CO-1

ACIP October 25, 2023

Susan Gerber, MD

Medical Director 

Presentation by GSK at ACIP Oct 25, 2023
CO-2

Substantial RSV Disease Burden and Unmet Medical Need in US 

Adults Aged 50–59 Years 

RSV-associated hospitalizations and medically-attended RSV illnesses are 

substantial among 50-59 YOA

Published incidence rates likely substantially underestimate RSV burden due to lack 

of awareness, standardized testing, and underdetection within surveillance studies

Comorbidities associated with severe RSV disease are prevalent among adults 

50–59 YOA

Presentation by GSK at ACIP Oct 25, 2023

1

2

3

Observed disparities by race and ethnicity are particularly pronounced with respect

to hospitalization rates among middle aged adults 50–64 YOA 4

YOA, years of age
CO-3

Disparities by Race and Ethnicity in RSV Hospitalization Rates 

Particularly Pronounced in Adults 50–64 Years

Hispanic: 1.0-1.9 times higher 

AI/AN, non-Hispanic: 1.6-2.1 times higher 

Black, non-Hispanic: 1.8-2.7 times higher

Among adults aged 50–64 YOA, 

unadjusted RSV-related hospitalization rates

(vs White, non-Hispanic) during 2018–2023 were:

Graphs independently created for GSK from original data; A/PI, Asian and Pacific Islander, AI/AN, America Indian or Alaska Native; 

1. CDC, https://www.cdc.gov/rsv/research/rsv-net/dashboard.html. (accessed October 2023)

A/PI, non-Hispanic White, non-Hispanic Hispanic AI/AN, non-Hispanic Black, non-Hispanic

Presentation by GSK at ACIP Oct 25, 2023

Unadjusted RSV-related hospitalization incidence per 100,000 

by race / ethnicity and season from RSV-NET data1

RSV 

Hospitalization 

Incidence per 

100,000

0

10

20

30

40

2018-2019 2019-2020 2020-2021 2021-2022 2022-2023

50–64 years
CO-4

Immune Response and Safety Among Adults 

50–59 Years of Age (RSV-OA=ADJ-018): 

Day 31 Analysis

Phase 3, observer-blind, randomized, placebo-controlled study to evaluate 

non-inferiority of the immune response and safety of RSVPreF3 + AS01E

vaccine in adults 50–59 years of age, including adults at increased risk of RSV 

lower respiratory tract disease, compared with adults 60 years of age and older

Presentation by GSK at ACIP Oct 25, 2023
CO-5

Primary Objective

ClinicalTrials.gov. NCT05590403. https://www.clinicaltrials.gov/study/NCT05590403; (accessed September 2023) 

1. RSV OA=ADJ-018 study protocol 

RSV-OA=ADJ-018 

Presentation by GSK at ACIP Oct 25, 2023

Primary objective: To demonstrate the non-inferiority of the humoral immune response in participants 

50–59 YOA with and without comorbidities well-documented to be related to RSV-associated severe disease 

compared with older adults (≥ 60 YOA) after RSVPreF3 + AS01E vaccine administration
CO-6

Primary Endpoints

Presentation by GSK at ACIP Oct 25, 2023

CI, confidence interval; SRR: SeroResponse Rate (% of participants with ≥4-fold increase from pre-vaccination serum antibody titers); 

GMT, geometric mean titer;ClinicalTrials.gov. NCT05590403. https://www.clinicaltrials.gov/study/NCT05590403; 

(accessed September 2023) 1. RSV OA=ADJ-018 study protocol 

Primary Endpoints

 RSV-A neutralization titers at 1 month 

after RSVPreF3 + AS01E administration

 RSV-B neutralization titers at 1 month 

after RSVPreF3 + AS01E administration

Success criteria1: Upper limit of 2-sided 

95% CI for GMT ratio is ≤ 1.5 and SRR 

difference is ≤10%

RSV-OA=ADJ-018 

Study populations:

