07 COVID Stokely 508

COVID -19 Vaccine Implementation
Shannon Stokley, DrPH
Deputy Director for Science Implementation
Immunization Services Division
National Center for Immunizations and Respiratory Diseases (NCIRD)
June 2024National Center for Immunization and Respiratory Diseases

2023 -2024 COVID -19 Vaccination Coverage
Percentage of Children Ages 6 Months –17 Years Who Are Up to Date with
the 2023-2024 COVID-19 Vaccine, NIS-CCM and NIS-FLU
As of May 11,
2024,
vaccination
coverage
among children
was 14.4% .
Data source, National Immunization Survey —COVID Child Module (NIS -CCM) and National Immunization Survey —Flu (NIS -Flu):
https://www.cdc.gov/vaccines/imz -managers/coverage/covidvaxview/interactive/children -coverage -vaccination.html
COVID -19 Vaccination Status Among Children Ages 6 Months –17 Years by
Demographics, NIS -FLU, May 5 –May 11, 2024 (n=2,950)
By age group:
• Vaccination coverage increased with
increasing age.
By race and ethnicity:
•Vaccination coverage was highest among
white, non-Hispanic children (15.2%) and
lowest among Black, non-Hispanic
children (10.9%).
Data source: National Immunization Survey – Flu Module  About the National Immunization Surveys | CDC
COVID -19 Vaccination Status Among Children Ages 6 Months –17 Years by
Demographics, NIS-FLU, May 5 –May 11, 2024 (n=2,950)
By urbanicity:
• Vaccination coverage was lowest in rural
areas (8.4%).
By household income:
•Vaccination coverage was highest among
households with an income greater than
$75k (18.0%) and lowest among
households with an income lower than
$75k (9.4-11.3%).
Data source: National Immunization Survey – Flu Module  About the National Immunization Surveys | CDC
Percentage of Adults ≥18 Years Who Are Up to Date with the
2023 -2024 COVID-19 Vaccine, NIS-ACM
Data source: https://www.cdc.gov/vaccines/imz -managers/coverage/covidvaxview/interactive/adult -coverage -vaccination.html  As of May 11,
2024,
vaccination
coverage
among adults
was 22.5% .
COVID- 19 Vaccination Status Among Adults Age ≥18 Years by
Demographics, NIS-ACM, April 28-May 25, 2024 (n=47,953)
Vaccinated with 2023-24 COVID-19 vaccine18.016.017.715.321.323.520.317.521.023.211.814.518.923.535.436.019.722.8
0.0 20.0 40.0 60.0 80.0 100.0AI/ANMulti/OtherNH/OPIHispanicBlackWhiteAsianRuralSuburbanUrban18-2930-3940-4950-6465-7475+MaleFemale
Weighted % (95% CI)28.921.324.821.118.216.519.625.910.722.6
0.0 20.0 40.0 60.0 80.0 100.0Transgender/NonbinaryCisgenderGay/Lesbian/Bisexual/OtherStraightIncome unknownBelow povertyAbove poverty, <$75KAbove poverty, ≥$75KNot insuredInsured
Weighted % (95% CI)
AI/AN: American Indian or Alaska Native; NH/OPI: Native Hawaiian or Other Pacific Islander
Data source: National Immunization Survey – Adult COVID Module About the National Immunization Surveys | CDC
COVID -19 vaccination coverage among adults ≥18 years of age,
NIS-ACM, 2022-23* and 2023- 24
Updated 2023 -24 COVID -19 vaccination coverage as of May 25 , 2024, is 5.1 percentage points below the 2022 -23
bivalent vaccine peak coverage of 27.5%.
*
Provider Recommendation for COVID -19
Vaccine
39.9%
21.3%
2021 August
(7 mo. after vaccine
available)2024 May
(8 mo. after updated
vaccine available)Healthcare provider COVID -19 vaccine
recommendations, NIS -ACM
Relative to 2021,
adults reported
fewer providers
are recommending
COVID -19
vaccines .Percent of adults whose healthcare
provider recommends COVID-19 vaccine
Data source: National Immunization Survey – Adult COVID Module About the National Immunization Surveys | CDC
Percent of Adults ≥18 Years of Age Who Reported Receiving Any Kind of
COVID-19 Vaccine Recommendation Since September 14, 2023, by Age Group,
Provider Recommendation Survey, April 12-25, 2024 (N=3,004)
66.873.4
020406080100
Received any recommendationWeighted % (95% confidence interval)Age 18 -64 Age 65+
18.240.7
15.522.1
020406080100
Received recommendation through
conversation with provider/office
(N=2,984)Received recommendation through
conversation with pharmacist/pharmacy
(N=3,010)Weighted % (95% confidence interval)Age 18 -64 Age 65+Percent of Adults ≥18 Years of Age Who Reported Receiving Active* COVID -
19 Vaccine Recommendation Since September 14, 2023,† by Age Group,
Provider Recommendation Survey, April 12-25, 2024
*"Active recommendation" was defined as a provider, nurse/MA, pharmacist, or pharmacy technician/assistant mentioning the COVID -19 vaccine in person or during a telehealth visit, or a
personal phone call from a provider or pharmacist/pharmacy.  “Passive recommendation" was defined as provider office reception staff mentioning the vaccine, seeing a sign at a provider
office or pharmacy, or receiving written information in person, an email, text message, automated phone call or voice message , or portal/app message from a provider office or pharmacy.
 †The denominator for these estimates includes all respondents who answered the questions and was not limited to those who repo rted visiting a provider during the respiratory virus
season.
Percent of Adults ≥18 Years of Age Who Reported Receiving COVID -19 Vaccine Offer,
Referral , or Recommendation at In -Person Visit  Since September 14, 2023 ,* by Age
Group, Provider Recommendation Survey, April 12 -25, 2024
*The denominator for these estimates was restricted to those who reported they had an in person visit to a provider since September 14, 2023.23.231.4
12.924.145.158.3
020406080100
Received offer (in office)
(N=1,984)Received referral (in office)
(N=1,980)Received recommendation (in office)
(N=1,987)Weighted % (95% confidence interval)Age 18 -64 Age 65+
41.641.546.4
41.440.439.2
33.3 31.030.7
14.717.3 16.4
13.319.3 19.127.232.0
22.2
020406080100
Protects me and loved ones Addressed concerns Negative effects of getting COVID -19
Especially important for you Personal/anecdotal experience None of the aboveWeighted % (95% confidence interval)Provider (N=531) Nurse/MA (N=265) Pharmacist (N=258)Topics Mentioned When Discussing Updated COVID -19 Vaccine with
Provider, Nurse/MA , or Pharmacist, Reported by Adults ≥18 Years of Age,
Provider Recommendation Survey, April 12 -25, 2024
Data source: “Provider Recommendation Survey”. 3,041 U.S. adults ages 18 years and older surveyed April 12 -25, 2024, via NORC’s probability -based AmeriSpeak  Panel . Data were weighted
to represent the non -institutionalized U.S. population and mitigate possible non -response bias. All responses are self -reported.
Association of Provider Offer, Active* vs Passive Recommendation for COVID -19
Vaccine Since September 14, 2023, with Vaccination Among Adults ≥18 Years of Age,
by Age Group, Provider Recommendation Survey, April 12 -25, 2024
*"Active recommendation" was defined as a provider, nurse/MA, pharmacist, or pharmacy technician/assistant mentioning the COV ID-19 vaccine in person or during a telehealth visit, or a personal phone call from
a provider or pharmacist/pharmacy.  “Passive recommendation" was defined as provider office reception staff mentioning the vaccine, seeing a sign at a provider o ffice or pharmacy, or receiving written information
in person, an email, text message, automated phone call or voice message, or portal/app message from a provider office or pha rmacy.
Data source: “Provider Recommendation Survey”. 3,041 U.S. adults ages 18 years and older surveyed April 12 -25, 2024, via NORC’s probability -based AmeriSpeak  Panel . Data were weighted to represent the non -
institutionalized U.S. population and mitigate possible non -response bias. All responses are self -reported.46.2%
29.1%
20.5%
11.3%
0 20 40 60 80No offer or
recommendation
(N=738)Not offered, received
ONLY passive rec
(N=750)Not offered, received
active rec
(N=413)Offered vaccine
by provider
(N=368)
Weighted % (95% confidence interval)Age 18 -64 (N=2,269)
51.8%
62.5%
46.9%
19.7%
0 20 40 60 80No offer or
recommendation
(N=177)Not offered, received
ONLY passive rec
(N=152)Not offered, received
active rec
(N=206)Offered vaccine
by provider
(N=171)
Weighted % (95% confidence interval)Age 65+ (N=706)
Frequency of recommending COVID -19 vaccination to
eligible adult patients

