Evidence to Recommendations Framework (Preliminary): 

Use of 20-valent Pneumococcal Conjugate Vaccine in U.S. CMiwako Kobayashi, MD, MPHPneumococcal Vaccines Work GroupAdvisory Committee on Immunization PracticesFebruary 22, 2023National Center for Immunization & Respiratory Diseases
Evidence to Recommendations (EtR) framew

EtR Domain QuestionPublic Health Problem • Is the problem of public health importance?

Benefits and Harms • How substantial are the desirable anticipated eff

• How substantial are the undesirable anticipated 

• Do the desirable effects outweigh the undesirab

• What is the overall certainty of this evidence for 

Values • Does the target population feel the desirable eff

to the undesirable effects?

• Is there important variability in how patients val

Acceptability • Is the intervention acceptable to key stakeholde

Feasibility • Is the intervention feasible to implement?Resource Use • Is the intervention a reasonable and efficient allo

Equity • What would be the impact of the intervention o
Evidence to Recommendations (EtR) framew

EtR Domain QuestionPublic Health Problem • Is the problem of public health importance?

Benefits and Harms • How substantial are the desirable anticipated eff

• How substantial are the undesirable anticipated 

• Do the desirable effects outweigh the undesirab

• What is the overall certainty of this evidence for 

Values • Does the target population feel the desirable eff

to the undesirable effects?

• Is there important variability in how patients val

Acceptability • Is the intervention acceptable to key stakeholde

Feasibility • Is the intervention feasible to implement?Resource Use • Is the intervention a reasonable and efficient allo

Equity • What would be the impact of the intervention o
All children under age 2 years have the same 

pneumococcal vaccine recommendations• 3 primary series and a booster=“3+1” schedule

PCV PCV PCV 

2 months 4 months 6 months 1

Primary Series 

Either PCV13 or PCV15 can be used for U.S. childre
All children under age 2 years have the same 

pneumococcal vaccine recommendations• 3 primary series and a booster=“3+1” schedule

PCV PCV PCV 

2 months 4 months 6 months 1

Primary Series 

Currently, either PCV13 or PCV15 can be used for U.S. children.

Should PCV20 be recommended as an oppneumococcal conjugate vaccination accto currently recommended dosing and schedules, for U.S. children aged <2 year
Children age ≥2 years with certain underlying 

recommended to receive PPSV23 in addition

Use of 15-Valent Pneumococcal Conjugate Vaccine Among U.S. Children: Updated Recommendations of the Advisory Committee on ImmunizatioPractices — United States, 2022 | MMWR (cdc.gov)

PPSV23

≥8 weeks

Recommended 

PCV doses PPSV23 

≥8 weeks ≥5 years

PPSV23

Recommended 

PCV doses

Note: Excludes catch-up vaccination schedules.CMC=chronic medical conditions, including chronic heart disease, chronic lung disease, diabetes mellitusCSF=cerebrospinal fluid 

Recommended 

PCV doses

Healthy 

children

CMC, CSF leak, 

cochlear 

implant

Immunocompromised

CMC aged 6–18 

years 
Should PCV20 without PPSV23 be recom

as an option for pneumococcal vaccinatioU.S. children aged 2–18 years with undermedical conditions that increase the risk pneumococcal disease?
PICO 

Question

Should PCV20 be recommended as an option for pneumo

for U.S. children?

Population All U.S. children aged <2 years U.S. children aged 2–

underlying medical c

Intervention

PCV20 according to currently recommended dosing and schedules

PCV20 (without PPSV

Comparison PCV13 or PCV15 according to currently recommended dosOutcomes VT-IPD, VT- pneumonia, VT- AOM, VT- pneumococcal deat

events following vaccination

VT: vaccine-type, IPD: invasive pneumococcal disease, AOM: acute otitis media 
EtR Domain: Public Health Problem
Summary of pneumococcal disease epidemio

in children• Use of PCVs (PCV7, PCV13) significantly decreased the incidence o

pneumococcal disease in U.S. children.

• Outpatient ARIs caused by pneumococcus, such as AOM, sinusitis, 

pneumonia, are common causes of outpatient visits and antibiotic 

• Risk of disease remains high in children with underlying condition

increase the risk of pneumococcal disease.

• In 2018–2019, the proportion of IPD caused by vaccine serotypes w

• PCV20, non-PCV13: ~30% of IPD• PCV15, non-PCV13: ~15% of IPD

Gierke. February 2023 ACIP meeting presentationKing. February 2023 ACIP meeting presentation 
Public Health Problem

Is pneumococcal disease of public health importanchildren? 

