Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases

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Pneumococcal Vaccines Work Group

October 2023, ACIP meeting

October 26, 2023

Miwako Kobayashi, MD, MPH
• The Pneumococcal Vaccines Work Group:

• Reviews current data on pneumococcal disease burden, and on the efficacy, 

effectiveness, immunogenicity, and cost-effectiveness of pneumococcal vaccines 

and assesses the strength of the evidence;

• Reviews current pneumococcal vaccine recommendations considering up-to-date 

evidence; and

• Develops revised or updated policy options for pneumococcal vaccines as needed.

Work Group Purpose

Advisory Committee on Immunization Practices (ACIP) Work Groups | CDC
ACIP Members

▪ Katherine Poehling (Chair)

▪ Sarah Long 

Ex Officio Members

▪ Jeffrey Kelman (CMS)

▪ Lucia Lee (FDA)

▪ Tina Mongeau (FDA)

▪ Uzo Chukwuma (IHS)

▪ Mamodikoe Makhene (NIH)

Liaison Representatives

▪ Lynn Fisher (AAFP)

▪ Mark Sawyer (AAP/COID)

▪ Jason Goldman (ACP)

▪ David Nace (AGS/AMDA)

▪ Cora Hoover (AIM)

▪ Risa Claytor (HRSA)

▪ James McAuley (IDSA)

▪ Aleksandra Wierzbowski (NACI)

▪ Robert Hopkins (NFID)

▪ Virginia Caine (NMA)

Consultants

▪ Monica Farley (VAMC/Emory)

▪ Keith Klugman (BMGF)

▪ Arthur Reingold (UC Berkley)

▪ Lorry Rubin (CCMC)

▪ Richard Zimmerman (U. of Pittsburgh)

Pneumococcal Vaccines Work Group
Division of Bacterial Diseases

▪ Diepreye Ayabina 

▪ Adam Cohen

▪ Ryan Gierke 

▪ Jennifer Farrar 

▪ Noele Nelson

Immunization Safety Office

▪ Pedro Moro 

Immunization Services Division

▪ Janelle King

▪ Andrew Leidner

▪ Liz Velazquez

Arctic Investigations Program

▪ Marc Fischer

CDC Lead

▪ Miwako Kobayashi

GRADE/EtR consultants

▪ Doug Campos-Outcalt

▪ Rebecca Morgan

CDC Contributors and Consultants
History of ACIP Pneumococcal Vaccine Recommendations 

through 2019

1984

PPSV23: Adults aged 

≥65 years and 

individuals with 

underlying conditions

2000 2010 2012 2014 2019

PCV7: Children PCV13: Children 

(replaced PCV7)

PCV13: Adults with 

immunocompromising 

conditions in addition 

to PPSV23

PCV13: All adults aged 

≥65 years in addition 

to PPSV23

PCV13: based on SCDM 

for adults aged ≥65 

years; routine PPSV23

recommendation

SCDM: shared clinical decision-making
Recent ACIP Pneumococcal Vaccine Recommendations, 

2021–2023

2021 2022 2023

PCV15: Children

PCV20: Expanded 

indication for adults 

who previously 

received PCV13

PCV20: Children

PCV15 and PCV20:

Adults who have not 

received PCV or whose 

vaccination history is 

unknown

Multiple updates have been made to adult 

pneumococcal vaccine recommendations since 2012.
▪Prior to the COVID-19 pandemic, estimated to have caused 

every year1:

– ≥100,000 non-invasive pneumococcal pneumonia hospitalizations

– ≥30,000 invasive pneumococcal disease (IPD) cases (e.g., bacteremic pneumonia, 

pneumococcal bacteremia, meningitis)

• 3,000 IPD deaths

▪Preliminary data show increase in IPD cases in late 20222

– Increase in other invasive bacterial infections reported in children3,4

Pneumococcal Disease Burden among U.S. Adults

1. Kobayashi M. October 20, 2021 ACIP Meeting Presentation. Considerations for Age-Based and Risk-Based Use of PCV15 and PCV20 among U.S. Adults and Proposed Policy 

Options. 

2. CDC Active Bacterial Core surveillance unpublished data

3. Notes from the Field: Update on Pediatric Intracranial Infections — 19 States and the District of Columbia, January 2016–March 2023 | MMWR (cdc.gov)

4. Notes from the Field: Increase in Pediatric Invasive Group A Streptococcus Infections — Colorado and Minnesota, October–December 2022 | MMWR (cdc.gov)
Invasive pneumococcal disease incidence among adults aged ≥65 years 

reached a historically low level early in the COVID-19 pandemic

IPD=invasive pneumococcal disease

CDC Active Bacterial Core surveillance

PCV13: children

PCV13: adults
Approximately 40% of IPD cases in adults aged ≥65 years were caused 

by serotypes not contained in currently recommended vaccines

CDC Active Bacterial Core surveillance
New Adult Pneumococcal Vaccines in Advanced Stages of Development

1 3 4 5 6

A

6

B

7 

F

9

V

1

4

1

8

C

1

9

A

1

9

F

2

3

F

2

2

F

3

3

F

8 1

0

A

1

1

A

1

2

F

1

5

B

2 9

N

1

7

F

2

0

1

5

A

1

5

C

1

6

F

2

3

A

2

3

B

2

4

F

3

1

3

5

B

PCV15

PCV20

PPSV23

PnMAPS24v

20

B

VAX-24 20

B

V116 20

A

24-valent pneumococcal vaccines 

• Completed phase 1/2 study for adults1 Pn-MAPS24v, GSK

• Completed phase 1/2 studies for adults, undergoing phase 2 studies 

in infants2

VAX-24, Vaxcyte

21-valent pneumococcal conjugate vaccine V116, Merck

• Completed phase 1/2 study for adults3

• Phase 3 studies in adults are currently ongoing

1. Chichili et al. Vaccine 2022; 2.ClinicalTrials.gov ID: NCT05266456, NCT05297578, and NCT05844423; 3. Platt et al. Lancet ID 2022. 
▪Review evidence on use of 21-valent pneumococcal conjugate 

vaccine (V116) for adults

– Biologics License Application for V116 to the FDA is anticipated in Q4 of 2023, with 

an anticipated FDA approval in the first half of 2024

Next Steps for Pneumococcal Vaccines Work Group
▪ Evidence to support EtR domains including,

– Epidemiology of pneumococcal disease among U.S. adults

– Assessment of pneumococcal disease caused by serotypes not included in V116 (but 

included in existing vaccines)

– Phase 2/3 clinical trial data on V116 among adults

– Feasibility and resource use involved in V116 use among adults

– Health equity considerations

▪Aim to have an ACIP vote on policy options shortly after FDA 

approval of V116

Data to be Reviewed by Work Group
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.

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.

Thank you!