 Most providers reported recommending the COVID -19 vaccine to adults most
of the time or always.
11.8%14.6%
7.4%40.0%
26.3%
0%20%40%60%80%100%% of respondents selecting
response option (n=433)
Never Sometimes Half the time Most of the time Always11.7%14.0%
8.2%40.6%
25.4%
0%20%40%60%80%100%% of respondents selecting
response option (n=342)
Never Sometimes Half the time Most of the time AlwaysAdults ages 18 –64 years Adults ages 65 years and older
Data source: HaPPI  Survey Collaborative, University of Iowa; RAND Corporation; CDC
Reasons reported for NOT recommending COVID -19
vaccine to eligible adult patients (18 –64 years )
Data source: HaPPI Survey Collaborative, University of Iowa; RAND Corporation; CDC48.0%
36.6%
35.4%
22.3%
22.0%
16.3%
14.9%
14.6%
13.9%
10.9%
10.6%
9.7%
8.9%
8.7%
5.9%
5.9%
4.5%
1.2%0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
The patient will refuse vaccination
They have a medical reason for not getting vaccinated
Patients are tired of hearing about COVID-19 vaccines
Patients are tired of hearing about vaccines in general
Other recommended vaccines for this age group are a bigger priority for me
Relatively high COVID-19 vaccine hesitancy for this age group in my community
The patient has concerns about their out-of-pocket vaccination cost
There isn’t enough time during a visit to discuss COVID -19 vaccines
Patients in this age group are unlikely to experience severe COVID-19 symptoms
Recommending COVID-19 vaccination could increase general vaccine hesitancy
There isn’t enough time during a visit to vaccinate
Other
Vaccination provides insufficient additional COVID-19 protection for this age group
If the patient is pregnant or trying to become pregnant
Vaccination doesn’t reduce COVID -19 severity for this age group
Vaccination is unnecessary for this age group if prior COVID-19 Hx
Patients in this age group are unlikely to get COVID-19
The COVID vaccine is unsafe for patients in this age group% of respondents selecting response option (n=404)
Frequency of recommending on -site COVID -19
vaccination to eligible pediatric patients
Approximately the same proportion of providers reported recommending the
vaccine sometimes, most of the time, and always.
16.7%25.5%
4.9%23.8% 24.7%
4.4%11.2%27.4%
7.1%26.0% 24.4%
3.6%10.4%25.8%
6.9%27.7% 28.2%
0.6%
0%20%40%60%80%100%
Never Sometimes Half the time Most of the time Always Don't see age
group% of respondents selecting
response option (n=365)
6 months-4 years 5-11 years 12-17 years
Data source: HaPPI Survey Collaborative, University of Iowa; RAND Corporation; CDC
Reasons reported for NOT recommending COVID -19
vaccine to eligible pediatric patients
Data source: HaPPI  Survey Collaborative, University of Iowa; RAND Corporation; CDC39.1%
37.4%
36.8%
36.5%
32.8%
22.3%
22.3%
21.2%
17.1%
15.1%
9.9%
9.6%
9.3%
7.0%
6.7%
5.8%
5.5%
2.9%0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Relatively high COVID-19 vaccine hesitancy for this age group in my community
The parent will refuse to have their child vaccinated
Other recommended vaccines for this age group are a bigger priority for me
The parent will be hesitant about having their child vaccinated
Parents are tired of hearing about COVID-19 vaccines
They have a medical reason for not getting vaccinated
Patients in this age group are unlikely to experience severe COVID-19 symptoms
Parents are tired of hearing about vaccines in general
COVID-19 vaccine recommendation could increase general vaccine hesitancy
There isn’t enough time during a visit to discuss COVID -19 vaccine concerns
The parent has concerns about their out-of-pocket vaccination cost
Vaccination provides insufficient additional COVID-19 protection for this age group
Other
Vaccination doesn’t reduce COVID -19 severity for this age group
There isn’t enough time during a visit to administer the vaccine
Vaccination is unnecessary for this age group if prior COVID-19 Hx
Patients in this age group are unlikely to get COVID-19
The COVID vaccine is unsafe for patients in this age group% of respondents selecting response option (n=345)
2024 -2025 COVID -19 Vaccine
Implementation
Prospective 2024 COVID -19 vaccine timeline
Apr May Aug Jul Jun Jan Dec Nov Oct Sept
WHO
Technical Advisory
Group on COVID- 19
Vaccine Composition
Recommendation:
Monovalent JN.1
lineage (4/15- 16)ACIP votes on
proposed
recommendations
(6/26–28)*FDA
Advises: Monovalent JN.1
lineage; KP .2, if feasible  Vaccine available to ship
(Potentially mid -Aug to late -Sept
contingent on FDA
authorizations/approvals)
Providers administer vaccine
(Orders anticipated in offices 1-2 weeks
after FDA action)
*CDC publishes MMWR policy note following ACIP and FDA action (potentially late August to late September).
**CDC updates COVID -19 Vaccine Interim Clinical Considerations immediately following FDA action.
•Similar to the 2023 -2024 season, CDC plans to approach the 2024 -2025
fall/winter respiratory season comprehensively.
-CDC will develop and deliver clinical education materials, tools, and training to
increase provider knowledge.2024 -25 respiratory virus vaccine program
Goal: To help prevent disease, disability, and
death from COVID-19, influenza, RSV, and other
respiratory diseases.

•The Affordable Care Act (ACA) requires insurers to cover most ACIP -
recommended vaccines without cost sharing by the next coverage year.1
•Section 3203 of the Coronavirus Aid, Relief, and Economic Security
(CARES) Act expedites coverage of COVID -19 vaccines beyond that which
is required of most preventive services.2Insurance plans will cover the 2024 -2025 COVID -19 vaccines
immediately
1. 42 U.S. Code § 300gg –13 - Coverage of preventive health services. https://www.law.cornell.edu/uscode/text/42/300gg -13
2. FAQs about Affordable Care Act Implementation Part 50: https://www.dol.gov/sites/dolgov/files/EBSA/about -ebsa/our -activities/resource -center/faqs/aca -part -50.pdf
•COVID -19 vaccines are covered under Medicare without cost -sharing.
•Most Medicaid beneficiaries have access to COVID -19 vaccines without cost -sharing.
•Inflation Reduction Act, passed in August 2022, includes key provisions:
-Eliminates cost -sharing for all ACIP -recommended vaccines under Medicaid and Medicare Part D
equivalent plans
-Expanded coverage of all ACIP -recommended vaccines without cost -sharing to adult Medicaid
beneficiaries
-Guarantees that nearly 50 million Medicare beneficiaries and more than 80 million Medicaid
beneficiaries will have access to all vaccines recommended by ACIP without cost -sharingIndividuals with Medicare and Medicaid will also have
access to COVID -19 vaccines at no cost
https://www.dol.gov/agencies/ebsa/about -ebsa/our -activities/resource -center/faqs/aca -part -58
https://www.healthcare.gov/coronavirus/
•Eligibility: Children 0 through 18 years of age who meet at least one of the
criteria:
-Medicaid eligible
-Uninsured, or
-American Indian/Alaska Native, or
-Underinsured*Eligible children can receive COVID -19 Vaccines at no cost
through the Vaccines for Children (VFC) Program
*Eligible to receive vaccine only through an enrolled Federally Qualified Health Center (FQHC), Rural Health Center (RHC) or a deputized provider under Delegation of Authority
https://www.cdc.gov/vaccines/programs/vfc/providers/index.html
•CDC’s Bridge Access Program has provided free COVID -19 vaccines to
adults without health insurance and adults whose insurance does not
cover all COVID -19 vaccine costs during the 2023 -2024 season.
•Due to the Congressional funding recissions, the Bridge Access Program
will sunset in August 2024, and will not be available to cover the 2024 -
2025 COVID -19 vaccine.COVID -19 Bridge Access Program
•Once 2024 -2025 COVID -19 vaccines become widely available,
Vaccines.gov will operate as a search tool to help people find
pharmacies near them.
•Users must verify vaccine availability for themselves. Pharmacy contact
information will be provided in the search results for that purpose, as
well as for users to inquire about appointments.Vaccines.gov
For more information, contact CDC/ATSDR
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov           www.atsdr.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 and the Agency for Toxic Substances and Disease Registry.
Thank you

Summary: COVID -19 Vaccine Implementation Shannon Stokley, DrPH Deputy Director for Science Implementation Immunization Services Division National Center for Immunizations and Respiratory Diseases (NCIRD) June 2024National Center for Immunization and Respiratory Diseases  2023 -2024 COVID -19 Vaccination Coverage Percentage of Children Ages 6 Months –17 Years Who Are Up to Date with  the 2023-2024 COVID-19 Vaccine, NIS-CCM and NIS-FLU As of May 11,  2024,  vaccination  coverage  among children  was…


01 inlfuenza loehr 508

National Center for Immunization & Respiratory Diseases
Influenza Work Group— Introduction
Dr. Jamie Loehr (Work Group Chair)
Advisory Committee on Immunization Practices
June 27, 2024
Influenza Work Group
ACIP  Members
•Jamie Loehr (Chair)
•Denise Jamieson
•Camille Kotton
•Robert Schechter
•Keipp Talbot
Ex Officio
•Timothy Brennan (FDA)
•Uzo Chukwuma (IHS)
•Michael Ison (NIH)
•Cynthia Nolletti (FDA)
•Jo Resnick (FDA)
•Chris Roberts (NIH)Liaison  Representatives and Consultants
•Robert Atmar
•Kevin Ault
•Ed Belongia
•Hank Bernstein
•Thomas Boyce
•Kris Bryant
•Doug Campos -Outcalt
•Sarah Coles
•Frances Ferguson
•Sandra Fryhofer
•Wendy Keitel
•Marie -Michèle  Léger
•Susan Lett
•Krissy Moehling•Zackary Moore
•Rebecca Morgan
•Jesse Papenburg
•William Schaffner
•Ken Schmader
•Tamara Sheffield
•Angela Sinilaite
•Peter Szilagyi
•Matthew Zahn
CDC Lead
•Lisa Grohskopf
2
CDC Participants
•Lenee Blanton
•Karen Broder
•Alicia Budd
•Jessie Chung
•Sascha Ellington
•Jill Ferdinands
•Brendan Flannery
•Andrew Kroger
•Samantha Olson
•David Shay
•Tom Shimabukuro
•Mark Tenforde
•Tim Uyeki
3
Influenza A(H5N1) in Dairy Cattle
Updates:
•Influenza A(H5N1 )  Update
⁻Dr. Vivien Dugan; Director, Influenza Division, CDC/NCIRD
•This topic is presented for information and discussion. Is
sue:
•Influenza A(H5N1) has been detected in dairy cows in 12 U.S. states
•Three human cases have been reported to date, associated with exposure to cows .
4
Proposed Recommendations for the 2024 -25 Season
Updates:
•Influenza Updates, Work Group Considerations, and Proposed Recommendations
f
or the 2024- 25 Influenza Season
⁻Dr. Lisa Grohskopf, CDC/NCIRD
•This topic includes proposed recommendations for vote.Is
sue:
•Influenza vaccination recommendations for the 2024 -2 5 season have been drafted.
•The draft recommendations include acknowledgement of the 2024 -25 U .S.
influenza vaccine composition.
•New recommendations are proposed for vaccination of solid organ transplant r
ecipients, based on an evidence review and Work Group discussion.
5
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.

Summary: National Center for Immunization & Respiratory Diseases Influenza Work Group— Introduction Dr. Jamie Loehr (Work Group Chair) Advisory Committee on Immunization Practices June 27, 2024 Influenza Work Group ACIP  Members •Jamie Loehr (Chair) •Denise Jamieson •Camille Kotton •Robert Schechter •Keipp Talbot Ex Officio •Timothy Brennan (FDA) •Uzo Chukwuma (IHS) •Michael Ison (NIH) •Cynthia Nolletti (FDA) •Jo Resnick (FDA) •Chris Roberts (NIH)Liaison  Representatives and Consultants •Robert Atmar…


02 influenza dugan 508

Highly Pathogenic
Avian Influenza
A(H5N1)
Vivien G. Dugan, PhD
Director, Influenza Division
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
June 27, 2024
•HPAI A(H5N1) detected in birds in 1996
 A(
H5N1) is n ot a new threat
•Sporadic HPAI A(H5N1) virus infections of
mammals
 have been reported since 2003 -2004
•A(H5N1) clade 2.3.4.4b viruses emerged in wild b
irds in 2020
•29 human cases of HPAI A(H5N1) have been d
etected globally since January 2022
U.K. (5), U.S. (4), Sp ain (2), Vietnam (2), China
(2), Ecuador, Cambodia (11), Chile, AustraliaOverview of HPAI A(H5N1)
Avian Influenza Communication Resources | Bird Flu | CDC2
Human A(H5N1) Cases Since 1997
Technical Report: June 2024 Highly Pathogenic Avian Influenza A(H5N1) Viruses | Bird Flu | CDC3

HPAI A(H5N1) in Dairy Cattle:
Current Situation and Response Updates
4
•USDA has confirmed A(H5N1) virus
in
fections of dairy herds in >100
farms across 12 states
Clade 2.3.4.4b virus
High levels of virus in raw milk
•Other animal species reported in a
ssociation with infected dairy
herds in the United States include:
Wild birds, cats, racoon, opossums
•Wide range of infected wild bi
rds, terrestrial and marine
mammal species worldwideHPAI A(H5N1) in Dairy Herds
Highly Pathogenic Avian Influenza (HPAI) Detections in Livestock ; WAHIS (woah.org)
5