□ No □ Probably no□ Probably yes□ Yes□ Varies□ Don’t know
Public Health Problem

Is pneumococcal disease of public health importanchildren? 

□ No □ Probably no□ Probably yes□ Yes□ Varies□ Don’t know

• Variability in Work Group mem

interpretations for children agesignificant reductions in pneum

• Most agreed that pneumococc

to be of public health importanremaining disease burden.
EtR Domain: Benefits and Harms
Outcome Importance Description 

VT- IPD CriticalVT- non-bacteremicpneumococcal pneumonia 

Critical

VT- acute otitis media CriticalVT- pneumococcal deaths Critical

Outcomes (Benefits)

Studies assessing PCV2clinical outcomes are cavailable PCV20 immunogen

GRADE

 PCV13/PPSV23 clin

studies for backgro

AOM=acute otitis media, IPD=invasive pneumococcal disease, VT=vaccine-type 
Outcomes (Harms)

Outcome Importance Description Serious adverse events Critical Safety data for PCV20 
Background
PCV13 effectiveness (3+1) in children, VT-IPD

Study Population Dosing schedule 

(Year of introduction)

Method Outcome Vaccine 

Effectiven

Savulescu, 2022

Children 2m –59m; Spidnet(12 European sites, 2012-2018

2+1 or 3+1 (variable)

Indirect cohort

3 + 1 doses, ≥12 months 89.7% 

(adjusted

Van der Linden, 2016*

Children <2 years; Germany (GNRCS)

3+1 (December 2009)

Indirect cohort

PCV13-type; post-booster 91% 

Weinberger, 2016

Children 2.5 –56m; Germany (ESPED)

3+1 (December 2009)

Indirect cohort

PCV13-type +6C; ≥2 dose before 12 months or one dose on/after 12 months

85% (adju

Dominguez, 2017

Children 7m -59m; Spain (Catalonia)

3+1 (public, July 2016)

Matched casecontrol

PCV13-type; 7-59m; ≥2 doses before 12 months or one dose after 12 months

78.9% 

Moore, 2016

Children 2-59m; US

3+1 (2010) Matched 

casecontrol

PCV13-type; ≥1 dose 86.0% 

(unadjust

* Adjusted by site, age, year of notification and at least one underlying disease

Post-licensure vaccine effectiveness studies have shown that PCV13 is highly effectivVT-IPD
PCV13 effectiveness, VT-pneumococcal pneu

Study Population Dosing schedule 

(Year of introduction)

Method Outcome 

Zhang, 2021 Children born 

December 2016 – November 2018, China

3+1 (2017) Indirect cohort;

VT-CAP defined as hospital discharge diagnosis code of pneumonia + deep upper respiratory aspirate with PCV13 serotypes. 

VT-CAP; ≥3 doses

Lewnard, 2021*

Children 4 to 59 months, Israel 

2+1 (2010) Nested case-control; 

Used:• PCV-conferred protection 

against VT pneumococcal carriage

• Protection against 

progression from carriage to pneumonia

CAP attributed to PCV13, 12-59 months; 2+1 doses

*funded by Pfizer

Limited data on PCV13 effectiveness against VT-pneumococcal pneumonia in children. PCV13 likely protective. 

CAP=community acquired pneumonia
PCV13 effectiveness, VT-AOM

Study Population Dosing schedule 

(Year of introduction)

Method Outcome VE 

Pichichero, 2018*

Children ≤36 months, United States

3+1 (2010) Prospective 

longitudinal cohort (PCV13 v PCV7 period)

PCV13-non-PCV7 serotypes; PCV13 full primary series (regardless of booster status) vs. PCV7 for middle-ear fluid samples at onset of AOM

86(a

Serotype 3; PCV13 full primary series (regardless of booster status) vs. PCV7 for middle-ear fluid samples at onset of AOM

5% (a

OchoaGondar, 2015

≤14 years; Spain (Catalonia region)

3+1 (2016, publicly available)

Indirect cohort PCV13-type; ≥1 dose 62

(u

Dagan, 2021*

Children 5 to 35 months, Israel

2+1 (2010) Nested casecontrol PCV13-type; ≥2 doses vs. 0 doses 77

(a

Serotype 3; ≥2 doses vs. 0 doses

89(a

*funded by Pfizer

Limited data on PCV13 effectiveness against VT-pneumococcal AOM in children. PCV13 likely protective. 
PPSV23 effectiveness, VT-IPD (Pre-PCV U.S. d

Pre-PCV era data showed that PPSV23 is protective against VT-IPD amchildren with underlying medical conditions. 

