03 RSV Adult Munjal 508

ACIP Presentation October 24, 2024
Iona Munjal, MD, FAAP
Clinical Research and
Development,
Pfizer Vaccines
Bivalent Stabilized Prefusion F
RSV A and RSV B strains
Adult
Active immunization for the prevention of LRTD
caused by RSV in individuals 60 years of age and
older.Maternal
Active immunization of pregnant individuals at 32
through 36 weeks gestational age for the
prevention of lower respiratory tract disease
(LRTD) and severe LRTD caused by respiratory
syncytial virus (RSV) in infants from birth through
6 months of age.
2
KPSC, Kaiser Permanente Southern California; IC, Immunocompromised; HR, High Risk•Revaccination through 5 RSV
seasons•Chronic
medical
conditions
•Non -
inferiority
demonstrated •Immuno -
compromising
and High Risk
conditions
•Efficacy
through 2
seasons•Efficacy
(including IC
and HR)•Non -
inferiority
demonstrated•Non -
inferiority
demonstrated
Ongoing Ongoing
Immunocompromised, or renal,
or hepatic impaired in EUGuillain -Barré Syndrome in US Atrial Fibrillation in US among
VA patientsNear Real -time Guillain -Barré
Syndrome in US
Adults ≥ 60Adults
18–59 Adults ≥ 18 Adults ≥ 65 Adults ≥ 65 Adults ≥ 60
3
KPSC, Kaiser Permanente Southern California; IC, Immunocompromised; HR, High Risk•Revaccination through 5 RSV
seasons•Chronic
medical
conditions
•Non -
inferiority
demonstrated •Immuno -
compromising
and High Risk
conditions
•Efficacy
through 2
seasons•Efficacy
(including
Immunocomp
romised and
High Risk)•Non -
inferiority
demonstrated•Non -
inferiority
demonstrated
Ongoing Ongoing
Immunocompromised, or renal,
or hepatic impaired in EUGuillain -Barré Syndrome in US Atrial Fibrillation in US among
VA patientsNear Real -time Guillain -Barré
Syndrome in US
Adults ≥ 60Adults
18–59 Adults ≥ 18 Adults ≥ 65 Adults ≥ 65 Adults ≥ 60
4
1. Belongia  EA, King JP , Kieke  BA, et al. Clinical features, severity, and incidence of RSV illness during 12 consecutive seasons in a community cohort of a dults ≥60 years old. Open Forum Infect Dis.  2018;5(12): ofy316 .
2. Wyffels  V, Kariburyo  F , Gavart  S, et al. A real -world analysis of patient characteristics and predictors of hospitalization among US Medicare beneficiaries wi th respiratory syncytial virus infection. Adv Ther . 2020;37(3):1203 -17.
3.Rates of Lower Respiratory T ract Illness in US Adults by Age and Comorbidity Profile | Infectious Diseases and Therapy (sprin ger.com) .
5Incidence rate and risk for severe complications from RSV infection (hospitalization,
mortality, etc.) are higher among immunocompromised adults and those with at risk
conditions1,2,3

Abbreviations: AE, adverse event; AESIs, adverse event of special interest; NDCMC, newly diagnosed chronic medical condition;  SAE, serious adverse event.
Clinicaltrials.gov NCT05842967
Immunocompromised
adults aged ≥18 years
RSVpreF
dose 1
Vaccine
administration IMBlood draw for
immunogenicityPhase 3, single -arm,
open -label, multicenter,
descriptive study
200 immunocompromised
participants aged ≥18 years
(~half aged ≥60 years)
11 sites in the USA
May 2023 – March 2024 RSVpreF
dose 2
e
Reactogenicity
e-diarye
e
6

Non -small cell lung cancer participants on per protocol therapy
Solid organ transplant recipients at least 3 months prior to enrollment
Including :
•Kidney (19%) •Lung (10%) •Liver (7%)
Participants with autoimmune inflammatory disorders  on active
immuno -modulator therapy
Including :
•Rheumatoid arthritis
•Systemic lupus erythematosus (SLE)
•Sjogren’s syndrome•Ulcerative colitis/Crohn’s disease
•Psoriasis/psoriatic arthritis
•Multiple sclerosis
Participants on hemodialysis  due to ESRD•Heart (2%)
7
Sex n (z%) n (%) n (%)
Female 56 (58.3) 53 (49.5) 109 (53.7)
Race
White 63 (65.6) 87 (81.3) 150 (73.9)
Asian 6 (6.3) 2 (1.9) 8 (3.9)
American Indian
or Alaska Native1 (1.0) 3 (2.8) 4 (2.0)
Black or African
American25 (26.0) 15 (14.0) 40 (19.7)
Ethnicity
Non -Hispanic/
non -Latino88 (91.7) 101 (94.4) 189 (93.1)
Hispanic/Latino 8 (8.3) 3 (2.8) 11 (5.4)
Age at Dose 1
Median (min, max) 51 (23, 59) 66 (60, 80) 60 (23, 80)
Immunocompromised and High Risk Conditions
Solid Organ Transplant 32 (33.3) 43 (40.2) 75 (36.9)
Autoimmune
Inflammatory Disorders
on Immunomodulator
Therapy44 (45.8) 53 (49.5) 97 (47.8)
Advanced NSCLC on
Therapy3 (3.1) 2 (1.9) 5 (2.5)
ESRD on Hemodialysis 20 (20.8) 11 (10.3) 31 (15.3)
8
Sex n (z%) n (%) n (%)
Female 56 (58.3) 53 (49.5) 109 (53.7)
Race
White 63 (65.6) 87 (81.3) 150 (73.9)
Asian 6 (6.3) 2 (1.9) 8 (3.9)
American Indian
or Alaska Native1 (1.0) 3 (2.8) 4 (2.0)
Black or African
American25 (26.0) 15 (14.0) 40 (19.7)
Ethnicity
Non -Hispanic/
non -Latino88 (91.7) 101 (94.4) 189 (93.1)
Hispanic/Latino 8 (8.3) 3 (2.8) 11 (5.4)
Age at Dose 1
Median (min, max) 51 (23, 59) 66 (60, 80) 60 (23, 80)
Immunocompromised and High Risk Conditions
Solid Organ Transplant 32 (33.3) 43 (40.2) 75 (36.9)
Autoimmune
Inflammatory Disorders
on Immunomodulator
Therapy44 (45.8) 53 (49.5) 97 (47.8)
Advanced NSCLC on
Therapy3 (3.1) 2 (1.9) 5 (2.5)
ESRD on Hemodialysis 20 (20.8) 11 (10.3) 31 (15.3)
9
Sex n (z%) n (%) n (%)
Female 56 (58.3) 53 (49.5) 109 (53.7)
Race
White 63 (65.6) 87 (81.3) 150 (73.9)
Asian 6 (6.3) 2 (1.9) 8 (3.9)
American Indian
or Alaska Native1 (1.0) 3 (2.8) 4 (2.0)
Black or African
American25 (26.0) 15 (14.0) 40 (19.7)
Ethnicity
Non -Hispanic/
non -Latino88 (91.7) 101 (94.4) 189 (93.1)
Hispanic/Latino 8 (8.3) 3 (2.8) 11 (5.4)
Age at Dose 1
Median (min, max) 51 (23, 59) 66 (60, 80) 60 (23, 80)
Immunocompromised and High Risk Conditions
Solid Organ Transplant 32 (33.3) 43 (40.2) 75 (36.9)
Autoimmune
Inflammatory Disorders
on Immunomodulator
Therapy44 (45.8) 53 (49.5) 97 (47.8)
Advanced NSCLC on
Therapy3 (3.1) 2 (1.9) 5 (2.5)
ESRD on Hemodialysis 20 (20.8) 11 (10.3) 31 (15.3)
10
Abbreviations: GMFR = geometric mean fold rise; GMT = geometric mean titer; NA = not applicable; RSV = respiratory syncytial virus.
11
1001,00010,000100,000
RSV A RSV BRSV 50% Neutralizing GMTsBefore Dose 1 1 Month after Dose 1 1 Month after Dose 2
8.3 7.5 9.0 7.8

