYs lost 

(~$100,000─$800,000/QALY); and month of administration (~$110,000─Millions/QALY).
12

Looking 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 pregnant person in time, how costeffective 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. As 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 incidence, costs per outcome, or QALY per outcome.

Looking at the incremental benefit of adding nirsevimab on top of RSVpreF by month 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

individuals born during the season, the ICERs for nirsevimab 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 mothers 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.
13

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 nirsevimab 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 nirsevimab 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 

marginal 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) summarized the key elements and findings of 

2 economic studies, the Pfizer Model and the University of Michigan-CDC (UM-CDC) Model, 

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 costeffective?” 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 costeffectiveness of vaccinating pregnant mothers 32─36 weeks of gestation ≥2 or more weeks

prior to the birth with RSVpreF vaccine compared to no vaccine.
14

The policy question has important implications for 2 groups of elements. The comparison of the 

2 economic models focuses 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 analyses and probabilistic simulation,

modeled 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 with 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 Pfizer 

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 Pfizer 

and about 10 times higher for the cost per death prevented. The CDC model reported a 65% 
15

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 QALYs among infants and caregivers.

To understand these persistent discrepancies in the UM-CDC model and the Pfizer model, an 

effort was made to identify 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 reported one-way sensitivity analyses. The 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 models were practically the same. Specifically, the risk of 

RSV hospitalization data used in both models was based on laboratory-confirmed RSVassociated 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 Phase 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 RSVpositive 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 vaccination, 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 used 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
16

waning assumption beyond available Phase 2 data. The CDC model tried to minimize this

uncertainty impact on its outcomes. Therefore, there was no effectiveness after the 6

th month.

Although the base-case case fatality rates 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 the 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 Phase 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 increase

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 considered 

only the point estimate for 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 focused 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 (cost of RSV-LRTI hospitalization: $20,000 or $50,000) and B (UMCDC 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 increase

in the risk of prematurity. Scenario F deals with the timing of vaccination. CDC is the only model 

that presented 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.
17

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 selected CDC 

inputs and returned most of its own inputs and assumptions piece-by-piece and cumulatively,

Pfizer returned 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 

analyses, 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, underestimating 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 visits, such as productivity 

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, differences 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—hypothetically severe vaccine-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 costeffectiveness 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 birth. 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
18

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 Harms 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
19

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 serious 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 certainty. 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 resulted 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 Framework. Shown here side-by-side are the Pfizer definitions of severe medicallyattended 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:
20

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 that not all of the 81 infants who met the severe

RSV definition within 0─180 days after birth were hospitalized, nor 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 Phase 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 those 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
21

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 pregnancy 

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─December 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
22

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 pregnancyrelated 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 postmarketing 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)
23

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 GBS 

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. There 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 “Small.” 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
24

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 “definitely” 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 England29 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 vaccine, 14% were “not sure,” 4% said 

“unlikely,” and 0.5% said “very unlikely.” When asked if RSV prevention with the Pfizer maternal 

RSV vaccine was acceptable to key stakeholders, the majority of the WG answered “yes” and a

minority answered “probably yes.”

In terms of the Feasibility 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 product should be refrigerated (2°–8°C) in the original container and protected from 

light. After reconstitution, the product should be administered within 4 hours 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 office.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/fluvaxview/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 - ABRYSVO (STN 125769/26) (fda.gov)

31 https://www.cdc.gov/flu/fluvaxview/pregnant-women-apr2022.htm
25

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, Tdap, 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 noninferiority 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, prenatal 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 infants 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
26

Regarding the Resource Use Domain, the ACIP heard presentations earlier from Drs. 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. Importantly, 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 per 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 costeffective 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 AI/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. Beginning 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 Immunization 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
27

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 summary, 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 stressed 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 
28

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 this 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 summarized 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 meeting, 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. From 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 have maternal vaccine-induced protection is 

40 https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html
29

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 costeffectiveness 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 sufficiently 

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
30

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 with 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 suggesting 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 clinical 

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
31

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).
32

Implementation Considerations for Maternal RSV Vaccine

Georgina Peacock, MD, MPH (CDC/NCIRD) presented maternal 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 some 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 barriers

for maternal immunization. Among providers, financial 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 VFC 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 insurance 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 VFC 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
33

