Pneumococcal 05 Kobayashi 508

Nationa  l Center  for  Immunizatio  n &  Respirator  y Diseases

  Evidence to Recommendations Framework (Preliminary):
Use of 20-valent Pneumococcal Conjugate Vaccine in U.S. Children
Miwako Kobayashi, MD, MPH
Pneumococcal Vaccines Work Group
Advisory Committee on Immunization Practices
February 22, 2023

          Evidence to Recommendations (EtR) framework
EtR Domain Question
Public Health Problem • Is the problem of public health importance?
Benefits and Harms • How substantial are the desirable anticipated effects?
• How substantial are the undesirable anticipated effects?
• Do the desirable effects outweigh the undesirable effects?
• What is the overall certainty of this evidence for the critical outcomes?
Values • Does the target population feel the desirable effects are large relative
to the undesirable effects?
• Is there important variability in how patients value the outcomes?
Acceptability • Is the intervention acceptable to key stakeholders?
Feasibility • Is the intervention feasible to implement?
Resource Use • Is the intervention a reasonable and efficient allocation of resources?
Equity • What would be the impact of the intervention on health equity?2

          Values •Does the target population feel the desirable effects are large relative
to the undesirable effects?
•Is there important variability in how patients value the outcomes?
Acceptability •Is the intervention acceptable to key stakeholders?
Feasibility •Is the intervention feasible to implement?
Resource Use •Is the intervention a reasonable and efficient allocation of resources?Evidence to Recommendations (EtR) framework
EtR Domain Question
Public Health Problem • Is the problem of public health importance?
Benefits and Harms • How substantial are the desirable anticipated effects?
• How substantial are the undesirable anticipated effects?
• Do the desirable effects outweigh the undesirable effects?
• What is the overall certainty of this evidence for the critical outcomes?
Equity • What would be the impact of the intervention on health equity?3

       All children under age 2 years have the same
pneumococcal vaccine recommendations
• 3 primary series and a booster=“3+1” schedule
PCV PCV PCV PCV 2months 4months 12–15 months 6months
Primary Series Booster
Either PCV13 or PCV15 can be used for U.S. children.
4

      Primary Series Booster
Currently, either PCV13 or PCV15 can be used for U.S. children.All children under age 2 years have the same
pneumococcal vaccine recommendations
• 3 primary series and a booster=“3+1” schedule
PCV PCV PCV PCV 2months 4months 12–15 months 6months
Should PCV20 be recommended as an option for
pneumococcal conjugate vaccination according to currently recommended dosing and schedules, for U.S. children aged <2 years?
5

 Children age ≥2 years with certain underlying conditions
recommended to receive PPSV23 in addition
PPSV23 Recommended
PCV doses Recommended
PCV doses Healthy
children
MC, CSF leak,
cochlear
implant
≥8 weeks
Recommended
PCV doses PPSV23 PPSV23 Immuno-
ompromised
≥8 weeks ≥5 years
MC aged 6–18
years PPSV23

  C
c
C
Note: Excludes catch-up vaccination schedules.
CMC=chronic medical conditions, including chronic heart disease, chronic lung disease, diabetes mellitus
CSF=cerebrospinal fluid
Use of 15-Valent Pneumococcal Conjugate Vaccine Among U.S. Children: Updated Recommendations of the Advisory Committee on Immunization
Practices — United States, 2022 | MMWR (cdc.gov) 6

Should PCV20 without PPSV23 be recommended
as an option for pneumococcal vaccination for U.S. children aged 2–18 years with underlying
medical conditions that increase the risk of pneumococcal disease?
7

         PICO
Question Should PCV20 be recommended as an option for pneumococcal vaccination
for U.S. children?
Population U.S. children aged 2–18 years with All U.S. children aged <2 years underlying medical conditions
Intervention PCV20 according to currently
recommended dosing and PCV20 (without PPSV23) schedules
Comparison PCV13 or PCV15 according to currently recommended dosing and schedules
Outcomes VT-IPD, VT- pneumonia, VT- AOM, VT- pneumococcal deaths, serious adverse events following vaccination
8 VT: vaccine-type, IPD: invasive pneumococcal disease, AOM: acute otitis media
EtR Dom  ain: P  ublic Healt  h Problem

     Summary of pneumococcal disease epidemiology
in children
• Use of PCVs (PCV7, PCV13) significantly decreased the incidence of
pneumococcal disease in U.S. children.
• Outpatient ARIs caused by pneumococcus, such as AOM, sinusitis, and pneumonia, are common causes of outpatient visits and antibiotic prescribing.
• Risk of disease remains high in children with underlying conditions that increase the risk of pneumococcal disease.
• In 2018–2019, the proportion of IPD caused by vaccine serotypes was:
• PCV20, non-PCV13: ~30% of IPD
• PCV15, non-PCV13: ~15% of IPD
Gierke. February 2023 ACIP meeting presentation
King. February 2023 ACIP meeting presentation 10

 Public Health Problem
Is pneumococcal disease of public health importance in U.S.
children?
□
□□□□□ N o
 Probably  no
 Probably  yes
 Yes  Varies  Don’t  know
11

  Public Health Problem
Is pneumococcal disease of public health importance in U.S.
children?
□
□ □ □ □ □ N o
Probably  no
Probably  yes
Yes Varies Don’t  know • Variability in Work Group members’
interpretations for children aged <2 years due to significant reductions in pneumococcal disease.
• Most agreed that pneumococcal disease continues to be of public health importance due to the remaining disease burden.
12
EtR Dom  ain: Benefits   and Harms

 Outcomes (Benefits)
Outcome Importance Description
VT- IPD Critical Studies assessing PCV20 against these
VT- non-bacteremic
pneumococcal pneumonia clinical outcomes are currently not Critical
available
VT- acute otitis media  PCV20 immunogenicity studies for Critical GRADE
VT- pneumococcal deaths Critical  PCV13/PPSV23 clinical outcome studies for background
AOM=acute otitis media, IPD=invasive pneumococcal disease, VT=vaccine-type 14

       Outcomes (Harms)
Outcome Importance Description
Serious adverse events Critical Safety data for PCV20 are available
15
Background

            PCV13 effectiveness (3+1) in children, VT-IPD
Study Population Dosin  g schedule
(Ye  ar o  f
introduction) Me thod Outcome Vaccine (95% CI)
Effectiveness
Savulescu,
2022 Children 2m – 59m; Spidnet
(12 European 2+1 or 3+1
(variable) Indirect cohort 3 + 1 doses, ≥12 months 89.7% (adjusted*) (82, 94)
sites, 2012 -
2018
V an
de  r
Linden,
2016* Childre  n <2
years;  German  y
(GNRCS) 3+1  (Decembe  r
2009) Indirec  t
cohort PCV13-type;  post-booster 91% (61,  99)
Weinberger,
2016 Childre  n 2.5  –
56m;  German  y
(ESPED) 3+1  (Decembe  r
2009) Indirec  t
cohort PCV13-type  +6C;  ≥2  dose  before  12
months  or one  dose  on/afte  r 12
months 85%  (adjusted) (64,  94)
Dominguez,
2017 Childre  n 7m  -
59m;  Sp  ain
(Catalonia) 3+1  (public,  Ju ly
2016) Matche  d
case-
control PCV13-type;  7-59m;  ≥2  doses  before
12 months  o r one  dose  afte  r 12
months 78.9% (52.8,  90.5)
Moore  ,
2016 Childre  n 2-
59m;  US 3+1  (2010) Matche  d
case-
control PCV13-type;  ≥1  dose 86.0%
(unadjusted) (75.5,  92.3)
* Adjusted by site, age, year of notification and at least one underlying disease
Post-licensure vaccine effectiveness studies have shown that PCV13 is highly effective against
VT-IPD 17

 PCV13 effectiveness, VT-pneumococcal pneumonia
Study Population Dosing schedule
(Year of introduction) Method Outcome VE (95% CI)
Zhang, 2021 Children  born
D
ecember  2016
– Novembe  r
2018,  China 3+1  (2017) Indirect  cohort;
VT-CAP  defined  as  hospita  l
discharge  diagnosis code  of
pneumonia  +  deep  uppe  r
respiratory  aspirate  with
PCV13  serotypes.  VT-CAP;  ≥3
doses 62.1  %
(adjusted) (26.3  , 80.5)
Lew
nard,
2021* Children 4 to 59
months, Israel 2+1 (2010) Nested  c ase-control  ;
Used: • PCV-conferred  protection
against VT  pneumococca  l
carriage
• Protection  agains  t
progression  fr  om carriage  t o
pneumonia CAP attributed
t o PCV13  , 12-
59  months;  2+1
doses 77
.0 %
(adjusted) (-16.0, 100.0)
CAP=community acquired pneumonia
*funded by Pfizer Limited data on PCV13 effectiveness against VT-pneumococcal
pneumonia in children. PCV13 likely protective. 18

    PCV13 effectiveness, VT-AOM
Study Population Dosing schedule
(Year of introduction) Method Outcome VE (95% CI)
Pichichero,
2018* Children  ≤ 36
month  s, United
States 3+1  (2010) Prospective
longitudina  l
cohor  t (PCV1  3 v
PCV  7 period) PCV13-non-PCV7 serotype  s;
PCV1  3 full  primar  y serie  s
(regardle  ss of  booste  r statu  s)
vs. PCV7  f or middle-ear  flui  d
samples  a t onse  t of  AOM
Serotype  3; PCV13  ful l
primary  serie  s (regardle  ss of
booste  r status)  vs. PCV  7 f  or
middle-ear  fluid  samples  a t
onse  t of  AOM 86  %
(adjusted)
5 %
(adjusted) (61 , 94)
(–181  , 68)
Oc
hoa-
Gondar, 2015 ≤14 years; Spain
(Catalonia region) 3+1 (2016, publicly available) Indirect cohort PCV13-type; ≥1 dose 62% (unadjusted) (-141, 95)
Dagan, 2021* Children 5 to 35 months, Israel 2+1 (2010) Nested case-control PCV13-type; ≥2 doses vs. 0 doses 77.4% (adjusted) (35.3, 92.1)
Serotype 3; ≥2 doses vs. 0 doses 89.0% (adjusted) (23.9, 98.4)
Limited data on PCV13 effectiveness against VT-pneumococcal AOM in
children. PCV13 likely protective. *funded by Pfizer 19

     PPSV23 effectiveness, VT-IPD (Pre-PCV U.S. data)
Pre-PCV era data showed that PPSV23 is protective against VT-IPD among
children with underlying medical conditions.
    Fiore et al. EID 1999 20

      PPSV23 effectiveness, non-invasive pneumococcal
disease
• No study on PPSV23 VE against AOM identified in a recent systematic review1
• Two randomized-controlled trials (RCTs)2,3 evaluated PCV7-PPSV23 in series
against AOM
• No efficacy in the PCV7-PPSV23 groups
1. Marra et al. Value Health 2022
2. Veenhoven et al. Lancet 2003
3. Van Kempen et al. Int J Pediatr Otorhinolaryngol 2006 21
GRADE:  PCV2  0 us  e  in children

       Evidence retrieval: PCV20 use in children
Clinicaltrials.gov
N=12
4 studie  s include  d fo  r GRADE
Phase  I I tria  l (published),  N=1
Phase  II I trial  s (unpublished),  N=3 Pubmed
N=62
PCV20  routi  ne use
(N=3)
Immunogenicity  (N=2)
Safety  (N=3) PCV20   use i  n childre  n
wit  h underlyi  ng
conditions
(N=1)
Immunogenicity  (N=1)
Safety  (N=1) Unpublishe  d data  from
pharmaceutica  l
company
N=3
23 Search terms used are provided in supplementary slides

    Summary of evidence:
Benefits, children <2 years
• Informed by 2 randomized controlled trials (Phase II and III)1,2
• Healthy children randomized to either PCV13 or PCV20
• PCVs given using 3+1 schedule
• Summary of findings
•PCV20 had numerically lower immune responses* vs. PCV13 for most of the
13 shared serotypes
•Post dose 3 :
•PCV20 did not meet noninferiority criteria vs. PCV13 for some serotypes
•Post dose 4 :
•PCV20 noninferior to PCV13 for all 13 shared serotypes
•PCV20 noninferior to PCV13** for all 7 additional serotypes
*measured as IgG GMCs and GMRs
**Compared with the serotype with lowest immune response among PCV13 serotypes except for serotype 3
1. Senders et al. PIDJ 2021
2. Pfizer unpublished data from B7471011 24

