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Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
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Pneumococcal Vaccines
June 2024, ACIP Meeting
June 27, 2024
Pneumococcal Vaccine Work Group Chair
James Loehr, MD, FAAFP
ACIP Members
▪Jamie Loehr (Chair)
▪Sarah Long
▪Robert Schechter
Ex Officio Members
▪Lucia Lee (FDA)
▪Tina Mongeau (FDA)
▪Uzo Chukwuma (IHS)
▪Mamodikoe Makhene (NIH, primary)
▪Meenu Upadhyay (NIH, alternate)
Liaison Representatives
▪Lynn Fisher (AAFP)
▪James Campbell (AAP/COID)
▪Jason Goldman (ACP)
▪David Nace (AGS/AMDA)
▪Cora Hoover (AIM, primary)▪Risa Claytor (HRSA)
▪James McAuley (IDSA)
▪Eva Wong (NACI)
▪Robert Hopkins (NFID, primary)
▪William Schaffner (NFID, alternate)
▪Virginia Caine (NMA)
Consultants
▪Monica Farley (VAMC/Emory)
▪Keith Klugman (BMGF)
▪George Kuchel (UConn)
▪Kathy Poehling (Wake Forest)
▪Arthur Reingold (UC Berkley)
▪Lorry Rubin (CCMC)
▪Richard Zimmerman (U. of Pittsburgh)Pneumococcal Vaccines Work Group
Division of Bacterial Diseases
▪Adam Cohen
▪Ryan Gierke
▪Noele Nelson
Immunization Safety Office
▪Pedro Moro
Immunization Services Division
▪Andrew Leidner
▪Liz VelazquezArctic Investigations Program
▪Marc Fischer
CDC Lead
▪Miwako Kobayashi
GRADE/ EtR consultants
▪Doug Campos -Outcalt
▪Rebecca MorganCDC Contributors and Consultants
051015202530354045
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022Cases per 100,000 population
YearAge <5 Age 19-49
Age 50-64 Age ≥65In 2020 during the COVID -19 pandemic, IPD rates reached a historically
low level in all age groups
PCV13: adultsPCV13: children
4COVID -19
Adapted from Gierke February 2024 ACIP meeting presentationIPD=invasive pneumococcal disease
During 2021 –2023, new pneumococcal conjugate vaccines PCV15
and PCV20 were recommended for both adults and children
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
PCV13=13 -valent pneumococcal conjugate vaccine
PCV15=15 -valent pneumococcal conjugate vaccine
PCV20=20 -valent pneumococcal conjugate vaccine
Adult Pneumococcal Vaccines
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
PCV21
1. U.S. FDA Approves CAPVAXIVE ™ (Pneumococcal 21 -valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults - Merck.com21-valent pneumococcal conjugate vaccine (CAPVAXIVETM, Merck):
•Approved by the FDA for adults aged ≥18 years on June 17, 20241
PCV13=13 -valent pneumococcal conjugate vaccine
PCV15=15 -valent pneumococcal conjugate vaccine
PCV20=20 -valent pneumococcal conjugate vaccine
PPSV23=23 -valent pneumococcal polysaccharide vaccine
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
B1
6
F7
C
PCV15
PCV20
PPSV23
PCV21
Pn-
MAPS24v
VAX -24
VAX -31
1. Chichili et al. Vaccine 2022; 2 .Vaxcyte Completes Enrollment of Phase 2 Study Evaluating VAX -24 for the Prevention of Invasive Pneumococcal Disease (IPD) in Infants - Vaxcyte , Inc. ; 3. Vaxcyte Doses First Participants in Phase 1/2 Clinical Study Evaluating VAX -31 for the
Prevention of Invasive Pneumococcal Disease in Adults - Vaxcyte , Inc. ; Investor Overview (vaxcyte.com) , May 8 202424-valent pneumococcal vaccines:
•Pn-MAPS24v (GSK): Completed phase 1/2 study for adults; Breakthrough Therapy Designation
granted and Phase 3 study in preparation; undergoing phase 2 studies in infants1
•VAX -24 (Vaxcyte ): Completed phase 1/2 studies for adults, completed enrollment for phase 2 studies
in infants2
31-valent pneumococcal vaccine (VAX -31, Vaxcyte ):
•Completed enrollment of phase 1/2 study in adults aged ≥50 years3
1345366
0102030405060708090100Percent IPD
PCV20/ non-PCV21 PCV20 and PCV21
PCV21/ non-PCV20 NVT747388
0102030405060708090100Percent IPD
PCV20/ non-PCV21 PCV20 and PCV21
PCV21/ non-PCV20 NVTProportion of IPD by vaccine -type among adults with a pneumococcal
vaccine indication, 2018−2022
PCV20/ non -PCV21 serotype: 1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F, 15B