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 increasing complexity of the maternal immunization schedule as 

illustrated in this figure:

The maternal immunization schedule is increasingly complex in terms of different 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 whether to administer maternal RSV

vaccine or infant nirsevimab. Studies continue to demonstrate that HCPs are pregnant people’s 

most trusted source of information on vaccines, and that provider recommendation is a strong

predictor of vaccination.54 However, one survey showed 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 reports 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
34

Moreover, state Immunization Information Systems (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 immunization 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 terms 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. Discussing 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 recently 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 Dosage

Refer 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
35

For the nirsevimab component, the only change was that now there are 2 components to the 

eligible groups:

❑ 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.”
36

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, ABRYSVOTM. 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 trials (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 births, 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 postmarketing commitments, along with the CDC and FDA systems presented during this meeting, 

are sensitive, timely, powerful, and can detect any safety signals should any arise. Pfizer wants

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.
37

Liaison Organization 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 OB-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 efficacious 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 is 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 WG, Dr. 

Hughes has reviewed these data extensively, along with the other experts 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 looks 

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 Midwives (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 Force on Maternal Immunizations and regularly updates and encourages 

members to recommend the 3 standard maternal immunizations throughout a shared decisionmaking 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. 
38

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 comprehensive 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 Hause from the vsafesm 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-safesm

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-
39

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 costeffectiveness, 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.
40

• 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 the assumption about persistence of antibodies and potential 

benefit. If a pregnant person received 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 RSVpreF 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 
41

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. Essentially, 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 UMCDC 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 reduce the 
42

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 change 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. There is a lot of complexity. Clearly documenting 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, there 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 to 

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.
43

• Ms. Hance (CMS) confirmed that Medicaid will cover the 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. Bahta 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 
44

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 nursery. 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 
45

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 

recommendation 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 costeffectiveness, 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 something 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.
46

• 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 communicated. While 

ACOG recognizes that there are some complexities 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.
47

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 issuefocused 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 CDC2023-0076. 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 Hull 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 
48

passive immunization, which ensures that it will be covered. We urge 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, white 

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 high-efficiency particulate 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.
49

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 
50

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 thinks 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 decisionmaking, 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 mothers and HCPs. Physicians also have 

personal preferences that are part of the physician-patient discussion. He thought the options 

were great. Pediatricians, infectious disease specialists, and neonatologists 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 providers, 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 delivers. People’s situations may change. Someone might leave the country,
51

their insurance status may change, their 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 costeffective, it is excellent 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 asks 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 nervous 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. What 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 will 

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?
52

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 prepared 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 barriers stop them from advancing a very good product.

ADULT AND PEDIATRIC IMMUNIZATION 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 Schedule that covers birth through 18 years of age and the Adult

Immunization Schedule 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 Appendix. 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.org)

❑ 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 drafts 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 pharmacists’ immunization authority to 

the schedule. Third, HCP knowledge and practices are related to the immunization 

57 www.cdc.gov/vaccines/schedules/index.html
53

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 ACA 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:
54

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 committee. 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 
55

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 looks 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 pharmacists 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, APhA 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
56

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 throughout 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 RSV, and for 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 prevention, 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 instrumental 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 voice 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 prevention of 

disease in both the young and the old.
57

Kayla McFeely, PharmD (NACDS) made a statement on behalf of the National Association of 

Chain Drug Stores. The NACDS strongly supports an updated schedule in an expedited 

fashion. As was presented, this issue is causing real-world vaccine access barriers and delayed 

vaccine uptake. Today, this is resulting in unnecessary scope of practice barriers in certain 

states that hinder pharmacists’ ability to administer RSV vaccines for older adults and it is 

impacting health insurers’ willingness to cover these vaccines. NACDS encourages CDC and 

ACIP to help avoid this challenge in the future by updating the immunization schedules effective 

immediately upon new recommendations in order to mitigate unnecessary access barriers and 

delays in vaccine uptake. NACDS is very much looking forward to the addenda in the coming 

week.

