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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 VelazquezArctic Investigations Program
▪Marc Fischer
CDC Lead
▪Miwako Kobayashi
GRADE/ EtR consultants
▪Doug Campos -Outcalt
▪Rebecca MorganCDC Contributors and Consultants
History of ACIP Pneumococcal Vaccine Recommendations
through 2019
1984PPSV23 :Adults aged
≥65 years and
individuals with
underlying conditions
2000 2010 2019 2014 2012
PCV7 :Children PCV13 :Children
(replaced PCV7)PCV13 :Adults with
immunocompromising
conditions in addition
to PPSV23PCV13 :All adults aged
≥65 years in addition
to PPSV23PCV13 :based on SCDM
for adults aged ≥65
years; routine PPSV23
recommendation
SCDM: shared clinical decision -making
Recent ACIP Pneumococcal Vaccine Recommendations,
2021 –2023
2021 2023 2022
PCV15 :ChildrenPCV20 :Expanded
indication for adults
who previously
received PCV13
PCV20 :ChildrenPCV15 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 children3,4Pneumococcal 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 amon g 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 2 023 | 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 surveillancePCV13: 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
A6
B7
F9
V1
41
8
C1
9
A1
9
F2
3
F2
2
F3
3
F8 1
0
A1
1
A1
2
F1
5
B2 9
N1
7
F2
01
5
A1
5
C1
6
F2
3
A2
3
B2
4
F3
13
5
B
PCV15
PCV20
PPSV23
Pn-
MAPS24v20
B
VAX -2420
B
V11620
A
24-valent pneumococcal vaccines
•Completed phase 1/2 study for adults1Pn-MAPS24v, GSK
•Completed phase 1/2 studies for adults, undergoing phase 2 studies
in infants2VAX -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 2024Next 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 V116Data 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!