Document text
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Summary of Work Group Interpretations of EtR and
Policy Option on PCV21 Use in Adults
June 2024, ACIP Meeting
June 27, 2024
Miwako Kobayashi, MD, MPH, FACP , FIDSA
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation
use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.
Policy Questions Being Considered by the Work Group
1. Should PCV21 be recommended for U.S. adults aged ≥19 years who
currently have a recommendation to receive a PCV*? (Group 1)
Comparison (current recommendations):
▪PCV -naïve adults aged ≥19 years
PCV20 OR PLUS PCV15 PPSV23†
† If adults previously received PPSV23 before receiving a dose of PCV15, it need not be followed by another dose of PPSV23
▪PCV -experienced adults aged ≥19 years who have not completed the recommended series
PCV20 1≥ dose of
PPSV23 OR
*Includes:
• Adults aged ≥65 years who have never received a PCV
• Adults aged 19 -64 years with a risk condition, who have never received a PCV
• Adults aged ≥19 year who have received a PCV (i.e., PCV7 or PCV13), but have not completed the recommended series
• PCV20 use based on shared clinical decision -making for adults ≥65 years who have
2 completed the recommended series with PCV13 and PPSV23
Policy Questions Being Considered by the Work Group
2. Should PCV21 be recommended for U.S. adults aged 50 -64 years who
currently do not have a risk -based pneumococcal vaccine indication?
(Group 2)
3. Should PCV21 be recommended for U.S. adults aged 19 -49 years who
currently do not have a risk -based pneumococcal vaccine indication?
(Group 3)
▪Questions 2 and 3 imply a new age -based recommendation for these age groups.
Comparison (current recommendation):
▪No vaccine
3
Evidence to Recommendations ( EtR ) framework
4 EtR Domain Question
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?
• What is the overall certainty of this evidence for the critical outcomes?
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 outcomes?
Acceptability • Is the intervention acceptable to key stakeholders?
Resource Use • Is the intervention a reasonable and efficient allocation of resources?
Feasibility • Is the intervention feasible to implement?
Equity • What would be the impact of the intervention on health equity?
Summary of Work Group Interpretation of the EtR Domains for EtR
Domains Public Health Problem, Benefits and Harms, and Equity
EtR Domains Group 1. Adults with
current PCV
recommendations Group 2. Adults aged
50–64 years, no risk -
based indication Group 3. Adults aged
19–49 years, no risk -
based indication
Public Health Problem Yes Probably Yes No/Probably No
Benefits and Harms
a. Benefits Moderate/Large Small/Moderate Minimal/Small
b. Harms Minimal
c. Benefit>Harm? Favors PCV21 use Favors PCV21/Favors no
vaccine (split)
d. Overall certainty: effectiveness Moderate
e. Overall certainty: safety Moderate
Equity Probably increased
5Kobayashi February 2024 ACIP meeting presentation
Evidence to Recommendations ( EtR ) framework
6 EtR Domain Question
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 outcomes?
Acceptability • Is the intervention acceptable to key stakeholders?
Resource Use • Is the intervention a reasonable and efficient allocation of resources?
Feasibility • Is the intervention feasible to implement?
EtR Values and Preferences
• Does the population feel that the desirable effects are large relative to
undesirable effects?
• Is there important uncertainty about or variability in how much people
value the main outcomes*?
