04 minhaj Mpox 508

Agency for Toxic Substances and Disease Registry National Center for Environmental Health
Centers for Disease Control and Prevention
Evidence to Recommendations Framework: Routine Vaccination with Jynneos for Adolescents at
Risk of Mpox
Faisal Syed Minhaj, PharmD, MPH Poxvirus and Rabies Branch Centers for Disease Control and Prevention Advisory Committee on Immunization Practices April 15, 2025
Does ACIP recommend vaccination* with the 2-dose †JYNNEOS vaccine series
for persons aged 12–17 years at risk for mpox §?EtR Question
*Interim recommendation to be revisited in 2-3 year s
† Dose 2 administered 28 days after dose 1
§Persons at risk:
1. Gay, bisexual, and other men who have sex with m en (MSM), or a person who has sex with
MSM, who in the past 6 months have had one of the f ollowing:
•A new diagnosis of ≥ 1 sexually transmitted disease
•More than one sex partner
•Sex at a commercial sex venue
•Sex in association with a large public event in a g eographic area where mpox
transmission is occurring
2. Sexual partners of persons with the risks descri bed in above
3. Persons who anticipate experiencing any of the a bove
Evidence to Recommendation Domains
Question(s) EtR Domain
•Is the problem of public health importance? Public Health Problem
•How substantial are the desirable anticipated effec ts?
•How substantial are the undesirable anticipated eff ects?
•Do the desirable effects outweigh the undesirable e ffects? Benefits and Harms
•Does the target population feel the desirable effec ts are large relative to the
undesirable effects?
•Is there important uncertainty or variability in ho w much people value the
main outcome? Values
•Is the intervention acceptable to key stakeholders? Acceptability
•What would be the impact on health equity? Equity
•Is the intervention feasible to implement? Feasibility
•Is the intervention a reasonable and efficient allo cation of resources? Resource Use
EtR Domain: Public Health Problem
Mpox current situation
Jynneos vaccine coverage in the United States among  people
at risk for mpox – June 2022 through September 2024
Overall vaccine coverage
1-dose: 42.2% and 2-dose: 26.2 %
Cumulative Monkeypox virus infections relative to
2022, by immunity level — United States, 2023
>50% is needed
to significantly
decrease the risk of
large outbreaks Cumulative
monkeypox
virus
infections,
relative to
2022
% Population at increased mpox risk with 1 or 2 dos es of Jynneos
Pollock ED. MMWR MorbMortal WklyRep 2023;72:568–573.
https://www.cdc.gov/cfa-modeling-and-forecasting/mp ox-gbmsm-
technical-brief/nov24-update/
U.S. mpox case trends in adolescents and children,
May 2022 through March 2025
Case Count Age
group
92 12-17
17 6-11
23 1-5
15 <1
147 Total

Are outbreaks of mpox of public health importance?
No Probably no Uncertain Yes
Varies
Probably Yes
EtR Domain: Benefits and Harms
•Adolescent arm met pre-specified criteria for non-inferior ity
-GMT ratio of adolescents to adults was 1.60 (CI 1.3 2, 1.95)
•Vaccine was safe and well tolerated in adolescents
-Solicited systemic and local AEs were similar betwe en adolescents and adults
•Systemic: 74% (CI 69, 79) vs 73% (CI 66, 79)
•Local: 88% (CI 84, 91) vs 91% (CI 87,95)
-Unsolicited related AEs: mainly injection site rela ted
-Dizziness in adolescents is common with vaccine adm inistration in this age group
and is not likely to represent a safety concern Adolescent safety and immunogenicity study summary
•Vaccine adverse event reporting system (VAERS) 1
-At least 1,245 vaccinees nationwide
-One report of syncope
-Three reports of unspecified mild local and systemi c reactions
•VSD 2
-88 vaccinees
-No adverse events of special interest observed
•V-safe 1
-No participants were <18 years of age
•EIND 3
-57 vaccinees
-21% reported local or systemic reactions. No seriou s adverse events were reported Adverse events among individuals <18 years of age
1) https://pubmed.ncbi.nlm.nih.gov/38647241/ 2) htt ps://pubmed.ncbi.nlm.nih.gov/39565485/ 3) https://p ubmed.ncbi.nlm.nih.gov/36480476/
How substantial are the desirable anticipated effects
Minimal Small Moderate Large
Don’t Know Varies

How substantial are the undesirable anticipated effects
Minimal Small Moderate Large
Don’t Know Varies

Do the desirable effects outweigh the undesirable ef fects?
Favors Intervention Favors Comparison Favors Both
Favors Neither Unclear

EtR Domain: Values
•NIH rapidly completed trial recruitment
•Participants were supportive in participating to help frien ds
•Adolescent Medicine Trials Network for HIV/AIDS Intervent ions (ATN)
youth advisors were surveyed and 12/13 respondents we re supportive of
vaccination
•When an outbreak occurred (i.e., 2022 global outbreak) , pediatric close
contacts were vaccinated Values Considerations
JYNNEOS first doses administered to children 17 yea rs
and younger by sex May 2022 – September 2024
Persons with no age data available were removed fro m the analysis Total first doses Age group
798 12-17
391 6-11
293 1-5
150 <1
1,632 Total
Does the target population feel that the desirable effects are large relative to the undesirable effec ts?
No Probably no Uncertain Yes
Varies
Probably Yes
Is there important uncertainty about or variability  in
how much people value the main outcomes?
Important uncertainty or variability Possibly important uncertainty or variability
No known undesirable outcomes
Probably no important uncertainty or variability No important uncertainty or variability
EtR Domain: Acceptability
•Mothers from the survey do not view their children at r isk for mpox.
-However, the intent to vaccinate is higher than exp ected.
•Vaccines were primarily given to adolescents both through  public health
and STI clinics.
•Among 21 surveyed ATN providers who provide care for at-risk adolescents:
-Over half already offer the mpox vaccine.
-95% would recommend mpox vaccines for eligible pati ents and do not have
concerns about recommending the vaccine.
-Majority expressed challenges associated with offer ing the vaccine; most
common concern was financial cost to the clinic. Summary of Acceptability data
Is the intervention acceptable to key stakeholders?
No Probably no Uncertain Yes
Varies
Probably Yes
EtR Domain: Health Equity
Vaccine administrations* and cases in adolescents by
race and ethnicity, May 2022 – March 2025
n=92 n=798
*Vaccine administration through September 2024, Case da ta
through March 2025 +Includes 3 mpox cases indicating Multiple races. Mul tiple
races was not reported for vaccine administration da ta.
If Hispanic or Latino was indicated for ethnicity, Race/ethnicity is indicated as Hispanic or Latino; if Hispanic or
Latino ethnicity was not indicated, Race/ethnicity is indicated
as Race Vaccine Administrations Mpox Cases
+
•No groups or settings were disadvantaged by recommend ation for JYNNEOS
use during mpox outbreaks.
•Immunogenicity is the same for immunocompetent persons 12-17 years.
•Implementation of vaccine should assure equitable access.
•Endorsement by ACIP could facilitate broad acceptance o f recommendation
(e.g., insurance, health departments, pharmacies). Health Equity
What would be the impact on health equity?
Reduced Probably Reduced Probably no impact Increased
Varies
Probably Increased
Don’t know

