National Center for Immunization & Respiratory Diseases

Considerations for Age-Based and Risk-Based Use of 

PCV15 and PCV20 among U.S. Adults and Proposed 

Policy Options

Miwako Kobayashi, MD, MPH

ACIP Meeting

October 20, 2021
Serotypes Contained in Current and New Pneumococcal Vaccines

1 3 4 5 6A 6B 7 F 9V 14 18

C

19

A

19

F

23

F

22

F

33

F

8 10

A

11

A

12

F

15

B

2 9N 17

F

20

PCV13

PCV15

PCV20

PPSV23

PCV13: 13-valent pneumococcal conjugate vaccine

PPSV23: 23-valent pneumococcal polysaccharide vaccine
Serotypes Contained in Current and New Pneumococcal Vaccines

• PCV15 non-PCV13: includes serotypes 22F and 33F

• PCV20 non-PCV13: includes serotypes 22F, 33F, 8, 10A, 11A, 12F, and 15B

• PPSV23 non-PCV20: includes serotypes 2, 9N, 17F, and 20

1 3 4 5 6A 6B 7 F 9V 14 18

C

19

A

19

F

23

F

22

F

33

F

8 10

A

11

A

12

F

15

B

2 9N 17

F

20

PCV13

PCV15

PCV20

PPSV23
Pneumococcal disease

 Invasive pneumococcal 

disease (IPD)

e.g., meningitis, bacteremia, 

bacteremic pneumonia

 Non-invasive disease

e.g., non-bacteremic pneumonia

Bacteremia

Pneumonia

Otitis media/sinusitis

Increasing 

burden

Meningitis

IPD
Estimated burden of pneumococcal disease in U.S. 

adults aged ≥19 years

 In 2017, ≥100,000 hospitalized pneumococcal pneumonia cases 

occurred1

 In 2019, ~30,000 IPD cases and ~3,000 IPD deaths occurred2

– ~43% of IPD in adults aged ≥65 years

– ~48% of IPD in adults aged 19–64 years with risk-based 

indications 

1. CDC SNiPP, 2017; 2. CDC ABCs, 2018 

>90% of the current adult IPD burden is in persons aged 19–64 

years with risk-based indications and persons aged ≥65 years
Classification of Risk Groups: Chronic Medical Conditions vs. 

Immunocompromising Conditions

19–64 years

None of the conditions 

listed below

No recommendation

Chronic medical 

conditions† (CMC)

PPSV23

Cochlear implant, CSF leak Both PCV13* and PPSV23

Immunocompromising 

conditions

Both PCV13* and PPSV23, repeat 

PPSV23 after 5 years

CSF: cerebrospinal fluid leak

PCV13: 13-valent pneumococcal conjugate vaccine

PPSV23: 23-valent pneumococcal polysaccharide vaccine

*If not previously given; †Examples include alcoholism, chronic heart/liver/lung disease, diabetes, cigarette smoking

https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf

Immunocompromising 

conditions (IC)

Chronic Medical 

Conditions (CMC)
PCV13 type: 27%

0

10

20

30

40

50

60

70

80

90

100

65+

Percent IPD

Age group (Years)

Proportion of IPD by Serotype Groups in Adults aged ≥65 Years

ABCs 2018–2019 

PCV15 non-PCV13 serotypes: 22F, 33F

PCV20 non-PCV15 serotypes: 8, 10A, 11A, 12F, 15B/C

PPSV23 non-PCV20 serotype: 2, 9N, 17F ,20 
PCV13 Type

PCV15, non-PCV13:

15%

0

10

20

30

40

50

60

70

80

90

100

65+

Percent IPD

Age group (Years)

Proportion of IPD by Serotype Groups in Adults aged ≥65 Years

ABCs 2018–2019 

PCV15 non-PCV13 serotypes: 22F, 33F

PCV20 non-PCV15 serotypes: 8, 10A, 11A, 12F, 15B/C

PPSV23 non-PCV20 serotype: 2, 9N, 17F ,20 
PCV13 Type

PCV20, non-PCV13:

29%

0

10

20

30

40

50

60

70

80

90

100

65+

Percent IPD

Age group (Years)

Proportion of IPD by Serotype Groups in Adults aged ≥65 Years

ABCs 2018–2019 

PCV15 non-PCV13 serotypes: 22F, 33F

PCV20 non-PCV15 serotypes: 8, 10A, 11A, 12F, 15B/C

PPSV23 non-PCV20 serotype: 2, 9N, 17F ,20 
Proportion of IPD by Serotype Groups in Adults aged 19–64 Years with 

Risk-based Indications 

ABCs 2017–2018 

PCV15 non-PCV13 serotypes: 22F, 33F

PCV20 non-PCV15 serotypes: 8, 10A, 11A, 12F, 15B/C

PPSV23 non-PCV20 serotype: 2, 9N, 17F ,20 

PCV13 Type: 

32% PCV13 Type: 

25%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

CMC IC

CMC: chronic medical conditions

IC: immunocompromising conditions
Proportion of IPD by Serotype Groups in Adults aged 19–64 Years with 

Risk-based Indications 

ABCs 2017–2018 

PCV15 non-PCV13 serotypes: 22F, 33F

PCV20 non-PCV15 serotypes: 8, 10A, 11A, 12F, 15B/C

PPSV23 non-PCV20 serotype: 2, 9N, 17F ,20 

PCV13 Type

12%

14%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

CMC IC

PCV15, nonPCV13 

CMC: chronic medical conditions

IC: immunocompromising conditions

PCV13 Type
Proportion of IPD by Serotype Groups in Adults aged 19–64 Years with 

Risk-based Indications 

ABCs 2017–2018 

PCV15 non-PCV13 serotypes: 22F, 33F

PCV20 non-PCV15 serotypes: 8, 10A, 11A, 12F, 15B/C

PPSV23 non-PCV20 serotype: 2, 9N, 17F ,20 

PCV13 Type

29%

28%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

CMC IC

CMC: chronic medical conditions

IC: immunocompromising conditions

PCV13 Type

PCV20, nonPCV13 
Updated Policy Questions for Consideration

 Should PCV20 alone OR PCV15 in series with PPSV23 be routinely 

recommended for US adults aged ≥65 years? 

 Should PCV20 alone OR PCV15 in series with PPSV23 be recommended 

for U.S. adults aged 19–64 years with certain underlying medical 

conditions or other risk factors*?

*alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes mellitus, chronic renal failure, nephrotic syndrome, 

immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human immunodeficiency virus, Hodgkin disease, 

leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or other 

hemoglobinopathies, CSF leak, or cochlear implant.
Current and Proposed Options for an Age-based Recommendation

Current Policy Proposed Policy Option

None of the conditions listed 

below

PCV13* based on shared clinical 

decision making, PPSV23 for all PCV20

OR

PCV15 and PPSV23

Chronic medical conditions† 

(CMC)

Cochlear implant, CSF leak

Immunocompromising Both PCV13* and PPSV23

conditions

PCV13: 13-valent pneumococcal conjugate vaccine, PCV15: 15-valent pneumococcal conjugate vaccine, 

PCV20: 20-valent pneumococcal conjugate vaccine, PPSV23: 23-valent pneumococcal polysaccharide vaccine

*If not previously given; †Examples include alcoholism, chronic heart/liver/lung disease, diabetes, cigarette smoking

https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf
Current and Proposed Options for a Risk-Based Recommendation 

Current policy Proposed Policy Option

None of the conditions 

listed below

No recommendation No recommendation

Chronic medical 

conditions† (CMC)

PPSV23

PCV20

OR

PCV15 and PPSV23

Cochlear implant, CSF leak Both PCV13* and PPSV23

Immunocompromising 

conditions

Both PCV13* and PPSV23, repeat 

PPSV23 after 5 years

PCV13: 13-valent pneumococcal conjugate vaccine

PPSV23: 23-valent pneumococcal polysaccharide vaccine

*If not previously given; †Examples include alcoholism, chronic heart/liver/lung disease, diabetes, cigarette smoking

https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf
Work Group Discussion Points on Proposed Options

