05 Dawson Mening 508

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Meningococcal
(Groups A, C, Y,
andW) Conjugate
Vaccine ( MenQuadfi®)
Extension of use to include
infants from 6 weeks of age

Agenda
Public health
burden of invasive
meningococcal
diseaseRationale for clinical
developmentClinical data from
infant studiesSummary
2
Public health burden of meningococcal disease
•Meningococcal disease remains a major global health challenge because it can strike quickly
and with devastating effect, taking a life in < 24 hours 1,2
•Case-fatality rate is ~10% to 15% even with appropriate treatment2
•~1 in 5 survivors suffer permanent sequelae3,4
•Since introduction of the first MenACWY  conjugate vaccine in 2005, MenACWY -D, IMD
caused by serogroups C, W, and Y has declined by > 90% among adolescents and young adults5
•Infants continue to have the highest incidence of IMD, so we would like to share
information about the performance of Sanofi's MenACYW -TT in this population
1. Thompson MJ, et al. Lancet . 2006;367(9508):397- 403. 2. WHO. https://www.who.int/en/news -room/fact -sheets/detail/meningococcal -meningitis  [accessed March 2020]. 3. CDC.
MMWR . 2013;62(RR -2):1-22. 4. Rosenstein NE, et al. N Engl J Med. 2001;344(18):1378- 1388. 5. MacNeil JR, et al . Clin Infect Dis  2018; 66:1276– 81.
Limb amputation
 Deafness
 Brain damage3
What is MenQuadfi (MenACYW -TT)?
•A quadrivalent meningococcal conjugate vaccine to help prevent invasive meningococcal disease
caused by serogroups A, C, W, and Y
•FDA approved on 23 April 2020 for use in persons 2 years of age and older
•Developed with the ambition of being:
•Used across a broad age range
oStudies to support expansion of age indication to include infants as young as 6 weeks of age are
completed
•Incorporated in various immunization schedules that exist worldwide
•Conjugated to tetanus toxoid (approximately 55 µg)
•Each 0.5 -mL intramuscular dose contains 10 µg each of the 4 meningococcal
polysaccharides
•Fully liquid solution that does not require reconstitution and supplied in a single -dose vial4
Age at First Dose Primary Vaccination Schedule
Infants aged from 6 weeks 4-dose series at 2, 4, 6 and between 12
and 18 months of age. The first dose may
be given as early as 6 weeks.
Infants aged 6 months through 23 months 2-dose series with the second dose
administered in the second year of life and at least 3 months after the first dose.
Individuals 2 years of age and older A single doseProposed Schedule for Primary Vaccination with MenACYW -TT5
Overview of MenQuadfi
Clinical Development
Toddlers
(12–23 Months)
Infants
(6 Weeks –11 Months)
MET42
Phase III
Schedule: 3+1 (2, 4, 6, 12– 18M)
Control MenACWY -CRM
USA
NCT03537508MET58
Phase III
Schedule: 2+1 (2, 4, 12– 18M)
and 3+1 (2, 4, 6, 12– 18M)
Control MCV4 -TT
Europe*
NCT03547271MET52
Phase III
Schedule: 1+1 (3, 12– 13M)
NI when co -ad MenB  and
standard of care vaccines§
(multi -dose)
UK
NCT03632720
MET61
Phase III
Schedule: 1+1 (6M+)
Controls MenACWY -CRM, MenACWY -D
USA
NCT03691610MET41
Phase III
Schedule: 3+1 (2, 4, 6, 12M)
Control MenACWY -CRM
USA
NCT03673462MET33
Phase III
Schedule: 2+1 (2 or 3, 6, 12M)
Control MenACWY -CRM in 3 +1
(2, 4, 6, 12M)
Russia, Mexico
NCT03630705
MEQ00089
Phase III
Schedule: 1+1 (6M+): 6- 7 +12- 13 M
Control: MCV4 -TT
EU
ONGOINGMEQ00065
Phase III
NI / Superiority
Controls MenC -conj and MCV4 -TT
(single -dose)
Denmark, Finland, Germany
NCT03890367
MEQ00086
Interchangeability
Toddlers (12−23M)
Toddlers primed with MenACWY -CRM or MCV4 -TTduring
1Y
Argentina
ONGOINGToddlers
(12–23 Month s)
MET54
Phase II
Control MCV4 -TT
(single dose )
Finland
NCT03205358
MET51
Phase III
Control: MCV4 -TT
(single dose )
Germany, Spain,
Finland, Hungary
NCT02955797
MET57
Phase III
Single dose co -ad* with MMR + varicella, DTaP -IPV-
HB-Hib, or PCV13 (single dose)
No Meninge vaccine control
South Korea, Russia, Mexico, Thailand
NCT03205371MenQuadfi
Clinical
Development
Program in
Infants and
Toddlers
  Coadministration study
  Booster dose study
MenACWY -TT = MenQuadfi , MenACWY -CRM = Menveo, MenACWY -D = Menactra , MCV4 -TT= Nimenrix  (not licensed in US)
-Studies in green font are completed
-Studies in black font are ongoing7
&
MET42
Immunogenicity and Safety
Study of a Quadrivalent
Meningococcal Conjugate
Vaccine (MenACYW -TT) when
Co-administered with Routine
Pediatric Vaccines in Healthy
Infants and Toddlers in the US
and Puerto Rico
Short Study Title Immune Non -inferiority, Safety and Co -
administration study in infants  & toddlers
Study PopulationAge group ≥ 42 to ≤ 89 days
Number of
participants2627
Meningococcal -vaccine naïve
Vaccine GroupsGroup 1: MenACYW -TT + Routine pediatric vaccines
Group 2: MenACWY -CRM + Routine pediatric
vaccines
Vaccination ScheduleSingle dose of MenACYW -TT or MenACWY -CRM (2,
4, 6, and 12 months )
Safety follow upImmediate
Unsolicited
Systemic
AEsWithin 30 minutes after each vaccination
Solicited
AEsDay 0 toDay 7 after each vaccination
Unsolicited
AEsD0 to D30 after each vaccination
SAEs
(AESIs and
MAAEs)Visit1 (day of firstvaccination) untiltheendof the
6-month follow -up period after thelastvaccination.MET42: Study design and demographic data9
Baseline CharacteristicsGroup  1
(N=1746)Group  2
(N=881)
Sex: n (%)
Male 918 (52.6) 466 (52.9)
Female 828 (47.4) 415 (47.1)
Sex ratio: Male/Female 1.11 1.12
Age: (Days)
Mean  (SD) 65.3 (8.02) 65.3 (7.81)
Min ; Max 42.0 ; 89.0 42.0 ; 89.0
Median 64.0 64.0
Racial  origin:  n (%)
American Indian or Alaska
Native 11 (0.6) 3 (0.3)
Asian 15 (0.9) 10 (1.1)
Black or African American 204 (11.7) 99 (11.2)
Native  Hawaiian  or Other  Pacific
Islander7 (0.4) 6 (0.7)
White 1428 (81.8) 722 (82.0)
Mixed  Origin 44 (2.5) 30 (3.4)
Unknown 19 (1.1) 6 (0.7)
Ethnicity:  n (%)
Hispanic or Latino 838 (48.0) 410 (46.5)
Not Hispanic or Latino 897 (51.4) 465 (52.8)
Unknown 3 (0.2) 4 (0.5)
Not reported 8 (0.5) 2 (0.2)
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers in the
US. ClinicalTrials.gov , Sanofi Pasteur, 15 Oct. 2024, https://clinicaltrials.gov/study/NCT03537508
AESI: Adverse events of special interest, MAAE: Medically attended adverse events.
MET42
Safety

24.126.6 28.4 29.833.2 34.7
13.6 13.619.6 18.927.330.134.433.825.528.6 20.220
9.57.512 14.212.712.911.811.4
8.56.5
66.4
1.11.21.72.12.93.4
0102030405060708090100
Crying abnormal Drowsiness Vomitting Fever Apetite lostGrade 1
Grade 2
Grade 3
Group 1: MenACYW -TT and routine pediatric  vaccines; Group 2: MenACWY -CRM and routine pediatric  vaccinesMET42: Solicited injection site & systemic reactions within 7 days after
any dose  11
Injection site Reactions
Tenderness was the most frequently reported solicited injection
site reaction. Erythema and swelling were reactions less
frequently experienced. Most solicited injection site reactions were
of Grade 1 or 2 intensity.Irritability was the most frequently reported solicited systemic
reaction, followed by crying abnormal, drowsiness & appetite lost.
Fever (33.4% vs 35.2%) and vomiting were reactions less frequently
experienced. Most solicited systemic reactions were of Grade 1 or 2
intensity
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers in the
US. ClinicalTrials.gov, Sanofi Pasteur, 15 Oct. 2024, https://clinicaltrials.gov/study/NCT03537508  Systemic Reactions
Irritability Crying abnormal Drowsiness Vomiting Fever34.5 35.332.1 30.9
23.5 21.823.6 23.6
11.7
0.91.29.1 8.7
0.20.5
0.20.4
0102030405060708090100
GROUP 1 GROUP 2 GROUP 1 GROUP 2 GROUP 1 GROUP 2
ERYTHEMA SWELLINGGrade 1
Grade 2
Grade 3
Tenderness Erythema SwellingAppetite
lostGroup  1Group 2 Group 2 Group 2 Group 2 Group  2 Group  2 Group 1 Group 1 Group 1 Group 1 Group  1Percentage of participants
Percentage of participants
MET42: Summary of results
Summary of SAEs, AESIs and unsolicited AEs after any vaccine injections
AESI: adverse events of special interest 99 subjects (5.7%) in Group 1 ( MenACYW -TT), 38 subjects (4.4%) in Group 2 ( MenACWY -CRM) reported SAEs during the study
18 subjects reported AESI during the study: 13 subjects (0.8%) in Group 1 ( MenACYW -TT) and 5 (0.6%) subjects in Group 2
(MenACWY -CRM)
There were 2 subjects (both in Group 1- MenACYW -TT) who discontinued due to SAEs ( Infantile spasms, Cardiac arrest )•2 subjects reported SAEs related to study vaccines during the study:
1 instance of febrile seizure in a participant in Group 1 ( MenACYW -TT) with prior history of seizures. The Febrile seizure was
an AESI (13 days after 15 -month dose)
1 subject reported fever post vaccination in Group 2 ( MenACWY -CRM) (8 hours following 2 -month dose)
•All AESIs were nonrelated to the study vaccines, except the one SAE mentioned above
•There was one death reported in the study. It was deemed unrelated to the study vaccine by the investigator and sponsor
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers in the
US. ClinicalTrials.gov, Sanofi Pasteur, 15 Oct. 2024, https://clinicaltrials.gov/study/NCT03537508  12
MET42
Immunogenicity