Outcomes
= Vaccine -type (VT) invasive pneumococcal disease (IPD), VT -non -bacteremic
pneumococcal pneumonia, VT -pneumococcal deaths, serious adverse events (SAEs)
14 17 10 7 38 45
46 47 37 32 37 38 11 6 7 8
0 10 20 30 40 50 60 70 80 90 100
age <5 years age 19-49 years age 50-64 years age ≥ 65 years
The proportion of IPD cases due to PCV20/non -PCV21
serotypes is relatively lower in older vs younger adults
Proportion of IPD by vaccine -type and age group, 2018−2022
PCV20/ non-PCV21 PCV20 and PCV21 PCV21/ non-PCV20 NVT
8CDCsActive Bacterial Core surveillance
54–62 % of IPD cases in adults were due to PCV20 serotypes
Proportion of IPD by vaccine -type and age group, 2018−2022
100
90
80
70
60
50
40
30
20
10
0 11 6 7 8
37 32 37 38
38 45
46 47 62% 56% 54%
14 17 10 7
age <5 years age 19-49 years age 50-64 years age ≥ 65 years
PCV20/ non-PCV21 PCV20 and PCV21 PCV21/ non-PCV20 NVT
CDCsActive Bacterial Core surveillance 9
Proportion of IPD by vaccine- type and age group, 2018−2022
100
90
80
70
60
50
40
30
20
10
0 11 6 7 8
37 32 37 38
77% 83% 85%
38 62% 45
46 4756% 54%
14 17 10 7
age <5 years age 19-49 years age 50-64 years age ≥ 65 years
PCV20/ non-PCV21
77–85% of IPD cases in adults were due to PCV21 serotypes
PCV20 a nd PCV21 PCV21/ non-PCV20 NVT
CDCsActive Bacterial Core surveillance
10
GRADE Summary of Findings Table
1: Adults currently recommended to receive PCV
a. These are all immunogenicity studies and there are no correlates of protection for some critical outcomes considered.
b. Noninferiority for GMT ratio was defined as the lower bound of the 95% CI of the estimated OPA GMT ratio ({PCV21:PPSV23} to b e > 0.33.
c. Superiority for GMT ratio was defined as the lower bound of the 95% CI of the estimated OPA GMT ratio [PCV21:PPSV23] to be > 1.0.
d. Noninferiority for GMT ratio was defined as the lower bound of the 2 sided 95% CI of the OPA GMT ratio [PCV21 / PCV20] to be >0.5.
e. Superiority for GMT ratio was defined as the lower bound of the 2 sided 95% CI of the OPA GMT ratio [PCV21 / PCV20] to be >2. 0.
Kobayashi February 2024 ACIP meeting presentation
11
GRADE Summary of Findings Table
1: Adults currently recommended to receive PCV
f. few vaccine -related serious adverse events reported.
g. Bronchospasm (V116 -005): 50 -year-old female in the sequential group with bronchospasm within 30 minutes after the 2ndvaccination (V116); duration 23 hours; resolved; Injection site cellulitis (V116 -006): 67 -year-old female in Cohort 1 (prior PPSV23) with i njection site cellulitis
on Day 6; duration 1.57 weeks; resolved (Merck, unpublished).
Kobayashi February 2024 ACIP meeting presentation
12
13 Recommendation by a healthcare provider was among the top
reasons influencing the likelihood of receiving a pneumococcal
vaccine
▪Recommendation by a healthcare provider was one of the top factors
influencing the likelihood of receiving a pneumococcal vaccine1, 2
▪Among adults aged 19–64 years with risk -based indications , the top reasons
for not getting a pneumococcal vaccine were2:
• Not knowing a pneumococcal vaccine was needed (32%)
• Never receiving a recommendation by a healthcare provider (28%)
1. Online survey conducted in February 2024, funded by Merck. The survey targeted 250 adults aged ≥65 years who previously recei ved a pneumococcal vaccine as an adult and
250 adults aged 50 –64 years (healthy & CMC) who have not previously received a pneumococcal vaccine as an adult. Participants we re being “in favor” or “neutral” toward
adult vaccinations
2. Online survey conducted in January 2024, by HaPPI Survey Collaborative. The survey Targeted adults aged 19 –64 years with underlying conditions (self -report) with
indications for risk -based pneumococcal vaccine indications
Does the population feel that the desirable effects are large
relative to undesirable effects?
▪The Work Group found it challenging to interpret this EtR domain due to limited data
1. Adults currently 2. Adults aged 50 –64 years with 3. Adults aged 19 –49 years
recommended to receive PCV no risk -based indication with no risk -based indication
□ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know □ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know
Minority opinion No
Probably no
Probably yes
Yes
Varies
Don’t know
Is there important uncertainty about or variability in how
much people value the main outcomes*?