Abbreviations: GMFR = geometric mean fold rise; GMT = geometric mean titer; NA = not applicable; RSV = respiratory syncytial virus.
12RSV A
6.4 7.2 8.6 6.4 21.0  18.8  13.8  12.5
1001,00010,000100,000
Solid Organ Transplant
(n=67)Autoimmune Inflammatory Disorders
(n=94)Non -Small Cell Lung Cancer
(n=3)End Stage Renal Disease on
Hemodialysis (n=28)RSV 50% Neutralizing GMTsBefore Dose 1 1 Month after Dose 1 1 Month after Dose 2
Abbreviations: GMFR = geometric mean fold rise; GMT = geometric mean titer; NA = not applicable; RSV = respiratory syncytial virus.
13RSV B
6.7 7.4 9.5 6.9 28.0  19.5  14.6  12.7
1001,00010,000100,000
Solid Organ Transplant
(n=67)Autoimmune Inflammatory Disorders
(n=94)Non -Small Cell Lung Cancer
(n=3)End Stage Renal Disease on Hemodialysis
(n=28)RSV 50% Neutralizing GMTsBefore Dose 1 1 Month after Dose 1 1 Month after Dose 2
Abbreviations: GMFR = geometric mean fold rise; GMT = geometric mean titer; NA = not applicable; RSV = respiratory syncytial virus; HR: High -risk; IC: Immunocompromised; PD1: Post dose 1.
14RSV A/B
12.1 8.7 17.9
1001,00010,000100,000
Pivotal Efficacy Study "RENOIR"
≥ 60 YearsImmunocompromised and High Risk Study
≥ 18 YearsAt Risk Immunobridging Study
18–59 YearsRSV 50% Neutralizing GMTsBefore Vax 1M after Dose 1
1. Severity definition: mild = no interference with daily activity; moderate = some interference with daily activity; severe = prevents daily activity.
2. Severity definition: mild = >2 –5 cm, moderate = >5 –10 cm; severe = >10 cm.
15
0%20%40%60%80%100%
18 to <60 ≥60 18 to <60 ≥60 18 to <60 ≥60% of Participation
0%20%40%60%80%100%
18 to <60 ≥60 18 to <60 ≥60 18 to <60 ≥60% of Participation
Mild Moderate SevereInjection Site Pain Redness Swelling
Injection Site Pain Redness Swelling26%
6.3% 3.7% 8.3% 2.8%16.8%
46.8%
2.1% 3.8% 3.2% 9.5%31.4%
16
0%20%40%60%80%100%
18 to
<60≥60 18 to
<60≥60 18 to
<60≥60 18 to
<60≥60 18 to
<60≥60 18 to
<60≥60 18 to
<60≥60 18 to
<60≥60% of Participation
0%20%40%60%80%100%
18 to
<60≥60 18 to
<60≥60 18 to
<60≥60 18 to
<60≥60 18 to
<60≥60 18 to
<60≥60 18 to
<60≥60 18 to
<60≥60% of Participation
Mild Moderate Severe1.0% 0.9% Fatigue Fever Headache Vomiting Diarrhea Nausea Muscle Pain Joint Pain
39.6% 44.9% 38.5%
22.4%
4.2% 0.9% 12.5% 8.4% 21.9% 17.8% 26% 20.6% 17.7% 21.5%
0.0% 0.0% Fatigue Fever Headache Vomiting Diarrhea Nausea Muscle Pain Joint Pain
37.2% 42.9%
24.5% 25.7%
2.1% 1.0% 6.4% 6.7% 11.7% 13.3% 19.1% 23.8%
11.7% 17.1%
AE: Adverse Event, AESI: Adverse Event of Special Interest (Guillain -Barré Syndrome, Acute polyneuropathy without an underlying etiology, Atrial Fibrillation, Preterm delivery, Hypertensive disorder of
pregnancy), SAE: Serious Adverse Event, NDCMC: Newly Diagnosed Chronic Medical Condition.
From Vaccination Through 1 -Month after Dose 2 Follow -Up Visit
Any Event 13 (13.5) 24 (22.4)
Severe 2 (2.1) 4 (3.7)
Related 0 2 (1.9)
From Vaccination Throughout the Study
AE of Special Interest 0 2 (1.9)
SAE 7 (7.3) 15 (14.0)
AEs leading to withdrawal after Dose 1 2 (2.1) 0
AE Leading to Death 0 0
NDCMCs 2 (2.1) 7 (6.5)
17
AE: Adverse Event, AESI: Adverse Event of Special Interest (Guillain -Barré Syndrome, Acute polyneuropathy without an underlying etiology, Atrial Fibrillation, Preterm delivery, Hypertensive disorder of
pregnancy), SAE: Serious Adverse Event, NDCMC: Newly Diagnosed Chronic Medical Condition.
From Vaccination Through 1 -Month after Dose 2 Follow -Up Visit
Any Event 13 (13.5) 24 (22.4)
Severe 2 (2.1) 4 (3.7)
Related 0 2 (1.9)
From Vaccination Throughout the Study
AE of Special Interest 0 2 (1.9)
SAE 7 (7.3) 15 (14.0)
AEs leading to withdrawal after Dose 1 2 (2.1) 0
AE Leading to Death 0 0
NDCMCs 2 (2.1) 7 (6.5)
18
From Vaccination Through 1 -Month after Dose 2 Follow -Up Visit
Any Event 13 (13.5) 24 (22.4)
Severe 2 (2.1) 4 (3.7)
Related 0 2 (1.9)
From Vaccination Throughout the Study
AE of Special Interest 0 2 (1.9)
SAE 7 (7.3) 15 (14.0)
AEs leading to withdrawal after Dose 1 2 (2.1) 0
AE Leading to Death 0 0
NDCMCs 2 (2.1) 7 (6.5)
AE: Adverse Event, AESI: Adverse Event of Special Interest (Guillain -Barré Syndrome, Acute polyneuropathy without an underlying etiology, Atrial Fibrillation, Preterm delivery, Hypertensive disorder of
pregnancy), SAE: Serious Adverse Event, NDCMC: Newly Diagnosed Chronic Medical Condition.1 | Pain in the extremity
 2 | Atrial Fibrillation
19
AE: Adverse Event, AESI: Adverse Event of Special Interest (Guillain -Barré Syndrome, Acute polyneuropathy without an underlying etiology, Atrial Fibrillation, Preterm delivery, Hypertensive disorder of
pregnancy), SAE: Serious Adverse Event, NDCMC: Newly Diagnosed Chronic Medical Condition.
From Vaccination Through 1 -Month after Dose 2 Follow -Up Visit
Any Event 13 (13.5) 24 (22.4)
Severe 2 (2.1) 4 (3.7)
Related 0 2 (1.9)
From Vaccination Throughout the Study
AE of Special Interest 0 2 (1.9)
SAE 7 (7.3) 15 (14.0)
AEs leading to withdrawal after Dose 1 2 (2.1) 0
AE Leading to Death 0 0
NDCMCs 2 (2.1) 7 (6.5)1 | Atrial Fibrillation
 2 | Atrial Fibrillation
20
AE: Adverse Event, AESI: Adverse Event of Special Interest (Guillain -Barré Syndrome, Acute polyneuropathy without an underlying etiology, Atrial Fibrillation, Preterm delivery, Hypertensive disorder of
pregnancy), SAE: Serious Adverse Event, NDCMC: Newly Diagnosed Chronic Medical Condition.
From Vaccination Through 1 -Month after Dose 2 Follow -Up Visit
Any Event 13 (13.5) 24 (22.4)
Severe 2 (2.1) 4 (3.7)
Related 0 2 (1.9)
From Vaccination Throughout the Study
AE of Special Interest 0 2 (1.9)
SAE 7 (7.3) 15 (14.0)
AEs leading to withdrawal after Dose 1 2 (2.1) 0
AE Leading to Death 0 0
NDCMCs 2 (2.1) 7 (6.5)
21
RSVpreF was well -tolerated with no safety
concerns among immunocompromised adults
aged 18 years or older
1 dose of RSVpreF elicited high GMT s and GMFRs
in the immunocompromised study populations
with no additional increase after a second dose
1 month apart
22
KPSC, Kaiser Permanente Southern California•Revaccination through 5 RSV
seasons•Chronic
medical
conditions
•Non -
inferiority
demonstrated •Immuno -
compromising
and High Risk
conditions
•Efficacy
through 2
seasons•Efficacy
(including
Immunocomp
romised and
High Risk)•Non -
inferiority
demonstrated•Non -
inferiority
demonstrated
Ongoing Ongoing
Immunocompromised, or renal,
or hepatic impaired in EUGuillain -Barré Syndrome in US Atrial Fibrillation in US among
VA patientsNear Real -time Guillain -Barré
Syndrome in US
Adults ≥ 60Adults
18–59 Adults ≥ 18 Adults ≥ 65 Adults ≥ 65 Adults ≥ 60
23
2434
3729
Abrysvo Alone
Abrysvo + 1
Abrysvo +2 or more
(n= 855, 200)
MedAdvisor  Solutions. Abrysvo  coadministration with 2 vaccines in adults 60 years of
age and older in Retail Pharmacies for October 2023. Unpublished data. October 2024
MedAdvisor  Solutions network covers about 65% of the US population (around 218
million patients) through 33,500 retail or grocer pharmacies.
Vaccine
administration IMBlood draw for
immunogenicityReactogenicity
e-diarye
COVID  = Comirnaty
RSVpreF: Abrysvo
QIV : Fluzone HD Quad
PLB  = Placebo
Assessing Safety, Tolerability and Non -inferiority Immunogenicity
25Randomized, parallel
group, observer -blinded
study
30 sites in the USA
~750 participants
aged ≥65 years
•No Prior RSV Vaccine
•No Flu vaccine ≤120 days
•At least 3 prior COVID -19
vaccines ≥150 days prior
Abbreviations: AE, adverse event; AESIs, adverse event of special interest; NDCMC ,
newly diagnosed chronic medical condition; SAE, serious adverse event.
Clinicaltrials.gov NCT05886777COVID + PLB
RSV + PLB
QIV + PLB
RSV + COVID + PLB
RSV + COVID + QIV
Groups  (n~150 per Group)+ e
Sex n (%) n (%) n (%) n (%) n (%)
Female 80 (53.3) 80 (52.6) 79 (53.0) 94 (59.9) 83 (52.5)
Race
White 131 (87.3) 140 (92.1) 135 (90.6) 139 (88.5) 138 (87.3)
Black or African American 13 (8.7) 10 (6.6) 9 (6.0) 14 (8.9) 13 (8.2)
American Indian or Alaska Native 1 (0.7) 0 1 (0.7) 0 1 (0.6)
Asian 2 (1.3) 1 (0.7) 3 (2.0) 3 (1.9) 5 (3.2)
Other 3 (2) 1 (0.7) 1 (0.7) 1 (0.6) 1 (0.6)
Ethnicity
Hispanic/Latino 10 (6.7) 17 (11.2) 12 (8.1) 18 (11.5) 15 (9.5)
Age at Vaccination (Years)
Median (min, max) 70 (65, 87) 71 (65, 85) 71 (65, 87) 70 (65, 87) 71 (65, 90)
Race Other: Native Hawaiian or other Pacific Islander, Multiracial, or Not reported
26
Abbreviations: GMR  = geometric mean ratio; NTS0  = 50% neutralizing titer; SARS -CoV -2 = severe acute respiratory syndrome coronavirus 2.
RSVPreF: NT: RSV -A 1.43 (1.131, 1.808)
RSVPreF: NT: RSV -B 1.37 (1.060, 1.773)
SARS -CoV -2 NT50 : Omicron BA.4 /BA.5 0.94 (0.673, 1.300)
SARS -CoV -2 NT50 : Reference Strain 0.97 (0.740, 1.281)
0.5 0.667 1.0 1.5 2.0
GMT Ratio
27
Abbreviations: GMR = geometric mean ratio; HAI= hemagglutination inhibition assay; NTS0 = 50% neutralizing titer; SARS -CoV -2 = s evere acute respiratory syndrome coronavirus 2.0.5 1.0 2.0 3.0 4.0 5.0
GMT Ratio
RSVPreF: NT: RSV -A 1.42 (1.123, 1.801)
RSVPreF: NT: RSV -B 1.27 (0.977, 1.651)
SARS -CoV -2 NT: Omicron BA.4/BA.5 0.86 (0.610, 1.208)
SARS -CoV -2 NT: Reference Strain 1.01 (0.764, 1.340)
HAI: H1N1  A/Victoria 2.49 (1.914, 3.232)
HAI: H3N2  A/Darwin 1.30 (1.049, 1.612)
HAI: B/Austria 1.58 (1.155, 2.165)
HAI: B/Phuket 3.49 (2.640, 4.604)
28
Abbreviations: GMR = geometric mean ratio; HAI= hemagglutination inhibition assay; NTS0 = 50% neutralizing titer; SARS -CoV -2 = s evere acute respiratory syndrome coronavirus 2.0.5 1.0 2.0 3.0 4.0 5.0
GMT Ratio
RSVPreF: NT: RSV -A 1.42 (1.123, 1.801)
RSVPreF : NT: RSV -B 1.27 (0.977, 1.651)
SARS -CoV -2 NT: Omicron BA.4/BA.5 0.86 (0.610, 1.208)
SARS -CoV -2 NT: Reference Strain 1.01 (0.764, 1.340)
HAI: H1N1  A/Victoria 2.49 (1.914, 3.232)
HAI: H3N2  A/Darwin 1.30 (1.049, 1.612)
HAI: B/Austria 1.58 (1.155, 2.165)
HAI: B/Phuket 3.49 (2.640, 4.604)
290.5
0.667
0%20%40%60%80%100%
COVID RSV QIV RSV +
COVIDRSV +
COVID
+ QIVCOVID RSV QIV RSV +
COVIDRSV +
COVID
+ QIVCOVID RSV QIV RSV +
COVIDRSV +
COVID
+ QIV% of Participation
Mild Moderate SevereInjection Site Pain Redness Swelling
62.7%
10.5% 51.7% 56.7% 53.8%
7.3%
2.6% 4.0% 12.7% 8.9% 9.3%
3.3% 6.0% 12.7%
7%
30
0%20%40%60%80%100%
COVID RSV QIV RSV +
COVIDRSV +
COVID
+ QIVCOVID RSV QIV RSV +
COVIDRSV +
COVID
+ QIVCOVID RSV QIV RSV +
COVIDRSV +
COVID
+ QIVCOVID RSV QIV RSV +
COVIDRSV +
COVID
+ QIV% of Participation
Mild Moderate Severe
5.3%10.5% 9.4%4.5%12.7%9.3%3.9% 2.0%10.2% 10.8% 8.7% 5.9% 4%10.2% 9.5% 10.7 9.9% 10.7%14.6% 14.0%0%20%40%60%80%100%
COVID RSV QIV RSV +
COVIDRSV +
COVID
+ QIVCOVID RSV QIV RSV +
COVIDRSV +
COVID
+ QIVCOVID RSV QIV RSV +
COVIDRSV +
COVID
+ QIVCOVID RSV QIV RSV +
COVIDRSV +
COVID
+ QIV% of ParticipationFever Vomiting Fatigue Headache
35.3%
24.3%28.9%38.9%46.8%
22.7%19.1%12.8%24.2%19.0%
1.3% 2.6% 0.7% 0.6% 1.3% 1.3% 0.0%1.9% 4.4%1.3%
Muscle Pain Diarrhea Chills Joint Pain
31
From Vaccination Through 1 -Month Follow -Up Visit
Any Event 12 (8) 11 (7.2) 12 (8.1) 14 (8.9) 14 (8.9)
Related 1 (0.7) 1 (0.7) 2 (1.3) 4 (2.5) 4 (2.5)
Immediate 0 0 0 0 1 (0.6)
Severe 1 (0.7) 0 0 0 1 (0.6)
From Vaccination Throughout the Study
SAE 4 (2.7) 2 (1.3) 2 (1.3) 1 (0.6) 3 (1.9)
AE Leading to Death 0 0 0 0 0
AE of Special Interest 9 (6) 2 (1.3) 3 (2) 5 (3.2) 4 (2.5)
AE: Adverse Event, AESI: Adverse Event of Special Interest (COVID -19, positive SARS -CoV -2 test, Guillain -Barré Syndrome, Acute p olyneuropathy without an underlying etiology, Atrial fibrillation,
Preterm delivery, Hypertensive disorder of pregnancy), SAE: Serious Adverse Event, NDCMC: Newly Diagnosed Chronic Medical Con dition.
32
From Vaccination Through 1 -Month Follow -Up Visit
Any Event 12 (8) 11 (7.2) 12 (8.1) 14 (8.9) 14 (8.9)
Related 1 (0.7) 1 (0.7) 2 (1.3) 4 (2.5) 4 (2.5)
Immediate 0 0 0 0 1 (0.6)
Severe 1 (0.7) 0 0 0 1 (0.6)
From Vaccination Throughout the Study
SAE 4 (2.7) 2 (1.3) 2 (1.3) 1 (0.6) 3 (1.9)
AE Leading to Death 0 0 0 0 0
AE of Special Interest 9 (6) 2 (1.3) 3 (2) 5 (3.2) 4 (2.5)
AE: Adverse Event, AESI: Adverse Event of Special Interest (COVID -19, positive SARS -CoV -2 test, Guillain -Barré Syndrome, Acute p olyneuropathy without an underlying etiology, Atrial fibrillation,
Preterm delivery, Hypertensive disorder of pregnancy), SAE: Serious Adverse Event, NDCMC: Newly Diagnosed Chronic Medical Con dition.
33
From Vaccination Through 1 -Month Follow -Up Visit
Any Event 12 (8) 11 (7.2) 12 (8.1) 14 (8.9) 14 (8.9)
Related 1 (0.7) 1 (0.7) 2 (1.3) 4 (2.5) 4 (2.5)
Immediate 0 0 0 0 1 (0.6)
Severe 1 (0.7) 0 0 0 1 (0.6)
From Vaccination Throughout the Study
SAE 4 (2.7) 2 (1.3) 2 (1.3) 1 (0.6) 3 (1.9)
AE Leading to Death 0 0 0 0 0
AE of Special Interest 9 (6) 2 (1.3) 3 (2) 5 (3.2) 4 (2.5)
AE: Adverse Event, AESI: Adverse Event of Special Interest (COVID -19, positive SARS -CoV -2 test, Guillain -Barré Syndrome, Acute p olyneuropathy without an underlying etiology, Atrial fibrillation,
Preterm delivery, Hypertensive disorder of pregnancy), SAE: Serious Adverse Event, NDCMC: Newly Diagnosed Chronic Medical Con dition.
34
From Vaccination Through 1 -Month Follow -Up Visit
Any Event 12 (8) 11 (7.2) 12 (8.1) 14 (8.9) 14 (8.9)
Related 1 (0.7) 1 (0.7) 2 (1.3) 4 (2.5) 4 (2.5)
Immediate 0 0 0 0 1 (0.6)
Severe 1 (0.7) 0 0 0 1 (0.6)
From Vaccination Throughout the Study
SAE 4 (2.7) 2 (1.3) 2 (1.3) 1 (0.6) 3 (1.9)
AE Leading to Death 0 0 0 0 0
AE of Special Interest 9 (6) 2 (1.3) 3 (2) 5 (3.2) 4 (2.5)
AE: Adverse Event, AESI: Adverse Event of Special Interest (COVID -19, positive SARS -CoV -2 test, Guillain -Barré Syndrome, Acute p olyneuropathy without an underlying etiology, Atrial fibrillation,
Preterm delivery, Hypertensive disorder of pregnancy), SAE: Serious Adverse Event, NDCMC: Newly Diagnosed Chronic Medical Con dition.
35
AE: Adverse Event, AESI : Adverse Event of Special Interest (COVID -19, positive SARS -CoV -2 test, Guillain -Barré Syndrome, Acute polyneuropathy without a n underlying etiology, Atrial fibrillation,
Preterm delivery, Hypertensive disorder of pregnancy), SAE: Serious Adverse Event, NDCMC : Newly Diagnosed Chronic Medical Condition.
From Vaccination Through 1 -Month Follow -Up Visit
Any Event 12 (8) 11 (7.2) 12 (8.1) 14 (8.9) 14 (8.9)
Related 1 (0.7) 1 (0.7) 2 (1.3) 4 (2.5) 4 (2.5)
Immediate 0 0 0 0 1 (0.6)
Severe 1 (0.7) 0 0 0 1 (0.6)
From Vaccination Throughout the Study
SAE 4 (2.7) 2 (1.3) 2 (1.3) 1 (0.6) 3 (1.9)
AE Leading to Death 0 0 0 0 0
AE of Special Interest 9 (6) 2 (1.3) 3 (2) 5 (3.2) 4 (2.5)
36
Safety and immunogenicity was demonstrated for a single dose of RSVpreF
in IC and HR adultsCo-administration is common; safety and immunogenicity data supports ACIP
co-administration guidelines regarding RSVpreF with COVID and/or
with Influenza Vaccines.
Ongoing Clinical T rials and Post -Licensure Studies continue to provide meaningful
data to assess the safety, effectiveness, and benefit/risk of the product. There have
been no new safety concerns identified in the post -licensure period to date.
37