95% CI of the single proportion calculated from the exact binomial method.
Group 1a: MenACYW -TT and routine vaccines at 2, 4, 6, and 12 to 15 months of age
Group 2a: MenACWY -CRM at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15
to 18 months of ageVaccine seroresponse * at day 30 after the booster dose (Group 1 vs Group 2) in Per -protocol Analysis Set
*hSBA  vaccine seroresponse  for serogroups A, C, Y, and W was defined as:
•For a subject with a pre -vaccination titer < 1:8, the post- vaccination titer had to be ≥ 1:16
•For a subject with a pre -vaccination titer ≥ 1:8, the post- vaccination titer had to be ≥ 4-fold greater than
       the pre -vaccination titerMET42 primary endpoint 1Percentage of subjects with vaccine seroresponse MET42: Post booster, MenACYW -TT seroresponse  rates were comparable to those
for MenACWY -CRM for serogroups A, Y, W and higher for serogroup C
79.497 96.4 97.6
77.688.292.396.4
0255075100
A C Y WParticipants achieving
seroresponse  (%, 95% CI)
Group 1a: MenACYW-TT (N=675) Group 2a: MenACWY-CRM (N=308)14
Primary objective 1 was met: The percentage of subjects who achieved vaccine seroresponse  rate post -dose 4 for meningococcal
serogroups A, C, W, and Y in MenACYW -TT (Group 1a) are non -inferior  to the corresponding percentages in MenACWY -CRM (Group 2a), as the
lower limit of the 2 -sided 95% confidence interval (CI) of the difference between MenACYW -TT (Group 1a) and MenACWY -CRM (Group 2a) were
higher than -10% for all 4 serogroups
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers in the
US. ClinicalTrials.gov, Sanofi Pasteur, 15 Oct. 2024, https://clinicaltrials.gov/study/NCT03537508
N: number of subjects in per -protocol analysis set 2, for booster series.
95% CI of the single proportion calculated from the exact binomial method.
Group 1a: MenACYW -TT and routine vaccines at 2, 4, 6, and 12 to 15 months of age
Group 2a: MenACWY -CRM at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15
to 18 months of age
PPAS, Per -Protocol Analysis SetMET42 primary endpoint 2Percentage of subjects with hSBA titer >= 1:8 ( seroprotection )MET42: Post 3 -dose infant series, MenACYW -TT seroprotection rates were higher
than those for MenACWY -CRM for all 4 serogroups
77.999 98.3 98.6
67.791.2 91.7 92.9
0255075100
A C Y WParticipants achieving
seroprotection (%, 95% CI)
Group 1a: MenACYW-TT (N=928) Group 2a: MenACWY-CRM (N=460)15
Primary objective 2 was met: Non-inferiority of the percentage of subjects with hSBA titers  to meningococcal serogroups A, C, Y,
and W ≥ 1:8 following administration of 3 doses of MenACYW -TT compared to 3 doses of MenACWY -CRM when given concomitantly with
pediatric routine vaccines  to infants and toddlers at 6 to 7 months of age was demonstrated as the lower limit of the 2 -sided 95% CI of the
difference in hSBA  seroprotection  rates (antibody titers ≥ 1:8) were > -10% for all 4 serogroups
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers in the
US. ClinicalTrials.gov, Sanofi Pasteur, 15 Oct. 2024, https://clinicaltrials.gov/study/NCT03537508
10.6
6.6461.3
4.4543.5
9.9757.9
9.0267.156.9678
90.9296
186387
175
1101001000Geometric means of hSBA
titers
Log scaleD0 D30MET42: Geometric mean of hSBA antibody titers pre-  and post - 4th dose
Summary of secondary immunogenicity results
D, day;
95% CI calculated using calculation for normal distribution on log10( titer) following by antilog transformation
Group 1a: MenACYW -TT and routine vaccines at 2, 4, 6, and 12 to 15 months of age
Group 2a: MenACWY -CRM at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of ageSecondary objective 2: Geometric mean of hSBA  antibody titers against meningococcal serogroups A, C, Y and W after 4th dose of
MenACYW -TT were comparable or generally higher for all serogroups for Group 1a vs Group 2a
Summary of geometric means of hSBA titers at D0 before the 4th dose and D30 after the 4th dose - Per-Protocol Analysis Set 3
Serogroup A C Y WGroup 1a Group 1a Group 1a Group 1a Group 2a Group 2a Group 2a Group 2a16
Secondary objective 1 was met: Non-inferiority of immune responses of the routine pediatric vaccines administered concomitantly with
MenACYW -TT as compared with MenACWY -CRM in infants and toddlers 6 weeks old to 18 months of age was demonstrated
Ab, antibody; ELISA, enzyme -linked immunosorbent assay; GMC, geometric mean concentrations; PRP, anti polyribosyl -ribitol  phosphate
*Pertussis antigen: PT, FHA, PRN, and FIM; †Polioviruses: type 1, type 2, type 3; ‡Pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B , 7F, 9V, 14, 18C, 19A, 19F, and 23F1st Year,
30 days after the
6-month
vaccinationHepatitis B % ≥10 mIU/mL 10% Yes
PRP % ≥0.15 µg/mL 5% Yes
PRP % ≥ 1.0 µg/mL 10% Yes
Polio† % ≥1:8 5% Yes
Rotavirus % ≥ 3 -fold rise 10% Yes
Rotavirus GMC (G1/G2 ratio) 1.5 Yes
Pertussis* GMC (G1/G2 ratio) 1.5 Yes
Pneumococcal‡ GMC (G1/G2 ratio) 2 YesEvaluation
TimeAntigen EndpointNon-
inferiority
marginNon-
inferiority?
2nd Year,
30 days after the 12-month
vaccinationMeasles % ≥ 255 mIU/mL 10% Yes
Mumps% ≥ 10 mumps Ab
units/mL10% Yes
Rubella % ≥ 10 IU/mL 10% Yes
Varicella % ≥ 5 gpELISA units/mL 10% Yes
Pneumococcal‡ GMC (G1a/G2a ratio) 2 Yes
2nd Year,
30 days after the
15-month
vaccinationPRP % ≥1.0µg/mL 10% Yes
Polio† % ≥1:8 5% Yes
Pertussis* Response rate 10% YesMET42: Results on concomitant administration of pediatric vaccines17
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers in the
US. ClinicalTrials.gov, Sanofi Pasteur, 15 Oct. 2024, https://clinicaltrials.gov/study/NCT03537508
MenACYW -TT was non -inferior  to MenACWY -CRM, based on hSBA  vaccine seroresponse  after the 4th dose, when the vaccines
were given at 2, 4, 6, and 12 months of age, along with routine pediatric vaccines
MenACYW -TT was non-inferior  to MenACWY -CRM, based on seroprotection  after the 3rd dose, when the vaccines were given at 2,
4, 6, and 12 months of age along with routine pediatric vaccinesPrimary immunogenicity objectives were met
Non-inferiority  of immune responses to routine pediatric vaccines administered concomitantly with MenACYW -TT as compared with
MenACWY -CRM in infants and toddlers 6 weeks old to 18 months of age was demonstrated
Geometric mean of hSBA  titers against meningococcal serogroups A, C, Y and W after 3rd dose of MenACYW- TT were comparable or
higher for all serogroups in  the MenACYW -TT group vs MenACWY -CRM group
There were no new safety concerns identified
The safety profile and tolerance of MenACYW -TT was comparable to MenACWY -CRM
Safety data from 3211 subjects who received 4 doses of MenACYW -TT (MET41 and MET42) are shown on later slidesSecondary immunogenicity objectives were met
SafetyMET42: Summary of results18
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers in the
US. ClinicalTrials.gov, Sanofi Pasteur, 15 Oct. 2024, https://clinicaltrials.gov/study/NCT03537508
MET41
Safety of a Quadrivalent
Meningococcal Conjugate
Vaccine ( MenACYW -TT)
Administered Concomitantly
with Routine Pediatric Vaccines
in Healthy Infants and Toddlers

Short Study Title Immune Non -inferiority, Safety and Co -administration
study in infants  & toddlers
Study PopulationAge ≥ 42 to ≤ 89 days
Number of
participants2797
Meningococcal -vaccine naïve
Study DesignGroup 1: MenACYW -TT + Routine pediatric vaccines
Group 2: MenACWY -CRM  + Routine pediatric vaccines
Vaccination ScheduleSingle dose of MenACYW -TT or MenACWY -CRM (2, 4,
6, and 12 months )
Safety follow upImmediate
Unsolicited
Systemic
AEsWithin 30 minutes after each vaccination
Solicited
AEsDay 0 toDay 7 after each vaccination
Unsolicited
AEsDay 0 untilthenextstudy visit
SAEs (AESIs
and MAAEs)Visit 1 (day of first vaccination) until the end of the 6 -
month follow -up period after the last vaccination.MET41: Phase III study of MenACYW -TT conjugate vaccine
administered to healthy infants and toddlers20
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers (MET41). ClinicalTrials.gov , Sanofi
Pasteur, 14 Dec. 2023, https://clinicaltrials.gov/study/NCT03673462  Baseline CharacteristicsGroup  1
(N=2099)Group  2
(N=362)
Sex: n (%)
Male 1101 (52.5) 362 (51.9)
Female 998 (47.5) 336 (48.1)
Sex ratio: Male/Female 1.10 1.08
Age: (Days)
Mean  (SD) 64.7 (6.63) 64.9 (6.77)
Min ; Max 42.0 ; 89.0 42.0 ; 89.0
Median 63.0 63.0
Racial  origin:  n (%)
American Indian or Alaska
Native 8 (0.4) 0
Asian 28 (1.3) 12 (1.7)
Black or African American 210 (10.0) 67 (9.6)
Native  Hawaiian  or Other  Pacific
Islander10 (0.5) 5 (0.7)
White 1719 (81.9) 580 (83.1)
Mixed  Origin 102 (4.9) 31 (4.4)
Unknown 12 (0.6) 0
Ethnicity:  n (%)
Hispanic or Latino 566 (27) 197 (28.2)
Not Hispanic or Latino 1526 (72.7) 499 (71.5)
Unknown 0 0
Not reported 7 (0.3) 9 (0.3)
Summary of SAEs, AESIs and unsolicited AEs after any vaccine injections
AESIs, adverse events of special interest; *Brighton Collaboration is a Global Standard for Case Definitions (and Guidelines) for Adverse Events Following Immunization (AEFI) and adverse events of special interest
(AESI). 12 discontinuations occurred due to AEs throughout the study129/2797 (4.6%) subjects reported serious adverse events (SAEs) . None of these SAEs were assessed to be related to the study vaccines.
20/2797 (0.7%) subjects reported 24 AESIs ( febrile or non -febrile seizures ), none related to the study vaccines.
•19/2080 (0.9%) of AESIs occurred in the MenACYW -TT group.
•1/697 (0.1%) of AESIs occurred in the MenACWY -CRM group. •The most common non -serious unsolicited adverse events (AEs) were in the "Infections and Infestations", with respiratory and
gastrointestinal infections being the most frequently reported
•108/2080 (5.2%) of subjects in the MenACYW -TT group reported SAEs.
•21/697 (3%) of subjects in the MenACWY -CRM group reported SAEs. MET41: Summary of results
•Confounding factors were identified in 21/24 (87.5%) of the AESI cases.
•22/24 (92%) of AESI cases did not meet the Brighton Collaboration* case definition criteria for febrile and non -febrile
seizures.
•7 subjects (all in MenACYW -TT) discontinued due to SAEs, including 3 deaths (non- accidental injury to the head, sudden
unexplained death in infancy, found unresponsive)
•None were considered related to the study vaccine or procedure by the investigator and sponsor.21
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers (MET41). ClinicalTrials.gov, Sanofi
Pasteur, 14 Dec. 2023, https://clinicaltrials.gov/study/NCT03673462
MET41 and MET42 pooled safety analysis22
0.52.1 1.25.2
0.3 1.1 0.93.7
0102030405060708090100
Within 7 days after any vaccine
injections (SafAS for full 4-dose)Within 30 days after any vaccine
injections (SafAS for full 4-dose)During 6-month follow-up period
(SafAS for full 4-dose)During the study
(SafAS for full 4-dose)MenACYW-TT + routine pediatric vaccines
(N=3211)MenACWY-CRM + routine pediatric vaccines(N=1327)
1. Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Health y Infants and Toddlers (MET41). ClinicalTrials.gov,
Sanofi Pasteur, 14 Dec. 2023, https://clinicaltrials.gov/study/NCT03673462   2. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered
Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US. ClinicalTrials.gov, Sanofi Pasteur, 15 Oct. 2024, https://clinicaltrials.gov/study/NCT03537508  Participants experiencing at least one SAEPercentage of participants
MET61
Phase III, modified double -blind,
randomized, parallel group,
active -controlled, multicenter
study of Quadrivalent
Meningococcal Conjugate
Vaccine ( MenACYW -TT) in
infants & toddlers from 6
through 23 months of age in the
United States
Short Study Title Immune Non -inferiority, Safety and Co -administration study in infants  &
toddlers
Study PopulationAge Infants 6 to 7 months; Toddlers 17 to 19 months
Number of
participants950
Study DesignGroup 1 : MenACYW -TT
conjugate vaccine + routine pediatric vaccines at 6 to 7months of age and 12 to
13months of age
Group 2 : MenACWY -CRM +
routine pediatric vaccines at 6 to 7months of age and 12 to
13months of ageGroup 3 : MenACYW -TT conjugate
vaccine at 17 to 19 months of age and 20 to 23 months of age
Group 4 : MenACWY -D at 17 to 19
months of age and 20 to 23 months of age
Safety follow upImmediate Unsolicited Systemic AEs: 30 minutes post- vaccination.
Solicited AEs: D0 to D7 post- vaccination
Unsolicited AEs: D0 until the next visit
SAEs (AESIs and MAAEs): Visit 1 to 6 -month follow -upMET61: Phase III Study of immunogenicity and safety of a quadrivalent
meningococcal conjugate vaccine administered concomitantly with routine
pediatric vaccines in healthy infants and toddlers
Baseline
CharacteristicsGroup 1+2Group
 3+4
Characteristic
(950)n=750 n=200
Sex, n (%)Male
Female398 (53.1)  100 (50.0)
352 (46.9) 100 (50.0)
Age in years,
mean (SD)6.01 (0.570) 17.9 (0.652)
Race, n (%)WhiteAfrican -
AmericanMixed Origin541 (72.1)
138 (18.4)
35 (4.5)166 (83.0)
22 (11.0)
9 (4.5)
Ethnicity, n
(%)
Hispanic or
Latino330 (44.0)66 (33.0)24
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers.
ClinicalTrials.gov, Sanofi Pasteur, 25 June 2024, https://clinicaltrials.gov/study/NCT03691610
MET61
Safety