PCV20/ in -PCV21 serotypes: 3, 6A, 7F, 19A, 22F, 33F, 8, 10A, 11A, 12F, +6C
PCV21/ non -PCV20 serotypes: 9N, 17F ,20, 15A, 15C, 16F, 23A, 23B, 24F, 31, 35B PCV21:
85% coverage
8PCV20:
54% coveragePCV21:
81% coverage
PCV20:
58% coverage19-64 years old ( with a risk -based indication ) ≥65 years old
Gierke February 2024 ACIP meeting presentation
▪Adults experiencing homelessness (especially Western United States)
•100–300 times higher serotype 4 IPD incidence reported in people experiencing
homelessness (PEH) vs. non -PEH in the Western United States1
▪Adults in Alaska (especially Alaska Native adults)
•88-fold increase in serotype 4 IPD incidence reported in adults in Alaska, 2011 –2018
vs. 2019 –20202 Increase in serotype 4 (included in currently available vaccines,
not in PCV21) IPD reported in certain subpopulations
1. Upsurge of Conjugate Vaccine Serotype 4 Invasive Pneumococcal Disease Clusters Among Adults Experiencing Homelessness in C alifornia, Colorado, and New Mexico | The
Journal of Infectious Diseases | Oxford Academic (oup.com)
2. Invasive Pneumococcal Disease and Potential Impact of Pneumococcal Conjugate Vaccines Among Adults, Including Persons Experie ncing Homelessness —Alaska, 2011 –2020 |
Clinical Infectious Diseases | Oxford Academic (oup.com)Kobayashi February 2024 ACIP meeting presentation
▪The following groups are currently recommended to receive a dose of
pneumococcal conjugate vaccine (PCV):
•Adults aged ≥65 years who have not received a PCV1
•Adults aged 19 –64 years with certain underlying conditions or risk factors2 who
have not received a PCV1
•Certain adults who have received PCV13 but have not received PCV203Current Pneumococcal Vaccine Recommendations for Adults
and Vaccine Coverage
1. Excludes PCV7
2. alcoholism; chronic heart, liver, or lung disease; chronic renal failure; cigarette smoking; cochlear implant; congenital or acquired asplenia; CSF leak; diabetes mellitus; generalized malignancy; HIV infection;
Hodgkin disease; immunodeficiency; iatrogenic immunosuppression; leukemia, lymphoma, or multiple myeloma; nephrotic syndrome; solid organ transplant; or sickle cell disease or other
hemoglobinopathies
3. Adults who have not completed the recommended vaccine series, or shared clinical decision -making for adults aged ≥65 years who h ave completed the recommended vaccine series
Pneumococcal Vaccine for Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices, United S tates, 2023 | MMWR (cdc.gov)
▪Coverage of ≥1 dose of any pneumococcal vaccine
•Adults aged 19 –64 years with risk -based indication: 22.2%
•Adults aged ≥65 years: 65.8%Adults with risk -based vaccine recommendations have lower
vaccine coverage compared with those with age -based
recommendations
Vaccination Coverage among Adults in the United States, National Health Interview Survey, 2021 | CDC
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
2. Should PCV21 be recommended for U.S. adults aged 50 –64 years who
currently do not have a risk -based pneumococcal vaccine indication?
3. Should PCV21 be recommended for U.S. adults aged 19 –49 years who
currently do not have a risk -based pneumococcal vaccine indication?
•Questions 2 and 3 would result in a new age -based recommendation for these groups.Policy Questions Being Considered by the Work Group
ACIP recommends PCV21 as an option for adults aged ≥19 years
who currently have a recommendation to receive a dose of PCV. Proposed Voting Language
13
Introduction Dr. Jamie Loehr (ACIP , WG Chair)
Economic analysis and public health impact of
PCV21 use in adultsDr. Charles Stoecker (Tulane)
Comparison of economic analysis of PCV21 use in
adultsDr. Andrew Leidner (CDC/NCIRD)
Summary of WG interpretation of EtR and policy
options on PCV21 use in adultsDr. Miwako Kobayashi (CDC/NCIRD)
Clinical considerations for PCV21 use in adults Dr. Miwako Kobayashi (CDC/NCIRD)Today’s Session