Summary: ACIP Presentation October 24, 2024 Iona Munjal, MD, FAAP Clinical Research and  Development, Pfizer Vaccines Bivalent Stabilized Prefusion F RSV A and RSV B strains Adult Active immunization for the prevention of LRTD  caused by RSV in individuals 60 years of age and  older.Maternal Active immunization of pregnant individuals at 32  through 36 weeks gestational age for the  prevention of lower respiratory tract disease  (LRTD) and severe LRTD caused by respiratory  syncytial virus (RSV) in…


04 RSV Adult Gerber 508

CO-1
Meeting of the Advisory Committee on
Immunization Practices (ACIP)
Centers for Disease Control and Prevention
October 24, 2024
Susan Gerber, MD
Medical Director
GSK
Presentation by GSK at ACIP October 24, 2024

CO-2
~ 9 million AREXVY doses administered in US to dateAREXVY Indications
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
YOA, years of age
FDA, 2024. AREXVY Prescribing Information (PI); https://www.fda.gov/media/167805/download (URL accessed Aug 2024)

CO-3
RSV- OA=ADJ -023: Immune response and safety among adult
lung and kidney transplant recipients ≥ 18 years of age
Preliminary results
A Phase 2b, randomized, controlled, open- label study to evaluate the immune response
and safety of the RSVPreF3 + AS01E vaccine in adults (≥18 years of age) when
administered to lung and kidney transplant recipients comparing a 1 versus a 2- dose
schedule and compared to adults (≥50 years of age) receiving 1 dose
NCT 05921903

CO-4
RSV- OA=ADJ -023: Phase 2b Study Design
Descriptive immunogenicity and safety study in lung and kidney transplant recipients ≥ 18 YOA versus adults ≥ 50 YOA
1-dose; n=125Study initiation:
 July 2023Visit 2*
 7–14 days
post-Dose 1Visit 3
1 month***
post-Dose 1
Cohort 1
Adults with
SOT ≥ 18 YOA
N=261
1-dose; n=131
Lung SOT, n=39
Kidney SOT, n=92
2-dose; n=130
Lung SOT, n=36
Kidney SOT, n=94Visit 4
1 month
post-Dose 2****Visit 6
12 months
post-last doseVisit 5
6 months
post-last doseVisit 1
Day 1
Safety
analysesSolicited AEs Within 7 days of a vaccine dose
Unsolicited AEs Within 30 days of a vaccine dose
SAEs, pIMDs , and AESIs related to transplantation Up to end of studyCurrent analysis
Adults
≥ 50 YOA
N=125
*Only in subset of study population, ~30% of participants; **Blood sample for CMI analysis collected at each visit only in su bset of study population (~30% of participants);
***Allowed interval range: 30 -60 days; ****For Adults with SOT 1 -dose group and Adults ≥ 50 YOA, Visit 4 refers to 1 -month post- Visit 3; AE, adverse event; AESI, adverse event of special interest;
CMI, cell- mediated immunity; HI, humoral immunity; pIMD , potential immune -mediated disorder; SAE, serious adverse event; SOT, solid organ transplant; YOA, years of ageRSVPreF3 + AS01E
Blood sample; HI, CMI**Cohort 2RSV-OA=ADJ -023
R
1:1

CO-5
Key Inclusion and Exclusion Criteria
Adults with SOT (kidney & lung) ≥ 18 YOA
Inclusion criteria:
ABO compatible allogeneic kidney or lung transplant (allograft)
> 12 months prior to first study intervention
Receiving maintenance immunosuppressive therapy for prevention of allograft rejection
Exclusion criteria:
Allograft rejection in 3 months prior to first dose
Current diagnosis of malignancy
Use of anti -CD20 or other B -cell mAb agents for prevention of allograft
rejection within 9 months of first doseInclusion criteria:  Stable lung function
Exclusion criteria:
•Acute pulmonary infection with 2 weeks of study intervention visit
•Diagnosis of chronic lung allograft dysfunction LungInclusion criteria:  Stable renal function
Exclusion criteria:
•Previous allograft loss secondary to recurrent primary kidney disease
•Significant proteinuria/albuminuriaKidney
Inclusion criteria:
Medically stable in investigator’s opinion
Participants with chronic stable conditions with or without specific treatment (e.g., diabetes mellitus, hypertension, cardiac disease)
Exclusion criteria:
Immunosuppressive or immunodeficient conditions
Unstable chronic illnessAdults ≥ 50 YOA
ABO, ABO blood group system; CD, cluster of differentiation; mAb , monoclonal antibody; SOT, solid organ transplant; YOA, years of age
ClinicalTrials.gov. NCT05921803. https://www.clinicaltrials.gov/study/NCT05921903  (accessed September 2024)RSV-OA=ADJ -023

