Centers for Disease Control and Prevention 

Evidence to Recommendations Framework 

Respiratory Syncytial Virus (RSV) in Adults 

GSK adjuvanted RSVpreF3 vaccine in older adults 

Pfizer bivalent RSVpreF vaccine in older adults 

Michael Melgar, MD 

Lead, Adult RSV ACIP Work Group 

ACIP Meeting 

February 23, 2023 
 

 

Evidence to Recommendations (EtR) Framework

Policy Questions 

 Should vaccination with GSK RSVpreF3 vaccine (120μg antigen + AS01E adjuvant, 1 

dose IM), rather than no vaccine, be recommended in persons aged ≥65 years?

 Should vaccination with GSK RSVpreF3 vaccine (120μg antigen + AS01E adjuvant, 1 

dose IM), rather than no vaccine, be recommended in persons aged ≥60 years?

 Should vaccination with Pfizer bivalent RSVpreF vaccine (120μg antigen, 1 dose IM), 

rather than no vaccine, be recommended in persons aged ≥65 years?

 Should vaccination with Pfizer bivalent RSVpreF vaccine (120μg antigen, 1 dose IM), 

rather than no vaccine, be recommended in persons aged ≥60 years?

2 
 

 

 

 

 

 

 

 

 

 

Evidence to Recommendations (EtR) Framework 

EtR Domain Question(s) 

Public Health Problem  Is the problem of public health importance?

Benefits and Harms  How substantial are the desirable anticipated effects?

 How substantial are the undesirable anticipated effects?

 Do the desirable effects outweigh the undesirable effects?

Values  Does the target population feel the desirable effects are large relative 

to the undesirable effects?

 Is there important variability in how patients value the outcome?

Acceptability  Is the intervention acceptable to key stakeholders?

Feasibility  Is the intervention feasible to implement?

Resource Use  Is the intervention a reasonable and efficient allocation of resources?

Equity  What would be in the impact of the intervention on health equity?

3 
 

Evidence to Recommendations (EtR) Framework 

EtR Domain 

Public Health Problem

Benefits and Harms 

Values 

Acceptability 

Feasibility 

Resource Use 

Equity 

Data on RSV in older adults will be presented 

4 
 

Evidence to Recommendations (EtR) Framework 

EtR Domain 

Public Health Problem

Benefits and Harms 

Values 

Acceptability 

Feasibility 

Resource Use 

Equity 

Use of RSV vaccines broadly will be presented 

5
 

Evidence to Recommendations (EtR) Framework 

EtR Domain 

Public Health Problem 

Benefits and Harms 

Values 

Acceptability 

Feasibility 

Resource Use 

Equity 

Manufacturer-specific data will be presented 

6
 

Public Health Problem 

Is RSV among older adults of public health importance? 
 

 

 

 

 

 

Among adults ≥65 years of

age in the United States,

RSV is associated with*... 

*There is substantial uncertainty 

in burden of disease, reflected in 

wide ranges here. 

6,000–10,0001–3 

deaths/year 

60,000–160,0004–8 

hospitalizations/year 

0.9–1.4 million5

medical encounters/year 

5. McLaughlin et al, Open Forum Infect Dis (2022): https://doi.org/10.1093/ofid/ofac300 

6. Zheng et al, Pneumonia (2022): https://doi.org/10.1186/s41479-022-00098-x 

7. Branche et al, Clinical Infect Dis (2022): https://doi.org/10.1093/cid/ciab595

8. CDC RSV-NET data 2016–2020 (unpublished) 

1. Thompson et al, JAMA (2003): https://doi.org/10.1001/jama.289.2.179 

2. Matias et al, Influenza Other Respi Viruses (2014): https://doi.org/10.1111/irv.12258

3. Hansen et al, JAMA Network Open (2022): 

https://doi.org/10.1001/jamanetworkopen.2022.0527

4. Widmer et al, JAMA Network Open (2012): https://doi.org/10.1093/infdis/jis309 

8 
 

 

0

50

100

150

200

250

300

350

Hospitalizations per 100,000 

237 to 325

42 to 53

7 to 11

26 to 36

50 to 67

69 to 84

111 to 133 

18-49 yr 50-59 yr 60-64 yr 65-69 yr 70-79 yr 80+ yr Overall 

2016-17 2017-18 2018-19 2019-20

 

RSV-associated hospitalization rates by adult age group,

RSV-NET 2016–2020

RSV-NET: unpublished data; https://www.cdc.gov/rsv/research/rsv-net/overview-methods.html. 

Rates are adjusted for the frequency of RSV testing during recent prior seasons and the sensitivity of RSV diagnostic tests.. Slide credit: Fiona Havers 

9 
25 23 

20 20 18

15

5

10

5 3

1 

0

18-49 50-64 ≥65

Age group (years) 

ICU admission Death 

Slide credit: Fiona Havers 

Percent 

 

Outcomes among adults ≥18 years hospitalized for 

RSV: RSV-NET 2017–18 to 2019–20 seasons (n=8,214)

Severe outcomes 

frequent among 

adults of all ages 

hospitalized for RSV 

10 
 

 

 

 

 

Adults with certain underlying medical conditions are 

at higher risk of RSV hospitalization 

 Immune compromise, especially hematopoietic stem cell transplant and 

solid organ transplant 

 Cardiovascular disease (e.g., congestive heart failure) 

 Diabetes mellitus 

 Chronic obstructive pulmonary disease (COPD) 

 Asthma 

1. Anderson et al, Diagn Microbiol Infect Dis (2016): https://doi.org/10.1016/j.diagmicrobio.2016.02.025

2. Prasad et al, Clin Infect Dis (2020): https://doi.org/10.1093/cid/ciaa730 

3. Kujawski et al, Plos One (2022): https://doi.org/10.1371/journal.pone.0264890

4. Branche et al, Clin Infect Dis (2022): https://doi.org/10.1093/cid/ciab595

11 
 

 

 

 

Summary 

 RSV is a frequent, often unrecognized, cause of severe respiratory 

illness, with incidence increasing with age among older adults 

 High proportion of those hospitalized with RSV have severe outcomes, 

including ICU admission and death 

 Death is more common with increasing age 

12 
Public Health Problem- Work Group Interpretation 

 Is RSV disease of public health importance among adults aged ≥65

years? 