50–59 YOA with comorbidities associated with RSV-LRTD vs ≥ 60 YOA 

50–59 YOA without comorbidities associated with RSV-LRTD vs ≥ 60 YOA 

Primary objective: To demonstrate the non-inferiority of the humoral immune response in participants 

50–59 YOA with and without comorbidities well-documented to be related to RSV-associated severe disease 

compared with older adults (≥ 60 YOA) after RSVPreF3 + AS01E vaccine administration
CO-7

Immunogenicity Endpoints

Presentation by GSK at ACIP Oct 25, 2023 ClinicalTrials.gov. NCT05590403. https://www.clinicaltrials.gov/study/NCT05590403; (accessed September 2023)

1. RSV OA=ADJ-018 study protocol 

50-59

RSV-OA=ADJ-018 

Primary Endpoints

 RSV-A neutralization titers at 1 month 

after RSVPreF3 + AS01E administration

 RSV-B neutralization titers at 1 month 

after RSVPreF3 + AS01E administration

Success criteria1: Upper limit of 2-sided 

95% CI for GMT ratio is ≤ 1.5 and SRR 

difference is ≤10%

Immunogenicity Endpoints

 RSV-A / RSV-B GMT pre vaccination and 

at 1, 6, and 12 months after vaccination

 Tertiary endpoint: analysis by 

baseline comorbidities

 Frequency of RSVPreF3 + AS01E

specific CD4+ T cells expressing at least 

2 activation markers at pre-vaccination 

and at 1, 6, and 12 months after 

vaccination

Primary objective: To demonstrate the non-inferiority of the humoral immune response in participants 

50–59 YOA with and without comorbidities well-documented to be related to RSV-associated severe disease 

compared with older adults (≥ 60 YOA) after RSVPreF3 + AS01E vaccine administration

Study populations:

50–59 YOA with comorbidities associated with RSV-LRTD vs ≥ 60 YOA 

50–59 YOA without comorbidities associated with RSV-LRTD vs ≥ 60 YOA 
CO-8

Safety Endpoints

AE, adverse events; SAE; serious adverse events; pIMD, potential immune mediated disease

ClinicalTrials.gov. NCT05590403. https://www.clinicaltrials.gov/study/NCT05590403; (accessed September 2023)

1. RSV OA=ADJ-018 study protocol Presentation by GSK at ACIP Oct 25, 2023

50-59

Safety Endpoints

 Solicited administration site / systemic 

event with onset within 4 days

 Unsolicited AEs within 30 days 

 SAEs and pIMDs up to Month 6

 Related SAEs, fatal SAEs and related 

pIMDs up to study end (Month 12)

Immunogenicity Endpoints

 RSV-A / RSV-B GMT pre vaccination and 

at 1, 6, and 12 months after vaccination

 Tertiary endpoint: analysis by 

baseline comorbidities

 Frequency of RSVPreF3 + AS01E

specific CD4+ T cells expressing at least 

2 activation markers at pre-vaccination 

and at 1, 6, and 12 months after 

vaccination

RSV-OA=ADJ-018 

Primary Endpoints

 RSV-A neutralization titers at 1 month 

after RSVPreF3 + AS01E administration

 RSV-B neutralization titers at 1 month 

after RSVPreF3 + AS01E administration

Success criteria1: Upper limit of 2-sided 

95% CI for GMT ratio is ≤ 1.5 and SRR 

difference is ≤10%

Primary objective: To demonstrate the non-inferiority of the humoral immune response in participants 

50–59 YOA with and without comorbidities well-documented to be related to RSV-associated severe disease 

compared with older adults (≥ 60 YOA) after RSVPreF3 + AS01E vaccine administration

Study populations:

50–59 YOA with comorbidities associated with RSV-LRTD vs ≥ 60 YOA 

50–59 YOA without comorbidities associated with RSV-LRTD vs ≥ 60 YOA 
CO-9

RSVPreF3 + AS01E

n=382

Study Design

Randomized, placebo-controlled, observer-blind, multi-country study

YOA, years of age; LRTD, lower respiratory tract disease; w/o, without; ClinicalTrials.gov. NCT05590403. 