          Summary of evidence:
Harms, children <2 years
• Serious adverse events (SAEs) across 3 studies (dose 1 through 6 months after
dose 4):
• PCV20: 4.5% (n=1,567) vs PCV13: 3.7% (n=1,376)
• None were considered to be vaccine-related
1. Senders et al. PIDJ 2021
2. Pfizer B7471011, unpublished data
3. Pfizer B7471013, unpublished data, limited to US and Puerto Rico sites 25

         Should PCV20 be recommended as an option for pneumococcal conjugate
vaccination according to currently recommended dosing and schedules, for U.S. children aged <2 years?
Type Outcome Importance Included in
evidence profile Certainty for
healthy individuals
VT- IPD Critical Yes Moderate
Benefits VT-pneumonia Critical Yes Moderate
VT- AOM Critical Yes Moderate
VT- pneumococcal
deaths Critical Yes Moderate
Harms SAEs following
vaccination Critical Yes Moderate
AOM=acute otitis media, IPD=invasive pneumococcal disease, SAE=serious adverse events, VT=vaccine-type 26

   Benefits and Harms
How substantial are the desirable anticipated effects?
 Routine PCV20 use for children aged <2 years
□ Minimal
 Small
 Moderate  Large  Varies  Don’t  know □□□□□• PCV20 provides the broadest
serotype coverage among available PCVs.
• Unknown how substantial the protection conferred from PCV20 will be based on available data.
27

        Benefits and Harms
How substantial are the undesirable anticipated effects?
 Routine PCV20 use for children aged <2 years
□ Minimal
Small
Moderate Large Varies Don’t  know □ □ □ □ □
28

   Benefits and Harms
Do the desirable effects outweigh the undesirable effects?
 Routine PCV20 use for children aged <2 years
□ Favor  s intervention*
 Favor  s current  recommendation
 Favor  s both
 Favor  s neither
 Varies
 Don’t  know □
□□□□
*Intervention: PCV20 use
Comparison: PCV13 or PCV15 use 29

      Benefits and Harms
Do the desirable effects outweigh the undesirable effects?
• Routine PCV20 use for children aged <2 years
Favors Intervention (PCV20):
• PCV20 is expected to prevent more disease compared with current PCVs (PCV13, PCV15)
Favors Both (PCV20 or PCV13/PCV15): • Clinical implications of the lower immunogenicity PCV20 compared with PCV13
unknown
• Clinical implications of improved immunogenicity of PCV15 against serotype 3*
unknown
*Banniettis. February 24, 2022 ACIP meeting presentation 30

    Summary of evidence:
Benefits, children 2–18 years with underlying conditions
• No studies conducted among children with underlying medical conditions
• Informed by 1 non-randomized trial (Phase III), no comparator
• Healthy children aged 15 months to 17 years received a dose of PCV20
• Children aged <5 years received ≥3 doses of PCV13
• Summary of findings
•PCV20 was immunogenic* for all 20 vaccine serotypes 1 month after
vaccination vs. pre-vaccination.
*Measured as IgG GMCs and GMFR and OPA GMFRs
Pfizer unpublished data from B7471014 31

    Summary of evidence:
Harms, children 2–18 years with underlying conditions
• Serious adverse events (SAEs) :
• PCV20: 0.6% (n=831)
• None were considered to be vaccine-related
Pfizer unpublished data from B7471014 32

         Should PCV20 without PPSV23 be recommended as an option for pneumococcal
vaccination for U.S. children aged 2–18 years with underlying medical conditions that increase the risk of pneumococcal disease?
Type Outcome Importance Included in evidence
profile Certainty for children
with underlying
conditions
VT-IPD Critical Yes Very Low
Benefits VT-pneumonia Critical Yes Very Low
VT-AOM Critical Yes Very Low
VT-pneumococcal
deaths Critical Yes Very Low
Harms SAEs following
vaccination Critical Yes Very Low
AOM=acute otitis media, IPD=invasive pneumococcal disease, SAE=serious adverse events, VT=vaccine-type 33

     Benefits and Harms
How substantial are the desirable anticipated effects?
 PCV20 use for children aged 2–18 years with underlying medical conditions
□ Minimal
 Small
 Moderate  Large  Varies  Don’t  know □□□□□• PCV20 provides the broadest
serotype coverage among available PCVs.
• Unknown how substantial the protection conferred from PCV20 will be based on available data.
• No data from this population.
34

            Benefits and Harms
How substantial are the undesirable anticipated effects?
 PCV20 use for children aged 2–18 years with underlying medical conditions
□ Minimal
 Small
 Moderate  Large  Varies  Don’t  know □□□□□
35

      Benefits and Harms
Do the desirable effects outweigh the undesirable effects?
 PCV20 use for children aged 2–18 years with underlying medical conditions
□
□
□ □ □ □ Favor  s intervention*
Favor  s current  recommendation
Favor  s both
Favor  s neither
Varies Don’t  know *Intervention: PCV20 use
Comparison: PPSV23 use after currently
recommended PCV (PCV13 or PCV15) doses
36

       Benefits and Harms
Do the desirable effects outweigh the undesirable effects?
 PCV20 use for children aged 2–18 years with underlying medical conditions
Favors Intervention (PCV20):
• PCV20 is expected to prevent more disease compared with current recommendations (PPSV23 after recommended PCV13/15 doses)
Favors Both (PCV20 or PPSV23 after recommended PCV13/PCV15 doses): • No data on PCV20 use in this population
• Clinical implications of improved immunogenicity of PCV15 against serotype 3*
unknown
*Banniettis. February 24, 2022 ACIP meeting presentation 37
EtR Dom  ain: Equity

    Compared with coverage among children with private
insurance only , children who were uninsured, and those
insured by Medicaid and other insurance was lower
≥3 PCV doses (%) ≥4 PCV doses (%)
Private insurance only (Ref)
(N=16,629) 96.2 90.0
Any Medicaid (N=10,200) 91.3* 78.8*
Other insurance (N=2,168) 91.1* 80.6*
Uninsured (N=608) 83.9* 62.3*
PCV=pneumococcal conjugate vaccine
*statistically significant difference compared with Ref.
Hill et al. MMWR 2023 39

    Nationally representative PPSV23 vaccine coverage
data among children with indications are limited
• Vaccine coverage among children with sickle cell anemia, Michigan Medicaid program1
• 4PCV + 1 PPSV23 at age 5 years: 64%
• 4PCV + 2 PPSV23 at age 10 years: 53%
• Self-administered survey of parents/guardians of children aged <18 years with
nephrotic syndrome2
• PPSV23 receipt: 43%
• Data from single-center quality improvement studies among children seen in specialty
care clinics reported 20–30% PPSV23 coverage at baseline3,4
1. Reeves et al. Pediatric Blood & Cancer, 2018
2. Tran et al. Frontiers in Pediatrics, 2021
3. Mirza et al. The Ochsner Journal, 2022 40 4. Harris et al. Pediatrics, 2022

41IPD incidence
rate difference
in children aged ≤17 years by census tract poverty,
ABCs 2010–2019
CDC ABCs, unpublished data All Serotypes PCV13 Serotypes PCV15/non-PCV13
PCV20/non-PCV13 PCV20/non-PCV15 Nonvaccine Serotypes

42IPD incidence
rate difference
in children aged ≤17
Nonvaccine Serotypes
years by census tract poverty,
ABCs 2010–2019
CDC ABCs, unpublished data PCV15/non-PCV13
PCV20/non-PCV13 PCV20/non-PCV15 For all serotypes and PCV13 serotypes, IPD incidence rate
difference between the highest and lowest census tract poverty categories decreased after PCV13 introduction. All Serotypes PCV13 Serotypes

43IPD incidence
rate difference
in children aged ≤17 years by census tract poverty,
ABCs 2010–2019
CDC ABCs, unpublished data All Serotypes PCV13 Serotypes PCV15/non-PCV13
PCV20/non-PCV13 PCV20/non-PCV15 Nonvaccine Serotypes Essentially no IPD incidence rate difference for the
PCV15, non-PCV13 serotypes.

44All Serotypes PCV13 Serotypes PCV15/non-PCV13
IPD incidence
rate difference
in children aged ≤17 years by census tract poverty,
ABCs 2010–2019
CDC ABCs, unpublished data PCV20/non-PCV13 PCV20/non-PCV15 Nonvaccine Serotypes • IPD incidence rate difference for the additional serotypes
contained in PCV20 remain
• Slightly larger incidence rate difference for non-vaccine serotypes

   Equity
What would be the impact of recommending PCV20 for U.S.
children on health equity?
□ Reduced
 Probably  reduced
 Probably  n o impact
 Probably  increased
 Increased
 Varie  s
 Don’t  kno  w □
□
□
□
□
□
45

  Equity
What would be the impact of recommending PCV20 for U.S.
children aged <2 years on health equity?
Probably reduced:
• New interventions are likely to be accessible to wealthy communities, first
VFC program mitigates inequities in access to recommended vaccines
Probably no impact: • Remaining disparities in vaccine-type disease seem to be minimal
Probably increased: • Post-PCV13 data showed that PCV13 reduced disparities in vaccine-type disease
VFC=Vaccines for Children

   Equity
What would be the impact of recommending PCV20 for U.S.
children aged 2–18 years with underlying medical conditions
on health equity?
Probably no impact:
• Risk-based recommendation is less likely to be equitable compared with routine
vaccine recommendations.
Probably increased:
• PCV20 use could simplify the pneumococcal vaccine recommendations and
improve vaccine coverage.

   Summary of Work Group Interpretation of the EtR Domains (Preliminary)
EtR Domains PCV20, <2 years (routine) PCV20, 2–18 years old
Public Health Problem Yes
Benefits and Harms
a. Benefits Moderate
b. Harms Minimal
c. Benefit>Harm? Favors intervention/Favors both (split)
d. Overall certainty:
effectiveness 2 (moderate) 4 (very low)
e. Overall certainty: safety 2 (moderate) 4 (very low)
Equity Probably increased (different opinions)
48

   Acknowledgements
• ACIP and the Pneumococcal Vaccines Work Group
• CDC contributors and consultants: Ryan Gierke, Jennifer Farrar, Kristin Andrejko,
Lindsay Zielinski, Emma Accorsi, Adam Cohen, Alison Albert, Noele Nelson, Pedro Moro, Elizabeth Velazquez, Marc Fischer, Katie Hamilton, Noelle Sobotka, Rebecca Morgan, Doug Campos-Outcalt
49
Supplementar  y Slides
GRADE  Summary  of Evidence
Search strategy: PCV20 use in children
No.
Database Strategy identified
Clinicaltrials.gov Inclusion: Relevant Phase 2, or 3 randomized controlled trials of PCV20
• Involved human subjects
• Reported primary data
• Included infants and children (age ≤18 years)
• Included data relevant to the efficacy or effectiveness or immunogenicity and safety
outcomes being measured
• Included data for the dosage and timing being recommended:
o 3+1 series for infants starting the vaccine series as currently recommended
o Catch-up vaccine schedule for older infants and children who did not start the 3+1 series
in time
o Use of PCV20 to complete the PCV13 series
o Use of PCV20 in series with PPSV23 in older children with underlying conditions in series
with PPSV23 Included  in
GRADE
12 3*
Pubmed
Medline “PCV20” or “20-valent pneumococcal conjugate vaccine” Included studies using the criteria listed above 62 1
Additional resources Unpublished and other relevant data by consulting with the vaccine manufacturer
2 3*

*Same trials. Unpublished data from these trials were obtained from pharmaceutical companies. 51

  Included Studies: Routine PCV20 Use in Children Aged <2 years
Author, year Study
design Intervention Country Age Total population N Intervention N comparison Outcomes Funding source
Phase II RCT 42–98
Senders, 2021 in healthy full-term
infants PCV20 @ 2, 4, 6,
and 12 months of age US days of age at
consent 460 232 228 Immuno-
genicity and safety Pfizer
B7471011 Phase III RCT
in healthy full-term
infants PCV20 @ 2, 4, 6,
and 12 – 15 months of age US, Puerto Rico 42–98
days of age at
consent 1998 1001 997 Immuno-
genicity and safety Pfizer
US, Puerto 42–98
B7471013 Phase III RCT in healthy infants PCV20 @ 2, 4, 6, and 12 – 15 months of age Rico,
Canada,
Chile, Argentin a, EU days of age at
consent 1511 1000 551 Safety Pfizer
52
RCT=Randomized Controlled Trial
Certainty assessment № of patients Results
Certainty Importance № of
studies Study
design Risk of
bias Inconsistency Indirectness Imprecision Other
considerations Intervention comparison Relative
(95% CI) Absolute
(95% CI)

