MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP) 

AUGUST 3, 2023 

MEETING SUMMARY 

CONTENTS 

THURSDAY: AUGUST 3, 2023 .................................................................................................................... 2 

WELCOME AND INTRODUCTIONS ...................................................................................... 2 

Call to Order/Roll Call ......................................................................................................... 2 

Announcements.................................................................................................................. 2 

MATERNAL/PEDIATRIC RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINES ................ 4 

Session Introduction ........................................................................................................... 4 

Evidence to Recommendations (EtR) Framework: Nirsevimab Updates ............................. 5 

Nirsevimab Implementation Considerations .......................................................................13 

Proposed Clinical Consideration Updates for Nirsevimab ..................................................19 

WG Considerations / Proposed Recommendations ...........................................................20 

Vaccines for Children Resolution .......................................................................................26 

PUBLIC COMMENTS............................................................................................................27 

VOTES ..................................................................................................................................30 

Vote #1 RSV Maternal/Pediatric Recommendations ..........................................................30 

Vote #2 RSV Maternal/Pediatric Recommendations ..........................................................30 

Vote #3: VFC Resolution: RSV Maternal/Pediatric.............................................................30 

CERTIFICATION.........................................................................................................................................33 

ACIP MEMBERSHIP ROSTER ..................................................................................................................34 

ACRONYMS USED IN THIS DOCUMENT.................................................................................................42 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

THURSDAY: AUGUST 3, 2023 

WELCOME AND INTRODUCTIONS 

Call to Order/Roll Call 

Dr. Grace Lee (ACIP Chair) called to order and presided over the August 3, 2023 Advisory 

Committee on Immunization Practices (ACIP) meeting. Dr. Lee 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 1:55 PM Eastern Time (ET). To create a fair and more efficient 

process, individuals interested in making an oral comment were asked to submit a request 

online in advance of the meeting. Priority is given to these advance requests. If more people 

make requests than can be accommodated, a blind lottery is conducted to determine who the 

speakers will be. Speakers selected in the lottery for this meeting were notified in advance of 

the meeting. Members of the public also may submit written comments via 

https://www.regulations.gov using Docket Number ID CDC-2023-0063. 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. Detailed instructions for submissions of names for potential candidates to serve 

as ACIP members are available on the ACIP website. The deadline for applications for ACIP 

membership has been extended to September 1, 2023 for the 4-year term beginning in July 

2024. 

By way of introduction to the topic of the day’s meeting, Dr. Wharton briefly reviewed 2 different 

processes for immunization, passive and active. Passive immunization involves the transfer of 

preformed antibody produced externally to provide protection to the recipient. Diphtheria 

antitoxin is still manufactured in horses, but most products for passive immunization come from 

human immune globulins. Some antibody products are made in cell culture systems. These 

2 
 

 

 

 

 

 

 

 

 

 

 

 

 

antibodies can provide excellent protection, but that protection wanes over time because the 

antibodies that are given only last so long. Transfer of maternal antibody across the placenta 

that provides protection in early infancy is another example of passive immunization. In contrast, 

active immunization that occurs with traditional vaccines comes from the response of the 

recipient’s own immune system. Immunological memory provides prolonged protection than 

occurs with passive immunization and can be lifelong. 

Advances in biotechnology offer the opportunity to prevent infectious diseases with long-acting 

monoclonal antibodies (mAbs)1 beyond what can be provided by traditional vaccines. When 

used for passive immunization, these products can provide a level of protection similar to what 

is observed with traditional vaccines, but for a limited period of time. They can be especially 

valuable when full protection is needed without delay and when a traditional vaccine is not 

available. For some indications, the protection provided by a long-acting monoclonal might be 

“long enough” to provide protection during the risk period with a single dose for the duration of a 

respiratory disease season, for a critical part of a pregnancy, or for the duration of travel. 

CDC will prioritize for ACIP consideration of those long-acting mAbs for prevention of infectious 

diseases that are: 1) expected to address conditions that result in a significant burden of 

disease to the public's health; 2) are not expected, based on the characteristics of the product 

itself, to present significant implementation issues for immunization providers (e.g., mode of 

administration, storage and handling, and frequency of administration); and 3) are expected to 

be priced at a level allowing for incorporation into immunization programs. She returned the 

floor to Dr. Lee who called upon Dr. John Farley to provide an overview from the Food and Drug 

Administration (FDA). 

John Farley, MD, MPH (Director, CDER/FDA) provided a few opening remarks on behalf of 

the FDA. He reported that the FDA approved Biologics License Application (BLA)-761328 on 

July 17, 2023 that licensed nirsevimab-alip injection with the trade name BeyfortusTM. The 

indication was based on the data from adequate and well-controlled trials contained within the 

BLA and reads as follows: 

BEYFORTUS is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor 

indicated for the prevention of RSV lower respiratory tract disease in: 

• Neonates and infants born during or entering their first RSV season. 

• Children up to 24 months of age who remain vulnerable to severe RSV disease 

through their second RSV season. 

The safety and efficacy of nirsevimab were supported by 3 clinical trials, Trials 03, 04, and 05. 

The primary measure of efficacy was the incidence of medically-attended RSV lower respiratory 

tract infection (MA-RSV LRTI). It was evaluated during the 150 days after nirsevimab 

administration. MA-RSV LRTI, the endpoint, included all healthcare provider (HCP) visits (e.g., 

physician office, urgent care, emergency room visits) and hospitalizations for LRTD disease with 

worsening clinical severity and a positive RSV test. Trial 03 included 1,453 preterm infants born 

at ≥29 weeks of gestational age up to <35 weeks of gestation who were born during or entering 

their first RSV season. Of the preterm infants enrolled in the trial, 969 were randomized to a 

single dose of nirsevimab and 484 were randomized to placebo. Nirsevimab reduced the risk of 

MA-RSV LRTI by approximately 70% relative to placebo. The primary analysis group in Trial 04 

1 https://www.who.int/images/default-source/departments/immunization-ivb/pdvac/who-monoclonalantibodies.jpg?sfvrsn=f0870999_3 

3 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

included 1,490 term and late preterm infants born at ≥35 weeks gestational age of whom 994 

were randomized to a single dose of nirsevimab and 496 were randomized to placebo. 

Nirsevimab reduced the risk of MA-RSV LRTI by approximately 75% relative to placebo in that 

trial. Trial 05 was randomized, double-blind placebo-controlled multi-center trial in infants at high 

risk for severe RSV disease. The trial enrolled 925 preterm infants as well as infants with 

chronic lung disease (CLD) of prematurity or congenital heart disease (CHD). These patients 

were randomized 2:1 to receive nirsevimab or palivizumab by intramuscular (IM) injection. The 

efficacy of nirsevimab for prevention of MA-RSV LRTI in these high-risk patients during RSV 

seasons 1 and 2 was extrapolated from efficacy in Trials 03 and 04, with demonstration of 

comparable serum nirsevimab exposures between the high-risk population in Trial 05 and the 

Trials 03 and 04 populations. 

FDA imposed 2 post-marketing requirements. One focused on monitoring the prevalence of 

RSV variants, including the frequency of known nirsevimab resistance-associated substitutions 

and the second requirement to phenotypically assess certain RSV-A and RSV-B substitutions. 

The sponsor has agreed to a number of post-marketing commitments. These include 

conducting the Harmony Study Extension that will evaluate antibody-dependent enhancement 

of RSV disease, and conducting an observational US-based long-term study of infants eligible 

to receive nirsevimab in their first year of life to assess the impact of RSV disease through Day 

511 post-dosing. The FDA has determined that a pharmacovigilance strategy is necessary to 

support coordinated monitoring and assessment of safety information from data sources across 

both FDA and CDC. ACIP recommendations will be factored into the final pharmacovigilance 

strategy as appropriate. The full details of this strategy will be finalized in a separate document 

within 90 days of marketing approval, and this pharmacovigilance strategy may be modified as 

safety information accumulates during the post-marketing period. Dr. Farley noted that FDA 

Review Team members joined the meeting and were available to answer questions. 

MATERNAL/PEDIATRIC RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINES 

Session Introduction 

Sarah S. Long, MD (Chair, Maternal/Pediatric RSV WG) reminded everyone that previous 

Maternal/Pediatric RSV WG presentations to the ACIP focused on nirsevimab, the long-acting 

monoclonal antibody against RSV; the epidemiology and burden of RSV in infants; the virology 

and immunology of RSV; the safety and efficacy of nirsevimab; the cost effectiveness analysis 

from a CDC model and a comparison with a manufacturer model; the Evidence to 

Recommendation (EtR) Framework findings for nirsevimab; and clinical considerations for 

nirsevimab. 

Dr. Long indicated that the sole focus of the presentations for this session would be on 

nirsevimab because on June 8, 2023, the FDA Antimicrobial Drug Advisory Committee 

(AMDAC) evaluated and voted on 2 questions: 

1. Is the overall benefit-risk assessment favorable for the use of nirsevimab for the 

prevention of RSV lower respiratory disease in neonates and infants born during or 

entering their first RSV season? 

2. Is the overall benefit-risk assessment favorable for the use of nirsevimab for the 

prevention of RSV lower respiratory tract disease in children up to 24 months of age who 

remain vulnerable to severe RSV disease through their second RSV season? 

4 
 

 

 

 

 

 

 

 

 

 

 

 

 

The AMDAC voted 21-0 in favor of the first question and 19-2 in favor of the second question. 

Many committee members recognized the need for guideline groups such as the American 

Academy of Pediatrics (AAP) and ACIP to provide additional recommendations on the use of 

nirsevimab. As Dr. Farley noted earlier, the FDA approved nirsevimab on July 17, 2023 for the 

prevention of RSV LRTD in neonates and infants born during or entering their first RSV season 

and in children who remain vulnerable to severe RSV disease through their second RSV 

season. 

The agenda for this ACIP session included updated EtR Framework findings for nirsevimab, 

nirsevimab implementation considerations, clinical considerations for nirsevimab, 

Maternal/Pediatric RSV WG considerations and proposed recommendations and voting 

language, and a Vaccines for Children (VFC) Resolution. Dr. Long concluded with the following 

proposed ACIP voting language so that members could be thinking about it throughout the 

presentations: 

 Infants aged <8 months born during or entering their first RSV season are recommended 

to receive one dose of nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5 kg)

 Children aged 8–19 months who are at increased risk of severe RSV disease and 

entering their second RSV season are recommended to receive one dose of nirsevimab 

(200 mg) 

Evidence to Recommendations (EtR) Framework: Nirsevimab Updates 

Jefferson Jones, MD, MPH, FAAP, CDR, USPHS (CDC/NCIRD Co-lead, Maternal/Pediatric

RSV WG) reiterated that the following 2 policy questions were considered by the Maternal/ 

Pediatric WG regarding nirsevimab: 

1. Should one dose of nirsevimab be recommended for infants aged <8 months born during or 

entering their first RSV season (50 mg for infants <5 kg and 100 mg for infants ≥5 kg)?

2. Should one dose of nirsevimab be recommended for children aged 8–19 months who are at 

increased risk of severe RSV disease and entering their second RSV season (200 mg)? 

The rationale for inclusion of these age groups was that given an average RSV season of 4–5 

months, infants aged 8 months and children aged 20 months would be experiencing their 

second and third RSV seasons, respectively. 