 The majority of work group members in support of proposed options:

• Either PCV20 alone or PCV15+PPSV23 at age ≥65 years

• Either PCV20 alone or PCV15+PPSV23 for adults aged 19-64 years with 

certain underlying medical conditions or other risk factors*

*alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes mellitus, chronic renal failure, nephrotic syndrome, 

immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human immunodeficiency virus, Hodgkin disease, 

leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or other 

hemoglobinopathies, CSF leak, or cochlear implant.
Main Reasons Against the Proposed Options

 Prefer an age-based recommendation at age 50 vs 65 years

– May reduce disparity in disease burden in adults aged 50–64 years 

– May provide more opportunities to vaccinate adults before they 

develop underlying conditions

 Concerns with PCV15 options given need to use in series with PPSV23 

– Logistically more challenging to administer different vaccines in series 

– Need to know the vaccination history to correctly complete series

– Can result in lower serotype coverage if series not completed
Age-based recommendation

age 50 vs. 65 years
Reasons for an Age-Based Recommendation at ≥65 years

 Due to potential waning of immunity, vaccination later in life may be 

favorable when risk of disease is higher

 Consistently cost-saving (lower cost and better health outcome compared 

to current recommendations) in cost-effectiveness analyses

 Proposed risk-based and age-based options still provide an opportunity 

for higher PCV coverage, which may prevent more disease compared with 

current recommendations and may address some health equity concerns
Reasons for an Age-Based Recommendation at ≥65 years

 Due to potential waning of immunity, vaccination later in life may be 

favorable when risk of disease is higher

 Consistently cost-saving (lower cost and better health outcome compared 

to current recommendations) in cost-effectiveness analyses

 Proposed risk-based and age-based options still provide an opportunity 

for higher PCV coverage, which may prevent more disease compared with 

current recommendations and may address some health equity concerns
Risk of pneumococcal disease increases with 

increasing age. 

0

5

10

15

20

25

30

35

40

45

18-34 35-49 50-64 65-74 75-84 ≥85

Incidence per 100,000 population or 

ABCs areas

Age in Years

IPD rate death rate

ABCs Report: Streptococcus pneumoniae, 2018. https://www.cdc.gov/abcs/reports-findings/survreports/spneu18.html
Life Expectancy at Age 50 vs 65 by Race/Ethnicity, US, 

2020

31.1

19.1

32.8

20.6

31.2

19.1

27.2

16.5

0

5

10

15

20

25

30

35

50 yrs 65 yrs

Years

Total (All) Total (Hisp) Total (NHW) Total (NHB)

In cost-effectiveness analysis, 

assumed that duration of protection 

of PCV was 15–20 years 

CEA: cost-effectiveness analysis, Hisp: Hispanic, NHW: Non-Hispanic white, NHB: Non-Hispanic Black

https://www.cdc.gov/nchs/data/vsrr/VSRR10-508.pdf
Reasons for an Age-Based Recommendation at ≥65 years

 Due to potential waning of immunity, vaccination later in life may be 

favorable when risk of disease is higher

 Consistently cost-saving (lower cost and better health outcome compared 

to current recommendations) in cost-effectiveness analyses

 Proposed risk-based and age-based options still provide an opportunity 

for higher PCV coverage, which may prevent more disease compared with 

current recommendations and may address some health equity concerns

QALY: quality-adjusted life year
Reasons for an Age-Based Recommendation at ≥65 years

 Due to potential waning of immunity, vaccination later in life may be 

favorable when risk of disease is higher

 Consistently cost-saving (lower cost and better health outcome compared 

to current recommendations) in cost-effectiveness analyses

 Proposed risk-based and age-based options still provide an opportunity 

for higher PCV coverage, which may prevent more disease compared with 

current recommendations and may address some health equity concerns

LC&LQ: Lower costs and lower QALYs

QALY: quality-adjusted life year
Age-based strategies, PCV20, CDC model

Scenario analyses, compared to current recommendations ($/QALY) 