CO-6
Demographic Characteristics Generally Balanced Between Groups
(Exposed Set)
CharacteristicAdults with SOT ≥ 18 YOA Adults ≥ 50 YOA
Total
(N=386)1-dose group
 (N=131)2-dose group
(N=130)1-dose group
 (N=125)
Age (years) at vaccination, mean (SD) 61.9 (9.3) 61.4 (8.4) 63.8 (8.2) 62.4 (8.7)
Age category, n (%)
18–49 YOA 9 (6.9) 8 (6.2) 0 (0.0) 17 (4.4)
50–59 YOA 37 (28.2) 41 (31.5) 44 (35.2) 122 (31.6)
≥ 60 YOA 85 (64.9) 81 (62.3) 81 (64.8) 247 (64.0)
Sex, n (%)
Female 54 (41.2) 50 (38.5) 66 (52.8) 170 (44.0)
Ethnicity, n (%)
Hispanic or Latino 12 (9.2) 5 (3.8) 22 (17.6) 39 (10.1)
Race, n (%)
American Indian or Alaska Native 0 (0.0) 1 (0.8) 0 (0.0) 1 (0.3)
Asian 26 (19.8) 33 (25.4) 10 (8.0) 69 (17.9)
Black or African American 11 (8.4) 8 (6.2) 4 (3.2) 23 (6.0)
White 89 (67.9) 79 (60.8) 95 (76.0) 263 (68.1)
Not reported or unknown 4 (3.1) 9 (6.9) 15 (12.0) 28 (7.3)
Multiple 1 (0.8) 0 (0.0) 1 (0.8) 2 (0.5)
SOT type, n (%)
Lung transplant 39 (29.8) 36 (27.7) - -
Kidney transplant 92 (70.2) 94 (72.3) - -
Interval between last transplantation and Visit 1
(months), median (min, max) 67 (12, 386) 60 (14, 450) - -RSV-OA=ADJ -023
Adults with SOT 1 -dose group: adults with kidney and lung transplant ≥18 YOA receiving 1 dose of RSVPreF3 + AS01E at Visit 1 (Day 1); Adults with SOT 2 -dose group: adults with kidney and lung
transplant ≥18 YOA receiving 2 doses of RSVPreF3 + AS01E at Visit 1 (Day 1) and Visit 3 (30– 60 days post -Dose 1); Adults ≥50 YOA group: adults ≥50 YOA receiving 1 dose of RSVPreF3 + AS 01E at
Visit 1 (Day 1); SD, standard deviation; SOT, solid organ transplant; YOA, years of age

CO-7
Worldwide Study Including 8 Countries
Canada (n=47)
Australia (n=26)
Japan (n=61)
Italy (n=28)
Germany (n=14)
United States (n=104)
Adults with SOT
≥ 18 YOAAdults
≥ 50 YOA
1-dose
group2-dose
group 1-dose
group
n (%) 39 (29.8) 33 (25.4) 32 (25.6)
SOT type, n (%)
Lung 10 (25.6) 8 (22.2) -
Kidney 29 (31.5) 25 (26.6) -
Spain (n=82)RSV-OA=ADJ -023
South Korea
(n=24)

CO-8
Immunogenicity
Preliminary results

CO-9
Co-primary Endpoints: RSV -A and RSV -B NAbs  Higher at
1 Month Post -Dose 2 vs Post- Dose 1 in Adults with SOT ≥ 18 YOA
Receiving 2 Doses of RSVPreF3 + AS01E*
NRSV-A NAb titers expressed as
MGI ratio MGI ratio (95% CI)
111 1.34 (1.20, 1.48)MGI =1 month  post−Dose  2 (Visit  4)
1 month  post−Dose  1 (Visit  3)
 RSV-A
MGI =1 month  post−Dose  2 (Visit  4)
1 month  post−Dose  1 (Visit  3)
 RSV-B0.5 1.0 1.5 2.0
NRSV-B NAb titers expressed as
MGI ratio MGI ratio (95% CI)
111 1.26 (1.14, 1.40)
0.5 1.0 1.5 2.0
*Adults with SOT ≥ 18 YOA receiving 2 doses of RSVPreF3 + AS01E at Visit 1 (Day 1) and Visit 3 (30– 60 days post -Dose 1)
CI, confidence interval; MGI, mean geometric increase; NAb, neutralizing antibody; SOT, solid organ transplant; YOA, years of ageRSV-OA=ADJ -023

CO-10
RSVPreF3 + AS01E Elicits Robust Humoral Immune
Responses in Kidney and Lung Transplant Recipients
SOT 1 -dose 114 114 114
SOT 2 -dose 110 110 110
≥ 50 YOA 105 105 105GMT,
ED60
(95% CI)
5005000
GMT,
ED60
 (95% CI)
Visit 3
1 month
post-Dose 1Visit 1 Visit 4
1 month
post-Dose 2**5005000
0 0.5 1 1.5 2
SOT 1 -dose 114 114 114
SOT 2 -dose 110 110 110
≥ 50 YOA 105 105 105Visit 4
1 month
post-Dose 2**Visit 1 Visit 3
1 month
post-Dose 1
*In participants with results available at all timepoints; **For Adults with SOT 1 -dose group and Adults ≥50 YOA, Visit 4 refers to 1 month post- Visit 3
Adults with SOT 1 -dose group: adults with kidney and lung transplant ≥18 YOA receiving 1 dose of RSVPreF3 + AS01E at Visit 1 (Day 1); Adults with SOT 2 -dose group: adults with kidney and lung
transplant ≥18 YOA receiving 2 doses of RSVPreF3 + AS01E at Visit 1 (Day 1) and Visit 3 (30– 60 days post -Dose 1); Adults ≥50 YOA group: adults ≥50 YOA receiving 1 dose of RSVPreF3 + AS 01E at
Visit 1 (Day 1); CI, confidence interval; ED60, estimated dilution 60; GMT, geometric mean titer; NAb, neutralizing antibody; SOT, solid organ transplant; YOA, years of ageRSV-OA=ADJ -023
RSV-A NAbs * RSV-B NAbs *
Adults with SOT ≥ 18 YOA
1-doseAdults with SOT ≥ 18 YOA 2-doseAdults ≥ 50 YOAn n

CO-11
5005000
5005000
5005000
5005000
5005000
5005000RSVPreF3 + AS01E Induced Similar RSV -A and RSV -B Neutralizing
Antibody Responses in Kidney and Lung Transplant Recipients
GMT,
ED60
(95% CI)
Visit 3
1 month
post-Dose 1Visit 1 Visit 4
1 month
post-Dose 2*
Kidney 1 dose 89 88 83
Kidney 2 dose 90 84 81
Lung 1 dose 34 35 33
Lung 2 dose 33 30 30Visit 3
1 month
post-Dose 1Visit 1 Visit 4
1 month
post-Dose 2*GMT,
ED60
(95% CI)
*For Adults with SOT 1 -dose group, Visit 4 refers to 1 month post- Visit 3; Adults with SOT 1 -dose group: adults with kidney and lung transplant ≥18 YOA receiving 1 dose of RSVPreF3 + AS01E at Visit
1 (Day 1); Adults with SOT 2 -dose group: adults with kidney and lung transplant ≥18 YOA receiving 2 doses of RSVPreF3 + AS01E at Visit 1 (Day 1) and Visit 3
(30–60 days post -Dose 1);CI, confidence interval; ED60, estimated dilution 60; GMT, geometric mean titer; SOT, solid organ transplant; YOA, years of ageRSV-OA=ADJ -023
RSV-A NAbs RSV-B NAbs
1 dose 2 doseKidney transplant
1 dose 2 doseLung transplantKidney 1 dose 89 88 83
Kidney 2 dose 90 84 81
Lung 1 dose 34 35 33
Lung 2 dose 33 30 30n n

CO-12
SOT
1-doseMC 94 94 88
No MC 29 29 28
SOT
2-doseMC 93 89 87
No MC 30 25 24
≥ 50 YOA 125 118 1105005000
5005000
5005000
SOT
1-doseMC 94 94 88
No MC 29 29 28
SOT
2-doseMC 93 89 87
No MC 30 25 24
≥ 50 YOA 125 118 1105005000
5005000
5005000Differences in RSV -A and RSV -B Neutralizing Antibody Responses
Induced by RSVPreF3 + AS01E by Presence or Absence of Mycophenolate
GMT,
ED60
(95% CI)GMT, ED60
(95% CI)
Visit 1 Visit 4
1 month
post-Dose 2*Visit 3
1 month
post-Dose 1Visit 1 Visit 4
1 month
post-Dose 2 *Visit 3
1 month
post-Dose 1
*For Adults with SOT 1 -dose group and Adults ≥50 YOA, Visit 4 refers to 1 month post- Visit 3; Adults with SOT 1 -dose group: adults with kidney and lung transplant ≥18 YOA receiving 1 dose of
RSVPreF3 + AS01E at Visit 1 (Day 1); Adults with SOT 2 -dose group: adults with kidney and lung transplant ≥18 YOA receiving 2 doses of RSVPreF3 + AS01E at Visit 1 (Day 1) and Visit 3 (30– 60 days
post- Dose 1); CI, confidence interval; ED60, estimated dilution 60; GMT, geometric mean titer; MC, mycophenolate; SOT, solid organ transplant; YOA, years of ageRSV-OA=ADJ -023
RSV-A NAbs RSV-B NAbs
MC No MCAdults with SOT ≥ 18 YOA
1-dose
MC No MCAdults with SOT ≥ 18 YOA
2-dose Adults ≥ 50 YOAn n

CO-13
RSVPreF3 + AS01E Induces Robust CD4+ T -cell Responses in
Kidney and Lung Transplant Recipients
MedianQ3
Q1
MinimumMaximumKey
n 23 24 22 23 28 27 28 26 31 28 24 28
Increased CD4+ T -cell
responses were
consistent across
immunocompromised
groups (1- dose, 2- dose)
and adults ≥ 50 YOA
1.010.0100.01000.010000.0
Frequency of
RSVPreF3 -specific
CD4+ T -cells*
(per million of
CD4+ T -cells)
V1 V2 V3 V4
Adults with SOT ≥ 18 YOA
1-dose groupAdults with SOT ≥ 18 YOA
2-dose groupV1 V3 V4 V1 V2 V4 V2 V3
Adults ≥ 50 YOA
*Expressing ≥ 2 activation markers including ≥1 cytokine among CD40L, 4- 1BB, IL -2, TNF -α, IFN-γ, IL-13, and IL -17
Adults with SOT 1 -dose group: adults with kidney and lung transplant ≥ 18 YOA receiving 1 dose of RSVPreF3 + AS01E at Visit 1 (Day 1); adults with SOT 2 -dose group: adults with kidney and lung
transplant ≥ 18 YOA receiving 2 doses of RSVPreF3 + AS01E at Visit 1 (Day 1) and Visit 3 (30– 60 days post -Dose 1); Adults ≥50 YOA group: adults ≥ 50 YOA receiving 1 dose of RSVPreF3 + A S01E at
Visit 1 (Day 1); CD, cluster of differentiation; IFN, Interferon; IL, interleukin; SOT, solid organ transplant; TNF, tumor necrosis factor; V,  Visit; YOA, years of ageRSV-OA=ADJ -023