As mentioned earlier, nirsevimab is a form of passive immunization against RSV. While it may 

be referred to as “immunization” during the presentations and discussion, it is passive 

immunization. Nirsevimab does not provide active immunity. Active immunity results from 

infection or vaccination, which triggers an immune response. Passive immunity is when a 

person receives antibodies from an external source. Examples include antibodies transferred 

from mother to baby through the placenta or breastmilk or direct administration of antibodies, 

such as intravenous immunoglobulin (IVIG) therapy or monoclonal antibodies such as 

nirsevimab.2 

2 https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm 

5 
 

 

 

 

 

 

 

 

 

 

In terms of the PICO components for Policy Question #1 in this EtR analysis, the population 

included infants aged <8 months born during or entering their first RSV season. The intervention 

was nirsevimab (1 injection prior to the start of RSV season or at birth if born during the season, 

50 mg if <5 kg or 100 mg if ≥5 kg). The comparison was no nirsevimab prophylaxis. The 

outcomes included MA-RSV-associated LRTI, RSV-associated LRTI with hospitalization, RSVassociated LRTI with intensive care unit (ICU) admission, RSV-associated death, all-cause 

medically attended LRTI, all-cause LRTI-associated hospitalization, and serious adverse events 

(SAEs). In terms of the EtR domains (e.g., Public Health Problem, Benefits and Harms, Values, 

Acceptability, Feasibility, Resource Use, and Equity), the domains of Benefits and Harms, 

Feasibility, and Resource Use included updates from what was presented during the February 

2023 ACIP meeting. 

To review the first domain of the Public Health Problem, data from the National Respiratory and 

Enteric Virus Surveillance System (NREVSS)3

, the primary source for monitoring RSV 

seasonality in the US, showed that there was very limited RSV circulation until late Spring 2021 

that was followed by a peak in activity in late Summer 2021. Transmission continued throughout 

the fall into December 2021. The most recent RSV season showed increasing RSV activity 

starting in late Summer 2022, with a peak in RSV transmission in October─November 2022. To 

summarize that, the 2022─2023 season began later than the 2021─2022 season but earlier 

than pre-pandemic seasons. This suggests an incremental reversion to pre-pandemic 

seasonality with winter peaks and highlights the uncertainty in when the next RSV season will 

start. 

In terms of epidemiology, RSV is the most common cause of hospitalization in US infants. The 

highest RSV hospitalization rates are in the first months of life. The risk declines by month with 

increasing age in infancy and early childhood. While prematurity and other chronic diseases 

increase the risk of RSV-associated hospitalization, most hospitalizations are in healthy term 

infants. The WG felt that RSV-associated disease in infants born during or entering their first 

RSV season is of public health importance. 

Regarding the Benefits and Harms domain, there have been no updates to the GRADE 

(Grading of Recommendation Assessment, Development and Evaluation) assessment of the 

evidence presented in February 2023. However, some additional data were received from 

pooled estimates combining Phase 2b and Phase 3 clinical trials estimate comparing the 

nirsevimab arm to the placebo arm in addition to concerns in terms of the certainty of 

assessment. The estimated efficacy was 79% for MA-RSV LRTI, 80.6% for hospitalization, and 

90% for ICU admission. No RSV-associated deaths were recorded, though this outcome could 

not be evaluated. The estimated efficacy against all-cause medically attended LRTI was 34.8% 

and against all-cause LRTI hospitalization was 44.9%. The risk ratio comparing SAEs in infants 

receiving nirsevimab versus receiving placebo was 0.73. 

In summary of GRADE for nirsevimab, there is high certainty that Nirsevimab is effective in 

preventing medically attended RSV and RSV hospitalization. In addition to preventing all-cause 

medically attended LRTI and LRTI hospitalization, there is moderate certainty that nirsevimab is 

effective in protecting against RSV LRTI with ICU admission and that SAEs are not more 

common in infants receiving nirsevimab compared with placebo. Additional safety data were 

provided during the AMDAC meeting on nirsevimab4

. The most commonly reported adverse 

reactions (ARs) were injection site reactions (0.3%) and rash (0.9%). The FDA noted an 

3 https://www.cdc.gov/mmwr/volumes/72/wr/mm7214a1.htm 

4 https://www.fda.gov/advisory-committees/advisory-committee-calendar/june-8-2023-meeting-antimicrobial-drugs-advisorycommittee-meeting-announcement-06082023 

6 
 

 

 

 

 

 

 

 

 

 

 

 

 

imbalance in deaths between nirsevimab and the control arms but determined that the deaths 

were unlikely to be related to nirsevimab. 

The sponsor shared data from the ongoing Phase 3b study known as HARMONIE.

5 The 

HARMONIE study enrolled 8,058 infants. The age at enrollment was: 49% <3 months, 24% 3-5 

months, and 28% ≥6 months. Of the infants, 85% were born at term and 50% were born during 

the RSV season. This study is being conducted in France, the United Kingdom (UK), and 

Germany. While these results are from August 8, 2022–February 28, 2023, the study is 

ongoing. The participants were randomized to nirsevimab or no injection, meaning the control 

group was not given a placebo injection. The primary endpoint was RSV hospitalization, which 

was a LRTI hospitalization with a positive RSV test. RSV tests were ordered by clinicians for 

patients with LRTI per the standard of care as opposed to systematically on all patients with 

LRTI hospitalizations. Participants will be followed for at least 12 months after randomization. At 

the end of the RSV season, the preliminary efficacy results were released, which were 

presented during this session. These results were with a median post-randomization follow-up 

time of 2.5 months. HARMONIE preliminary results reported an efficacy against RSV 

hospitalization of 83%, 76% against severe disease (e.g., oxygen saturation below 90% and 

oxygen given), and 58% against all-cause hospitalization with LRTI during the RSV season. For 

safety, Grade 1 AEs were reported to be slightly higher in the nirsevimab arm (29%) versus the 

no intervention arm (25%). The rates of Grade 2 and Grade 3 AEs were similar between the 

nirsevimab and control arms. It is important to note that these results have not been peerreviewed or published in the scientific literature. 

To summarize the Benefits and Harms domain, the overall GADE grade evidence rating was 

moderate. The results were downgraded based on imprecision for protection against ICU 

admissions because of few recorded events and imprecision of SAEs because rare events are 

unlikely to be detected. The WG felt that the desirable anticipated effects of nirsevimab were 

moderate to large, that the undesirable anticipated effects of nirsevimab were minimal to small, 

and that the desirable effects outweighed the undesirable effects and favored nirsevimab over 

no intervention. 

The next domain is Values, for which no updates were available. In a survey of people currently 

pregnant or pregnant within the last 12 months conducted by the CDC, the University of Iowa, 

and the Rand Corporation on RSV immunizations, only 33% of respondents thought their baby 

“definitely” or “probably would” get an RSV infection within 1 year after being born. Despite 

being unsure or perceiving RSV risk to be low, respondents were worried that their baby would 

need to be hospitalized if they got sick with RSV (mean response 4 of 5, with 5 being most 

worried). Of the respondents, 70% said they “definitely” or “probably would” get an RSV 

antibody injection for their baby if safe and effective. The WG determined that the target 

population probably feels that the desirable effects are large relative to undesirable effects. The 

WG varied in whether they felt there was important uncertainty about, or variability in, how much 

people value the main outcomes. 

5 Study not peer-reviewed and information provided directly by sponsor; https://www.clinicaltrials.gov/study/NCT05437510 

7 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

The next domain is Acceptability with key stakeholders, for which no updates were available. In 

a survey of US pediatric providers, over 85% agreed that parents need more information about 

RSV, that immunization could help prevent RSV, and that immunization policy should ensure all 

children get access.6 The American Academy of Pediatrics (AAP) and the National Foundation 

for Infectious (NFID) Disease Roundtable have stated the need for safe and effective RSV 

prevention products.7 The WG felt that passive immunization with nirsevimab was or probably 

was acceptable to key stakeholders. 

Feasibility domain considerations were reviewed in the next presentation by Dr. Georgina 

Peacock, but the WG felt that nirsevimab probably will be feasible to implement. 

The Resource Use domain, the primary source of data was a cost-effectiveness analysis 

performed by the University of Michigan. Since the cost-effectiveness analysis was presented to 

ACIP in February 2023, the company provided an updated cost estimate of the product. The list 

price was estimated to be $495 and the cost for the VFC program was estimated to be $395. 

Assuming nirsevimab is administered as 50% under the VFC and 50% under private insurance, 

the average price was $445. This price was not final at the time of this session per the WG’s 

understanding. Mortality assumptions were modified to include individuals at increased risk of 

severe disease and savings from not using palivizumab to those recommended to receive it 

were incorporated. Other inputs were unchanged from the previous model presented during the 

February 23, 2023 ACIP meeting. The number needed to immunize with nirsevimab to prevent 

1 health outcome was 17 for an outpatient visit, 18 for an ED visit, 128 for inpatient, 581 for ICU 

admission, 24 per inpatient day, and 194 per ICU day. The cost per health event averted was 

$2,662 per outpatient visit, $7,473 per ED visit, $19,909 per inpatient admission, $90,494 per 

ICU admission, $3,687 per inpatient day, and $30,165 per ICU day. The updated base case 

results of the cost-effectiveness analysis was $102,811 per quality adjusted life year saved. The 

WG felt that nirsevimab is or probably is a reasonable and efficient use of resources. A full 

presentation for this updated cost-effectiveness analysis was included in the extra slides. 

The primary update to the Equity domain was that that if ACIP recommends use of nirsevimab, 

ACIP also would vote on a VFC Resolution for nirsevimab. To summarize equity, national 

studies of death certificates found higher rates among non-Hispanic Black children compared 

with non-Hispanic White infants and children 1─4 years of age.

8 ICU admission rates for RSV 

among non-Hispanic Black infants <6 months of age were 1.2 to 1.6 times higher than among 

non-Hispanic White infants.9 RSV hospitalization rates were 4 to 10 times higher among Alaska 

Native and American Indian (AI/AN) children <24 months of age than the rate in the general 

population.10 Studies of RSV hospitalization by race and ethnicity have differing results.11 The 

WG felt that nirsevimab would increase health equity. 

6 https://admin.allianceforpatientaccess.org/wp-content/uploads/2023/01/AfPA-and-NCfIH_The-Indirect-Impact-of-RSV_SurveyReport_Jan-2023.pdf 7 AAP COID BGC Pediatrics 2014 Aug;134(2):415-20; and https://www.nfid.org/wp-content/uploads/2022/04/NFID-RSV-Call-toAction.pdf 

8 Hansen J Infect Dis 2022 Aug 15;226(Suppl 2):S255-S266 9 Unpublished data from RSV-NET, CDC 10 Atwell Pediatrics 2023, e2022060435 11 Hall Pediatrics 2013 Aug;132(2):e341-8; Hall NEJM 2009;360(6):588–598; Iwane Pediatrics 2004 Jun;113(6):1758-64, findings 

differed by age group; and Rha Pediatrics 2020 Jul;146(1):e20193611, findings differed by age group 

8 
 

 

 

 

 

 

 

 

Displayed in this table are the WG’s judgments of the EtR Framework analysis for the first RSV 

season indication: 

The WG felt that the desirable consequences clearly outweigh the undesirable consequences in 

most settings, with a minority opinion that the desirable consequences probably outweigh the 

undesirable consequences. The WG recommended the intervention for all infants in their first 

RSV season. 

To review the EtR analysis for the second RSV indication, the population is children aged 8–19 

months who are at increased risk of severe RSV disease and who are entering their second 

RSV season. The intervention was nirsevimab (200 mg [2 x 100 mg] injection near start of 

second RSV season) and the comparison was no nirsevimab prophylaxis. The outcomes were 

the same as those used for the first indication. Domains with updates unique to the second 

season included the Public Health Problem and Resource Use. 

For the Public Health Problem, the WG previously presented that they felt the risk groups to 

receive nirsevimab for the second RSV season could be based on the AAP recommendation for 

palivizumab for a child’s second RSV season.12 The WG assumed nirsevimab to be cost-saving 

compared with palivizumab. The proposed recommendation to receive nirsevimab when 

entering their second RSV season would include the following groups: 

 Children with CLD of prematurity if they require medical support (chronic corticosteroid

therapy, diuretic therapy, or supplemental oxygen) during the 6-month period before the

start of the second RSV season

 Children with severe immunocompromise

 Children with cystic fibrosis if manifestations of severe lung disease (previous hospitalization

for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that

persist when stable) or weight for length <10th percentile

12 American Academy of Pediatrics. Committee on Infectious Diseases [Respiratory Syncitial Virus.] In: Kimberlin DW, Barnett ED, 

Lynfield R, Sawyer MH, eds. Red Book : 2021 Report of the Committee on Infectious Diseases. Itasca, IL: American Academy of 

Pediatrics, 2021 

9 
 

 

 

 

 

 

 

 

 

 

 

 

To evaluate the evidence if other risk groups should be considered for a recommendation, CDC 

conducted 2 analyses, a systematic review of the literature and an analysis of the MarketScan 

national claims database. The systematic review included any studies that compared RSV 

hospitalization rates among children with risk factors to a healthy control among children 6─24 

months of age. Among 3,825 abstracts reviewed, 6 studies were identified. CLD, CHD, and 

neuromuscular disease (NMD) were analyzed in these studies. These studies indicated an 

increased risk of hospitalization for these risk factors. No studies evaluating other risk factors 

were identified. 