MET61: Solicited injection site reactions within 7 days after any dose
Group 1 (G1): MenACYW -TT vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2 (G2): MenACWY -CRM vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 3 (G3): MenACYW -TT vaccine at 17 to 19 months of age and 20 to 23 months of age
Group 4 (G4): MenaACWY -D vaccine at 17 to 19 months of age and 20 to 23 months of age26
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers.
ClinicalTrials.gov, Sanofi Pasteur, 25 June 2024, https://clinicaltrials.gov/study/NCT03691610  Majority of injection site reactions were Grade 1 (erythema and swelling) and Grade 1 & 2 (tenderness)33.130.236.333
029.9 27.831.9
24
02219.624.2
1314
11.711
7
00.81.20
2
00.3
0.91.1
12.5
2.30
1
00
0.6 0
0
00.30.30
0
0102030405060708090100
G1 G2 G3 G4 G1 G2 G3 G4 G1 G2 G3 G4
Erythema SwellingInjection Site Reactions
Grade 1
Grade 2
Grade 3
TendernessPercentage of participants
MET61: Solicited systemic reactions within 7 days after any dose  27
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers.
ClinicalTrials.gov, Sanofi Pasteur, 25 June 2024, https://clinicaltrials.gov/study/NCT03691610  25.828.724.227
026.4 26.9 26.422
03231.3
23.1 23
015.719.623.1 23
01110.36.71124.2 20.8
20.919
016.611.7 11
9
010.4 11.4
7.74
05.93.57.7 9
04.9 5.56.766.75
3.36
2 1.81.1
32.5 3.2
0
31.71.20 2
0.9 1.2 1.11
0102030405060708090100
Crying abnormal Drowsiness Appetite lost FeverSystemic Reactions
Grade 1
Grade 2
Grade 3
Irritability Crying abnormal Drowsiness Appetite lost FeverG1 G2 G3 G4 G1 G2 G3 G4 G1 G2 G3 G4 G1 G2 G3 G4 G1 G2 G3 G4
Vomiting  occurred less frequently, with 11.8%, 10.8%, 7.7%, and 9% reported in groups 1, 2, 3, and 4, respectivelyPercentage of participants
Group 1 (G1): MenACYW -TT vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2 (G2): MenACWY -CRM vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 3 (G3): MenACYW -TT vaccine at 17 to 19 months of age and 20 to 23 months of age
Group 4 (G4): MenaACWY -D vaccine at 17 to 19 months of age and 20 to 23 months of age
Summary of safety events after any vaccine injections
AESIs, adverse events of special interest MET61: Summary of results28
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers.
ClinicalTrials.gov, Sanofi Pasteur, 25 June 2024, https://clinicaltrials.gov/study/NCT03691610  •A total of 6 participants (1.6%) in Group 1 (MenACYW -TT), 12 participants (3.3%) in Group 2 (MenACWY -CRM), 1 participant (1.0%)
in Group 3 (MenACYW -TT), and 4 participants (3.9%) in Group 4 (MenACWY -D) reported SAEs during the study
•One participant (1.0%) in Group 4 ( MenACWY -D) experienced an SAE (febrile convulsions) that was considered related to vaccination.
This was reported as an adverse event of special interest (AESI).
•All other SAEs were evaluated as non -related to vaccination by Investigators and Sponsor•One participant in Group 2 ( MenACWY -CRM) experienced an immediate unsolicited AE (head injury)
•There  was 1 SAE (acute myeloid leukemia not related to the study vaccines), leading to study discontinuation in Group 2 ( MenACWY -
CRM)
•One participant (0.3%) in Group 1 (MenACYW -TT), 2 participants (0.6%) in Group 2 (MenACWY -CRM), and 2 participants (1.9%) in
Group 4 (MenACWY -D) reported an AESI during the study.  None of these AESI were related to the study vaccines.
•No deaths were reported during the study
MET61
Immunogenicity

MET61: Post booster, MenACYW -TT seroresponse rates were high and
comparable to those for MenACWY -CRM for all 4 serogroups
95% CI of the single proportion calculated from the exact binomial method.
Group 1: MenACYW -TT vaccine + routine pediatric  vaccines at 6 to 7 months of age and 12 to 13
months of age
Group 2: MenACWY -CRM + routine pediatric  vaccines at 6 to 7 months of age and 12 to 13
months of ageVaccine seroresponse* at day 30 after the booster dose (Group 1 vs Group 2) in Per -protocol Analysis Set
*hSBA  vaccine seroresponse  for serogroups A, C, Y, and W was defined as: •For a subject with a pre -vaccination titer < 1:8, the post- vaccination titer had to be
≥1:16
•For a subject with a pre -vaccination titer ≥ 1:8, the post- vaccination titer had to be
≥4-fold greater than the pre -vaccination titer89.499.3 98.6 99.3
82.997.6 97.792.9
0255075100
A C Y WParticipants achieving
seroresponse (%, 95% CI)
Group 1: MenACYW-TT (N=180) Group 2: MenACWY-CRM (N=163)MET 61 primary endpoint 130
Primary objective 1 was met: Post second vaccination at 12 to 13 months of age, non -inferiority of the group 1 vs. group 2 showed the lower
limit of the 95% confidence interval (CI) of the difference in hSBA  seroresponse  for meningococcal serogroups A, C, W, and Y was above - 10%
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers.
ClinicalTrials.gov, Sanofi Pasteur, 25 June 2024, https://clinicaltrials.gov/study/NCT03691610  Percentage of subjects with vaccine seroresponse
Seroprotection : hSBA  antibody titers  ≥ 1:8
N: number of subjects in per -protocol analysis set 2, for booster series.
95% CI of the single proportion calculated from the exact binomial method.
Group 1: MenACYW - TT vaccine + routine pediatric  vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2: MenACWY -CRM + routine pediatric  vaccines at 6 to 7 months of age and 12 to 13 months of age
PPAS, Per -Protocol Analysis SetPercentage of subjects with seroprotection
95.3100 100 1009398.1 97.5 95.6
0255075100
A C Y WParticipants achieving
seroprotection (%, 95% CI)
Group 1: MenACYW-TT (N=180) Group 2: MenACWY-CRM (N=163)MET 61 secondary endpoint 131
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers.
ClinicalTrials.gov, Sanofi Pasteur, 25 June 2024, https://clinicaltrials.gov/study/NCT03691610  MET61: Post booster, MenACYW -TT seroprotection  rates were high and
comparable to those for MenACWY -CRM for all 4 serogroups
Secondary objective was met: Post-second vaccination at 12 -13 months, group 1 demonstrated that at D30, the lower limit of the 95%
confidence interval (CI) for the difference in subjects achieving seroprotection  (hSBA  ≥1:8) for serogroups A, C, W, and Y was above - 10%
compared to group 2.
MET61 : Geometric mean of hSBA  antibody titers pre- and post -2nd
vaccination with MenACYW -TT and MenACWY -CRM

32Summary of secondary immunogenicity results
D, day; GMT, geometric mean titer ; hSBA , human serum bactericidal assay;
95% CI calculated using calculation for normal distribution on log10( titer) following by antilog transformation
Group 1: MenACYW -TT vaccine  + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2: MEenACWY -CRM vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of ageSecondary objective: At D0 (pre- dose 1), baseline hSBA  GMTs for serogroups A, C, Y, and W were comparable between groups, but at D30
post-dose 2 (12– 13 months), they were higher in Group 1 for all serogroups
Summary of geometric means of hSBA  titers at pre-dose D1 and D30 after the 2nd vaccination at 12 -13 months dose -  Per-Protocol Analysis Set 2
Serogroup A C Y W32Geometric  means of hSBA
titers
Log scale
4.73 4.64
2.57 2.48 2.54 2.37 2.23 2.311841191473
319423
133442
106
110100100010000
Group 1 Group 2 Group 1 Group 2 Group 1 Group 2 Group 1 Group 2D1 D30
MET61 : Geometric mean hSBA  titers pre - and post -2nd vaccination with
MenACYW -TT and MenACWY -D
33Summary of secondary immunogenicity results
D, day; GMT, geometric mean titer ; hSBA , human serum bactericidal assay;
95% CI calculated using calculation for normal distribution on log10( titer) following by antilog transformation
Group 3: MenACYW -TT vaccine at 17 to 19 months of age and 20 to 23 months of age
Group 4: MenACWY -D at 17 to 19 months of age and 20 to 23 months of ageSecondary objective: At D0 (pre- dose 1), hSBA  GMTs were comparable between groups, but at 30 days post -dose 2 (20– 23 months), they
were higher in Group 3 for all serogroups
Summary of geometric means of hSBA  titers at pre-dose D1 and D30 after the 2nd vaccination at 20 -33 months dose -  Per-Protocol Analysis Set 2
Serogroup A C Y W33Geometric means of hSBA
titers
Log scale
4.293.432.1 2.41 2.44 2.442.02 2.1245
13.21727
59.4284
45.5202
25
110100100010000
Group 3 Group 4 Group 3 Group 4 Group 3 Group 4 Group 3 Group 4D1 D30
Group 3 Group 4 Group 3 Group 4 Group 3 Group 4 Group 3 Group 4
Summary of immunogenicity findings
Seroresponses  at day 30 following the first dose of MenACYW -TT vaccine co -administered with routine pediatric  vaccines were non-
inferior  to those seen after administration of a primary dose of MenACWY -CRM with routine pediatric  vaccines MET61: Summary of results
• The percentages of participants in both groups with ≥4 -fold rise in titers  pre- vs 30 days post -dose 2 were
comparable for all 4 serogroupsSix to 7 months following administration of a dose of MenACYW -TT vaccine to infants 6 -7 months of age , geometric mean
titers  (GMTs) were comparable  to those seen after administration of a dose of MenACWY -CRM for serogroup A and higher for
serogroups C, W, and Y
Thirty days after dose 2 administered at 20 -23 months of age , the hSBA  GMTs were higher for all serogroups in
participants administrated MenACYW -TT vaccine compared to those who received MenACWY -D
• The percentages of participants with a ≥ 4-fold rise in hSBA  GMTs  for serogroups C, Y, and W were comparable
between the 2 vaccine groups and higher for serogroup A after MenACYW -TT vaccine administration compared to
MenACWY -D
MenACYW -TT vaccine  is immunogenic and  demonstrates  an acceptable  safety  profile
when  administered  to infants  6 months  through 23 months  of age in a 2-dose
schedule .34
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric  Vaccines in Healthy Infants and Toddlers.
ClinicalTrials.gov , Sanofi Pasteur, 25 June 2024, https://clinicaltrials.gov/study/NCT03691610
Conclusion
MenACYW -TT demonstrated robust immunogenicity & reassuring safety
profile in infants & toddlers starting vaccination as early as 6 weeks of
age
•The expanded indication for MenACYW -TT is a valuable public health option to facilitate
immunization across the lifespan from 6 weeks & above
•Immunogenicity  results demonstrate non -inferior immune responses, administered with
routine pediatric vaccines, compared to currently licensed MenACWY  conjugate vaccines
•No unexpected safety concerns were found in infants and toddlers (from 6 weeks to 23
months) compared to the safety profile in individuals ≥2 years and other licensed
MenACWY  conjugate vaccines
•No relevant safety profile differences were observed based on sex or race
•The safety profile of 237 infants with a history of preterm birth (31-36 weeks
gestational age)** was comparable to infants who had been born full -term, with no new
safety concerns or AEs leading to study discontinuation
 36** all prematurely born infants were either enrolled in studies MET41 and MET42
Thank
you