CO-14
Safety
Preliminary results

CO-15
Solicited AEs Broadly Similar Between SOT Groups and ≥ 50 YOA
Group (Within 7 Days Post- Vaccination)
Grade 3 AEs were defined as administration -site erythema or swelling with a diameter >100 mm, fever with a temperature >39.0° C/102.2° F, and administration -site pain, headache, fatigue, myalgia, and
arthralgia that prevented normal activity. Adults with SOT 1 -dose group: adults with kidney and lung transplant ≥18 YOA receiving 1 dose of RSVPreF3 + AS01E at Visit 1 (Day 1); Adults with SOT 2 -
dose group: adults with kidney and lung transplant ≥18 YOA receiving 2 doses of RSVPreF3 + AS01E at Visit 1 (Day 1) and Visit 3 (30– 60 days post -Dose 1); Adults ≥50 YOA group: adults ≥50 YOA
receiving 1 dose of RSVPreF3 + AS01E at Visit 1 (Day 1); AE, adverse event; CI, confidence interval; SOT, solid organ transplant; YOA, years of age0102030405060708090100
Local SystemicErythema Arthralgia Fatigue Fever ≥38° C Headache Myalgia Swelling Pain8.5
(5.4, 12.6)8.5
(4.1, 15.0) 8.8
(4.5, 15.2)72.2
(66.3, 77.6) 68.6
(59.5, 76.9)76.0
(67.5, 83.2)
7.3
(4.5, 11.2)5.1
(1.9, 10.7)13.1
(9.3, 17.9)16.1
(10.0, 24.0)33.2
(27.5, 39.3)39.8
(30.9, 49.3)
1.2
(0.2, 3.3)1.7
(0.2, 6.0)24.7
(19.6, 30.4)25.4
(17.9, 34.3)29.0
(23.5, 34.9)32.2
(23.9, 41.4)
2.4
(0.5, 6.9)12.0
(6.9, 19.0)38.4
(29.8, 47.5)
0.8
(0.0, 4.4)35.2
(26.9, 44.2)39.2
(30.6, 48.3)Post-Dose 1
(Pooled SOT 1-dose  and 2-dose  groups; N=259)
Post-Dose 2 (SOT 2-dose  group; N=118)
Adults ≥ 50 YOA (N=125)
Incidence  of solicited Grade 3 AEs were low across groups (≤ 3% for any AE in any group)Participants
% (95% CI)RSV-OA=ADJ -023

CO-16
020406080100Related Unsolicited AEs Similar Between Groups
(Within 30 Days Post -Vaccination)
Most events in SOT groups
reflect background
morbidity (e.g. range of
infections, gastrointestinal and general AEs)
No pattern or clustering of events types to suggest a
safety concern
Adults with SOT 1 -dose group: adults with kidney and lung transplant ≥18 YOA receiving 1 dose of RSVPreF3 + AS01E at Visit 1 (Day 1); Adults with SOT 2 -dose group: adults with kidney and lung
transplant ≥18 YOA receiving 2 doses of RSVPreF3 + AS01E at Visit 1 (Day 1) and Visit 3 (30– 60 days post -Dose 1); Adults ≥50 YOA group: adults ≥50 YOA receiving 1 dose of RSVPreF3 + AS 01E at
Visit 1 (Day 1); AE, adverse event; CI, confidence interval; SOT, solid organ transplant; YOA, years of ageParticipants
% (95% CI)
Unsolicited AEs Related unsolicited AEsRSV-OA=ADJ -023
6.1
(3.5, 9.8)4.0
(1.3, 9.1)6.6
(2.9, 12.6)20.7
(15.9, 26.1)20.8
(14.1, 29.0)30.6
(22.5, 39.6)Post-Dose 1
(Pooled SOT 1-dose  and 2-dose  groups; N=261)
Post-Dose 2
(SOT 2-dose  group; N=121)
Adults ≥ 50 YOA (N=125)
Grade 3

CO-17
SAEs Similar Between Dose 1 and Dose 2 SOT Groups
(Up to Safety Data Lock Point)
Adults with SOT 1 -dose group: adults with kidney and lung transplant ≥18 YOA receiving 1 dose of RSVPreF3 + AS01E at Visit 1 (Day 1); Adults with SOT 2 -dose group: adults with kidney and lung
transplant ≥ 18 YOA receiving 2 doses of RSVPreF3 + AS01E at Visit 1 (Day 1) and Visit 3 (30– 60 days post -Dose 1); Adults ≥50 YOA group: adults ≥50 YOA receiving 1 dose of RSVPreF3 + AS 01E at
Visit 1 (Day 1); CI, confidence interval; GBS, Guillain -Barré syndrome; pIMD , potential immune -mediated disease; SAE, serious adverse event; SOT, solid organ transplant; YOA, years of ageParticipants
% (95% CI)
020406080100
3.8
(1.3, 8.7)2.4
(0.5, 6.9)10.7
(5.8, 17.7)9.2
(4.8, 15.5)
Post -Dose 1
SOT 1-dose  group Post -Dose 1
SOT 2-dose  group Post -Dose 2
SOT 2-dose  group Post -Dose 1
Adults ≥50 YOA
N 131 130 121 125
Median
follow -up170 days 30-60 days 136 days 171 daysNo specific pattern or clustering of SAEs
No cases of GBS or atrial fibrillationRSV-OA=ADJ -023

CO-18
AReSVi -006 Pivotal Efficacy Study:
Preliminary Updates from Season 3
Phase 3, Randomized, Placebo- Controlled, Multi -Country Study to Demonstrate Efficacy &
Safety of Single & Annual Revaccination Doses in Adults 60 Years & Older
NCT04886596

CO-19
RSV annual (N=4,968)
RSV 1 dose (N=4,988)
Placebo (N=10,031)RSV Season 1AReSVi -006 Phase 3 Trial Design1-4
Randomization (1:1)Re-randomization (1:1)RSV Season 2 RSV Season 3
RSVPreF3 + AS01E
(N=12,468)
Placebo
(N=12,498)D1RSVPreF3 + AS01E
Placebo
Older adults
≥ 60 YOANH: 1st Oct 2021 to 30 Apr 2022
SH: 1st Mar 2022 to 30 Sep 2022NH: 1st Oct 2022 to 31 Mar 2023
SH: 1st Mar 2023 to 30 Sep 2023
Primary endpoint: To demonstrate efficacy of RSVPreF3 + AS01E in prevention of RSV LRTD** in adults ≥ 60 YOA during first season2
Confirmatory secondary endpoints: To demonstrate efficacy of RSVPreF3 + AS01E in the prevention of RSV LRTD ** in adults ≥ 60 YOA over three seasons,
following a single dose and annual revaccination of RSVPreF3 + AS01E, and for each RSV subgroup (A and B) separately2
All RSV -LRTD** cases adjudicated by independent external adjudication committeeNH: 1st Oct 2023 to 30 Apr 2024
SH: 1st Mar 2024 to 30 Apr2024
RSV annual 1+1(N=3,582)
4,*
Figure adapted from Ison  MG et al. Clin Infect Dis 2024. under the terms of the CC BY 4.0 Attribution License (https://creativecommons.org/licenses/by/4.0/ ); *Some participants in NH who came at
their Pre -season 3 visit before the approval of protocol amendment 5 received Dose 3; **LRTD defined as ≥2 lower respiratory symptoms/signs for ≥24 hours including ≥1 lower respiratory sign OR
≥3 lower respiratory symptoms for ≥24 hours. All cases of RSV were RT -PCR confirmed; D, day; LRTD, lower respiratory tract disea se; N, number of participants in the modified exposed set (S1),
dose 2- modified exposed set (S2), participants in the dose 2 -modified exposed set who did not receive dose 3 (RSV annual group);
NH, Northern Hemisphere; RT -PCR, reverse transcription -polymerase chain reaction; S, season; SH, Southern Hemisphere; YOA, years of age;
1. ClinicalTrials.gov, 2024. NCT04886596.; 2. Papi  A et al. N Engl J Med 2023;388:595– 608; 3. Ison MG et al. Clin Infect Dis 2024;78:1732– 1744; 4. Unpublished dataEnd of
Study
Analysis
Study start
NH: 25 May 20212AReSVi- 006
RR

CO-20
~25,000 Participants Randomized in 17 Countries
Northern Hemisphere
(N=23,018
incl. ~9,000 in NA)
Southern Hemisphere
(N=1,948)
Austria
BelgiumEstoniaFinlandGermanyItalyPolandRussiaSpainUK
JapanSouth Korea
CanadaUnited StatesMexico
AustraliaNew Zealand
South Africa
RSVPreF3 Vaccine for Respiratory Syncytial Virus (RSV) in Older Adults. Presented at VRBPAC Meeting, March 1, 2023; FDA.gov (URL  accessed August 2024);
NA, North America; UK, United Kingdom; VRBPAC, Vaccines and Related Biological Products Advisory CommitteeAReSVi- 006

CO-21
AReSVi -006 Case Definitions1,2
Signs and symptoms in addition to ≥ 1 RSV -positive swab detected by qRT-PCR
ARI
≥ 2 respiratory  symptoms or signsOR

≥ 1 respiratory and 1 systemic symptom or sign for at least 24 hours Respiratory symptoms or signs
Fever/feverishness
Fatigue
Body aches
Headache
Decreased appetiteUpper respiratory symptoms
or signsLower respiratory
symptomsLower respiratory signsSystemic symptoms or signs
Sputum
Cough
DyspneaWheezing
Crackles/rhonchi
Tachypnea
Hypoxemia
O2 supplementNasal congestion
Sore throat
LRTD*≥ 2 lower respiratory symptoms or signs (≥ 1 sign) OR

≥ 3 lower respiratory symptoms for at least 24 hours Sputum
Cough
DyspneaLower respiratory
symptomsLower respiratory signs
Wheezing
Crackles/rhonchi
Tachypnea
Hypoxemia
O
2 supplement
Severe LRTD*≥ 2 lower respiratory signsOR
episode preventing normal,everyday activitiesLower respiratory signs
Wheezing
Crackles/rhonchi
Tachypnea
Hypoxemia
O
2 supplement
*USPI case definitions ; ARI, acute respiratory infection; LRTD, lower respiratory tract disease; qRT-PCR, quantitative reverse transcription -polymerase chain reaction;
1. GSK’s RSVPreF3 OA Vaccine (AREXVY). Presented at ACIP, 21 June 2023 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2023- 06-21-23/03- RSV- Adults -Friedland -508.pdf  (URL
accessed August 2024); 2. Papi  A et al. N Engl J Med 2023;388:595– 608AReSVi- 006