EtR Domain: Feasibility
•Wide range of vaccinators can administer vaccine (pediatr icians,
pharmacists, public health nurses)
•Wide range of potential facilities: public health, STI clinic, a dolescent health
clinic, pediatrician offices
•Same Immunization Information Systems (IIS) requirement s and reporting
infrastructure as other vaccines
•Limitations to access
-Poor access in rural communities
-Cost of vaccine and 10 vial minimum ordering quanti ty could hinder practices
stocking vaccine
-Pediatricians may defer to STI/adolescent clinics Feasibility Considerations
•Two doses, 28 days apart requires follow up and reminde rs
•JYNNEOS, once thawed/refrigerated, is good for either 4 or 8 weeks,
allowing time to schedule a second dose.
•Frozen storage is ~18 months Feasibility Considerations
Is the intervention feasible to implement?
No Probably no Uncertain Yes
Varies
Probably Yes
EtR Domain: Resource Use
•JYNNEOS is commercially available
-Similar mechanisms for billing/reimbursement
•Medicaid/Medicare/317 funding/VFC
•Generally, vaccines are a good use of resources
•Cost-effectiveness of vaccination in adolescents is uncer tain Resource Use
Is the intervention a reasonable and efficient allocation of resources?
No Probably no Uncertain Yes
Varies
Probably Yes
Balance of Consequences
Summary of Work Group Interpretation of EtR Domains
Work Group Interpretation EtR Domain
Yes Public Health Problem Benefits and Harms
Large Benefits
Small Harms
Favors intervention Benefit>Harm?
Values
Probably yes Desirable>Undesirable?
Possibly important OR probably no important
uncertainty or variability Uncertainty?
Probably yes Acceptability
Probably increased Equity
Probably yes Feasibility
Probably yes Resource Use
Balance of consequences
There is
insufficient evidence to determine the balance of consequences Desirable consequences clearly
outweigh
undesirable consequences in most settings Desirable consequences
probably
outweigh
undesirable consequences in most settings The balance
between the desirable and undesirable consequences is closely
balanced or
uncertain Undesirable consequences
probably
outweigh
desirable consequences in most settings Undesirable consequences clearly
outweigh
desirable consequences in most settings
ACIP recommends vaccination* with the 2-dose †JYNNEOS vaccine series for
persons aged 12–17 years at risk for mpox §?Proposed Recommendation 2
*Interim recommendation to be revisited in 2-3 year s
† Dose 2 administered 28 days after dose 1
§Persons at risk:
1. Gay, bisexual, and other men who have sex with m en (MSM), or a person who has sex with
MSM who in the past 6 months have had one of the fo llowing:
•A new diagnosis of ≥ 1 sexually transmitted disease
•More than one sex partner
•Sex at a commercial sex venue
•Sex in association with a large public event in a g eographic area where mpox
transmission is occurring
2. Sexual partners of persons with the risks descri bed in above
3. Persons who anticipate experiencing any of the a bove
Tentative timeline for ACIP discussions and votes
ACIP Meeting:
Presentation
of two EtR
April 2025 ACIP Meeting:
Voting on two
EtR
June 2025 Continue monitoring
mpox epidemiology
and vaccine
recommendations
Ongoing
The findings and conclusions in this report are tho se of the authors and do not
necessarily represent the official position of the Centers for Disease Control and
Prevention Thank you

Summary: Agency for Toxic Substances and Disease Registry National Center for Environmental Health  Centers for Disease Control and Prevention  Evidence to Recommendations Framework: Routine Vaccination with Jynneos for Adolescents at   Risk of Mpox  Faisal Syed Minhaj, PharmD, MPH Poxvirus and Rabies Branch Centers for Disease Control and Prevention Advisory Committee on Immunization Practices April 15, 2025  Does ACIP recommend vaccination* with the 2-dose †JYNNEOS vaccine series  for persons aged…


01 Marx Lyme 508

Introduction to the
Lyme Disease Vaccines Work Group
Grace E. Marx, MD, MPH
Lead, Lyme Disease Vaccines Work Group
April 15, 2025
Advisory Committee on Immunization PracticesNational Center for Emerging and Zoonotic Infectious Diseases