Fiore et al. EID 1999 
PPSV23 effectiveness, non-invasive pneumoc

disease• No study on PPSV23 VE against AOM identified in a recent system• Two randomized-controlled trials (RCTs)2,3 evaluated PCV7-PPSV23 

against AOM

• No efficacy in the PCV7-PPSV23 groups

1. Marra et al. Value Health 20222. Veenhoven et al. Lancet 20033. Van Kempen et al. Int J Pediatr Otorhinolaryngol 2006 
GRADE: PCV20 use in children
Evidence retrieval: PCV20 use in children

Clinicaltrials.gov

N=12

4 studies included for GRADE

Phase II trial (published), N=1

Phase III trials (unpublished), N=3

Pubmed

N=62

PCV20 routine use

(N=3)

Immunogenicity (N=2)

Safety (N=3)

PCV20 use in children 

with underlying 

conditions

(N=1)

Immunogenicity (N=1)

Safety (N=1)

Unpublis

phar

co

Search terms used are provided in supplementary slides 
Summary of evidence: 

Benefits, children <2 years • Informed by 2 randomized controlled trials (Phase II and III)1,2

• Healthy children randomized to either PCV13 or PCV20• PCVs given using 3+1 schedule

• Summary of findings

•PCV20 had numerically lower immune responses* vs. PCV13 for 

13 shared serotypes

•Post dose 3: 

•PCV20 did not meet noninferiority criteria vs. PCV13 for some serotypes 

•Post dose 4: 

•PCV20 noninferior to PCV13 for all 13 shared serotypes 

•PCV20 noninferior to PCV13** for all 7 additional serotypes

*measured as IgG GMCs and GMRs**Compared with the serotype with lowest immune response among PCV13 serotypes except for serotype 31. Senders et al. PIDJ 20212. Pfizer unpublished data from B7471011
Summary of evidence: 

Harms, children <2 years • Serious adverse events (SAEs) across 3 studies (dose 1 through 6 m

dose 4):

• PCV20: 4.5% (n=1,567) vs PCV13: 3.7% (n=1,376)

• None were considered to be vaccine-related

1. Senders et al. PIDJ 20212. Pfizer B7471011, unpublished data3. Pfizer B7471013, unpublished data, limited to US and Puerto Rico sites 
Should PCV20 be recommended as an option for pneumococcal conju

vaccination according to currently recommended dosing and schedulechildren aged <2 years?

Type Outcome Importance

Included in 

evidence profile

Benefits

VT- IPD Critical Yes 

VT-pneumonia Critical Yes 

VT- AOM Critical Yes 

VT- pneumococcal 

deaths Critical Yes 

Harms SAEs following vaccination Critical Yes 

AOM=acute otitis media, IPD=invasive pneumococcal disease, SAE=serious adverse events, VT=
□ Minimal

□ Small□ Moderate□ Large□ Varies□ Don’t know

Benefits and HarmsHow substantial are the desirable anticipated effects Routine PCV20 use for children aged <2 years

• PCV20 prov

serotype coavailable PC

• Unknown h

protection cPCV20 will bavailable da
Benefits and Harms

How substantial are the undesirable anticipated effe Routine PCV20 use for children aged <2 years

□ Minimal□ Small□ Moderate□ Large□ Varies□ Don’t know
Benefits and Harms

Do the desirable effects outweigh the undesirable ef Routine PCV20 use for children aged <2 years

□ Favors intervention*□ Favors current recommendation□ Favors both□ Favors neither□ Varies□ Don’t know *Intervention: PCV20 u

Comparison: PCV13 or 
Benefits and Harms

Do the desirable effects outweigh the undesirable • Routine PCV20 use for children aged <2 yearsFavors Intervention (PCV20):• PCV20 is expected to prevent more disease compared with current 

(PCV13, PCV15)

Favors Both (PCV20 or PCV13/PCV15):• Clinical implications of the lower immunogenicity PCV20 compared 

unknown

• Clinical implications of improved immunogenicity of PCV15 against 

unknown

*Banniettis. February 24, 2022 ACIP meeting presentation 
Summary of evidence: 

Benefits, children 2–18 years with underlying condit• No studies conducted among children with underlying medical con

• Informed by 1 non-randomized trial (Phase III), no comparator

• Healthy children aged 15 months to 17 years received a dose of 

• Children aged <5 years received ≥3 doses of PCV13

• Summary of findings

•PCV20 was immunogenic* for all 20 vaccine serotypes 1 month 

vaccination vs. pre-vaccination. 