A(H5N1) Human Cases
•April 1 – Texas announced 1st human infection
of HPAI A(H5N1) virus*
•May 22 – Michigan announced 2nd human
infection of influenza A (H5)†
•May 30 –Michigan announced 3rd human
infection of influenza A (H5)†
•Adults working at dairy farms and in contact
with cows
•1st and 2nd cases reported conjunctivitis only,
3rd reported minor respiratory symptoms
•All offered oseltamivir, mild illness and recovered without hospitalization
•No human- to-human transmission
* Health Alert: First Case of Novel Influenza A (H5N1) in Texas, March 2024 | Texas DSHS
† Influenza A (H5N1) (michigan.gov)6
A(H5N1) Human Cases – Virus Sequences to Date
•Diagnostics: No impact to current CDC influenza diagnostic
assay's ability to detect A(H5N1) viruses
•Treatments: No known markers of resistance to FDA
approved antiviral drugs (polymerase acidic inhibitor: baloxavir ;
neuraminidase inhibitors: oseltamivir, peramivir, and zanamivir)
•Candidate Vaccine Viruses (CVVs)
HA of human influenza virus very closely related to two available CVVs
CVVs expected to provide good protection against this virus
7
•Since March 2024, d uring the current HPAI A(H5N1) outbreak in dairy cattle, at least 690 people monitored from affected
farms, at least 51 tested, 3 positives (1 in TX, 2 in MI, last case detected May 30, 2024)
•Since March 2024, public health laboratory monitoring includes testing of 30,163 specimens have been tested using a
p
rotocol that would have detected A(H5N1) and other novel virusesSurveillance, Human Monitoring, and Testing
How CDC is monitoring influenza data among people to better understand the current avian influenza A (H5N1) situation | Bird Flu | CDC, Weekly U.S. Influenza Surveillance Report | CDC8
No indicators of unusual influenza activity in
people, including avian influenza A(H5N1)

‘High’ Wastewater Sites and H5 Detections
How CDC is monitoring influenza data among people to better understand
the current avian influenza A (H5N1) situation | Bird Flu | CDCDeveloped Levels for Influenza
A Virus in Wastewater
•Influenza A Virus Level metric
•Compare current level to levels
at the
 same site during the
2023- 2024 influenza season
•Flag ≥80th percentile as “high”
•Outreach to state/local part
ners in "high" areas, as
well as notifying state, local, and federal partners
9Data from June 2, 2024 – June,15, 2024
Epidemiologic Investigations
•Health and agricultural partners at local,
state and federal level, and affected farms using One Health approach
•Important public health questions
Evidence of infection in exposed populations?
Spectrum of illness and rate of asymptomatic
infections?
Types of exposure on farms/dairies?
Behaviors associated with human infections or protection from infection?
•Assess risk for symptomatic and
asymptomatic infection and a survey to
assess exposures
10
 Avian Influenza Communication Resources | Bird Flu | CDC
Summer Influenza Surveillance Priorities
•Continued monitoring of people with recent exposure on confirmed farms
•Facilitate detection of A(H5N1) human cases in the community through
enhanced, national surveillance at seasonal influenza levels
Subtyping of influenza A positive specimens, expanded specimen sources
Continued surveillance of lab- confirmed influenza associated hospitalizations
through FluSurv -NET
•Continued follow -up for areas that flag in syndromic and wastewater data
•Provider outreach to continue influenza testing through summer,
particularly for patients with recent history of relevant exposures
CDC Strategy for Enhanced Summer 2024 Influenza Surveillance | Avian Influenza (Flu) 11
Global Surveillance is Central to Prevention and Mitigation
•Characterize human
and z
oonotic
influenza viruses
•Contribute data for bi
annual vaccine
composition
•Generate and e
valuate Candidate
Vaccine Viruses
•147 WHO National Influenza Centers in 123 Member States (CDC Atlanta Influenza Laboratory is one)
•7 WHO Collaborating Centers for Influenza (CDC is one)
•12 WHO H5 Reference Laboratories
 Global Influenza Surveillance and Response System (GISRS) (who.int)12
Public Health Risk
•Overall risk to the public remains low
•Increased risk with exposure to
infected animals or environment
(occupational, recreational)
•Exposed individuals should monitor
for symptoms after first exposure
and for 10 days after last exposure
Highly Pathogenic Avian Influenza A(H5N1) Virus in Animals: Interim Recommendations for
Prevention, Monitoring, and Public Health Investigations | Avian Influenza (Flu) (cdc.gov)
Avian Influenza Communication Resources | Bird Flu | CDC13
CDC’s HPAI A(H5N1)
Response Priorities
•CDC leads public health activities and is
working closely with USDA, FDA, and
state and local public health agencies
•Supporting and engaging public health and agricultural partners using a One
Health approach
•Protecting human health and safety
•Understanding risk to people from A(H5N1) viruses
•Assessing A(H5N1) viruses for genetic
changes
14Avian Influenza Communication Resources | Bird Flu | CDC
Resources from CDC
15•Situation Updates
CDC A(H5N1) Bird Flu Response Update | Avian Influenza (Flu)
•Surveillance Updates
How CDC is monitoring influenza data among people to better
understand the current avian influenza A (H5N1) situation | Avian
Influenza (Flu)
•Technical Report
Technical Report: Highly Pathogenic Avian Influenza A(H5N1) Viruses | Avian Influenza (Flu) (cdc.gov)
•Updated Recommendations
Highly Pathogenic Avian Influenza A(H5N1) Virus in Animals: Interim
Recommendations for Prevention, Monitoring, and Public Health Investigations | Bird Flu | CDC
Recommendations for Worker Protection and Use of Personal
Protective Equipment (PPE) to Reduce Exposure to Novel Influenza A Viruses Associated with Severe Disease in Humans
•CDC Public Health Science Agenda
CDC Public Health Science Agenda for Highly Pathogenic Avian
Influenza A(H5N1) – June 2024 | Bird Flu | CDC
CDC A(H5N1) Bird Flu Response Update June 21, 2024 | Bird Flu | CDC
Questions

Summary: Highly Pathogenic  Avian Influenza  A(H5N1) Vivien G. Dugan, PhD Director, Influenza Division National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention June 27, 2024 •HPAI A(H5N1) detected in birds in 1996  A( H5N1) is n ot a new threat •Sporadic HPAI A(H5N1) virus infections of  mammals  have been reported since 2003 -2004 •A(H5N1) clade 2.3.4.4b viruses emerged in wild b irds in 2020  •29 human cases of HPAI A(H5N1) have been d etected globally…


03 influenza grohskopf 508

U.S. Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
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.
Influenza Updates, Work Group Considerations, and
Proposed Recommendations for the 2024 -25
Influenza Season
Lisa Grohskopf, Jill Ferdinands, and Lenee Blanton
Influenza Division, CDC/NCIRD
June 27, 2024
Jill Ferdinands
Lenee Blanton
Lindsay Trujillo
Joanna Taliano
Andrew Leidner
Rebecca Morgan
Doug Campos- O utcaltAcknowledgements
2
U.S. Influenza vaccine composition for the 2024 -2 5 season
Brief end- of-s eason influenza vaccine safety update
Higher dose and adjuvanted influenza vaccines for solid organ
t
ransplant recipients: Evidence to Recommendations (EtR) Discussion
Proposed recommendations for the 2024 -2 5 seasonOverview
3
Influenza Updates
4
All influenza vaccines marketed in the United States for the 2024- 2 5 season will be
trivalent
There will be no influenza B/Yamagata component, following no confirmed
d
etections of wild -type influenza B/Yamagata viruses since March 2020
U.S. influenza vaccine composition for 2024- 2 5 includes an update to the influenza
A(H3N2) component:
–AnA/V ictoria/4897/2022 (H1N1)pdm09 -like virus for egg -based vaccines
or an A/Wisconsin/67/2022 (H1N1)pdm09 -like virus for cell and recombinant vaccines;
–An A /Thailand/8/2022 (H3N2)- like virus for egg -based vaccines
or an A/Massachusetts/18/2022 (H3N2) -like virus for cell and recombinant vaccines;
–A B/Austria/1359417/2021 (B/Victoria lineage) -l ike virusU.S. Influenza Vaccine Composition for the 2024 -25
Influenza Season
Vaccines and Related Biological Products Advisory Committee March 5, 2024 Meeting Announcement - 03/05/2024 | FDA 5
Immunization Safety Office
Centers for Disease Control and PreventionNATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES
End- of-Season Update: 2023 -2024
Influenza Vaccine Safety Monitoring
•~158 million doses of influenza vaccine distributed in United States*
•Vaccine Adverse Event Reporting System (VAERS) ( co-managed by CDC and
FDA)
-No new safety concerns identified for influenza vaccines
•Vaccine Safety Datalink (VSD) ( collaboration between CDC and 13
integrated healthcare organizations)
-VSD monitors pre -s pecified outcomes using rapid cycle analysis (RCA)**
-~4.8 million doses of influenza vaccine administered in VSD through 5/31/2024
-No new safety concerns identified in influenza vaccine monitoringVaccine Safety Update: 2023 -2024 Influenza Season
12*As of March 9, 2024, Weekly Flu Vaccination Dashboard | FluVaxView | Seasonal Influenza (Flu) |
** Outcomes monitored in VSD for influenza vaccines: acute disseminated encephalomyelitis (ADEM), anaphylaxis (case counts), Bell's palsy,
encephalitis, Guillain- Barré syndrome, seizures, and transverse myelitis; Li et al. Post licensure surveillance of influenza vaccines in the Vaccine
Safety Datalink in the 2013– 2014 and 2014– 2015 seasons (wiley.com)  Pharmacoepidemiol  Drug Saf. 2016 Aug;25(8):928- 34. •.
Higher Dose and Adjuvanted Influenza Vaccines
for Solid Organ Transplant Recipients: EtR Discussion
Background
8
Solid Organ Transplantation in the United States
National Data, Organ Transplant and Procurement Network (OPTN). National data - OPTN (hrsa.gov)
U.S. Organ Transplants Performed, 2023
All 46,632  (100)
By age group N (%)
<18 years 1,916        (4)
18-64 years 33,610      (72)
≥65 years 11,104     (24)
Organ(s) N (%)
Kidney 27,332     (59)
Liver 10,660    (23)
Heart 4,545     (10)
Lung 3,026       (6)
Kidney/pancreas 812       (2)
Pancreas 102       (0.2)
Heart/lung 54       (0.1)
05000100001500020000250003000035000400004500050000
2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022Total Solid Organ Transplants Performed
in the U.S. By Year, 2000- 2023
Transplants, n
9
Per ACIP recommendations, SOT recipients should receive an age-ap propriate
inactivated or recombinant influenza vaccine (i.e., an IIV or RIV)
–Live attenuated influenza vaccine (LAIV) is not recommended for immunocompromised populations
Immunosuppressive regimens might contribute to diminished response to vaccines
High- d ose (HD -IIV) and adjuvanted (aIIV) inactivated influenza vaccines have been
studied in SOT recipients
American Society for Transplantation (AST) states that high- d ose or boosted dosing
might be preferable post -transplant
HD-I IV and aIIV are approved for ages ≥65 years, and might not be covered by
insurance when administered to persons under age 65 yearsRecommendations for Influenza Vaccination of SOT
Recipients
ACIP , Prevention and Control of Seasonal Influenza with Vaccines, 2023 -24. https://www.cdc.gov/mmwr/volumes/72/rr/rr7202a1.htm
Danziger -Isakov L et al, Clin Transplant 2019;33(9):e1356310
Should high- do se inactivated, adjuvanted inactivated, and/or
recombinant influenza vaccines be recommended as an option for
influenza vaccination of solid organ transplant recipients who are younger than the approved age indication?
–<65 years for high -d ose and adjuvanted influenza vaccines
–<18 years for recombinant influenza vaccine
 Policy Question
11
Public Health Importance
EtR Domain 1
12
The number of transplants performed
ea
ch year, and post -transplant survival
have increased
     Approximately 430,000 recipients a
live in 2020
–0.1% of U.S. populationPublic Health Importance —Scope of Population