•Most common vector -borne disease in the U.S.
•An estimated 476,000 people in the U.S. diagnosed and treated for Lyme
disease each year1
•Estimated to cost $345– 968 million annually in health care costs2Public Health Problem –Lyme disease
1. Kugeler K et al. Emerg  Infect Dis 2021: 27(2):616– 619.
2. Hook S. et al. Emerg  Infect Dis 2022: 28(6):1170– 1179.
•1990s
-Several vaccines developed, each containing OspA  antigens from Borrelia burgdorferi
-OspA  antibodies neutralize spirochete in the tick midgut, thus preventing
transmission
-LYMErix ® licensed 1998; available  1998 – 2002 until discontinued by manufacturer
due to low demand
•2010s – 2020’s
-Steady increase in Lyme disease incidence, with expansion outward from high -
incidence areas in the Northeast, mid -Atlantic, and Midwest
-VLA15, a multivalent recombinant protein vaccine , currently in phase 3 clinical trials
-mRNA vaccine candidates in early clinical trialsLyme Disease Vaccines Development
•Review epidemiology and burden of Lyme disease
•Review data about risk for Lyme disease
•Review safety, immunogenicity, and efficacy data for Lyme disease vaccine
candidates
•Review economic analyses related to Lyme disease vaccination
•Develop Lyme disease vaccination policy options
•Identify areas where additional data are neededACIP Lyme Disease Vaccines Work Group Objectives
•Chair and work group members
-TBD
•Lead
-Grace MarxACIP Lyme Disease Vaccines Work Group
•May  2025 – first work group meeting
•June 2025 – ACIP presentation
-Epidemiology, burden, and clinical manifestations of Lyme diseaseACIP Lyme Disease Vaccines Work Group Initial Timeline
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.
Thank you.

Summary: Introduction to the  Lyme Disease Vaccines Work Group Grace E. Marx, MD, MPH Lead, Lyme Disease Vaccines Work Group April 15, 2025 Advisory Committee on Immunization PracticesNational Center for Emerging and Zoonotic Infectious Diseases  •Most common vector -borne disease in the U.S.  •An estimated 476,000 people in the U.S. diagnosed and treated for Lyme  disease each year1 •Estimated to cost $345– 968 million annually in health care costs2Public Health Problem –Lyme disease 1. Kugeler K et…


03 influenza Shimabukuro 508

Highly Pathogenic
Avian Influenza A
(H5N1)
Tom Shimabukuro, MD, MPH, MBA

Influenza Division
National Center for Immunization and Respiratory
Diseases (NCIRD)
Centers for Disease Control and Prevention (CDC)
October 23, 2024
HPAI A(H5N1)/ HPAI A(H5)  Human Cases Since 1997
Past Reported Global Human Cases with Highly Pathogenic Avian Influenza A(H5N1) (HPAI H5N1) by Country, 1997 -2024 | Bird Flu | C DC (Thru Aug 7, 2024; may include  A(H5)+, presumed H5N1 cases) 2

•Historically, human infections have been
the result of:
▪Poultry exposures
oDirect/close contact with sick or
dead poultry
oVisiting a live poultry market
▪Exposure to other infected animals
oDirect contact or close exposure
(swans, dairy cows)
▪Limited, non -sustained human -to-
human transmission has occurred
globally in the past (not in the
United States)Historical Human Exposures to HPAI A(H5N1) Viruses
3
CDC’s Priorities
•Supporting and engaging  public
health and agricultural partners
•Protecting human health and
safety
•Understanding risk to people
from HPAI A(H5N1) viruses
•Assessing HPAI A(H5N1) viruses
for genetic changes
Avian Influenza Social Media Toolkit | Bird Flu | CDC
4

HPAI A(H5N1) Situation Update – Dairy Herds
•As of October 18, 2024, USDA
has confirmed HPAI A(H5N1)
in U.S. dairy herds in 324
farms across 14 states
▪Dairy cow illness was observed in
early 2024
▪Significant decrease in milk
production and quality
▪March 25, 2024 : USDA reported
HPAI A(H5N1) confirmed in cows
from Texas and Kansas
Highly Pathogenic Avian Influenza (HPAI) Detections in Livestock | Animal and Plant Health Inspection Service (usda.gov)  5

HPAI A(H5) Human Cases, United States, During 2024
6
H5 Bird Flu: Current Situation | Bird Flu | CDC  (all cases ≥18 years old, data through Oct 18, 2024)•Cases with dairy cattle and poultry exposures
have been clinically mild
▪Mainly eye symptoms (conjunctivitis, eye
discharge)
▪Some cases reported mild respiratory and
systemic symptoms (e.g., subjective fever)
•The Missouri case had multiple underlying health
conditions and was hospitalized with
gastrointestinal symptoms, chest pain, and other
symptoms not typical of a respiratory illness and
tested positive for influenza A
▪Illness was not severe, patient treated with
oseltamivir and recovered
▪Specimen was identified and confirmed as
HPAI A(H5N1) through regular surveillance
▪Serology results are pending on the case, a
symptomatic household contact of the case,
and several exposed healthcare workers
who experienced mild respiratory illness
Influenza A(H5) Human Cases –Virus Sequences to Date
•Sequences maintain primarily avian genetic characteristics and lack
changes that would make the virus better adapted to infect or spread
among humans
•Diagnostics :No impact to the current CDC influenza diagnostic
assay's ability to detect A(H5N1) viruses
•Treatments :No known markers of resistance to FDA approved antiviral
drugs for influenza
•Candidate Vaccine Viruses (CVVs)
▪Hemagglutinins of human influenza viruses remain antigenically related to two
available CVVs
How CDC is monitoring influenza data among people to better understand the current avian influenza A (H5N1) situation | Bird Flu | CDC7
•All people with direct or close exposure to animals infected
with influenza A(H5N1) should be monitored for illness
during exposure and for 10 days after their last exposure
•Signs/symptoms may include:
▪feeling feverish, cough, sore throat, runny or stuffy nose, muscle or
body aches, headaches , fatigue , eye redness (or conjunctivitis) ,
shortness of breath or difficulty breathing
▪less commonly, diarrhea, nausea, vomiting, or seizures
•If signs/symptoms develop, seek medical evaluation for
possible influenza testing and antiviral treatment
•Symptomatic persons should isolate away from others during
this evaluation
•State and local h ealth de partments are monitoring workers on
impacted farms and can facilitate testing and treatmentSymptom Monitoring Recommendations
https://my.clevelandclinic.org/health/diseases/22401 -bird-flu
8Highly Pathogenic Avian Influenza A(H5N1) Virus in Animals: Interim Recommendations for Prevention, Monitoring, and Public He alth
Investigations | Bird Flu | CDC ; Interim Guidance on Specimen Collection and Testing for Patients with Suspected Infection with Novel Influenza
A Viruses Associated with Severe Disease or with the Potential to Cause Severe Disease in Humans | Bird Flu | CDC
•CDC is continuing to
support state and local
health departments
monitoring exposed
people during and for 10
days after last exposureOngoing Human Monitoring
H5 Bird Flu: Current Situation | Bird Flu | CDC
How CDC is monitoring influenza data among people to better understand
the current avian influenza A (H5N1) situation | Bird Flu | CDC
(Through Oct 18, 2024)
9