CO-22
Single Dose of RSVPreF3 + AS01E Demonstrates Clinically
Meaningful Vaccine Efficacy Against RSV -LRTD* Over 3 RSV
Seasons1-4
*VE is maintained up to end of Season 3 NH. Confirmatory secondary endpoint is demonstrated with LL >20%; **96.95% CI; ***97.5% CI; ****95% CI; *****VE was estimated using a Poisson model
adjusted for age, region, and season (“with season as a covariate”) or for age and region (“without season as a covariate”; p ost-hoc analyses). For Season only VE, season could not be considered a
covariate, so data are presented in the “without season as a covariate” column; CI, confidence interval; LRTD, lower respirat ory tract disease; m, month; n/a, not applicable; NH, Northern Hemisphere;
S, Season; SH, Southern Hemisphere; VE, vaccine efficacy .
1. Papi  A et al. N Engl J Med 2023;388:595– 608; 2. Ison MG et al. Clin Infect Dis 2024;78:1732– 1744; 3. Gerber S. AREXVY (Adjuvanted RS VPreF3) 2 -Year Update. Presented at ACIP 26 June 2024.
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2024- 06-26-28/03- RSV- Adult- Gerber -508.pdf (accessed August 2024); 4.  Unpublished dataSeason
(median follow -up time)RSVPreF3 +
AS01E Placebo% VE (CI)*****
W/ season
covariateW/o season
covariate Number of events (n/N)
Season 1** (end of NH S1; 6.7m)
1 7 / 12,466 40 / 12,494 n/a 82.6 (57.9, 94.1)
Season 1 + 2*** (end of NH S2; 17.8m)
2 30 / 12,469 139 / 12,498 67.2 (48.2, 80.0) 74.5 (60.0, 84.5)
2 calendar years****
(end of SH S2; 23.3m)3 32 / 12,468 154 / 12,498 67.7 (52.3, 78.7) 73.3 (60.7, 82.4)
Season 1 –3***
(end of NH S3; 30.6m)4 48 / 12, 468 215 / 12,498 62.9 (46.7, 74.8) 69.1 (55.8, 78.9)
0% 20% 40% 60% 80% 100%AReSVi- 006
Vaccine Efficacy (CI) *****

CO-23
Vaccine Efficacy of Single Dose of RSVPreF3 + AS01E Against
Severe RSV -LRTD Over 3 RSV Seasons1-4
Season
(median follow -up time)RSVPreF3 +
AS01E Placebo% VE (95% CI) *
W/ season
covariateW/o season
covariate Number of events (n/N)
Season 1 (end of NH S1; 6.7m)
1 1 / 12,466 17 / 12,494 n/a 94.1 (62.4, 99.9)
Season 1 + 2 (end of NH S2; 17.8.m)
2 7 / 12,469 48 / 12,498 78.8 (52.6, 92.0) 82.7 (61.6, 93.4)
2 calendar years (end of SH S2; 23.3m)
3 9 / 12,468 54 / 12,498 74.9 (48.4, 89.2) 78.6 (56.3, 90.7)
Season 1 –3
(end of NH S3; 30.6m)4 15 / 12,468 75 / 12,498 67.4 (42.4, 82.7) 72.3 (51.3, 85.2)
0% 20% 40% 60% 80% 100%
*VE estimated using Poisson model adjusted for age, region, and season (“with season as a covariate”) or for age and region (“ without season as a covariate”; post hoc analyses). For Season only
VE, season could not be considered a covariate, so data are presented in the “without season as a covariate” column ; CI, confidence interval; LRTD, lower respiratory tract disease; m, month; n/a, not
applicable; NH, Northern Hemisphere; S, Season; SH, Southern Hemisphere; VE, vaccine efficacy; 1. Papi  A et al. N Engl J Med 2023; 2. Ison  MG et al. Clin Infect Dis 2024; 3. Gerber S. AREXVY
(Adjuvanted RSVPreF3) 2 -Year Update. Presented at ACIP 26 June 2024. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2024- 06-26-28/03- RSV- Adult- Gerber -508.pdf (accessed August
2024); 4. Unpublished dataAReSVi- 006
Vaccine Efficacy (95% CI)

CO-24
Single Dose of RSVPreF3 + AS01E Shows Consistent
Vaccine Efficacy for Subgroups Over 3 RSV Seasons
*COPD, asthma, any chronic respiratory/pulmonary disease, diabetes type 1 or type 2, chronic heart failure, advanced liver or  renal disease; **97.5% CI for confirmatory secondary endpoint; 95% CI for
other endpoints; ***Vaccine efficacy was estimated using a Poisson model adjusted for age, region, and season (“with season a s a covariate”);
COPD, chronic obstructive pulmonary disease; CI, confidence interval; LL, lower limit; LRTD, lower respiratory tract disease; VE, vaccine efficacy; YOA, years of age. Unpublished dataAReSVi- 006
RSVPreF3 +
AS01E Placebo
Number of events (n/N)
LRTD 48 / 12,468 215 / 12,498
RSV-A 14 / 12,468 80 / 12,498
RSV-B 34 / 12,468 135 / 12,498
Severe LRTD 15 / 12,468 75 / 12,498
60–69 YOA 28 / 6962 117 / 6981
70–79 YOA 15 / 4489 85 / 4489
≥1 pre -existing comorbidity of interest*25 / 5014 116 / 4951
≥1 cardiorespiratory condition of interest 17 / 2577 85 / 2504
≥1 endocrine metabolic condition of interest 12 / 3243 55 / 3274
Pre-frail 12 / 4794 67 / 4779
0% 20% 40% 60% 80% 100%
Vaccine Efficacy (CI)**,***
Confirmatory
secondary
endpoints
VE cannot be
reliably estimated
for adults
≥ 80 YOA and frail
group as too few
cases were
observed
VE with season covariateMedian Follow -up: 30.6 Months
62.9% (46.7, 74.8)
69.8% (42.2, 85.7)
58.6% (35.9, 74.1)
67.4% (42.4, 82.7)
60.3% (39.5, 74.8)
70.6% (48.4, 84.3)
64.7% (45.1, 78.1)
68.1% (45.7, 82.3)
63.9% (31.4, 82.5)
70.1%  (43.9, 85.3)LL of the 2- sided CI for
vaccine efficacy was > 20%

CO-25
Vaccine Efficacy of Single Dose of RSVPreF3 + AS01E
Against RSV- LRTD by RSV Season1-4
*96.95% CI for the primary endpoint (S1 RSV -LRTD, overall); 95% CI for other endpoints; CI, confidence interval; LRTD, lower resp iratory tract disease; m, month; n/a, not applicable; NH, Northern
Hemisphere; S, Season; SH, Southern Hemisphere; VE, vaccine efficacy
1. Papi  A et al. N Engl J Med  2023;388:595– 608; 2. Ison MG et al. Clin Infect Dis 2024;78:1732– 1744; 3. GSK. Data on File; 2024N557587_00; 4. Unpublished dataSeason
(median follow -up time)RSVPreF3 +
AS01E Placebo
% VE  (CI)* Number of events (n/N)
Season 1 (end of NH S1; 6.7m)
1 7 / 12,466 40 / 12,494 82.6 (57.9, 94.1)
Season 2 only (end of NH S2; 6.3m)
2 20 / 4991 91 / 10,031 56.1 (28.2, 74.4)
Season 2 only (end of SH S2; 11.9m)
3 22 / 4988 106 / 10,031 58.5 (33.9, 75.0)
Season 3 only (end of NH S3; 7m)
4 16 / 4988 61 / 10,031 48.0 (8.7, 72.0)Vaccine Efficacy (CI)*
0% 20% 40% 60% 80% 100%AReSVi- 006

CO-26
Vaccine Efficacy of Single Dose of RSVPreF3 + AS01E Against
RSV-LRTD in Adults with ≥ 1 Comorbidity of Interest* by RSV Season1-4
*Conditions of interest included any chronic respiratory/pulmonary disease (including chronic obstructive pulmonary disease an d asthma) and chronic heart failure (cardiorespiratory), and diabetes
mellitus type 1 or type 2 and advanced liver or renal disease (endocrine or metabolic); CI, confidence interval; COPD, chroni c obstructive pulmonary disease; LRTD, lower respiratory tract disease;
m, month; NH, Northern Hemisphere; S, Season; SH, Southern Hemisphere; VE, vaccine efficacy; YOA, years of age
1. Papi  A et al. N Engl J Med  2023;388:595– 608; 2. Ison MG et al. Clin Infect Dis 2024;78:1732– 1744; 3. GSK. Data on File; 2024N557587_00;  4. Unpublished dataSeason
(median follow -up time)RSVPreF3 +
AS01E Placebo
% VE (95% CI) Number of events (n/N)
Season 1 (end of NH S1; 6.7m)
1 1 / 4937 18 / 4861 94.6 (65.9, 99.9)
Season 2 only (end of NH S2; 6.3m)
2 12 / 1981 48 / 3895 51.5 (7.4, 76.6)
Season 2 only
(end of SH S2; 11.9m)3 13 / 1990 55 / 3916 54.2 (15.1, 77.1)
Season 3 only
(end of NH S3; 7m)4 8 / 2000 37 / 3924 57.8 (8.0, 83.0)Vaccine Efficacy (95% CI)
0% 20% 40% 60% 80% 100%AReSVi- 006

CO-27
~ 25,000 participants in pivotal efficacy trial
Cumulative follow -up occurred across all groups for median of
31.7 months
Safety profile of vaccine in adults ≥ 60 YOA remains acceptable
and consistent with label1
Frequency of SAEs/ pIMDs  remained low and similar across groups
No reports of GBS, ADEMSafety Profile Remains Consistent and Acceptable Over
3 Seasons
ADEM, acute disseminated encephalomyelitis; GBS, Guillain -Barré syndrome; pIMD , potential immune -mediated disease; SAE, serious adverse event;
YOA, years of age; 1. FDA, 2024. AREXVY Prescribing Information (PI); https://www.fda.gov/media/167805/download (URL accessed  Aug 2024)AReSVi- 006

CO-28
Public Health Benefits with RSVPreF3 + AS01E Vaccination Over 3 Years
71,85595,759
020,00040,00060,00080,000100,000120,000
RSV-LRTD Cases Averted493657
0100200300400500600700
RSV-related Deaths Averted+23,904 averted  +164 averted
7,0099,340
01,0002,0003,0004,0005,0006,0007,0008,0009,00010,000
RSV-related Hospitalizations
Averted+2,331 averted
Potential RSV outcomes averted with vaccination vs no vaccination over 3 years based on 30.6- month follow up from
Study 006 and over 2 years based on 23.3- month follow -up from Study 006 among US adults aged 50- 59 years with COPD
Estimated
Outcomes
Averted
Assuming same vaccination coverage as influenza vaccines from 2022- 2023 season (https://www.cdc.gov/flu/fluvaxview/interactive -general -population.htm); Analysis includes 3,299,241 US adults
with COPD aged 50 -59 years, with 1,652,920 (50.1%) receiving RSVPreF3 + AS01E; Estimated health outcomes over 2 years based on vaccine efficacy estimates using 23.3- month follow -up data from
RSV OA=ADJ -006 Phase 3 Trial; Estimated health outcomes over 3 years based on vaccine efficacy estimates using 30.6- month follow -up data from RSV OA=ADJ -006 Phase 3 Trial