Dr. Zimmerman MD, MPH (APRT) said he was joining the chorus on behalf of the Association 

of Prevention, Teaching, and Research in supporting ongoing efforts to update the immunization 

schedule in a more real-time fashion for two basic reasons. One is to make it easier for

practitioners and clinicians to keep up-to-date with the rapid patient changes in vaccine science, 

and second is for what has been mentioned by so many others—the financial barriers. This is

particularly important as he works in a Federally Qualified Health Center (FQHC) where he sees 

firsthand the issues of disparities, equity, and the financial barriers to preventive services,

including vaccinations. 

Closing Remarks

Dr. Lee thanked all of the ACIP Liaison Members for engaging so deeply and passionately

about the issue, and CDC and Dr. Schilley for leading these discussions. It was clear that there 

is consensus for a dynamic immunization schedule and for it not to be a barrier to

implementation. She emphasized that it had been a tough few years for everyone, including a 

tough month for their CDC colleagues. As everyone could tell, the same people are presenting 

week after week and preparing for these meetings. She recognized them for the incredible work 

that they do on behalf of the committee and on behalf of the public to be able to make sure that 

there is robust deliberation on all of these decisions that are in front of the ACIP. She expressed 

appreciation to the CDC for ensuring that these challenging decisions are discussed openly and 

transparently through the convening of the advisory committee. As challenging as it is to meet 

so frequently, as a member and soon to be a member of the public, she thinks this is an

incredibly important process that continues to be upheld by the CDC—even through the

pandemic. Those who are providing the vaccines and counseling patients and the health care 

workforce on vaccines and immunizations appreciate being able to hear these discussions in 

order to be able to better reflect the nuances, complexities, and deep understanding and 

thought that goes into these decisions. These are not simple decisions that the ACIP makes on 

behalf of the US population, but the decisions have a lot of thought and care put into them by

the CDC team, WG members, ACIP members, Liaisons, and Ex Officio partners. It is incredible 

to be able to bring this to the public in such a thoughtful and meaningful way. She thanked 

everyone for their hard work throughout the day and over the past few years. With no additional 

business, she officially adjourned the meeting. 
58

CERTIFICATION

Upon reviewing the foregoing version of the September 22, 2023 ACIP meeting minutes, Dr. 

Grace Lee, ACIP Chair, certified that to the best of her knowledge, they are accurate and 

