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Pneumococcal Vaccines
October 2024, ACIP Meeting
October 23, 2024
Pneumococcal Vaccines Work Group Chair
James Loehr, MD, FAAFPNational Center for Immunization and Respiratory Diseases
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Pneumococcal Vaccines Work Group
ACIP Members
Jamie Loehr
Mini Kamboj
George Kuchel
Robert Schechter
Ex Officio Members
Lucia Lee
Tina Mongeau
Uzo Chukwuma
Mamodikoe Makhene
Meenu Upadhyay
Risa Claytor
Liaison Representatives
Lynn Fisher
Monica Ardura
Jason Goldman(Chair)
(FDA)
(FDA)
(IHS)
(NIH, primary)
(NIH, alternate)
(HRSA)
(AAFP)
(AAP/COID)
(ACP , primary)Saba Hasan
David Nace
Cora Hoover
James McAuley
Eva Wong
Robert Hopkins
William Schaffner
Virginia Caine
Mary Hayney
Consultants
Monica Farley
Keith Klugman
Kathy Poehling
Arthur Reingold
Lorry Rubin
Richard Zimmerman(ACP , alternate)
(AGS/ PALTmed )
(AIM)
(IDSA)
(NACI)
(NFID, primary)
(NFID, alternate)
(NMA)
(APhA )
(Emory)
(Gates Foundation)
(Wake Forest)
(UC Berkeley)
(CCMC)
(U of Pittsburgh)
CDC Contributors and Consultants
CDC Lead
•Miwako Kobayashi
Division of Bacterial Diseases
•Emma Accorsi
•Alison Albert
•Adam L. Cohen
•Ryan Gierke
•Shelby Miller
•Noele Nelson
•Wei Xing
Arctic Investigations Program
•Marc FischerImmunization Safety Office
•Tarayn Fairlie
•Julianne Gee
•Pedro Moro
•John Su
Immunization Services Division
•Sofia Bletnitsky
•Andrew Leidner
•Liz Velazquez
GRADE/ EtR consultants
•Doug Campos -Outcalt
•Rebecca Morgan
Currently Recommended Adult Pneumococcal Vaccines
1. U.S. FDA Approves CAPVAXIVE
(Pneumococcal 21 -valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults - Merck.com1 3 4 5 6
A6
B7
F9
V1
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C1
9
A1
9
F2
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F2
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F3
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F8 1
0
A1
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F1
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B2 9
N1
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B
PCV15
PCV20
PPSV23
PCV21
21-valent pneumococcal conjugate vaccine (CAPVAXIVETM, Merck):
•Approved by the FDA for adults aged ≥18 years on June 17, 20241
PCV15=15 -valent pneumococcal conjugate vaccine
PCV20=20 -valent pneumococcal conjugate vaccine
PCV21=21 -valent pneumococcal conjugate vaccine
PPSV23=23 -valent pneumococcal polysaccharide vaccine
1345366
0102030405060708090100 Percent IPD
PCV20/ non-PCV21 PCV20 and PCV21
PCV21/ non-PCV20 NVT747388
0102030405060708090100 Percent IPD
PCV20/ non-PCV21 PCV20 and PCV21Proportion 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
5PCV20:
54% coveragePCV21:
81% coverage
PCV20:
58% coverage19-64 years old ( with a risk -based indication ) ≥65 years old
Gierke February 2024 ACIP meeting presentation
New Adult Pneumococcal Vaccines in Advanced Stages of Development
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. VAX-31 Phase ½ Study
Topline Results in Adults Aged 50 and Older. September 3, 20241 3 4 5 6
A6
B7
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V1
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8
C1
9
A1
9
F2
3
F2
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F3
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F8 1
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B7
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PCV15
PCV20
PPSV23
PCV21
Pn-
MAPS24v
VAX -24
VAX -31
24-valent pneumococcal vaccines:
•Pn-MAPS24v (GSK): Completed phase 1/2 study for adults; Breakthrough Therapy Designation granted and
next steps in preparation; undergoing phase 2 studies in infants1
•VAX-24 (Vaxcyte ): Completed enrollment for phase 2 studies in infants2; topline results anticipated in 2025
31-valent pneumococcal vaccine (VAX -31, Vaxcyte ):
•Reported topline results of phase 1/2 study in adults aged ≥50 years3; plan to initiate phase 3 pivotal non -
inferiority study by mid-2025
•Plans to initiate VAX -31 Infant Phase 2 Study in Q1 of 2025 following IND submission and clearance
Adults 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
PCV203
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 m yeloma; 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) 7
PCV21 is unique from other PCVs in that it was
developed to target adult disease
•PCV21 was developed to target pneumococcal serotypes that commonly
cause disease in adults.
•The manufacturer currently does not have plans to seek an indication for
routine PCV21 use in infants.
•The manufacturer will seek an indication for use of PCV21 in children aged
2–18 years with a risk condition for which there is a phase 3 trial currently
in progress.*
-PCV7 and PCV13 provided indirect protection against vaccine serotypes when
used in children.
-We do not expect PCV21 to offer similar indirect protection from its additional
serotypes.