Given the limited evidence available in the systematic review, CDC conducted an analysis of the 

MarketScan national claims database for select risk factors for severe RSV disease during the 

second RSV season using data from 2015─2021. Using International Classification of Diseases 

(ICD)-9 and ICD-10 codes, children were identified with and without selected conditions (e.g., 

CLD, CHD, Down syndrome, NMD, pulmonary malformations, immunodeficiency, cystic fibrosis) 

and children who were hospitalized with RSV. The rates of RSV hospitalization among children 

with a chronic condition were compared to children without any of these chronic conditions. 

Increased rates of hospitalization were seen for all conditions. It is important to note that a 

primary limitation in this study is that RSV testing may be more common for children with risk 

conditions, inflating RSV-specific hospitalization rates. 

Several prior studies have documented increased incidence of RSV hospitalizations among 

AI/AN children.13 One study found that rates of RSV hospitalization in AI/AN children were 4 to 

10 times the average rates of US children overall aged 12─23 months as determined from the 

New Vaccine Surveillance Network (NVSN).

14 These studies have been conducted in specific 

populations and may not be broadly representative of the risk in all AI/AN children. Findings of 

these studies do not separate environmental, sociocultural, or other factors that may increase 

severe disease risk. And some AI/AN communities are also in remote areas that can make 

transportation of children with severe RSV to an appropriate health care setting more 

challenging.15 

To summarize the Public Health Problem domain, the WG group felt that evidence for RSV 

burden among children 8─19 months entering their second RSV season with specific risk 

conditions is limited. The WG felt that nirsevimab should be recommended to the same groups 

the AAP recommends for palivizumab for the second RSV season. The WG also felt that 

nirsevimab should be recommended to AN/AI children entering their second RSV season. In 

addition, the WG felt that RSV disease among children who are at high risk of severe disease16 

in their second RSV season was of public health importance. 

13 Atwell 2023 Pediatrics 2023 Jul 14;e2022060435; Karron et al. J Infect Dis 1999; Holman et al. Pediatrics 2004; Lowther et al. J 

Ped Infect Dis 2000 14 Atwell 2023 Pediatrics 2023 Jul 14;e2022060435 15 American Academy of Pediatrics. Committee on Infectious Diseases [Respiratory Syncytial Virus.] In: Kimberlin DW, Barnett ED, 

Lynfield R, Sawyer MH, eds. Red Book: 2021 Report of the Committee on Infectious Diseases. Itasca, IL: American Academy of 

Pediatrics, 2021. 16 For groups recommended to receive palivizumab in their second RSV season by the American Academy of Pediatrics and 

American Indian and Alaska Native children 

10 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Moving to the Benefits and Harms domain, a pharmacokinetic trial17 was conducted that 

randomized children at risk of severe RSV disease to palivizumab or nirsevimab. In the second 

RSV season, 220 participants received nirsevimab and 42 received palivizumab. Among those 

who received nirsevimab, 2 pharmacokinetic endpoints have been reported. The Day 150 

nirsevimab concentrations compared with the Phase 3 Prevention of Medically Attended Lower 

Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term 

Infants (MELODY) efficacy trial among late preterm and term infants that showed efficacy. The 

proportion of participants who had an area under the curve (AUC) nirsevimab concentration 

above a target based on the efficacy trial data in term and preterm infants of 12.8 mg day/ml. 

Among recipients of nirsevimab, Day 150 concentrations were higher in the high-risk infants 

who received 200 mg in the second RSV season (Trial 05) that infants who received 50 mg (if 

<5kg) or 100 mg (if >5kg) in Phase 3 MELODY trial (Trial 04). For the other pharmacokinetic 

endpoint among recipients of nirsevimab in the second RSV season, most had an AUC 

nirsevimab concentration above the target threshold. Among infants with CLD and CHD, 97.7% 

and 100% respectively had concentrations above that target threshold. For safety, no AEs were 

judged to be related to nirsevimab or palivizumab in the second RSV season follow-up period.18 

In summary of GRADE for the second RSV season, nirsevimab may be effective in preventing 

MA-RSV LRTI, but with low certainty. The prevalence of SAEs was not significantly different in 

the intervention group or control group, but the certainty of evidence was very low. No data were 

available for other outcomes. Overall, the evidence rating was very low certainty (Type 4). This 

was downgraded on indirectness because of the use of pharmacokinetic data as a surrogate for 

efficacy, the population did not include children who match the proposed indication outside of 

CLD and CHD, the study was small in size, and no placebo group was included for a 

comparison. For groups recommended to receive palivizumab in their second RSV season by 

the AAP and AI/AN children, the WG felt that the desirable anticipated effects were moderate, 

the undesirable anticipated effects were minimal, and the desirable effects outweighed the 

undesirable effects and favored nirsevimab over no intervention. 

No additional data were available for the domains of Values or Acceptability specific to high-risk 

populations in their second RSV season. The WG determined that for groups recommended to 

receive palivizumab in their second RSV season by the AAP and AI/AN children, the target 

population probably feels that the desirable effects are large relative to undesirable effects. The 

WG also felt that there probably was not important uncertainty or variability in how much people 

valued the main outcomes. The WG felt that prevention with nirsevimab was, or probably was, 

acceptable to the key stakeholders. For feasibility, an additional visit to a provider might be 

needed for administration of nirsevimab prior to the beginning of the second RSV season. The 

WG felt that nirsevimab was probably feasible to implement among children 8─19 months of 

age at increased risk of severe RSV disease entering their second RSV season for groups 

recommended to receive palivizumab in their second RSV season by the AAP and AI/AN 

children. 

17 Domachowske J, Madhi SA, Simões EAF, Atanasova V, Cabañas F, Furuno K, et al. Safety of nirsevimab for RSV in infants with 

heart or lung disease or prematurity. New England Journal of Medicine. 2023;386(9): 892–894. doi:10.1056/NEJMc2112186 18 Source: FDA briefing document for Antimicrobial Drugs Advisory Committee June 8, 2023 meeting 

11 
 

 

 

 

 

 

 

 

 

 

For the Resource Use domain, the inputs were updated similar to the cost-effectiveness 

analysis for the first RSV season indication. As presented in February 2023, theoretical groups 

of children with increased risk were created with 2, 4, 6, and 10 times higher risk than the 

general population 8─19 months as of October for beginning of RSV season. Compared with 

February, 2 scenarios were created to account for the uncertainty in mortality in this group. As 

previously presented, the incidence of RSV-associated hospitalization and incidence per 

hospitalization were increased. For the other scenario, the incidence of RSV-associated 

hospitalization was increased. However, the mortality per hospitalization was not changed 

because of lack of evidence. No increases were made to the incidence of outpatient and ED 

visits, healthcare costs, or quality adjusted life years (QALY) lost with RSV disease for these 

increased risk groups due to lack of data.19 The cost was updated to $890 for nirsevimab per 

child based on 2 times the $445 per dose assumed in the first season analysis to account 

for the 200 mg injections needed. Baseline mortality estimates were modified to include highrisk individuals and other inputs were unchanged similar to the first season model. This table 

displays the updated results: 

The WG felt that nirsevimab use among children 8─19 months of age entering their second 

RSV season who are at increased risk of severe disease is probably a reasonable and efficient 

allocation of resources. Like all domains, this assumes increased risk of severe disease refers 

to groups recommended to receive palivizumab in their second RSV season by the AAP and 

also including AI/AN children. 

For the Equity domain, no updated information is available. As previously presented, equity 

issues differ by chronic condition among infants and young children. AI/AN children have 

reported higher hospitalization incidence rates than the general population during their second 

RSV season. Non-Hispanic Black and Hispanic populations have higher reported rates of 

preterm birth than non-Hispanic White populations. The WG felt that nirsevimab use probably 

would increase health equity. 

19 Same assumption as previous model presented at February 23, 2023 ACIP meeting 

12 
 

 

 

 

 

 

 

 

 

Displayed in this table are the WG’s judgments of the EtR Framework analysis for children at 

high risk entering their second RSV season: 

After reviewing the totality of the data presented during this session and acknowledging 

uncertainties around the aspects of the data, the WG felt that the desirable consequences 

probably outweigh the undesirable consequences in most settings, with a minority opinion that 

desirable consequences clearly outweigh the undesirable consequences. The WG proposed to 

ACIP to recommend the intervention for groups recommended to receive palivizumab in their 

second RSV season by the AAP and for AI/AN children. 

Nirsevimab Implementation Considerations 

Georgina Peacock, MD, MPH, FAAP (CDC/NCIRD) briefly reviewed some of the many 

implementation considerations related to nirsevimab, such as the definition of “vaccine,” cost, 

storage and handling, hospital dosing, outpatient dosing, coding and Immunization Information 

Systems (IISs), timing of vaccination, second year vaccinations, vaccine administration, safety 

reporting, and vaccine confidence and demand. There are some mitigation strategies and CDC 

is exploring others internally and with its partners in the field. 

One issue that has arisen is the definition of “vaccine.” There is no statutory definition of 

“vaccine” in the statute for the VFC program (section 1928 of the Social Security Act).

20 There 

also is no statutory definition of “vaccine” in the Affordable Care Act (ACA) (section 2713 of PHS 

Act),21 or its implementing regulations, which has a provision that mandates coverage of 

vaccine recommendations included on CDC’’s immunization schedules. Therefore, CDC has 

determined that nirsevimab is eligible for inclusion in the Childhood Immunization Schedule and 

the VFC. It is important to note that some states do have different definitions of “vaccine” in their 

state statutes, which may affect the state purchase of vaccine in universal purchase states. 

However, it does not affect the use of federally purchased vaccine in states. 

20 https://www.ssa.gov/OP_Home/ssact/title19/1928.htm 21 https://www.federalregister.gov/documents/2015/07/14/2015-17076/coverage-of-certain-preventive-services-under-the-affordablecare-act 

13 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nirsevimab is a costly product. If nirsevimab is recommended by ACIP, it will be covered by 

insurance and included in the VFC program. It is important to make sure that there is equitable 

access to nirsevimab. The cost of nirsevimab is a potential implementation barrier, particularly 

for outpatient settings or ambulatory practices. In the provider agreement for VFC providers, 

there is a provision that if a practice has both public and private payers, they must carry stock. 

Recognizing that this may be challenging for some practices, CDC is working through some 

potential short-term solutions that could be implemented during the ramp-up of inclusion of 

nirsevimab in the VFC program. 

This product is similar to other routine vaccines for children in terms of storage, handling, and 

administration. Nirsevimab is administered as an intramuscular (IM) injection using a singledose pre-filled syringe and can be administered simultaneously with other childhood vaccines. 

Dosing is weight-based (50 mg if <5 kg; 100 mg if ≥5 kg; 200 mg (2x100 mg) for high-risk 

children entering second RSV season). Storage and handling are similar to other routine 

vaccines. Nirsevimab is stored in a refrigerator at 2-80 C and may be kept at room temperature 

(20-250 C) for up to 8 hours. 

There have been some questions about scope of practice issues. Different jurisdictions or states 

may have different scope of practice statutes related to who can administer injectable 

therapeutics versus vaccines. CDC conducted a scan of different state statutes or laws to 

determine who is allowed to administer therapeutics. It appears that in most states, medical 

assistants who frequently do administer vaccines also will be able to deliver injection drugs. 

While there is some variability, this does not appear to be major issue related to scope of 

practice. 

There have been conversations about where doses will be given and the age of the infant. 