complete. Her original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC.
59

ACIP MEMBERSHIP ROSTER 

CHAIR

LEE, Grace M, MD, MPH 

Associate Chief Medical Officer for Practice Innovation 

Lucile Packard Children’s Hospital 

Professor of Pediatrics, Stanford University School of Medicine 

Stanford, CA 

Term: 8/4/2021 – 6/30/2023

EXECUTIVE SECRETARY

WHARTON, Melinda, MD, MPH

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Atlanta, GA

MEMBERS

BAHTA, Lynn, RN, MPH, CPH 

Immunization Program Clinical Consultant 

Infectious Disease, Epidemiology, Prevention & Control Division 

Minnesota Department of Health 

Saint Paul, Minnesota 

Term: 7/1/2019 – 6/30/2023

CHEN, Wilbur H, MD, MS, FACP, FIDSA 

Professor of Medicine 

Center for Vaccine Development and Global Health 

University of Maryland School of Medicine 

Baltimore, MD 

Term: 12/23/2020 – 6/30/2024 

DALEY, Matthew F, MD 

Senior Investigator 

Institute for Health Research, Kaiser Permanente Colorado 

Associate Professor of Pediatrics 

University of Colorado School of Medicine 

Aurora, CO 

Term: 1/4/2021 – 6/30/2024 

KOTTON, Camille Nelson, MD, FIDSA, FAST 

Clinical Director, Transplant and Immunocompromised Host Infectious Diseases 

Infectious Diseases Division, Massachusetts General Hospital 

Associate Professor of Medicine, Harvard Medical School 

Boston, MA 

Term: 12/23/2020 – 6/30/2024 
60

LOEHR, Jamie, MD, FAAFP

Owner, Cayuga Family Medicine

Ithaca, New York

Term: 7/26/2021 – 6/30/2025

LONG, Sarah S, MD 

Professor of Pediatrics 

Drexel University College of Medicine 

Section of Infectious Diseases 

St. Christopher’s Hospital for Children 

Philadelphia, Pennsylvania 

Term: 12/24/2020 – 6/30/2024 

MCNALLY, Veronica V, JD 

President and CEO Franny 

Strong Foundation 

West Bloomfield, Michigan 

Term: 10/31/2018 – 6/30/2022 

POEHLING, Katherine A, MD, MPH 

Professor of Pediatrics and Epidemiology and Prevention 

Director, Pediatric Population Health 

Department of Pediatrics 

Wake Forest School of Medicine 

Winston-Salem, NC 

Term: 7/1/2019 – 6/30/2023 

SÁNCHEZ, Pablo J, MD 

Professor of Pediatrics 

The Ohio State University – Nationwide Children’s Hospital 

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases 

Director, Clinical & Translational Research (Neonatology) 

Center for Perinatal Research 

The Research Institute at Nationwide Children's Hospital Columbus, Ohio 

Term: 7/1/2019 – 6/30/2023 

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine 

Vanderbilt University 

Nashville, TN 

Term: 10/29/2018 – 6/30/2022 
61

EX OFFICIO MEMBERS 

Centers for Medicare and Medicaid Services (CMS)

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification Centers 

for Medicare and Medicaid Services 

Baltimore, MD 

Food and Drug Administration (FDA) 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD 

Health Resources and Services Administration (HRSA) 

GRIMES, Reed, MD, MPH

CDR, USPHS

Director, Division of Injury Compensation Programs 

Health Systems Bureau

Health Resources and Services Administration

Rockville, MD

Indian Health Service (IHS) 

CLARK, Matthew, MD, FAAP, FACP

Physician

Chair, IHS National Pharmacy & Therapeutics Committee

Durango, CO

Office of Infectious Disease and HIV/AIDS Policy (OIDP)

MARSHALL, Valerie, MPH, PMP

CDR, USPHS

Deputy Director

Office of the Assistant Secretary for Health

Department of Health and Human Services

Washington, DC

National Institutes of Health (NIH) 

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) 

Bethesda, MD 
62

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP)

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, University of 

Michigan Medical School 

Medical Director, Dominos Farms Family Medicine 

Ann Arbor, MI 

American Academy of Pediatrics (AAP) 

O’LEARY, Sean, MD, MPH

Professor of Pediatrics

Pediatric Infectious Diseases

General Academic Pediatrics

Children’s Hospital Colorado

University of Colorado School of Medicine

American Academy of Pediatrics (AAP) 

Red Book Editor

KIMBERLIN, David, MD 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine

Birmingham, AL 

American Academy of Physician Assistants (AAPA) 

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs 

American Academy of Physician Assistants 

Alexandria, VA 

American College Health Association (ACHA) 

CHAI, Thevy S., MD 

Director of Medical Services 

Campus Health Services 

University of North Carolina at Chapel Hill Chapel Hill, 

NC 

American College Health Association (ACHA) (alternate) 

LEE, Sara, MD

Assistant Vice President of University Health and Counseling Services

Chief Health Officer

Case Western Reserve University

Cleveland, OH
63

American College of Nurse Midwives (ACNM) 

HAYES, Carol E., CNM, MN, MPH 

Lead Clinician 

Clinical Quality Compliance and Management 

Planned Parenthood Southeast Atlanta, GA 

American College of Nurse Midwives (ACNM) (alternate) 

MEHARRY, Pamela M., PHD, CNM 

Midwifery Educator, Human Resources for Health 

In partnership with University of Rwanda and University of Illinois, Chicago 

American College of Obstetricians and Gynecologists (ACOG) 

ECKERT, Linda O, MD, FACOG 

Professor, Department of Obstetrics & Gynecology 

Adjunct Professor, Department of Global Health 

University of Washington 

Seattle, WA

American College of Physicians (ACP) 

GOLDMAN, Jason M, MD, FACP 

Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic University, Boca 

Raton, Florida 

Private Practice 

Coral Springs, FL 

American Geriatrics Society (AGS) 

SCHMADER, Kenneth, MD 

Professor of Medicine-Geriatrics Geriatrics 

Division Chief 

Duke University and Durham VA Medical Centers 

Durham, NC 

America’s Health Insurance Plans (AHIP) 

