National Center for Immunization & Respiratory Diseases

Pneumococcal Vaccines

Katherine A. Poehling, MD, MPH

Pneumococcal Vaccines Work Group Chair

Advisory Committee on Immunization Practices

June 25, 2021
Pneumococcal Vaccines Work Group

• ACIP Members • Liaison Representatives and Consultants

- Katherine Poehling (Chair)

- Keipp Talbot

- Sarah Long 

- Lynn Fisher (AAFP)

- Mark Sawyer (AAP/COID)

- Jason Goldman (ACP)

- David Nace (AGS/AMDA)

- Emily Messerli (AIM)

- Oliver Baclic (NACI)

- Carol Baker (IDSA)

- William Schaffner (NFID)

- Virginia Caine (NMA)

- Monica Farley (VAMC/Emory)

- Keith Klugman (BMGF)

- Arthur Reingold (UC Berkley)

- Lorry Rubin (CCMC)

- Cynthia Whitney (Emory)

- Richard Zimmerman (U. of Pittsburgh) 

• Ex Officio Members

- Jeffrey Kelman (CMS)

- Lucia Lee (FDA)

- Tina Mongeau (FDA)

- Thomas Weiser (IHS)

- Kristina Lu (NIH)

• CDC Lead

- Miwako Kobayashi (NCIRD)
Pneumococcal Vaccines Work Group

• CDC Contributors

- Tamara Pilishvili (Respiratory Diseases Branch)

- Ryan Gierke (Respiratory Diseases Branch)

- Jennifer Farrar (Respiratory Diseases Branch)

- Penina Haber (Immunization Safety Office)

- Pedro Moro (Immunization Safety Office)

- Sarah Schillie (Immunization Services Division)

- Marc Fischer (Arctic Investigations Program)

- Jessica MacNeil (ACIP Secretariat) 

• GRADE/EtR consultants

- Doug Campos-Outcalt

- Rebecca Morgan
Current and New Pneumococcal Vaccines 

 Current

– 23-valent pneumococcal polysaccharide vaccine (PPSV23), Merck

– 13-valent pneumococcal conjugate vaccine (PCV13), Pfizer

 New

– 20-valent pneumococcal conjugate vaccine (PCV20), Pfizer

• Licensed for use in adults aged ≥18 years on June 8th1

– 15-valent pneumococcal conjugate vaccine (PCV15), Merck

• BLA filed to FDA, licensure anticipated in July 20212

1. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-prevnar-20tm-pfizers-pneumococcal-20-valent

2. https://www.merck.com/news/u-s-fda-accepts-for-priority-review-the-biologics-license-application-for-v114-mercks-investigational-15-

valent-pneumococcal-conjugate-vaccine-for-use-in-adults-18-years-of-age-and-older/
Current Adult Pneumococcal Vaccine Recommendations

19–64 years ≥65 years

None of the conditions listed below No recommendation PCV13* based on shared 

clinical decision making, 

PPSV23 for all

Chronic medical conditions† (CMC) PPSV23 PCV13* based on shared 

clinical decision making, 

PPSV23 for all

Cochlear implant, CSF leak Both PCV13* and PPSV23 Both PCV13* and PPSV23

Immunocompromising conditions Both PCV13* and PPSV23, 

repeat PPSV23 after 5 years

Both PCV13* and PPSV23

PCV13: 13-valent pneumococcal conjugate vaccine

PPSV23: 23-valent pneumococcal polysaccharide vaccine

*If not previously given; †Examples include alcoholism, chronic heart/liver/lung disease, diabetes, cigarette smoking

https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf
Current Adult Pneumococcal Vaccine Recommendations (simplified)

19–64 years ≥65 years

None of the conditions listed below No recommendation

PCV13* based on 

shared clinical decision 

making, PPSV23 for all Chronic medical conditions† (CMC) PPSV23

Cochlear implant, CSF leak

Immunocompromising conditions PCV13-PPSV23 series

PCV13: 13-valent pneumococcal conjugate vaccine

PPSV23: 23-valent pneumococcal polysaccharide vaccine

*If not previously given; †Examples include alcoholism, chronic heart/liver/lung disease, diabetes, cigarette smoking

https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf
Guiding Principles Proposed by the Work Group

• Decisions on policy options should be supported by best-available evidence

• Simplification of pneumococcal vaccine recommendations, which might improve 

uptake

• Disparities in pneumococcal disease burden and vaccine coverage should be 

reduced 

• Timely recommendations for each new vaccine should be made after FDA 

licensure
Overarching Policy Questions Under Consideration by the Work Group

• Should PCV15 be routinely recommended in adults aged ≥50 or ≥65 years?