1. Adults currently recommended to receive PCV
□ Important uncertainty or variability
□ Probably important uncertainty or variability
□ Probably not important uncertainty or variability
□ No important uncertainty or variability
□ No known undesirable outcomes
15* Vaccine -type (VT) IPD, VT -non -bacteremic pneumococcal pneumonia, VT -pneumococcal deaths, serious adverse events
Probably important uncertainty or variability
Probably not important uncertainty or variability
Is there important uncertainty about or variability in how
much people value the main outcomes*?
2. Adults aged 50 –64 years with no risk -based indication
□ Important uncertainty or variability
□
□
□ No important uncertainty or variability
□ No known undesirable outcomes
16*Vaccine -type (VT) IPD, VT -non -bacteremic pneumococcal pneumonia, VT -pneumococcal deaths, serious adverse events
Is there important uncertainty about or variability in how
much people value the main outcomes*?
3. Adults aged 19 –49 years with no risk -based indication
□ Important uncertainty or variability
□ Probably important uncertainty or variability
□ Probably not important uncertainty or variability
□ No important uncertainty or variability
□ No known undesirable outcomes
* Vaccine -type (VT) IPD, VT -non -bacteremic pneumococcal pneumonia, VT -pneumococcal deaths, serious adverse events
17
EtR Acceptability
• Is the intervention acceptable to key stakeholders*?
Key Stakeholders
= healthcare providers, healthcare delivery systems, the public
Online surveys among healthcare providers to understand
vaccine preference
▪Expressed more challenges in identifying patients eligible for pneumococcal
vaccination based on risk factors vs age1
• Focus during visit is on other priorities during the visit (e.g., other vaccinations,
treatment, counseling)
• Most commonly identified challenge among physicians and NP/PAs
• Unknown pneumococcal vaccination history of the patient
• Unknown underlying health condition of patient
• Most commonly identified challenge among pharmacists
▪Providers reported they were slightly likely (32%), likely (39%), or extremely likely
(19%) to support ACIP lowering the age -based recommendation for pneumococcal
vaccines from adults aged ≥65 years to ≥50 years2
1. Online survey conducted in February 2024 by ZS, funded by Merck. 502 HCPs (physicians, NP/PAs, pharmacists who vaccinate) par tic
19 ipated; majority (70%) physicians
2. Online survey conducted from March –May 2024 by OPEN Health, funded by Merck. Included a total of 340 HCPs consisting of physicia ns, nurse practitioners, pnysician
assistants, and pharmacists
Is the intervention acceptable to key stakeholders?
1. Adults currently 2. Adults aged 50 –64 years with 3. Adults aged 19 –49 years
recommended to receive PCV no risk -based indication with no risk -based indication
□ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know □ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know □ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know
Minority opinion
20
EtR Resource Use
• Is PCV21 use a reasonable and efficient allocation of resources for adults?
Summary of findings from economic analysis
Policy question
populations Strategy details Summary across available models
1. Currently
recommended adults Age -based PCV21 Cost -saving to $58,000 per QAL Y
gained
Risk -based PCV21 Cost -saving in all three models
2. Ages 50 –64 years PCV21 $3,000 to $270,000 per QAL Y gained
PCV20 $37,000 to $630,000 per QAL Y gained
3. Ages 19 –49 years PCV21 $650,000 per QAL Y gained to
“Dominated”
Supplemental dose Supplemental dose with
PCV21 $210,000 to $510,000 per QAL Y
gained
Leidner June 2024 ACIP meeting presentation
22
Summary of findings from economic analysis
Policy question
populations Strategy details Summary across available models
1. Currently
recommended adults Age -based PCV21 Cost -saving to $58,000 per QAL Y
gained
Risk -based PCV21 Cost -saving in all three models
2. Ages 50 –64 years PCV21 $3,000 to $270,000 per QAL Y gained
PCV20 $37,000 to $630,000 per QAL Y gained
3. Ages 19 –49 years PCV21 $650,000 per QAL Y gained to
“Dominated”
Supplemental dose Revaccination with PCV21 $210,000 to $510,000 per QAL Y
gained
23
Summary of findings from economic analysis
Policy question
populations Strategy details Summary across available models
1. Currently
recommended adults Age -based PCV21 Cost -saving to $58,000 per QAL Y
gained
Risk -based PCV21 Cost -saving in all three models
2. Ages 50 –64 years PCV21 $3,000 to $270,000 per QAL Y gained
PCV20 $37,000 to $630,000 per QAL Y gained
3. Ages 19 –49 years PCV21 $650,000 per QAL Y gained to
“Dominated”
Supplemental dose Revaccination with PCV21 $210,000 to $510,000 per QAL Y
gained
24
Is PCV21 use a reasonable and efficient allocation of
resources for adults?