25

Analysis Strategy Base case 

PCV waning 

20 years

PCV coverage 

higher than in 

base case

Indirect 

effects

Lower PCV20 

VE

Healthimproving 

scenarios

Cost-saving 

scenarios

Age-based PCV20 

at age 65 Cost-savinga Cost-savinga Cost-savinga Cost-savinga Cost-savinga 5 of 5 5 of 5

Age-based PCV20 

at age 50

LC&LQb

(5,300,000) Cost-savinga 7,000 Cost-savinga LC&LQb(944,000) 3 of 5 2 of 5

a. Cost-saving indicates an intervention strategy yielded higher health outcomes (more QALYs, fewer episodes of disease) and lower costs than the comparator. b. LC&LQ indicates a strategy yielded lower health outcomes (fewer QALYs, more episodes of disease) and lower costs than the comparator.

Dominated Higher costs 

& higher 

health

LC&LQ Cost-saving

Higher 

QALYs

Lower 

QALYs

Higher costs

Lower costs

C

R

• PCV20 at age 65 consistently showed that the intervention was 

“cost-saving” in different scenarios.

• PCV20 at age 50 resulted in worse health in some CDC scenarios. 

Sept 2021 ACIP meeting presentation
Age-based strategies, PCV20, CDC model

Scenario analyses, compared to current recommendations ($/QALY) 

26

Analysis Strategy Base case 

PCV waning 

20 years

PCV coverage 

higher than in 

base case

Indirect 

effects

Lower PCV20 

VE

Healthimproving 

scenarios

Cost-saving 

scenarios

Age-based PCV20 

at age 65 Cost-savinga Cost-savinga Cost-savinga Cost-savinga Cost-savinga 5 of 5 5 of 5

Age-based PCV20 

at age 50 LC&LQb Cost-savinga 7,000 Cost-savinga LC&LQb 3 of 5 2 of 5

a. Cost-saving indicates an intervention strategy yielded higher health outcomes (more QALYs, fewer episodes of disease) and lower costs than the comparator. b. LC&LQ indicates a strategy yielded lower health outcomes (fewer QALYs, more episodes of disease) and lower costs than the comparator.

Dominated Higher costs 

& higher 

health

LC&LQ Cost-saving

Higher 

QALYs

Lower 

QALYs

Higher costs

Lower costs

C

R

• PCV20 at age 65 consistently showed the intervention was “costsaving” in different scenarios.

• PCV20 at age 50 resulted in worse health in some CDC scenarios. 

Sept 2021 ACIP meeting presentation, QALY: quality-adjusted life year
Age-based strategies, PCV20, all models

Compared to current recommendations ($/QALY)

a. Cost-saving indicates an intervention strategy yielded higher health outcomes (more QALYs, fewer episodes of disease) and lower costs than the comparator. 27

b. LC&LQ indicates a strategy yielded lower health outcomes (fewer QALYs, more episodes of disease) and lower costs than the comparator.

Analysis Strategy CDC model Merck model Pfizer model

Age-based PCV20 

at age 65 Cost-savinga Cost-savinga

to 39,000 Cost-savinga

Age-based PCV20 

at age 50 LC&LQb 174,000 to 

514,000 18,000

Dominated Higher costs 

& higher 

health

LC&LQ Cost-saving

Higher 

QALYs

Lower 

QALYs

Higher costs

Lower costs

C

R

• CEA models from other groups showed PCV20 use at age 65 was 

“cost-saving” in most cases.