Since Feb 2024, public health laboratory monitoring includes testing of over 54,360 specimens using a protocol that
would have detected influenza A(H5) or other novel influenza viruses, 1 person has tested positive (the Missouri case)Surveillance, 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 | CDC10
No indicators of unusual influenza
activity in people, including avian
influenza A(H5N1)
Findings from a Michigan Seroprevalence Study
•In June 2024, Michigan Department of Health collected blood
samples from 35 dairy workers
▪had varying roles, but most worked with infected cows
▪less than half reported using masks or goggles
•Samples were tested for antibodies against influenza A(H5N1)
virus and a seasonal influenza virus
•None of the participants showed neutralizing antibodies specific
to avian influenza A(H5N1) virus, although many showed
antibody responses to seasonal influenza virus
•This suggests that these people were not previously infected
with influenza A (H5N1) despite high risk of exposure
11
Ferret Studies
•Ferret model permits study of influenza disease severity and transmissibility
at the same time
•Ferrets present with many clinical signs of infection shared by humans
▪But not conjunctivitis
•Limitations of ferret model
▪Ferrets  in sustained contact 24/7
▪Inoculation doses used in these studies may not be representative of natural exposure
in humans
▪Ferrets used in most studies have no preexisting antibodies to influenza, unlike most
humans who have had disease or vaccinations
▪General limitations of animal models
12
Pathogenesis and Transmission of Human Influenza
A(H5N1) Viruses in Ferrets
13*Pulit -Penaloza  et al, manuscript in press; †Brock et al, manuscript in preparationInfluenza A(H5N1) VirusMean  Max
Weight Loss
(inoculated ferrets)Lethality
(inoculated ferrets)Direct Contact
Transmission
(ferrets co -housed)Resp Droplet
Transmission
(refer to image)
A/Texas/37/2024(H5N1)
(1st human case in 2024)* 13% 9/9 (100%) 3/3 (100%) 4/6 (66%)
A/Michigan/90/2024 (H5N1)
(2ndhuman case in 2024)†9.1% 0/6 (0%) 3/3 (100%) 2/3 (66%)
Respiratory droplet (airborne)
transmission model
Inoculated ferretNaïve ferret
Direct contact
transmission model
Ferret Studies Summary
•Severity
▪The Michigan human A(H5N1) virus caused less severe disease  in ferrets than the Texas
human A(H5N1) virus
▪Less mean maximum weight loss, 9.1% vs. 13%
▪Lower lethality, 0/6 (0%) vs. 9/9 (100%)
•Transmission
▪The Michigan human A(H5N1) virus still transmits with some capacity by the respiratory
droplet route, similar to  what was observed with Texas human A(H5N1) virus
•These findings are important because the Michigan human A(H5N1) virus
better represents currently circulating viruses compared to the Texas human
A(H5N1) virus
14
CDC Influenza Risk Assessment Tool (IRAT)
•Evaluative tool for prioritizing
resources for pandemic
preparedness
•Viruses scored using 10 risk
elements by U.S. government
subject matter experts for
emergence and public health
impact
•Emergence  is the risk of a novel
influenza virus acquiring the
ability to spread easily and
efficiently in people
•Public health impact is the
potential severity of human
disease caused by the virus, the
burden on society if a novel
influenza virus were to begin
spreading efficiently and
sustainably among people1.Genomic variation
2.Receptor binding
3.Transmission in Laboratory animals
4.Antivirals and Treatment Options
5.Existing Population Immunity
6.Disease Severity and Pathogenesis
7.Antigenic Relationship to Vaccine Candidates
8.Global Geographic Distribution
9.Infection in Animals, Human Risk of Infection
10.Human Infections and Transmission
Virus
Population
Ecology
Influenza Risk Assessment Tool (IRAT) | Pandemic Flu | CDC 15
0.00.51.01.52.02.53.03.54.04.55.05.56.06.57.07.58.08.59.09.510.0
0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 8 8.5 9 9.5 10Impact
EmergenceIRAT Virus Emergence and Impact – Comparison of Risk Scores
Influenza Risk Assessment Tool (IRAT) | Pandemic Influenza (Flu) | CDC• X: H5N1 clade 2.3.4.4b [A/Texas/37/2024ª] (X)
Emergence = 5.8, Impact = 6.1
• A: Highest emergence score Eurasian Avian/swine H1N1 in China
Emergence = 7.5, Impact = 6.9
• C: Highest Impact score avian H7N9 in China
 Emergence = 6.5, Impact = 7.5Data
labelInfluenza VirusEmergence
ScoreImpact
Score
A A(H1N1) [A/swine/Shandong/1207/2016] 7.5 6.9
B A(H3N2) variant [A/Ohio/13/2017] 6.6 5.8
C A(H7N9) [A/Hong Kong/125/2017] 6.5 7.5
E A(H9N2) Y280 lineage [A/Anhui -Lujiang/13/2018] 6.2 5.9
F A(H3N2) variant [A/Indiana/08/2011] 6.0 4.5
X A(H5N1) clade 2.3.4.4b [A/Texas/37/2024A] 5.8 6.1
G A(H1N2) variant [A/California/62/2018] 5.8 5.7
I A(H5N6) clade 2.3.4.4b [A/Sichuan/06681/2021] 5.3 6.3
J A(H5N1) Clade 1 [A/Vietnam/1203/2004] 5.2 6.6
KA(H5N1) Clade 2.3.4.4b [A/mink/Spain/3691 -
8_22VIR10586 -10/2022]5.1 6.2
L A(H5N6) [A/Yunnan/14564/2015] –like 5.0 6.6
N A(H5N8) clade 2.3.4.4b [A/Astrakhan/3212/2020] 4.6 5.2
OA(H5N1) clade 2.3.4.4b [A/American
wigeon/South Carolina/AH0195145/2021]4.4 5.1
Q A(H5N8) [A/gyrfalcon/Washington/41088/2014] 4.2 4.6
U A(H7N8) [A/turkey/Indiana/1573 -2/2016] 3.4 3.9
VA(H7N9) [A/chicken/Tennessee/17 -007431 -
3/2017]3.1 3.5X: Texas H5N1 2024
K: mink/Spain H5N1 2022
O: wigeon/SC H5N1 2021
16
IRAT Summary
•The IRAT is an evaluative tool used by public health partners  for prioritizing
resources for influenza pandemic preparedness
•ItisNOT intended to predict a pandemic and is NOT to be used to assess the
overall population risk nor individual risk
•Using A(H5N1) clade 2.3.4.4b [A/Texas/37/2024(H5N1)] as the prototype virus, the
score remains in the "moderate" potential pandemic influenza risk category
•The mean -high and mean -low acceptable score ranges for all the clade 2.3.4.4b
viruses overlap, indicating that these viruses remain similar, and their overall risk
scores remain "moderate"
•Based on available data, CDC’s current assessment is that the risk to the general
public from avian influenza A(H5N1) virus remains low
17
Public Health Risk
•Overall risk to the public for HPAI A(H5N1)
remains low
•Greater risk for people with close,
prolonged, or unprotected exposures to
infected animals, or to environments
contaminated by infected animals
•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 Social Media Toolkit | Bird Flu | CDC
18
Avian Influenza Social Media Toolkit | Bird Flu | CDC
Avian Influenza Social Media Toolkit | Bird Flu | CDC
19
Resources from CDC
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
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
20
Acknowledgments
CDC Influenza Division
•Virology, Surveillance, and Diagnosis Branch
•Epidemiology and Prevention Branch
•Immunology and Pathogenesis Branch
•Global Influenza Branch
•Office of the Director
CDC 2024 Influenza A(H5N1) Response
21
Thank you

