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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)
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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.
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