Sept 2021 ACIP meeting presentation, QALY: quality-adjusted life year
• CDC model showed PCV15+PPSV23 at age 50 resulted in lower health outcomes

• Merck model showed PCV15+PPSV23 at age 50 was less cost-effective than age 65

QALY: quality-adjusted life year

Analysis Intervention Comparator CDC Model Merck model

Age-based PCV15+PPSV23 at age 

50

Current 

recommendations

LC&LQa 555,556 to 640,015

Age-based PCV15+PPSV23 at age 

65

Current 

recommendations

Cost-savingb 237,026 to 282,140

Sensitivity Analysis: 

Cost-saving

Age-based strategy, PCV15+PPSV23, all models

Compared to current recommendations ($/QALY)

a. LC&LQ indicates a strategy yielded lower health outcomes (fewer QALYs, more episodes of disease) and lower costs than the comparator. b.Cost-saving indicates an intervention strategy yielded higher health outcomes (more QALYs, fewer episodes of disease) and lower costs than the comparator.
Sept 2021 ACIP meeting presentation

• CDC CEA model showed that PCV15+PPSV23 at age 65 

was “cost-saving” in all scenarios considered.
Reasons for an Age-Based Recommendation at ≥65 years

 Due to potential waning of immunity, vaccination later in life may be 

favorable when risk of disease is higher

 Consistently cost-saving (lower cost and better health outcome compared 

to current recommendations) in cost-effectiveness analyses

 Proposed risk-based and age-based options still provide an opportunity 

for higher PCV coverage, which may prevent more disease compared with 

current recommendations and may address some health equity concerns
Estimated Proportion of Adults aged 19–64 years with CMC/IC who 

Ever Received Pneumococcal Vaccination, NHIS 2018

Sample 

size % (95% CI)

Overall 5,851 23.3% (22.0, 24.6)

White 4,048 23.6% (22.1, 25.2)

Black 696 25.7% (21.8, 30.0)

Hispanic 656 18.5% (15.2, 22.4)*

Asian 192 25.0% (17.3, 34.5)

Other 259 25.8% (19.3, 33.5)

National Health Interview Survey, 2018; CMC: chronic medical conditions; IC: immunocompromising conditions 

*p<0.05 for comparisons with white as the reference.
The new risk-based policy option may help improve vaccine 

uptake in adults with indications. 

Current policy

19–64 years old 

New Policy Option 

Considered

Chronic medical conditions 

(CMC) PPSV23

PCV15 and PPSV23

OR

PCV20

Cochlear implant, CSF leak Both PCV13 and PPSV23

Immunocompromising 

conditions

Both PCV13 and PPSV23, repeat PPSV23 

after 5 years

*

National Health Interview Survey, 2017–2018
Current and New Pneumococcal Vaccines: PCVs vs. PPSV23

1 3 4 5 6A 6B 7 F 9V 14 18

C

19

A

19

F

23

F

22

F

33

F

8 10

A

11

A

12

F

15

B

2 9N 17

F

20

PCV13

PCV15

PCV20

PPSV23

PCV PPSV23

Basic Vaccine Composition Capsular polysaccharides 

conjugated to CRM197 Carrier 

Protein

Capsular polysaccharide 

antigens

Mechanism of action T-cell dependent T-cell independent

Memory B cell production Yes No

PCV: pneumococcal conjugate vaccine, PPSV23: 23 -valent pneumococcal polysaccharide vaccine
Key Vaccine Effectiveness/Waning Assumptions

September CDC Model (base case)

PCV PPSV23

Duration of protection 15 years: no decline for 5 yrs1, 

linear decline to 0 over 10yrs

15 years: linear decline to 0 

over 15 years

Vaccine Effectiveness vs.

Vaccine-type IPD*

Healthy/CMC: 75 (41.4, 90.8)1

IC: 25.0 (13.8, 30.3)2

Healthy/CMC: 59.7 (47.4, 69.1)3

IC: 7.9 (0, 34.2)3

Vaccine Effectiveness vs.

Vaccine-type pneumonia*

Healthy: 66.7 (11.8. 89.3)4

CMC: 40.3 (11.4, 60.2)4

IC: 15.0 (4.7, 21.8)2

Healthy/CMC: 20 (0, 40)5

IC: 6.7 (0, 13.3)2

CMC: Chronic medical conditions, IC: immunocompromising conditions

Adapted from Leidner September 2021 ACIP Presentation 

*For PCVs, different vaccine effectiveness assumptions were used against serotype 3 disease

1. Bonten et al. NEJM 2015, 2. Assumed 1/3 of healthy/CMC adults, Cho et al. Vaccine 2013, 3. Meta-analysis of Andrews 2012, Rudnick 2013, and Djennad 2018, restricting to PPSV23 VE within 5 years 

of vaccination , 4. Suaya et al. Vaccine 2018, 5. Lawrence et al. PLoS Med 2020
Under the new risk-based policy option, more adults will be 

recommended to receive new PCVs.