Median recipient survival (years)
Organ 1987 -2012 1987 -2021
Kidney 12.4 14.8
Liver 11.6 14.6
Heart 9.5 11.7
Lung 5.2 5.6
Pancreas 13.3 16.1
Recipients alive, n
Organ June 2015 June 2020
Kidney 200,000 255,738
Liver 74,945 98,842
Heart 29,172 37,419
Lung 12,100 17,500
Pancreas 14,161 19,458
*Considering recipients of the most commonly transplanted organs,
for whom systemic immunosuppression is generally required
Organ Transplant and Procurement Network (OPTN). National data - OPTN (hrsa.gov)
Rana et al, JAMA Surgery 2015; 150(3):252 -259
Ferreira et al, Digestive Diseases and Sciences 2023;68:3810 -3817  OPTN/SRTR 2015 Annual Data Report
OPTN/SRTR 2020 Annual Data Report 2020 ADR (hrsa.gov) 13
SOT recipients require lifelong immunosuppressive medications.
Manifestations of influenza can be more severe
–Lower respiratory tract disease, including pneumonia, occurs in 22 -49%  of SOT
recipients
In a 5 -year cohort of SOT recipients with influenza (n=477):
•21% had lower respiratory tract disease on presentation
•69% were hospitalized
•11% admitted to an intensive care unit
•  8% required mechanical ventilation
•
3% died (all- c auses) within 30 days
     Public Health Importance —Disease Burden
14Mombelli et al, Exp Rev Anti- infect Ther 2020;18:103 -112
Kumar et al, Cin Infect Dis 2018;67:1322 -1329

Is influenza among solid organ transplant recipients a problem of public health
importance?
No
Probably no
Probably yes
Yes
Varies
Don’t know
     WG Judgement: Public Health Importance
1515
Benefits and Harms
EtR Domain 2
16
 Population, Intervention, Comparator, and Outcomes
Population Solid organ transplant recipients aged ≥6 months
Interventions High -dose (HD -IIV), MF59 -djuvanted (aIIV), or recombinant (RIV) trivalent or quadrivalent influenza
vaccines
Comparator Single intramuscular dose of trivalent or quadrivalent unadjuvanted standard dose influenza vaccines
Outcomes Primary outcomes
Benefits:
•Medically-attended influenza (Critical)
•Influenza -associated hospitalization (Critical)
•Laboratory-confirmed influenza —immunogenicity data acceptable (Important)
Harms:
•Transplant rejection or graft failure (Critical)
•Neuroinflammatory conditions , e.g. GBS, ADEM (Critical)
•Other immune -related adverse events, including new onset or exacerbation of an autoimmune
condition (Critical)
17
9 papers describing 9 studies:
– 8 randomized; 1 cohort
Vaccines and comparisons:
–HD- IIV3 vs. SD -IIV3    2
–Double-dose vs. single-dose SD-IIV3  2
–aIIV3 vs. SD - IIV3    3
–aIIV3 vs. HD - IIV3 vs. SD -IIV4   1
–aIIV3 (most participants, no comparator) 1
–No papers examining RIV
Transplant populations:
–Kidney  4
–Heart  1
–Mixed 4    (40 -80% kidney)No papers reported on medically -
a
ttended influenza, neuroinflammatory
conditions, or immune -mediated adverse
events (all critical outcomes)
Only one pediatric study (omitted from
m
eta-analysis/GRADE)
Cohort study excluded from GRADE g
iven small size, lack of a comparison
group, and availability of randomized studies
7 papers included in GRADEStudy Characteristics (n=9)
18
Summary—Benefits: aIIV3 vs SD- IIV
19Outcome N studies
(n participants)Pooled RR (95% CI) GRADE Certainty Importance
Influenza- associated hospitalization 1  (403) 2.90  (0.12, 70.71) Low Critical
Medically -attended influenza 0 - - Critical
Lab- confirmed influenza 1  (403) 0.97  (0.43, 2.18) Moderate Important
Seroconversion to H1N1 3  (558) 1.37  (1.09, 1.72) Low Important
Seroconversion to H3N2 3  (558) 1.51  (1.25, 1.82) Low Important
Seroconversion to B 3  (558) 1.64  (1.28, 2.11) Low Important
Seroprotection to H1N1 3  (558) 1.06  (0.98, 1.14) Very low Important
Seroprotection to H3N2 3  (558) 1.20  (1.07, 1.33) Low Important
Seroprotection to B 3  (558) 1.17  (1.01, 1.34) Low Important
Summary—Benefits: HD- IIV3 vs SD- IIV
20Outcome N studies
(n participants)Pooled RR (95% CI) GRADE Certainty Importance
Influenza- associated hospitalization 1  (393) 3.05  (0.12, 74.32) Low Critical
Medically -attended influenza 0 - - Critical
Lab- confirmed influenza 2  (565) 1.09  (0.52, 2.27) Moderate Important
Seroconversion to H1N1 2  (554) 2.46  (1.86, 3.27) Moderate Important
Seroconversion to H3N2 2  (554) 1.67  (1.38, 2.02) Moderate Important
Seroconversion to B 2  (554) 1.90  (1.46, 2.46) Moderate Important
Seroprotection to H1N1 2  (554) 1.03  (0.95, 1.11) Low Important
Seroprotection to H3N2 2  (554) 1.13  (1.01, 1.26) Moderate Important
Seroprotection to B 2  (554) 1.22  (1.08, 1.38) Moderate Important
Summary—Harms
21Outcome Studies (N) Pooled RR (95% CI) GRADE Certainty Importance
aIIV3 vs SD-IIV
Graft rejection 3  (517) 0.28  (0.06, 1.34) Moderate Critical
Neuroinflammatory events 0 - - Critical
Other autoimmune events 0 - - Critical
HD-IIV3 vs SD-IIV
Graft rejection 3  (579) 1.00  (0.32, 3.06) Moderate Critical
Neuroinflammatory events 0 - - Critical
Other autoimmune events 0 - - Critical
Summary of Evidence: aIIV3 vs SD -IIV
Outcome Importance No. studies Included in profile Favored vaccine Certainty
Benefits
Medically -attended influenza Critical 0 - - -
Influenza- associated hospitalization Critical 1 Yes Neither Low
Laboratory -confirmed influenza Important 1 Yes Neither Moderate
Immunogenicity (surrogate outcome)
Seroconversion to A(H1N1) Important 3 Yes aIIV3 Low
Seroconversion to A(H3N2) Important 3 Yes aIIV3 Low
Seroconversion to B Important 3 Yes aIIV3 Low
Seroprotection to A(H1N1) Important 3 Yes Neither Very Low
Seroprotection to A(H3N2) Important 3 Yes aIIV3 Low
Seroprotection to B Important 3 Yes aIIV3 Low
HarmsTransplant rejection/graft failure Critical 3 Yes Neither Moderate
Neuroinflammatory conditions Critical 0 - - -
Other immune -mediated adverse events Critical 0 - - -
22
Summary of Evidence: HD -IIV3 vs SD- IIV
Outcome Importance No. studies Included in profile Favored vaccine Certainty
Benefits
Medically -attended influenza Critical 0 - -
Influenza- associated hospitalization Critical 1 Yes Neither Low
Laboratory -confirmed influenza Important 2 Yes Neither Moderate
Immunogenicity (surrogate outcome)
Seroconversion to A(H1N1) Important 3 Yes HD-IIV3 Moderate
Seroconversion to A(H3N2) Important 3 Yes HD-IIV3 Moderate
Seroconversion to B Important 3 Yes HD-IIV3 Moderate
Seroprotection to A(H1N1) Important 3 Yes Neither Low
Seroprotection to A(H3N2) Important 3 Yes HD-IIV3 Moderate
Seroprotection to B Important 3 Yes HD-IIV3 Moderate
HarmsTransplant rejection/graft failure Critical 3 Yes Neither Moderate
Neuroinflammatory conditions Critical 0 - -
Other immune -mediated adverse events Critical 0 - -
23
Few studies; most are small (4 of 7 have <100 participants)
No direct evidence of relative benefit or either HD -i iv3 or aIIV3 vs SD -IIV
–Only indirect evidence (immunogenicity)
Variability in timing of immunogenicity endpoints and how they are
rep
orted
No information for critical outcomes of medically -a ttended influenza,
neuroinflammatory conditions, or other immune- mediated events
–Given study sizes, power probably not adequate
No evaluations of RIV
 Limitations
24
How substantial are the desirable anticipated effects?
Minimal
Small
Moderate
Large
Varies
Do
n’t know
     WG Judgement: Benefits and Harms
25
How substantial are the undesirable anticipated effects?
Minimal
Small
Moderate
Large
Varies
Don’t know
     WG Judgement: Benefits and Harms
26
Do desirable effects outweigh undesirable effects?
Favors intervention
Favors comparison
Favors both
Favors neither
Varies
Don’t know
     WG Judgement: Benefits and Harms
27
Benefits of the intervention
No studies found
Very low
Low
Moderate
High

 Harms of the intervention No studies found
Very low
Low
Moderate
HighBenefits and Harms: Certainty of Evidence
28What is the overall certainty of the evidence for the critical outcomes?
Values and Preferences
EtR Domain 3
29
No direct evidence was identified reflecting values or preferences for specific influenza
vac
cine types among SOT recipients
There might be a healthcare provider preference for HD -II V, evidenced by the
recommendations of the American Society for Transplantation and various transplant programs
 Values and Preferences for Influenza Vaccine Types
Danziger -Isakov L et al, Clin Transplant 2019;33(9):e13563
COVID -19 and Flu Vaccination Information for Transplant Patients - Penn Medicine30
Does the target population feel that the desirable effects are large relative to undesirable
effects?
No
Probably no
Probably yes
Yes
Varies
Don’t know
     WG Judgement: Values
31
Is there important uncertainty about or variability in how much people value the main
outcomes?
Important uncertainty or variability
Probably important uncertainty or variability
Probably not important uncertainty or variability
No important uncertainty or variability
No known undesirable outcomes
     WG Judgement: Values
32
Acceptability
EtR Domain 4
33
Acceptability of a recommendation for high- d ose vaccine is possibly
evidenced by recommendations of the AST and some transplant
programs for high- dose vaccine
Acceptability might be limited among healthcare and public health
s
ystems and insurers by need for changes in standing orders,
immunization information systems, and electronic medical record platforms
 Acceptability Considerations
34
Is the intervention acceptable to key stakeholders?
No
Probably no
Probably yes
Yes
Varies
Don’t know
     WG Judgement: Acceptability
35
Resource Use
EtR Domain 5
36
No economic analysis was conducted:
–Population ~430,000 as of 2020
–Insufficient data concerning relative effectiveness of influenza vaccines in SOT populations
–Insufficient data indicating extent to which use of these vaccines is already occurring among off -l abel
age group SOT recipients
HD-I IV3 and aIIV3 more costly ($73- 77) than unadjuvanted influenza vaccines ($21 -34)
 Is the Intervention a Reasonable and Efficient Allocation of
Resources?
Influenza Vaccine Pricing (2023 -24), CMS.gov ( https://www.cms.gov/medicare/payment/part -b-drugs/vaccine -pricing  )37
Is the intervention a reasonable and efficient allocation of resources?
No
Probably no
Probably yes
Yes
Varies
Don’t know
     WG Judgement: Resource Use
38
Equity
EtR Domain 6
39
No literature was found concerning use of enhanced influenza vaccines
a
mong transplant recipients
Among Medicare beneficiaries aged ≥65 years in a single- se ason (2015 -16),
Black, Asian, and Hispanic persons were 26% to 32% less likely to receive HD-IIV3 than White persons
A WG member noted other potential barriers for SOT recipients:
–SOT recipients face barriers to receiving newer influenza vaccines as they are usually
e
xcluded from clinical trials, and there are few data for this population
–Transplant programs with greater financial resources might be able to purchase va
ccines for their patients, whereas those less well- resourced might notEquity
Mahmud et al, Lancet Healthy Longevity 2021;2:e143 -e153
40
What would be the impact on health equity?