GRUBB, Jessica, MD

Medical Director, Infectious Diseases 

Elevance Health Companies/Carelon

Charleston, SC

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA

Washington, DC 

American Immunization Registry Association (AIRA) (alternate)

LONDO, Courtnay, MA

Senior Program Manager

Washington, DC
64

American Medical Association (AMA)

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine Emory 

University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA) 

RITTLE, Charles (Chad), DNP, MPH, RN Assistant 

Professor, Nursing Faculty

Chatham University, School of Health Sciences 

Pittsburgh, PA 

American Osteopathic Association (AOA) 

GROGG, Stanley E, DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA) 

GOODE, Jean-Venable "Kelly" R., PharmD, BCPS, FAPhA, FCCP

Professor and Director, PGY1 Community-Based Pharmacy Residency Program

School of Pharmacy, Virginia Commonwealth University

Richmond, VA

Association of Immunization Managers (AIM) 

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health

Bismarck, ND 

Association for Prevention Teaching and Research (APTR) 

ZIMMERMAN, Richard, MD, MPH

Professor

University of Pittsburgh School of Medicine

Department of Family Medicine and Clinical Epidemiology

Pittsburgh, PA

Association of State and Territorial Health Officials (ASTHO) 

JUTHANI, Manisha, MD

Commissioner

Connecticut Department of Public Health

Hartford, CT

Biotechnology Industry Organization (BIO) 

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 
65

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

Canadian National Advisory Committee on Immunization (NACI) 

DEEKS, Shelley, MD, MHSc, FRCPC, FAFPHM

Deputy Chief Medical Officer of Health, Department of Health and Wellness, Nova Scotia

Associate Professor, Dalla Lana School of Public Health, University of Toronto

Chair, National Advisory Committee on Immunization

Halifax, Nova Scotia

Infectious Diseases Society of America (IDSA) 

DUCHIN, Jeffrey, MD

Health Officer, Public Health - Seattle and King County

Professor in Medicine, Division of Allergy and Infectious Diseases

University of Washington School of Medicine and School of Public Health

Seattle, WA

International Society for Travel Medicine (ISTM) 

BARNETT, Elizabeth D, MD Professor of 

Pediatrics 

Boston University School of Medicine 

Boston, MA 

National Association of County and City Health Officials (NACCHO)

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 

National Association of County and City Health Officials (NACCHO) (alternate)

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease

Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine 

Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health

Seattle, WA 

National Association of Pediatric Nurse Practitioners (NAPNAP) 

STINCHFIELD, Patricia A, RN, MS, CPNP 

Director 

Infectious Disease/Immunology/Infection Control

Children's Hospitals and Clinics of Minnesota 

St. Paul, MN 
66

National Association of Pediatric Nurse Practitioners (NAPNAP) (alternate)

DESHON, Dana, DNP, APRN, CPNP-PC Order of Saint Francis Medical Group Morton 

Pediatrics Morton, IL

National Foundation for Infectious Diseases (NFID) 

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

National Foundation for Infectious Diseases (NFID) (alternate)

DALTON, Marla, PE, CAE 

Executive Director & CEO 

National Foundation for Infectious Diseases (NFID) 

Bethesda, MD 

National Medical Association (NMA) 

WHITLEY-WILLIAMS, Patricia, MD Professor and Chair 

University of Medicine and Dentistry of New Jersey Robert Wood 

Johnson Medical School 

New Brunswick, NJ 

Pediatric Infectious Diseases Society (PIDS) 

PAULSEN, Grant, MD

Associate Professor of Pediatrics

Pediatric Infectious Diseases

Cincinnati Children’s Hospital Medical Center

Cincinnati, OH

Pediatric Infectious Diseases Society (PIDS) (alternate)

ROSS, Shannon A, MD, MSPH

Professor of Pediatrics

Birmingham School of Medicine 

University of Alabama 

Birmingham, AL

Pharmaceutical Research and Manufacturers of America (PhRMA) 

ROBERTSON, Corey, MD, MPH 

Senior Director, US Medical, Sanofi Pasteur 

Swiftwater, PA 

Society for Adolescent Health and Medicine (SAHM) 