Current policy

19–64 years old 

New Policy Option 

Considered

Chronic medical conditions 

(CMC) PPSV23

PCV15 and PPSV23

OR

PCV20

Cochlear implant, CSF leak Both PCV13 and PPSV23

Immunocompromising 

conditions

Both PCV13 and PPSV23, repeat PPSV23 

after 5 years

*

National Health Interview Survey, 2017–2018

90%*

10%*
The new risk-based policy option may prevent more disease in populations 

with higher burden of chronic medical conditions before age 65 years.

Nowalk et al. Journal of the National Medical Association 2019. 

Chronic medical conditions: chronic heart, lung, or liver disease; diabetes mellitus; alcoholism; 

asthma; cirrhosis

Proportion with chronic 

medical conditions
Use of PCV15 in series with PPSV23
Reasons for an PCV15+PPSV23 Series Option

 Provides broad serotype coverage

 Age-based use at age 65 was cost-saving (lower cost and better health 

outcomes compared to current recommendations) according to CDC’s 

cost-effectiveness analysis

 PCV13+PPSV23 series is currently used
 Provides broad serotype coverage

1 3 4 5 6A 6B 7 F 9V 14 18

C

19

A

19

F

23

F

22

F

33

F

8 10

A

11

A

12

F

15

B

2 9N 17

F

20

PCV13

PCV15

PCV20

PPSV23

Reasons for an PCV15+PPSV23 Series Option
Reasons for an PCV15+PPSV23 Series Option

 Provides broad serotype coverage

 Age-based use at age 65 was cost-saving (lower cost and better health 

outcome compared to current recommendations) according to CDC’s costeffectiveness analysis

 PCV13+PPSV23 series is currently used

• Adults aged ≥19 years with immunocompromising conditions, cochlear 

implant, cerebrospinal fluid (CSF) leak

• Adults aged ≥65 years* based on shared clinical decision-making

*adults without immunocompromising conditions, cochlear implant, CSF leak
In Medicare beneficiaries aged ≥65 years, the proportion of adults 

who received both PCV13 and PPSV23 increased over time.

42 45 45 44 44 44 45 46

0 0 2

14

22 26 30 32

0

10

20

30

40

50

60

70

80

90

100

2011 2013 2014 2015 2016 2017 2018 2019

Percentage receiving at least 1 dose

Enrollment Period

PPSV23 PCV13 and PPSV23

PPSV23 routinely recommended

PCV13 routinely recommended*

Adapted from: Pneumococcal vaccination among U.S. Medicare beneficiaries aged ≥65 years, 2010 -2019 | CDC

*In 2019, ACIP recommended shared clinical decision-making for PCV13 use in adults aged ≥65 years without immunocompromising conditions, CSF leak, or 

cochlear implant
WG Discussion on Potential for a Preferential 

Recommendation

In favor of a preferential recommendation 

 Implementation challenges with PCV15-PPSV23 series

 PCV20 is likely to provide improved protection against the 5 serotypes 

included in PPSV23 but not in PCV15

1 3 4 5 6

A

6

B

7 

F

9

V

14 18

C

19

A

19

F

23

F

22

F

33

F

8 10

A

11

A

12

F

15

B

2 9

N

17

F

20

PCV15

PCV20

PPSV23
WG Discussion on Potential for a Preferential 

Recommendation

Against a preferential recommendation:

 No studies directly comparing PCV15 and PCV20 efficacy and safety

 The potential impact of PCV20 use alone is unknown

• Clinical relevance of lower immunogenicity for PCV20 vs. PCV13 

unknown

• No data in immunocompromised adults

• Losing protection against PPSV23, non-PCV20 serotypes 
Summary of Evidence, PCV15-PPSV23 series: 