Summary: Highly Pathogenic  Avian Influenza A  (H5N1) Tom Shimabukuro, MD, MPH, MBA   Influenza Division National Center for Immunization and Respiratory  Diseases (NCIRD) Centers for Disease Control and Prevention (CDC) October 23, 2024 HPAI A(H5N1)/ HPAI A(H5)  Human Cases Since 1997 Past Reported Global Human Cases with Highly Pathogenic Avian Influenza A(H5N1) (HPAI H5N1) by Country, 1997 -2024 | Bird Flu | C DC (Thru Aug 7, 2024; may include  A(H5)+, presumed H5N1 cases) 2  •Historically, human…


01 Chikungunya Asturias 508

CHIKUNGUNYA VACCINES
ACIP Meeting
October 23, 2024
Edwin Asturias, MD
Chair, ACIP Chikungunya Vaccines Work Group
•Chikungunya Vaccines Work Group formed in May 2022
•Chikungunya vaccines
-Live attenuated vaccine licensed in November 2023 (manufactured by Valneva)
-Virus -like particle vaccine submitted to FDA for licensure (manufactured by
Bavarian Nordic)
•Some recommendations developed, and others under development, for
use of chikungunya vaccines among U.S. persons at risk of chikungunya
including travelers, laboratory workers, and residents of U.S. territories and
states with risk of transmissionBackground
•October 2022– October 2023
-Chikungunya virus disease and its sequelae
-Chikungunya epidemiology globally and among U.S. travelers and laboratory
workers
-Live attenuated chikungunya vaccine including immunogenicity, safety, and other topics
•February 2024
-ACIP approved recommendations for use of live attenuated chikungunya vaccine among U.S. travelers and laboratory workers
•June 2024
-Epidemiology of chikungunya in U.S. territories and states
-Cost -effectiveness of use of live attenuated chikungunya vaccine among adults
living in U.S. territories Recap of previous Work Group ACIP presentations
1. Update on chikungunya and chikungunya vaccines
2. Virus -like particle chikungunya vaccine
3. Work Group interpretation of chikungunya virus -like particle vaccine
dataOverview of today’s session
Chikungunya Vaccines Work Group members
ACIP ACIP Liaisons Invited Consultants ( cont )
Edwin Asturias, Univ Colorado Elizabeth Barnett, ISTM Margaret Ryan, DoD
Lin Chen, Mount Auburn Hosp James Campbell, AAP Steven Schofield, CATMAT
Mary Pat Friedlander, AAFP David Shlim, Jackson Hole Travel & Trop Med
CDC Lead Saroj Rai, AIM Nestor Sosa, Uni New Mexico Hospital
Susan Hills, DVBD Sanet Torres, San Jorge Children & Women's Hospital
Invited Consultants Kirsten Vannice, Bill & Melinda Gates Foundation
Ex Officio Alan Barrett, Univ Texas Galveston Mary Wilson, Univ California San Francisco
Robin Levis, FDA Beth Bell, Univ Washington
Sixun Yang, FDA Carina Blackmore, Florida Dept Health
Lesley Dupuy (NIH) Alan Lam, DoD
Chikungunya Vaccines Work Group CDC participants
DVBD DGMH GRADE/ETR consultants
Sarah Guagliardo Kevin O’Laughlin Doug Campos -Outcalt
Ann Powers Rebecca Morgan
Erin Staples DHQP
Parker Acevedo Michael McNeil ACIP Secretariat
Laura Adams Jessica MacNeil, NCIRD
Joshua Wong GID Leslie Lee, NCIRD
Pierre Muhoza
NCEZID
Rita Helfand

Summary: CHIKUNGUNYA VACCINES ACIP Meeting October 23, 2024 Edwin Asturias, MD Chair, ACIP Chikungunya Vaccines Work Group •Chikungunya Vaccines Work Group formed in May 2022  •Chikungunya vaccines  -Live attenuated vaccine licensed in November 2023 (manufactured by Valneva) -Virus -like particle vaccine submitted to FDA for licensure (manufactured by  Bavarian Nordic)  •Some recommendations developed, and others under development, for  use of chikungunya vaccines among U.S. persons at risk of…