*Measured as IgG GMCs and GMFR and OPA GMFRsPfizer unpublished data from B7471014 
Summary of evidence: 

Harms, children 2–18 years with underlying c• Serious adverse events (SAEs) :

• PCV20: 0.6% (n=831) 

• None were considered to be vaccine-related

Pfizer unpublished data from B7471014 
Should PCV20 without PPSV23 be recommended as an option for pne

vaccination for U.S. children aged 2–18 years with underlying medical increase the risk of pneumococcal disease?

Type Outcome Importance

Included in evidence 

profile

Benefits

VT-IPD Critical Yes 

VT-pneumonia Critical Yes 

VT-AOM Critical Yes 

VT-pneumococcal 

deaths Critical Yes 

Harms SAEs following vaccination Critical Yes 

AOM=acute otitis media, IPD=invasive pneumococcal disease, SAE=serious adverse events, VT=
□ Minimal

□ Small□ Moderate□ Large□ Varies□ Don’t know

Benefits and Harms

How substantial are the desirable anticipated effects? PCV20 use for children aged 2–18 years with underlying medical co

• PCV20 provid

serotype covavailable PCV

• Unknown ho

protection cowill be based 

• No data from 
Benefits and Harms

How substantial are the undesirable anticipated effec PCV20 use for children aged 2–18 years with underlying medical co

□ Minimal□ Small□ Moderate□ Large□ Varies□ Don’t know
Benefits and Harms

Do the desirable effects outweigh the undesirable ef PCV20 use for children aged 2–18 years with underlying medical c

□ Favors intervention*□ Favors current recommendation□ Favors both□ Favors neither□ Varies□ Don’t know

*Intervention: PCV20 usComparison: PPSV23 usrecommended PCV (PCV
Benefits and Harms

Do the desirable effects outweigh the undesirable ef PCV20 use for children aged 2–18 years with underlying medical cFavors Intervention (PCV20):• PCV20 is expected to prevent more disease compared with current

recommendations (PPSV23 after recommended PCV13/15 doses)

Favors Both (PCV20 or PPSV23 after recommended PCV13/PCV15 dos• No data on PCV20 use in this population• Clinical implications of improved immunogenicity of PCV15 against s

unknown

*Banniettis. February 24, 2022 ACIP meeting presentation 
EtR Domain: Equity
Compared with coverage among children with priv

insurance only, children who were uninsured, and t

insured by Medicaid and other insurance was lowe

≥3 PCV doses (%) ≥4 PC

Private insurance only (Ref)(N=16,629)

96.2 90.0

Any Medicaid(N=10,200)

91.3* 78.8

Other insurance(N=2,168)

91.1* 80.6

Uninsured(N=608)

83.9* 62.3

PCV=pneumococcal conjugate vaccine*statistically significant difference compared with Ref.Hill et al. MMWR 2023 
Nationally representative PPSV23 vaccine cov

data among children with indications are limi

• Vaccine coverage among children with sickle cell anemia, Michigan 

• 4PCV + 1 PPSV23 at age 5 years: 64%

• 4PCV + 2 PPSV23 at age 10 years: 53%

• Self-administered survey of parents/guardians of children aged <18 

nephrotic syndrome

2

• PPSV23 receipt: 43%

• Data from single-center quality improvement studies among childr

care clinics reported 20–30% PPSV23 coverage at baseline3,4

1. Reeves et al. Pediatric Blood & Cancer, 2018

2. Tran et al. Frontiers in Pediatrics, 20213. Mirza et al. The Ochsner Journal, 20224. Harris et al. Pediatrics, 2022
IPD incidence 

rate difference

in children aged ≤17 years by census tract poverty,ABCs 2010–2019

CDC ABCs, unpublished data

All Serotypes PCV13 Serotypes 

PCV20/non-PCV13 PCV20/non-PCV15 
IPD incidence 

rate difference

in children aged ≤17 years by census tract poverty,ABCs 2010–2019

CDC ABCs, unpublished data

All Serotypes PCV13 Serotypes 

PCV20/non-PCV13 PCV20/non-PCV15 

For all serotypes and PCV13 serotypes, IPD incidence rate difference between the highest and lowest census tract poverty categories decreased after PCV13 introduction. 
IPD incidence 