https://www.clinicaltrials.gov/study/NCT05590403; (accessed September 2023) 1. RSV OA=ADJ-018 study protocol 

Randomization (2:1)

RSVPreF3 + AS01E Study initiation: Current analysis

October 2022

Blood sample

Visit 1

Day 1

Visit 2

Day 31

Visit 3

Month 6

Visit 4

Month 12

Cohort 1: 

Adults 50–59 YOA, n=1140

Cohort 1b

n=570 R

RSVPreF3 + AS01E

n=383

Placebo group

n=192

Cohort 1a

n=570

R

RSVPreF3 + AS01E

n=386

Placebo 

n=191

Month 6 analysis

Placebo

Cohort 2: 

≥ 60 YOA, n=380

Safety monitoring

Cohort 1b: 

Adults w/o comorbidities associated 

with RSV-LRTD

 Participants with chronic stable medical 

conditions with or without specific 

treatment, such as hypertension, 

hypercholesterolemia, or 

hypothyroidism, and not at increased 

risk for RSV-LRTD 

Cohort 1a: 

Adults with comorbidities associated 

with RSV-LRTD

 Participants with ≥ 1 of following 

medical conditions:

 Chronic pulmonary disease resulting 

in activity restricting symptoms or use 

of long-term medication

 Chronic cardiovascular disease

 Diabetes mellitus types 1 and 2

 Chronic kidney disease

 Chronic liver disease 

Cohort 2: ≥ 60 YOA cohort

 Participants with chronic stable medical 

conditions

Presentation by GSK at ACIP Oct 25, 2023

Inclusion Criteria1

RSV-OA=ADJ-018 
CO-10

8 Countries with Enrolled Participants 

N=1,534 (Exposed Set)

Canada

N=220

Argentina

N=178

Netherlands 

N=39

Japan

N=150

Poland 

N=144 Spain 

N=198

United States

N=357

Germany 

N=248

Presentation by GSK at ACIP Oct 25, 2023

RSV-OA=ADJ-018 
CO-11

Demographic Characteristics Well-Balanced

Exposed Set 50 – 59 YOA

Cohort 1a: Adults with comorbidities associated 

with RSV-LRTD

50 – 59 YOA 

Cohort 1b: Adults without comorbidities 

associated with RSV-LRTD ≥ 60 YOA

Characteristic

RSVPreF3 + AS01E

(N=386)

Placebo

(N=191)

RSVPreF3 + AS01E

(N=383)

Placebo

(N=192)

RSVPreF3 + AS01E

(N=382)

Total

(N=1534)

Mean age, years (SD) 55.3 (2.8) 55.6 (2.8) 54.8 (2.8) 54.7 (2.8) 69.5 (6.9) 58.6 (7.5)

Age category, n (%)

50–59 YOA 386 (100) 191 (100) 383 (100) 192 (100) 0 1152 (75.1)

60–69 YOA 0 0 0 0 203 (53.1) 203 (13.2)

70–79 YOA 0 0 0 0 130 (34.0) 130 (8.5)

≥ 80 YOA 0 0 0 0 49 (12.8) 49 (3.2)

Female, n (%) 186 (48.2) 85 (44.5) 221 (57.7) 119 (62.0) 188 (49.2) 799 (52.1)

Body Mass Index (BMI) kg/m2, mean (SD) 30.9 (6.8) 31.3 (7.3) 28.4 (5.9) 28.4 (6.7) 28.1 (6.0) 29.3 (6.6)

Race, n (%)

American Indian or Alaska Native 4 (1.0) 3 (1.6) 1 (0.3) 0 (0) 1 (0.3) 9 (0.6)

Asian 42 (10.9) 23 (12.0) 41 (10.7) 22 (11.5) 44 (11.5) 172 (11.2)

Black or African American 15 (3.9) 3 (1.6) 14 (3.7) 8 (4.2) 11 (2.9) 51 (3.3)

Native Hawaiian or Other Pacific Islander 0 (0) 2 (1.0) 0 (0) 0 (0) 1 (0.3) 3 (0.2)