ReducedProbably reducedProbably no impactProbably increasedIncreased
Varies
Don’t know
     WG Judgement: Equity
41
Feasibility
EtR Domain 7
42
Factors favoring feasibility
The recommendation might improve
a
ccess, if more likely to be covered by
insurance.
If covered, insurance and r
eimbursement concerns should be
minimal.
Vaccination should be easily im
plementable in office and retail
settings that serve adults.
The vaccines are licensed and r
outinely stocked.
 Factors not favoring feasibility
A recommendation stating that vaccines
a
re acceptable options (as opposed to a
preferential recommendation) might not compel insurers to cover them.
Use of vaccine in a new age group might r
equire changes in standing orders,
Electronic Medical Record programming, and immunization information systems.Feasibility
43
Is the intervention feasible to implement?
No
Probably no
Probably yes
Yes
Varies
Don’t know
     WG Judgement: Balance of Consequences
44
Balance of Consequences and
Sufficiency of Information
45
Undesirable consequences c learly outweigh  desirable consequences in most settings
Undesirable consequences pr obably outweigh desirable consequences in most settings
The balance between desirable and undesirable consequences  i s closely balanced or uncertain
Desirable consequences pr obably outweigh undesirable consequences in most settings
Desirable consequences c learly outweigh  undesirable consequences in most settings
There is insufficient evidence to determine the balance of consequences
     WG Judgement: Balance of Consequences
46
Is there sufficient evidence to move forward with a recommendation
Yes
No
     WG Judgement: Sufficiency of Information
47
Proposed Recommendations
48
Routine annual influenza vaccination is recommended for all persons aged
≥
6 months without contraindications.
–Same as previously
All persons should receive an age- a ppropriate influenza vaccine (i.e., one
approved for their age), with the following exception: solid organ transplant recipients aged 18 through 64 years on immunosuppressive medication regimens may receive either  HD -IIV3 or aIIV3 as an
acceptable option (without a preference over other age- appropriate IIV3s
or RIV3). Proposed Recommendations for Influenza Vaccination,
2024 -25 (For Vote)
49
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.
50

Summary: U.S. Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases 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. Influenza Updates, Work Group Considerations, and  Proposed Recommendations for the 2024 -25  Influenza Season Lisa Grohskopf, Jill Ferdinands, and Lenee Blanton…


01 Pneumococcal Loehr 508

Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
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.
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

Summary: Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases 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. 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…


02 Pneumococcal Stoecker 508

1Economic Assessment of PCV21 in U.S. Adults
Charles Stoecker
Tulane University
School of Public Health and Tropical Medicine
ACIP
June 27, 2024

