01 Pneumococcal Loehr 508

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Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
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Pneumococcal Vaccines
February 2024, ACIP Meeting
February 29, 2024
Pneumococcal Vaccine Work Group ChairJames Loehr, MD, FAAFP
ACIP Members
Jamie Loehr  (Chair, acting)
Sarah Long 
Ex Officio Members
Jeffrey Kelman  (CMS)
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)
Kathy Poehling         (Wake Forest)
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
Invasive pneumococcal disease incidence reached a historically low level 
early in the COVID -19 pandemic but is returning toward pre -COVID 
levels
IPD=invasive pneumococcal disease; 2022 data in gray are preliminary
ABCs Bact  Facts Interactive Data Dashboard | CDC

Around the same time, 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
Additional Pneumococcal Vaccines in Advanced Stages of Development
1 3 4 5 6
A6B7 F9V1418C19A19F23F22F33F8 1
0
A11
A1
2F15B2 9N17F2015A15C16F23A23B24F3135B
PCV15
PCV20PPSV23
Pn-
MAPS24v20
B
VAX -2420B
V11620
A
1. Chichili  et al. Vaccine 2022; GSK Pipeline assets and clinical trials appendix Q4 2023  2. Wassil et al. Lancet ID 2023, ClinicalTrials.gov ID: NCT05297578, and NCT05844423; 3. FDA Grants Priority Review to Merck’s 
New Biologics License Application for V116, an Investigational, 21- valent Pneumococcal Conjugate Vaccine Specifically Designed t o Protect Adults -  Merck.com . 24-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, undergoing phase 2 studies in infants2
21-valent pneumococcal conjugate vaccine (V116, Merck):
• BLA accepted by the FDA for priority review3
25-valent  pneumococcal vaccine candidate (IVT PCV -25, Iventprise )
•Completed Phase 2 dose ranging  study in young adults1
31-valent  pneumococcal conjugate vaccine candidate (VAX- 31, Vaxcyte )
•Completed enrollment of Phase 1/2 study in adults aged ≥50 years2Additional Pneumococcal Vaccines Under Development
1. Inventprise  Completes Vaccination of Participants in a Phase 2 Dose Ranging Study of its 25 Valent Pneumococcal Vaccine Candidate –  Inventprise
2. Vaxcyte  Completes Enrollment of Phase 1/2 Study Evaluating VAX- 31 for the Prevention of Invasive Pneumococcal Disease (IPD) in Adults Aged 50 and Older - Vaxcyte , Inc.
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 PCV203 Current 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
• U.S. adults aged 19– 64 years with a risk condition, who have never received a PCV
• U.S. adults aged ≥19 year who have received a PCV (i.e., PCV7, PCV13, or PCV15), but have not completed the recommended series
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 
Considering:
Additional pneumococcal vaccines for adults are currently under investigation and 
may be approved in the near future, and  
Dynamic changes in pneumococcal disease incidence are anticipated post -COVID -19 
and with increased uptake in PCV15/PCV20 in children and adults
 
1. Do you have any feedback on the policy questions being considered by the WG?2. What additional data would be helpful to inform the discussions on PCV21 use in 
adults? Questions for the Committee
Introduction Dr. Jamie Loehr (ACIP , WG Chair)
Current epidemiology of invasive pneumococcal 
disease among adults in the United StatesMr. Ryan Gierke (CDC, NCIRD)
Interim results from the Pneumococcal pNeumonia  Epidemiology, Urine serotyping, and 
Mental Outcomes (PNEUMO) US studyDr. Wesley Self (Vanderbilt University Medical Center)
Phase 3 clinical trial data of PCV21 Dr. Heather Platt
Post -licensure PCV20 safety dataDr. Pedro Moro (CDC/NCEZID)Dr. Richard Forshee  (FDA)
Preliminary WG interpretations of EtR and Next 
StepsDr. Miwako Kobayashi (CDC, NCIRD)Today’s Session