1. Adults currently 2. Adults aged 50 –64 years with 3. Adults aged 19 –49 years
recommended to receive PCV no risk -based indication with no risk -based indication
□ No
Probably no
Probably yes
□ Yes
Varies
Don’t know □
□
□
□ □ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know
25 □ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know
Minority opinion
EtR Feasibility
• Is PCV21 use feasible to implement?
Considerations:
Financial barriers, simplicity and integration, access
Is PCV21 feasible to implement?
▪WG interpretation of feasibility generally mirrors interpretation for resource use.
▪Some expressed the interpretation of group 2 may depend on whether there are
different age -based recommendations for PCV21 and other PCVs
1. Adults currently 2. Adults aged 50 –64 years with 3. Adults aged 19 –49 years
recommended to receive PCV no risk -based indication with no risk -based indication
□
□
□
□
□□No
Probably no
Probably yes
Yes
Varies
Don’t know
27 □
□□
□
□□ No
Probably no
Probably yes
Yes
Varies
Don’t know
□
□
□□□ No
Probably no
Probably yes
Yes
Varies
Don’t know □
Equity Probably increased
–
-–
-
Summary of Work Group Interpretation of the EtR Domains
EtR Domains Group 1. Adults with current PCV
recommendations Group 2. Adults aged 50 64
years, no risk based indication Group 3. Adults aged 19 49
years, no risk based indication
Public Health Problem Yes Probably Yes No/Probably No
Benefits and Harms
a. Benefits Moderate/Large Small/Moderate Minimal/Small
b. Harms Minimal
c. Benefit>Harm?
d. Overall certainty: effectiveness Favors PCV21 use
Moderate Favors PCV21/Favors no
vaccine (split)
e. Overall certainty: safety Moderate
28 Values and Preferences
a. Desirable>Undesirable? Probably Yes Probably Yes Varies
b. Uncertainty? Probably important/not important Probably important Important/Probably important
uncertainty uncertainty uncertainty
Acceptability Yes Probably Yes Probably No/No
Resource Use Yes Yes/Probably Yes No
Feasibility Yes Yes/Probably Yes Probably No/No
Summary: Work Group Interpretation
1. Should PCV21 be recommended for U.S. adults aged ≥19 years who currently have a
recommendation to receive a PCV*?
*Includes:
• Adults aged ≥65 years who have never received a PCV
• Adults aged 19 –64 years with a risk condition, who have never received a PCV
• Adults aged ≥19 year who have received a PCV (i.e., PCV7 or PCV13), but have not completed the recommended series
• PCV20 use based on shared clinical decision -making for adults ≥65 years who have completed the recommended series with
PCV13 and PPSV23
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
29
Summary: Work Group Interpretation
2. Should PCV21 be recommended for U.S. adults aged 50–64 years who currently do
not have a risk -based pneumococcal vaccine indication?
• “Desirable consequences probably outweigh undesirable consequences in most settings ” was selected the most,
but did not reach the majority
• Some selected “Desirable consequences clearly outweigh undesirable consequences “ and “The balance between
desirable and undesirable consequences is closely balanced or uncertain ”, but few believed that undesirable
consequences outweighed desirable consequences.
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
30
Summary: Work Group Interpretation
3. Should PCV21 be recommended for U.S. adults aged 19–49 years who currently do
not have a risk -based pneumococcal vaccine indication?
*this implies a new age -based recommendation for adults aged ≥19 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
31
Additional considerations
What would be the impact of recommending PCV21 use for all adults
aged 50 –64 years on health equity?