2Conflicts of Interest
❑Dr. Stoecker has no conflicts of interest to declare.
3Acronyms
❑ PCV: pneumococcal conjugate vaccine
❑ PCV20: 20 valent PCV
❑ PCV21: 21 valent PCV
❑ VE: vaccine effectiveness
❑ VT: vaccine type
❑ ST: serotype
❑ NBP: non -bacteremic  pneumonia
❑ IPD: invasive pneumococcal disease
❑ IPT: inpatient
❑ OPT: outpatient
❑ QALY: quality adjusted life year
❑ IC: immunocompromised
❑ CMC: chronic medical conditions, but not IC
❑ NIS: National Immunization Survey
❑ ABCs: Active Bacterial Core Surveillance System
4Methods:  Study Question
❑Evaluate cost effectiveness of using PCV21 in adults
❑Evaluate
▪Program cost/savings
▪Changes in disease, medical costs, nonmedical costs, and work
productivity costs
•Limited societal perspective
▪Population
•Separate cohorts of 4,256,608 19 -year -olds, 3,990,700 42 -year -olds,
4,051,078 50 -year -olds, or 3,567,978 65 -year -olds for specific questions
•Separate model buckets for:
oImmunocompromised (IC) – HIV, Cancer, Organ Transplants,
Dialysis
oChronic medical conditions (CMC) – Diabetes, Heart Disease, Lung
Disease, Liver Disease, Alcoholism
oOthers –”General”
5Methods:  Interventions
❑Five strategies to evaluate
Intervention Comparator
Question 1a Age -based vaccination at 65 with PCV21 Age -based vaccination at 65 with PCV20
Question 1b Risk -based vaccination with PCV21 Risk -based vaccination with PCV20
Question 2 Age -based vaccination at 50 with PCV21 Age -based vaccination at 65 with PCV21
Question 3 Age -based vaccination at 19 with PCV21 Age -based vaccination at 50 with PCV21
Supplemental PCV21 Dose after PCV20
Vaccination at 65 with PCV20 and 66 with PCV21
(all) Age -based vaccination at 65 with PCV20
Vaccination at 65 with PCV20 and 70 with PCV21
(all) Age -based vaccination at 65 with PCV20
Risk -based vaccination with PCV20 and
vaccination after 1 year with PCV21 (CMC/IC) Risk -based vaccination with PCV20
Risk -based vaccination with PCV20 and
vaccination after 5 years with PCV21 (CMC/IC) Risk -based vaccination with PCV20
6Methods:  Economic Model
❑Cohort Model
▪Cost per quality adjusted life year (QALY) gained
▪Cost per life year gained
❑Compare each intervention to comparator strategy and
calculate incremental cost effectiveness ratio
▪Divide change in costs by change in QALYs
❑Costs in 2023$
▪Inflated by the Medical Care component of Consumer Price Index
❑Future costs and outcomes discounted by 3% annually
7Methods:  Health Outcomes
❑
❑
❑
❑
❑
❑
❑Cases of Invasive Pneumococcal Disease (IPD)
Cases of Hospitalized (IPT) Nonbacteremic Pneumonia
(NBP)
Cases of outpatient (OPT) NBP
Deaths due to IPD
Deaths due to IPT NBP
QAL Ys
Life Y ears
8Conceptual Model
NBP
Background mortality from non-pneumococcus related illness is included in all branches, but not displayed in the model for brevity.IPT Case
IPT Case
OPT Case
9Model Inputs
❑
❑
❑IPD rates, all -cause IPT and OPT NBP rates, IPD cases resulting in
fatality were estimated by age - and risk group (general/CMC/IC).
Age -group specific IPT NBP case fatality rates were applied to all
risk groups
Vaccine effectiveness (VE) was estimated by risk group and
outcome (IPD/NBP).
▪
▪VE against serotype 3 was lower than other VT
VE was the same across PCV20 and PCV21
❑
❑Vaccine coverage was estimated by age group (19 –49, 50 –64, 65+)
and scenario (risk based, supplemental)
Herd inputs updated from previous iteration
▪
▪
▪New baseline estimation strategy
Bigger initial effect
Plateau after 6 years
See supplemental slides for the specific estimates used in the model.
10Serotype Group18-49
Years50-64
Years65-74
Years75-84
Years85+
Years
% PCV20 only -4-19F
   (1, 5, 6B, 9V, 14, 18C, 23F, 15B, including
isolates reported as 15BC)1.99% 1.52% 3.09% 1.01% 1.08%
% PCV20 & PCV21 -3
(6A, 7F, 19A, 22F, 33F, 8, 10A, 11A, 12F) +6C 34.44% 41.95% 32.72% 32.32% 33.33%
% PCV21 only -35B
   (9N, 17F, 20, 15A, 15C, 16F, 23A, 23B, 24F, 31)30.13% 30.70% 31.48% 29.29% 35.48%
% serotype 3 13.91% 12.46% 17.28% 21.21% 14.25%
% serotype 4 4.97% 2.43% 1.23% 0.00% 0.00%
% serotype 19F 4.97% 4.56% 3.70% 3.03% 3.01%
% serotype 35B 2.65% 0.91% 4.32% 5.05% 3.23%
Ratio PCV21 only:PCV20 only serotypes 2.75 3.71 4.46 8.50 9.46
Source: Active Bacterial Core Surveillance 2018 -2019. For multivariate sensitivity analyses distributions are beta -pert with -/+20% for low and high.IPD Serotype Distributions, General
11Serotype Group18-49
Years50-64
Years65-74
Years75-84
Years85+
Years
% PCV20 only -4-19F
   (1, 5, 6B, 9V, 14, 18C, 23F, 15B, including
isolates reported as 15BC)0.49% 0.71% 1.88% 2.17% 1.81%
% PCV20 & PCV21 -3
(6A, 7F, 19A, 22F, 33F, 8, 10A, 11A, 12F) +6C 36.99% 33.62% 30.36% 32.79% 28.62%
% PCV21 only -35B
   (9N, 17F, 20, 15A, 15C, 16F, 23A, 23B, 24F, 31)30.33% 32.67% 30.83% 32.52% 33.70%
% serotype 3 11.34% 17.96% 21.91% 17.07% 17.39%
% serotype 4 9.99% 4.35% 1.25% 0.27% 0.72%
% serotype 19F 3.08% 2.45% 2.66% 2.44% 2.17%
% serotype 35B 2.59% 3.01% 4.23% 5.15% 6.88%
Ratio PCV21 only:PCV20 only serotypes 2.43 4.75 6.06 7.72 8.63IPD Serotype Distributions, CMC
Source: Active Bacterial Core Surveillance 2018 -2019. For multivariate sensitivity analyses distributions are beta -pert with -/+20% for low and high.
12IPD Serotype Distributions, IC
Serotype Group18-49
Years50-64
Years65-74
Years75-84
Years85+
Years
% PCV20 only -4-19F
   (1, 5, 6B, 9V, 14, 18C, 23F, 15B, including
isolates reported as 15BC)6.02% 3.92% 3.30% 2.88% 0.00%
% PCV20 & PCV21 -3
(6A, 7F, 19A, 22F, 33F, 8, 10A, 11A, 12F) +6C 28.92% 31.63% 30.03% 37.50% 48.31%
% PCV21 only -35B
   (9N, 17F, 20, 15A, 15C, 16F, 23A, 23B, 24F, 31)31.33% 33.73% 33.99% 26.44% 25.84%
% serotype 3 15.66% 8.43% 11.55% 10.10% 4.49%
% serotype 4 1.20% 1.20% 1.32% 0.00% 0.00%
% serotype 19F 3.61% 3.61% 3.30% 1.44% 5.62%
% serotype 35B 6.02% 6.63% 8.91% 9.62% 5.62%
Ratio PCV21 only:PCV20 only serotypes 3.45 4.62 5.42 8.35 5.60
Source: Active Bacterial Core Surveillance 2018 -2019. For multivariate sensitivity analyses distributions are beta -pert with -/+20% for low and high.
13NBP Serotype Distributions
Serotype Group18-49
Years50-64
Years65+
Years
% PCV20 only -4-19F
   (1, 5, 6B, 9V, 14, 18C, 23F, 15B)0.6% 0.7% 1.1%
% PCV20 & PCV21 -3
(6A, 7F, 19A, 22F, 33F, 8, 10A, 11A, 12F) +6C 3.0% 4.5% 3.9%
% PCV21 only -35B
   (9N, 17F, 20, 15A, 15C, 16F, 23A, 23B, 24F, 31)3.2% 4.2% 2.4%
% serotype 3 1.1% 2.0% 1.4%
% serotype 4 0.0% 0.2% 0.2%
% serotype 19F 0.1% 0.9% 0.7%
% serotype 35B 0.8% 0.6% 0.7%
Ratio PCV21 only:PCV20 only serotypes 5.7 2.7 1.6
Source: Merck adjusted SSUAD serotype distribution data.
Note that the serotype distribution is among all community -acquired pneumonia, not limited to pneumococcal pneumonia.
 For multivariate sensitivity analyses distributions are beta -pert with -/+20% for low and high.
14Waning Immunity Assumptions
❑
❑No decline in effectiveness for first five years a
Wane to zero over next 10 years b
aPatterson  S, Webber C, Patton M, Drews  W, Huijts  SM, Bolkenbaas  M, et al. A post hoc assessment of duration of protection in CAPiTA  (Community
Acquired Pneumonia immunization Trial in Adults). Trials in Vaccinology. 2016;5.:92 -96.
b van Werkhoven  CH, Huijts  SM, Bolkenbaas  M, Grobbee  DE, Bonten  MJ. The Impact of Age on the Efficacy of 13 -valent Pneumococcal Conjugate
Vaccine in Elderly. Clin Infect Dis 2015;61(12):1835 -8.00.20.40.60.81
0 5 10 15 20% Initial Effectiveness
Years Since Vaccination
15Vaccine Price
❑
❑
▪
❑
❑
❑PCV20 $288.66a
PCV21 $319.43b
Sensitivity analysis with PCV21 price 5% higher ($335.60)
Administration 19 -64 years: $30.49c
Administration 65+ years:  $21.07d
Travel + patient time cost: $44.46e
a Payment Allowance Limits for Medicare Part B for PCV20.
b Applied ratio of PCV21 to PCV20 price from manufacturer model and applied to PCV20 Medicare price. Sensitivity analysis uses upper bound of manufacturer
PCV21 price range.
c Tsai et al. AJPM 2019. Updated to 2023 dollars.
d Average Medicare maximum allowable reimbursement for immunization administration (HCPCS code 90471) across all Medicare Admin istrative Contractors,
2023.
e Travel cost from Maciosek  et al. Am J Prev Med 2006. Updated to 2023 dollars.
16Sensitivity Analyses
❑
▪
❑
❑
▪
❑
▪
▪
❑Higher PCV21 Price
5% higher: $335.60 vs $319.43
No PCV20 type indirect protections for adults from
childhood program
Serotype 4 disease at 30% of pneumococcal disease
Decrease other serotypes proportionally to preserve overall
disease rates
Fix disease QAL Y decrements by age
Only for moving age -based recommendation to 19 or 50 years
Set QALY decrements to age 19 decrements for all ages
Alternate QAL Y decrements
17PCV21 Overview
Question 1a
PCV1 @Age 65Question 1b
PCV21 @CMC/ICQuestion 2
PCV21 @Age 50Question 3
PCV21 @Age 19
Health Outcomes
IPD Cases -889 ( -1099, -624) -194 ( -233, -139) 215 ( -101,534) 223 (112,339)
Hospitalized Pneumonia Cases -1630 ( -2210, -929) -368 ( -489, -207) 1050 (423,1751) 350 (159,544)
Non -hospitalized Pneumonia
Cases -3663 ( -5050, -2082) -1427 ( -1927, -801) 247 ( -1732,2421) 926 (77,1911)
Deaths due to IPD -108 ( -137, -74) -23 (-28,-16) 36 (-3,75) 28 (16,42)
Deaths due to Pneumonia -60 (-90,-31) -11 (-16,-6) 48 (14,86) 11 (4,20)
QALYs 1302 (926,1613) 363 (265,435) 52 (-633,744) -507 ( -759, -261)
Life-years 2082 (1476,2591) 513 (376,614) -389 ( -1331,564) -682 ( -1010, -360)
Costs (million $)
Total Cost 5 (-12,30) -29 (-38,-17) -5 (-119,121) 185 (111,254)
Medical Costs -60 (-74,-42) -26 (-31,-18) -34 (-74,9) 35 (18,51)
Vaccine Costs 90 (79,101) 12 (12,13) 75 (-108,258) 129 (40,219)
Work Loss -24 (-30,-17) -16 (-20,-11) -47 (-78,-16) 21 (9,33)
Cost Ratios ($)
Cost/QALY4,132 (C -S, 18,599) C-S (C-S, C-S)C-S (187,994*,
162,634) D (D, D)
Cost/Life -year2584 (C -S, 11,579) C-S (C-S,  C -S)13,675* (89,406*,
214,539) D(D, D)
95% CI in parenthesis; * Indicates dollars saved per QALY or Life -year lost; C -S indicates cost -saving; D indicates dominated.
18Question 1a: Vaccination at age 65 with PCV21
BasePCV21 @
$335.60PCV20 Child
Indirect 0%Serotype 4 @
30%Tang QALY
Values
Health Outcomes
IPD Cases -889 -889 -855 152 -889
Hospitalized Pneumonia Cases -1,630 -1,630 -1,019 -422 -1,630
Non -hospitalized Pneumonia Cases -3,663 -3,663 -2,320 -807 -3,663
Deaths due to IPD -108 -108 -104 18 -108
Deaths due to Pneumonia -60 -60 -37 -16 -60
QALYs 1,302 1,302 1,098 -45 1,321
Life-years 2,082 2,082 1,771 -74 2,082
Costs (million $)
Total Cost $5 $37 $24 $85 $5
Medical Costs -$60 -$60 -$46 -$5 -$60
Vaccine Costs $90 $121 $90 $90 $90
Work Loss -$24 -$24 -$20 $1 -$24