Summary: FOR USE ONLY BY SANOFI MEDICAL AFFAIRS FOR SCIENTIFIC EXCHANGE PURPOSES. DO NOT COPY OR DISTRIBUTEMAT-US-2204183 -R -NONDISTRIB -EXP 7/3/26 Meningococcal  (Groups A, C, Y,  andW) Conjugate  Vaccine ( MenQuadfi®) Extension of use to include  infants from 6 weeks of age  Agenda Public health  burden of invasive  meningococcal  diseaseRationale for clinical  developmentClinical data from  infant studiesSummary 2 Public health burden of meningococcal disease  •Meningococcal disease remains a major…


06 Schillie mening 508

Work Group Considerations Regarding
MenQuadfi in Infants
Sarah Schillie, MD, MPH, MBA
Advisory Committee on Immunization Practices
April 16, 2025National Center for Immunization & Respiratory Diseases
1
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position o f
the U. S. Centers for Disease Control and Prevention.
Studies Reviewed
Three Phase III studies in U.S. infants aged 6 weeks – 19
months
– 4,321 infants enrolled in MenACWY -TT arm
•2 studies:  3+1 schedule (ages 2, 4, 6, 12 or 12– 18 months)
•1 study:  1+1 schedule (age ≥6 months)
–Comparator vaccine:  1,717 infants received MenACWY -CRM or
MenACWY -D
Vaccine co -administered with pediatric vaccines (6 arms)
2 of 13
Seroresponse:  Met42
3 of 13

Seroresponse:  Met61
4 of 13
4 of 11
Solicited Local and Systemic Adverse Reactions:  Met42
Group 1=
MenACWY -TT
+ routine pediatric vaccines
Group 2
=MenACWY -
CRM + routine pediatric vaccines
5 of
 13

Solicited Local Adverse Reactions:  Met61
Group 1= MenACWY -TT +
routine pediatric vaccines
at 6-7 months and 12 -13
months
Group 2 =MenACWY -CRM
+ routine pediatric
vaccines at 6 -7 months
and 12 -13 months
Group 3 =MenACWY -TT at
17-19 months and 20 -23
months
Group 4 =MenACWY -D at
17-19 months and 20 -23
months
6 of 13
Solicited Systemic Adverse Reactions:  Met61
Group 1= MenACWY -TT +
routine pediatric vaccines
at 6-7 months and 12 -13
months
Group 2 =MenACWY -CRM
+ routine pediatric
vaccines at 6 -7 months
and 12 -13 months
Group 3 =MenACWY -TT at
17-19 months and 20 -23
months
Group 4 =MenACWY -D at
17-19 months and 20 -23
months
7 of 13
SAEs, AESIs, and Unsolicited AEs
Met41:  Imbalance of febrile/non- febrile seizures
–19 subjects in intervention group (n=2080, 0.9%) vs. 1 in
comparison group (n=697, 0.1%) with febrile or non -febrile
seizures
–All deemed not related to study vaccine by primary investigator and sponsor
Met42:  1 febrile seizure who received study vaccine
–Prior history of seizures/deemed related to study vaccine
SAE, serious adverse event; AESI, adverse event of special interest; AE, adverse event8 of 13
SAEs, AESIs, and Unsolicited AEs, cont.
4 total deaths, all in intervention group and all deemed
unrelated to study vaccine by primary investigator and sponsor
–Met41:
•Non -accidental injury of the head (30 days after vaccination)
•Sudden unexplained death in infancy (24 days after vaccination)
•Found by parent unresponsive in bed (4 days after vaccination)
–Met42:
•Cardiac arrest (6 days after vaccination)
–Met61:
•No deaths
SAE, serious adverse event; AESI, adverse event of special interest; AE, adverse event9 of 13
Pooled Safety Analysis:  Met41 and Met42
10 of 13

Summary
Post -dose 4 seroresponse  overall similar for MenQuadfi vs. comparator
–Higher GMTs for Serogroup C among MenQuadfi  recipients (vs. comparator)
Safety
–Solicited local and systemic reactions generally similar between
study groups
•Local reactions slightly greater for MenQuadfi  in Met61
–Among MenQuadfi recipients in Met41 and Met42, greater
proportion of:
•Febrile/non -febrile seizures
•Serious Adverse Events
•Deaths 11 of 13
Summary, cont.
Results among healthy infants may not be representative of
results for infants recommended for vaccine based on risk factors
–Similar studies typically limited to healthy infants
High attrition rates
–Attributed to out -of-window visits, missed blood draws, COVID -19
pandemic
Benefits of another vaccine option may outweigh risks
12 of 13
13Acknowledgements
Lucy McNamara
Avnika Amin
Alison Albert
Amy Rubis
LeAnne Fox
Noele Nelson
Susan Hariri
2 of 1113 of 13

Summary: Work Group Considerations Regarding  MenQuadfi in Infants Sarah Schillie, MD, MPH, MBA Advisory Committee on Immunization Practices April 16, 2025National Center for Immunization & Respiratory Diseases 1 The findings and conclusions in this report are those of the authors and do not necessarily represent the official position o f  the U. S. Centers for Disease Control and Prevention. Studies Reviewed Three Phase III studies in U.S. infants aged 6 weeks – 19  months – 4,321 infants enrolled in…


01 Shaw Adult RSV 508

RSV Vaccination in Adults:
Introduction
Albert Shaw, MD, PhD
Chair, Adult RSV Work Group
Advisory Committee on Immunization Practices
April 16, 2025National Center for Immunization and Respiratory Diseases
2Adult RSV Work Group Membership
ACIP Voting Members
Albert Shaw (Chair)
Helen Chu
Mini Kamboj
Keipp Talbot
Ex Officio Members
Nicholas Geagan (FDA)
Rachel Zhang (FDA)
Michelle Juaneza (HRSA)
Uzo Chukwuma (IHS)
Sonnie Kim (NIH/NIAID)CDC Co -Leads
Amadea Britton
Michael Melgar
Diya SurieConsultants
Robert Atmar (Baylor College of Medicine)
Peter Donofrio (Vanderbilt University)
Marie Griffin (Vanderbilt University)
Camille Kotton (Massachusetts General Hospital)
Cynthia Lucero (Veterans Health Administration)
Tracy Ruckwardt (NIH/NIAID)
Jonathan Temte  (University of Wisconsin)Liaisons
Bindy Crouch (AIM)
April Killikelly (NACI, PHAC)
Gretchen LaSalle (AAFP)
Ruth Lynfield (NFID)
Steven Pergam (IDSA)
Kenneth Schmader (AGS)
Winnie Siu (NACI, PHAC)
Elizabeth Skoy ( APhA )
Vidya Sundareshan (ACP)
Katherine Williams (APTR)
3CDC Contributors
Melissa Coughlin
Fatima Dawood
Jarrett Gartin
Monica Godfrey
Fiona Havers
Suzanne Heitfield
Michele Hlavsa
Jefferson Jones
Ruth Link -Gelles
Amber Kautz
Agustin  Lopez
Josephine Mak
Meredith McMorrow
Noelle -Angelique MolinariDanielle Moulia
Ismael Ortega -Sanchez
Lakshmi Panagiotakopoulos
Pragna Patel
Monica Patton
Amanda Payne
Mila Prill
Lauren Roper
Melisa Shah
Natalie Thornburg
Dennis Wang
Trang WisardImmunization Safety Office
Tarayn Fairlie
Julianne Gee
Anne Hause
Sarah Meyer
Michael McNeil
Pedro Moro
Christine Olson
David Shay
John Su
Evelyn Twentyman
Eric WeintraubImmunization Services Division
Carla Black
Kayla Calhoun
Nicole Dowling
Jennifer Kriss
Andrew Leidner
Jamison Pike
Influenza Division
Jill Ferdinands
Lisa GrohskopfNCIRD Office of the Director
Jessica MacNeil
Hannah Rosenblum
Melinda WhartonCoronavirus and Other Respiratory Viruses Division
4June 2024  ACIP Recommendations for RSV Vaccination
in Older Adults:
ACIP recommends all adults aged ≥75 years and adults aged 60 –74 years
who are at increased risk of severe RSV disease receive a single dose of RSV
vaccine.1,2
1. Recommendation is for any Food and Drug Administration –approved RSV vaccine ( Arexvy  [GSK];
Abrysvo  [Pfizer]; or mResvia  [Moderna]). There is no product preference.
2. Eligible adults are currently recommended to receive a single dose of RSV vaccine; adults who have
already received RSV vaccination should not receive another dose.
5Chronic medical conditions and other risk factors associated
with increased risk of severe RSV disease
Neurological or neuromuscular conditions
causing impaired airway clearance or
respiratory muscle weaknessChronic cardiovascular
disease
Moderate or severe
immunocompromise Diabetes mellitus
complicated by chronic kidney disease,
neuropathy, retinopathy or other end -
organ damage or requiring treatment
with insulin or sodium -glucose
cotransporter -2 (SGLT2) inhibitorSevere obesity
(body mass index
≥40 kg/m2)Chronic lung
or respiratory
disease
End stage renal
disease/dialysis
dependenceChronic liver
diseaseChronic hematologic
conditions
Residence in a
nursing homeOther chronic medical conditions or risk factors that a
provider determines would increase risk of severe disease
due to viral respiratory infection (e.g., frailty)
Britton A, Roper LE, Kotton CN, et al. Use of Respiratory Syncytial Virus Vaccines in Adults Aged ≥60 Years: Updated Recommen dations of the Advisory Committee on Immunization Practices — United States, 2024. MMWR Morb  Mortal Wkly  Rep 2024;73:696 -702.
DOI: http://dx.doi.org/10.15585/mmwr.mm7332e1 .
6•Protein subunit (based on RSV F protein in prefusion conformation)
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•Messenger RNA (mRNA, encoding RSV F protein in prefusion conformation)
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download
7•Protein subunit
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•mRNA
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
Approved for prevention of
lower respiratory tract
disease (LRTD) caused by RSV
in adults aged ≥60 years
1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download
8•Protein subunit
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•mRNA
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
Approved for prevention of
LRTD caused by RSV in adults
aged 50 –59 years who are at
increased risk for LRTD
caused by RSV*
1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download*There is no current ACIP recommendation for RSV
vaccination in adults aged <60 years, except  for the maternal
vaccination recommendation:
https://www.cdc.gov/mmwr/volumes/72/wr/mm7241e1.htm
9•Protein subunit
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•mRNA
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
Approved for prevention of
LRTD caused by RSV in adults
aged 18 –59 years who are at
increased risk of LRTD
caused by RSV*
1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download*There is no current ACIP recommendation for RSV
vaccination in adults aged <60 years, except  for the maternal
vaccination recommendation:
https://www.cdc.gov/mmwr/volumes/72/wr/mm7241e1.htm
10•Protein subunit
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•mRNA
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
Also approved and
recommended for active
immunization in pregnancy*
at 32 –36 weeks gestational
age for the prevention of
LRTD and severe LRTD caused
by RSV in infants from birth
through 6 months of age.
*There is no current ACIP recommendation for RSV
vaccination in adults aged <60 years, except  for the maternal
vaccination recommendation:
https://www.cdc.gov/mmwr/volumes/72/wr/mm7241e1.htm  1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download
11•Protein subunit
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•mRNA
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
PDUFA: Prescription Drug User Fee Act
1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download
4. https://investors.modernatx.com/news/news -details/2025/Moderna -Reports -Fourth -Quarter -and-Fiscal -Year -2024 -Financial -Results -and-Provides -Business -
Updates/default.aspx  Moderna has submitted
an application for
licensure for adults aged
18–59 years who are at
increased risk of LRTD
caused by RSV. PDUFA
date June 12th, 2025.4
12•Adult RSV Work Group will propose a policy recommendation for age expansion of
the use of RSV vaccines to include adults aged 50 -59 years at increased risk of severe
RSV disease.
•Immunobridging  and safety data in adults aged 50 -59 years at increased risk of
severe RSV disease were previously presented to ACIP by GSK and Pfizer; today
Moderna will present immunobridging  and safety data in adults aged 18 -59 years at
increased risk.
•ACIP will also see presentations from manufacturers on immunogenicity and safety
of re -vaccination and economic analyses of RSV vaccination in adults aged 50 -59
years at increased risk.
•Then we will share the complete Evidence to Recommendation framework and
propose a policy recommendation for an ACIP vote.Today’s meeting
13
Acknowledging there is also one FDA -approved vaccine for RSV
prevention in adults aged <50 years, the Work Group continues to
evaluate recommendations for RSV vaccination in this age group
14•The Work Group recognizes that certain adults aged <50 years may
benefit from RSV vaccination
•However, the Work Group has indicated there are likely important
differences in considering a recommendation for adults aged <50 years
compared to adults aged ≥50 years, including:
-Absolute risk of RSV -associated disease and which medical conditions increase risk the most
-Risk-benefit balance
-Cost -effectiveness
-Importance of ability to restore protection with revaccination
•As of today’s meeting, information on the absolute risk of RSV -
associated disease among adults with risk conditions is still being
analyzed and estimates of risk -benefit balance and cost -effectiveness of
vaccination in younger adults are not yet available. Policy for the use of RSV vaccines in adults aged <50
years will be revisited at the June 2025 meeting.
15•The Work Group is also reviewing or anticipates reviewing the following data
deemed critical for a recommendation in adults aged <50 years:
-The projected balance of public health benefits and risks considering uncertainty in vaccine -
associated Guillain -Barré syndrome risk in a younger population
-Evidence of RSV vaccine immunogenicity or effectiveness in adults with the most severely
immunocompromising conditions
-The duration of protection over time in adults aged ≥60 years who were vaccinated in 2023
-Available data on immunogenicity of revaccination with different vaccine platforms and
revaccination intervals
•The Work Group has indicated it needs to review these data and needs additional
time to consider the best policy option in adults aged <50 years.
•The Work Group welcomes ACIP’s thoughts about adults aged <50 years during
discussion at the end of today’s session. Policy for the use of RSV vaccines in adults aged <50
years will be revisited at the June 2025 meeting.
16Agenda: Wednesday April 16, 2025
•Manufacturer Presentation: mRNA -1345 (Moderna)
Immunogenicity in Adults Aged 18 -59 Years at Increased Risk; 24 -
Month Re -Vaccination
•Manufacturer Presentation: Arexvy  (GSK) 36 -Month Re -
Vaccination
•Economic Analysis of Adult RSV Vaccination, including benefits
and risk discussion
•Comparison of Economic Analyses of Adult RSV Vaccination