Racial disparities due to PCV13 -type IPD decreased after
pediatric PCV13 use
▪Racial disparities in IPD incidence exist
▪Remaining disparities in IPD incidence are
primarily due to non -PCV13 -type disease
Adapted from Kobayashi February 2024 ACIP meeting presentation
Figure: ABCs unpublished data
1. Vaccination Coverage among Adults in the United States, National Health Interview Survey, 2021 | CDC
33
Racial disparities due to PCV13 -type IPD decreased after
pediatric PCV13 use
▪Racial disparities in IPD incidence exist
▪Remaining disparities in IPD incidence are
primarily due to non -PCV13 -type disease
Adapted from Kobayashi February 2024 ACIP meeting presentation
Figure: ABCs unpublished data
1. Vaccination Coverage among Adults in the United States, National Health Interview Survey, 2021 | CDC
34
5.9
PCV21
type: 8 5% 8.2
PCV21
type: 82% 35.5
43.2
49.0
pe: 59% ty PCV20 39.1
type: 49%
9.7 9.5 PCV21 serotypes caused >80% of IPD cases in both Black and White
adults 50 –64 years; there was a larger difference in % of IPD cases
caused by PCV20 serotypes between Black and White adults 50 –64 years
PCV20/non-PCV21 PCV20 and PCV21 PCV21/non-PCV20 NVT
PCV20
ABCs 2018 –2022 unpublished data WHITE BLACK
35
35 IPD rates in Black adults peak at a younger age compared
with Non -Black adults
30
25
20
15
10
5
0
40-44 45-49 50-54 55-59 60-64 65+ 40-44 45-49 50-54 55-59 60-64 65+
Black Black Black Black Black Black Non Black Non Black Non Black Non Black Non Black Non Black IPD rate for adults aged ≥65 years across all
race/ethnicity (24/100,000)
ABCs 2018 –2019 unpublished data
36
Differences in prevalence of risk conditions among Black vs
Non -Black adults may be contributing
▪The proportion of immunocompromised individuals was similar for both racial groups
at age 50 years and throughout the lifespan
Racial Disparities in Adult Pneumococcal Vaccination Indications and Pneumococcal Hospitalizations in the U.S -PubMed (nih.gov)
37
Adults with risk -based vaccine indications 19 –64 years had lower
vaccine coverage compared with adults ≥65 years; differences in vaccine
coverage by race/ethnicity existed
Age group % (95% CI)
Overall (≥65 years) 65.8 (64.4 -67.2)
White 70.1 (68.8 -71.4)
Black 54.8 (50.6 -59.0)*
Hispanic 46.2 (40.9 -51.6)*
Asian 55.8 (48.7 -62.7)*
Other 62.5 (53.1 -71.1)
Overall (19 –64years with risk -based indication ) 22.2 (21.0 -23.5)
Vaccination Coverage among Adults in the United States, National Health Interview Survey, 2021 | CDC
*p<0.05 for comparisons with White as the reference
38
Increase in serotype 4 IPD cases has been reported in
certain adult populations in recent years
▪Serotype 4 is contained in existing pneumococcal vaccines but not PCV21
▪Serotype 4 IPD cases had nearly been eliminated after PCV7 use in
children but IPD clusters have been reported in certain populations (e.g.,
people experiencing homelessness)1,2,3
▪In certain areas, increase in serotype 4 IPD cases observed in routine
surveillance in recent years, especially post -2020, after near elimination
• Increase reported in Western United States (Alaska4, Navajo Nation5, ABCs CO/NM/
OR sites6)
▪Appears to primarily affect adults aged <65 years with risk -based
pneumococcal vaccine indications
1. Callaway et al. MMWR 2023 ; 2. McKee et al. CCDP 2018 ; 3. Beall et al. JID 2021 ; 4. Orell et al. ISPPD 2024; 5
. Johns Hopkins Center for Indigenous Health and Navajo
Epidemiology Center 2024 ; 6. CDC Active Bacterial Core surveillance unpublished data 39
Summary of Work Group discussions on lowering
the age -based recommendation for PCV21 to age
≥50 years
Pros and Cons of lowering the age -based recommendation
for PCV21 from ≥65 years to ≥50 years
Pros:
▪Potential to improve vaccine coverage in
adults aged 50 –64 years who currently have
risk-based vaccine indications
▪Potential to prevent more disease from broad
pneumococcal serotype coverage with PCV21
▪Potential to reduce racial disparities in