02 Chikungunya Hills 508

Update on chikungunya and chikungunya vaccinesNational Center for Emerging and Zoonotic Infectious Diseases
Susan Hills MBBS MTH
CDC Lead , Chikungunya Vaccines Work Group
Arboviral Diseases Branch
Division of Vector -Borne Diseases
Fort Collins, Colorado
ACIP Meeting, October 23, 2024
•Mosquito -borne disease
•Key vectors are Aedes aegypti
and Aedes albopictus mosquitoesChikungunya
2
Distribution and virus transmission
Typically tropical
and subtropical
regions
Periodically
causes large
outbreaks, often
with high attack
rates
Countries and territories with current or past transmission of chikungunya
virus 3
Key features of acute chikungunya virus disease
Febrile illness with typically severe
arthralgia, can be debilitating
Other symptoms include headache, rash, myalgia, anorexia
No anti -viral treatment available and
management is supportive
Image above from : https://www.paho.org/en/topics/chikungunya
4
•Rare serious complications (e.g.,
myocarditis, hepatitis, neurologic illness)
•Deaths rare and reported mostly in
-Older adults, particularly those with
comorbidities
-Young infants infected perinatally or by mosquito bitesComplications of chikungunya
5
Image from : https://www.paho.org/en/topics/chikungunya
Bin S et al, Clin Case Rep 2023
•Acute symptoms usually resolve in 7 –10 days
•Some patients have continuation or relapse
of symptoms
•Ongoing arthralgia of variable severity might be present in up to ~50% at 3 months and
~30% at 12 months
1Chronic arthralgia following chikungunya
1Based on recent meta -analysis (Lindsey N. Chronic arthralgia after chikungunya. US Advisory Committee on Immunization Practices meeting, June 2023)  6
•Approximately 100 –200 reported cases
annually
•Infection most commonly acquired in
locations in Asia and Americas
•Greatest risk factor for travelers is traveling to area with outbreakChikungunya among U.S. travelers
7
Chikungunya vaccines
•Manufactured by Valneva as IXCHIQ
•Licensed November 9, 2023
•Age group currently adults ≥18 years
•Single dose schedule Live attenuated chikungunya vaccine
9
•ACIP recommends  the live attenuated chikungunya vaccine for persons
aged ≥18 years traveling to a country or territory where there is a
chikungunya outbreak
•In addition, the vaccine may be considered for the following persons
traveling to a country or territory without an outbreak but with evidence of chikungunya virus transmission among humans within the last 5 years
-Persons aged >65 years, particularly those with underlying medical conditions,
who are likely to have at least moderate exposure* to mosquitoes, OR
-Persons staying for a cumulative period of 6 months or moreRecommendations for travelers approved February 2024
*Moderate exposure could include travelers who might have at least 2 weeks (cumulative) of exposure to mosquitoes in indoor o r
outdoor settings10
•ACIP recommends live attenuated chikungunya vaccine for
laboratory workers with potential for exposure to chikungunya
virusRecommendations for use among laboratory workers
approved February 2024
11
•Adolescents aged 12 –17 years: expected submission to FDA in 2024
•Children aged 1 –11 years: clinical trial began December 2023
•Long term persistence trial ongoing
-High seroresponse  rate (97%) at 2 years
-Monitoring continuing through 10 years to determine if booster dose
needed in futureUpdates on live attenuated chikungunya vaccine
12
•Manufactured by Bavarian Nordic
•Licensure possible February 2025
•Intended age group is adolescents and adults aged ≥12 years
•Single dose schedule Virus -like particle chikungunya vaccine
13
Licensure through accelerated approval pathway
Traditional approval challenging and clinical development would likely
have been delayed
–Efficacy trial with disease endpoint difficult as outbreaks unpredictable and
duration can be relatively short
–No established immunologic correlate of protection
Accelerated approval pathway endorsed at FDA VRBAC* meeting, 2019
–FDA can grant for products for serious conditions that fill unmet medical need
–Effectiveness demonstrated by controlled trials showing vaccine has effect on surrogate endpoint reasonably likely to predict clinical benefit
–Marker of protection for virus -like particle vaccine based on neutralizing
antibody titer estimated from validated non -human primate model
–Post -licensure requirement for controlled trials to confirm clinical benefit
*Vaccines and Related Biological Products Advisory Committee 14
ACIP recommendations for use of chikungunya vaccines
Population Live attenuated vaccine Virus -like particle vaccine
Travelers Completed*Pending†
Laboratory workers Completed Pending
Residents of U.S. territories
with transmission risk Pending Pending
Residents of U.S. states with transmission risk Pending Pending
*Adults aged ≥18 years        †Adolescents and adults aged ≥12 years
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: Update on chikungunya and chikungunya vaccinesNational Center for Emerging and Zoonotic Infectious Diseases Susan Hills MBBS MTH CDC Lead , Chikungunya Vaccines Work Group Arboviral Diseases Branch Division of Vector -Borne Diseases Fort Collins, Colorado ACIP Meeting, October 23, 2024 •Mosquito -borne disease •Key vectors are Aedes aegypti  and Aedes albopictus mosquitoesChikungunya  2 Distribution and virus transmission Typically tropical  and subtropical  regions Periodically  causes…