•Evidence to Recommendations
•Clinical Considerations

•ACIP discussion and vote •Dr. Frances Priddy (Moderna)
•Dr. Susan Gerber (GSK)
•Dr. Ismael Ortega -Sanchez (CDC) on behalf of Dr.
David Hutton (University of Michigan)
•Dr. Ismael Ortega -Sanchez (CDC)
•Dr. Michael Melgar, Dr. Diya Surie (CDC)
•Dr. Diya Surie (CDC)
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.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: RSV Vaccination in Adults: Introduction Albert Shaw, MD, PhD Chair, Adult RSV Work Group Advisory Committee on Immunization Practices April 16, 2025National Center for Immunization and Respiratory Diseases 2Adult RSV Work Group Membership ACIP Voting Members Albert Shaw (Chair) Helen Chu Mini Kamboj Keipp Talbot  Ex Officio Members Nicholas Geagan (FDA) Rachel Zhang (FDA)  Michelle Juaneza (HRSA) Uzo Chukwuma (IHS) Sonnie Kim (NIH/NIAID)CDC Co -Leads Amadea Britton Michael Melgar Diya…


02 Priddy Adult RSV 508

1
© 2025  Moderna,  inc. All rights  reserved.RSV Vaccine  (mRNA -1345)  Update:
-Safety  & Immunogenicity  in 18-59 Year  Olds
at increased  Risk for RSV Disease *
-Revaccination  of Adults  at 12 or 24 Months *
ACIP
Frances  Priddy,  MD MPH
April  16, 2025
* mRESVIA  has not been  authorized  for these  indications
2
RSV Vaccine  (mRNA -1345)  Clinical  Development
NCT05127434,  NCT05330975,  NCT06060457,  NCT06067230
Efficacy,  Immunogenicity,  Safety,  and Correlate  of Protection
Adults  ≥60 years
Study  301
Adults  ≥50 years
Study  302 - Part A and B
Concomitant  Administration
with Standard  Dose  Influenza  or
COVID -19
Adults  ≥65 years
Study  304
Concomitant  Administration
with High  Dose  Influenza
Adults  18-59 years
Study  303 – Part A
Safety  and Immunogenicity  in
Adults  at Increased  Risk
Adults  ≥50 years
Study  302 – Part CAdults  ≥60 years
Study  301 – Part BAdults  with SOT ≥18 years
Study  303 – Part B
12 Month  Revaccination
 24 Month  Revaccination
Safety  and Immunogenicity  in
Immunocompromised
© 2025  Moderna,  inc. All rights  reserved.
3
Adult  RSV hospitalizations
•37% in 18-64-year -olds
•24% in 50-64-year -olds
•22% required  ICU
admission
•3% in-hospital mortalityComorbidityIncidence  rate ratio  for those  with versus  those
without  comorbidity  among  adults  18-64 years
0 40
Asthma2.0 – 3.6
CAD0.9 – 7.0
Diabetes3.4 – 11.4
COPD3.2 – 6.4
CHF*13.3 – 33.2US Hospitalization  Rates  for RSV in 18-64 Year  Olds  with
Underlying  Conditions
CAD  - coronary  artery  disease;  CHF - congestive  heart  failure;  COPD  - chronic  obstructive  pulmonary  disease;  RSV - respiratory  syncytial  virus
*CHF  age 20-59 years
Branche  AR, et al. Clin Infect  Dis. 2022.
RSV-NET Analysis  –Adults  Hospitalized
with Laboratory  Confirmed  RSV
2016 -2023  (N=16,575)Estimated  incidence  of RSV-associated  Hospitalization
in 2 Regions  of New  York  State,  US, 2017 -2020  (N=1099)
Havers  FP, et al. JAMA  Netw  Open . 2024.
© 2025  Moderna,  inc. All rights  reserved.
4
© 2025  Moderna,  inc. All rights  reserved.mRNA -1345  in Adults,18 -59 Years,
at Increased  Risk of RSV Disease
Study  303, Part A
ISIRV  2025
5Study  Design  – Randomized  Double -Blind  Study  in
18-59-Year -Old Adults  at Increased  Risk of RSV Disease
Study  303, Part A
Coronary  Artery  Disease  (CAD)
and/or
Congestive  Heart  Failure  (CHF)mRNA -1345  Dose
COPD,  Persistent  Asthma , Pulmonary
Fibrosis,  and/or  Other  Chronic
Respiratory  DiseasesUnderlying  Disease  Category
50 µg
N ~ 150
50 µg
N ~ 150
50 µg
N ~ 200Diabetes  Mellitus  1 or 2•Day 29 immunogenicity
compared  between  this
population  and adults
≥60 years  in pivotal
efficacy  trial
•Participants  followed  for
24 months
United  States
 Canada
 United  Kingdom
© 2025  Moderna,  inc. All rights  reserved.
6
Comparison  of seroresponse  rates  (SRR)  of 50 µg high-risk 18-59 years  olds vs
50 µg ≥ 60-year -olds in pivotal  efficacy  study
•Criteria  for Noninferiority:  95% CI of SRR difference  LB > -10%
Secondary  ObjectiveKey Study  Objectives
Study  303, Part A
Primary  Objectives
1.Safety  and tolerability  of the vaccine  in high-risk 18-59-year -olds
2.Compare  RSV-A and RSV-B GMTs  at Day 29 after  a single  dose  of 50 µg in
high-risk adults,  18-59 years,  versus  adults  ≥60 years  in the pivotal  phase  2/3
efficacy  trial
•Criteria  for Noninferiority:  95% CI of GMR  LB > 0.667
© 2025  Moderna,  inc. All rights  reserved.LB – lower  bound,  CI – confidence  interval;  GMR – geometric  mean  ratio;  SCR – seroconversion  rate;  SRR – seroresponse  rate
7
(stage  0,1,2,3,4)
© 2025  Moderna,  inc. All rights  reserved.Underlying  Medical  Conditions  of Study  Participants
Physician -documentation  required  for all underlying  medical  conditions
•CAD
•CHF*
•Chronic  respiratory  disease
− COPD*
− Persistent  asthma  – requiring  ≥1 maintenance  medication
− Pulmonary  fibrosis
− Other  chronic lung  disease
•Stable  type  1 or type  2 diabetes  mellitus
− Controlled  with ≥1 medication  started  90 days  prior  to Day 1
CAD,  coronary  artery  disease;  CHF,  congestive  heart  failure;  COPD,  chronic  obstructive  pulmonary  disease;  RSV, respiratory  syncytial  virus.
*Severity  of CHF and COPD  assessed  at baseline  using  NYHA  Functional  Classification  for CHF (stage  I, II, III, IV), or modified  MRC  Dyspnea  Scale  for COPD
8
Sept  18, 2024  data  cutoff
© 2025  Moderna,  inc. All rights  reserved.Demographics  of Study  Participants
Study  303, Part A, Safety  Set
mRNA -1345  (50 µg)
Medical  History  Category18-59 years
N = 50250-59 years
N = 306
Median  Age,  years  (range) 53 (19-59) 56 (50-59)
Female,  n (%) 269 (54%) 158 (52%)
Race/Ethnicity,  n (%)
White 401 (80%) 238 (78%)
Black  or African  American 85 (17%) 64 (21%)
Asian 4 (1%) 2 (1%)
Hispanic  / Latino  Ethnicity 140 (28%) 88 (29%)
•Study  population  was racially/ethnically  diverse
© 2025  Moderna,  inc. All rights  reserved.
9
Safety  – mRNA -1345  in Adults,
18-59 Years,  at Increased  Risk of
RSV Disease
Study  303, Part A
10
Local  Reactions  - Vaccine  Generally  Well Tolerated  in Adults,
18-59 Years,  at Increased  Risk for RSV Disease
Solicited  Local  Reactions  within  7 Days  of Injection  compared  to Older  Adults  ≥60 Years
Solicited Safety  Set – Studies  303 Part A (N = 502) & 301 (N = 18,160)
74%
56%
2% 2%5% 4%17%15%
0%20%40%60%80%100% Injection  Site Injection  Site Injection  Site Axillary  Swelling
Pain Erythema  Swelling  or Tenderness
Grade  3 or 4
Grade  2
Grade  1
Study  303
Sept  18, 2024  data  cutoff  - Study  303
© 2025  Moderna,  inc. All rights  reserved.Study  301 Study  303 Study  301 Study  303 Study  301 Study  303 Study  301
•Injection  site pain  was more  common  among  high -risk adults,  18-59 years,  than  adults  ≥ 60 years
•Rates  of other  local  reactions  generally  similar  across  age groups
•Mostly  grade 1 -2, onset  days  1-2; median  duration  of 2 days;  1 grade  4 pain
11Systemic  Reactions  - Vaccine  Generally  Well Tolerated  in
Adults,  18-59 Years,  at Increased  Risk for RSV Disease
Solicited  Systemic  Reactions  within  7 Days  of Injection  compared  to Older  Adults  ≥60 Years
Solicited Safety  Set – Studies  303 Part  A (N = 502) & 301 (N = 18,160)
4% 3%33%
27%37%
31%29%26%23% 22%
11%7%20%
12%20%40%60%80%100%Nausea/
VomitingChills
0%
Study  303 Study  301  Study  303 Study  301 Study  303 Study  301  Study  303 Study  301 Study  303 Study  301  Study  303 Study  301  Study  303 Study  301
•Rates  of systemic  reactions  generally  similar  or slightly  higher  among  18-59-year -olds vs adults  ≥60 years  old
•Mostly  grade  1-2, onset  days  1-2; median  duration  of 2 days;  no grade  4 reactions
Fever  Headache  Fatigue  Myalgia  Arthralgia
Grade  3
Grade  2
Grade  1
Sept  18, 2024  data  cutoff  – Study  303
© 2025  Moderna,  inc. All rights  reserved.
12
•No anaphylaxis,  thrombocytopenia,  Guillain -Barré  syndrome,  acute  disseminated
encephalomyelitis  (ADEM),  or acute  myocarditis  or acute  pericarditisUnsolicited  Adverse  Events  Within  28 Days  After  mRNA -1345
Regardless  of Relationship  to Study  Vaccination
Study  303, Part A - Adults  at Increased  Risk of RSV – Safety  Set
Sept  18, 2024  data  cutoff
30 µg, N=497;  50 µg, N=502
* 30 µg group,  50-59 year  olds,  unrelated  to study  injection  by investigator:  one case  of pneumonia,  one case  of asthma  exacerbation,  both  RSV RT-PCR negative
© 2025  Moderna,  inc. All rights  reserved.mRNA -1345
18-59 years
Total  = 999mRNA -1345
50-59 years
N = 607
All, n (%) 226 (22.6%) 131 (21.6%)
Non-Serious 224 (22.4%) 129 (21.3%)
Serious 2 (0.2%)* 2 (0.3%)*
Fatal 0 0
Medically -Attended 117 (11.7%) 68 (11.2%)
Leading  to Study  Discontinuation 0 0
Severe 2 (0.2%)* 2 (0.3%)*
Any Adverse  Event  of Special  Interest  (AESI) 0 0
© 2025  Moderna,  inc. All rights  reserved.
13
Immunogenicity  – mRNA -1345  in
Adults,18 -59 Years,  at Increased  Risk
of RSV Disease
Study  303, Part A
14
mRNA -1345  Vaccination  (50 µg) in Adults,18 -59 Years  at