Approximately 10% of birthing hospitals participate in the VFC program. There has been a 

suggestion that if nirsevimab were to be given in the hospital, this would be similar to what is 

done with hepatitis B vaccine. Hepatitis B vaccine is bundled into a payment model for newborn 

care. It is important to note that hepatitis B vaccine costs approximately $13 to $16 a dose.22 If 

nirsevimab were to be included in a bundled payment model, it may take time for that to be put 

into practice. Regardless of where the dose is given, it is critical to ensure that documentation of 

nirsevimab administration and all parties involved are sent to the primary care provider (PCP). 

There are some potential challenges with nirsevimab being entered into IISs since it is a 

therapeutic versus a vaccine. Comprehensive maternal-neonatal records will become even 

more critical if maternal RSV vaccine is licensed and recommended and will adds to the need 

for communication between maternal records, hospital records, and ambulatory settings or 

primary care offices. Regarding outpatient administration, communication from the birthing 

hospital is extremely important related to this product. CDC also recognizes that an initial 

investment by pediatricians who are unsure on the demand for this product may create some 

challenges. Historically, there has been a lag in insurance payments for new products. 

Because of the uniqueness of this product, there is a need to consider different coding 

requirements. The initial meeting and American Medical Association (AMA) decision pertaining 

to Current Procedural Terminology (CPT) codes classified nirsevimab as a drug or a 

therapeutic. That means that currently, it is associated with an administration code that does not 

include a counseling component and is not eligible for a standalone counseling component. 

CDC understands that there are efforts underway potentially to propose a unique code for this 

22 https://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html 

14 
 

 

 

 

 

 

 

product that would include counseling and storage and handling components. Again, there may 

be potential challenges in recording the doses in IISs. 

This graphic depicts the complexity of the steps involved in paring systems for administering a 

newly authorized vaccine across the US, which illustrates that there are numerous processes 

and partners involved and that it takes time: 

To further detail IISs and vaccine forecasting considerations, coding of nirsevimab as a 

therapeutic instead of a vaccine could create challenges with internal provider ordering, 

provision of a vaccine record, and interoperability and data exchange with electronic health 

records (EHRs) and IISs. In addition, there are some forecasting issues related to Clinical 

Decision Support (CDS) systems for immunizations. The dosage is determined by weight, but 

CDS systems do not have access to patient weight. This could create challenges with 

forecasting doses. Second season recommendations also may be challenging. In addition, CDS 

systems are unable to take into account maternal vaccination history for forecasting of infant 

nirsevimab immunization. 

Special considerations also add complexity. Timing of vaccination is based on RSV season. 

Tropical climates may have different or unpredictable seasonality when compared with most of 

the continental US (CONUS). There also is variability in different localities. For example, 

seasonality in Alaska is less predictable and of longer duration. For those who are going to 

receive a second dose, high-risk populations must be defined and palivizumab 

recommendations must be clarified in the setting of nirsevimab availability. 

Reporting of AEs is more complicated for nirsevimab than other immunizations being classified 

as a therapeutic versus a vaccine. If nirsevimab is administered alone, suspected AEs are 

reported to MedWatch. If nirsevimab is administered simultaneously with any vaccine, 

suspected AEs are reported to the Vaccine Adverse Event Reporting System (VAERS) and 

additional reporting to MedWatch will not be needed. 

In terms of introduction of nirsevimab in the context of coming out of a pandemic during which 

there have been many conversations about vaccine confidence and demand, it is not clear 

whether physicians and the public will accept this new product and/or what the demand would 

be. In addition, this is occurring at the same time as commercialization of COVID-19 vaccine 

and seasonal influenza vaccine administration. Vaccine hesitancy and the need for counseling 

15 
 

 

 

 

 

 

 

 

 

 

 

 

 

are anticipated regarding all vaccines and products. In addition, there have been efforts to 

weaken school immunization requirements and expand vaccine exemptions at the state level. 

This also feeds into vaccine confidence and demand issues. 

In conclusion, this summarizes just some of the potential issues with implementation of 

nirsevimab. The risks during this season’s rollout include timing of availability of doses, provider 

hesitancy, and uptake. The recommendations will be complex with regard to hospital versus 

outpatient administration and seasonality and timing. Lessons learned with respect to hepatitis 

A and B should be considered. In addition, there may be unintended consequences. Therefore, 

it is important that all partners involved in this are thinking through potential implementation 

issues moving forward to ensure that the product has good uptake and infants are protected. 

Discussion Points 

Dr. Poehling requested that the FDA or the vaccine manufacturer share the list price and 

bounds in the most recent iteration. Because there is availability of the product in 2 formulations 

(e.g., 50 mg and 100 mg) she asked for confirmation that they both would be priced the same in 

order to ensure that infants can receive the appropriate dosing without an additional cost 

concern. Another potential concern that Dr. Peacock raised regarding the CPT code defining 

nirsevimab as a drug or therapeutic. While the ACA covers vaccines, there are a lot of private 

insurance plans that have high deductibles. This raised a concern about whether large co-pays 

could be anticipated for many families. 

Dr. Ritchey responded that Sanofi Vaccines is committed to making BeyfortusTM successful and 

cost-effective for all infants entering their first RSV season. Consistent with the analysis shared 

by ACIP and the WG, assuming an all-infant recommendation and inclusion in the VFC program 

to ensure access for those infants, Sanofi Vaccines’ pricing will be cost-effective with a 

commercial list price of $495 and a lower VFC price of $395 to reflect that volume that is 

purchased through the program. The 50 mg and 100 mg formulations would be $495, which 

means that 2 doses given for 200 mg would be $990. 

In terms of private insurance and the potential for high co-pays, Dr. Peacock reached out to 

billing experts and reported that nirsevimab would be covered under the ACA as an 

immunization with no co-pay if it is recommended by the ACIP. 

Dr. Talbot asked whether the AMA would reconsider its classification of nirsevimab as a drug 

and therapeutic. When the term “drug and therapeutic” is used, patients are going to think that 

this is a treatment for RSV rather than a prevention. This will make educating families much 

more difficult. 

As a member of the WG, Ms. Stinchfield (NAPNAP) thanked Dr. Peacock for outlining the 

significant implementation challenges discussed with the WG. Coming from the private sector 

hospital and clinic settings, she encouraged all of her colleagues across the US to use Dr. 

Peacock’s very detailed presentation as a template for the work that needs to be done and 

starting now with the patient education, staff education, storage and handling, electronic medical 

records (EMRs), et cetera. The numerous considerations for implementation should not be 

barriers. They are just going to take some work beginning immediately. 

Dr. Hopkins (NFID) emphasized that addressing potential issues around collaboration and 

communication would be critical to do as soon as possible with regard to this product and for 

RSV prevention in infants in general. 

16 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regarding the cost-effectiveness results for children 8─19 months of age, Dr. Cieslak (CSTE) 

said he was surprised to see that the WG thought the costs were reasonable. He asked Dr. 

Jones to explain the risk category for the base case scenario and the rationale for apparently 

upping that 10-fold in the sensitivity analysis. 

Dr. Jones indicated that the baseline risk was based on those who would be entering their 

second RSV season in October who would be 8─19 months of age per NVSN rates for the 

general population. Because the analysis was considering those at increased risk and there was 

a lack of data on what the hospitalization rate would be for these increased risks, theoretical risk 

groups were created to estimate what the rates may be. This was the reason the WG did not 

expand beyond those who already were recommended to receive palivizumab. Instead using 

palivizumab as a 5-dose monthly monoclonal antibody product for those who are recommended 

to receive palivizumab, switching them to nirsevimab would be assumed to be a cost-saving in 

that scenario. That is the scenario the WG interpreted as being a reasonable allocation of 

resources. 

Dr. Loehr asked Dr. Jones to clarify if Slide 55 was saying that some people have a higher risk 

but there are no data. He asked for clarification about whether there were any data on the 

children who received palivizumab to give them a sense of how much more likely they are to be 

in the hospital than the average 12-month-old or 18-month-old. He agreed that switching to 

nirsevimab would be very expensive if the increased risk is not significant. 

Dr. Jones responded that the lack of data on the increased incidence rate of hospitalization or 

other health outcomes for those at increased risk is most concerning. Based on the lack of data 

in a review of the evidence, the AAP recommends palivizumab only in the second season for a 

fairly select group. The WG reviewed that paper and did the systematic review, and found a 

very limited set of data that showed an increased risk of 2, 4, and 4 times the risk. The 

MarketScan analysis showed higher prevalence ratios of hospitalization, but the WG had 

considerable concern about whether those represent the truth or if those are inflated due to 

RSV testing of high-risk populations versus the general population. Given the lack of data, the 

WG did not have confidence in what the rates would be. 

Dr. Loehr agreed that if nirsevimab is on the immunization schedule, it will get covered without 

co-pay under the ACA. However, he reiterated something he has brought up many times. This 

will take time. He just had to research this for a presentation and confirmed that insurance 

companies have 1 year after approval and until the following plan year. If ACIP approved a 

product in February 2023, insurance plans would have until February of 2024 to cover it without 

cost. If the ACIP approved nirsevimab during this meeting, it could be 18 months before it would 

be covered. There are insurance companies that would begin covering it immediately upon 

approval of the ACIP’s recommendation by the CDC director. He encouraged insurance 

colleagues to simply adopt that policy because it is in the best interest of patients and 

communities. 

Dr. Lee invited Dr. Grubb from America’s Health Insurance Plans (AHIP) to comment on this, 

recognizing that there is heterogeneity by health plan. 

From a state health department point of view, Ms. Bahta highlighted that bundling as has been 

done with hepatitis B may be a challenge going forward with only 10% of hospitals enrolled in 

the VFC program. It would be a major onboarding project to get state programs enrolled in the 

17 
 

 

 

 

 

 

 

 

 

 

 

VFC program. There also would be major challenges in practically implementing screening for 

eligibility. 

Dr. Daley expressed appreciation for the additional thought and care the WG put into including 

AI/AN populations in terms of second season dosage. Given the data that were presented on 4 

to 10 times the hospitalization rate during the second season, the argument is compelling. 

However, he wondered about the aspects of acceptability and feasibility whether there are any 

data to speak to the ability to implement that as a strategy. 

Dr. Jones indicated that while they do not have any specific data points, they have been in 

discussions with colleagues from the Indian Health Service (IHS) and CDC’s Office of Tribal 

Affairs and Strategic Alliances (OTASA) that works with the agency’s tribal partners and are 

continuing to receive feedback. These clinical considerations are being proposed and a VFC 

vote was planned during this meeting, but there are always opportunities to receive more 

feedback. 

Dr. Clark (IHS) reported that the IHS is in the process of evaluating the logistical implications of 

this recommendation for the IHS system of care, including federal, tribal, and urban programs. 

This is a high priority given the increased risk to the IHS’s patient population. 

Dr. Poehling emphasized that as Dr. Peacock mentioned in her presentation, careful thought 

must be given to the potential for an RSV vaccine recommendation for pregnant persons. This 

would be the first time that a vaccine given to a pregnant person would make a modification 

necessary in the vaccines that person’s child receives. This has major implications for IISs and 

in terms of avoiding record scatter and duplication of efforts. 

Dr. Lee pointed out that this is a new era with regard to thinking about prevention more broadly. 

In terms of innovation, this is an important step forward for prevention activities. However, 

implementation does take time and there are a lot of complexities with regard to this type of 

product. This is one of the first products the ACIP is considering in this way. Everyone must 

work together to consider how to set up implementation in systems across various settings. 

While this is going to be difficult in the short-term, this product will open up many more 

opportunities and will have major benefits in the long-term. Recognizing that the numbers would 

be small, she asked whether there are any data on immunocompromised populations to 

understand whether at 150 days, the level of immunity is durable. 

Dr. Jones indicated that the company had a small safety trial in an immunocompromised 

population and called upon Sanofi Vaccines to comment further. 

Dr. Christian Felter, Sanofi, reported that the immunocompromised study is ongoing. While 

there are no additional data at this point, the pharmacokinetics of nirsevimab is consistent 

across populations. Significant differences have not been observed in any populations. It is 

known that the duration of protection lasts at least 50 days and there are signals that it may last 

longer than that. 