  -Vaccine effectiveness
21 2 RCT Not
serious Not serious Seriousa Not serious Not serious 921-1022 910-989 • PCV20 had numerically lower
immune responses compared with PCV13 for most of the
13 shared serotypes.
• PCV20 did not meet
noninferiority criteria for some serotypes after dose 3.
• PCV20 noninferior to PCV13 for all 13 shared serotypes after dose 4.
• PCV20 noninferior to PCV13
b
for all 7 additional serotypes after dose 4. Moderate Critical GRADE Summary of Findings: Routine PCV20 use in Children Aged <2 Years

                    a. These are all immunogenicity studies and there are no correlates of protection for most outcomes.
b. Compared with serotype with lowest immune response among PCV13 serotypes except for serotype 3
References
1. Senders S, Klein NP, Lamberth E, Thompson A, Drozd J, Trammel J, Peng Y, Giardina PC, Jansen KU, Gruber WC, Scott DA, Watson W. Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States. Pediatr Infect Dis J. 2021 Oct
1;40(10):944-951. doi: 10.1097/INF.0000000000003277. 53 2.B7471011. A Phase 3, Randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in healthy infants
Certainty assessment № of patients Results
Certainty Importance № of
studies Study
design Risk of
bias Inconsistency Indirectness Imprecision Other
considerations Intervention Comparison Relative
(95% CI) Absolute
(95% CI)
Serious Adverse Events (SAEs) following vaccination

   -21 3 RCT Not Not serious Not serious Seriousa Not serious 4.5% 3.7% No vaccine-related
serious (n=1567) (n=1376) serious adverse events Moderate Critical
reported GRADE Summary of Findings: Routine PCV20 use in Children Aged <2 Years

                            a. No v
accine-related serious adverse events reported
References
1.Senders S, Klein NP, Lamberth E, Thompson A, Drozd J, Trammel J, Peng Y, Giardina PC, Jansen KU, Gruber WC, Scott DA, Watson W. Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States. Pediatr Infect Dis J. 2021 Oct 1;40(10):944-951. doi: 10.1097/INF.0000000000003277. 2.B7471011. A Phase 3, Randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in healthy infants 3.B7471013. A Phase 3, Randomized, double-blind trial to evaluate the safety of a 20-valent pneumococcal conjugate vaccine in healthy infants. Data limited to U.S. and Puerto Rico sites.
54
Included Study: PCV20 Use in Children Aged 2–18 Years with Underlying
Medical Conditions
Author, year
B7471014

 Study design Intervention Country Age Total
population N Intervention N comparison Outcomes
Funding
source
Single dose PCV20 @ 15m to <24m; 15m
previous
vaccination ≥3 to
<24m 209 209 N/A
Phase III doses of PCV13
Immuno-genicity and
safety Pfizer Clinical Trial
in healthy
children,
some previously Single dose PCV20 @ 2y to <5y; previous
vaccination ≥3
doses of PCV13 US 2y to <5y 216 216 N/A
vaccinated Single dose PCV20 @ 5y to <10y
Single dose PCV20
@ 10 to <18y 5y to <10y 201 201 N/A
55 10y to <18y 205 205 N/A
GRADE Summary of Findings: PCV20 Use in Children Aged 2–18 Years
with Underlying Medical Conditions
Certainty assessment № of patients Results
Certainty Importance № of
studies Study
design Risk of
bias Inconsistency Indirectness Imprecision Other
considerations Intervention comparison Relative
(95% CI) Absolute
(95% CI)
Vaccine effectiveness

     11 Non-RCT Very
Serious
a Not
applicable Very
Seriousb,c Not
serious Not serious 752-75 7 None IgG GMCs were higher 1-
month post-PCV20 dose compared to before vaccination for 13/13 shared serotypes and 7/7 additional serotypes, for all age groups
Very Low Critical

                a. Study design is an open label non-randomized controlled trial with no comparator group. Downgraded for lack of randomization, lack of blinding, and lack of a comparison group.
b. Study population did not include children with underlying conditions
c. This is an immunogenicity study and there are no correlates of protection for some critical outcomes considered
References
B7471014. Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age 56
GRADE Summary of Findings: PCV20 use in Children Aged 2–18
Years With Underlying Medical Conditions
Certainty assessment № of patients Results
Certainty Importance № of
studies Study design Risk of
bias Inconsistency Indirectness Imprecision Other
considerations PCV20 Intervention Relative
(95% CI) Absolute
(95% CI)
Serious Adverse Events (SAEs) following vaccination

   11 Non-
randomized
trial Serious
a Not
applicable Seriousb Seriousc Not serious 0.6%
(n=831) No vaccine-related
SAEs reported Very Low Critical

                a. Study design is an open label non-randomized controlled trial with no comparator group
b. Study population did not include children with underlying conditionsc. No vaccine-related serious adverse events reported; relative risk crossing 1
Reference
B7471014. Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
57

Summary: Nationa  l Center  for  Immunizatio  n &  Respirator  y Diseases                                Evidence to Recommendations Framework (Preliminary):  Use of 20-valent Pneumococcal Conjugate Vaccine in U.S. Children  Miwako Kobayashi, MD, MPH  Pneumococcal Vaccines Work Group  Advisory Committee on Immunization Practices  February 22, 2023                                                                                Evidence to Recommendations (EtR) framework …


01 RSV Mat Peds Long 508

Maternal/Pediatric Respiratory Syncytial Virus (RSV)
Work Group
Sarah S. Long, MD
Chair, Maternal/Pediatric RSV Work Group
ACIP Meeting
June 28, 2024National Center for Immunization and Respiratory Diseases

•RSV prevention in infants during their first RSV season (i.e., aged <8 months)
-To protect infants in their first season , either maternal RSV vaccination ( Abrysvo ,
Pfizer), or use of nirsevimab (Beyfortus , Sanofi and AstraZeneca) in the infant is
recommended to prevent RSV lower respiratory tract disease
-Administration of both products is not needed for most infants
•Children ages 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
nirsevimabTwo products are recommended to protect infants and
young children from RSV lower respiratory tract disease
https://www.cdc.gov/mmwr/volumes/72/wr/mm7234a4.htm
https://www.cdc.gov/mmwr/volumes/72/wr/mm7241e1.htm  2
Timing of RSV vaccine  and nirsevimab
Figure represents recommended timing of immunization product deployment for most of the continental U.S. In jurisdictions with
seasonality that differs from most of the continental United States (e.g., Alaska, jurisdictions with tropical climates), pro viders should
follow state, local, or territorial guidance on timing of administration
 Mother can get RSV vaccine
(Abrysvo) during pregnancy
Infant can get RSV antibody
(nirsevimab) after birth
•Maternal RSV vaccine
-For pregnant people at 32 –36 weeks’ gestation, vaccinate using seasonal administration
(meaning September –January in most of the United States)
•Nirsevimab1
-For infants <8 months of age, immunize shortly before season onset (e.g., October)
-Forinfants born during October –March , immunize within 1 week of birthTiming of administration of maternal Pfizer RSV vaccine (Abrysvo)
and nirsevimab (Beyfortus)
https://www.cdc.gov/mmwr/volumes/72/wr/mm7234a4.htm; https://www.cdc.gov/mmwr/volumes/72/wr/mm7241e1.htm
1In jurisdictions with seasonality that differs from most of the continental United States (e.g., Alaska, jurisdictions with t ropical climates), providers should follow state, local, or
territorial guidance on timing of administration
  3
•Multiple products introduced in the same season
created confusion among healthcare workers as to
which groups were eligible for which immunizations
•Rare reports of administration errors were received
by the Vaccine Adverse Events Reporting System
(VAERS)
-Reports of pregnant persons receiving Arexvy
(GSK’s vaccine for older adults)
-Reports of children receiving RSV vaccine instead
of monoclonal antibody products (e.g.,
nirsevimab )
-Wrong dose ( nirsevimab ) administered
•CDC made additional resources available and
increased education efforts with healthcare
providersVaccine administration errors reported in young
children and pregnant people
Information on Respiratory Syncytial Virus (RSV) Vaccine Administration
Errors in Young Children and Pregnant People
Administration of the GSK Respiratory Syncytial Virus Vaccine to Pregnant
Persons in Error - PubMed (nih.gov)
Incorrect Administration of Adult RSV Vaccines to Young Children - PubMed
(nih.gov)5

Work group members (external)
ACIP Members
Sarah Long (chair)
Oliver Brooks
Camille Kotton
Denise JamiesonConsultants
Cody Meissner (Dartmouth Geisel School of Medicine)
Helen Chu (University of Washington)
Natasha Halasa (Vanderbilt University)
Daniel Feikin  (World Health Organization)
Kevin Ault (Western Michigan University)
Pablo Sanchez (Nationwide Children’s Hospital)
Liaisons
James McAuley (IDSA)
Brenna L. Hughes (ACOG)
Nicole Chaisson  (AAFP)
Sean O’Leary (AAP)
Jennifer Schuster (PIDS)
Molly Howell (AIM)
Dana DeShon  (NAPNAP)GRADE/ EtRConsultants
Doug Campos -Outcalt
Rebecca MorganEx Officio Members
Lucia Lee (FDA -CBER)
Judy Beeler (FDA -CBER)
Yodit Belew (FDA -CDER)
Yugenia Hong -Nguyen (FDA -CDER)
Sonnie Kim (NIH -NIAID)
April Killikelly (Public Health Agency of Canada)
Winnie Siu (Public Health Agency of Canada)
Jessica Lee (CMS/CMCS)
T erry Dalle -T ezze (HRSA)
Matthew Clark (IHS)
6
Work group members (CDC)
Amber Winn
Chris Taylor
Tami Skoff
Angie Campbell
Michael Melgar
Amanda Payne
Noelle Molinari
Claire Midgley
Fiona Havers
Pragna  Patel
Amadea BrittonRuth Link -Gelles
Megan Wallace
Monica Godfrey
Karen Broder
Naomi T epper
Heidi Moline
Hannah Rosenblum
Derrell Powers
Raigan Wheeler
Sally Ezra
Manisha PatelCDC ACIP Staff
Melinda Wharton
Stephanie Thomas
Jessica MacNeilDemorah  Hayes
Elizabeth Greene
Monica Patton
Jarrett Gartin
Dennis Wang
Jordan Singleton
Trang Nguyen Wisard
Fatimah Dawood
John Su
Michael McNeilCDC
Katherine Fleming -Dutra (co -lead)
Jefferson Jones (co -lead)
Danielle Moulia
Meredith McMorrow
Mila Prill
Natalie Thornburg
Aron Hall
Ismael Ortega -Sanchez
Melissa Coughlin
Jamison Pike
Lauren RoperA. Patricia Wodi
Christine Olson
Anne Hause
Andrew Leidner
David Shay
Sarah Meyer
Kristen Folsom
Julianne Gee
Agustin Lopez
Lakshmi Panagiotakopoulos
7
•Implementation and uptake of nirsevimab  and maternal RSV vaccine — Dr.
Shannon Stokley (CDC/NCIRD)
•Maternal RSV vaccine safety surveillance — Dr. Pedro Moro (CDC/NCEZID)
•Summary of effectiveness of nirsevimab  in infants — Dr. Amanda Payne
(CDC/NCIRD)
•Work Group considerations — Dr. Jefferson Jones (CDC/NCIRD)Agenda
8
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position
of the U.S. Centers for Disease Control and Prevention.
Thank you

Summary: Maternal/Pediatric Respiratory Syncytial Virus (RSV)  Work Group Sarah S. Long, MD Chair, Maternal/Pediatric RSV Work Group ACIP Meeting June 28, 2024National Center for Immunization and Respiratory Diseases   •RSV prevention in infants during their first RSV season (i.e., aged <8 months) -To protect infants in their first season , either maternal RSV vaccination ( Abrysvo ,  Pfizer), or use of nirsevimab (Beyfortus , Sanofi and AstraZeneca) in the infant is  recommended to prevent RSV lower…