Increased  Risk of RSV Disease  Meets  Pre-Specified  Noninferiority
Criteria  -RSV-A and RSV-B
Study  303, Part A & Study  301
GMR  – Geometric  mean  ratio;  Sept  18, 2024  data  cutoff0.667
AntibodyGMR  (95%  CI)
at Month  1
RSV-A Neutralizing  Antibody  (IU/mL) 1.16 (1.05,  1.29)
RSV-B Neutralizing  Antibody  (IU/mL) 1.14 (1.04,  1.24)
0.5 1
GMR  (95%  CI)2 1.5
•All GMR  non-inferiority  criteria  met (LB of the 2-sided  95% CI of GMR  > 0.667)
comparing  18-59-year -olds vs ≥60-year -olds in efficacy  trial
© 2025  Moderna,  inc. All rights  reserved.
15RSV-A Neutralizing  Antibody  GMT  after  50 µg of mRNA -1345  in
Adults,  18-59 Years,  at Increased  Risk of RSV Disease,  by Age
Study  303, Part A
100000
RSV-A GMT  comparable  between  18-49 and  50-59 year  olds
1432164718977 19271
10010001000018-49 Years  (N=189)  50-59 Years  (N=305)
© 2025  Moderna,  inc. All rights  reserved.GMT
(95%  CI)
RSV-AD1 D29 D1 D29
16
RSV-B Neutralizing  Antibody  GMT  after  50 µg of mRNA -1345  in
Adults,  18-59 Years,  at Increased  Risk of RSV Disease,  by Age
RSV-B GMT  comparable  between  18-49 and 50-59 year  olds
93910936678 6745
100100010000Study  303, Part A
18-49 Years  (N=189)  50-59 Years  (N=305)
© 2025  Moderna,  inc. All rights  reserved.GMT
(95%  CI)
D1 D29 D1 D29
RSV-B
© 2025  Moderna,  inc. All rights  reserved.17
RSV-A Neutralizing  Antibody  GMT  after  50 µg of mRNA -1345  in Adults,  18-59
Years,  at Increased  Risk of RSV Disease  by Primary  Risk Factor  and BMI
Study  303, Part A
GMT;  Geometric  Mean  Titer
15611678
1527 15801511 1590 1578148219158 19036 19905
1678120675 1891520320
100100010000100000
GMT
(IU/mL)All High -Risk
Adults
18-59 YearsCoronary
Artery  Disease/
Congestive
Heart  Failure
20140BMI < 30
kg/m2Chronic  Lung  Diabetes
DiseaseBMI ≥ 30
kg/m2BMI < 40
kg/m2BMI ≥ 40
kg/m2
D1 D29 D1 D29 D1 D29 D1 D29 D1 D29 D1 D29 D1 D29 D1 D29
RSV-A
•Individuals  with medical  risk factors  for RSV show  consistent  RSV-A neutralizing  antibody  responses
compared  to entire  study  population;  no impact  of BMI on antibody  response
•Similar  results  for RSV-B
GBS – Guillain -Barré  syndrome,  ADEM  – acute  disseminated  encephalomyelitis
© 2025  Moderna,  inc. All rights  reserved.
18Summary  – RSV Vaccine  (mRNA -1345)  in Adults,
18-59 Years,  at Increased  Risk of RSV Disease
•Vaccine  generally  well tolerated  across  all ages
•No safety  concerns  identified  (no reports  of thrombocytopenia,  GBS,  ADEM,
acute  myocarditis  and/or  pericarditis)Safety
•RSV-A & RSV-B immune  responses  non-inferior  to adults  ≥60 years  in pivotal
efficacy  trial; similar  efficacy  inferred
•Immunogenicity  consistent  across  age groups,  including  50-59 years,  and
underlying  medical  conditionsImmunogenicity
•Substantial  burden  of RSV-associated  hospitalizations  in adults,  18-59 years
•mRNA -1345  has the potential  to also protect  adults,  18-59 years,  at increased
risk of severe  RSV disease
•Data  under  review  by FDA;  PDUFA  date  June  12, 2025Public  Health
Impact
© 2025  Moderna,  inc. All rights  reserved.
19
Revaccination  of Healthy  Adults
at 12 or 24 Months
ESCMID  2025
© 2025  Moderna,  inc. All rights  reserved.
20RSV Case  Accrual  and Efficacy  Analyses  through  3 Seasons
in the Phase  2/3 Pivotal  Trial
Study  301
10
9
8
7
6
5
4
3
2
1
0
2021  2022  2023  2024
1. CDC.  Respiratory  Syncytial  Virus  Hospitalization Surveillance  Network  (RSV-NET). https://www.cdc.gov/respiratory -viruses/data -research/dashboard/most -
impacted -hospitalizations.html  2. Based  on final FDA Package  InsertOverall  US
2021 -2023  RSV
Hospitalization
Rate  per
100,000  Adults
≥ 65 Years1
2021 -2022
RSV Season  12022 -2023
RSV Season  22023 -2024
RSV Season  3LRTD  2+
CasesPrimary  Analysis
Nov ‘21 – Nov ’2285
174Efficacy2
50.3%
(37.5%,  60.7%)LRTD  2+
62.5%
(47.7%,  73.1%)78.7%
(62.8%,  87.9%)
Durability  through
Season  2
Nov ‘21 – Apr ‘23
Durability  through
Season  3
Nov ‘21 – Mar ‘2456.7%
33.1%,  72.6%)Severe  RSV
(shortness  of
breath)
74.6%
(50.7%,  86.9%)86.7%
(41.9%,  97.0%)
338
21
Vaccination  Regimens  – Revaccination  Studies  in Adults
Study  302 & Study  301 (50 µg)
Day 1 12 Months
RSV Vaccine
(mRNA -1345)N
RSV Vaccine
(mRNA -1345)544
RSV Vaccine
(mRNA -1345)1502RSV Vaccine
(mRNA -1345)24 MonthsRevaccination
PlaceboStudy  302
≥50 Years
© 2025  Moderna,  inc. All rights  reserved.Study  301
Part B
≥60 Years2:1
Vaccine:  Placebo
12-month  data  presented  at June  2024  ACIP  meeting
22Revaccination  at 12 Months  with mRNA -1345  Meets
Pre-Specified  Noninferiority  Criteria  -RSV-A
Study  302C  – Adults  ≥50 Years  – Per Protocol  Set (N=524)
214818283
455419662
100100010000100000
1 2 3 4 5 9 10 11 12 13 14
Part C
12 Month  Revaccination0
Part B
Dose  16 7 8
Study  MonthRSV-A Neutralizing  Antibody
GMT
(IU/mL)
•RSV-A neutralizing  antibodies  detectable  at 12 months  post-vaccination
•Revaccination  1 year  after  primary  vaccination  elicits  responses  similar  to those  following  primary  dose
•Revaccination  met non-inferiority  success  criteria  for RSV-A & RSV-B (LB of 95% CI of GMR  > 0.667)
© 2025  Moderna,  inc. All rights  reserved.
23
© 2025  Moderna,  inc. All rights  reserved.24 Month  Revaccination  – Demographics  of Study  Participants
Study  301, Part B, Safety  Set
mRNA -1345  (50 µg)
N = 998
Age (Years) Median  (range) 68.0 (60-91)
Sex, n (%) Female 508 (51%)
White 798 (80%)
Race/Ethnicity,  n (%)Black  or African  American 161 (16%)
Asian 14 (1%)
Hispanic  / Latino  Ethnicity 234 (23%)
≥1 Comorbidity 321 (32%)
Diabetes  (Type  1 or 2) 194 (19%)
Asthma 85 (9%)
Comorbidities,  n (%) Chronic  Obstructive  Pulmonary  Disease  (COPD) 54 (5%)
Advanced  Liver  or Renal  Disease 11 (1%)
Chronic  Heart  Failure  (CHF) 13 (1%)
Chronic  Respiratory  Disease 2 (0.2%)
Body  Mass  Index,  n (%) ≥30 kg/m2 317 (32%)
24
© 2025  Moderna,  inc. All rights  reserved.Safety  –
Revaccination  at 24 Months
SAE – serious  adverse  event;  AESI  – adverse  event  of special  interest
End of study  analysis  (last subject  last visit Oct 23, 2024)
© 2025  Moderna,  inc. All rights  reserved.
25
Safety  - Revaccination  at 24 Months  with mRNA -1345
Study  301B,  Adults  ≥60 Years  (N=998)
•Revaccination  generally  well tolerated
•Local  and systemic  reactions  were  mainly  Grade  1-2, with median  onset  on
Day 2, and median  2-day duration
•Comparable  to reactogenicity  after  primary  dose
•No safety  concerns  identified
•No reports  of:
•Deaths,  SAEs,  or AESIs  as assessed  as vaccine -related  by the investigator
•Anaphylaxis
•Guillain  Barre  Syndrome
•Acute  disseminated  encephalomyelitis  (ADEM)
•Acute  myocarditis  or acute  pericarditis
26
© 2025  Moderna,  inc. All rights  reserved.Immunogenicity  –
Revaccination  at 24 Months
27
Revaccination  at 24 Months  with mRNA -1345  Meets
Pre-Specified  Noninferiority  Criteria  -RSV-A
Study  301B  – Adults  ≥60 Years  – Per Protocol  Set (N=956)
204817157
417512340
1000
100
0 1 2 3 4 5 6 7 8 9 10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26
Dose  1 Study  Month  24 Month  Revaccination10000100000
GMT
(IU/mL)RSV-A Neutralizing  Antibody
•RSV-A neutralizing  antibodies  detectable  at 24 months  post-vaccination
•Revaccination  at 24 months  after  primary  vaccination  elicits  responses  similar  to those  following  primary  dose
•Revaccination  met non-inferiority  success  criteria for  RSV-A & RSV-B (LB of 95% CI of GMR  > 0.667)
© 2025  Moderna,  inc. All rights  reserved.
28
Predicted  Vaccine  Efficacy  for the 12-Month  Period  Following
24 Month  Revaccination  with mRNA -1345
Neutralizing  AntibodyDay 29
GMT  After
Revaccination RSV-LRTD  2+ RSV-LRTD  3+
RSV-A (IU/mL) 1238260%
(43, 74)68%
(44, 84)
RSV-B (IU/mL) 402458%
(40, 73)67%
(44, 84)
0.0 0.2 0.4 0.6 0.8 1.0
Predicted  Vaccine
Efficacy  (95%  CI)
0.0 0.2 0.4 0.6 0.8 1.0
Predicted  Vaccine
Efficacy  (95%  CI)
© 2025  Moderna,  inc. All rights  reserved.Study  P301  Part B Per-Protocol  Set ≥60 Years,  N = 956
Correlate  of protection  model  suggests  revaccination  restores  vaccine  efficacy
29
Summary  – RSV Vaccine  (mRNA -1345)  Revaccination
•Revaccination  generally  well tolerated;  no safety  concerns  identified
•No reports  of GBS,  ADEM,  acute  myocarditis  and/or  pericarditis
•Durability  of immune  response  demonstrated  out to 24 months
•Revaccination  at 12 or 24 months:
•Restores  immune  response;  met noninferiority  criteria
•Expected  to provide  comparable  vaccine  efficacy  to that after
primary  doseSafety  &
Immunogenicity
•Revaccination  has the potential  to provide  sustained  protection
against  RSVPublic  Health
Impact  of
Revaccination
© 2025  Moderna,  inc. All rights  reserved.GBS – Guillain -Barré  syndrome,  ADEM  – acute  disseminated  encephalomyelitis
30
30
© 2025  Moderna,  inc. All rights  reserved.THANK  YOU!•Investigators
•Study  site personnel
•Laboratory  personnel
•Most  importantly,  the individuals  who
participated  in these  trials