No Probably 

No 

Probably 

Yes Yes Varies Don’t 

know 

13 
Benefits and Harms 

- How substantial are the desirable anticipated effects? 

- How substantial are the undesirable anticipated effects? 

- Do the desirable effects outweigh the undesirable effects? 
 

Benefits and Harms 

 GSK adjuvanted RSVpreF3 vaccine 

– Grading of Recommendations, Assessment, Development and 

Evaluation (GRADE) Summary 

– Number-needed-to-vaccinate (NNV) analysis 

 Pfizer bivalent RSVpreF vaccine 

– GRADE Summary 

– NNV analysis 

15
16

 

 

 

GRADE Framework: PICO Question 

Population 



Intervention 

Comparison 

Outcomes 

Persons aged ≥60 years

GSK RSVpreF3 vaccine (120 μg antigen + AS01E adjuvant, 1 dose IM) 

-orPfizer bivalent RSVpreF vaccine (120μg antigen, 1 dose IM) 

No RSV vaccine 

 RSV lower respiratory tract illness/disease (LRTI/LRTD) 

 Medically attended RSV LRTI/LRTD 

 Hospitalization for RSV respiratory illness 

 Severe RSV respiratory illness requiring supplemental O2 or other 

respiratory support 

 Death due to RSV respiratory illness 

 Serious Adverse Events (SAEs) 

 Inflammatory neuropathy (e.g., Guillain-Barré syndrome) 

 Reactogenicity (grade ≥3)
GRADE: GSK adjuvanted RSVpreF3 

17 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GSK, Benefits: vaccine efficacy estimates 

OutcomeImportance Data sources Vaccine efficacy estimatea 

(95% confidence interval)

Concerns in certainty 

assessment 

Benefits 

RSV Lower Respiratory Tract Disease 

(LTRD) Critical One phase 3 RCTb 82.5% (60.9%, 92.1%) Indirectness (serious)c 

Medically attended RSV LRTD Critical One phase 3 RCTb 87.5% (58.4%, 96.2%) Indirectness (serious)c 

Hospitalization for RSV respiratory 

illness Important One phase 3 RCTb Unable to evaluated 

Severe RSV respiratory illness 

requiring O2/respiratory support Important One phase 3 RCTb Unable to evaluatee 

Death due to RSV respiratory illness Important One phase 3 RCTb Unable to evaluatef 

RCT: Randomized control trial 

a Efficacy estimates were independently calculated using counts of events and participants in the GSK pivotal phase 3 trial interim analysis. Data provided by manufacturer. 

Efficacy was calculated as 1 – relative risk. Events of each outcome were included if they occurred on or after day 15 after injection. 

b Papi A, Ison MG, Langley JM, et al. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. 2023. NEJM. https://doi.org/10.1056/nejmoa2209604 c Underrepresentation of adults aged ≥80 years, exclusion of persons with immune compromise.

d Three RSV-associated hospitalizations occurred in the modified exposed set up to the data lock point for the interim analysis. Information was not provided by study arm 

(intervention vs. placebo) to avoid unblinding of cases. 

e 31 cases of LRTD requiring oxygen supplementation were identified; 4 of the 31 cases were associated with RSV. All 4 cases occurred in the placebo arm. Measures of 

relative and absolute risk were not calculated due to small number of events. 

f No RSV-associated deaths were recorded in the interim analysis. 

18 
 

 

 

 

 

 

 

 

 

 

GSK, Harms: relative risk 

OutcomeImportance Data sources Relative risk estimatea 

(95% confidence interval)

Concerns in certainty 

assessment 

Harms 

Serious adverse events (SAEs) Critical One phase 3 RCT, 

one phase 1/2 RCT 1.03 (0.92, 1.17) None serious 

Inflammatory neuropathy Important One phase 3 RCT 

one phase 1/2 RCT Unable to evaluateb 

Reactogenicity (grade ≥3) Important One phase 3 RCT 

one phase 1/2 RCT 4.10 (1.99, 8.45) None serious 

RCT: Randomized control trial 

a Pooled relative risk estimates were independently calculated using counts of events and participants in the GSK pivotal phase 3 trial interim analysis (Papi A, et al. NEJM 

2023 https://doi.org/10.1056/nejmoa2209604), as well as from a placebo-controlled phase 1/2 dosing selection study (Leroux-Roels I, et al. J Infect Dis. 2022 

https://doi.org/10.1093/infdis/jiac327). Data provided by manufacturer. 

b No events recorded in studies included in GRADE. One event of Guillain-Barré syndrome recorded in a recipient of the investigational vaccine in an open label trial without a 

placebo arm. This study was not included in GRADE assessment due to lack of an unvaccinated comparator. 

19 
 

 

 

 

 

 

 

 

 

 

 

GSK, Harms: relative risk 

OutcomeImportance Data sources Relative risk estimatea 

(95% confidence interval)

Concerns in certainty 

assessment 

Harms 

Serious adverse events (SAEs) Critical One phase 3 RCT, 

one phase 1/2 RCT 1.03 (0.92, 1.17) None serious 

Inflammatory neuropathy Important One phase 3 RCT 

one phase 1/2 RCT Unable to evaluateb 

Reactogenicity (grade ≥3) Important One phase 3 RCT 

one phase 1/2 RCT 4.10 (1.99, 8.45) None serious 

RCT: Randomized control trial 

a Pooled relative risk estimates were independently calculated using counts of events and participants in the GSK pivotal phase 3 trial interim analysis (Papi A, et al. NEJM 

2023 https://doi.org/10.1056/nejmoa2209604), as well as from a placebo-controlled phase 1/2 dosing selection study (Leroux-Roels I, et al. J Infect Dis. 2022 

https://doi.org/10.1093/infdis/jiac327). Data provided by manufacturer. 

b No events recorded in studies included in GRADE. One event of Guillain-Barré syndrome recorded in a recipient of the investigational vaccine in an open label trial without a 

placebo arm. This study was not included in GRADE assessment due to lack of an unvaccinated comparator. 