CO-29
Overview of Clinical Development Program

CO-30
Overview of Clinical DevelopmentCo-administration
Safety, reactogenicity, and Immunogenicity
RSV OA=ADJ -011 study
(Extension of Study 002)
Adults  ≥ 60 YOA
Persistence and safety and immunogenicity of
a re-vaccination doseRSV OA=ADJ -002 study
Adults 18– 40 or 60– 80 YOA
First-in-human safety, immunogenicity,
formulation, and dosing selectionAReSVi -006 study
Adults  ≥ 60 YOA
Pivotal efficacy study
AReSVi -004 study
Adults  ≥ 60 YOA
Safety, reactogenicity, immunogenicity,
persistence, and re- vaccination
RSV OA=ADJ -023 study
Immunocompromised adults ≥ 18 YOA
(lung and kidney transplant recipients)
Safety and immunogenicity
Phase 1/2 Phase 2b Phase 3
CompletedOngoing/in progress/
data not yet public
RSV OA=ADJ -017 study
Adults ≥ 65 YOA
Co-administration with FLU -aQIV
RSV OA=ADJ -007 study
Adults ≥ 60 YOA
Co-administration with FLU -QIV
RSV OA=ADJ -008 study
Adults  ≥ 65 YOA
Co-administration with FLU -QIV-HD
RSV OA=ADJ -018 study
Adults 50−59 YOA (incl. adults at
increased risk of RSV -LRTD) vs ≥ 60 YOA
Safety, reactogenicity, immunogenicity
RSV OA=ADJ -025 study
Adults 18– 49 YOA at increased risk
vs adults ≥ 60 YOA
Immunogenicity and safety
RSV OA=ADJ -012 study
(Extension of Study 006)
Extension & crossover study
in adults ≥ 60 YOA
Immunogenicity and safety of different
re-vaccination schedules and persistence of
single dose
RSV OA=ADJ -020 study
Adults  ≥ 50 YOA
Co-administration with HZ/ su vaccine
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;
M: month; PCV20, 20 -valent pneumococcal conjugate vaccine; RSV -LRTD: respiratory syncytial virus lower respiratory tract disease; YOA: years of age
All studies ClinicalTrials.gov; All URLs accessed October 2024
RSV OA=ADJ -019 study
Adults  ≥ 60 YOA
Co-administration with PCV20
RSV OA=ADJ -013 study
 Adults ≥ 50 YOA
Co-administration with
COVID -19 mRNA vaccine

CO-31
Summary

CO-32
Conclusions
For solid organ transplant recipients on mycophenolate, a second dose of RSVPreF3 + AS01E
resulted in RSV -A and RSV -B neutralizing antibody responses close to levels observed in adults
≥ 50 YOA at same time pointOne dose of RSVPreF3 + AS01E provides robust RSV -A and RSV -B neutralizing antibody
responses and high CD4+ T -cell responses; acceptable safety profile in kidney and lung
transplant recipients ≥ 18 YOA
1
Ahead of this year’s RSV season, it is important to protect vulnerable individuals ≥ 50 YOA who
are at high-risk for severe RSV disease RSVPreF3 + AS01E provides clinically meaningful efficacy over 3 seasons
(median follow up time 30.6 months) in ≥ 60 YOA, with a continued acceptable safety profile
Estimated public health benefits of RSVPreF3 + AS01E are increased given its efficacy
over 3 seasons as compared to previous efficacy estimates
2
3
4
5

CO-33
Meeting of the Advisory Committee on
Immunization Practices (ACIP)
Centers for Disease Control and Prevention
October 24, 2024
Susan Gerber, MD
Medical Director
GSK
Presentation by GSK at ACIP October 24, 2024

Summary: CO-1 Meeting of the Advisory Committee on  Immunization Practices (ACIP) Centers for Disease Control and Prevention October 24, 2024 Susan Gerber, MD Medical Director  GSK Presentation by GSK at ACIP October 24, 2024  CO-2 ~ 9 million AREXVY doses administered in US to dateAREXVY Indications  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…


05 RSV Adult Lloyd 508

1
Evaluation of Guillain -Barré Syndrome (GBS)
following Respiratory Syncytial Virus (RSV)
Vaccination Among Adults 65 Years and Older

Dr. Patricia Lloyd, ScM PhD
Health Statistician
Office of Biostatistics and Pharmacovigilance
Center for Biologics Evaluation and Research
U. S. Food & Drug Administration
MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)
Respiratory Syncytial Virus (RSV) Vaccine, Adults
October 23 -24, 2024
2
Outline
•Introduction
•Presentation of End -of-Season SCCS Analysis Results and
Comparison to Early -Season Results
•Discussion
•Conclusions
3
Introduction
•Three RSV vaccines were approved for use in the U.S. in adults 60 years and
older
▪RSVPreF3+AS01 (GSK – AREXVY®) – May 3, 2023
▪RSVPreF  (Pfizer – ABRYSVO®) – May 31, 2023
▪mRNA -1345 (Moderna – mRESVIA®) – May 31, 2024*
•Pre-licensure clinical trials identified a small number of GBS cases in
RSVPreF3+AS01 and RSVPreF  vaccines
•Reports submitted to Vaccine Adverse Events Reporting System (VAERS)
identified higher GBS rates post -RSVPreF3+AS01 and RSVPreF  vaccination than
expected background rates
* The analyses described in this presentation included vaccinations through Jan 2024, which was prior to the approval of mRNA -1345 vaccine
4
RSV Vaccine Post -Market Analyses
AnalysesIncludes Vaccines
Administered
ThroughData
Through
DateNumber of DosesNumber
GBS
Cases RSV PreF3+AS01 RSVPreF
Early -Season SCCS October 22, 2023 April 6, 2024 872,068 456,107 28
End-of-Season SCCS January 28, 2024 July 13, 2024 2,202,247 1,024,442  95•Post-market analyses* to assess the safety of RSV vaccines among Medicare
Fee-for-Service (FFS) beneficiaries ages 65 and older
* The analyses described in this presentation included vaccinations through Jan 2024, which was prior to the approval of mRNA -1345 vaccine.
5
Self-Controlled Case Series (SCCS) Design
Days 43 -90 Days 1 -42
365 Days Prior
Study Start Date
May 2023End-of-Season
Study End Date
July 2024
RSV Vaccination (Day 0)
* The clean window is relative to the outcome date; risk and control intervals are relative to the vaccination date
Ɨ Incident GBS identified in inpatient – primary position only; ICD -10-CM DGN G61.0= Risk Interval
= Control Interval
= GBS Outcome Ɨ= Clean Window (365 days)*
GBS Outcomes
Observed Through
Apr 2024Vaccinations
through
Jan 2024