Ms. Rebecca Coyle (AIRA) pointed out that Dr. Peaccock did a fabulous job of outlining many of 

the challenges for IISs. About 80% of the data come from EHRs and pharmacy systems, which 

is a very heterogeneous group of systems. She cautioned that there will be challenges with 

EHRs in terms of how quickly EHRs can adopt this and enter it into their systems to be able to 

send it to an IIS. 

18 
 

 

 

 

 

 

 

 

 

 

 

Proposed Clinical Consideration Updates for Nirsevimab 

Jefferson Jones, MD, MPH, FAAP, CDR, USPHS (CDC/NCIRD Co-lead, Maternal/Pediatric

RSV WG) reviewed proposed clinical consideration updates for nirsevimab. For the timing of 

nirsevimab, providers should target administration in the first week of life for infants born shortly 

before the start of the RSV season for infants <8 months of age and shortly before the start of 

the RSV season for children 8─19 months of age who are at increased risk of severe RSV 

disease. While the optimal timing for nirsevimab administration is shortly before the season, it 

may be given at any time during the RSV season for age-eligible infants and children who have 

not yet received a dose. Based on pre-pandemic patterns, this means nirsevimab could be 

administered in most of the continental US from October through the end of March. 

Because the timing of the onset, peak, and decline of RSV activity may vary by jurisdiction, 

providers can adjust administration schedules based on local epidemiology. For infants born 

shortly before or during the RSV season, nirsevimab should be administered within 1 week of 

birth. Administration can be during the birth hospitalization or in the outpatient setting. Infants 

with prolonged birth hospitalizations due to prematurity or other causes should receive 

nirsevimab shortly before or promptly after discharge. Tropical climates may have seasonality 

that differs from most of the continental US or that is unpredictable. This may include Southern 

Florida, Hawaii, Guam, Puerto Rico, the US Virgin Islands (USVI), and the US-affiliated Pacific 

Islands. In Alaska, RSV seasonality is less predictable, and the duration of RSV seasons is 

often longer than the national average. Providers in these jurisdictions should consult state, 

local, or territorial guidance on the timing of nirsevimab administration. 

In accordance with CDC's general best practices for immunizations, simultaneous 

administration of nirsevimab with age-appropriate vaccines is recommended. In clinical trials, 

when nirsevimab was given concomitantly with routine childhood vaccines, the safety and 

reactogenicity profile of the co-administered regimen was similar to the childhood vaccines 

given alone.23 When co-administered, nirsevimab is not expected to interfere with the immune 

response to other childhood immunizations.24 

Children 8–19 months of age are recommended to receive nirsevimab when entering their 

second RSV season because of increased risk of severe disease. This includes children with 

CLD of prematurity who required medical support (chronic corticosteroid therapy, diuretic 

therapy, or supplemental oxygen) any time during the 6-month period before the start of the 

second RSV season; children with severe immunocompromise; children with cystic fibrosis with 

manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in 

the first year of life or abnormalities on chest imaging that persist when stable) or weight-forlength <10th percentile; and AI/AN children. 

Nirsevimab is recommended for infants <8 months of age born during or entering their first RSV 

season, including those recommended to received palivizumab by the AAP.

25 Nirsevimab is 

recommended for children 8─19 months of age with increased risk of severe RSV disease and 

entering their second RSV season, including those recommended to receive palivizumab by 

23 https://www.accessdata.fda.gov/spl/data/2f08fa60-f674-432d-801b-1f9514bd9b39/2f08fa60-f674-432d-801b-1f9514bd9b39.xml 24 Espocito Front Immunol. 2021 Aug 11;12:708939 25 American Academy of Pediatrics. Committee on Infectious Diseases [Respiratory Syncytial Virus.] In: Kimberlin DW, Barnett ED, 

Lynfield R, Sawyer MH, eds. Red Book: 2021 Report of the Committee on Infectious Diseases. Itasca, IL: American Academy of 

Pediatrics, 2021. 

19 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AAP. Per the FDA label, children who have received nirsevimab should not receive palivizumab 

for the same RSV season.26 

In terms of precautions and contraindications, providers administering nirsevimab should follow 

ACIP’s general practice guidelines for immunization. Nirsevimab should not be administered to 

persons with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a 

product component. As mentioned in an earlier presentation, AEs after administration of 

nirsevimab without co-administration with any vaccine can be reported to MedWatch online at 

www.fda.gov/medwatch or by phone at 1-800-FDA-1088. AEs or suspected AEs events 

following co-administration of nirsevimab with any vaccine should be reported to the VAERS 

and additional reporting of the same AE to MedWatch is not needed. 

WG Considerations / Proposed Recommendations 

Jefferson Jones, MD, MPH, FAAP, CDR, USPHS (CDC/NCIRD Co-lead, Maternal/Pediatric

RSV WG) summarized WG considerations and presented the proposed recommendations. In 

terms of safety monitoring for nirsevimab, FDA will monitor safety reports submitted by patients, 

providers, and the manufacturer to the FDA Adverse Event Reporting System (FAERS) and 

VAERS. FDA will monitor other data sources, including the scientific literature, the applicant’s 

periodic safety reports, ongoing clinical studies, and potential other sources (e.g., medical billing 

and EHRs). CDC will monitor reports submitted to VAERS that involve simultaneous 

administration of nirsevimab with childhood vaccines and also will monitor the safety of 

nirsevimab in the Vaccine Safety Datalink (VSD). CDC will leverage existing vaccine 

effectiveness platforms. The NVSN is an active surveillance system for acute respiratory 

infection (ARI) at 7 pediatric medical centers that can assess effectiveness against outpatient 

and ED visits and hospitalizations. This platform can capture nirsevimab receipt through parent 

interviews, medical record reviews at the primary care provider and birth hospital, and through 

state IISs. Virtual SARS-CoV-2, Influenza, or other Respiratory Viruses Network (VISION) is a 

multi-site EHR-based network that can assess effectiveness against ED and urgent care visits, 

hospitalization, and critical illness. Nirsevimab effectiveness analyses will be limited to 

integrated healthcare system sites that will have more complete capture of nirsevimab receipt 

through IIS linkage and claims data. CDC will monitor nirsevimab effectiveness throughout the 

season, but end-of-season estimates likely will be the most accurate. The power to estimate 

effectiveness depends on nirsevimab uptake and RSV incidence. 

RSV genomic surveillance also will be important. Mutations resulting in nirsevimab resistance 

have been rarely reported.27 Sanofi and AstraZeneca are sponsoring INFORM-RSV, a global 

genomic surveillance study in children less than 5 years, to monitor evolution of RSV strains, Fprotein antigenic sites, and their relationships with clinical features of RSV disease.28 CDC is 

planning genomic surveillance of pediatric and adult RSV specimens, including whole genomic 

surveillance. This surveillance will monitor for changes in the F-protein that might result in 

nirsevimab resistance. 

For the indication for infants <8 months of age born during or entering the RSV season, the WG 

found that nirsevimab is safe and effective in reducing the risk of RSV disease, including 

hospitalization due to RSV. The WG shared the concerns as outlined in the presentation by Dr. 

Peacock on implementation considerations. The WG felt that the use of nirsevimab would be a 

reasonable and efficient allocation of resources, but many WG members prefer a lower cost per 

26 https://www.accessdata.fda.gov/spl/data/2f08fa60-f674-432d-801b-1f9514bd9b39/2f08fa60-f674-432d-801b-1f9514bd9b39.xml 27 Ahani et al. Nat Comm 2023 14:4347; and Wilkins et al. Lancet Infect Dis 2023; 23: 856–66 28 Tabor 2020 Dec 17;59(1):e01828-20 

20 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

dose. The WG felt that there were limited efficacy and safety data for the indication for children 

8─19 months of who had increased risk of severe RSV disease and were entering their second 

RSV season. Additionally, there were limited data on the burden of severe disease in the 

second RSV season for children with chronic conditions. Therefore, the WG supported the 

recommendation of nirsevimab being given to children 8─19 months of age entering their 

second RSV season for those who are recommended for palivizumab by the AAP in their 

second RSV season and for AI/AN children as described in clinical considerations. The 

following is the proposed ACIP voting language: 

 Infants aged <8 months born during or entering their first RSV season are recommended 

to receive one dose of nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5 kg)

 Children aged 8–19 months who are at increased risk of severe RSV disease and 

entering their second RSV season are recommended to receive one dose of nirsevimab 

(200 mg) 

Discussion Points 

Referring to Slide 5, Dr. Loehr requested clarification that nirsevimab will not interfere with 

measles, mumps, and rubella (MMR) and varicella vaccines. In general, there are 

considerations for immunoglobulins and live vaccines. In addition, he asked for clarification 

about when to start nirsevimab. 

Dr. Jones replied that the WG had a presentation and discussion on this. The data are fairly 

limited on nirsevimab being co-administered with vaccines and immunogenicity. Per discussions 

with expert input from CDC immunologists, the risk appears to be low. Per the FDA label and 

CDC’s general best practices for immunization, the WG felt it appropriate to recommend coadministration of nirsevimab for age-appropriate vaccines. 

Dr. Natalie Thornburg emphasized that there are not a lot of data on co-administration of 

monoclonal antibody prophylaxis with childhood immunization, given that they are not yet widely 

used. There are some data for infants who have received palivizumab, with no indication that 

they interfere with vaccine responses. Most of the data that are available for co-administration of 

vaccines or inhibition of vaccines deal with live-attenuated vaccines. Obviously, this product is 

not a vaccine. It is a passive immunization product for which the mechanisms of inhibitions are 

not relevant. 

In terms of when to start nirsevimab, Dr. Jones reiterated that the trials showed an efficacy of 

150 days and that there were some data suggesting that efficacy may last longer than 150 days. 

It is important to try to time administration between October through March, which is shortly 

before the RSV season. 

Dr. Poehling requested input from FDA or Dr. Shimabukuro about how they would collaborate 

with the FAERS and VAERS systems in terms of ensuring that everything is captured and there 

is a complete picture. 

Dr. Shimabukuro responded that first and foremost, CDC works closely with FDA to monitor 

vaccine safety. For nirsevimab, CDC has worked closely with the Center for Drug Evaluation 

and Research (CDER), the Center for Biologics and Research (CBER), and NCIRD to develop 

a comprehensive monitoring approach. As mentioned, the home for possible AEs involving 

21 
 

 

 

 

 

 

 

 

 

 

 

nirsevimab will be the FDA’s FAERS system. Reports involving nirsevimab and other vaccines 

will be sent to VAERS. There is a process for addressing mis-routed reports. 

Dr. Poehling stressed that the cost per dose was weighing heavily on her. While she understood 

that these have been expensive studies and the company’s process needs to compensate for 

that work, she remained concerned about equity. Hospitals will have 1 week to administer this 

and there will be a cost differential for a baby born in July versus one born in October. 

Therefore, it seemed prudent to have private practices administer it versus the hospital. Also 

exacerbating this issue is the rural-urban differential in that locations in rural America would not 

have access to this. 

Dr. Sanchez emphasized that if nothing else was learned from COVID-19, it was that no one 

knows when the RSV seasons will start this year. Continued monitoring of local epidemiology 

will help to understand when the optimal time will be to start administering nirsevimab. In terms 

of implementation issues, this is a new medication that will be given to every infant <8 months of 

age. However, the benefit will be huge. The main issue for him is whether they will be able to 

get a supply for the coming season. Those who have been administering palivizumab really 

want nirsevimab. While there will be issues of implementation, he does not think they will be 

insurmountable. 

Dr. Talbot expressed concern about nirsevimab being referred to interchangeably as a drug and 

therapeutic even though ACIP is treating it as a vaccine. For the purpose of monitoring, 

considerable effort needs to be made to term this one way to prevent some of the complications 

that will occur. 

Dr. Daley noted that he had received some detailed questions from colleagues, such as whether 

it would be considered an administration error if a child who is 8.5 months old and is not in a 

high-risk group presents in December during a bad RSV season and receives nirsevimab. He 

also stressed the importance of communication to providers about what to say when parents 

ask whether nirsevimab is a vaccine. He feels like those conversations are going to come up 

thousands of times, and it would help providers to be able to answer this question in a 

transparent, honest, and succinct way. 