03 Chikungunya Jenkins 508

CHIKV VLP vaccine
Bavarian Nordic’s chikungunya vaccine candidate
October 2024
Victoria Jenkins, PhD, MBA
VP Regulatory Affairs & CHIKV Program LeadBavarian Nordic
vije@bavarian -nordic.com
2E protein
Membrane
Capsid shell
RNA
CHIKV VLP vaccine
Chikungunya virus3CHIKV virus -like particle vaccine (CHIKV VLP)1
CHIKV, chikungunya virus; VLP, virus -like particle ; BLA, Biologics License Application; PDUFA, Prescription Drug User Free Act
1. Bennett SR, et al. Lancet Infect Dis. 2022;22(9):1343−1355. 2. Basore K et al. Cell. 2019 Jun 13;177(7):1725- 1737. 3. Sun S, et al. ELife. 2013;2:e00435
•Comprised of 3 recombinant  chikungunya virus (CHIKV)
structural proteins that assemble into virus- like particles, which
mimic  the CHIKV but cannot replicate
•Adjuvanted with aluminum hydroxide; single 40 µg VLP dose (0.8
mL) in a pre -filled syringe; administered IM
•Priority Review for the BLA granted by FDA (PDUFA target action date: 14th Feb 2025)
•Proposed indication: prevention of disease caused by
CHIKV infection in individuals 12 years of age and older
•Proposed contraindications: hypersensitivity, including
severe allergic reaction (anaphylaxis), to any component
•It was agreed with regulators to use a defined threshold of serum neutralizing antibodies as a surrogate endpoint of efficacy
in phase 3 clinical trials
Cryo-electron microscopy reconstruction of CHIKV VLP2

CHIKV- luciferase assay developed to evaluate v accine efficacy
measures cross- neutralization
Vaccine strain
Assay strainPhylogenetic analysis of CHIKV isolates based on a 1kb fragment in the E1 gene1
Asian
West AfricanECSA
3
1. Parola P, de Lamballerie  X, Jourdan J, Rovery C, Vaillant V, Minodier  P, et al. Emerg  Infect Dis. 2006;12(10):1493- 1499. •CHIK181/25 live -attenuated virus (Asian
lineage AF15561) engineered to express
luciferase transgene (CHIKV -luc assay
reporter)
•Neutralization assay based on 80% (NT80)
reduction of luciferase activity following Vero cell infection with CHIKV -luc
•CHIKV -luc virus used in the assay is
heterologous to the CHIKV VLP (Asian vs West African)
ECSA, East-Central -South -African    * CHIKV strain that was used as a challenge in nonhuman primate serum transfer study (next slide) *
Conservative serum neutralizing antibody (SNA) threshold chosen for phase 3
study immunogenicity endpoints based on NHP data & regulatory agency recommendations
CHIKV, chikungunya virus; NHPs, nonhuman primate; SNA, serum neutralizing antibodies; CI, confidence interval
Data presented at ESCMID Global 2024 (not yet published in a peer- reviewed article)
*FDA and EMASerum passive transfer and challenge
study in NHP
•NHPs received pooled sera from human
participants vaccinated with CHIKV VLP at
various dilutions i ntravenously and were
challenged  with CHIKV 24 hours later
•Logistic regression model:
•SNA titer of 50 results in 99.97% [81-100]
probability of protection against viremia
•Regulatory agencies*  proposed and agreed a
more conservative SNA titer threshold of 100
to be an acceptable surrogate endpoint
PredictedObserved
95%-CI
Pre-challenge SNA Titer (Day 0)Probability of protection against viremia
4

1. Bennett et al. Safety and immunogenicity of PXVX0317, an aluminium  hydroxide -adjuvanted chikungunya virus -like particle vaccine: a randomized, double- blind, parallel -group, phase 2 trial. Lancet  Infect Dis. 2022;22(9):1343- 55.
2. ClinicalTrials.gov ID: NCT05065983; 3. ClinicalTrials.gov ID: NCT03992872; 4. ClinicalTrials.gov ID: NCT05072080; 5. Clini calTrials.gov ID: NCT05349617. 6. Chang et al. Safety and tolerability of chikungunya virus- like particle vaccine in healthy adults: a phase 1 dose- escalation trial. Lancet,  vol. 384,9959 (2014):2046-
52. 7. Goo et al. A virus -like particle vaccine elicits broad neutralizing antibody responses in humans to all chikungunya virus genotypes. J In fect Dis, vol. 214,10 (2016):1487- 1491. 8. Chen et al . Effect of a chikungunya virus -like particle vaccine on safety and tolerability outcomes: A randomized clinical trial. JAMA, vo l.
323,14 (2020):1369- 1377. 9. McCarty et al . Chikungunya virus virus -like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals. Vaccine, vol. 41,42 (2023):6146- 6149. 9
BLA, Biologics license application 5CHIKV VLP vaccine clinical program
Study description Study designStudy phase
and numberAge range
(years)Number of participants
(vaccine recipients)
•Dose- and dose -schedule finding randomized, double -blind,
parallel- groupPhase 21
PXVX- CV-317-
00118 - 45 445 (441)
•Immunogenicity & Safety and tolerability of 40ug dose open labelPhase 22
EBSI-CV-317-01018 - 45 25 (25)
•Immunogenicity and safety in prior alphavirus vaccine
recipientsopen label, parallel -group Phase 23
EBSI-CV-317-00218 - 65 60 (60)
•Immunogenicity & Safety and tolerability
•Lot-to-lot consistencyrandomized, double -blind,
placebo -controlledPhase  34 (pivotal)
EBSI-CV-317-00412 - <65 3254 (2790)
•Immunogenicity & Safety and tolerabilityrandomized, double -blind,
placebo -controlledPhase  35 (pivotal)
EBSI-CV-317-005≥65 413 (206)

Immune response according to dose and dosing schedule
PXVX- CV-317-001
Phase 2
6
7•At year 1, Group 8 had significantly
higher GMTs vs Group 1 (491.7 vs
243.4; p -value=0.0019); this was
maintained at year 2 (279.7 vs 169.8;
p-value=0.0369)
•AEs mostly mild to moderate; no serious treatment -related unsolicited
AEs
•Local AEs more frequent in 40 ug adjuvanted CHIKV VLP group (40%) than in unadjuvanted group (23%)Single 40 µg CHIKV VLP adjuvanted dose had superior immunogenicity after
first vaccination, showed a rapid and durable response, and was well -tolerated
Primary Endpoint: GMT of anti -CHIKV SNA level on Day 57 (28 days after last vaccination); adjuvant =  aluminum hydroxide
Vertical bars denote 95% confidence interval. GMT = geometric mean titer; NT80 = Neutralization Titer showing 80% neutralization
Bennett et al. Lancet Infect Dis. 2022;22(9):1343- 55.
(n=42)(n=46)
(n=42)(n=40)(n=38)(n=39)