Total of 1 case of inflammatory neuropathy among approximately 

15,000 investigational vaccine recipients across all clinical trials 20 
 

 

 

Summary of GRADE for GSK RSVPreF3 vaccine in older adults 

OutcomeImportance Design 

(# of studies)

FindingsEvidence 

type

Benefits 

RSV Lower Respiratory Tract 

Disease (LTRD) Critical RCT (1) GSK RSVpreF3 likely reduces RSV LRTD. Moderate 

Medically attended RSV 

LRTD Critical RCT (1) GSK RSVpreF3 likely reduces medically attended RSV LRTD. Moderate 

Hospitalization for RSV 

respiratory illness Important RCT (1) Only three events, unknown whether in vaccine or placebo arm Unable to evaluate 

Severe RSV respiratory 

illness requiring 

O2/respiratory support 

Important RCT (1) Measures of relative and absolute risk not calculated due to small 

number of events. 

Unable to 

evaluate 

Death due to RSV respiratory 

illness Important RCT (1) No events observed Unable to evaluate 

Harms 

Serious adverse eventsCritical RCT (2) GSK RSVpreF3 results in little to no differences in SAEs. High 

Inflammatory neuropathy Important RCT (2) No events observed in placebo-controlled trials. Single case 

observed in an open-label uncontrolled study. 

Unable to 

evaluate 

Reactogenicity (grade ≥3) Important RCT (2) GSK RSVpreF3 increases severe reactogenicity events. High 21 
Summary of GRADE for GSK RSV vaccine in older adults 

Overall evidence rating: Moderate certainty 22 
 

 

 

 

 

 

Number needed to vaccinate (NNV): GSK RSVpreF3 

 Derived from cost effectiveness analysis performed by U. Michigan 

 Time horizon: one year 

Number of vaccinations 

required to prevent... Adults aged ≥65 years Adults aged ≥60 years

1 RSV outpatient visita 84 vaccinations 90 vaccinations 

1 RSV hospitalizationb 1,097 vaccinations 1,348 vaccinations 

1 RSV deathc 21,442 vaccinations 27,284 vaccinations 

a Incidence rates of RSV illness requiring outpatient visit taken from McLaughlin et al, OFID (2022) (unadjusted for RSV under-detection by NP swab RT-PCR). Vaccine efficacy (VE) against 

this outcome assumed to be equal to that against medically attended acute respiratory illness (ARI) caused by RSV (GSK AReSVi-006 trial, unpublished).

b Incidence rates of RSV hospitalization taken from RSV-NET 2015–2019 (unpublished). VE against RSV-associated hospitalization assumed to be equal to that against medically attended 

lower respiratory tract disease (LRTD) caused by RSV (GSK AReSVi-006 trial, unpublished). c Probability of in-hospital death among adults hospitalized for RSV taken from RSV-NET 2015–2019 (unpublished). VE against RSV-associated death assumed to be equal to that against 

medically attended lower respiratory tract disease (LRTD) caused by RSV (GSK AReSVi-006 trial, unpublished).

23 
 

 

 

Benefits and Harms GSK adjuvanted RSVpreF3 vaccine 

 How substantial are the desirable anticipated effects among adults 

aged ≥65 years (relative to no RSV vaccine)?

– How substantial is the anticipated protective effect against: 

• RSV lower respiratory tract disease (LRTD) 

• Medically attended RSV LRTD 

• Hospitalization for RSV respiratory illness 

• Severe RSV respiratory illness requiring supplemental O2/respiratory 

support 

• Death due to RSV respiratory illness 

Minimal Small Moderate Large Varies Don’t know 

24 
 

 

 

Benefits and Harms GSK adjuvanted RSVpreF3 vaccine 

 How substantial are the undesirable anticipated effects among 

adults aged ≥65 years (relative to no RSV vaccine)?

– How substantial is the anticipated effect on: 

• Serious Adverse Events (SAEs) 

• Inflammatory neuropathy (e.g., Guillain-Barré Syndrome) 

• Reactogenicity (grade ≥3)

Minimal Small Moderate Large Varies Don’t know 

Minority opinion 25
 

 

 

Benefits and Harms GSK adjuvanted RSVpreF3 vaccine 

 Do the desirable effects outweigh the undesirable effects among 

adults aged ≥65 years?

– What is the balance between the desirable effects relative to 

the undesirable effects?

Favors intervention (GSK RSVpreF3 vaccine) 

Favors comparison (no vaccine) 

Favors both 

Favors neither 

Unclear 

Minority opinion 26
GRADE: Pfizer bivalent RSVpreF 

27 
 

 

 

 

 

 

 

 

 

 

 

 

 

Pfizer, Benefits: vaccine efficacy estimates 

OutcomeImportance Data sources Vaccine efficacy estimatea 

(95% confidence interval)

Concerns in certainty 

assessment 

Benefits 

RSV Lower Respiratory Tract Illness 

(LRTI)b Critical One phase 3 RCT 85.7% (37.9%, 98.4%) Indirectness (serious)c 

Medically attended RSV LRTIb Critical One phase 3 RCT 80.0% (6.3%, 97.9%) Indirectness (serious)c 

Hospitalization for RSV respiratory 

illness Important Counts not 

provided Unable to evaluated 

Severe RSV respiratory illness 

requiring O2/respiratory support Important Counts not 

provided Unable to evaluated 

Death due to RSV respiratory illness Important One phase 3 RCT Unable to evaluatee 

RCT: Randomized control trial 

a Efficacy estimates were independently calculated using counts of events and person-time observation in the Pfizer pivotal phase 3 trial interim analysis. Data provided by 

manufacturer. Efficacy was calculated as 1 – incidence rate ratio. Events of each outcome were included if they occurred on or after day 15 after injection.

b Pfizer pivotal phase 3 trial included co-primary outcomes of LRTI with ≥2 lower respiratory signs or symptoms, and LRTI with ≥3 lower respiratory signs or symptoms. In 

GRADE, the outcome of LRTI with ≥3 lower respiratory signs or symptoms was used. c Underrepresentation of adults aged ≥80 years, exclusion of persons with immune compromise.

d Counts of event were not provided by manufacturer. 

e No RSV-associated deaths were recorded in the interim analysis. 