*NCT06177912 8
Summary of Work Group (WG) discussion presented
at the June 2024 ACIP meeting
•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 majority of WG members believed there was insufficient evidence
presented to support lowering the age -based recommendation for other
recommended PCVs (i.e., PCV15, PCV20).
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Requests from the Committee to the WG at the June
ACIP meeting
•Present summary of data on whether age -based recommendation for
pneumococcal vaccines should be lowered to age ≥50 years for all PCVs
(not just PCV21) at the October ACIP meeting
-Voting members felt that there were not enough data to make a decision on PCVs
other than PCV21
-Anticipating implementation challenges by having different age -based
recommendations by vaccine
•Request to also consider discontinuing the recommendation for PPSV23
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PICO for WG discussion through October 2024
CMC=chronic medical conditions (i.e., alcoholism; chronic heart disease, including congestive heart failure and cardiomyopath ies; chronic liver disease; chronic lung disease, including
chronic obstructive pulmonary disease, emphysema, and asthma; cigarette smoking; or diabetes mellitus); IC=immunocompromising condition(i.e., chronic renal failure, nephrotic
syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, HIV infection, Hodgkin disease, leukemia, l ymp homa, multiple myeloma, solid organ transplant,
congenital or acquired asplenia, or sickle cell disease or other hemoglobinopathies). Those with a cerebrospinal fluid leak a nd a cochlear implant are also included among those with a
risk-based vaccine indication.Policy question: Should a single dose of pneumococcal conjugate vaccine (PCV) be recommended
for all PCV -naïve adults aged 50 –64 years?
Population PCV-naïve adults aged 50 –64 years in the United States
Intervention One dose of PCV15*, PCV20, or PCV21
*In series with PPSV23
Comparison Current risk -based vaccine recommendation (CMC or IC)
Outcomes Vaccine type (VT) -invasive pneumococcal disease, VT -non-bacteremic pneumococcal
pneumonia, VT -pneumococcal mortality, serious adverse events
Initial Policy Options Considered by the WG
1. Lower the age -based recommendation for all PCVs to age ≥50 years
2. Lower the age -based recommendation for all PCVs to age ≥60 years or
age ≥55 years
3. Lower the age -based recommendation to age ≥50 years for PCV21 only
4. Shared clinical decision -making for PCV use for adults aged 50 –64 years
who currently do not have a risk -based vaccine indication
5. Status quo (i.e., age -based at age ≥65 years, risk -based for younger
adults)
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Primary Options Considered by the WG
1. Lower the age -based recommendation for all PCVs to age ≥50 years
Lower the age -based recommendation for all PCVs to age ≥60 years (or age
≥55 years)
3. Lower the age -based recommendation to age ≥50 years for PCV21 only
Shared clinical decision -making for PCV use for adults aged 50 –64 years who
currently do not have a risk -based vaccine indication
5. Status quo (i.e., age -based at age ≥65 years, risk -based for younger
adults)
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Final recommendation of the WG
1. Lower the age -based recommendation for all PCVs to age ≥50 years
- Majority supported this option after targeted discussion of the policy question
- Future booster dose may be needed to avoid increased pneumococcal disease
burden in older adults
- Key uncertainties remain:
• Indirect effects from new pediatric pneumococcal vaccines
• Duration of protection from adult vaccination
• Impact of new higher -valency vaccines for adults
Lower the age -based recommendation for all PCVs to age ≥60 years (or age
≥55 years)
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Key factors in the WG recommendations
1. Health equity: Higher pneumococcal disease rates in Black/African American adults,
with earlier peak
2. Risk prevalence: 33 –54% of adults aged 50 –64 years already with indication for risk -
based pneumococcal vaccination*
3. Vaccine coverage: Age -based recommendation likely to improve uptake vs. risk -
based recommendation
4. Simplicity: Easier to implement uniform recommendation across all PCVs
5. Economic consideration: PCV21 at age 50 (and 65 years) had lower cost/QALY
gained than PCV20 , while both PCV21 and PCV20 improved health outcomes
6. Serotype coverage: the serotype compositions of PCV20 and PCV21 are quite
different
*Data is for adults with any of the following condition and is not an exhaustive list of conditions: chronic heart disease, c hronic lung disease, chronic liver disease, diabetes, smoking,
alcoholism, weakened immune system due to prescriptions, weakened immune system due to health condition, solid cancer (not in cluding non -melanoma skin cancer or unknown type
of skin cancer) and blood cancer. Source NHIS 2020.
†Except for In certain adult populations in the western United States where high percentages (i.e., ≥30%) of IPD caused by se rotype 4 have occurred15
Today’s Session
16Introduction Dr. Jamie Loehr (ACIP , WG Chair)
Economic Analysis and public health impact
of PCV use for adults aged ≥50 yearsDr. Charles Stoecker (Tulane)
Summary of economic analyses of PCV use
in adults aged ≥50 yearsDr. Andrew Leidner
(CDC/NCIRD)
Summary of WG Interpretation of EtR and
policy options on PCV use in adults aged
≥50 yearsDr. Miwako Kobayashi
(CDC/NCIRD)
Clinical considerations for PCV use in adultsDr. Miwako Kobayashi
(CDC/NCIRD)