02 RSV Mat Peds Stokley 508

Implementation and Uptake of Nirsevimab and
Maternal Vaccine
Shannon Stokley, DrPH
Deputy Director for Science Implementation
Immunization Services Division
National Center for Immunizations and Respiratory Diseases (NCIRD)
June 2024National Center for Immunization and Respiratory Diseases

2023 -2024 Coverage for Nirsevimab and
Maternal Vaccination
Percent of pregnant persons ages 18 –49 years vaccinated with RSV vaccine
overall and by race and ethnicity, Vaccine Safety Datalink
•17.8% of pregnant persons vaccinated overall
•Vaccination coverage ranged from 10.3% among Black pregnant persons
to 24.8% among Asian pregnant persons
Data source: https://www.cdc.gov/vaccines/imz -managers/coverage/rsvvaxview/pregnant -persons -coverage -intent.html
Monthly nirsevimab  receipt and intent among women ages 18 –49 years who
have an infant <8 months, National Immunization Survey -Adult COVID
Module (NIS -ACM)
13.520.628.740.5 43.0 41.340.0 26.931.421.7 16.7 22.835.7 47.330.131.530.024.310.95.29.86.310.3 11.6
0102030405060708090100
Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24Percent
Data source: https://www.cdc.gov/vaccines/imz -managers/coverage/rsvvaxview/nirsevimab -coverage.html
•51.2% of infants are estimated to be protected from RSV by either receipt of nirsevimab  or maternal RSV
vaccination.
•Infants eligible for nirsevimab : 3,900,000
-Those 0 –7 months old during October 2023 –March 2024
-Born March 2023 –March 2024
-Assume 300,000 babies born each month
-43.0%  received nirsevimab  (from  February  NIS-ACM)
•Infants eligible for protection by maternal vaccination (a subset of infants eligible for nirsevimab ): 1,800,000
-Born October 2023 –March 2024
-Born to mot hers 32 -36 weeks' gestation and eligible for RSV vaccination September 2023 –January 2024
-17.8%  of mothers  received RSV vaccination (from VSD data through January 2024)
•Estimated number of infants who received nirsevimab  = .430*3,900,000 = 1,677,000
•Estimated number of infants protect by maternal RSV vaccination = .178*1,800,000 = 320,400
•Percent protected by either = 1,677,000 + 320,400 / 3,900,000 = 51.2%Proportion of infants protected from RSV by receipt of nirsevimab  or
maternal RSV vaccination
Data sources: https://www.cdc.gov/vaccines/imz -managers/coverage/rsvvaxview/nirsevimab -coverage.html , https://www.cdc.gov/vaccines/imz -
managers/coverage/rsvvaxview/pregnant -persons -coverage -intent.html , https://wonder.cdc.gov/
•IQVIA* data:
-Among women ages 18 -49 years in the U.S., during September 30, 2023, through April 20, 2024:
•A total of 223,466 projected RSV vaccine doses were administered
–96,611 (43%) in physician medical offices**. Using a sample of 2,866 office -based physicians,
vaccinations are projected to the ~700,000 office -based physicians in the U.S.
–126,865 (57%) in U.S. retail pharmacies. Using a sample of 40,469 pharmacies , vaccinations
are projected to  the ~57,000 pharmacies  in the U.S .
•NIS-ACM:
-National survey data
-Among 1,483 pregnant women <50 years surveyed between December 2023 -March 2024,
80(5.4%) had already received the RSV vaccine
•15% in a pharmacy or drug store
•85% in a medical office (doctor’s office/clinic/hospital/health dept)Location of Maternal RSV Vaccine Administration
*Data sources: Immunization Services Division’s custom IQVIA Longitudinal Prescription Claims ( LRx) + Medical Claims (Dx) data files (delivery date April 20,
2024).  ** The projection to office -based physicians uses a list of US licensed office -based MDs and DOs maintained by the AMA.
•IQVIA data limitations
-May not be representative
•Uninsured pregnant people are not represented in medical office estimates.
•Projected physician medical office estimates are based on a small sample of physicians.
•Data do not include vaccinations administered at other medical settings such as public health clinics
and other settings including workplaces and community locations.
-There is no pregnancy variable in these IQVIA data
•Estimates include women of reproductive age who received an RSV vaccine during September
2023 –January 2024. This could include women who were not pregnant when vaccinated or were
pregnant but vaccinated outside the recommended 32 -36 weeks gestation period.
•NIS-ACM data limitations:
-Small sample size
-Gestational age at the time of vaccination is unknown
•Pregnancy status at time of interview was known, but not gestational age; only some of those
identified as pregnant would have been eligible for RSV vaccine at 32 -36 weeks gestation during the
September -January window for maternal RSV vaccination in most of the U.S. (e.g., in each month,
many would have been at <32 weeks gestation when interviewed)Location of Maternal RSV Vaccine Administration: Limitations
Implementation
Prospective 2024 RSV immunization timeline
Aug Sep Oct Nov Dec Jan
Maternal RSV vaccination
resumes in most of continental
U.S. (9/1)Nirsevimab  administration resumes in most of continental U.S.; broad
availability (10/1)Limited availability
of nirsevimab  (9/1)
•New  immunization products
•Licensure/launch occurred in
Aug/Sep, which prevented planning
in advance of the season
•Complex  clinical recommendations,
nuanced communications
•Lack of awareness  among
healthcare providers
•Challenging have provider/patient
conversations about vaccination in
the context of nirsevimab  shortages•Cost and reimbursement  issues
during the first year
•Access  issues —lack of supply at
many OBGYN offices, denial at
pharmacies, requirement of
prescription
•Lack of data on coadministration
•No ability to link maternal and infant
immunization records
•Concerns about safety, efficacyChallenges with maternal RSV vaccination during the 2023 -2024 season
•There is no anticipated supply/demand mismatch.
•The Pfizer RSV vaccine is already available in the field.
-However, providers who will vaccinate only pregnant persons may need to
rebuild inventory for the 2024 -2025 season.
-Plans are to have vaccine available for administration September 2024 –January
2025 for most of the U.S.Maternal vaccine supply for the 2024 -2025 season
CDC Campaign: From Me, To You

•Timing of policy decision
-FDA licensure (July 17) of nirsevimab  required special session of ACIP (August 3) leaving <2 months for distribution and roll out
planning for October 1 launch
-Limited time for engagement with key stakeholders and implementing partners to ensure healthcare workers were aware of new
product recommendations and could start procurement processes
•Procurement and insurance coverage
-Vaccines for Children (VFC) procurement expedited to ensure availability of nirsevimab  for eligible infants and young children (~50%
of US children); maternal vaccine for eligible pregnant people aged <19 years
-Healthcare providers were uncertain of need/demand given that private insurance companies have 12 months to adopt ACIP -
endorsed vaccine recommendations
-Demand was strong from parents of young children, many of whom were willing to pay for nirsevimab /vaccine if insurance would not
cover
-Nirsevimab  orders exceeded anticipated demand rapidlyChallenges in initial implementation of nirsevimab
targeting infants during the 2023 -2024 season
•Limited supply of nirsevimab  (100mg and 50mg
formulations) meant clinicians were uncertain
how to ration or prioritize few available doses
•CDC issued an official Health Advisory notice via
the Health Alert Network to prioritize available
doses to high -risk infants and younger infants
•By January, demand had decreased and
additional supply was available allowing return
to original recommendationsInsufficient supply of nirsevimab  to meet demand in
2023 -2024 season
Health Alert Network (HAN) - 00499 | Limited Availability of Nirsevimab  in the United States —Interim CDC Recommendations to Protect
Infants from Respiratory Syncytial Virus (RSV) during the 2023 –2024 Respiratory Virus Season

•National shortage during 2023 -24 due to faulty assumptions about uptake, presentation mix
•Manufacturer supply plan for 2024 -25 is focused on
-Increased volume of product
-Frontloading of supply
-Revised mix of presentations
•Requirements of supply plan include significant logistical actions, regulatory input and
approvals, careful risk management
•Limited availability beginning early Sep, ramping up during Sep, broadly available by Oct 1
•Broadly available supply essential to promote confidence in vaccines/vaccine supply
and  program implementation
•Promoting vaccination prior  to broadly available supply risks confusion, disappointment, and
decreased confidence among providers and the publicNirsevimab  supply for the 2024 -2025 season
Birthing Hospital Enrollment into VFC: Strategy
291 291 293307332348 351 355 359 364 367
050100150200250300350400
July 2023 Aug 2023 Sept 2023 Oct 2023 Nov 2023 Dec 2023 Jan 2024 Feb 2024 Mar 2024 Apr 2024 May 2024
(2)Birthing Facilities Enrolled in VFC: August 2023 - May 2024
Birthing Facilities Enrolled in VFC: August 2023- May 2024
Linear (Birthing Facilities Enrolled in VFC: August 2023- May 2024)
(1) These newly enrolled provider counts include 7 providers who were previously enrolled in the VFC program.
(2) Data for May 2024 is through May 8, 2024.
•Engaging in data gathering activities:
-Held series of focus groups to identify facilitators and barriers to enrolling hospitals in VFC
-National survey of birthing hospitals
-Mapping hospitals by number of VFC -eligible births, VFC enrollment, and nirsevimab  administration
history
•Planned activities to scale -up enrollment:
-Disseminating promising practices and success stories
-Development of “Promising Practices” FAQ document
-Working closely with immunization awardees to track process and provide support
•Implementing activities to reduce enrollment burden:
-Awardees can enroll birthing hospitals as “specialty providers”; this allows birthing hospitals to offer only
nirsevimab  and HepB  vaccination birth dose
•Collaborating with partnersActivities to Increase Hospital VFC Enrollment
For more information, contact CDC/ATSDR
1-800-CDC -INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov           www.atsdr .cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Closing Slide / Disclaimer

Summary: Implementation and Uptake of Nirsevimab and  Maternal Vaccine Shannon Stokley, DrPH Deputy Director for Science Implementation Immunization Services Division National Center for Immunizations and Respiratory Diseases (NCIRD) June 2024National Center for Immunization and Respiratory Diseases  2023 -2024 Coverage for Nirsevimab and  Maternal Vaccination Percent of pregnant persons ages 18 –49 years vaccinated with RSV vaccine  overall and by race and ethnicity, Vaccine Safety Datalink •17.8% of…