Summary: 1 © 2025  Moderna,  inc. All rights  reserved.RSV Vaccine  (mRNA -1345)  Update: -Safety  & Immunogenicity  in 18-59 Year  Olds  at increased  Risk for RSV Disease * -Revaccination  of Adults  at 12 or 24 Months * ACIP Frances  Priddy,  MD MPH  April  16, 2025 * mRESVIA  has not been  authorized  for these  indications 2 RSV Vaccine  (mRNA -1345)  Clinical  Development NCT05127434,  NCT05330975,  NCT06060457,  NCT06067230 Efficacy,  Immunogenicity,  Safety,  and Correlate  of Protection…


03 Gerber Adult RSV 508

CO-1
Meeting of the Advisory Committee on
Immunization Practices (ACIP)
Centers for Disease Control and Prevention
April 16, 2025
Susan Gerber, MD
Medical Director
GSK
Presentation by GSK at ACIP April 16, 2025
CO-2
AREXVY Indications and Updates
AREXVY is indicated for active immunization for prevention of lower respiratory tract disease
(LRTD) caused by RSV in
▪Individuals ≥ 60 YOA
▪Individuals 50-59 YOA at increased risk for LRTD caused by RSV
~ 11 million AREXVY doses administered in US through March *
*Up to March 2025; YOA, years of age; LRTD: lower respiratory tract disease
FDA, 2024. AREXVY Prescribing Information (PI); https://www.fda.gov/media/167805/download (URL accessed January 2025) Presentation by GSK at ACIP April 16, 2025
CO-3
Clinical Development
Presentation by GSK at ACIP April 16, 2025
CO-4
Key Studies in Current US Clinical Development Plan
Pivotal efficacy
in ≥ 60 YOASafety, immunogenicity,
persistence and
revaccination
in ≥ 60 YOA Co-administration7–12
Immunogenicity &
safety in 50 -59 YOA
(incl. AIR)Immunogenicity &
safety in
18-49 YOA AIRImmunogenicity &
safety in
Immunocompromised
≥ 18 YOA
(lung and kidney SOT)▪AReSVi -006
▪Complete▪RSV OA=ADJ -012
▪Ongoing
▪Extension of AReSVi -006Safety, immunogenicity,
persistence and
revaccination
in ≥ 60 YOA
▪AReSVi -004
▪Ongoing▪COVID -19 mRNA  vaccine
(RSV OA=ADJ -013; Ongoing)
▪PCV20  (RSV OA=ADJ -019; Complete )
▪HZ/su (RSV OA=ADJ -020; Complete )
▪FLU-QIV (RSV OA=ADJ -007; Complete )
▪FLU-aQIV  (RSV OA=ADJ -017; Complete )
▪FLU-QIV-HD (RSV OA=ADJ -008; Complete )
▪RSV OA=ADJ -018
▪Complete▪RSV OA=ADJ -025
▪Ongoing
▪RSV OA=ADJ -023
▪OngoingPhase 2b Phase 3
AIR, at increased risk; FLU -aQIV , adjuvanted quadrivalent influenza vaccine; FLU -QIV, quadrivalent influenza vaccine; FLU -QIV-HD, high -dose quadrivalent influen za vaccine;
HZ/su, herpes zoster recombinant subunit vaccine; PCV20, 20 -valent pneumococcal conjugate vaccine;
SOT, solid organ transplant; YOA, years of age; All studies ClinicalTrials.gov; All URLs accessed February 2025 Presentation by GSK at ACIP April 16, 2025
CO-5
Immunogenicity of AREXVY in Adults ≥ 60 YOA Evaluated in
Two Complementary Trials
AReSVi -006 RSV 1 Dose
(N=12,468)
AReSVi -006 Placebo
Crossover (N=12,498)M48 Revaccination (N≈1,000)Timepoint   D1 M13 M24 M25 M60 M12 M36 M37 M48 M49Final End of
Study analysisRSV OA=ADJ -012 AReSVi -004Completed
RSV 1 Dose (N≈330)
RSV M12, M24
Revaccination (N≈990)
RSV M24 Revaccination
(N≈330)R RSV 1 dose (N≈1,000) AReSVi -006
Crossover F irst Dose RSVPreF3 + AS01E (N≈6,600)
All studies available on clinicaltrials.gov; All URLs accessed April 2025. Presentation by GSK at ACIP April 16, 2025All participants followed for safety
RSVPreF3 + AS01E
PlaceboAReSVi -004 / RSV OA=ADJ -012
R M36 Revaccination (N≈1,000)
RSV M36 revaccination (N≈100)
RSV 1 dose (N≈125)D31
CO-6
AReSVi -004: Immunogenicity and Persistence of Single
Dose of AREXVY Vaccine and Different Revaccination
Schedules in Adults ≥ 60 YOA
Randomized, open -label, multi -country study (NCT04732871)
Preliminary updated results
Presentation by GSK at ACIP April 16, 2025
CO-7
RSV-A and RSV -B Neutralizing Antibody Titers After
12-, 24-, and 36 -Month Vaccination Intervals
RSV M12, M24 Revaccination RSV M24 Revaccination RSV 1 Dose RSV M36 Revaccination
1000.010000.0
GMT (ED60)
[95%CI]
M
6M
12M
18M
24M
25M
13D
31D
1M
36M
37M
301000.010000.0
M
6M
12M
18M
24M
25M
13D
31D
1M
36M
37M
30
Timepoint TimepointGMT (ED60)
[95%CI]RSV-A Serum Neutralization Titers RSV-B Serum Neutralization Titers
RSV 1 dose (N=112 -121): Participants receiving single dose (Dose 1) of RSVPreF3 + AS01E at Day 1; RSV M12, M24 revaccination (N=247 -341): Participants receiving first dose (Dose 1) of RSVPreF3 +
AS01E at Day 1, followed by revaccination doses at 12 months and 24 months post Dose 1; RSV M24 revaccination (N=223 -318): Participan ts receiving first dose (Dose 1) of RSVPreF3 + AS01E at Day 1
followed by revaccination dose at 24 months post Dose 1; RSV M36 Revaccination (N=98 -107): Participants receiving first dose (Do se 1) of RSVPreF3 + AS01E at Day 1, followed by revaccination dose
at 36 months post Dose 1. ED, estimated dilution; GMT, geometric mean titerAReSVi -004
Presentation by GSK at ACIP April 16, 2025
CO-8
RSVPreF3 -Specific CD4+ T -Cells*: Consistent Responses
Post Each Vaccination Dose
RSVPreF3
CD4+ T-cells, /106 cells
(geometric mean [95% CI])
0.0500.01000.01500.02000.02500.03000.0
M
6M
12M
18M
24M
25M
13D
31D
1M
36M
37M
30
Timepoint
*Expressing ≥ 2 activation markers including ≥ 1 cytokine among CD40L, 4 -1BB, IL -2, TNF -a, IFN -g, IL-13, IL -17; RSV 1 dose (N=31 -42): Participants receiving single dose (Dose 1) of RSVPreF3 + AS01E
at Day 1; RSV M12, M24 revaccination (N=215 -286): Participants receiving first dose (Dose 1) of RSVPreF3 + AS01E at Day 1, followed by revaccination doses at 12 months and 24 months post Dose 1;
RSV M24 revaccination (N=68 -88): Participants receiving first dose (Dose 1) of RSVPreF3 + AS01E at Day 1 followed by revaccination dose at 24 months post Dose 1; RSV M36 Revaccination (N=31 -
37): Participants receiving first dose (Dose 1) of RSVPreF3 + AS01E at Day 1, followed by revaccination dose at 36 months post Dose 1.
CD, cluster of differentiation; IL, interleukin; NAb, neutralizing antibody; TNF, tumor necrosis factorAReSVi -004
RSV M12, M24 Revaccination RSV M24 Revaccination RSV 1 Dose RSV M36 Revaccination
Presentation by GSK at ACIP April 16, 2025
CO-9
RSV OA=ADJ -012: I mmunogenicity  of Different Revaccination
Schedules and Persistence of a Single Dose of AREXVY Vaccine
in Adults Aged ≥ 60 YOA Who Participated in Pivotal AReSVi -006
Efficacy Study
Open -label extension and crossover study (NCT06534892)
Preliminary results
Presentation by GSK at ACIP April 16, 2025
CO-10
RSV-A and RSV -B NAb Titers After Initial Dose and 36 -Month
Revaccination Similar Regardless of Comorbidities of Interest*
100100010000
GMT
(ED60)
[95%CI]
\
100100010000
\M
12M
24D
31M
36M
37
TimepointM
12M
24D
31D
1M
36M
37
Timepoint≥1 comorbidity of interest* Overall No comorbidity
*COPD, asthma, any chronic respiratory/pulmonary disease, diabetes type 1 or type 2, chronic heart failure, advanced liver or renal disease; ED, estimated dilution; GMT, geometric mean titer; NAb,
neutralizing antibody; 1. Unpublished data; 2. Feldman RG et al. Clin Infect Dis  2024;  Day 1 to M12: All participants who received one dose of RSVPreF3 + AS01E in AReSVi -006 ( Immunosubset ); M24:
All participants randomized into RSV_1dose group ( Immunosubset ) in AReSVi -006 who did not receive additional doses of vaccine;
M36 - M37: All participants who received second dose of RSVPreF3 + AS01E approximately 36 Months post -primary dose Presentation by GSK at ACIP April 16, 2025RSV-A Serum Neutralization Titers RSV-B Serum Neutralization Titers
GMT
(ED60)
[95%CI]AReSVi -006 / RSV OA=ADJ -012
544
328519
315416
246180
94552
412535
379
872 834 662 274 964 914No comorbidity (n)
≥ 1 comorbidity (n)
Overall (n)544 519 417 180 552 535
328 315 246 94 412 379
872 834 663 274 964 914D
1
CO-11
100100010000
100100010000RSV-A and RSV -B NAb Titers After Initial Dose and 36 -Month
Revaccination Similar Regardless of Frailty Status
\M
12M
24D
31D
1M
36M
37\M
12M
24D
31D
1M
36M
37
ED, estimated dilution; GMT, geometric mean titer; NAb, neutralizing antibody; Unpublished data; Day 1 to M12: All participants who received one dose of adjuvanted RSVPreF3 vaccine in RSV
OA=ADJ -006 ( Immunosubset ); M24: All participants randomized into the RSV_1dose group ( Immunosubset ) in RSV OA=ADJ -006 who did not receive additional doses of vaccine;
M36 - M37: All participants who received a second dose of adjuvanted RSVPreF3 vaccine approximately 36 Months post -primary doseRSV-A Serum Neutralization Titers RSV-B Serum Neutralization Titers
GMT
(ED60)
[95%CI]GMT
(ED60)
[95%CI]Overall Frail Pre-frail Fit
Timepoint Timepoint16
38214
35515
2875
11121
39719
374
474 465 360 158 541 516Frail (n)
Pre-frail (n)
Fit (n)
872 834 662 274 964 914 Overall (n)16 14 15 5 21 19
382 355 287 111 397 374
361 158 541 516 474 465
872 834 663 274 964 914AReSVi -006 / RSV OA=ADJ -012
Presentation by GSK at ACIP April 16, 2025
CO-12
Increase in RSV -A and RSV -B NAb Titers Following Revaccination
with AREXVY at 36 Months Across Pre -Revaccination Levels
110100100010000100000Pre-revaccination