28 
 

 

 

 

 

 

 

 

 

 

 

Pfizer, Harms: relative risk 

OutcomeImportance Data sources Relative risk estimatea 

(95% confidence interval)

Concerns in certainty 

assessment 

Harms 

Serious adverse events 

(SAEs) Critical One phase 3 RCT 

one phase 1/2 RCT 1.01 (0.88 to 1.16) None serious 

Inflammatory neuropathy Important One phase 3 RCT 

one phase 1/2 RCT Unable to evaluateb 

Reactogenicity (grade ≥3) Important One phase 3 RCT 

one phase 1/2 RCT 1.47 (0.88 to 2.46) Imprecision (serious)c 

RCT: Randomized control trial 

a Pooled relative risk estimates were independently calculated using counts of events and participants in the Pfizer pivotal phase 3 trial interim analysis, as well as from a 

placebo-controlled phase 1/2 formulation selection study (Falsey A, et al. J Infect Dis. 2022 https://doi.org/10.1093/infdis/jiab611p). Data provided by manufacturer. 

b In the Pfizer pivotal phase 3 trial interim analysis, 2 events of Guillain-Barré syndrome were recorded in the intervention arm, compared with zero in the placebo arm. No 

events were recorded in the phase 1/2 formulation selection study. Measures of relative and absolute risk were not calculated due to small number of events. c 95% confidence interval for measure of absolute risk included potential for both benefit and harm.

29 
 

 

 

 

 

 

 

 

 

 

 

 

Pfizer, Harms: relative risk 

OutcomeImportance Data sources Relative risk estimatea 

(95% confidence interval)

Concerns in certainty 

assessment 

Harms 

Serious adverse events 

(SAEs) Critical One phase 3 RCT 

one phase 1/2 RCT 1.01 (0.88 to 1.16) None serious 

Inflammatory neuropathy Important One phase 3 RCT 

one phase 1/2 RCT Unable to evaluateb 

Reactogenicity (grade ≥3) Important One phase 3 RCT 

one phase 1/2 RCT 1.47 (0.88 to 2.46) Imprecision (serious)c 

RCT: Randomized control trial 

a Pooled relative risk estimates were independently calculated using counts of events and participants in the Pfizer pivotal phase 3 trial interim analysis, as well as from a 

placebo-controlled phase 1/2 formulation selection study (Falsey A, et al. J Infect Dis. 2022 https://doi.org/10.1093/infdis/jiab611p). Data provided by manufacturer. 

b In the Pfizer pivotal phase 3 trial interim analysis, 2 events of Guillain-Barré syndrome were recorded in the intervention arm, compared with zero in the placebo arm. No 

events were recorded in the phase 1/2 formulation selection study. Measures of relative and absolute risk were not calculated due to small number of events. c 95% confidence interval for measure of absolute risk included potential for both benefit and harm.

Total of 2 cases of inflammatory neuropathy among approximately 

26,000 investigational vaccine recipients across all clinical trials 30 
 

 

 

 

Summary of GRADE for Pfizer RSV vaccine in older adults 

OutcomeImportance Design 

(# of studies)

FindingsEvidence 

type

Benefits 

RSV Lower Respiratory Tract 

Illness (LRTI) Critical RCT (1) Pfizer RSVpreF likely reduces RSV LRTI. Moderate 

Medically attended RSV LRTI Critical RCT (1) Pfizer RSVpreF likely reduces medically attended RSV LRTI. Moderate 

Hospitalization for RSV 

respiratory illness Important No data Unable to evaluate 

Severe RSV respiratory illness 

requiring O2/respiratory 

support 

Important No data Unable to 

evaluate 

Death due to RSV respiratory 

illness Important RCT (1) No events observed Unable to evaluate 

Harms 

Serious adverse events(SAEs) Critical RCT (2) Pfizer RSVpreF results in little to no difference in SAEs. High 

Inflammatory neuropathy Important RCT (2) Measures of relative and absolute risk not calculated due to 

small number of events. 

Unable to 

evaluate 

Reactogenicity (grade ≥3) Important RCT (2) Pfizer RSVpreF likely increases severe reactogenicity events. Moderate 31 
Summary of GRADE for Pfizer RSV vaccine in older adults 

Overall evidence rating: Moderate certainty 32 
 

 

 

 

 

 

Number needed to vaccinate (NNV): Pfizer RSVpreF 

 Derived from cost effectiveness analysis performed by U. Michigan 

 Time horizon: one year 

Number of vaccinations 

required to prevent... Adults aged ≥65 years Adults aged ≥60 years

1 RSV outpatient visita 95 vaccinations 103 vaccinations 

1 RSV hospitalizationb 1,275 vaccinations 1,567 vaccinations

1 RSV deathc 24,927 vaccinations 31,717 vaccinations 

a Incidence rates of RSV illness requiring outpatient visit taken from McLaughlin et al, OFID (2022) (unadjusted for RSV under-detection by NP swab RT-PCR). Vaccine efficacy (VE) against 

this outcome assumed to be equal to that against medically attended acute respiratory illness (ARI) caused by RSV (Pfizer RENOIR trial, unpublished). 

b Incidence rates of RSV hospitalization taken from RSV-NET 2015–2019 (unpublished). VE against RSV-associated hospitalization assumed to be equal to that against medically attended 

lower respiratory tract illness (LRTI) with ≥3 symptoms, caused by RSV (Pfizer RENOIR trial, unpublished). c Probability of in-hospital death among adults hospitalized for RSV taken from RSV-NET 2015–2019 (unpublished). VE against RSV-associated death assumed to be equal to that against 

medically attended lower respiratory tract illness (LRTI) with ≥3 symptoms, caused by RSV (Pfizer RENOIR trial, unpublished). 33 
 

 

 

Benefits and Harms Pfizer bivalent RSVpreF vaccine 

 How substantial are the desirable anticipated effects among adults 

aged ≥65 years (relative to no RSV vaccine)?