Benefits (VT-IPD, pneumonia, deaths)

 PCV15-PPSV23 vs. PCV13-PPSV23 immunogenicity: 

– In three phase 3 RCTs*, geometric mean titers (GMTs) and % 

seroresponders were higher in PCV15-PPSV23 recipients for some 

shared serotypes

Adapted from June 2021 ACIP presentation 

*V114-016, V114-017, V114-018
Summary of Evidence from PCV20 studies: 

Benefits (VT-IPD, pneumonia, deaths)

 PCV20 vs. PCV13 (comparison of 13 shared serotypes): 

– PCV20 recipients had lower responses by GMT and % seroresponders

(12–13/13 serotypes) 

• Met noninferiority criteria for all shared serotypes by GMT ratio in 

phase 3 trials*.

*B7471007 (Phase 3), *Klein et al. 2021 (Phase 3), Hurley et al. 2021 (Phase 2)

Adapted from September 2021 ACIP presentation 

1 3 4 5 6

A

6B 7 F 9V 14 18

C

19

A

19

F

23

F

22

F

33

F

8 10

A

11

A

12

F

15

B

2 9N 17

F

20

PCV13

PCV20
Summary of Evidence from PCV20 studies: 

Benefits (VT-IPD, pneumonia, deaths) in adults with CMC/IC

Certainty assessment No of patients Results

No of Certainty

studies Study design Risk of bias Inconsistency Indirectness Imprecision Other 

considerations Intervention comparisone Relative 

effect

Absolute 

effect

Vaccine effectiveness (Vaccine-type invasive pneumococcal disease, Vaccine-type non-bacteremic pneumococcal pneumonia, Vaccine-type pneumococcal mortality)

2 1,2,3 Randomized 

studies

Not 

serious

Not serious Very serious 

a,b,c,d

Not serious Not serious 3417 2802 PCV20 vs. PCV13: Across 

all studies non-inferiority 

met for all 13 shared 

serotypes 

PCV20 had slightly lower 

immune responses vs. 

PCV13 for all 13 shared 

serotypes.

PCV20 vs. PPSV23 (nonPCV13 serotypes): Noninferiority met for all 

serotypes in at least one 

study, but ST8 inferior in 

some studies.

PCV20 had greater 

immune responses vs. 

PPSV23 for 6 of 7 nonPCV13 shared serotypes.

3

Low

a. These are all immunogenicity studies and there are no correlates of protection. 

b. B7471007, Klein et al., and Hurley et al. enrolled healthy adults (some with chronic stable conditions, but focus is not those with immunocompromising or chronic medical conditions).

c. B7471007 provided primary PCV20 vs PCV13 immunogenicity outcomes for adults ≥60 and then showed non-inferiority for PCV20 in 18-49 year-olds compared to PCV20 in 60-64 year-olds. Did not directly compare 

immunogenicity of PCV20 vs PCV13 in 18-49 year-olds. 

d. Hurley et al. only enrolled 60-64 year -olds. 

e. Patient no. based on minimum number of patients included in immunogenicity comparisons presented; some comparisons may have had more patients than this minimum.

f. No vaccine-related serious adverse events reported; sample size relatively small September 2021 ACIP presentation 1. B7471007 (Phase 3), 2. Klein et al. 2021 (Phase 3), 3. Hurley et al. 2021 (Phase 2)
Proportion of IPD by Serotype Groups in Adults aged 19–64 Years with 

Risk-based Indications 

ABCs 2017–2018 

PCV15 non-PCV13 serotypes: 22F, 33F

PCV20 non-PCV15 serotypes: 8, 10A, 11A, 12F, 15B/C

PPSV23 non-PCV20 serotype: 2, 9N, 17F ,20 

PCV20 types

15%

12%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

CMC IC

CMC: chronic medical conditions

IC: immunocompromising conditions

PCV20 types

PPSV23, nonPPSV20 types
8%

0

10

20

30

40

50

60

70

80

90

100

65+

Pecent IPD

Age group (Years)

In adults aged ≥65 years, additional serotypes contained in PPSV23 but 

not PCV20 comprise 8%, when PPSV23 coverage is 50–60%1,2. 