rate difference

in children aged ≤17 years by census tract poverty,ABCs 2010–2019

CDC ABCs, unpublished data

All Serotypes PCV13 Serotypes 

PCV20/non-PCV13 PCV20/non-PCV15 

Essentially no IPD incidence PCV15, non-PCV13 serotype
IPD incidence 

rate difference

in children aged ≤17 years by census tract poverty,ABCs 2010–2019

CDC ABCs, unpublished data

All Serotypes PCV13 Serotypes 

PCV20/non-PCV13 PCV20/non-PCV15 

• IPD incidence rate difference for the additi

contained in PCV20 remain

• Slightly larger incidence rate difference for 

serotypes
Equity

What would be the impact of recommending PCV20 children on health equity?

□ Reduced□ Probably reduced□ Probably no impact□ Probably increased□ Increased□ Varies □ Don’t know 
Equity

What would be the impact of recommending PCV2children aged <2 years on health equity?Probably reduced:• New interventions are likely to be accessible to wealthy communitie

VFC program mitigates inequities in access to recommended vaccinProbably no impact:• Remaining disparities in vaccine-type disease seem to be minimal Probably increased:• Post-PCV13 data showed that PCV13 reduced disparities in vaccine-

VFC=Vaccines for Children
Equity

What would be the impact of recommending PCV2children aged 2–18 years with underlying medical con health equity?Probably no impact:• Risk-based recommendation is less likely to be equitable compared 

vaccine recommendations. 

Probably increased:• PCV20 use could simplify the pneumococcal vaccine recommendati

improve vaccine coverage. 
Summary of Work Group Interpretation of the EtR Domains (Prelimin

EtR Domains PCV20, <2 years (routine) PCV20, Public Health Problem YesBenefits and Harms

a. Benefits Moderate

b. Harms Minimalc. Benefit>Harm? Favors intervention/Favors botd. Overall certainty: 

effectiveness

2 (moderate) 4 (

e. Overall certainty: safety 2 (moderate) 4 (

Equity Probably increased (different o
Acknowledgements

• ACIP and the Pneumococcal Vaccines Work Group• CDC contributors and consultants: Ryan Gierke, Jennifer Farrar, Kr

Lindsay Zielinski, Emma Accorsi, Adam Cohen, Alison Albert, NoelPedro Moro, Elizabeth Velazquez, Marc Fischer, Katie Hamilton, NoRebecca Morgan, Doug Campos-Outcalt
Supplementary Slides

GRADE Summary of Evidence
Search strategy: PCV20 use in children

Database Strategy

Clinicaltrials.gov Inclusion: Relevant Phase 2, or 3 randomized controlled trials of PCV20

• Involved human subjects• Reported primary data• Included infants and children (age ≤18 years)• Included data relevant to the efficacy or effectiveness or immunogenicity and safety 

outcomes being measured

• Included data for the dosage and timing being recommended:

o 3+1 series for infants starting the vaccine series as currently recommendedo Catch-up vaccine schedule for older infants and children who did not start the 3+1 series 

in time

o Use of PCV20 to complete the PCV13 serieso Use of PCV20 in series with PPSV23 in older children with underlying conditions in series 

with PPSV23

PubmedMedline

“PCV20” or “20-valent pneumococcal conjugate vaccine” Included studies using the criteria listed above 

Additional resources

Unpublished and other relevant data by consulting with the vaccine manufacturer

*Same trials. Unpublished data from these trials were obtained from pharmaceutical companies. 
Included Studies: Routine PCV20 Use in Children Aged <2 ye

Author, year Study design Intervention Country Age Total population N Intervention N compariSenders, 2021

Phase II RCT in healthy full-term infants

PCV20 @ 2, 4, 6, and 12 months of age

US

42–98 days of age at consent

460 232 228

B7471011

Phase III RCT in healthy full-term infants

PCV20 @ 2, 4, 6, and 12 – 15 months of age

US, Puerto Rico

42–98 days of age at consent

1998 1001 997

B7471013

Phase III RCT in healthy infants

PCV20 @ 2, 4, 6, and 12 – 15 months of age

US, Puerto Rico, Canada, Chile, Argentina, EU

42–98 days of age at consent

1511 1000 551 

RCT=Randomized Controlled Trial
GRADE Summary of Findings: Routine PCV20 use in Children Ag

Certainty assessment No of patients Results

No of 

studies

Study 

design

Risk of 

bias Inconsistency Indirectness Imprecision Other considerations Intervention comparison Relative (95% CI) 

Vaccine effectiveness

21-2 RCT Not serious Not serious Serious

a Not serious Not serious 921-1022 910-989

• PCV20 had numer

immune responsewith PCV13 for m13 shared serotyp

• PCV20 did not me

noninferiority critsome serotypes a

• PCV20 noninferio

for all 13 shared safter dose 4. 