pneumococcal disease burden given the
differences in when pneumococcal disease
rates peak and prevalence of conditions that
increase the risk of pneumococcal disease
41
Pros and Cons of lowering the age -based recommendation
for PCV21 from ≥65 years to ≥50 years
Cons:
▪Lack of data on duration of protection from vaccination
▪Potential unintended consequences of worsening health
equity by improving access to those who already have
good access to healthcare
▪Higher Cost/QAL Y gained (~270K/QAL Y gained) reported in
some economic models
▪Uncertainties with serotype 4 (serotype contained in
existing vaccines but not PCV21) disease trends
▪Implementation challenges of having different
recommendations by product ( i.e, 1 PCV option for adults
50–64 years without a risk condition; 3 PCV options for
adults with a risk condition)
42
Summary of WG discussion
▪The WG agreed that available evidence supports PCV21 use for adults currently
recommended to receive a PCV
▪The WG could not reach a consensus on whether the age -based recommendation for
PCV21 should be lowered from ≥65 years to ≥50 years
▪The WG did not support lowering the age -based recommendation for PCV21 to age 19
years
▪The majority of WG members believed there was insufficient evidence to support
lowering the age -based recommendation for currently recommended vaccines
43
Proposed Voting Language
Proposed Voting Language
ACIP recommends PCV21 as an option for adults aged ≥19 years
who currently have a recommendation to receive a dose of PCV.
45
Clinical Guidance for Implementation
Proposed Language
47 PCV -naïve adults (or adults with unknown history)
A single dose of PCV21 is recommended as an option for all
adults aged ≥65 years and for adults aged 19 –64 years with
certain underlying conditions or risk factors* who have not
received a PCV or whose vaccination history is unknown.
Rationale:
▪PCV21 is added as an option to the current recommendation to use either PCV20 alone or PCV15 in
series with PPSV23 (if PPSV23 not given previously) for these adults; barrier to implementation is likely
low.
▪PCV21 exhibited comparable safety and immunogenicity findings to comparator vaccines in clinical
trials.
▪Economic evaluations were consistently favorable (cost -saving to 58,000 USD/QAL Y gained).
*Alcoholism; chronic heart, liver, or lung disease; chronic renal failure; cigarette smoking; cochlear implant; congenital or acquired asplenia; cerebrospinal fluid leak; diabetes
mellitus; generalized malignancy; HIV; Hodgkin disease; immunodeficiency; iatrogenic immunosuppression; leukemia, lymphoma, o r multiple myeloma; nephrotic syndrome; solid
organ transplant; sickle cell disease; or other hemoglobinopathies.
PCV -naïve adults (or adults with unknown history)
Underlying
conditions Previous
vaccination
history Age 19 –64 years Age ≥65 years
None None No vaccine recommendation PCV21
OR
PCV20
OR
PCV15 ≥1yr PPSV23*
Chronic
medical
conditions None
PCV21
OR
PCV20
OR
≥8wks†
PCV15 PPSV23*
≥1yr
*If adults previously received PPSV23 before receiving a dose of PCV15, it need not be followed by another dose of PPSV23
†A minimum interval of 8 weeks can be considered for adults with an immunocompromising condition, cochlear implant, or cerebro spinal fluid leak CSF leak,
cochlear
implant None
Immuno -
compromised None
48
Pneumococcal Vaccine for Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices, United S tates, 2023 | MMWR (cdc.gov)
PCV -experienced adults who completed the recommended
vaccine series
Shared clinical decision -making is recommended regarding use
of a supplemental PCV20 or PCV21 dose for adults aged ≥65
years who have completed their recommended vaccine series
with both PCV13 and PPSV23.
Rationale:
▪This adds PCV21 as an option to the current shared clinical decision -making recommendation for
PCV20 among adults aged ≥65 years who completed the recommended vaccine series with
PCV13+PPSV23.