– How substantial is the anticipated protective effect against: 

• RSV lower respiratory tract disease (LRTD) 

• Medically attended RSV LRTD 

• Hospitalization for RSV respiratory illness 

• Severe RSV respiratory illness requiring supplemental O2/respiratory 

support 

• Death due to RSV respiratory illness 

Minimal Small Moderate Large Varies Don’t know 

34 
 

 

 

Benefits and Harms Pfizer bivalent RSVpreF vaccine 

 How substantial are the undesirable anticipated effects among 

adults aged ≥65 years (relative to no RSV vaccine)?

– How substantial is the anticipated effect on: 

• Serious Adverse Events (SAEs) 

• Inflammatory neuropathy (e.g., Guillain-Barré Syndrome) 

• Reactogenicity (grade ≥3)

Minimal Small Moderate Large Varies Don’t know 

Minority opinion 35
 

 

 

Benefits and Harms Pfizer bivalent RSVpreF vaccine 

 Do the desirable effects outweigh the undesirable effects among 

adults aged ≥65 years?

– What is the balance between the desirable effects relative to 

the undesirable effects?

Favors intervention (Pfizer RSVpreF vaccine) 

Favors comparison (no vaccine) 

Favors both 

Favors neither 

Unclear 

Minority opinion 36
Values 

Do older adults feel the desirable effects of RSV vaccination are 

large relative to the undesirable effects? 

Is there important variability in how older adults value the main 

outcomes? 
 

 

 

Survey of vaccination intent for an RSV vaccine among 

U.S. adults aged ≥60 years

 Designed to assess vaccination intentions for a hypothetical RSV vaccine 

 Data collection period: December 23–31, 2022 

 Final sample: 586 respondents (98.7% completion rate)

GENDER RACE/ETHNICITY AGE 

56.3% Female

43.7% Male or other 

gender identity 

74.9% Non-Hispanic White 

12.4% Non-Hispanic Black 

9.1% Hispanic

70.6% 60–70 years 

29.4% ≥70 years

CDC and University of Iowa/RAND survey, unpublished 

38 
 

 

68% of respondents said they ‘definitely’ or ‘probably’ 

would get vaccinated if a safe and effective FDAapproved RSV vaccine was available 

Definitely or 

probably would 

get vaccinated 

Unsure 

Definitely or 

probably would 

not get vaccinated 

CDC and University of Iowa/RAND survey, unpublished 

39 
77% said they ‘definitely’ or ‘probably’ would get an 

RSV vaccine if it were recommended by a healthcare 

provider 

Definitely or 

probably would 

get vaccinated 

Unsure 

Definitely or 

probably would 

not get vaccinated 

CDC and University of Iowa/RAND survey, unpublished 

40 
% of respondents who expressed hesitancy to receive an RSV vaccine (n=378) 

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 

I don’t know enough about RSV 

Long-term safety 

Short-term safety 

Cost concerns 

Don’t trust an RSV vaccine 

I’ve gotten too many vaccines 

RSV vaccine might cause RSV 

RSV vaccine might make infection worse 

None of these 

An RSV vaccine wouldn’t work well 

Other 

I don’t like needles 

Not at risk of getting RSV 

Would not get sick if I got RSV 

Against my religious beliefs 

I’ve already had RSV 

No time to get vaccinated 

RSV is not real 

41.0% 

39.4% 

29.1% 

13.0% 

11.9% 

11.1% 

9.3% 

9.3% 

9.3% 

5.8% 

5.6% 

5.3% 

4.5% 

4.2% 

1.6% 

0.8% 

0.8% 

0.5% 

 

 

Lack of RSV knowledge and safety concerns were 

among the top reasons for not wanting an RSV vaccine 

CDC and University of Iowa/RAND survey, unpublished 

41 
 

 

 

 

Values 



–

–

Do older adults feel that the desirable effects of RSV vaccination are 

large relative to the undesirable effects?

How do older adults view the balance of desirable versus 

undesirable effects?

Would older adults feel that the benefits outweigh the harms?

No Probably no Probably Yes Yes Varies Don’t know 

42 
 

 

 

Values 

 Is there important uncertainty about, or variability in, how much older 

adults value the main outcomes?

– Is there evidence that the variability is large enough to lead to 

different decisions?

Important uncertainty or variability 

Probably important uncertainty or variability 

Probably not important uncertainty or variability 

No important uncertainty or variability 

No known undesirable outcomes 

43 
Acceptability 

Would recommending RSV vaccines for older adults be 

acceptable to key stakeholders? 
 

 

 

 

 

Vaccine Policy Collaborative Initiative 

 Survey of physicians, February–March 2017 

 National network of 930 primary care physicians who agreed to 

participate in surveys about vaccine policy issues 

– 620 physicians (67%) completed the survey

– Responses analyzed from 317 respondents (51%) who reported

caring for ≥1 adult patient with possible RSV in the preceding 12

months 

Hurley LP, Allison MA, Kim L, et al. Primary care physicians’ perspectives on respiratory syncytial virus (RSV) disease in adults and a potential RSV vaccine for adults. 2019 Vaccine 

37(4): 565-570. ISSN 0264-410X. https://doi.org/10.1016/j.vaccine.2018.12.031. 45
Physician Perception of Importance of RSV as a pathogen in 

the following groups of patients, United States, 2017 (n = 317)

A majority of physicians believed 

that RSV was a very important 

pathogen in adults of any age 

with an immunocompromising 

condition (57%) and adults aged 

≥65 years with cardiopulmonary 

disease (56%).