(Month 36 )Post-revaccination
(Month 37 )
1 2 3
Quartile*
N 225 227 226 2264110100100010000100000
1 2 3
Quartile*
N 226 226 226 2264
*Participants grouped into quartiles depending on pre -revaccination NAb titers . Participants in quartile 1 had lowest pre -revaccination NAb and those in quartile 4 had highest;
Participants receiving first dose (Dose 1) of RSVPreF3 + AS01E at Day 1 (in AReSVi -006 study) followed by revaccination
dose at 36 months post Dose 1 (in RSV OA=ADJ -012 study); ED, estimated dilution; GMT, geometric mean titer; NAb, neutralizing antibody
Unpublished data Presentation by GSK at ACIP April 16, 2025RSV-A Serum Neutralization Titers RSV-B Serum Neutralization TitersRSV OA=ADJ -012
4.9 3.1 2.3 1.5Fold increase
(by GMTs)
GMT
(ED60)
[95%CI]GMT
(ED60)
[95%CI]4.7 2.9 2.5 1.6Fold increase
(by GMTs)
CO-13
Lower Pre -Revaccination RSV -A and RSV -B NAb Titers
Associated with Higher Seroresponse  Rates (≥ 4 -Fold Increase)
After Revaccination at 36 Months
Participants with
≥ 4-fold increase in
RSV-B NAb titers  at
M37 vs M36
[95% CI]
0%20%40%60%80%100%
0 1 2 3 422.6
(17.3, 28.6)
8.8
(5.5, 13.3)29.6
(23.8, 36.1)52.7
(45.9, 59.3)
1 2 3 4
Quartile*Participants with
≥ 4-fold increase in
RSV-A NAb titers  at
M37 vs M36
[95% CI]
0%20%40%60%80%100%
0 1 2 3 418.1
(13.3, 23.8)
7.5
(4.4, 11.8)33.9
(27.8, 40.5)56.9
(50.1, 63.5)
1 2 3 4
Quartile*
n / N 128 / 225 77 / 227 41 / 226 17 / 226RSV OA=ADJ -012
*Participants grouped into quartiles depending on pre -revaccination NAb titers . Participants in quartile 1 had lowest pre -revaccination NAb and those in quartile 4 had highest;
Participants receiving first dose (Dose 1) of RSVPreF3 + AS01E at Day 1 (in AReSVi -006 study) followed by revaccination
dose at 36 months post Dose 1 (in RSV OA=ADJ -012 study); NAb, neutralizing antibody Presentation by GSK at ACIP April 16, 2025RSV-A Serum Neutralization Titers RSV-B Serum Neutralization Titers
n / N 119 / 226 67 / 226 51 / 226 20 / 226
CO-14
AReSVi -004 and RSV OA=ADJ -012: Safety Results
Preliminary updated results
Presentation by GSK at ACIP April 16, 2025
CO-15
0%20%40%60%80%100%Safety and Reactogenicity Profile in Individuals Revaccinated
at Month 36 Similar to First Dose
Solicited AEs reported within 4 days of each vaccine dose (Exposed Set)
% of
Participants
[95% CI]Grade 3
Arthralgia Fatigue Fever Headache Myalgia Erythema Pain Swelling
Unsolicited AEs, SAEs, Fatal SAEs and pIMDs  of individuals who were revaccinated at Month 36 also similar to those vaccinated at Day 1LocalRSV M36 Revaccination
(Day 1 Dose)RSV M36 Revaccination
(M36 Dose)
4.615.164.8
57.5
2.87.514.817.932.434.0
1.93.821.3 20.832.435.8M36 Revac
(Day 1)
M36 Revac
(M36)
M36 Revac
(Day 1)
M36 Revac
(M36)
M36 Revac
(Day 1)
M36 Revac
(M36)
M36 Revac
(Day 1)
M36 Revac
(M36)
M36 Revac
(Day 1)
M36 Revac
(M36)
M36 Revac
(Day 1)
M36 Revac
(M36)
M36 Revac
(Day 1)
M36 Revac
(M36)
M36 Revac
(Day 1)
M36 Revac
(M36)AReSVi -004
RSV 36M revaccination: Participants receiving the first dose (Day 1 Dose) of RSVPreF3 + AS01E at Day 1 followed by a revaccination dose at 36 months (M36 Dose) post -Dose 1.
Grade 3: >100 mm for erythema and swelling; significant pain at rest, prevents normal everyday activities for pain; prevents normal activity for headache, fatigue, myalgia,
and arthralgia; >39.0 °C (102.2 °F) for fever. AE, adverse event; SAE, serious adverse event; pIMD , potential immune -mediated diseaseSystemic
Presentation by GSK at ACIP April 16, 2025
CO-16
39.3
31.7
2.235.5
27.9
2.3
0%20%40%60%80%100%
▪Safety profile after revaccination of AREXVY acceptable and consistent with first dose in RSV OA=ADJ -012
▪No events of GBS or ADEM reported in RSV OA=ADJ -012Safety Profile of Revaccination at Month 36 Similar to
First -Vaccination Dose in Crossover Group RSV OA=ADJ -012
Presentation by GSK at ACIP April 16, 2025Grade 3
Any unsolicited AE within
30 days post -vaccinationM36 Revaccination
(N = 993)Crossover
First Dose RSVPreF3 + AS01E
(N = 6,638)
Any vaccine -related unsolicited AE
within 30 days post -vaccinationAny SAE up to 6 months
post -vaccinationParticipants
Reporting
Event
(95% CI)
*Solicited AEs not collected in RSV OA=ADJ -012
CO-17
Summary: AReSVi -004 and RSV OA=ADJ -012
Robust humoral and cellular immune responses observed with AREXVY revaccination
▪Humoral immune responses similar among participants with ≥ 1 comorbidity of interest or
frailty status compared to overall population
▪RSV neutralizing antibody responses observed after revaccination at 36 -month interval
similar to RSV neutralizing antibody responses after revaccination at 24 -month interval
▪The lower the pre -revaccination RSV -A and RSV -B neutralizing titers, the higher the
seroresponse  rates after revaccination at 36 months
Safety and reactogenicity of revaccination is similar as compared with first dose
Presentation by GSK at ACIP April 16, 2025
CO-18
224403757
0100200300400500600700800
RSV-Related DeathsRSV Outcomes Estimated to be Avoided with Vaccination vs
No Vaccination Over 3 Years Based on Vaccine Efficacy Results
from AReSVi -006 (30.6 -Month Median Follow Up)
3,1835,7369,838
02,0004,0006,0008,00010,00012,000
RSV-Related Hospitalizations
Presentation by GSK at ACIP April 16, 2025Estimates are based on GSK modeling that synthesized multiple published and public sources, and involved assumptions to infor m certain parameters, including variability in RSV -related mortality
by age. Key references for model inputs include: Singer et al., Poster Presentation at RSV Symposium 2025; La et al., Human V accines & Immunotherapeutics , 2024; Branche et al., Clin Infect Dis,
2022; McLaughlin et al., Open Forum Infect Dis, 2022;  Tseng et al., J Infect Dis, 2020 ; Ison et al., Poster Presentation at CHEST 2024 .
COPD = chronic obstructive pulmonary disease; YOA = years of ageDiabetes COPD Heart Failure
Estimated RSV
Outcomes
Avoided
per 1 Million
AREXVY
Vaccinations
Among Adults
50-59 YOA
CO-19
Conclusion
Presentation by GSK at ACIP April 16, 2025
Real world vaccine effectiveness data, along with ongoing immunogenicity studies,
will inform optimal revaccination timing
~13 million US adults 50 -59 YOA  at risk for severe RSV disease
▪Over 3 years, vaccination with AREXVY* may help prevent an estimated
▪~3,218 hospitalizations in individuals with heart failure
▪~8,638 hospitalizations in individuals with COPD
▪~8,164 hospitalizations in individuals with diabetes
Evidence to support revaccination with AREXVY
▪Robust humoral and cellular immune responses following revaccination at
24 and 36 -month intervals
▪Lower pre -revaccination titers elicit higher seroresponse  rates after revaccination
▪Safety and reactogenicity of revaccination is similar as compared with first dose
*Based on GSK modeling 46.2% uptake = flu vaccine uptake in group
CO-20
Meeting of the Advisory Committee on
Immunization Practices (ACIP)
Centers for Disease Control and Prevention
April 16, 2025
Susan Gerber, MD
Medical Director
GSK
Presentation by GSK at ACIP April 16, 2025
CO-21
•AREXVY is contraindicated in anyone with a history of a severe allergic reaction ( eg, anaphylaxis) to any
component of AREXVY
•The results of a postmarketing  observational study suggest an increased risk of Guillain -Barré syndrome during the
42 days following vaccination with AREXVY
•Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following
administration of AREXVY
•Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY .
Procedures should be in place to avoid injury from fainting
•Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished
immune response to AREXVY
•In adults 60 years of age and older, the most commonly reported adverse reactions (≥10%) were injection site pain
(60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%)
•In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain
(75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling
(10.4%)
•There are no data on the use of AREXVY in pregnant or breastfeeding individuals. AREXVY is not approved for use
in persons <50 years of age
•Vaccination with AREXVY may not result in protection of all vaccine recipientsAREXVY Important Safety InformationAREXVY Indication
AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD)
caused by respiratory syncytial virus (RSV) in:
•individuals 60 years of age and older;
•individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV

Summary: CO-1 Meeting of the Advisory Committee on  Immunization Practices (ACIP) Centers for Disease Control and Prevention April 16, 2025 Susan Gerber, MD Medical Director  GSK Presentation by GSK at ACIP April 16, 2025 CO-2 AREXVY Indications and Updates AREXVY is indicated for active immunization for prevention of lower respiratory tract disease  (LRTD) caused by RSV in ▪Individuals ≥ 60 YOA ▪Individuals 50-59 YOA at increased risk for LRTD caused by RSV ~ 11 million AREXVY doses administered in US…