White 324 (83.9) 158 (82.7) 320 (83.6) 158 (82.3) 324 (84.8) 1284 (83.7)

Multiple 1 (0.3) 1 (0.5) 4 (1.0) 3 (1.6) 0 (0) 9 (0.6)

Unknown 0 (0) 1 (0.5) 3 (0.8) 1 (0.5) 1 (0.3) 6 (0.4)

Ethnicity, n (%)

Hispanic or Latino 63 (16.3) 35 (18.3) 48 (12.5) 23 (12.0) 50 (13.1) 219 (14.3)

Unknown 0 (0) 0 (0) 0 (0) 1 (0.5) 1 (0.3) 2 (0.1)

Presentation by GSK at ACIP Oct 25, 2023 SD, standard deviation; *Participants with underlying medical conditions such as chronic pulmonary and cardiovascular diseases, 

diabetes mellitus types 1 and 2, and chronic liver and renal diseases

RSV-OA=ADJ-018 
CO-12

Clinical Characteristics Well-Balanced

Exposed Set 50 – 59 YOA

Cohort 1a: Adults with comorbidities associated 

with RSV-LRTD

50 – 59 YOA 

Cohort 1b: Adults without comorbidities 

associated with RSV-LRTD ≥ 60 YOA

Characteristic

RSVPreF3 + AS01E

(N=386)

Placebo

(N=191)

RSVPreF3 + AS01E

(N=383)

Placebo

(N=192)

RSVPreF3 + AS01E

(N=382)

Total

(N=1534)

Comorbidity of interest, n (%)

1 pre-existing comorbidity of interest 269 (69.7) 140 (73.3) 0 (0) 0 (0) 93 (24.3) 502 (32.7)

≥ 2 pre-existing comorbidities of interest 117 (30.3) 51 (26.7) 0 (0) 0 (0) 51 (13.4) 219 (14.3)

Chronic pulmonary disease 147 (38.1) 77 (40.3) 0 (0) 0 (0) 58 (15.2) 282 (18.4)

Chronic cardiovascular disease 124 (32.1) 58 (30.4) 0 (0) 0 (0) 56 (14.7) 238 (15.5)

Diabetes mellitus 188 (48.7) 91 (47.6) 0 (0) 0 (0) 68 (17.8) 347 (22.6)

Chronic liver or renal disease 56 (14.5) 23 (21.0) 0 (0) 0 (0) 18 (4.7) 97 (6.3)

Smoking status for tobacco, n (%)

Current smoker 83 (21.5) 49 (25.7) 66 (17.2) 36 (18.8) 45 (11.8) 279 (18.2)

Former smoker 133 (34.5) 50 (26.2) 99 (25.8) 37 (19.3) 133 (34.8) 452 (29.5)

Never smoker 170 (44.0) 92 (48.2) 217 (56.7) 119 (62.0) 204 (53.4) 802 (52.3)

Unknown 0 (0) 0 (0) 1 (0.3) 0 (0) 0 (0) 1 (0.1)

Presentation by GSK at ACIP Oct 25, 2023 *Participants with underlying medical conditions such as chronic pulmonary and cardiovascular diseases, diabetes mellitus types 

1 and 2, and chronic liver and renal diseases

Comorbidities: Overall, most common comorbidity of interest was diabetes mellitus and 

least common was chronic liver or renal disease

RSV-OA=ADJ-018 
CO-13

Immunogenicity

RSV-OA=ADJ-018: Day 31 Analysis (Preliminary) 

Data Lock Point: July 26, 2023

Presentation by GSK at ACIP Oct 25, 2023
CO-14

GMT Ratio 

(without comorbidities associated with RSV-LRTD)

GMT Ratio

(95% CI)

RSV-A

Cohort 2 (≥ 60) divided by

Cohort 1b (50–59)

0.95

(0.83, 1.09)

RSV-B

Cohort 2 (≥ 60) divided by

Cohort 1b (50–59)

0.90

(0.79, 1.03)