 

 

 

 

 

Hurley LP, Allison MA, Kim L, et al. Primary care physicians’ perspectives on respiratory syncytial virus (RSV) disease in adults and a potential RSV vaccine for adults. 2019 Vaccine 

37(4): 565-570. ISSN 0264-410X. https://doi.org/10.1016/j.vaccine.2018.12.031. 46
Physician Perception of Importance of RSV as a pathogen in 

the following groups of patients, United States, 2017 (n = 317)

One third of physicians believed 

that RSV was a very important 

pathogen in adults 50–64 years 

with cardiopulmonary disease 

(35%) and adults ≥65 years 

without cardiopulmonary 

disease (31%).

 

 

 

Hurley LP, Allison MA, Kim L, et al. Primary care physicians’ perspectives on respiratory syncytial virus (RSV) disease in adults and a potential RSV vaccine for adults. 2019 Vaccine 

37(4): 565-570. ISSN 0264-410X. https://doi.org/10.1016/j.vaccine.2018.12.031. 47 
 

 

 

Acceptability 

 Would recommending RSV vaccines for adults aged ≥65 years be 

acceptable to key stakeholders?

– Are there key stakeholders that would not accept the distribution of 

benefits and harms?

– Are there key stakeholders that would not accept the undesirable 

effects in the short term for the desirable effects (benefits) in the 

future?

No Probably No Probably Yes Yes Varies Don’t know 

48 
Feasibility 

Is RSV vaccination for older adults feasible to implement? 
 

 

Barriers to implementation of a novel RSV vaccine may 

include: 

 Vaccine storage and handling requirements 

 Complexity of the adult vaccination schedule (including coadministration) 

 Financial barriers 

50
51

 

 

 

 

 

 

Storage & handling requirements 

GSK RSVpreF3 Pfizer RSVpreF 

Supplied as single dose Supplied as single dose, or as a 5-pack or 

10-pack of single-dose kits 

Reconstitution required: single dose vial 

of lyophilized powder (antigen 

component) + single dose vial of liquid 

(adjuvant component) 

Reconstitution required: single dose vial 

of lyophilized powder, reconstitution 

supplies included in kit 

Both components should be refrigerated 

(2–8°C) in original container, protected 

from light 

Product should be refrigerated (2–8°C) in 

original container, protected from light 

After reconstitution, the product should 

be administered within 4 hours, otherwise 

discarded 

After reconstitution, the product should 

be administered within 4 hours, otherwise 

discarded 
 

 

Older adult routine immunization schedule is 

becoming more complex 

https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html 

50-64 years ≥65 years

Influenza 

inactivated (IIV4) or 

Influenza 

recombinant (RIV4) 

1 dose annually 

Tetanus, diphtheria, 

pertussis 

(Tdap or Td) 

1 dose Tdap, then Td or Tdap booster every 10 years 

Zoster recombinant 

(RZV) 2 doses 

Pneumococcal 

(PCV15, PCV20,

PPSV23) 

1 dose PCV15 followed by PPSV23

OR 

1 dose PCV20 (see notes) 

1 dose PCV15 followed by PPSV23

OR 

1 dose PCV20 

 Potential fall or other regularly scheduled COVID-19 vaccine 

 Clinicians may face competing vaccine priorities 52
 

 

 

Time/financial barriers 

 Older adults without health insurance coverage may experience financial 

hardship obtaining an RSV vaccine. 

 Financial hardship may also arise if vaccine recipients need to take time off 

from work to receive an RSV vaccine, or due to post-vaccination 

reactogenicity. 

53
 

 

 

 

Feasibility 

 Is the GSK adjuvanted RSVpreF3 vaccine feasible to implement among 

adults aged ≥65 years?

 Is the Pfizer bivalent RSVpreF vaccine feasible to implement among adults 

aged ≥65 years?

No Probably No Probably Yes Yes Varies Don’t know 

54
Resource Use 

Is an RSV vaccine program for older adults a reasonable and 

efficient allocation of resources? 
 

 

 

 

 

 

 

 

 

Work group considerations 

 RSV vaccination for older adults could be a cost-effective intervention 

 There is substantial uncertainty in the net societal costs of an RSV 

vaccination program for older adults, driven by: 

– Uncertainty in incidence of severe RSV illness 

– Uncertainty in vaccine acquisition cost 

– Uncertainty in duration of protection from RSV vaccination 

 None of the three models incorporated medical costs of longer-term 

sequelae of RSV infection (e.g., admission to skilled nursing facilities) 

 Vaccination of older age groups would be more cost effective than 

vaccination of younger age groups 

56
 

 

 

 

Resource Use 





Is use of GSK adjuvanted RSVpreF3 vaccine among adults aged ≥65

years a reasonable and efficient allocation of resources, compared with 

no RSV vaccine?

Is use of Pfizer bivalent RSVpreF vaccine among adults aged ≥65

years a reasonable and efficient allocation of resources, compared with 

no RSV vaccine?

No Probably No Probably Yes Yes Varies Don’t know 

57
 

Equity 

What would be the impact on health equity of recommending 

RSV vaccines in older adults? 
 

 

 

Incidence of RSV 

hospitalization is 

higher among 

persons in lowincome ZIP codes 

Zheng Z, et al. Estimated incidence of respiratory hospitalizations attributable to RSV infections across age and socioeconomic groups. 

Pneumonia (Nathan). 2022 Oct 25;14(1):6. doi: 10.1186/s41479-022-00098-x. 