Dr. Jones indicated that the current recommendation is that nirsevimab is recommended for 

children less than 8 months of age. Having high-risk conditions is an exception. Children 8–19 

months who are at increased risk of severe RSV disease and entering their second RSV season 

are recommended to receive one 200 mg dose of nirsevimab. CDC is working on education and 

other materials to help providers and webinars and updated websites are planned for the near 

future. 

Based on the available evidence, Ms. McNally requested more information about whether there 

is any reason to believe that there would be harm to an infant if there was maternal vaccination 

and nirsevimab was given to the infant. In addition, she asked whether a Vaccine Information 

Statement (VIS) sheet would be provided to parents of infants receiving nirsevimab and what 

the adjudication mechanism would be for claims of potential injury from nirsevimab. 

Dr. Jones noted that questions referring to maternal vaccine are generally deferred pending 

FDA licensure of a maternal vaccine. Maternal antibody from infection is certainly present in 

infants, and nirsevimab was likely given to infants born to mothers who were infected recently or 

during pregnancy. The consensus is that there is not thought to be any risk from that. 

22 
 

 

 

 

 

 

 

 

 

 

Dr. Peacock indicated that there would be something similar to VIS sheets. Because nirsevimab 

is not a vaccine, the sheet will be called something else but will look similar. 

Dr. Grimes from the Health Resources and Services Administration (HRSA) indicated that for 

vaccines, the criteria for coverage is typically for routinely administered vaccines and 

adjudication is through the national Vaccine Injury Compensation Program (VICP). That is when 

a vaccine has been recommended by CDC for routine administration to children or pregnant 

women, subject to an excise tax by federal law, and added to the Vaccine Injury Table by the 

Secretary of HHS. The Vaccine Act that governs the VICP does not define “vaccine.” Of those 3 

criteria are met, there is potential route for coverage within the VICP. The VICP and VFC 

programs are separate. Inclusion in the VFC would not trigger inclusion in the VICP or vice 

versa. 

Dr. Lee praised the work that CDC is doing with AHIP, but expressed concern about the 

financing of prevention. While nirsevimab is a fantastic product that has not been available 

previously and that has many benefits in terms of the durability of protection compared to other 

antibody products that have been used previously for high-risk children, there are challenges in 

the ambulatory setting. Pediatricians, family practice doctors, and birthing hospitals essentially 

have been asked to pay upfront for the cost of products, including vaccines, and then hope for 

adequate reimbursement. Pediatricians and family practitioners in small practices will be 

bearing the brunt the upfront cost and potentially losing money to be able to deliver these 

preventive interventions. In terms of thinking about more innovative strategies for prevention, 

she put out a general plea for reconsideration of where the risk will occur. The high cost is a 

burden and disincentive for getting people to do the right thing. Dr. Lee emphasized the critical 

importance of aligning incentives and securing the ability to ensure adequate reimbursement, 

even at-cost reimbursement. 

Dr. Grubb (AHIP) stressed that while activities would depend upon what the ACIP recommends, 

compliance issues would be very similar to compliance issues for any other vaccine. She noted 

that other members of AHIP had joined the meeting, and they would take the input back to 

AHIP. This is going to involve a multi-layered response because there are many questions with 

regard to issues, such as coding. AHIP looks forward to working with CDC and ACIP on these 

issues. 

Dr. Kotton stressed that because nirsevimab is passive immunization, there could be issues 

entering administration into the immunization record and other places. For instance, it was 

difficult to get Evusheld into the immunization records in Epic. 

Dr. Jones replied that CDC is aware of this issue and continues to work with national and 

internal partners to address it. 

Dr. Poehling said that while she liked the voting language that was presented and recognized 

that it was time-limited, ACIP was in a difficult position because FDA was currently reviewing a 

maternal vaccine. The way she interpreted the language was that if the maternal vaccine is 

subsequently approved, both nirsevimab and the maternal vaccine would be given. She 

stressed that she was not ready to make that decision during this meeting and requested input 

on the WG’s thoughts about how they thought the ACIP should address this. For example, 

would ACIP have to meet again to vote on maternal vaccine. 

Dr. Jones reiterated that the WG would revisit the recommendation at such time that a maternal 

vaccine is licensed by FDA. 

23 
 

 

 

 

 

 

 

 

 

 

 

Dr. Lee confirmed that the ACIP would have to convene again to vote on a maternal RSV 

vaccine and discuss any implications related to the use of nirsevimab at that time. 

Dr. Fryhofer (AMA) said that speaking as a practicing physician, she applauded the WG’s 

recommendation to include giving a dose of nirsevimab to AI/AN children in their second RSV 

season. Based on the presentations, the rate of RSV hospitalization for these children is 4 to 10 

times that of the general population. It also is known that the maternal mortality rates for their 

mothers are over twice as high as rates for white women. ACIP and practicing physicians often 

hear about VAERS, but are not as familiar with FAERS. She was relieved to hear that CDC and 

FDA work so closely together to make sure that any reported concerns will be made available 

to the appropriate agency. In terms of CPT coding, she attended a meeting earlier in the year as 

AMA Board Chair of the AMA CPT Advisory Committee. The nuances discussed throughout the 

day in the ACIP meeting between vaccines and passive immunizations like nirsevimab have 

been anticipated and the issues are already being discussed. And as pointed out in Dr. 

Peacock's presentation, the issue about it not being eligible for standalone counseling is an 

important one that she will share with the AMA Advisory Committee. 

Dr. Whitley-Williams (NMA) applauded the WG and presenters for their careful considerations 

and deliberations. She noted that she just returned from the national meeting of the National 

Medical Association (NMA), which is comprised predominantly of African-American physicians. 

The presentations during that meeting included a talk on RSV vaccines and another on 

nirsevimab, which were well-received. In attendance were pediatricians, physicians, 

academicians, and inner city and rural providers. Concerns were raised about how nirsevimab 

would be recorded and that registries may not be available in the rural areas. She urged that 

any communications emphasize the importance of the first of nirsevimab being given in the 

hospital prior to discharge, particularly in rural areas where nirsevimab may not be included as 

part of the armamentarium of medications. Also important is clear communication that this is a 

biologic not a vaccine. 

Dr. Loehr said he was looking forward to 2 years from now when this was all in the past. This is 

a spectacular advancement that is going to help families and offices and keep children out of 

the hospital that will be covered by insurance 2 years from now and all implementation activities 

will be in place. While there will be growing pains, he emphasized that they should not lose sight 

of how important this advancement is. With regard to the vote language in front of the ACIP, he 

favored the first proposal completely. He was wrestling with the second proposal, given that it 

would be a very expensive proposal recommendation with a lot of extrapolations. However, he 

thought it would promote equity. While he had not decided yet how he would vote, he wanted to 

express his hesitation about the second proposal. 

In terms of the second proposal, Dr. Long pointed out that the groups who are part of the AAP 

recommendations are already receiving palivizumab, which would be much more expensive 

than nirsevimab. The only expansion of the group would be to include AI/AN children who are at 

6 to 10 times higher risk for severe disease and hospitalization than the general population. The 

WG thinks that this would be a very small group of children of about 1% of the population of 

children 8─19 months. These children already are costing a lot of money because of 

palivizumab and there are not sufficient data to say that the indication for passive protection 

should be removed for those who are already receiving palivizumab. 

24 
 

 

 

 

 

 

 

 

 

 

 

 

Dr. Jones added that the second indication is expected to be cost-saving for children who 

currently are recommended by AAP to receive palivizumab. Another consideration for the AI/AN 

Children is that there are many geographic areas where children who get severe RSV require 

emergency air transport to receive appropriate medical care, which was another consideration 

of the WG. 

Ms. Howell indicated that she was representing the Association of Immunization Managers 

(AIM), which is a membership association comprised of the 64 federally-funded state, territorial, 

and city health agencies that administer immunization programs at the local level that administer 

the VFC locally and oversee the implementation of IISs. As a group, AIM has been anticipating 

nirsevimab availability for a while and has been looking forward to planning assumptions and 

collaborating with CDC and others to overcome the challenges regarding implementation. She 

pointed out that there is a fee cap in the VFC for the administration of vaccines that are included 

in the VFC, and asked whether the fee cap also would apply to nirsevimab even though it is 

being classified as a drug and not a vaccine. 

Ms. Hance, Centers for Medicare and Medicaid Services (CMS) indicated that because 

nirsevimab would be administered under the VFC program, the vaccine administration fee 

ceiling would have to apply. She explained that the ceiling is the amount a state Medicaid 

agency can reimburse a provider, and that a state Medicaid agency has the flexibility to set the 

rate up to that ceiling. 

Dr. Poehling made a motion to approve the ACIP voting language as presented, which Dr. 

Sanchez seconded. 

Dr. Hopkins (NFID) commented that the National Foundation for Infectious Diseases (NFID) has 

posted a number of educational materials on RSV and that following the actions of the ACIP on 

nirsevimab, they will continue to provide educational materials supporting providers, patients, 

and families going forward. 

Dr. Lee asked whether there is a minimum interval for children who might be eligible in their 

second RSV season, such as a child who is born at the end of season one but who a 

practitioner wants to protect through season two. 

Dr. Jones responded that there is no minimal interval. Based on pre-pandemic seasonality, 

high-risk infants born at the end of March would be a little over 6 months before the beginning of 

October when the second RSV season would start. 

In terms of equity, Dr. Daley pointed out that there is a risk of making health equity worse or 

increasing inequity with a new product that has so many challenges. While there appears to be 

a great opportunity to improve health equity with nirsevimab, it is extremely important to 

consider those who are coming from a more disadvantaged situation, such as living in a rural 

area of the country. Regarding implementation, he asked Dr. Peacock to speak to how the ACIP 

could help with some of the challenges she raised in her presentation and whether there were 

any other issues the committee should discuss during this public session. 

Dr. O’Leary, Pediatric Infectious Diseases Society (PIDS), noted that many of the PIDS 

concerns were addressed during this session and expressed excitement about the potential to 

prevent many hospitalizations. PIDS is working internally and with its partners in the federal, 

state, and local governments to focus on the issue of equity as this product is rolled out. AAP 

25 
 

 

 

 

 

 

 

 

 

 

 

also is working on potential implementation issues and barriers, including communications and 

crafting implementation guidance for its partners. 

Dr. Peacock expressed appreciation for all of the comments and the recognition that 

implementation is going to be challenging. It is important to remember that this is a new and 

very exciting product, and this is going to be a transitionary season. She captured a list of 

important issues raised related to insurance, coding, equity, et cetera. The VFC is an example 

of a program that has successfully addressed health equity issues over the last 30 years. It 

provides access not only to children who are on Medicaid, but also children who are underinsured or uninsured and AI/AN children. All of these considerations are very important, and it 

will be necessary to work hand-in-hand with vaccine providers, physicians, nurses, health 

departments, and others who are involved to ensure that as much access as possible is 

provided during the initial implementation and moving forward. It appears that this season may 

be different from the last couple of years. As a reminder, hepatitis B began with a different 

recommendation and eventually became given regularly in hospitals. In the near-term with the 

rollout, more nirsevimab may be given in the outpatient setting. It is important to take a step 

back and appreciate that this is an amazing time in terms of RSV. 

Vaccines for Children Resolution 

Jeannie Santoli, MD, MPH (CDC/NCIRD) explained that the purpose of this resolution was to 

add the monoclonal antibody preparation nirsevimab for infants to prevent RSV disease to the 

VFC program. The first eligible group is infants <8 months of age born during or entering their 

first RSV season. The second eligible group is children 8─19 months of age as noted in Table 1 

who are at increased risk of severe RSV disease and entering their second RSV season. Table 

1 describes children at increased risk of severe RSV disease and Table 2 explains the 

recommended immunization schedule and dosage intervals. 

For recommended dosage, readers are referred to the product package insert. For 

contraindications and precautions, readers are referred to the package inserts available at: 

https://www.accessdata.fda.gov/spl/data/2f08fa60-f674-432d-801b-1f9514bd9b39/2f08fa60-

f674-432d-801b-1f9514bd9b39.xml. 