Cost Ratios ($)
Cost/QALY 4,132 28,061 21,947 Dominated 4,073
Cost/Life -year 2,584 17,549 13,602 Dominated 2,584Cohort of 65 -year -olds.  Comparator is PCV20 at age 65.
19Question 1b: Vaccination at CMC/IC with PCV21
BasePCV21 @
$335.60PCV20 Child
Indirect 0%Serotype 4 @
30%Tang QALY
Values
Health Outcomes
IPD Cases-194 -194 -188 29 -194
Hospitalized Pneumonia Cases-368 -368 -265 -190 -368
Non -hospitalized Pneumonia Cases
-1,427 -1,427 -1,128 -694 -1,427
Deaths due to IPD-23 -23 -22 3 -23
Deaths due to Pneumonia-11 -11 -8 -6 -11
QALYs363 363 324 29 361
Life-years513 513 458 32 513
Costs (million $)
Total Cost-$29 -$22 -$24 $3 -$29
Medical Costs-$26 -$26 -$22 -$7 -$26
Vaccine Costs$12 $19 $12 $12 $12
Work Loss-$16 -$16 -$14 -$3 -$16
Cost Ratios ($)
Cost/QALYCost -Saving Cost -Saving Cost -Saving 111,812 Cost -Saving
Cost/Life -year Cost -Saving Cost -Saving Cost -Saving 98,126 Cost -SavingCohort of 42 -year -olds.  Comparator is PCV20 at CMC/IC.
20Question 1b: Vaccination at CMC/IC with PCV21
Cohort of 42 -year -olds.  Comparator is PCV20 at CMC/IC.
Serotype 4 @
5%Serotype 4 @
10%Serotype 4 @
15%Serotype 4 @
20%Serotype 4 @
25%Serotype 4 @
30%Serotype 4 @
35%
Health Outcomes
IPD Cases -184 -141 -99 -56 -13 29 72
Hospitalized Pneumonia Cases -345 -314 -283 -252 -221 -190 -159
Non -hospitalized Pneumonia
Cases-1,327 -1,201 -1,074 -947 -821 -694 -567
Deaths due to IPD -21 -16 -11 -6 -2 3 8
Deaths due to Pneumonia -11 -10 -9 -8 -7 -6 -5
QALYs 345 282 218 155 92 29 -35
Life-years 486 395 304 214 123 32 -58
Costs (million $)
Total Cost -27 -21 -15 -9 -3 3 9
Medical Costs -24 -21 -17 -14 -10 -7 -3
Vaccine Costs 12 12 12 12 12 12 12
Work Loss -15 -13 -10 -8 -5 -3 0
Cost Ratios ($)
Cost/QALY Cost -Saving Cost -Saving Cost -Saving Cost -Saving Cost -Saving 111,812 Dominated
Cost/Life -year Cost -Saving Cost -Saving Cost -Saving Cost -Saving Cost -Saving 98,126 Dominated
Base case serotype 4 distributions are age, risk, and disease condition specific as displayed earlier in the slides.  They ra nge  from 0 to 9.99%
21Question 2: Vaccination at age 50
BasePCV21 @
$335.60PCV20 Child
Indirect 0%Serotype 4 @
30%Fix QALY
DecrementsTang QALY
Decrements
Health Outcomes
IPD Cases215 215 398 131 215 215
Hospitalized Pneumonia Cases1,050 1,050 2,220 775 1,050 1,050
Non -hospitalized Pneumonia
Cases247 247 2,175 282 247 247
Deaths due to IPD36 36 62 23 36 36
Deaths due to Pneumonia48 48 93 35 48 48
QALYs52 52 -283 45 -3 17
Life-years-389 -389 -1,061 -257 -389 -389
Costs (million $)
Total Cost-$5 -$3 -$4 $19 -$5 -$5
Medical Costs-$34 -$34 -$25 -$23 -$34 -$34
Vaccine Costs$75 $78 $75 $75 $75 $75
Work Loss-$47 -$47 -$54 -$33 -$47 -$47
Cost Ratios ($)
Cost/QALYCost -Saving Cost -Saving 15,489* 429,479 1,739,015* Cost -Saving
Cost/Life -year 13,675* 6,916* 4,138* Dominated 13,675* 13,675*Cohort of 50 -year -olds.  Comparator is PCV21 at CMC/IC or age 65.
* Dollars saved per QALY or Life -year lost.
22Question 2 Modeling Strategies
❑“Moving age -based recommendation from 65 to 50”
▪Shifts disease burden from younger to older adults
▪Save the cost of vaccinating 65 -year -olds
❑“Adding vaccination at 50 in addition to 65”
▪Isolates disease burden reduction from 50– to 64 -year -olds
•Convenient since we assume 15 -year vaccine duration
▪Clinicians may be unwilling to not re -vaccinate at age 65 in above
recommendation
23Question 2: Vaccination at age 50 and 65
BasePCV21 @
$335.60PCV20 Child
Indirect 0%Serotype 4 @
30%Fix QALY
DecrementsTang QALY
Decrements
Health Outcomes
IPD Cases -424 -424 -560 -307 -424 -424
Hospitalized Pneumonia Cases -462 -462 -412 -306 -462 -462
Non -hospitalized Pneumonia
Cases-3,202 -3,202 -3,835 -2,184 -3,202 -3,202
Deaths due to IPD -41 -41 -53 -30 -41 -41
Deaths due to Pneumonia -8 -8 -3 -5 -8 -8
QALYs 1,105 1,105 1,408 780 1,096 1,074
Life-years 1,262 1,262 1,574 895 1,262 1,262
Costs (million $)
Total Cost $298 $317 $253 $344 298 $298
Medical Costs -$84 -$84 -$110 -$59 -84 -$84
Vaccine Costs $450 $468 $450 $450 450 $450
Work Loss -$67 -$67 -$87 -$47 -67 -$67
Cost Ratios ($)
Cost/QALY 269,932 286,553 179,685 440,518 272,038 277,778
Cost/Life -year 236,322 250,873 160,744 384,319 236,322 236,322Cohort of 50 -year -olds.  Comparator is PCV21 at CMC/IC or age 65.
24Question 3: Vaccination at age 19
BasePCV21 @
$335.60PCV20 Child
Indirect 0%Serotype 4 @
30%Fix QALY
DecrementsTang QALY
Decrements
Health Outcomes
IPD Cases223 223 373 158 223 223
Hospitalized Pneumonia Cases350 350 564 244 350 350
Non -hospitalized Pneumonia
Cases926 926 1,649 659 926 926
Deaths due to IPD28 28 46 20 28 28
Deaths due to Pneumonia11 11 17 8 11 11
QALYs-507 -507 -835 -358 -509 -498
Life-years-682 -682 -1,113 -481 -682 -682
Costs (million $)
Total Cost$185 $190 $222 $168 $185 $185
Medical Costs$35 $35 $57 $25 $35 $35
Vaccine Costs$129 $134 $129 $129 $129 $129
Work Loss$21 $21 $35 $15 $21 $21
Cost Ratios ($)
Cost/QALYDominated Dominated Dominated Dominated Dominated Dominated
Cost/Life -year Dominated Dominated Dominated Dominated Dominated DominatedCohort of 19 -year -olds.  Comparator is PCV21 at CMC/IC or age 50.
25Supplemental PCV21 One Year after PCV20 (all)
BasePCV21 @
$335.60PCV20 Child
Indirect 0%Serotype 4 @
30%Tang QALY
Decrements
Health Outcomes
IPD Cases-847 -847 -866 -525 -847
Hospitalized Pneumonia Cases-1,875 -1,875 -1,973 -1,276 -1,875
Non -hospitalized Pneumonia Cases
-3,981 -3,981 -4,065 -2,690 -3,981
Deaths due to IPD-104 -104 -107 -65 -104
Deaths due to Pneumonia-70 -70 -74 -48 -70
QALYs1,261 1,261 1,285 808 1,286
Life-years2,059 2,059 2,110 1,325 2,059
Costs (million $)
Total Cost$557 $584 $555 $587 $557
Medical Costs-$65 -$65 -$67 -$43 -$65
Vaccine Costs$644 $671 $644 $644 $644
Work Loss-$23 -$23 -$23 -$15 -$23
Cost Ratios ($)
Cost/QALY442,010 463,475 431,656 726,607 433,172
Cost/Life -year 270,614 283,756 262,879 443,207 270,614Cohort of 66 -year -olds.  Comparator is no additional vaccine.
26Supplemental PCV21 Five Years after PCV20 (all)
BasePCV21 @
$335.60PCV20 Child
Indirect 0%Serotype 4 @
30%Tang QALY
Decrements
Health Outcomes
IPD Cases-1,035 -1,035 -1,300 -673 -1,035
Hospitalized Pneumonia Cases-3,360 -3,360 -4,852 -2,355 -3,360
Non -hospitalized Pneumonia Cases
-5,770 -5,770 -8,028 -4,015 -5,770
Deaths due to IPD-129 -129 -163 -84 -129
Deaths due to Pneumonia-132 -132 -193 -93 -132
QALYs1,580 1,580 2,099 1,064 1,600
Life-years2,608 2,608 3,460 1,757 2,608
Costs (million $)
Total Cost$485 $510 $439 $524 $485
Medical Costs-$102 -$102 -$142 -$70 -$102
Vaccine Costs$608 $634 $608 $608 $608
Work Loss-$22 -$22 -$28 -$15 -$22
Cost Ratios ($)
Cost/QALY306,901 323,076 209,103 492,194 302,891
Cost/Life -year 185,860 195,656 126,871 298,071 185,860Cohort of 70 -year -olds.  Comparator is no additional vaccine.
27Supplemental PCV21 1/5 years after PCV20 Among Adults with CMC/IC
Comparator is no additional vaccine.
1 Year
Cohort @411 Year
Cohort @451 Year
Cohort @555 Years
Cohort @415 Years
Cohort @455 Years
Cohort @55
Health Outcomes
IPD Cases-508 -532 -514 -553 -580 -584
Hospitalized Pneumonia Cases-933 -990 -1,056 -1,049 -1,119 -1,239
Non -hospitalized Pneumonia
Cases-3,593 -3,504 -3,031 -3,903 -3,823 -3,448
Deaths due to IPD-57 -62 -63 -63 -68 -73
Deaths due to Pneumonia-29 -32 -37 -34 -37 -44
QALYs936 981 897 1,004 1,053 1,010
Life-years1,320 1,394 1,332 1,424 1,506 1,504
Costs (million $)
Total Cost$314 $291 $199 $314 $287 $208
Medical Costs-$66 -$68 -$61 -$71 -$73 -$69
Vaccine Costs$421 $399 $289 $428 $402 $309
Work Loss-$41 -$40 -$28 -$44 -$42 -$31
Cost Ratios ($)
Cost/QALY335,330 296,483 221,736 312,933 272,520 206,191
Cost/Life -year 237,779 208,572 149,339 220,664 190,605 138,491
28Alternate Efficiency Measures
(Does not account for overlap between measures)
Number needed to vaccinate to prevent…
PCV21
@65PCV21
@CMC/ICPCV21
@50 & @65PCV21 Suppl
@66PCV21 Suppl
@70
Hospitalization 643 572 7,127 512 300
Case 263 180 974 209 130
Death 9,758 9,026 155,708 8,087 5,109
PCV21
@65PCV21
@CMC/ICPCV21
@50 & @65PCV21 Suppl
@66PCV21 Suppl
@70
Hospitalization $2,227 Cost -Saving $335,952 $205,491 $111,219
Case $906 Cost -Saving $72,898 $83,279 $47,910
Death $33,521 Cost -Saving $6,139,249 $3,220,043 $1,879,564 $ per averted…
29Limitations
❑Sequelae from IPD not modeled explicitly
❑Ranges on serotype distributions and other IPD data from ABCs
are +/ - 25% by assumption
❑Uncertainties about the pneumococcal disease trends due to
pneumococcal serotypes that are no longer included in PCV21
(e.g., serotype 4, 19F)
❑Uncertainties about the indirect effects from pediatric PCV20 use
❑Disruption from changing pneumococcal schedule not modeled
❑Disease rates are constant within specified age bins as single -year
of age disease estimates are unlikely to be precise.
30Summary
❑ Replacing PCV20 with PCV21 at age 65 increases QAL Ys with modest increases in
cost
▪Simulations range from $4,000 to $28,000 / QALY in several scenarios
▪Replacing PCV20 with PCV21 is dominated (lower QALYs and more costs) in a scenario where
serotype 4 disease accounts for 30% of pneumococcal disease
❑ Replacing PCV20 with PCV21 at diagnosis of IC or CMC before age 65 is cost -saving
▪Cost is $110,000/QALY in a scenario where serotype 4 disease accounts for 30%
▪At serotype 4 disease rates at 35% or above it results in decreased QALYs
❑ Moving PCV21 vaccination from age 65 to age 50 increases case counts and deaths,
but also results in gains in QAL Ys
▪Disease burden is shifted from younger adults to older adults who have lower background
QALY values
❑ Vaccinating at both age 50 and age 65 costs $300,000/QAL Y
▪ Sensitivity analyses range from $200,000/QALY to $400,000/QALY
❑ Vaccinating with PCV21 at age 19 instead of age 50 is dominated
▪ Less health (both lower QALYs and more cases) and increased costs
❑ Supplemental PCV21 at age 65 that includes all adults that previously had PCV20
(at age 65 or at CMC/IC) costs $400,000/QAL Y
▪ If the supplemental dose  is delayed until age 70 the cost drops to $300,000/QALY
❑ Supplemental PCV21 for the CMC/IC population ranges from $200,000 to $300,000
per QAL Y in the base case
▪ Cost per QALY is 5 -30% lower if PCV21 is delayed 5 years after PCV20 vaccination rather than 1 year afterward
▪ Assuming no herd immunity from childhood PCV20 program is associated with the lowest cost per QALYs
31Thank you!
Please send comments to:
cfstoecker@tulane.edu
Contributors:
Andrew Leidner
Miwako Kobayashi
Bo-Hyun Cho
Yin Wang
Cheryl Ward
National Center for Immunization & Respiratory Diseases
HSREB – Econ Team