MIDDLEMAN, Amy B, MD, MSEd, MPH 

Professor of Pediatrics 

Chief, Section of Adolescent Medicine 

University of Oklahoma Health Sciences Center

Oklahoma City, OK 
67

Society for Healthcare Epidemiology of America (SHEA)

DREES, Marci, MD, MS 

Chief Infection Prevention Officer & Hospital Epidemiologist 

ChristianaCare 

Wilmington, DE 

Associate Professor of Medicine 

Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA
68

ACRONYMS USED IN THIS DOCUMENT

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics

ACA Affordable Care Act 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices

ACNM American College of Nurse-Midwives 

ACOG American College of Obstetricians and Gynecologists

ACP American College of Physicians 

AE Adverse Event

AESI Adverse Events of Special Interest 

AHIP America’s Health Insurance Plans

AI/AN American Indian/Alaskan Native 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AMA American Medical Association

APhA American Pharmacists Association 

AR Adverse Reaction 

ARI Acute Respiratory Illness 

ASTHO Association of State and Territorial Health Officers 

CDC Centers for Disease Control and Prevention

CDER Center for Drug Evaluation and Research 

CMS Center for Medicare and Medicaid Services

COI Conflict of Interest 

CONUS Continental United States 

CPT Current Procedural Terminology 

CSTE Council of State and Territorial Epidemiologists 

DFO Designated Federal Official

DMC Data Monitoring Committee 

DSMB Data Safety Monitoring Board 

EBV Epstein-Barr Virus 

ED Emergency Department

EHRs Electronic Health Records 

EMR Electronic Medical Record 

ET Eastern Time

EtR Evidence to Recommendation 

FDA Food and Drug Administration

FQHC Federally Qualified Health Center 

GBS Guillain–Barré Syndrome

GEE generalized estimating equation 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

HCP Healthcare Personnel / Providers

HCRU Health Care Resource Utilization 

HHS (Department of) Health and Human Services

HRSA Health Resources and Services Administration 

ICD International Classification of Diseases 
69

ICER Incremental Cost-Effectiveness Ratio 

ICU Intensive Care Unit

IDSA Infectious Disease Society of America 

IFDO Intrauterine Fetal Demise Outcomes 

IHS Indian Health Service 

IIS Immunization Information System 

IM Intramuscular

IRA Inflation Reduction Act of 2022 

ISO Immunization Safety Office 

IT Information Technology 

IVIG Intravenous Immunoglobulin Therapy 

LMP Last Menstrual Period 

LRTD Lower Respiratory Tract Disease 

LRTI Lower Respiratory Tract Illness 

MA-RSV LRTI Medically-Attended RSV Lower Respiratory Tract Infection 

MASO Management Analysis and Services Office 

MedDRA Medical Dictionary for Regulatory Activities 

mAbs Monoclonal Antibodies 

MMWR Morbidity and Mortality Weekly Report

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada

NAPNAP National Association of Pediatric Nurse Practitioners 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

NCIRD National Center for Immunization and Respiratory Diseases 

NDC National Drug Code 

NFID National Foundation for Infectious Diseases 

NIAID National Institute of Allergy and Infectious Diseases

NIH National Institutes of Health

NMA National Medical Association 

NNV Number Needed to Vaccinate 

NREVSS National Respiratory and Enteric Virus Surveillance System 

NVSN New Vaccine Surveillance Network 

OIDP Office of Infectious Disease and HIV/AIDS Policy

PCP Primary Care Provider/Practitioner

PHAC Public Health Agency Canada 

PICO Population, Intervention, Comparison, Outcomes

PIDS Pediatric Infectious Disease Society 

PSA Probabilistic Sensitivity Analysis 

QALY Quality-Adjusted Life Year

RSV Respiratory Syncytial Virus 

RSVpreF RSV Prefusion F Protein Vaccine

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

SHEA Society for Healthcare Epidemiology of America 

SoC Standard of Care 

URTI Upper Respiratory Tract Infection 

US United States

USG United States Government

USVI US Virgin Islands 
70

VAERS Vaccine Adverse Event Reporting System

VE Vaccine Efficacy

VE Vaccine Effectiveness

VFC Vaccines For Children 

VRBPAC Vaccines and Related Biological Products Advisory Committee

VSD Vaccine Safety Datalink

WG Work Group