0.5 1.0 1.5 2.0

Co-Primary Endpoint Met: Humoral Response to RSV Vaccine

Demonstrated Non-Inferiority in Adults 50–59 YOA vs Adults ≥ 60 YOA

Day 31, Per Protocol Set for Humoral

Success Criteria: Upper limit of 2-sided CI for GMT ratio is ≤1.5

Presentation by GSK at ACIP Oct 25, 2023

Cohort 1a: Adults 50-59 with comorbidities associated with RSV-LRTD ; Cohort 1b: Adults 50-59 without comorbidities associated with RSV-LRTD; Cohort 2: Adults ≥ 60 YOA

GMT, geometric mean titer; CI, confidence interval; LRTD, lower respiratory tract disease; Preliminary data; RSV response evaluated using NAb (ED60); 

ED60, serum estimated dilution inducing 60% inhibition in plaque-forming units; Nab, neutralizing antibody

GMT Ratio 

(with comorbidities associated with RSV-LRTD)

GMT Ratio

(95% CI)

RSV-A

Cohort 2 (≥ 60) divided by

Cohort 1a (50–59)

0.84

(0.73, 0.96)

RSV-B

Cohort 2 (≥ 60) divided by

Cohort 1a (50–59)

0.82

(0.72, 0.93)

0.5 1.0 1.5 2.0
CO-15

Seroresponse Rate [SRR] 

(without comorbidities associated with RSV-LRTD)

SRR Difference

(95% CI)

RSV-A

Cohort 2 (≥ 60) minus

Cohort 1b (50–59)

−2.54

(−8.45, 3.40)

RSV-B

Cohort 2 (≥ 60) minus

Cohort 1b (50–59)

−3.82

(−10.27, 2.68)

Co-Primary Endpoint Met: SRRs for RSV-A and RSV-B NAbs

Demonstrated Non-Inferiority in Adults 50–59 YOA vs Adults ≥ 60 YOA

Day 31, Per Protocol Set for Humoral

-15.0 -10.0 -5.0 0.0 5.0 10.0 15.0

Presentation by GSK at ACIP Oct 25, 2023

Success Criteria: Upper limit of 2-sided CI for SRR difference is <10%

RSV-OA=ADJ-018 

Seroresponse Rate [SRR]

(with comorbidities associated with RSV-LRTD)

SRR Difference

(95% CI)

RSV-A

Cohort 2 (≥ 60) minus

Cohort 1a (50–59)

−6.67

(−12.26, −1.12)

RSV-B

Cohort 2 (≥ 60) minus

Cohort 1a (50–59)

−7.60

(−13.79, −1.40)

-15.0 -10.0 -5.0 0.0 5.0 10.0 15.0

Cohort 1a: Adults 50-59 with comorbidities associated with RSV-LRTD ; Cohort 1b: Adults 50-59 without comorbidities associated with RSV-LRTD; Cohort 2: 

Adults ≥ 60 YOA; Preliminary data; RSV response evaluated using NAb (ED60); SRR, Seroresponse rate defined as % of participants with 

≥ 4-fold increase of post-vaccination titers vs pre-vaccination titers (post-vacc titers/pre-vacc titers ≥ 4)
CO-16

1

10

100

1000

10000

100000

PRE PI(D31)

Cohort 1b: 

50–59 YOA

without comorbidities

Frequency of RSVPreF3 Specific CD4+ T-Cell Response 

Consistent for 50–59 YOA Compared with ≥ 60 YOA

PI(D31)

Increase in RSVPreF3 

specific CD4+ 

T-cells observed in all 

groups that received 

RSVPreF3 + AS01E

vaccine

1

10

100

1000

10000

100000

PRE PI(D31)

Cohort 1a:

50–59 YOA 

with comorbidities

1

10

100

1000

10000

100000

PRE

Cohort 2:

≥ 60 YOA

Frequency of 

RSVPreF3 

Specific 

CD4+T-cells 

Presentation by GSK at ACIP Oct 25, 2023

Q1 and Q3 are 25th and 75th percentiles. PRE, Pre-vaccination; PI(D31), 1 month post RSV vaccination; Q, quartile; 