6
SCCS Analysis: Study Methods
Study Design Self-Controlled Case Series (SCCS)
Data Sources
/Study
Population•Medicare Fee -for-Service (FFS) (Parts A, B and D) beneficiaries aged 65 years and older
•Enrolled  on date of first observed RSV vaccination and during 1 -year prior to vaccination
•Incident GBS case during the observation period (i.e., no GBS event in the clean window)
•Vaccinated with either RSVPreF3+AS01 or RSVPreF prior to Jan 28, 2024
Study Period May 2023 – Jul 2024
GBS Outcome
Definition•Risk Interval: 1 - 42 days
•Control Interval: 43 - 90 days
•Care Setting: inpatient – primary position only; ICD -10-CM DGN G61.0
Statistical
Analyses•Incidence Rate Ratios (IRR)
•Absolute Risk: Attributable Risk (AR) per 100,000 doses and 100,000 person -years (PY)
•Adjustment for outcome -dependent observation time (Farrington), seasonality, PPV
•Chart -confirmed analysis with Farrington and seasonality adjustments
•Secondary analyses: IRR, AR stratified by same day concomitant vaccination with 2023 -2024
COVID -19, 2023 -2024 influenza, pneumococcal, and shingles vaccines
Study end date for End of Season SCCS analysis was July 13, 2024
Note: RSV vaccinations observed prior to Jan 28, 2024 were needed for 90% complete observation in 90 days post vaccination
7
End-of-Season SCCS Analysis
Weekly  Uptake Trends in for RSVPreF3+AS01 and RSVPreF  Vaccines
020,00040,00060,00080,000100,000120,000140,000160,000
Jul-23 Aug-23 Sep-23 Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Apr-24 May-24 Jun-24Number of RSV Vaccinations
Calendar WeekRSVPreF3+AS01
RSVPreFEnd-of-Season
Vaccination
Cutoff  Date 01/28/2024
End of 90 -day
observation
period from
cutoff dateAdditional
11 weeks
for 90%
complete
claimsEarly -Season
Vaccination
Cutoff Date 10/22/2023
Data Through Date: July 13, 2024
8
SCCS Analysis: Descriptive Results
Case Counts for GBS following RSV vaccination by Vaccine Type
*n = Medicare beneficiaries that received one RSV vaccination and eligible for early - and end -of-season SCCS analysis are presen ted. Product -specific and total dose counts
may not equal due to rounding
Ɨ Cell suppressed to protect patient confidentialityCase Population Eligibility
CriteriaEarly -Season SCCS Analysis End-of-Season SCCS Analysis
RSV Vaccinations
(n = 1.3 M doses)*RSV Vaccinations
(n = 3.2 M doses)*
RSVPreF3+AS01
(n = ~872k doses)*RSVPreF
(n = ~456k doses)*RSVPreF3+AS01
(n = 2.2 M doses)*RSVPreF
(n = 1.0 M doses)*
Total GBS cases [total number of
days in study period]160 [339 days] 92 [311 days] 236 [437 days] 130 [409 days]
GBS cases  during 90 -day
observation period 105 74 119 89
Incident GBS cases after applying
clean window restriction55 36 <70 <50
GBS cases qualifying for SCCS
analyses11 17 56 39
Early -Season Data Through Date: April 6, 2024
End-of-Season Data Through Date: July 13, 2024
9
GBS Medical Record Review (MRR) Results
GBS MRR Overall
Total GBS Cases and Records Requested 95
Records Received and Adjudicated 75
Chart -Confirmed GBS Cases* (Level 1, Level 2, Level 3) 51
Insufficient Evidence or Not a Case* (Level 4, Level 5) 24
Records Not Returned 20
Category PPV** with 95% Confidence Interval (CI)
Overall 68.0% (56.8%, 77.5%)
Risk Interval 62.3% (48.8%, 74.1%)
Control Interval 81.8% (61.5%, 92.7%)
** PPV calculations include all GBS case records assigned a case classification based on the MRR in the denominatorCase Classification of GBS Medical Records
Positive Predictive Value (PPV) of GBS* Medical records were adjudicated per the Brighton Collaboration clinical case definition for GBS
10
 SCCS analyses including most adjustments are highlighted in red
Farrington -Adjusted Analysis = Outcome -Dependent Observation Time Adjustment A statistically significant elevation in GBS risk was observed with
seasonality, Farrington, PPV adjusted analysis that included chart -confirmed and non -returned cases:
RSVPreF3+AS01
2.46 (95% CI: 1.19, 5.08)
Comparison of Early vs. End of Season Results
GBS and RSVPreF3+AS01
Incidence Rate Ratio (IRR) with 95% Confidence Intervals (95% CI)
11
 SCCS analyses including most adjustments are highlighted in red
Farrington -Adjusted Analysis = Outcome -Dependent Observation Time Adjustment An elevated but non -statistically significant IRR was observed for GBS
with seasonality, Farrington, PPV adjusted analysis that included chart -confirmed and non -returned cases:
RSVPreF
2.02 (95% CI: 0.93, 4.40)
Comparison of Early vs. End of Season Results
GBS and RSVPreF
IRR with 95% CI
12
Seasonality, Farrington Analysis, and PPV -Based Multiple Imputation – Chart Confirmed + Not Returned
Cases
Inferential Analysis Results RSVPreF3+AS01 RSVPreF
Eligible Vaccines 2,202,247 1,024,442
*Cases in the Risk Interval 24 18
*Cases in the Control Interval 11 <11
IRR (95% CI) 2.46 (1.19, 5.08) 2.02 (0.93, 4.40)
AR per 100,000 Doses (95% CI) 0.65 (0.18, 1.12) 0.90 ( -0.02, 1.81)
AR Per 100,000 PY (95% CI) 5.71 (1.61, 9.80) 7.82 ( -0.17, 15.81)
PY = Person -YearsEnd-of-Season SCCS Results: GBS and RSV Vaccination
IRR and Attributable Risk (AR)
*Cases in risk and control intervals are the average number of true cases in the multiple imputation process
Small cell sizes <11; suppressed to protect patient confidentiality
13
RSVPreF3+AS01 RSVPreF
Eligible Vaccines 2,202,247 1,024,442
Total GBS Cases 56 39
Number (%) with any concomitant
vaccination20 (35.7%) 19 (48.7%)End-of-Season Descriptive Results:
Concomitant Vaccination among GBS Cases
Concomitant vaccination is defined as vaccination on the same day as RSV vaccination with at least one of
2023 -2024 COVID -19, 2023 -2024 influenza, pneumococcal, and shingles vaccines.
14
Seasonality and Farrington Adjusted Analysis, All CasesSecondary End -of-Season SCCS Results:
GBS risk by vaccine type and concomitant vaccination
IRR and 95% CI
There was no evidence of difference in GBS risk among persons with and without same day concomitant
vaccination with RSV vaccines
15
Seasonality and Farrington Adjusted Analysis
Inferential Analysis ResultsWith Concomitant
VaccinationWithout Concomitant
Vaccination
Eligible Vaccines 833,067 1,369,180
Cases in the Risk Interval <15 <30
Cases in the Control Interval <11 <11
IRR (95% CI) 2.19 (0.87, 5.49) 3.47 (1.61, 7.46)
AR per 100,000 Doses (95% CI) 0.85 ( -0.09, 1.79) 1.40 (0.72, 2.09)
AR Per 100,000 PY* (95% CI) 7.40 ( -0.79, 15.59) 12.27 (6.26, 18.28)
*PY = Person -YearsSecondary End -of-Season SCCS Results:
Concomitant Vaccination among GBS cases vaccinated
with RSVPreF3+AS01 – IRR and AR
Small cell sizes <11; suppressed to protect patient confidentiality
16
Seasonality and Farrington Adjusted Analysis
Inferential Analysis ResultsWith Concomitant
VaccinationWithout Concomitant
Vaccination
Eligible Vaccines 420,764 603,678
Cases in the Risk Interval <15 <20
Cases in the Control Interval <11 <11
IRR (95% CI) 2.26 (0.89, 5.73) 4.48 (1.50, 13.42)
AR per 100,000 Doses (95% CI) 1.59 ( -0.18, 3.35) 2.06 (0.99, 3.12)
AR Per 100,000 PY* (95% CI) 13.85 ( -1.55, 29.25) 18.01 (8.70, 27.31)Secondary End -of-Season SCCS Results:
Concomitant Vaccination among GBS cases vaccinated
with RSVPreF  – IRR and AR
*PY = Person -YearsSmall cell sizes <11; suppressed to protect patient confidentiality
17
SCCS Design: Strengths and Limitations
Strengths Limitations
•SCCS study design provides robust
adjustment for potential time -
invariant confounding
•Large database facilitates more
precise evaluation of GBS
•Study findings are generalizable to
U.S. population 65 years and older
•Medical Record Review improved
classification of GBS•Potential misclassification of GBS in
administrative claims data
•The study is not intended to compare
GBS risk between the two vaccine
products
•IRR estimates may be sensitive to the
number of records returned and
adjudicated through MRR
•Potential misspecification of post -RSV
vaccination risk and control intervals for
GBS
•Potential for residual confounding
•Attributable risk based on small number
of cases may be difficult to interpret
18
Discussion
•Observed vs. Expected Analysis
▪An elevated risk of GBS was observed following both RSV vaccines
▪Results were not statistically significant for RSVPreF3+AS01 when adjusting for PPV
•Early -Season SCCS
▪Statistically significant elevation in GBS risk was observed following RSVPreF  vaccine
▪Results did not remain statistically significant for RSVPreF  vaccine when adjusting for PPV -
based multiple imputations
•End-of-Season SCCS
▪A statistically significant elevated IRR was observed for GBS following vaccination with
RSVPreF3+AS01; GBS risk was elevated yet not statistically significant following RSVPreF
vaccination
▪Results remained the same when restricting to confirmed GBS cases through MRR
▪There was no evidence of difference in GBS risk among persons with and without same day
concomitant vaccination with RSV vaccines
19
Conclusions
•Our findings suggest an increased GBS risk following RSVPreF 3+AS01  and
RSVPreF  among adults aged 65 years and older
•These results are consistent with pre -licensure clinical trials and surveillance
systems such as VAERS
•End-of-season SCCS analyses  results are largely chart -confirmed from MRR
and include approximately three times more vaccine doses and GBS cases
compared to the early season SCCS results
•GBS risk following vaccination with RSVPreF3+AS01 and RSVPreF  is rare, with
less than 10 cases per 1 million vaccinations
•There is no difference in GBS risk among persons with and without same
day concomitant vaccination with RSV vaccines
References
20
1. Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted ( Arexvy ). Vaccines and Related Biological Products Advisory
Committee Meeting. FDA Briefing Document. March 1, 2023. https://www.fda.gov/media/165622/download
2. Respiratory Syncytial Virus Stabilized Bivalent Prefusion F Subunit Vaccine ( Abrysvo ). Vaccines and Related Biological Products
Advisory Committee Meeting. FDA Briefing Document. March 1, 2023. https://www.fda.gov/media/165625/download
3. Hause  AM, M.P., Baggs  J, et al, , Early Safety Findings Among Persons Aged ≥60 Years Who Received a Respiratory Syncytial
Virus Vaccine — United States. 2024, Centers for Disease Control and Prevention (CDC),: MMWR and Morbidity and Mortality
Weekly Report.
4. Petersen I, Douglas I, Whitaker H. Self controlled case series methods: an alternative to standard epidemiological study desi gns.
2016;354:i4515.
5. Evaluation of Multiple Safety Outcomes following Respiratory Syncytial Virus (RSV) Vaccination in Adults 60 Years and Older.
BEST Initiative. Center for Biologics Evaluation and Research (CBER). United States Food and Drug Administration (U.S. FDA).
https://bestinitiative.org/wp -content/uploads/2024/01/BEST_RSV_Safety_Older_Adults_2023 -2024.pdf
6. Sejvar  JJ, Kohl KS, et al, Guillain –Barré syndrome and Fisher syndrome: Case definitions and guidelines for collection, analysis,
and presentation of immunization safety data, Vaccine, Volume 29, Issue 3, 2011. https://doi.org/10.1016/j.vaccine.2010.06.003 .
7. Farrington, C. P., Anaya -Izquierdo, K., Whitaker, H. J., Hocine , M. N., Douglas, I., & Smeeth, L. (2011). Self -Controlled Case
Series Analysis With Event -Dependent Observation Periods. Journal of the American Statistical Association, 106(494), 417 –426.
https://doi.org/10.1198/jasa.2011.ap10108
8. Arya, D.P., et al. Surveillance for Guillain -Barré syndrome after 2015 -2016 and 2016 -2017 influenza vaccination of Medicare
beneficiaries. Vaccine, 2019. 37(43): p. 6543 -6549.
Acknowledgements
21
U.S. Food and Drug Administration
Steven A. Anderson
Richard A. Forshee
Henry T. Zhang
Narayan Nair
Krista Fekecs
Acumen
Purva Shah
Nimesh Shah
Zhiruo Wan
Mao Hu
Meng Chen
Centers for Medicare & Medicaid ServicesJing Wang
Yue Wu
Yoganand Chillarige
Acumen’s Physician TeamJoann F. Gruber
Tainya C. Clarke

Summary: 1 Evaluation of Guillain -Barré Syndrome (GBS)  following Respiratory Syncytial Virus (RSV)  Vaccination Among Adults 65 Years and Older   Dr. Patricia Lloyd, ScM PhD Health Statistician Office of Biostatistics and Pharmacovigilance Center for Biologics Evaluation and Research U. S. Food & Drug Administration MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) Respiratory Syncytial Virus (RSV) Vaccine, Adults  October 23 -24, 2024 2 Outline •Introduction •Presentation of End…


04 Schillie mening 508

Introduction to MenQuadfi Label Change for
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.
MenACWY Vaccines Available for Use in the
United States*
Manufacturer Trade Name AbbreviationLicensed
Age GroupACIP
Recommended
Age Group*
Sanofi Pasteur Menactra MenACWY -D9 months –55
years≥9 months
Sanofi Pasteur MenQuadfi MenACWY -TT ≥2 years ≥2 years
GlaxoSmithKline Menveo MenACWY -CRM2 months –55
years≥2 months **
*Same product preferred, but not required, for all doses in a series
**Includes off -label recommendations for persons 56 years and older2 of 6
MenACWY Vaccine Recommendations*
Routinely recommended for persons at age 11–12 years and
16 years
Recommended for persons aged ≥2 months with risk factors:
–Complement component deficiencies or complement inhibitor use
–Anatomic or functional asplenia
–HIV infection
–Microbiologists routinely exposed to N. meningitidis isolates
–Persons at increased risk during an outbreak
–Persons who live in or travel to countries in which meningococcal disease is
hyperendemic or epidemic
*Mbaeyi SA, Bozio CH, Duffy J, et al. Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization
Practices, United States, 2020. MMWR Recomm Rep 2020;69(No. RR -9):1– 41. DOI: http://dx.doi.org/10.15585/mmwr.rr6909a1 .
3 of 6
MenACWY Vaccine Recommendations
for Persons with Risk Factors*
<2 Years:
–Age 2 months:  4 -dose series (2, 4, 6, 12 mos)
–Age 3 –6 months:  3 - or 4- dose series (dose 2 [and dose 3 if applicable] ≥8 wks after
previous dose until a dose is received at age ≥7 mos, followed by an additional dose
≥12 wks later and at age >12 mos)
–Age 7 –23 months:  2- dose series (dose 2 ≥12 wks after dose 1 and at age >12 mos)
≥2 Years:  2 -dose primary series, with doses separated by 8 wks**
Booster dose:
–Age <7 years:  3 yrs after primary series and every 5 yrs thereafter
–Age ≥7 years:  5 yrs after primary series and every 5 yrs thereafter
            *Mbaeyi SA, Bozio CH, Duffy J, et al. Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization
Practices, United States, 2020. MMWR Recomm Rep 2020;69(No. RR -9):1– 41. DOI: http://dx.doi.org/10.15585/mmwr.rr6909a1 .
**Medical risk factors4 of 6
MenQuadfi Proposed Licensure in Infants
With discontinuation of Menactra, Menveo is the only
MenACWY vaccine available in the United States for persons under 2 years of age
Sanofi Pasteur seeking infant indication for MenQuadfi for the following ages at initiation (anticipated May 2025):
–6 weeks –5 months:  2, 4, 6, 12– 18 months (first dose may be administered as
early as 6 weeks)
–6–23 months:  2- dose series with 2nd dose administered in second year of life
and ≥3 months after 1st dose
–≥2 years:  1 dose
5 of 6
6Acknowledgements
Lucy McNamara
Avnika Amin
Amy Rubis
Susan Hariri
Noele Nelson
LeAnne Fox
Alison Albert
6 of 6

Summary: Introduction to MenQuadfi Label Change for  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. MenACWY Vaccines Available for Use in the  United States* Manufacturer Trade Name AbbreviationLicensed  Age…