03 RSV Mat Peds Moro 508

Pedro L. Moro, MD, MPH
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention (CDC)NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES
Maternal RSV vaccine safety surveillance
Advisory Committee on Immunization Practices (ACIP)
June 28, 2024
▪The findings and conclusions in this presentation are those of the author
and do not necessarily represent the official position of the CDC
▪The use of product trade names is for identification purposes onlyDisclaimer
2
▪Background
▪CDC vaccine safety monitoring for Pfizer RSV vaccines in pregnancy:
•Vaccine Adverse Event Reporting System (VAERS)
•V-Safe
•Vaccine Safety Datalink (VSD)
▪SummaryTopics
3
▪In clinical trials among pregnant persons at 24 –36 weeks’ gestation, more preterm births were noted
among Pfizer RSV vaccine recipients compared to placebo (differences not statistically significant)
▪Post -licensure safety surveillance of the Pfizer RSV vaccine in pregnant persons was initiated during
the 2023 -2024 season
▪The patterns of reported local and systemic (e.g., headache) symptoms in V -safe and VAERS after
maternal P fizer RSV vaccine were consistent with its pre -licensure safety profile
▪Among reports received in VAERS after maternal Pfizer RSV vaccine, the most frequent adverse
events reported were p regnancy -specific conditions (e.g., preterm delivery) , as expected for a vaccine
recommended at 32 -36 weeks’ gestational age
▪Preliminary findings in the VSD observed that the incidence of preterm births is 4.1% among pregnant
persons who received Pfizer RSV vaccine during the 2023 -2024 respiratory season. This was within
the expected range of the incidence of preterm births at 32 -36 weeks’ gestation (3.1 - 6.1%) before
introduction of this vaccine
▪CDC and FDA will continue to monitor maternal RSV vaccine safety in VAERS, V-safe and VSDKey points up front
4
▪In clinical trials among pregnant persons at 24 –36 weeks’ gestation, more preterm
births were noted among Pfizer RSV vaccine recipients compared to placebo, but the
differences were not statistically significant
•To avoid the potential risk of preterm birth before 32 weeks’ gestation, FDA approved the
maternal Pfizer RSV vaccine ( Abrysvo ) for use in pregnant persons at 32 through 36 weeks’
gestational age1
▪The label for Pfizer RSV vaccine notes potential risk of preterm birth under warnings
and precautions section1
▪In addition, more hypertensive disorders of pregnancy were observed among vaccine
recipients compared to placebo recipients, but the differences were not statistically
significant
▪Post -licensure safety surveillance of the new Pfizer RSV vaccine in pregnant persons is
of great importance to ensure maternal Pfizer RSV safety at the population level and
the benefits of using the vaccine in pregnant persons to protect infants from RSV LRTD
outweigh possible risksBackground
RSV: respiratory syncytial virus; LRTD: lower respiratory tract disease
1  https://www.fda.gov/media/168889/download  5
VAERS is the nation’s early warning system for vaccine safety
Co-managed by
CDC and FDA
https://vaers.hhs.gov/
6
VAERS ADVERSE EVENT REPORTING SYSTEM (VAERS)
Strengths
▪National data
▪Accepts reports from anyone
▪Rapidly detects safety signals
▪Can detect rare adverse events
▪Data available to publicLimitations
▪Reporting bias
▪Inconsistent data quality and
completeness
▪Lack of unvaccinated comparison
group
▪Generally cannot assess causality
•VAERS accepts all reports from all reporters without making judgments on
causality or judging clinical seriousness of the event
•As a hypothesis generating system, VAERS identifies potential vaccine safety
concerns that can be studied in more robust data systems7
Approaches to analyzing VAERS data
▪For more than a decade VAERS has been used as part of vaccine safety surveillance
for vaccines used in pregnancy (e.g., influenza, Tdap, COVID -19)1,2
• Descriptive analysis
•Clinical review of individual reports
•Aggregate descriptions of automated data (e.g., counts of reported adverse
events)
•Calculation of reporting rates for pregnancy outcomes (if doses of a vaccine
administered in pregnancy or vaccination coverage data are available)
▪Clinical review of infant’s medical records at birth and for the first 3 months of life
(enhanced surveillance)
1Moro et al.  Obstetrics & Gynecology 140(3):p 421 -427, September 2022. https://journals.lww.com/greenjournal/Fulltext/2022/09000/Safety_of_Booster_Doses_of_Coronavirus_Disease.11.aspx
2Moro et al. Vaccine. 34(20):p2349 -2353, April 2016. https://www.sciencedirect.com/science/article/pii/S0264410X16300329?via%3Dihub 8
Characteristics of maternal Pfizer RSV vaccine reports submitted to VAERS
(as of June 3, 2024)
Characteristics N (%)
Number of reports 121
Maternal deaths 0
Pregnancy -specific adverse event(s) reports 52 (43)
Maternal age in years, median (range) 1 32 (21 -41)
Maternal age ≥ 35 years 24 (20)
Onset interval in days from vaccination to adverse event, median (interquartile range) 1 (0,4)
Gestational age2 in weeks at time of vaccination, median (range) 34 (9,37)
Type of reporter
Patient/relative3 60 (50)
Provider 36 (30)
Vaccine manufacturer 19 (16)
Other 6 (5)
1 Age not provided in 15 reports; 2 Gestational age at vaccination available for 90 reports; unknown for 31 reports
3 Pregnant persons represented 70% of those who reported a preterm delivery
From October 2023 through March 2024 an estimated 320,400 pregnant persons received RSV vaccine (Peacock. Implementation and Uptake of Nirsevimab  and Maternal RSV Vaccine.
Advisory Committee on Immunization Practices. June 28, 2024.9
Most frequently reported MedDRA Preferred Terms1 among reports (n=121)
to VAERS following Pfizer RSV vaccination in pregnant persons (as of June 3,
2024)
Rank MedDRA PT (not mutually exclusive) N (%)
1 Premature delivery 29 (24)
2 Premature labor 18 (15)
3 Caesarean section 18 (15)
4 Uterine contractions during pregnancy 16 (13)
5 Headache 15 (12)
6 Nausea 13 (11)
7 Fever 13 (11)
8 Vomiting 12 (10)
9 Pain 11 (9)
10 Preterm premature rupture of membranes 10 (8)
1 Medical Dictionary for Regulatory Activities Preferred Terms ( https://www.meddra.org/how -to-use/basics/hierarchy ); MedDRA PTs not mutually exclusive
From October 2023 through March 2024, an estimated 320,400 pregnant persons received RSV vaccine (Peacock. Implementation and  Uptake of Nirsevimab  and
Maternal RSV Vaccine. Advisory Committee on Immunization Practices. June 28, 2024.10
Adverse events among pregnant persons following Pfizer RSV vaccination in VAERS
(as of June 3, 2024)
Adverse event N (%)
Pregnancy specific 52 (43)
 Premature delivery (< 37 weeks' gestation) 37 (31)
 High blood pressure/gestational hypertension1 4 (3)
 Infant death2 1 (1)
 Stillbirth  (≥ 20 weeks' gestation) 3 (2)
 Delivery/labor/contractions 3 (2)
 Premature rupture of membranes 2 (2)
 Other3 2 (2)
Non -pregnancy specific 69 (57)
 General disorders and administration site conditions
 (mostly injection site and systemic reactions)41 (34)
 Vaccination errors4 21 (17)
 Infections and infestations 3 (2)
 Neurological disorders (Bell’s palsy)6 2 (2)
 Other4 5 (4)
1  One report of thrombocytopenia that met Brighton level 2 criteria was reported in a patient with elevated blood pressure foll owing vaccination
2 35-week infant with anoxic brain injury and neonatal death after emergent C -section, resuscitation, and hospital transfer 4 days  after vaccination
3 Other includes one report each of premature infant incorrectly classified as preterm (37w), a patient who underwent labor at 37 weeks, 6 days
4  Vaccination errors included: eight reports of vaccine given outside recommended gestational period, six given outside season,  three reports
   of an additional dose of RSV given during same season, before approval in two, subcutaneous route in one, storage issue for
   Covid -19 vaccine, not RSV. Three reports of adverse events with vaccination errors
5 Other includes two reports of no adverse event, and one each of diarrhea, infant with jaundice, and a report of rash
From October 2023 through March 2024, an estimated 320,400 pregnant persons received RSV vaccine (Peacock. Implementation
and Uptake of Nirsevimab  and Maternal RSV Vaccine. Advisory Committee on Immunization Practices. June 28, 2024.
6 No verified cases of Guillain -Barre Syndrome reported11
12Preterm deliveries (as of June 3, 2024)
Risk factors and clinical information2
▪ 22 reported a medical condition or
complication that increased risk for preterm
delivery (e.g., elevated blood pressure, history
of preterm delivery)
▪ 12 had insufficient information (no medical
records)
▪ 3 uncomplicated pregnancies (no reported
factors)
▪ 8 deliveries were inducedClassification1N
Late preterm (34 -36 weeks) 27
Early preterm (≥ 32 - <34 weeks) 7
Very preterm (28 - < 32 weeks) 0
Extremely preterm (< 28 weeks) 0
Unknown gestational age 3
Total 37**
1 Based on ACOG and WHO definitions
2 Median maternal age at vaccination was 33 years (range 25 -40 years); median onset interval from vaccination to preterm birth
was 3 days (range 0 -31 days)
From October 2023 through March 2024, an estimated 320,400 pregnant persons received RSV vaccine (Peacock.
Implementation and Uptake of Nirsevimab  and Maternal RSV Vaccine. Advisory Committee on Immunization Practices. June 28, 2024 .
13Characteristics and outcomes of infants born to Pfizer RSV recipients
Characteristics N (%)
Number of infants175
Premature at birth (< 37 weeks)238 (51)
Gestational age at birth (weeks) 3, median (range) 36 (32 – 41)
Infants at term 33 (44)
Sex
 Male 32 (43)
 Female 34 (45)
 Unknown sex 9 (12)
Infant deaths41
Infant born with low birth weight (< 2,500 g) 16 (21)
NICU admission524
 Condition or reason for admission in NICU (not mutually exclusive)
 Respiratory distress
 Prematurity
 Fetal distress
 Unknown10 (42)
7 (29)
1 (4)
9 (38)
1 66 infants born of a single pregnancy; 6 from 3 twin pregnancies; 3 data not reported
2 Includes 6 infants from three twin pregnancies
3 Gestational age at birth unknown for 4 reports
4 35-week infant with anoxic brain injury and neonatal death after emergent C -section, resuscitation, and hospital transfer 4 day s after vaccination
5 NICU admission unknown in 20 (39%) reports
From October 2023 through March 2024, an estimated 320,400 pregnant persons received RSV vaccine (Peacock. Implementation
and Uptake of Nirsevimab  and Maternal RSV Vaccine. Advisory Committee on Immunization Practices. June 28, 2024.
▪Among reports received, local and systemic symptoms (e.g., headache) were
frequently reported in VAERS after Pfizer RSV vaccine consistent with pre -licensure
studies in pregnant persons
▪In clinical trials among pregnant persons at 24 –36 weeks’ gestation, more preterm
births were noted among Pfizer RSV vaccine recipients compared to placebo
▪The label for Pfizer RSV vaccine notes potential risk of preterm birth under warnings
and precautions section
▪Patients (pregnant persons) were the most common reporters (50%) overall and
represented 70% of those who reported a preterm delivery
▪Reports of pregnancy specific conditions (e.g., preterm delivery) were not
unexpected for the Pfizer RSV vaccine, which is recommended at 32 -36 weeks’
gestation in pregnancyVAERS Summary
14
V-safe
15
▪Surveys sent daily during the first week after vaccination, then weekly through week 6
▪Daily surveys solicit adverse events and health impacts after vaccination
•Local  reactions (e.g., pain, redness, swelling)
•Systemic reactions (e.g., fatigue, headache, muscle pain)
•Health impacts (e.g., unable to perform normal daily activities, missed school or
work, or received medical care)
•Additional questions for persons who reported immunocompromise at vaccination
▪Weekly surveys solicit new symptoms or conditions after vaccination
▪Maternal RSV protocol includes additional questions about current and prior
pregnanciesIn Fall 2023 V-safe expanded to include RSV vaccine
16
Characteristics of persons aged 16 -49 years with
reported RSV vaccination during pregnancy*
* For 1,116 V -safe participants aged 16 -49 years enrolled in the maternal RSV protocol with ≥1 completed daily survey during Aug ust 21, 2023 – May 20,
202417
Reactions and health impacts reported for persons aged 16 -49
years with reported RSV vaccination during pregnancy (n=1,116)*
0102030405060708090100
Any symptoms Injection site
reactionSystemic reaction Unable to complete
daily activitiesUnable to work or
attend schoolGot medical care
Pfizer
* For 1,116 V -safe participants aged 16 -49 years enrolled in the maternal RSV protocol with ≥1 completed daily survey
during August 21, 2023 – May 20, 202418
Vaccine Safety Datalink
19
Vaccine Safety Datalink (VSD) 2024
▪Collaborative project between CDC and
integrated healthcare organizations
▪Monitors safety of vaccines used in the
US, primarily through real -world data of
rare and serious events following
vaccination
▪Includes data on ~15.5 million
individuals across all sites annually
▪~ 115,000 annual live births
▪Data is organized using a common data
model with standardized coding
systems
20
▪Determine cumulative historical  incidence rates of preterm birth among
singleton pregnancies in the VSD reaching specified gestational ages from
22–36 weeks during 2017 –2022
▪Determine incidence of preterm births in RSV vaccinated pregnant
persons1,2VSD Prenatal RSV Vaccine Surveillance
1For RSV vaccines administered at 30 to less than 37 weeks’ gestation
2Pfizer RSV should be administered at 32 through 36 weeks’ gestation
https://www.fda.gov/media/168889/download21
Preterm births in VSD – Historical incidence of preterm births and preterm
births following RSV vaccine during pregnancy at 9 VSD sites
Incidence of preterm births among singleton pregnancies in the VSD reaching
specified gestational ages from 22 –36 weeks during 2017 –2022
▪In VSD, 10,295 RSV vaccines were administered at 30 to less than 37 weeks gestational age among
pregnant persons during 2023 –2024 respiratory season with 427 preterm births among vaccinees.
▪The preterm birth incidence was 4.1% which is within the expected range (3.1–6.1%) based on
historical data.
22
▪Pregnant persons, RSV vaccinated: unexposed at same gestational week
▪Create propensity scores to account for confounding
▪Outcomes
•Acute safety outcomes (e.g., anaphylaxis, Guillain -Barré syndrome)
•Preterm birth
•Stillbirth
•Preeclampsia/eclampsia/HELLP*
▪2023 -2024 analysis pending, data available later this yearVSD 1:1 Matched analysis (ongoing)1
*Hemolysis, elevated liver enzymes, low platelet count
1https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2023 -09-22/02 -Mat-Peds -DeSilva -508.pdf  23
▪Local and systemic symptoms were reported to V -safe following Pfizer RSV vaccine in
pregnant persons, with a frequency similar to that observed in pre -licensure trials;
few pregnant people in V -safe reported medical care for symptoms1
▪Among reports received in VAERS after maternal Pfizer RSV vaccine, the most
frequent adverse events reported were local and systemic symptoms (e.g., headache)
and pregnancy specific conditions (e.g., preterm delivery), as expected for a vaccine
recommended for pregnant persons at 32 -36 weeks’ gestation
▪Post -licensure vaccine safety data from VAERS and V -safe during first season after
maternal Pfizer RSV vaccine are consistent with the pre -licensure safety profile
▪Preliminary findings in the VSD observed that the incidence of preterm births is 4.1%
among pregnant persons who received Pfizer RSV vaccine during the 2023 -2024
respiratory season. This was within the expected range of the incidence of preterm
births at 32 -36 weeks’ gestation (3.1 - 6.1%) before introduction of this vaccine
▪CDC and FDA will continue to monitor maternal RSV vaccine safety in VAERS, V -safe
and VSDSummary
24 1 https://www.fda.gov/vaccines -blood -biologics/abrysvo
Acknowledgements
▪CDC Immunization Safety Office
•VAERS Team
•V-safe Team
•Clinical Immunization Safety Assessment (CISA) Project
•Vaccine Safety Datalink (VSD)
▪Food and Drug Administration
•Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and
Research
▪National Center for Immunization and Respiratory Diseases
•Coronavirus and Other Respiratory Viruses Division
25
For more information, contact CDC/ATSDR
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov           www.atsdr.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Closing Slide / Disclaimer
The findings and conclusions in this presentation are those of the authors
and not necessarily represent the official position of CDC