Frequency of RSVPreF3 specific CD4+T-cells expressing ≥ 2 markers including ≥ 1 cytokine (CD40L, 4-1BB, TNF-α, IFN-γ, IL-13, 

and IL-17 (per million of CD4+T-cells by intracellular cytokine staining) - per protocol set for cell mediated immune response

Median

Q3

Q1

Minimum

Maximum

Key

N = 55 N = 45 N = 46 N = 44 N = 24 N = 22
CO-17

Safety

RSV-OA=ADJ-018: 6 Month Analysis

Safety Lock Point: July 21, 2023

Presentation by GSK at ACIP Oct 25, 2023
CO-18

Solicited Local and Systemic Adverse Events (AE)

Low reporting (< 5%) of Grade 3 events across groups; 

Most common local AE: pain and systemic AEs: fatigue, headache, myalgia

Percent of 

Participants 

(95% CI)

0.0

0.0

1.1

0.0

0.8

3.2

0.5

3.7

0.0

2.1

0.0

0.0

0.3

0.0

0.0

1.6

0.0

1.8

1.6 1.1

3.4

0.5

2.1

1.1 1.8

0.3 0.5 0.0 0.5 0.0

3.4

1.0

1.8

1.1 0.8

2.7

0.0

2.4

1.1

0.8

11.9

0.5

14.5

0.5

12.1

76.4

10.5

75.2

13.8

61.1

9.3

1.0

11.6

0.5

7.6

26.0

5.8

20.8

10.1 12.9

43.8

17.3

35.9

19.0 23.7

3.7 1.0 2.6 1.1 1.6

35.8

16.8

27.7

16.9 21.1

39.0

5.8

32.2

13.8

21.1

0

25

50

75

100

Cohort 1b RSV

Cohort 1b Placebo

Cohort 1a* RSV

Cohort 1a* Placebo

Cohort 2

Cohort 1b RSV

Cohort 1b Placebo

Cohort 1a* RSV

Cohort 1a* Placebo

Cohort 2

Cohort 1b RSV

Cohort 1b Placebo

Cohort 1a* RSV

Cohort 1a* Placebo

Cohort 2

Cohort 1b RSV

Cohort 1b Placebo

Cohort 1a* RSV

Cohort 1a* Placebo

Cohort 2

Cohort 1b RSV

Cohort 1b Placebo

Cohort 1a* RSV

Cohort 1a* Placebo

Cohort 2

Cohort 1b RSV

Cohort 1b Placebo

Cohort 1a* RSV

Cohort 1a* Placebo

Cohort 2

Cohort 1b RSV

Cohort 1b Placebo

Cohort 1a* RSV

Cohort 1a* Placebo

Cohort 2

Cohort 1b RSV

Cohort 1b Placebo

Cohort 1a* RSV

Cohort 1a* Placebo

Cohort 2

Erythema Pain Swelling Arthralgia Fatigue Fever ≥ 38°C Headache Myalgia

Local Systemic

Any

Presentation by GSK at ACIP Oct 25, 2023

Error bars show 95% CIs for total AEs. Grade 3: >100 mm for erythema and swelling; Grade 3 pain: significant pain at rest; prevents normal 

everyday activities. Fever: temperature ≥38.0 C/100.4 F by any route (oral, axillary or tympanic); Grade 3 fever: >39.0 C/102.2 F. Grade 3 

headache, fatigue, myalgia, arthralgia: preventing normal activity

Solicited AEs Reported Within 4 Days of Vaccination (Exposed Set)

RSV-OA=ADJ-018 

Cohort 1a: Adults with comorbidities associated with RSV-LRTD 

Cohort 1b: Adults without comorbidities associated with RSV-LRTD 

Cohort 2: ≥ 60 YOA

Grade 3
CO-19

13.1

0.5 0 0

13.5

2.1

0 0

14.5

3.6

0 1.0

10.5

2.6

0 0.5

16.2

2.4

0 0.8

0

25

50

75

100

Unsolicited AEs SAEs pIMDs

Unsolicited AEs, SAEs, Fatal SAEs, and pIMDs

Exposed Set

Fatal SAEs

Cohort 1a: 

Adults with comorbidities 

associated with RSV-LRTD 

Percent of 

Participants 

(95% CI)

Presentation by GSK at ACIP Oct 25, 2023

Grade 3: >100 mm for erythema and swelling; Grade 3 pain: significant pain at rest; prevents normal everyday activities. 