• PCV20 noninferio

for all 7 additionaafter dose 4.

a. These are all immunogenicity studies and there are no correlates of protection for most outcomes. b. Compared with serotype with lowest immune response among PCV13 serotypes except for serotype 3References1. Senders S, Klein NP, Lamberth E, Thompson A, Drozd J, Trammel J, Peng Y, Giardina PC, Jansen KU, Gruber WC, Scott DA, Watson W. Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infa1;40(10):944-951. doi: 10.1097/INF.0000000000003277.2.B7471011. A Phase 3, Randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in healthy infants 
GRADE Summary of Findings: Routine PCV20 use in Children A

Certainty assessment No of patients Resu

No of 

studies

Study 

design

Risk of 

bias Inconsistency Indirectness Imprecision Other considerations Intervention Comparison Relative (95% CI) 

Serious Adverse Events (SAEs) following vaccination

21-3 RCT Not 

serious

Not serious Not serious Serious

a Not serious 4.5% 

(n=1567)

3.7% 

(n=1376)

No vaccin

serious adve

repo

a. No vaccine-related serious adverse events reportedReferences1.Senders S, Klein NP, Lamberth E, Thompson A, Drozd J, Trammel J, Peng Y, Giardina PC, Jansen KU, Gruber WC, Scott DA, Watson W. Safety and Immunogenicity o

Vaccine in Healthy Infants in the United States. Pediatr Infect Dis J. 2021 Oct 1;40(10):944-951. doi: 10.1097/INF.0000000000003277.2.B7471011. A Phase 3, Randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in healthy infants

3.B7471013. A Phase 3, Randomized, double-blind trial to evaluate the safety of a 20-valent pneumococcal conjugate vaccine in healthy infants. Data limited to U.S. 
Included Study: PCV20 Use in Children Aged 2–18 Years with 

Medical Conditions

Author, year Study design Intervention Country Age Total population N Intervention N com

B7471014

Phase III Clinical Trial in healthy children, some previously vaccinated

Single dose PCV20 @ 15m to <24m; previous vaccination ≥3 doses of PCV13

US

15m to <24m

209 209 N/A

Single dose PCV20 @ 2y to <5y; previous vaccination ≥3 doses of PCV13

2y to <5y 216 216 N/A

Single dose PCV20 @ 5y to <10y

5y to <10y 201 201 N/A

Single dose PCV20 @ 10 to <18y

10y to <18y

205 205 N/A 
GRADE Summary of Findings: PCV20 Use in Children Aged 2

with Underlying Medical Conditions

Certainty assessment No of patients Results

No of 

studies

Study 

design

Risk of 

bias Inconsistency Indirectness Imprecision Other considerations Intervention comparison Relative (95% CI) 

Vaccine effectiveness

11 Non-RCT

Very 

Serious

a

Not 

applicable

Very 

Seriousb,c

Not 

serious Not serious 752-757 None

IgG GMCs were higmonth post-PCV20 compared to beforvaccination for 13/serotypes and 7/7 serotypes, for all a

a. Study design is an open label non-randomized controlled trial with no comparator group. Downgraded for lack of randomization, lack of blinding, and lack of a comparison grob. Study population did not include children with underlying conditionsc. This is an immunogenicity study and there are no correlates of protection for some critical outcomes consideredReferencesB7471014. Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age 
GRADE Summary of Findings: PCV20 use in Children 

Years With Underlying Medical Conditions

Certainty assessment No of patients Re

No of 

studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations PCV20 Intervention Relative (95% CI) 

Serious Adverse Events (SAEs) following vaccination

1

1

Nonrandomized 

trial

Serious

a

Not 

applicable Serious

b Serious

c Not serious 0.6% (n=831) No vacci

SAEs r

a. Study design is an open label non-randomized controlled trial with no comparator groupb. Study population did not include children with underlying conditionsc. No vaccine-related serious adverse events reported; relative risk crossing 1 ReferenceB7471014. Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age