59
 

Age of adults hospitalized with RSV, by race and 

ethnicity, RSV-NET 

N Median age, years 

(interquartile range) 

All 9,163 70 (58–81) 

Race and ethnicity 

White, non-Hispanic 5,596 73 (62–83) 

Black, non-Hispanic 1,731 60 (50–70) 

Hispanic 713 65 (50–77) 

Asian or Pacific Islander, non-Hispanic 518 77 (64–85)

American Indian or Alaska Native, 

non-Hispanic 

56 57 (47–71) 

CDC RSV-NET data 2015–2020 (unpublished) 

60
 

Age of adults hospitalized with RSV, by race and 

ethnicity, RSV-NET 

N Median age, years 

(interquartile range) 

All 9,163 70 (58–81) 

Race and ethnicity 

White, non-Hispanic 5,596 73 (62–83) 

Black, non-Hispanic 1,731 60 (50–70) 

Hispanic 713 65 (50–77) 

Asian or Pacific Islander, non-Hispanic 518 77 (64–85)

American Indian or Alaska Native, 

non-Hispanic 

56 57 (47–71) 

CDC RSV-NET data 2015–2020 (unpublished) 

61
 

 

 

 

 

 

 

Chronic medical conditions associated with increased risk of RSV disease 

are more prevalent in U.S. adults in certain demographic groups

Heart failure Coronary heart 

disease 

Diabetes 

mellitus 

COPDa Asthma 

Black, nonHispanicb ↑c ↑↑c ↑c,d ↑e,f 

AI/ANg, nonHispanicb ↑↑h ↑↑h ↑e 

Hispanica ↑c,d,h ↓e,f 

Asian, nonHispanicb ↓c ↓c ↑c,d ↓h ↓e 

Lower income or 

SESi ↑j ↑h,j,k ↑h,l ↑h ↑e,f,h 

a COPD = chronic obstructive pulmonary disease 

b Compared with non-Hispanic White adults c Tsao et al, Circulation (2022): https://doi.org/10.1161/cir.0000000000001052

d Cheng et al, JAMA (2019): https://doi.org/10.1001/jama.2019.19365 e https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm 

f Bhan et al, Am J Public Health (2015): https://doi.org/10.2105/ajph.2014.302172

g AI/AN = American Indian or Alaska Native 

h NHIS 2018: https://www.cdc.gov/nchs/nhis/shs/tables.htm 

i SES = socio-economic status 

j Abdalla et al, JAMA Netw Open (2020): 

https://doi.org/10.1001%2Fjamanetworkopen.2020.18150

k Hamad et al, JAMA Cardiol (2020): https://doi.org/10.1001/jamacardio.2020.1458

l Beckles and Chou, MMWR (2016): http://dx.doi.org/10.15585/mmwr.mm6545a4 62
 

 

 

Access to an RSV vaccine may be determined by health 

insurance coverage 

0%

5%

10%

15%

20%

55-64 ≥65

Percentage of U.S. 

adults without health 

insurance 

Age group (years) 

American Indian or Alaska Native, 

non-Hispanic 

Hispanic 

Black, non-Hispanic 

Asian, non-Hispanic 

White, non-Hispanic 

U.S. Census Bureau, 2021 American Community Survey 1-year estimates: https://data.census.gov/table 

63
 

 

 

Access to an RSV vaccine may be determined by health 

insurance coverage 

Age group 

(years) Percentage of population without health insurance 

Below 

poverty 

1.0–1.9x 

poverty 

2.0–2.9x 

poverty 

≥3.0x

poverty 

19–64 23.0% 22.2% 16.8% 6.5%

≥65 2.3% 1.0% 0.9% 0.5%

Example income for 2-person household $18,145 $36,290 $54,435

without children, age <65 years

U.S. Census Bureau, 2021 American Community Survey 1-year estimates: https://data.census.gov/table 

64
 

 

Equity 

 What would be the impact on health equity of recommending RSV 

vaccines in adults aged ≥65 years?

Reduced 

Probably reduced 

Probably no impact 

Probably increased 

Increased 

Varies 

Don’t know 

65
Summary 
 

 

 

 

 

 

 

 

 

 

 

Domain Question Work Group Judgements 

Adults aged ≥65 years GSK Pfizer 

Public Health 

Problem Is RSV of public health importance? Yes 

Benefits and 

Harms 

How substantial are the desirable anticipated effects? Moderate – Large Moderate – Large 

How substantial are the undesirable anticipated effects? Minimal – Small Minimal – Small 

Do the desirable effects outweigh the undesirable effects? Favors intervention Favors intervention 

What is the overall certainty of the evidence profile? Moderate Moderate 

Values 

Does the target population feel the desirable effects are large 

relative to the undesirable effects? Yes/Probably yes 

Is there important variability in how patients value the 

outcomes? Important variability/Probably important variability 

Acceptability Is the intervention acceptable to key stakeholders? Yes/Probably yes 

Feasibility Is the intervention feasible to implement? Yes/Probably yes Yes/Probably yes 

Resource Use Is the intervention a reasonable and efficient allocation of 

resources? Yes/Probably yes Yes/Probably yes 

Equity What would be the impact on health equity? Increased/Probably increased 

67
 

 

 

 

 

 

 

 

Work Group interpretation 

 GSK’s adjuvanted RSVpreF3 and Pfizer’s bivalent RSVpreF vaccines both 

have demonstrated significant efficacy against lower respiratory tract 

illness caused by RSV among older adults 

– Trials underpowered to show efficacy against RSV hospitalization 

– Groups at highest risk of severe RSV disease were under-represented in 

clinical trials 

 At least one case of inflammatory neuropathy has been observed among 

recipients of each investigational vaccine 

 If licensed, post licensure surveillance for both safety and vaccine 

effectiveness will be critical 

68
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Choice of age threshold at which to recommend* RSV vaccines 

Pros Cons 

Age ≥65 years • Greater risk of RSV disease and therefore 

more favorable population-wide balance 

of risks and benefits of vaccination (in 

light of 1–2 cases of inflammatory 

neuropathy observed) 

• Aligns with licensure for adjuvanted and 

high-dose influenza vaccines and agebased pneumococcal vaccination 

• Lost opportunity to prevent additional disease 

in the 60–64 age group, who are 

disproportionately from racial and ethnic 

groups impacted by RSV at earlier ages 

Age ≥60 years • Potential to prevent a greater total 

burden of disease (e.g., number of 

hospitalizations) 

• Increases access to adults 60–64 with

medical risk factors for severe RSV 

disease (disproportionately in racial and 

ethnic groups impacted by RSV at earlier 

ages) 

• Uninsured adults would have difficulty 

obtaining vaccination (disproportionately aged 

60–64 in racial, ethnic and socioeconomic

groups at greater risk) 

• May experience more difficulty achieving 

clinician adoption of the recommendation 

among patients 60–64

• Less efficient allocation of societal resources 

*FDA has not yet completed review of safety and efficacy data for the GSK RSVpreF3 vaccine and the Pfizer RSVpreF 

vaccine. ACIP recommendations would be made only if the vaccines are approved and licensed by the FDA. 