• Should PCV15 be recommended in younger adults with underlying medical 

conditions?

• Should PCV20 be routinely recommended in adults aged ≥50 or ≥65 years?

• Should PCV20 be recommended in younger adults with underlying medical 

conditions?

• Should recommendations be made for PCV15 and PCV20 alone or in series with 

PPSV23?
Policy Options for Cost-Effectiveness Analysis

The following 8 strategies were compared to the current pneumococcal vaccine 

recommendations.

Age 19–64 years with underlying conditions All aged ≥65 years

Strategy a PCV15 PCV15

Strategy b PCV20 PCV20

Strategy c PCV15+PPSV23 PCV15+PPSV23

Strategy d PCV20+PPSV23 PCV20+PPSV23

Age 19–49 years with underlying conditions All aged ≥50 years

Strategy a PCV15 PCV15

Strategy b PCV20 PCV20

Strategy c PCV15+PPSV23 PCV15+PPSV23

Strategy d PCV20+PPSV23 PCV20+PPSV23
Policy Options for Cost-Effectiveness Analysis

After reviewing the results of the cost-effectiveness analysis and estimated public health 

impact from each policy option, the Work Group focused on the following 4 options.

Age 19–64 years with underlying conditions All aged ≥65 years

Strategy a PCV15 PCV15

Strategy b PCV20 PCV20

Strategy c PCV15+PPSV23 PCV15+PPSV23

Strategy d PCV20+PPSV23 PCV20+PPSV23

Age 19–49 years with underlying conditions All aged ≥50 years

Strategy a PCV15 PCV15

Strategy b PCV20 PCV20

Strategy c PCV15+PPSV23 PCV15+PPSV23

Strategy d PCV20+PPSV23 PCV20+PPSV23
Grading of Recommendations, Assessment, Development and Evaluation 

(GRADE)

 PCV15 and PCV20

– New vaccines under consideration

– Licensure based on non-inferior immunogenicity compared to current 

vaccines (PCV13, PPSV23 for non-PCV13 serotypes)

– Currently no data on efficacy against clinical outcomes

 PCV13 and PPSV23

– Data on efficacy/effectiveness against disease outcomes available

PCV13 and PPSV23 data reviewed for background, 

GRADE based on PCV15 and PCV20 immunogenicity studies
Today’s Pneumococcal Vaccines Session Outline

Introduction Dr. Katherine Poehling 

(ACIP, WG Chair)

Updates on epidemiology of pneumococcal disease in U.S. adults Mr. Ryan Gierke 

(CDC/NCIRD)

Cost effectiveness of PCV15 and PCV20 use in U.S. adults Dr. Charles Stoecker 

(Tulane)

GRADE for age-based PCV15 and PCV20 use in U.S. adults Ms. Jennifer Farrar 

(CDC/NCIRD)

EtR summary of age-based PCV15 and PCV 20 use in U.S. adults Dr. Miwako Kobayashi 

(CDC/NCIRD)

Summary and Timeline Dr. Miwako Kobayashi 

(CDC/NCIRD)
October 

‘20 ACIP

February 

‘21 ACIP

June ‘21 

ACIP

October 

‘21 ACIP

Initial Proposed Timeline of ACIP Presentations

Presentation on:

• Epidemiology of current 

U.S. pneumococcal 

disease

• New vaccine products 

and summary of phase 

3 study results

• Policy question(s) 

proposed by the WG

Presentation on:

• Cost-effectiveness 

analysis

• EtR/GRADE

Vote (if licensed)
June ‘21 

ACIP

Sept ‘21 

ACIP

October 

‘21 ACIP

Proposed Timeline of ACIP Presentations

Presentation on:

• Cost-effectiveness 

analysis and public 

health impact

• GRADE/EtR for use of 

PCV15/20 in older 

adults

Vote on 

recommendations 

for all newly 

licensed vaccines

Presentation on:

• Comparison of costeffectiveness analyses

• GRADE/EtR for use of 

PCV15/20 in adults 

with underlying 

conditions