Document text
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, 20231
2
3
Observed disparities by race and ethnicity are particularly pronounced with respectto hospitalization rates among middle aged adults 50 –64 YOA4
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 higherAmong 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, 2023Unadjusted RSV -related hospitalization incidence per 100,000
by race / ethnicity and season from RSV -NET data1
RSV
Hospitalization
Incidence per
100,000
010203040
2018-2019 2019-2020 2020-2021 2021-2022 2022-202350–64 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, 2023Primary objective: To demonstrate the non-inferiority of the humoral immune response in participants
50–59YOA 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, 2023CI, 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
50–59YOA 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, 2023ClinicalTrials.gov. NCT05590403. https://www.clinicaltrials.gov/study/NCT05590403 ; (accessed September 2023)
1. RSV OA=ADJ -018 study protocol
50-59RSV-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 vaccinationPrimary objective: To demonstrate the non-inferiority of the humoral immune response in participants
50–59YOA 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
50-59Safety 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 + AS01
E
specific CD4+ T cells expressing at least 2 activation markers at pre -vaccination
and at 1, 6, and 12 months after vaccinationRSV-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
50–59YOA 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=382Study 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 + AS01ECurrent analysis Study initiation:
October 2022
Blood sampleVisit 1
Day 1Visit 2
Day 31Visit 3
Month 6Visit 4
Month 12
Cohort 1:
Adults 50– 59 YOA, n=1140
Cohort 1b
n=570 RRSVPreF3 + AS01E
n=383
Placebo group
n=192Cohort 1a
n=570RRSVPreF3 + AS01E
n=386
Placebo
n=191
Month 6 analysis
PlaceboCohort 2:
≥ 60 YOA, n=380
Safety monitoringCohort 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 cohortParticipants with chronic stable medical conditions
Presentation by GSK at ACIP Oct 25, 2023Inclusion Criteria1RSV-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, 2023RSV-OA=ADJ -018
CO-11
Demographic Characteristics Well -Balanced
Exposed Set50 –59 YOA
Cohort 1a: Adults with comorbidities associated
with RSV -LRTD50 –59 YOA
Cohort 1b: Adults without comorbidities
associated with RSV -LRTD ≥ 60 YOA
CharacteristicRSVPreF3 + 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, 2023SD, 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 diseasesRSV-OA=ADJ -018
CO-12
Clinical Characteristics Well -Balanced
Exposed Set50 –59 YOA
Cohort 1a: Adults with comorbidities associated
with RSV -LRTD50 –59 YOA
Cohort 1b: Adults without comorbidities
associated with RSV -LRTD ≥ 60 YOA
CharacteristicRSVPreF3 + 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 diseaseRSV-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 2.0Co-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, 2023Cohort 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 antibodyGMT 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, 2023Success 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
110100100010000100000PRE PI(D31)Cohort 1b:
50–59 YOA
without comorbiditiesFrequency 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
110100100010000100000PRE PI(D31)Cohort 1a:
50–59 YOA
with comorbidities
110100100010000100000PRECohort 2:
≥ 60 YOA
Frequency of
RSVPreF3
Specific
CD4+T -cells
Presentation by GSK at ACIP Oct 25, 2023Q1 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 responseMedianQ3
Q1
MinimumMaximumKey
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 A Es: fatigue, headache, myalgia
Percent of
Participants
(95% CI)
0.0
0.01.1
0.00.83.2
0.53.7
0.02.1
0.0
0.00.3
0.00.01.6
0.01.8
1.6 1.13.4
0.52.1
1.11.8
0.30.5 0.00.5 0.03.4
1.01.8
1.10.82.7
0.02.4
1.10.8
11.9
0.514.5
0.512.176.4
10.575.2
13.861.1
9.3
1.011.6
0.57.626.0
5.820.8
10.112.943.8
17.335.9
19.0 23.7
3.7 1.0 2.61.1 1.635.8
16.827.7
16.9 21.139.0
5.832.2
13.821.1
0255075100
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 SystemicAny
Presentation by GSK at ACIP Oct 25, 2023Error 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 activitySolicited 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 YOAGrade 3
CO-19
13.1
0.5 0 013.5
2.1
0 014.5
3.6
01.010.5
2.6
0 0.516.2
2.4
00.8
0255075100
SAEs pIMDs Unsolicited AEsUnsolicited AEs, SAEs, Fatal SAEs, and pIMDs
Exposed Set
Fatal SAEsCohort 1a:
Adults with comorbidities
associated with RSV -LRTD
Percent of
Participants
(95% CI)
Presentation by GSK at ACIP Oct 25, 2023Grade 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 diseaseWithin 30 days Up to Data Lock Point, September 01, 2023RSVPreF3 + AS01EGrade 3Cohort 1b:
Adults without comorbidities
associated with RSV -LRTD
RSVPreF3 + AS01E
PlaceboRSVPreF3 + AS01E
Placebo
10 1
2.1
0.5RSV-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 v accine 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 seasonsRSV-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, 20231. 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 efficacy2
AREXVY is well tolerated with a favorable safety profile in 50– 59 YOA 3
CO-26
ACIP October 25, 2023
Susan Gerber, MD
Medical Director
Presentation by GSK at ACIP Oct 25, 2023