Summary: Pedro L. Moro, MD, MPH  Division of Healthcare Quality Promotion Centers for Disease Control and Prevention (CDC)NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES Maternal RSV vaccine safety surveillance Advisory Committee on Immunization Practices (ACIP) June 28, 2024 ▪The findings and conclusions in this presentation are those of the author  and do not necessarily represent the official position of the CDC ▪The use of product trade names is for identification purposes…


04 RSV Mat Peds Payne 508

Summary of effectiveness of nirsevimab  in infants
Amanda Payne, PhD, MPH
Coronavirus and Other Respiratory Viruses Division
Centers for Disease Control and Prevention
June 28, 2024National Center for Immunization and Respiratory Diseases
•Real -world vaccine/product effectiveness methods
•Effectiveness of nirsevimab  in the United States
-RSV-associated emergency department encounters & hospitalization, VISION
-RSV-associated medical encounters and hospitalization, NVSN
•Effectiveness of nirsevimab  globally
•ConclusionsAgenda
Real -world vaccine/product effectiveness
context and methods
•Efficacy: the degree to which an immunization prevents disease under
ideal and controlled conditions  (i.e., measured in clinical trials)
•Effectiveness: the degree to which an immunization prevents disease
under real -world conditions (i.e., measured in post -licensure observational
studies)
In this presentation,
we’ll discuss product effectiveness (“PE”)
from real -world data.Efficacy ≠ effectiveness
•Limited supply of nirsevimab  (100mg and 50mg
formulations) meant clinicians were uncertain
how to ration or prioritize few available doses
•CDC issued an official Health Advisory notice via
the Health Alert Network to prioritize available
doses to high -risk infants and younger infants
•By January, demand had decreased and
additional supply was available allowing return
to original recommendationsInsufficient supply of nirsevimab  to meet demand in
2023 -2024 season
Health Alert Network (HAN) - 00499 | Limited Availability of Nirsevimab  in the United States —Interim CDC Recommendations to Protect
Infants from Respiratory Syncytial Virus (RSV) during the 2023 –2024 Respiratory Virus Season

Case ControlPerson with acute
respiratory illness
RSV test
RSV immunization
status
Observational effectiveness measured in a
test-negative design (TND) study
Effectiveness = 1 – (odds ratio ) x 100%    Odds ratio = 𝑂𝑑𝑑𝑠  𝑜𝑓 𝑖𝑚𝑚𝑢𝑛𝑖𝑧𝑎𝑡𝑖𝑜𝑛 𝑐𝑎𝑠𝑒𝑠
𝑂𝑑𝑑𝑠  𝑜𝑓 𝑖𝑚𝑚𝑢𝑛𝑖𝑧𝑎𝑡𝑖𝑜𝑛 𝑐𝑜𝑛𝑡𝑟𝑜𝑙𝑠Key features of a TND
•Real -world circumstances
•Most heterogenous study population,
often “all comers”
•Reduces bias from health -care seeking behavior
Considerations
•Validity dependent on test performance
•Residual confounding is possible
Slide courtesy of Ruth Link -Gelles, PhD MPH Chua H, Feng S, Lewnard  JA, et al. The use of test -negative controls to monitor vaccine effectiveness: a systematic review of methodology. Epidemiology 2020;31:43 -64.
Virtual SARS -CoV-2, Influenza, and Other
respiratory viruses Network (VISION)
•Population: Visiting a participating ED for or hospitalized with RSV -like
illness (RLI)*
•Immunization data:  Infant and maternal RSV immunization status
documented by electronic health records, state and city registries, and
claims data (subset of sites)
•Covariate data:  Documented in electronic health records
-Underlying medical conditions:  ICD -10 discharge diagnosis codes at time of
RLI encounter
-Patient characteristics
•Date of birth
•Census tract of residence
•SexVISION Multi -Site Network of Electronic Health Records (EHRs)
127 emergency rooms and 107 hospitals
VISION 2.0 partners included in this analysis –
ED: Columbia, HealthPartners Institute, Intermountain Healthcare,
KPSC, KPCHR, Regenstrief
Inpatient : Columbia, HealthPartners Institute, Intermountain, KPSC,
KPCHR, Regenstrief
*≥1 ICD -10 discharge diagnosis code indicating RSV -like illness (RLI)
ED = emergency department
ED Encounters and Hospitalizations for RSV -like illness* among infants in their first RSV
season, by immunization and RSV positivity status – VISION, October 2023 – March 2024
ED Encounters and Hospitalizations for RSV -like illness* among infants in their first RSV
season, by immunization and RSV positivity status – VISION, October 2023 – March 2024
ED Encounters and Hospitalizations for RSV -like illness* among infants in their first RSV
season, by immunization and RSV positivity status – VISION, October 2023 – March 2024
ED Encounters and Hospitalizations for RSV -like illness* among infants in their first RSV
season, by immunization and RSV positivity status – VISION, October 2023 – March 2024
•Population:
-Infants aged <8 months as of October 1, 2023, or born after October 1, 2023
-Visiting a participating ED for or hospitalized with RSV -like illness (RLI)
-With RSV test result within 10 days before or 72 hours after encounter
•Cases:   RLI with positive  RSV antigen or NAAT test*
•Controls:   RLI with negative RSV NAAT test
•Study period:  October 8, 2023 – March 31, 2024
•Exclusion criteria:
-Children aged <7 days
-Children born after September 22, 2023, without linkage to maternal records
-Evidence of maternal RSV vaccination or palivizumab administration
-Receipt of unrecommended nirsevimab dose(s)†
-<7 days between nirsevimab dose and RLI encounter
-Indeterminate RSV test result
•Statistical Analysis:  Adjusted OR comparing odds of immunization‡ among cases vs. controls estimated
using  multivariable logistic regression models, adjusting for age, race and ethnicity, sex, calendar day (days
since Oct 8, 2023), and geographic region → PE = (1 -aOR) X 100%Test-negative design (TND) analysis of first season nirsevimab  product effectiveness (PE) against
RSV-associated ED encounters and hospitalization – VISION, October 8, 2023 – March 31, 2024
*RSV -positive encounters with positive SARS -CoV -2 and/or influenza test result were (i.e., coinfections) were excluded.
† Unrecommended nirsevimab  dose(s) defined as:  nirsevimab doses administered on or before October 1, 2023, and receipt of >1 nirsevimab  dose.  Nirsevimab  doses in older children may be
administered as 2 injections on the same day; this was considered one ‘dose’.
‡Immunization defined as one nirsevimab  dose ≥7 days prior to encounter index date.
NAAT = nucleic acid amplification test | OR = odds ratio | aOR  = adjusted odds ratio | PE = product effectiveness
First season nirsevimab product effectiveness (PE) against RSV-associated ED
encounters and hospitalization – VISION, October 8, 2023 – March 31, 2024
Outcome | Nirsevimab
dosage patternTotal
encountersRSV -positive
encounters
N (Row %)Median days
since dose
(IQR)Adjusted
PE (95% CI)*
RSV -associated ED encounter
No nirsevimab  doses4,610 1,988 (43)N/A ref
Nirsevimab , ≥7 days prior 442 63 (14) 53 (27 -84) 77 (69 -83)
RSV -associated hospitalization
No nirsevimab  doses927 601 (65)N/A ref
Nirsevimab , ≥7 days prior 93 4 (4) 48 (25 -84) 98 (95 -99)
0 20 40 60 80 100
*Odds ratio used to calculate VE estimate was adjusted for age, race and ethnicity, sex, calendar day (days since Oct 8, 2023), and geographic region
N/A = not applicable | ref = reference groupNirsevimab was effective against RSV-associated ED encounters and
hospitalization among infants in their first RSV season.
New Vaccine Surveillance Network (NVSN)Update to Moline HL, Tannis  A, Toepfer  AP , et al. Early Estimate of Nirsevimab  Effectiveness for Prevention of Respiratory Syncytial
Virus –Associated Hospitalization Among Infants Entering Their First Respiratory Syncytial Virus Season — New Vaccine
Surveillance Network, October 2023 –February 2024. MMWR Morb  Mortal Wkly  Rep 2024;73:209 –214. DOI:
http://dx.doi.org/10.15585/mmwr.mm7309a4

NVSN is a prospective, population -based surveillance network for
pediatric acute respiratory illness (ARI) at 7 U.S. medical centers.
Children <18 years of age with ARI are enrolled
year -round in the outpatient, urgent care,
emergency department (ED), and hospital settings.
Surveillance Objectives:
–Determine the etiology and burden of laboratory -
confirmed acute viral respiratory diseases in children
–Characterize the clinical and epidemiologic factors of
pediatric ARI and associated syndromes
–Evaluate vaccine effectiveness (VE) using a test -
negative design (TND) and impact of vaccines and
other immunoprophylaxis  products.