▪Some WG members were in favor of expanding this indication to adults who received all recommended
vaccine doses with a single dose of PCV20 or PCV15+PPSV23 (especially for adults with risk conditions)
but others felt that there was insufficient evidence to support that.
▪A phase 3 clinical trial on PCV21 use among PCV -experienced children with risk conditions is underway1;
proposal to discuss PCV21 use in children and adults with risk conditions who completed
49 recommended
vaccine series together.
1. NCT06177912
PCV -experienced adults who completed the
recommended vaccine series
Underlying
conditions
None
Chronic
medical
conditions
CSF leak,
cochlear
implant
Immuno -
compromised Age 19 –64 years
No vaccine recommendation Age ≥65 years
≥8wks* PCV13 PPSV23 ≥1yr
AND
PCV21Shared clinical ≥5yrs ORdecision -making
PCV20
Pneumococcal Vaccine for Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices, United S tates, 2023 | MMWR (cdc.gov)
50
PCV -experienced adults who have not completed the
recommended vaccine series
A single dose of PCV21 is recommended as an option for adults
aged ≥19 years who have started their pneumococcal vaccine
series with PCV13 but have not received all recommended
PPSV23 doses.
Rationale:
▪This adds PCV21 as an option to the current recommendation to complete the vaccine series with either
a dose of PCV20 or ≥1 dose of PPSV23.
▪In addition to those who started the series with PCV13, adults who received PCV15 but have not
completed the series with PPSV23 will have an option to complete the series with either a dose of
PCV21 or PCV20 if they no longer have access to PPSV23.
51
PCV -experienced adults who have not completed the
recommended vaccine series
Underlying
conditions Age 19 –64 years Age ≥65 years
None PCV21
OR
PCV13* ≥1yr PCV20
OR
PPSV23 Chronic
medical
conditions
CSF leak,
cochlear
implant PCV21
PCV13* ≥1yr OR
PCV20
OR
PCV13 ≥8wks PPSV23
OR
PCV13 ≥8wks PPSV23 ≥5yrs PPSV23 PCV21
OR
≥5yrs PCV20
OR
PPSV23
52 Immuno -
compromised
*includes adults who received PCV15 if PPSV23 not available
53 Populations at increased risk of serotype 4 disease
(draft language)
In certain communities where there are high proportions (i.e.,
≥30%) of disease due to serotypes unique to currently
recommended vaccines (e.g., serotype 4), those vaccines may
provide more protection against locally circulating strains
compared to PCV21. Those who may be at increased risk of
disease due to serotype 4 include adults aged <65 years in the
Western United States with certain underlying conditions or risk
factors* that increase the risk of pneumococcal disease.
*Alcoholism; chronic heart, liver, or lung disease; chronic renal failure; cigarette smoking; cochlear implant; congenital or acquired asplenia; cerebrospinal fluid leak; diabetes
mellitus; generalized malignancy; HIV; Hodgkin disease; immunodeficiency; iatrogenic immunosuppression; leukemia, lymphoma, o r multiple myeloma; nephrotic syndrome; solid
organ transplant; sickle cell disease; or other hemoglobinopathies.
Acknowledgments
▪ACIP and the Pneumococcal Vaccines Work Group
▪Active Bacterial Core surveillance sites and program
▪Charles Stoecker, Yin Wang (Tulane University)
▪Laura Hammitt, Catherine Sutcliffe, Tori Sergent (Johns Hopkins Center for Indigenous
Health)
▪CDC contributors and consultants: Ryan Gierke, Jennifer Farrar, Andrew Leidner,
Kristin Andrejko, Lindsay Zielinski, Emma Accorsi, Wei Xing, Adam Cohen, Alison
Albert, Angela Jiles, Noele Nelson, Kimberly Fox, Pedro Moro, Bo -Hyun Cho, Elizabeth
Velazquez, Janelle King, Fangjun Zhou, Marc Fischer, Laurie Orell, Cheryl Ward,
Rebecca Morgan, Doug Campos -Outcalt
- - - -
- - -Thank you
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.
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