Fever: temperature ≥38.0 C/100.4 F by any route (oral, axillary or tympanic); Grade 3 fever: >39.0 C/102.2 F. Grade 3 headache, fatigue, 

myalgia, arthralgia: preventing normal activity; SAE; serious adverse events; pIMD, potential immune mediated disease

Within 30 days Up to Data Lock Point, September 01, 2023

RSVPreF3 + AS01E

Grade 3 Cohort 1b: 

Adults without comorbidities 

associated with RSV-LRTD 

RSVPreF3 + AS01E

Placebo

RSVPreF3 + AS01E

Placebo

1 0 1

2.1

0.5

RSV-OA=ADJ-018 

Cohort 2: 

≥ 60 YOA
CO-20

Summary of RSV-OA=ADJ-018 Results
CO-21

Summary: Immune Response Among Adults 50–59 YOA 

Non-inferiority success criteria met in adults 50–59 YOA with and without 

comorbidities associated with RSV-LRTD compared with adults ≥ 60 YOA

Presentation by GSK at ACIP Oct 25, 2023

Vaccine efficacy can be inferred in adults 50–59 YOA, including those with 

comorbidities associated with RSV-LRTD

High vaccine efficacy from pivotal Phase 3 in adults ≥ 60 YOA

 RSV-LRTD = 82.6% for season 1

 Severe RSV-LRTD = 94.1% for season 1

 ≥ 1 comorbidity associated with RSV-LRTD = 94.6%

 Durable efficacy across 2 full seasons

RSV-OA=ADJ-018 
CO-22

Summary: Immune Response and Safety Among Adults 50–59 YOA

Non-inferiority success criteria met in adults 50–59 YOA with and without 

comorbidities associated with RSV-LRTD compared with adults ≥ 60 YOA

Presentation by GSK at ACIP Oct 25, 2023

Vaccine efficacy can be inferred in adults 50–59 YOA, including those with

comorbidities associated with RSV-LRTD

Safety profile for 50–59 YOA groups consistent with profile observed in 

adults ≥ 60 YOA

RSV-OA=ADJ-018 
CO-23

Overall AREXVY Safety Update

Presentation by GSK at ACIP Oct 25, 2023
CO-24

Clinical studies

 As of Oct. 16, 2023, no reports of ADEM in GSK database

 Two unconfirmed reports of ADEM in Co-administration Study 

(RSV OA=ADJ-007) with AREXVY + FLU-QIV1

 Both diagnoses updated by investigator and no longer reported as 

ADEM

Post Authorization 

 As of Oct. 13, 2023, ≥ 2.1 million doses of AREXVY administered* in US

 Reported AEs reflect known safety profile**

Safety Update

Presentation by GSK at ACIP Oct 25, 2023

1. https://clinicaltrials.gov/study/NCT04841577

*IQVIA NPA Rapid Weekly TRx; **Based on GSK safety database lock Oct. 16 

ADEM, acute disseminated encephalomyelitis
CO-25

Overall Summary

Presentation by GSK at ACIP Oct 25, 2023

Severe RSV disease among adults 50–59 YOA with certain comorbidities presents 

significant unmet medical need 1

RSV-OA=ADJ-018 provides data to address this medical need; showing comparable 

immunogenicity to those ≥ 60 YOA, inferring vaccine efficacy 2

3 AREXVY is well tolerated with a favorable safety profile in 50–59 YOA 
CO-26

ACIP October 25, 2023

Susan Gerber, MD

Medical Director 

Presentation by GSK at ACIP Oct 25, 2023