The following standard statement regarding updates based on published documents also is 

included in the resolution: 

[If an ACIP recommendation or notice regarding RSV prevention is published within 6 months 

following this resolution, the relevant language above (except in the eligible groups sections) 

will be replaced with the language in the recommendation and incorporated by reference to the 

publication URL.] 

Discussion Points 

Referring to Slide 10, Dr. Daley suggested working on the wording of the timing. While he 

thought they knew what was intended, it could be clearer. 

Dr. Kotton’s requested further clarification of what was meant by “children with severe 

immunocompromised” meant and asked whether further definitions would be provided. 

Dr. Jones replied that initially, specific examples were included. However, there was concern 

that if the recommendations were overly prescriptive, it may miss others who would qualify. 

26 
 

 

 

Dr. Long added that those caring for immunocompromised patients are the best ones to make 

these decisions. 

Dr. Kotton advocated for clinicians to have some type of guidance, but then leave a more open 

clause like, “as well as other children deemed to be severely immunocompromised by their care 

team.” She stressed that clinicians have been clamoring for fairly specific guidance from the 

CDC regarding immunization recommendations, as it can be hard to fully understand what the 

recommendations mean. From her perspective, further guidance could be useful. Outstanding 

guidance was provided by the CDC during the COVID-19 pandemic regarding the definition of 

who is moderately to severely immunocompromised, which she thought changed the field for 

the better. She suggested including additional input. 

Dr. Lee agreed that it would be extremely beneficial to have at least some “big picture” guidance 

on that in the Clinical Considerations. 

Ms. Goode (APhA) requested clarification on the second vote language about whether someone 

receiving a dose in the first season before 8 months of age should receive a second dose in the 

second season. 

Dr. Jones clarified the recommendations were independent, with the second pertaining to 

children at increased risk. The FDA label specifies that those who received palivizumab in their 

first RSV season can receive nirsevimab in their second RSV season. There are no 

disqualifications for the second RSV season related to what did or did not happen in the first 

RSV season. 

Dr. Long stressed that this was somewhat confusing, but the WG wanted to be sure not to use 

the words “second dose” so that the recommendation would not be misinterpreted as 2 doses 

being needed. 

Dr. Poehling made a motion to accept the VFC Resolution as proposed with the clarification in 

the table as noted during the discussion. Dr. Sanchez seconded the motion. 

PUBLIC COMMENTS 

Overview 

The floor was opened for public comment on August 3, 2023 at 2:00 PM ET. Given that many 

more individuals registered to make oral public comments than could be accommodated during 

this meeting, selection was made randomly via a lottery. Dr. Lee provided a gentle reminder that 

the ACIP appreciates diverse viewpoints that are respectful in nature and issue-focused rather 

than comments directed at individuals. The comments made during the meeting are included in 

this document. Members of the public also were invited to submit written public comments to 

ACIP through the Federal eRulemaking Portal under Docket Number ID CDC-2023-0063. Visit 

http://www.regulations.gov for access to the docket or to submit comments or read background 

documents and comments received. 

27 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Public Comments 

Ms. Susan Hepworth

National Coalition for Infant Health 

Thank you so much and thank you for this opportunity to make these comments on behalf of the 

National Coalition for Infant Health. We are made up of more than 200 professional, clinical, 

community health, and family support organizations—all with the focus of improving the lives of 

all infants and their families. I just first want to thank the committee for prioritizing this review of 

this immunization. I know the committee has undertaken so much over the last few years 

throughout the public health emergency, so we appreciate your prioritizing this review among 

what I know are many other competing priorities. We are incredibly pleased and want to thank 

you for voting in favor of the VFC resolution. This is a huge step toward ensuring equitable 

access and reducing the burden of RSV. I would like to make one additional comment and that 

is the coalition’s strong support of equitable and timely access to this prevention in hospitals, 

birthing centers, and provider settings. I know this was something that was included in a recent 

letter from the American Academy of Pediatrics as well. With strong, clear guidance and 

recommendations from the CDC for babies to receive this new immunization prior to being 

discharged from the hospital, all babies will have the opportunity to be immunized and protected 

before they even leave the hospital setting. I think this measure is what is truly going to ensure 

equitable access for all infants, and it is also going to ensure a major reduction in the burden of 

RSV. As has been spoken about in prior meetings, the burden of RSV is multifaceted. It is not 

just medical, but it is emotional, and it is financial for families as well. With clear guidance, I 

think we will be able to ensure that we will not have further existing health disparities. I just want 

to thank you all for what you do to protect and improve the health and safety of our nation’s 

infants and children. Thank you for the opportunity to give these comments. 

Laura Burns 

Transplant Recipients and Immunocompromised Patient Advocacy Group 

My name is Laura Burns and I represent TRAIPAG, Transplant Recipient and 

Immunocompromised Patient Advocacy Group. Being immunocompromised and vulnerable to 

disease, we have a deep sense of kinship with the infants so vulnerable to RSV. We urge you to 

protect these children and to recommend nirsevimab for RSV prevention. It has been approved 

by the FDA and, with your vote, it will be covered by insurance as required under the ACA. But 

insurance only covers about 50% of babies, so ACIP members, we intrigue you to resolve that 

nirsevimab be added to the Vaccines for Children program so that all babies can be protected. 

Nirsevimab would be the first passive immunization product to be included in the CDC 

Immunization Schedule, but we think that there is little distinction to be made between active 

and passive immunization. The key is what prevents disease. Indeed, Congress sees it this 

way, too. Under 26 USC 4132, the term "vaccine" means “any substance designed to be 

administered to a human being for the prevention of one or more diseases.” Nirsevimab fits that 

bill. Looking to the future, TRAIPAG anticipates you will be faced with a similar decision greatly 

affecting our health. Our group represents people of all ages, from people with blood cancers, 

autoimmune diseases, organ transplants. Since most of us have low or no response to 

vaccines, in all fairness, we need alternative preventions. A number of monoclonal antibodies, 

for example, are in development for the prevention of COVID: Invivyd, AstraZeneca 

SUPERNOVA 3152. Also, antivirals. If one or more of them “passes muster” with the FDA, we 

hope that ACP will show the same deliberative care for vulnerable adults that you’re showing 

today for infants and that you recommend passive immunizations when they work. This in turn 

would guarantee that insurance will cover it. Likewise, as there is no vaccines for adults 

28 
 

 

 

 

 

 

 

 

 

 

 

 

program yet, the CDC should include whichever preventions work, active or passive, in both the 

bridge access and the VFC programs. This will ensure equity and that everyone, child or adult, 

will have affordable access to life-saving immunizations at least through 2024. Thinking back, I 

want you to know that Evusheld was a godsend for us and for our families and friends who got 

to be with us. So was REGEN-COV for post-exposure prophylaxis (PEP) before that. 

Unfortunately, not all of us had access. With commercialization, equitable access is an even 

larger issue, but one you should tackle. If you will indulge me for just a few seconds, Dr. Lee, we 

were truly heartened by your comments today earlier about how groundbreaking this step is and 

how it opens up new avenues for preventing disease in the immunocompromised. While it may 

be initially complicated, it will be well worth working through those issues. Thank you and thank 

you all very, very much for all you do. We urge you to vote “yes” on all of these. 

Claire Hannan 

Executive Director 

Association of Immunization Managers 

Good afternoon and thank you for the opportunity to comment on the potential implementation 

of the RSV monoclonal antibody, nirsevimab. We are excited that this groundbreaking 

opportunity to protect infants from RSV. I’m Claire Hannan, Executive Director of the 

Association of Immunization Managers, or AIM. AIM is a membership association whose 

members direct the immunization programs in the 64 federally-funded state, territorial, and local 

health agencies. In partnerships with CDC, these jurisdictions administer the Vaccines for 

Children, or VFC, program and work to assure protection of the population through vaccination. 

Last week, we polled jurisdictions about their ability to incorporate nirsevimab into their 

programs, including the Vaccines for Children program, and you’ve discussed this mightily today 

already. Among respondents, 52% report that their immunization information systems can 

document nirsevimab, 22% cannot, and 26% report that it is unknown. Reported challenges 

include lack of funding for the IIS vendor and lack of information on coding. 68% report that their 

IIS can be used for ordering nirsevimab in the VFC program, 14% that their IIS cannot be used, 

and 18% report unknown. Additional time and funding were the cited barriers to incorporate into 

IIS ordering applications. Additional challenges cited in the poll include the lack of participation 

of birthing hospitals in the VFC program, concern about data exchange between electronic 

health records and IIS, and lack of adequate time and guidance to prepare. The poll 

demonstrates that time and funding are needed to incorporate this new product into VFC and 

other existing programs. However, the jurisdictions have not received guidance or assumptions 

to prepare for potential recommendation, such as the information needed to incorporate 

nirsevimab into VFC ordering applications and packaging and storage information. Jurisdictions 

have not been able to hold discussions with CDC or IIS vendors to address challenges with 

coding and tracking. What is most concerning to the incorporation of this potentially life-saving 

product into existing childhood programs is that jurisdictions have suffered an average loss of 

20% in funding for their IIS due to rescission of COVID funds. ACIP is holding this special 

meeting in August in order to vote on this life-saving product in time for the upcoming flu and 

RSV season. However, jurisdictions responsible for implementation have not been involved in 

the planning discussions. The lack of federal communication to and coordination with jurisdiction 

immunization programs continues to impact the ability of immunization program managers to roll 

out new and important products with maximum impact. They cannot be expected to deploy 

critical products such as nirsevimab without the information and time needed to execute these 

programs. We urge our federal partners to find ways to work with jurisdictions and provide 

planning assumptions earlier in the process and to share critical information as it becomes 

available. Thank you so much for the opportunity to comment today. 

29 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

VOTES 

Dr. Grace Lee (ACIP Chair) pointed out that while the votes for the recommendations were 

moved and seconded together, the ACIP would vote on each proposed recommendation and 

the VFC Resolution separately: 

Vote #1 RSV Maternal/Pediatric Recommendations 

Infants aged <8 months born during or entering their first RSV season are recommended to 

receive one dose of nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5 kg).

Vote #2 RSV Maternal/Pediatric Recommendations 

Children aged 8–19 months who are at increased risk of severe RSV disease and entering their 

second RSV season are recommended to receive one dose of nirsevimab (200 mg). 

Vote #3: VFC Resolution: RSV Maternal/Pediatric 

Approve the Vaccines for Children (VFC) Resolution for nirsevimab. 

Motion/Vote #1 RSV Maternal/Pediatric 

Dr. Poehling made a motion to amend the proposed Vote #1 recommendation stating, “Infants 

aged <8 months born during or entering their first RSV season are recommended to receive one 

dose of nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5 kg). Dr. Sanchez 

seconded the motion. No COIs were declared. The motion carried with 10 affirmative votes, 0 

negative votes, and 0 abstentions. The disposition of the vote was as follows: 

10 Favored: Bahta, Chen, Daley, Lee, Loehr, Long, McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

Motion/Vote #2 RSV Maternal/Pediatric 

Dr. Poehling made a motion to amend the proposed Vote #2 recommendation stating, “Children 

aged 8–19 months who are at increased risk of severe RSV disease and entering their second 

RSV season are recommended to receive one dose of nirsevimab (200 mg).” Dr. Sanchez 

seconded the motion. No COIs were declared. The motion carried with 10 affirmative votes, 0 

negative votes, and 0 abstentions. The disposition of the vote was as follows: 

10 Favored: Bahta, Chen, Daley, Lee, Loehr, Long, McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

30 
 

 

 

 

 

 

 

 

 

 

 

 

Motion/Vote #3: VFC Resolution RSV Maternal/Pediatric 

Dr. Poehling made a motion to amend the proposed Vote #3 recommendation for the VFC 

Resolution stating, “Approve the Vaccines for Children (VFC) Resolution for nirsevimab.” Dr. 

Sanchez seconded the motion. No COIs were declared. The motion carried with 11 affirmative 

votes, 0 negative votes, and 0 abstentions. The disposition of the vote was as follows: 

11 Favored: Bahta, Chen, Daley, Kotton, Lee, Loehr, Long, McNally, Poehling, Sanchez, 

Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

Discussion Points 

Dr. Talbot expressed her excitement about nirsevimab, which she thinks will be incredible and 

life-changing. She emphasized that as had been pointed out, there are a lot of logistics to work 

out. 