69
Evidence to Recommendations Framework 

Summary: Work Group Interpretations (GSK RSVpreF3) 

70 
 

 

Evidence to Recommendations Framework 

Summary: Work Group Interpretations (GSK RSVpreF3) 

Among adults aged ≥65 years: Minority opinion 

Balance of 

consequences 

Undesirable 

consequences 

clearly outweigh 

desirable 

consequences in 

most settings 

Undesirable 

consequences 

probably 

outweigh 

desirable 

consequences in 

most settings 

The balance 

between 

desirable and 

undesirable 

consequences is 

closely balanced 

or uncertain 

Desirable 

consequences 

probably 

outweigh 

undesirable 

consequences in 

most settings 

Desirable 

consequences 

clearly outweigh 

undesirable 

consequences in 

most settings 

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences 

Among adults aged ≥60 years: 

Balance of 

consequences 

Undesirable 

consequences 

clearly outweigh 

desirable 

consequences in 

most settings 

Undesirable 

consequences 

probably 

outweigh 

desirable 

consequences in 

most settings 

The balance 

between 

desirable and 

undesirable 

consequences is 

closely balanced 

or uncertain 

Desirable 

consequences 

probably 

outweigh 

undesirable 

consequences in 

most settings 

Desirable 

consequences 

clearly outweigh 

undesirable 

consequences in 

most settings 

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences 

71 
 

 

 

 

 

Evidence to Recommendations Framework 

Summary: Work Group Interpretations (GSK RSVpreF3) 

Type of recommendation, adults aged ≥65 years

We do not recommend the intervention 

We recommend the intervention for individuals based on shared clinical decision-making 

We recommend the intervention 

Type of recommendation, adults aged ≥60 years*

We do not recommend the intervention 

We recommend the intervention for individuals based on shared clinical decision-making 

We recommend the intervention 

*Minority opinion: shared clinical decision-making for individual adults aged 60–64 years

Minority opinion 72 
Evidence to Recommendations Framework 

Summary: Work Group Interpretations (Pfizer RSVpreF) 

73 
 

 

Evidence to Recommendations Framework 

Summary: Work Group Interpretations (Pfizer RSVpreF) 

Among adults aged ≥65 years: Minority opinion 

Balance of 

consequences 

Undesirable 

consequences 

clearly outweigh 

desirable 

consequences in 

most settings 

Undesirable 

consequences 

probably 

outweigh 

desirable 

consequences in 

most settings 

The balance 

between 

desirable and 

undesirable 

consequences is 

closely balanced 

or uncertain 

Desirable 

consequences 

probably 

outweigh 

undesirable 

consequences in 

most settings 

Desirable 

consequences 

clearly outweigh 

undesirable 

consequences in 

most settings 

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences 

Among adults aged ≥60 years: 

Balance of 

consequences 

Undesirable 

consequences 

clearly outweigh 

desirable 

consequences in 

most settings 

Undesirable 

consequences 

probably 

outweigh 

desirable 

consequences in 

most settings 

The balance 

between 

desirable and 

undesirable 

consequences is 

closely balanced 

or uncertain 

Desirable 

consequences 

probably 

outweigh 

undesirable 

consequences in 

most settings 

Desirable 

consequences 

clearly outweigh 

undesirable 

consequences in 

most settings 

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences 

74 
 

 

 

 

 

Evidence to Recommendations Framework 

Summary: Work Group Interpretations (Pfizer RSVpreF) 

Type of recommendation, adults aged ≥65 years

We do not recommend the intervention 

We recommend the intervention for individuals based on shared clinical decision-making 

We recommend the intervention 

Type of recommendation, adults aged ≥60 years*

We do not recommend the intervention 

We recommend the intervention for individuals based on shared clinical decision-making 

We recommend the intervention 

*Minority opinion: shared clinical decision-making for individual adults aged 60–64 years

Minority opinion 75
Acknowledgements  Doug Campos-Outcalt  Katherine Fleming-Dutra  Monica Godfrey  Fiona Havers  Anne Hause  Jefferson Jones  Megan Lindley  Meredith McMorrow  Rebecca Morgan  Neil Murthy  Sara Oliver  Christine Olson  Ismael Ortega Sanchez 

 David Shay  Amanda Payne  Huong Pham  Jamison Pike  Tamara Pilishvili  Mila Prill  Lauren Roper  Diya Surie  Christopher Taylor  Evelyn Twentyman  Megan Wallace  Michael Whitaker  Patricia Wodi 

76
 

 

 

 

Policy questions for ACIP 

 Should vaccination with GSK RSVpreF3 vaccine (120μg antigen + AS01E adjuvant, 1 

dose IM), rather than no vaccine, be recommended in persons aged ≥65 years?

 Should vaccination with GSK RSVpreF3 vaccine (120μg antigen + AS01E adjuvant, 1 

dose IM), rather than no vaccine, be recommended in persons aged ≥60 years?

 Should vaccination with Pfizer bivalent RSVpreF vaccine (120μg antigen, 1 dose IM), 

rather than no vaccine, be recommended in persons aged ≥65 years?

 Should vaccination with Pfizer bivalent RSVpreF vaccine (120μg antigen, 1 dose IM), 

rather than no vaccine, be recommended in persons aged ≥60 years?
 

 

 

For more information, contact CDC 

1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the 

official position of the Centers for Disease Control and Prevention.