NVSN Data Collection
•Caregiver interview
-Race and ethnicity, preterm status, date of symptom onset, breastfeeding status
•Specimens
-Mid-turbinate nasal swab collected from all children for RSV testing by reverse -
transcription polymerase chain reaction; results of both clinical and surveillance
testing are collected
-Sequencing of RSV -positive specimens to monitor for substitutions in the
nirsevimab  binding site
•Medical chart abstraction
-Age, underlying medical conditions, clinical course of illness, insurance status
•Immunization status ( nirsevimab , palivizumab, and maternal RSV vaccine)
-Ascertained by parent report and confirmed with state immunization information
system, electronic health record, or birth record

During 2023 -2024, RSV prevention products became available in the U.S. after
the RSV season started
ACIP = Advisory Committee on Immunization Practices
NVSN = New Vaccine Surveillance Network
NREVSS = National Respiratory and Enteric Virus Surveillance System Nirsevimab  recommended by  ACIPPfizer maternal RSV vaccine ( Abrysvo )
recommended by ACIP
All NVSN sites had some
nirsevimab availability by
mid-October
Among 2,383 infants in
their first RSV season
•11.1% received
nirsevimab
•2.2% received
palivizumab
•3.4% (of 1,542
infants <6 months
of age at
enrollment) had
history of maternal
RSV vaccination, April 2023 through April 2024
During 2023 -2024, RSV prevention products became available in the U.S. after
the RSV season started
ACIP = Advisory Committee on Immunization Practices
NVSN = New Vaccine Surveillance Network
NREVSS = National Respiratory and Enteric Virus Surveillance System Nirsevimab  recommended by  ACIPPfizer maternal RSV vaccine ( Abrysvo )
recommended by ACIP
All NVSN sites had some
nirsevimab availability by
mid-October
Among 2,383 infants in
their first RSV season
•11.1% received
nirsevimab
•2.2% received
palivizumab
•3.4% (of 1,542
infants <6 months
of age at
enrollment) had
history of maternal
RSV vaccination, April 2023 through April 2024
During 2023 -2024, RSV prevention products became available in the U.S. after
the RSV season started
ACIP = Advisory Committee on Immunization Practices
NVSN = New Vaccine Surveillance Network
NREVSS = National Respiratory and Enteric Virus Surveillance System Nirsevimab  recommended by  ACIPPfizer maternal RSV vaccine ( Abrysvo )
recommended by ACIP
All NVSN sites had some
nirsevimab availability by
mid-October
Among 2,383 infants in
their first RSV season
•11.1% received
nirsevimab
•2.2% received
palivizumab
•3.4% (of 1,542
infants <6 months
of age at
enrollment) had
history of maternal
RSV vaccination, April 2023 through April 2024
Test-negative design (TND) analysis of first season nirsevimab  product effectiveness (PE) against
medically attended RSV -associated ARI episodes and RSV -associated hospitalization – NVSN,
October 2023 – March 2024
*Acute respiratory illness (ARI) defined as  >1 of the following sign/symptoms: fever, cough, earache, nasal congestion, runn y nose, sore throat, vomiting after coughing, shortness of breath (rapid or
shallow breathing), wheezing, apnea, or apparent life -threatening event or brief resolved unexplained event
†State -level RSV RT -PCR percent positivity thresholds of 3% were used to define the beginning and end weeks of the analysis by si te
‡Immunization defined as one nirsevimab  dose ≥7 days prior to symptom onset.
OR = odds ratio | aOR  = adjusted odds ratio | PE = product effectiveness
•Population:
-Infants <8 months as of October 1, 2023, or born after October 1, 2023
-Enrolled from participating medical center
-ARI*
•Case patients  – children with medically attended ARI who tested positive for RSV by surveillance or clinical testing
•Control patients  – children with medically attended ARI who tested negative for RSV by surveillance or clinical testing
•Study period: October 2023 – March 2024†
•Exclusion criteria:
• Chart review incomplete for underlying conditions, preterm status, insurance status, highest level of care, clinical course o f
illness
• Immunization status unverified for nirsevimab  and palivizumab receipt and maternal RSV vaccination
• Receipt of palivizumab or history of maternal RSV vaccination during pregnancy
• Unknown or inconclusive RSV test result
• Receipt of nirsevimab  <7 days prior to ARI symptom onset
•Statistical Analysis:  Adjusted OR comparing odds of immunization‡ among cases vs. controls estimated
using  multivariable logistic regression models, adjusting for site, age in months, month of enrollment, and
presence of >1 high -risk medical condition for severe RSV disease → PE = (1 -aOR) X 100%
First season nirsevimab product effectiveness (PE) against medically attended RSV -
associated ARI and RSV -associated hospitalization – NVSN, October 2023 – March 2024*
Outcome | Nirsevimab
dosage patternTotal
encountersRSV -positive
encounters
N (Row %)Median days
since dose
(IQR)Adjusted
PE (95% CI)†
Medically Attended
RSV -associated
ARI episode‡
No nirsevimab  doses1,575 755 (48)N/A ref
Nirsevimab, ≥7 days prior§120 9 (8) 42 (21 -73) 89 (77 -94)
RSV -associated hospitalization
No nirsevimab  doses807 526 (65)N/A ref
Nirsevimab , ≥7 days prior 63 6 (10) 38 (15 -67) 91 (79 -96)
0 20 40 60 80 100
*State -level RSV RT -PCR percent positivity thresholds of 3% were used to define the beginning and end weeks of the analysis by si te
†Multivariable logistic regression models compared the odds of vaccination among RSV case and control patients while adjusting  for site, age in months, month of enrollment, and presence of >1 high -risk
medical condition for severe RSV disease.
§Immunization defined as one nirsevimab  dose ≥7 days prior to symptom onset.
ARI = acute respiratory illness | N/A  = not applicable | ref  = reference groupNirsevimab was effective against medically attended RSV -associated ARI
episodes and RSV -associated hospitalization.
Summary of US data
Outcome/Analysis Vaccine efficacy /effectiveness  (%)
Clinical trial, RSV -associated LRTI 79 (69 -86)
Clinical trial, RSV -associated LTRI with hospitalization 81 (62 -90)
Clinical trial, RSV -associated LRTI with ICU admission 90 (16 -99)
VISION, RSV -associated emergency department visits 77 (69 -83)
VISION, RSV -associated hospitalization 98 (95 -99)
NVSN, medically attended RSV -associated ARI episode 89 (77 -94)
NVSN, RSV -associated hospitalization 91 (79 -96)Observational data indicate nirsevimab is working as expected
(vs. RCT results) during the first RSV season after approval
among infants in their first RSV season
https://www.cdc.gov/mmwr/volumes/72/wr/mm7234a4.htm
RCT = randomized clinical trial | ARI = acute respiratory illness0 20 40 60 80 100
Results may not be comparable
across studies due to differences in
outcome definitions, timing, and
other factors.
•High product effectiveness should be interpreted with caution
-Short interval from administration to respiratory illness onset
-Unable to assess duration of protection during the 2023 -2024 RSV season
•Residual confounding was possible
•Misclassification of RSV immunization status was possible
•These results only reflect PE among infants in their first RSV season (not among
children at increased risk in their second RSV season)
•VISION:
-Cases may have sought care for something other than RSV
-All RSV testing was clinician -directed
-EHR data may not fully capture all underlying medical conditions, which may be associated
with likelihood of immunization and risk of severe RSV disease
•NVSN:
-May not be nationally representativeLimitations of test-negative design (TND) analyses of first season
nirsevimab  product effectiveness (PE), October 2023 – March 2024
Nirsevimab  effectiveness – evidence from
literature
Nirsevimab product effectiveness (PE) among infants in their first RSV season –
Data* from Spain and France
Study Endpoint PE (95% CI)†
RSV -associated hospitalization82 (66 - 90)
88 (82 - 91)
89 (70 - 96)
84 (77 - 90)†
70 (38 - 89) †
81 (61 - 91)
RSV -associated LRTI requiring oxygen87 (69 – 94)
86 (42 - 96)
RSV -associated ICU admission90 (76 – 96)
86 (13 – 98)
76 (49 – 89)
RSV and/or bronchiolitis attended in the ED88 (70 – 95)
55 (48 – 62)
Bronchiolitis or viral pneumonia attended in primary
care setting48 (42 – 53)
61 (24 – 80)
Medically attended RSV infection69 (52 – 80)
74 (65 – 80)
0 20 40 60 80 100
*References provided on backup slide 32.
†PE estimates generated from the same study, using different methods.
LRTI = lower respiratory tract infection | ICU = intensive care unit
Conclusions
•Nirsevimab was effective against RSV -associated ED encounters and hospitalization
among infants in their first RSV season during the
2023 -2024 RSV season
•Due to timing of authorization/recommendation of RSV prevention products and RSV
activity during the 2023 -2024 RSV season:
-US-based analyses may be subject to residual confounding due to prioritization of nirsevimab
doses
-Short time between nirsevimab administration and outcomes, limiting ability to assess duration of
protection
-Limited ability to assess effectiveness of maternal RSV vaccines
•Ongoing monitoring of post -licensure nirsevimab and maternal RSV vaccine
effectiveness will continueConclusions
Acknowledgements
CDC
Amadea Britton
Allison Ciesla
Benjamin Clopper
Fatimah S. Dawood
Monica Dickerson
Katherine Fleming -Dutra
Sascha Ellington
Shikha Garg
Leah Goldstein
Casey Kalman
Amber Kautz
Ruth Link -Gelles
Josephine Mak
Erin McKeever
Meredith McMorrow
Morgan Najdowski
Lakshmi Panagiotakopoulos
Caitlin Ray
Ayzsa Tannis
Mark Tenforde
Ariana Toepfer
Megan Wallace
Ryan WiegandVISION Collaborators
Westat
Sarah Bell
Steph Battan -Wraith
Angela Cheung
Margaret Dunne
Patrick Mitchell
Sarah Reese
Elizabeth Rowley
Janet Watts
Zack Weber
Columbia University
Karthik Natarajan
HealthPartners
Malini B. DeSilva
Intermountain Health
Kristin Dascomb
Kaiser Permanente Center for Health Research
Stephanie A. Irving
Kaiser Permanente Southern California
Sara Tartoff
Regenstrief
Shaun J. Grannis
University of Colorado
Toan C. Ong
+ many more site staff!NVSN Collaborators
Cincinnati Children’s Hospital
Mary Staat
Texas Children’s Hospital
Julie Boom
Leila Sahni
Children’s Mercy Hospital
Jennifer Schuster
Rangaraj Selvarangan
Vanderbilt University Medical Center
Natasha Halasa
UPMC Children’s Hospital
John Williams
Marian Michaels
University of Rochester Medical Center
Geoff Weinberg
Peter Szilagyi
Seattle Children’s Hospital
Jan Englund
Eileen Klein
Hospitalized population comparison for VISION and NVSN
VISION , no. (col %) NVSN , no. (col %)
Characteristic Total no. of
patientsRSV
case -patientsRSV
control -patientsTotal no. of
patientsRSV
case -patientsRSV
control -patients
All hospitalizations 1,020 605 415 870 532 338
Median age, months (IQR) 4 (1-7) 3 (1-6) 4 (1-7) 3 (1-6) 3 (1-5) 3 (1-6)
Gestational age
Preterm (<37 weeks) 133 (13) 59 (10) 74 (18) 180 (21) 102 (19) 78 (23)
Term (≥37 weeks) 508 (50) 323 (53) 185 (45) 687 (79) 428 (81) 259 (77)
Unknown 379 (37) 223 (37) 156 (38) 3 (0) 2 (0) 1 (0)
Race/ethnicity
Black or African American, Non -Hispanic 77 (8) 48 (8) 29 (7) 113 (13) 56 (11) 57 (17)
White, Non -Hispanic 437 (43) 268 (44) 169 (41) 390 (45) 266 (50) 124 (37)
Hispanic or Latino 394 (39) 234 (39) 160 (39) 248 (29) 146 (27) 102 (30)
Other, Non -Hispanic 75 (7) 33 (6) 42 (10) 107 (12) 58 (11) 49 (14)
Unknown 37 (4) 22 (4) 15 (4) 12 (1) 6 (1) 6 (2)
High risk conditions for severe RSV disease
None 796 (78) 529 (87) 267 (64) 832 (96) 520 (99) 281 (83)
≥1 224 (22) 76 (13) 148 (36) 38 (4) 12 (2) 26 (8)
Immunization status
No nirsevimab 927 (91) 601 (99) 326 (79) 807 (93) 526 (99) 281 (83)
Nirsevimab , ≥7 days earlier 93 (9) 4 (1) 89 (21) 63 (7) 6 (1) 57 (17)
Empirical studies* on nirsevimab product effectiveness (PE) among infants in their first RSV season
Citation Country Sample Size
(Number of
Infants)Study Design PE (95% Confidence Interval)
Ares -Gomez et al., 2024 Spain 10,259 Prospective CohortHospitalization for RSV -related LRTI: 82% (95% CI: 66% - 90%)
Severe RSV -related LRTI requiring oxygen support: 87% (95% CI: 69% - 94%)
All-cause LRTI hospitalizations: 69% (56% - 78%)
All-cause hospitalizations:  66% (56% - 74%)
Coma et al., 2024 Spain 26,525Retrospective
CohortHospital admission for RSV -related disease: 88% (95% CI: 82% - 91%)
Hospital ER visits due to bronchiolitis: 55% (95% CI: 48% - 62%)
Medically attended RSV infection: 69% (95% CI: 52% - 80%)
Primary care attended bronchiolitis: 48% (95% CI: 42% - 53%)
Viral pneumonia diagnosed in primary care: 61% (95% CI: 24% - 80%)
ICU admission for RSV -related disease: 90% (95% CI: 76% - 96%)
Estrella -Porter et al., 2024 Spain 27,362Retrospective
CohortMedically attended RSV infection: 74% (95% CI: 65% - 80%)
Ezpeleta et al., 2024 Spain 1,177 Prospective CohortHospitalization due to RSV: 89% (95% CI: 70% - 96%)
RSV infection attended in the ER: 88% (95% CI: 70% - 95%)
RSV ICU admission: 86% (95% CI: 13% - 98%)
Lopez -Lacort et al., 2024 Spain 166Screening and Test
negative case
controlRSV -LRTI hospital admission (pooled data across several regions):
Screening methods: 84% (95% CI: 77% - 90%)
Test negative design: 70% (95% CI: 38% - 89%)
Paireau  et al., 2024 France 288Test negative case
controlRSV bronchiolitis hospitalized In the pediatric ICU: 76% (95% CI: 49% - 89%)
Aguera  et al., 2024 Spain 181Test negative case
controlHospitalization for RSV -related LRTI:  81% (95% CI:  61% - 91%)
Severe RSV -related LRTI requiring NIV/CMV:  86% (95% CI:  42% - 96%)
*Published during June 20, 2023, through June 21, 2024
LRTI = lower respiratory tract infection | ER = emergency room | ICU = intensive care unit | CI = confidence interval | NIV: noninvasive ventilation | CMV:  continuous mandatory ventilation