32IPD Rates per 100k
Source: Active Bacterial Core Surveillance System, 2017 -2018; NHIS 2017 –2018. For multivariate sensitivity analyses distributio ns are beta -pert with -/+20% for
low and high. Risk Group19-49
Years50-64
Years65-74
Years75-84
Years85+
Years
General 2.09 6.09 8.25 13.90 33.06
CMC 8.09 24.04 25.89 33.34 58.57
IC 16.22 37.28 35.10 36.81 46.38
33NBP Hospitalization Rates per 100k
Source: MarketScan  & Optum databases. 2013 -2015 data. (Pelton et al. CID 2019) (95% CIs in parenthesis)Risk
Group19-49
Years50-64
Years65-74
Years75+
Years
General 35 (35, 36) 88 (87, 90) 191 (185, 197) 957 (938, 975)
CMC 207 (202, 212) 429 (423, 425) 941 (925, 957) 2745 (2717, 2774)
IC 701 (681, 721) 1226 (1207, 1244) 2124 (2087, 2162) 3992 (3944, 4040)
34NBP Outpatient  Rates per 100k
Source: Tong et al. 2014 data. BMC Health Serv Res 2018. For multivariate sensitivity analyses distributions are beta -pert with -/+20% f or low and high.Risk Group19-49
Years50-64
Years65-74
Years75-84
Years85+
Years
General 322.92 385.04 491.98 1366.22 2378.97
CMC 1872.91 1886.72 2410.70 3962.03 6899.00
IC 6361.40 5352.10 5461.00 5738.10 9991.70
35IPD Cases Resulting in Fatality
Source: Active Bacterial Core Surveillance System, 2017 -2018. For multivariate sensitivity analyses distributions are beta -pert with -/+20% for low and high.Risk Group19-49
Years50-64
Years65-74
Years75-84
Years85+
Years
General 5.54% 8.73% 7.93% 11.25% 17.30%
CMC 7.24% 11.06% 12.22% 12.82% 22.97%
IC 10.04% 14.27% 13.97% 11.33% 17.62%
36IPT NBP Cases Resulting in Fatality
Base Low High
18-49 Years 1.6 0.4 2.9
50-64 Years 2.8 1.1 4.4
65-74 Years 3.5 1.5 5.5
75-84 Years 4.1 2.2 6.0
85+ Years 5.3 3.3 7.2
Source: NIS2018 (lower bound: ICD -10 code J13 or J181 for primary diagnosis; upper bound: ICD -10 code J13 or J181 in ANY locatio n; base: mean of LB and UB).
Low and High parameters used in beta -pert distribution
37Vaccine Effectiveness
a. Bonten  NEJM 2015 (per protocol)
b. Point estimate from Pilishvili et al. ISPPD2018 abstract, lower bound set to 0, upper bound from Lewis 2020 ISPPD poster
c. Suaya  Vaccine 2018; 1477 -1483.
d. Applied the ratio of IPD VE/Pneumonia VE for all PCV13 types to the point estimate for ST3 IPD VE.  General CMC IC
PCV vs VT ( -ST3) IPDa 75.0 (41.4, 90.8) 75.0 (41.4, 90.8) 25.0 (13.8, 30.3)
PCV vs ST3 IPDb 26.0 (0, 53.4) 26.0 (0, 53.4) 8.7 (0, 17.8)
PCV vs VT ( -ST3) NBPc 66.7 (11.8, 89.3) 40.3 (11.4, 60.2) 15.0 (4.7, 21.8)
PCV vs ST3 NBPd 15.6 (0, 32.0) 15.6 (0, 32.0) 5.2 (0, 10.7)
38Coverage Rates
Base Lowe Highe
PCV Age -based 19 -49a 22.2 17.76 26.64
PCV Age -based 50 -64b 39.65 23.3 56
PCV, Age -based 65+c 56 49 63
Risk -based (at development of CMC/IC)a 22.2 21 23.5
PCV21 supplemental dosed 40.7 11.2 63.4
a. NHIS 2021 data https://www.cdc.gov/vaccines/imz -managers/coverage/adultvaxview/pubs -resources/vaccination -coverage -adults -2021.html ; Low and
high in age -based 19 -49 context are -/+20% of base case; low and high in risk -based context are bounds of the 95% CI for coverag e among individuals
eligible for risk -based vaccination
b. Low: NHIS 2021 for Zoster Vaccine in adults 60 -64 years; high: base estimate for PCV15/PCV20 coverage in adults 65 years and old er; base: mean
c. High: NHIS 2021 any pneumococcal coverage; low: any PCV13 coverage data in Medicare beneficiaries aged ≥65 years, 2019; base:  mean
d. % of PCV20 recipients who received PCV13 among Medicare Parts A/B beneficiaries as of Jan 17, 2024; low: coverage at age 66 y ears; high: coverage at
age 80 -84 years
e. Parameters for beta -pert distribution
39Herd Effects from PCV20 in Children
❑Apply serotype group -specific declines observed in
PCV13 types (+6C, -3, -19F) in adults after PCV13
introduction in children
❑Apply to additional types in PCV20
❑Run versions of the model with and without these herd
effects to assess importance
Year Base Lower Upper
1 0.755161 0.707483 0.813869
2 0.496227 0.459737 0.53535
3 0.339094 0.312705 0.372755
4 0.244074 0.220786 0.268572
5 0.187125 0.166702 0.206661
6 0.156599 0.138492 0.177142
7+ No further declinesRemaining Share of Disease
Source: Unpublished CDC model.
40Utility Decrements
Variable QAL Y DecrementsaImplied Healthy Days
Lostb
IPD0.0709
(0.0509, 0.0909)25.9
IPT NBP0.0709
(0.0509, 0.0909)25.9
OPT NBP0.0045
(0.00399, 0.00501)1.6
a QALY values from Mangen  et al. 2015 Eur Respir J (95% CIs in parenthesis)
b Health days lost were include on this slide to illustrate in relatable terms the magnitude of health loss associated with QAL Y decrements. Healthy days lost
calculated by multiplying QALY decrement by 365.
c Alternate values are inverse variance weighted values from Tang et al. 2021 J Pub Health. Source material places higher decre ment on outpatient disease
than inpatient disease for age 65+.Pneumococcal Disease
Treatment Intensity, AgeQALY
Decrement
Outpatient, 19 -64 0.0094
Inpatient, 19 -64 0.0396
Outpatient, 65+ 0.0586
Inpatient, 65+ 0.0087Alternate Utility Decrementsc
41Baseline QAL Y Values
Age General CMC/IC
50-55 0.83 (0.78,0.88) 0.72 (0.67,0.77)
56-60 0.81 (0.76,0.86) 0.69 (0.64,0.74)
61-65 0.77 (0.72,0.82) 0.63 (0.58,0.68)
66-70 0.76 (0.71,0.81) 0.57 (0.52,0.62)
71-75 0.74 (0.69,0.79) 0.54 (0.49,0.59)
76-80 0.7 (0.65,0.75) 0.52 (0.47,0.57)
81-85 0.63 (0.58,0.68) 0.51 (0.46,0.56)
86+ 0.51 (0.46,0.56) 0.51 (0.46,0.56)
Sisk, 2003.
42Disease Cost (2023$)
Data for ages 19 -64 from MarketScan  2019 -2022. Data for 65+ from CMS Medicare claims 2019 -2022.  95% CI from bootstrapping mean values with 1,000
iterations. All costs converted to 2023$ using CPI Medical Care before bootstrapping. See appendix slide for ICD -10 codes.Disease Setting Cost 95% CI
19-64 YearsIPD IPT $64,018.10 $61,559.31 $66,424.61
NBP IPT $58,423.99 $55,923.53 $60,908.13
NBP OPT $362.38 $339.44 $385.24
65+ YearsIPD IPT $27,564.22 $27,039.18 $28,149.20
NBP IPT $21,300.64 $20,825.64 $21,800.98
NBP OPT $318.22 $308.06 $328.70
43ICD -10 Codes for Medical Cost Extraction
Disease ICD-10 Codes
IPD A40.3, A40.9+B95.3, A41.9+B95.3, R78.81+B95.3, G00.1, G00.2+B95.3,
G00.9+B95.3, G03.9+B95.3, J86.x+B95.3, J85.1+B95.3, A40.3 + at least one code
from "All -cause", A40.9+B95.3 + at least one code from "All -cause",
A41.9+B95.3 + at least one code from "All -cause", R78.81+B95.3 + at least one
code from "All -cause", A40.9 & J13, A41.9 & J13, R78.81 & J13, M00.1x,
K65.8+B95.3, I30.1+B95.3, I33.0+B95.3, I33.9 +B95.3, K65.2+B95.3,
M86.1x/M86.2x/M86.9+B95.3, M00.0x, M00.2x, M00.8x, M00.9 + B95.3
NBP J13, J15.9+B95.3, J18.0/J18.1+B95.3, J18.8/J18.9+B95.3
All-cause (for
satisfying some
definitions of
IPD)J12.x (J12.0, J12.1, J12.2, J12.3, J12.81, J12.89, J12.9), J13, J18.1, A48.1, J14, J15.0,
J15.1, J15.2x (J15.20, J15.211, J15.212, J15.29), J15.3, J15.4, J15.5, J15.6, J15.8,
J15.9, J15.7, J16.x (J16.0, J16.8), A22.1, A37.X1, B25.0, B44.0, J17, J18.0, J18.2,
J18.8, J18.9, J09.X1, J10.0x (J10.00, J10.01, J10.08), J11.0x (J11.00, J11.08)
44Work Loss
AgeLabor Force
Participation
Rate (%)aMedian Daily
Wage ($)b
19 to 24 71 99.71
25 to 34 83.2 148.86
35 to 44 83 175.57
45 to 54 81.1 176.14
55 to 64 65.2 169.43
65 to 74 26.6 157.29
75+ 8.2 157.29
a US Bureau of Labor Statistics.
b Current Population Survey, 2023.
c Altawalbeh  SM, Wateska  AR, Nowalk  MP, Lin CJ, Harrison LH, Schaffner W, Zimmerman RK, Smith KJ. Societal cost of racial pneumococcal disease disparities in
US adults aged 50 years or older. Applied Health Economics and Health Policy. 2024 Jan;22(1):61 -71.
d Used ratio of days of work loss from outpatient (14) to inpatient pneumonia (18) allowed by Marine Corps policy and applied t o inpatient durations of illness
from Altawalbeh  2024. Vold  Pepper P, Owens DK. Cost -effectiveness of the pneumococcal vaccine in the United States Navy and Marine Corps. Clinical
infectious diseases. 2000 Jan 1;30(1):157 -64.Base High Low
Inpatientc 34 17 51
Outpatientd 26.4 13.2 39.7Labor Force Participation and Daily Wage Duration of Work Loss
45Question 1a: Vaccination at age 65 with PCV21
Serotype 4
@ 5%Serotype 4
@ 10%Serotype 4
@ 15%Serotype 4
@ 20%Serotype 4
@ 25%Serotype 4
@ 30%Serotype 4
@ 35+%
Health Outcomes
IPD Cases -749 -569 -389 -209 -28 152
Hospitalized Pneumonia Cases -1,498 -1,282 -1,067 -852 -637 -422
Non -hospitalized Pneumonia
Cases-3,350 -2,841 -2,333 -1,824 -1,316 -807
Deaths due to IPD -91 -69 -47 -25 -4 18
Deaths due to Pneumonia -55 -47 -39 -32 -24 -16
QALYs 1,132 897 661 426 191 -45
Life-years 1,808 1,431 1,055 679 302 -74
Costs (million $)
Total Cost 15 29 43 57 71 85
Medical Costs -54 -44 -34 -24 -15 -5
Vaccine Costs 90 90 90 90 90 90
Work Loss -21 -17 -12 -8 -4 1
Cost Ratios ($)
Cost/QALY 13,436 32,640 65,513 134,710 374,763 Dominated Dominated
Cost/Life -year 8,412 20,443 41,059 84,543 236,327 Dominated DominatedCohort of 65 -year -olds.  Comparator is PCV20 at age 65.
Base case serotype 4 distributions are age, risk, and disease condition specific as displayed earlier in the slides.  They ra nge  from 0 to 9.99%

Summary: 1Economic Assessment of PCV21 in U.S. Adults Charles Stoecker Tulane University School of Public Health and Tropical Medicine ACIP June 27, 2024  2Conflicts of Interest ❑Dr. Stoecker has no conflicts of interest to declare. 3Acronyms ❑ PCV: pneumococcal conjugate vaccine ❑ PCV20: 20 valent PCV ❑ PCV21: 21 valent PCV ❑ VE: vaccine effectiveness ❑ VT: vaccine type ❑ ST: serotype ❑ NBP: non -bacteremic  pneumonia ❑ IPD: invasive pneumococcal disease ❑ IPT: inpatient ❑ OPT: outpatient ❑ QALY:…