Dr. Long recognized the remarkable, committed work of the WG who engaged in many 

discussions about all of the issues raised during this meeting. She felt that the WG thoroughly 

dealt with what they could based on the available data and their best assumptions for the 

unknowns. This is a milestone in that it is the first antibody protection against the remarkably 

high remaining burden of disease in children, so parents should be relieved that they will not 

have to be concerned about the likelihood that their children could be hospitalized with RSV 

disease. As with every breakthrough, there is the feeling of responsibility and the burden that 

this is the first time an antibody will be administered universally. All of the safeguards are in 

place and there have been no signals of AEs within the small trials that were conducted. The 

WG also does not believe there is any biologic plausibility that there will be any interference with 

any immunization or live virus vaccine. The WG was extraordinarily disappointed with the pricesetting of the manufacturer and wanted to assure the ACIP and public that should a maternal 

vaccine be licensed, the WG will address the cost issue of that product as well. 

Dr. Sanchez agreed that this is great and exciting news for a product that everyone has been 

eagerly awaiting. There has been considerable experience with palivizumab, which has to be 

given monthly and has high costs as well. Practitioners have been waiting to be able to give 

safe and effective protection to every baby and this is fantastic news. While this is just the first 

step, it is an extremely important step in the right direction for the major public health problem of 

RSV. 

Dr. Lee echoed all of the comments regarding what an amazing milestone this is, emphasized 

the importance of continuing to monitor ongoing effectiveness and safety, and pointed out the 

importance of the ACIP hearing updated presentations in the future to demonstrate that there is 

follow-up on these specific areas and the impact of implementation on equity. While she 

recognized that implementation is not necessarily the purview of the ACIP, how nirsevimab use 

gets implemented and its impact on equity may impact how the ACIP rethinks recommendations 

in the future. She expressed gratitude to the CDC team, the FDA team, the WG, and everyone 

else who has done a phenomenal job steering this through and getting this product to market. 

31 
 

 

 

 

 

 

 

Dr. Daley thank CDC colleagues for their work on getting the ACIP to the point at which they 

could vote on a VFC Resolution for nirsevimab. He suspected that it was not an easy 

undertaking. He emphasized that the folks within CDC are tremendously devoted to public 

health and have been doing everything they could to make this happen. He recalled that during 

the February 2023 ACIP meeting, this looked somewhat more daunting, yet now they had voted 

on the recommendations and the VFC Resolution. He expressed gratitude to those who saw 

this as so important to include this in the VFC Program in order to provide the maximum public 

health benefit for RSV. 

Dr. Romero added his thanks to the members of the ACIP and the WG for all of the deliberation 

and work they all put into this effort. This marked a historic event and he thought they would be 

able to look back in a short period of time and see what a major impact this vote has had on the 

health and well-being of children in the US. He said he thought this would mark one of the major 

accomplishments of the ACIP, for which he congratulated the committee. 

32 
 

CERTIFICATION 

Upon reviewing the foregoing version of the August 3, 2023 ACIP meeting minutes, Dr. Grace 

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

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

(MASO) of CDC. 

33 
 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP MEMBERSHIP 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 

34 
 

 

 

 

 

 

 

 

 

 

 

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 

35 
 

 

 

 

 

 

 

 

 

 

 

 

EX OFFICIO MEMBERS 

Centers for Medicare and Medicaid Services (CMS)

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification Centers 

for Medicare and Medicaid Services 

Baltimore, MD 

Food and Drug Administration (FDA)

FINK, Doran, MD, PhD 

Deputy Director, Clinical, Division of Vaccines and Related Products Applications 

Office of Vaccines Research and Review 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD 

Health Resources and Services Administration (HRSA)

RUBIN, Mary, MD 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

Indian Health Service (IHS)

CLARK, Matthew, MD, FAAP, FACP 

Physician 

Chair, IHS National Pharmacy & Therapeutics Committee 

Durango, CO 

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

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

National Institutes of Health (NIH)

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) 

Bethesda, MD 

36 
 

 

 

 

 

 

 

 

 

 

 

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP)

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, University of 

Michigan Medical School 

Medical Director, Dominos Farms Family Medicine 

Ann Arbor, MI 

American Academy of Pediatrics (AAP)

MALDONADO, Yvonne, MD 

Senior Associate Dean for Faculty Development and Diversity 

Professor of Pediatrics and Health Research and Policy 

Chief, Division of Pediatric Infectious Diseases 

Stanford University School of Medicine 

Stanford, CA 

American Academy of Pediatrics (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) 

MCMULLEN, Sharon, RN, MPH, FACHA 

Assistant Vice President of Student & Campus Life for Health and Wellbeing Cornell Health 

Ithaca, NY 

American College of Nurse Midwives (ACNM)

HAYES, Carol E., CNM, MN, MPH 

Lead Clinician 

Clinical Quality Compliance and Management 

Planned Parenthood Southeast Atlanta, GA 

37 
 

 

 

 

 

 

 

 

 

 

American College of Nurse Midwives (ACNM) (alternate) 

MEHARRY, Pamela M., PHD, CNM 

Midwifery Educator, Human Resources for Health 

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

American College of Obstetricians and 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)

GLUCKMAN, Robert A, MD, MACP 

Chief Medical Officer, Providence Health Plans 

Beaverton, OR 

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA 

Washington, DC 

American Medical Association (AMA)

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine Emory 

University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA)

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

Professor, Nursing Faculty 

Chatham University, School of Health Sciences 

Pittsburgh, PA 

38 
 

 

 

 

 

 

 

American Osteopathic Association (AOA) 

GROGG, Stanley E, DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA)

HOGUE, Michael D., PharmD, FAPhA, FNAP 

Dean and Professor of Loma Linda University School of Pharmacy 

Director, Center for Interprofessional Education & Practice 

Loma Linda, CA 

Association of Immunization Managers (AIM)

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health 

Bismarck, ND 

Association for Prevention Teaching and Research (APTR) 

ZIMMERMAN, Richard, MD, MPH 

Professor 

University of Pittsburgh School of Medicine 

Department of Family Medicine and Clinical Epidemiology 

Pittsburgh, PA 

Association of State and Territorial Health Officials (ASTHO)

SHAH, Nirav D, MD, JD 

Director 

Maine Center for Disease Control and Prevention 

Augusta, ME 

Biotechnology Industry Organization (BIO)

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

Council of State and Territorial Epidemiologists (CSTE)

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

Council of State and Territorial Epidemiologists (CSTE) (alternate) 

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

39 
 

 

 

 

 

 

 

Canadian National Advisory Committee on Immunization (NACI)

DEEKS, Shelley, MD, MHSc, FRCPC, FAFPHM 

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

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

Chair, National Advisory Committee on Immunization 

Halifax, Nova Scotia 

Infectious Diseases Society of America (IDSA)

BAKER, Carol J., MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine 

Houston, TX 

International Society for Travel Medicine (ISTM)

BARNETT, Elizabeth D, MD 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 

National Foundation for Infectious Diseases (NFID)

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

40 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

National Foundation for Infectious Diseases (NFID) (alternate) 

DALTON, Marla, PE, CAE 

Executive Director & CEO 

National Foundation for Infectious Diseases (NFID) 

Bethesda, MD 

National Medical Association (NMA) 

WHITLEY-WILLIAMS, Patricia, MD Professor and Chair 

University of Medicine and Dentistry of New Jersey Robert Wood 

Johnson Medical School 

New Brunswick, NJ 

Pediatric Infectious Diseases Society (PIDS) 

O’LEARY, Sean, MD, MPH 

Associate Professor of Pediatrics 

Pediatric Infectious Diseases 

General Academic Pediatrics 

Children’s Hospital Colorado 

University of Colorado School of Medicine 

Pediatric Infectious Diseases Society (PIDS) (alternate) 

SAWYER, Mark H, MD 

Professor of Clinical Pediatrics 

University of California, San Diego School of Medicine 

San Diego, CA 

Pharmaceutical Research and Manufacturers of America (PhRMA)

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 

Society for Healthcare Epidemiology of America (SHEA)

DREES, Marci, MD, MS 

Chief Infection Prevention Officer & Hospital Epidemiologist 

ChristianaCare 

Wilmington, DE 

Associate Professor of Medicine 

Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA 

41 
42 

 

 

ACRONYMS USED IN THIS DOCUMENT

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics 

ACA Affordable Care Act 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices 

ACOG American College of Obstetricians and Gynecologists 

ACP American College of Physicians 

AE Adverse Event 

AHIP America’s Health Insurance Plans 

AI/AN American Indian/Alaskan Native 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AMA American Medical Association 

AMDAC Antimicrobial Drug Advisory Committee 

AOA American Osteopathic Association 

APhA American Pharmacists Association 

AR Adverse Reaction 

ARI Acute Respiratory Illness 

ASTHO Association of State and Territorial Health Officers 

AUC Area Under the Curve 

BLA Biologics License Application 

CDC Centers for Disease Control and Prevention 

CDER Center for Drug Evaluation and Research 

CDS Clinical Decision Support 

CHD Chronic Heart Disease 

CLD Chronic Lung Disease 

CMS Center for Medicare and Medicaid Services 

COI Conflict of Interest 

CONUS Continental United States 

CPT Current Procedural Terminology 

CSTE Council of State and Territorial Epidemiologists 

DFO Designated Federal Official 

DoD Department of Defense 

DSMB Data Safety Monitoring Board 

ED Emergency Department 

EHRs Electronic Health Records 

EMR Electronic Medical Record 

ET Eastern Time 

EtR Evidence to Recommendation 

FAERS FDA Adverse Event Reporting System 

FDA Food and Drug Administration 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

HARMONIE Hospitalized RSV Monoclonal Antibody Prevention 

HCP Healthcare Personnel / Providers 

HHS (Department of) Health and Human Services 
 

 

 

 

 

HRSA Health Resources and Services Administration 

ICU Intensive Care Unit 

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IIS Immunization Information System 

IM Intramuscular 

IT Information Technology 

IVIG Intravenous Immunoglobulin Therapy 

LRTD Lower Respiratory Tract Disease 

LRTI Lower Respiratory Tract Illness 

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

MASO Management Analysis and Services Office 

MELODY Prevention of Medically Attended Lower Respiratory Tract Infection Due to 

Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants 

mAbs Monoclonal Antibodies 

MMWR Morbidity and Mortality Weekly Report 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada 

NAPNAP National Association of Pediatric Nurse Practitioners 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

NCIRD National Center for Immunization and Respiratory Diseases 

NFID National Foundation for Infectious Diseases 

NIAID National Institute of Allergy and Infectious Diseases 

NIH National Institutes of Health 

NMA National Medical Association 

NMD Neuromuscular Disease 

NVAC National Vaccine Advisory Committee 

NVPO National Vaccine Program Office 

NVSN New Vaccine Surveillance Network 

OIDP Office of Infectious Disease and HIV/AIDS Policy 

OTASA Office of Tribal Affairs and Strategic Alliances 

PCP Primary Care Provider/Practitioner 

PCR Polymerase Chain Reaction 

PEP Post-Exposure Prophylaxis 

PHAC Public Health Agency Canada 

PICO Population, Intervention, Comparison, Outcomes 

PIDS Pediatric Infectious Disease Society 

QALY Quality-Adjusted Life Year 

RCT Randomized Controlled Trial 

SAB Spontaneous Abortion 

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

SHEA Society for Healthcare Epidemiology of America 

SME Subject Matter Expert 

UK United Kingdom 

US United States 

USG United States Government 

USVI US Virgin Islands 

VAERS Vaccine Adverse Event Reporting System 

43 
VE Vaccine Efficacy 

VE Vaccine Effectiveness 

VFC Vaccines For Children 

VICP National Vaccine Injury Compensation Program 

VIS Vaccine Information Statement 

VISION Virtual SARS-CoV-2, Influenza, or Other Respiratory Viruses Network 

VSD Vaccine Safety Datalink 

WG Work Group 

44