Summary: Summary of effectiveness of nirsevimab  in infants Amanda Payne, PhD, MPH Coronavirus and Other Respiratory Viruses Division Centers for Disease Control and Prevention June 28, 2024National Center for Immunization and Respiratory Diseases •Real -world vaccine/product effectiveness methods •Effectiveness of nirsevimab  in the United States -RSV-associated emergency department encounters & hospitalization, VISION -RSV-associated medical encounters and hospitalization, NVSN •Effectiveness of…


05 RSV Mat Peds Jones 508

Maternal/Pediatric RSV Work Group Considerations
CDR Jefferson Jones, MD MPH FAAP, USPHS
Co-lead, Respiratory Syncytial Virus Vaccines – Maternal/Pediatric
Work Group
Coronavirus and Other Respiratory Viruses Division
ACIP General Meeting
June 28, 2024National Center for Immunization and Respiratory Diseases
•Anticipated supply of maternal RSV vaccine and nirsevimab
•Updates on post -introduction nirsevimab and maternal RSV vaccine safety
and effectiveness monitoring
•Revaccination of pregnant people during subsequent pregnanciesOutline
•For maternal RSV vaccine, no anticipated supply/demand mismatch
•For nirsevimab, limited availability beginning early September, ramping up
during September, broadly available by October 1
•Original ACIP recommendations (as published in MMWR ) apply for 2024 -
25 RSV season
•All infants are recommended to be protected by either maternal RSV
vaccination or nirsevimab for the 2024 -25 RSV seasonAnticipated supply of maternal RSV vaccine and
nirsevimab for 2024 –2025 RSV season
Updates on post -introduction nirsevimab and
maternal RSV vaccine safety and effectiveness
monitoring
•Among reports received in VAERS after maternal Pfizer RSV vaccine, the
most frequent adverse events reported were local and systemic symptoms
(e.g., headache) and pregnancy specific conditions (e.g., preterm delivery)
-Expected for a vaccine recommended for pregnant persons at 32 -36 weeks’
gestation
-No verified reports of Guillain Barré syndrome
•Preliminary findings in the Vaccine Safety Datalink (VSD) suggest that the
incidence of preterm births is 4.1% among pregnant persons who received
Pfizer RSV vaccine during the 2023 -2024 respiratory season
-Within VSD’s expected historical range of the incidence of preterm births at 32 -36
weeks’ gestation (3.1–6.1%) before introduction of this vaccine
-Matched analysis for preterm birth and other safety outcomes is in progressMaternal RSV vaccine safety
The Vaccine Adverse Event Reporting System (VAERS)
Vaccine Safety Datalink (VSD) | CDC
•Suspected adverse reactions after nirsevimab administration are
recommended to be reported to MedWatch
-These reports are entered into the FDA Adverse Event Reporting System (FAERS)
database
•If administered on the same day as a vaccine, suspected adverse reactions
after nirsevimab are reported to VAERS
-FDA/CDER reviewers review these VAERS reports
•Similar to VAERS, an incidence of an adverse event cannot be determined
from voluntary reportingNirsevimab adverse event reporting
FDA Adverse Event Reporting System (FAERS) Public Dashboard | FDA
•The most frequently reported adverse events involved patients who
reportedly developed breakthrough RSV infections despite receiving
nirsevimab, and included signs, symptoms, or complications of these
infections (e.g., bronchiolitis)
•Cases of serious hypersensitivity reactions with nirsevimab were identified
in the post -marketing setting and the product labeling was updated in
February 2024
-Serious hypersensitivity reactions have been reported following BEYFORTUS
administration. These reactions included urticaria, dyspnea, cyanosis, and/or
hypotonia.
•No additional safety signals have been identified at this timeSummary of nirsevimab post -marketing adverse
events reported to FAERS and VAERS
FDA Adverse Event Reporting System (FAERS) Public Dashboard | FDA
•Safety data on nirsevimab  and maternal RSV vaccine are reassuring, but
population -based studies with comparison groups are needed and pending
•Because of U.S. recommendation that Pfizer maternal RSV vaccine be given
at 32 –36 weeks gestation, unlikely to accumulate U.S. data on safety of
vaccine given at 24 –31 weeks gestation
•Hypersensitivity reactions in young infants are rare and can be difficult to
discern from startle reactions or vasovagal reactions1WG considerations on safety
1Agrabenhenrich  et al. 2016 J Allergy Clin Immunol
•Effectiveness against RSV -associated hospitalization was 91% in NVSN and
98% in VISION
•Effectiveness against any medically attended RSV -associated ARI episode
in NVSN was 89%, and effectiveness against RSV -associated ED visits was
77% in VISION
•CDC platform estimates are consistent with studies in Europe,1
•Longer follow up time needed to determine duration of protection
•Limited impact on RSV hospitalization burden, likely because of late
administration
-Substantial decreases in RSV -associated hospitalizations in young infants reported
in Spain, Luxembourg, and Italy with early implementation and high coverage2Nirsevimab effectiveness
1 Consolati  Vaccine 2024 ; Ezpeleta  Vaccine 2024 ; Lopez -Lacort  Eurosurveillance 2024 ; Ares -Gomez Lancet Inf Dis 2024;  Coma SSRN preprint 2024 ;
2Ernst Eurosurveillance 2024 ; Consolati  Vaccine 2024 ; Mazagatos  Influenza Other Respir Viruses 2024
•Unable to estimate maternal RSV vaccine effectiveness during the 2023 -24
season due to
-Limited uptake of maternal RSV vaccine
-Early onset of the 2023 -2024 RSV season
-Timing of vaccine rollout
•CDC will continue to monitor maternal RSV vaccine effectiveness in future
seasonsMaternal RSV vaccine effectiveness
•Evidence shows nirsevimab to be highly effective
•Duration of protection from nirsevimab and maternal vaccination remains
unknown
•Important studies are needed for 2024 -25 season and future RSV seasons
-Maternal vaccine effectiveness
-Nirsevimab effectiveness with longer follow up time, which should be available
with earlier widespread availability
-Nirsevimab effectiveness among children aged 8 –19 months with increased risk
for severe disease during their second RSV season
-Impact on RSV burden when nirsevimab and maternal vaccine are given with
earlier administration and potentially increased uptakeWG considerations on effectiveness
Revaccination of pregnant people during
subsequent pregnancies
•ACIP recommendations for Pfizer RSV maternal vaccine state that
-Currently, no data are available on either the efficacy of the first lifetime dose to
protect infants born after subsequent pregnancies or the safety of additional
doses given during subsequent pregnancies. Additional data are needed to
determine whether additional seasonal doses during subsequent pregnancies are
indicated, and ACIP might update recommendations in the future, as data become
available.
•Still no data on additional RSV vaccine doses in subsequent pregnancies
•There are potentially people who received an RSV vaccine during
pregnancy for the 2023 -24 RSV season who could have a subsequent
pregnancy during the 2024 -2025 RSV seasonAdditional RSV vaccine doses in subsequent
pregnancies
Pfizer ABRSYSVO vaccine efficacy against primary clinical trial
outcomes over time among adults aged ≥60 years
Vaccine Primary outcomeEfficacy (95% CI),
months 0 –12aEfficacy (95% CI),
months 13 –24a
Pfizer ABRYSVORSV LRTI with ≥2 lower
respiratory sx62%  (41, 76)
Median 12 months follow -up per
participant55%  (26, 73)
Median 6 months follow -up per
participant
RSV LRTI with ≥3 lower
respiratory sx86%  (63, 96)
Median 12 months follow -up per
participant74%  (27, 92)
Median 6 months follow -up per
participant
Abbreviations: CI: confidence interval, LRTI: lower respiratory tract illness, sx: signs or symptoms, LRTD: lower respiratory tract disease
a.Nominal 12 -month efficacy. Not all trial participants contributing to each estimate had 12 months’ follow up time. Median per -
participant follow -up time is reported below each estimate.
•Antibody titer lower following 2nd dose at 12 months than initial response
•Antibody titer prior to 2nd dose above baselinePfizer RSV vaccine Phase 1/2 immunogenicity results in
nonpregnant adults
J Infect Dis , jiae185, https://doi.org/10.1093/infdis/jiae185
•ACIP Tdap recommendations state that "When ACIP considered
recommending Tdap vaccination during each pregnancy, the safety
information concerning booster doses of Tdap in pregnant women
previously vaccinated with Tdap was not available"
•"ACIP recognized the need for safety studies of severe adverse events
when Tdap is administered during subsequent pregnancies but concluded
that the potential benefit of preventing pertussis morbidity and mortality
in infants too young to be fully vaccinated outweighs the theoretical
concern of possible localized severe adverse events in pregnant women
receiving Tdap. ACIP also concluded that experience with tetanus toxoid –
containing vaccines suggests no excess risk for severe adverse events
among women receiving Tdap with each pregnancy."Tdap recommended during each pregnancy
Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committe e on Immunization Practices
(ACIP) | MMWR (cdc.gov)
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) in Pregn ant Women — Advisory
Committee on Immunization Practices (ACIP), 2012 (cdc.gov)
•Concerning that data in older adults suggest revaccination does not
restore antibody levels to those after first dose
-Antibody levels are particularly important for maternal vaccination since infants
are protected through transplacental transfer of antibodies
•RSV vaccine differs from Tdap vaccine
-Maternal RSV vaccine has a potential safety concern for preterm birth and
hypertensive disorders of pregnancy
-Alternative product, nirsevimab, exists that can protect infants from severe RSV
for subsequent pregnanciesWG consideration on additional RSV vaccine doses in
subsequent pregnancies
https://www.cdc.gov/mmwr/volumes/72/wr/mm7241e1.htm
•Additional data are needed prior to recommending RSV vaccine during
each pregnancy (i.e., during subsequent pregnancies)
-Antibody data in pregnant people and infants with vaccination during subsequent
pregnancies
-Safety data (e.g., reactogenicity) with vaccination during subsequent pregnancies
-Safety data of RSV vaccine during the first pregnancy it is administered,
particularly regarding outcomes of preterm birth and hypertensive disorders of
pregnancyWG considerations for needed data to make RSV vaccine
recommendations during subsequent pregnancies
•People who received a maternal RSV vaccine during a previous pregnancy
are not recommended to receive additional doses during future
pregnancies
•Infants born to people who were vaccinated only during a prior pregnancy
should receive nirsevimab
•Recommendations can be updated in the future if additional data are
availableRecommendations for additional RSV vaccine doses in
subsequent pregnancies
https://www.cdc.gov/mmwr/volumes/72/wr/mm7241e1.htm
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position
of the Centers for Disease Control and Prevention.

Summary: Maternal/Pediatric RSV Work Group Considerations CDR Jefferson Jones, MD MPH FAAP, USPHS Co-lead, Respiratory Syncytial Virus Vaccines – Maternal/Pediatric  Work Group Coronavirus and Other Respiratory Viruses Division ACIP General Meeting June 28, 2024National Center for Immunization and Respiratory Diseases •Anticipated supply of maternal RSV vaccine and nirsevimab •Updates on post -introduction nirsevimab and maternal RSV vaccine safety  and effectiveness monitoring •Revaccination of…