ABCs 2018–2019 

PCV15 non-PCV13 serotypes: 22F, 33F

PCV20 non-PCV15 serotypes: 8, 10A, 11A, 12F, 15B/C

PPSV23 non-PCV20 serotype: 2, 9N, 17F ,20 

1. Surveillance of Vaccination Coverage Among Adult 

Populations — United States, 2014 | MMWR (cdc.gov)

2. Pneumococcal vaccination among U.S. Medicare 

beneficiaries aged ≥65 years, 2010-2019 | CDC

PCV20 types

PPSV23, non-PPSV20 types
Summary of WG Considerations: Age-Based at Age 50 vs. 65 years

In favor of age-based at age 50 years In favor of age-based at age 65 years

• May reduce disparity in disease burden 

in adults aged 50–64 years 

• May provide more opportunities to 

vaccinate adults before they develop 

underlying conditions

• Potential for waning immunity makes it 

favorable to vaccinate later in life when 

risk of disease is higher 

• Consistently cost-saving* in costeffectiveness analyses

• Still provides an opportunity for higher 

PCV coverage in adults vs. current 

recommendations

*lower cost and better health outcome compared to current recommendations
Summary of WG Considerations: PCV20 Use Alone OR PCV15+PPSV23

Advantages of PCV20 Use Alone Disadvantages of PCV20 Use Alone

• Acceptable and feasible to implement a 

single vaccine option

• Cost-saving* in cost-effectiveness 

analyses

• Expected to provide better protection for 

the serotypes covered by PPSV23 alone

• Clinical significance of lower 

immunogenicity vs. PCV13 unknown

• No data in immunocompromised adults

• Losing protection against PPSV23, nonPCV20 serotypes 

Advantages of PCV15+PPSV23 Disadvantages of PCV15+PPSV23

• Provides broad serotype coverage

• Age-based use at age 65 was cost-saving* 

according to CDC’s cost-effectiveness 

analysis

• Logistically more challenging to 

administer PCV15-PPSV23 vaccine series 

• Need to know vaccination history to 

correctly complete series

• Can result in lower serotype coverage if 

series not completed

*lower cost and better health outcome compared to current recommendations
Unknown Impact of Use of New PCVs in Children in the Future on 

Adult Pneumococcal Disease Burden

Adult

2021 2022 2023

Pediatric

PCV20 and PCV15 

Licensure

PCV20 Licensure 

anticipated Q2 ‘23

PCV15 Licensure 

anticipated Q1–2 ‘22

<1 year ~1 year
Proposed Age-based Recommendation

Adults 65 years of age or older who have not previously 

received a pneumococcal conjugate vaccine or whose previous 

vaccination history is unknown should receive a pneumococcal 

conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, 

this should be followed by a dose of PPSV23. 
Proposed Risk-based Recommendation

Adults aged 19 years of age or older with certain underlying 

medical conditions or other risk factors* who have not 

previously received a pneumococcal conjugate vaccine or 

whose previous vaccination history is unknown should receive a 

pneumococcal conjugate vaccine (either PCV20 or PCV15). If 

PCV15 is used, this should be followed by a dose of PPSV23. 

*alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes mellitus, chronic renal 

failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized 

malignancy, human immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple 

myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or other 

hemoglobinopathies, CSF leak, or cochlear implant.
Discussion 
Acknowledgements

 ACIP and the Pneumococcal Vaccines Work Group

 CDC contributors and consultants: Tamara Pilishvili, Ryan Gierke, Jennifer

Loo Farrar, Lana Childs, Amadea Britton, Chukwuebuka Nsofor, Brittany

White, Fahmina Akhter, Mahamoudou Ouattara, Penina Haber, Pedro

Moro, Sarah Schillie, Tammy Zulz, Marc Fischer, Andrew Leidner, Tandin

Dorji, Wei Xing, Nong Shang, Rebecca Morgan, Doug Outcalt-Campos
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.

Thank you