Pivotal phase 3 studies
EBSI-CV-317-004 in individuals 12 to <65 years
EBSI-CV-317-005 in individuals ≥65 years
8
Richardson et al. Safety and Immunogenicity of an Adjuvanted Chikungunya Virus (CHIKV) Virus -like Particle (VLP) Based Vaccine in Two Pivotal Ph ase 3 Trials, ≥12 Years of Age. IDWeek oral presentation, 14 October 2023, Boston, MA.
AE = adverse event; AESI = adverse event of special interest; MAAE = medically attended adverse event; SAE = serious adverse event9Design of the two pivotal phase 3 studies
End of study
Placebo
(n=464)Adolescents
and Adults
12 to <65 years CHIKV VLP
(n=2790)
CHIKV VLP
(n=206)
Placebo
(n=207)Adults ≥65 yearsEBSI-CV-317-004
EBSI-CV-317-0051 15 22 29 phone 92 phone 183 Day:
IP administrationScreening visit
(within 30 days of Day 1)Treatment and observation Follow -up
Solicited AEs
Unsolicited AEs
SAEs/AESI/MAAEs1 8 15 22 29 phone 92 phone 183 Day:Primary Immunogenicity Endpoint
10Primary and key secondary objectives in phase 3 studies
EBSI-CV-317-004
12 to <65 years of age
Coprimary :
•SNA GMT at Day 22 versus placebo
•Difference in seroresponse rate1 versus
placebo at Day 22
•Safety
•Lot consistency of anti- CHIKV SNA GMT at
Day 22 (18 to 45 years)
Key Secondary:
•Seroresponse rates at Day 8, Day 15, Day
183 versus placeboEBSI-CV-317-005
≥65 years of age
Coprimary :
•SNA GMT at Day 22 versus placebo
•Difference in seroresponse rate1 versus
placebo at Day 22
•Safety
Key Secondary:
•Seroresponse rates at Day 15 and Day 183
versus placebo
1 Seroresponse  rate (considered the presumptive seroprotection  rate) was defined as the percentage of participants who achieve a CHIKV -luc neutralization titer (NT80) ≥100
GMT = geometric mean titer; SNA = serum neutralizing antibody

Balanced demographic characteristics in study including adolescents
and adults 12 to <65 years of age
1 Demographic characteristics of the IEP are displayed. 2 Percentages are based on the number of participants in each study arm.
BMI, body mass index; CHIKV, chikungunya virus; IEP, immunogenicity -evaluable population; LLOQ, lower limit of quantitation; SD, standard deviation; VLP, virus -like particle; B avarian Nordic data on file. Characteristic1 CHIKV VLP (n=2794) Placebo (n=464) Total (N=3258)
Age (years)
Mean (SD) 39 (14.3) 39 (14.4) 39 (14.3)
Age group, n (%)2
12 to 17 years 217 (7.8) 37 (8.0) 254 (7.8)
18 to 45 years 1636 (58.6) 270 (58.2) 1906 (58.5)
46 to 64 years 941 (33.7) 157 (33.8) 1098 (33.7)
Sex, n (%)2
Male 1358 (48.6) 233 (50.2) 1591 (48.8)
Female 1436 (51.4) 231 (49.8) 1667 (51.2)
Race, n (%)2
White 2043 (73.1) 341 (73.5) 2384 (73.2)
American Indian or Alaska Native 30 (1.1) 2 (0.4) 32 (1.0)
Asian 79 (2.8) 16 (3.4) 95 (2.9)
Black or African American 534 (19.1) 89 (19.2) 623 (19.1)
Native Hawaiian or Other Pacific Islander 6 (0.2) 4 (0.9) 10 (0.3)
Multiracial 78 (2.8) 8 (1.7) 86 (2.6)
Not reported 24 (0.9) 4 (0.9) 28 (0.9)
Ethnicity – n(%)2
Hispanic or Latino 506 (18.1) 71 (15.3) 577 (17.7)
Not Hispanic or Latino 2226 (79.7) 379 (81.7) 2605 (80.0)
Not reported 61 (2.2) 14 (3.0) 75 (2.3)
Unknown 1 (<0.1) 0 1 (<0.1)
BMI (kg/m2)
Mean (SD) 26.79 (4.53) 26.46 (4.61) 26.74 (4.54)

Balanced demographic characteristics in study including adults ≥65
years of age
1 Demographic characteristics of the IEP are displayed. 2 Percentages are based on the number of participants in each study arm.
BMI, body mass index; CHIKV, chikungunya virus; IEP, immunogenicity -evaluable population; LLOQ, lower limit of quantitation; SD, standard deviation; VLP, virus -like particle; B avarian Nordic data on file. Characteristic1CHIKV VLP (n=206) Placebo (n=207) Total (N=413)
Age (years)
Mean (SD) 71 (5.3) 71 (4.5) 71 (4.9)
Age group, n (%)2
65 to 74 years 159 (77.2%) 159 (76.8%) 318 (77.0%)
≥75 years 47 (22.8%) 48 (23.2%) 95 (23.0%)
Sex, n (%)2
Male 81 (39.3%) 90 (43.5%) 171 (41.4%)
Female 125 (60.7%) 117 (56.5%) 242 (58.6%)
Race, n (%)2
White 176 (85.4%) 168 (81.2%) 344 (83.3%)
American Indian or Alaska Native 1 (0.5%) 1 (0.5%) 2 (0.5%)
Asian 4 (1.9%) 1 (0.5%) 5 (1.2%)
Black or African American 20 (9.7%) 29 (14.0%) 49 (11.9%)
Multiracial 4 (1.9%) 5 (2.4%) 9 (2.2%)
Not reported 1 (0.5%) 3 (1.4%) 4 (1.0%)
Ethnicity – n(%)2
Hispanic or Latino 93 (45.1%) 90 (43.5%) 183 (44.3%)
Not Hispanic or Latino 112 (54.4%) 116 (56.0%) 228 (55.2%)
Not reported 1 (0.5%) 1 (0.5%) 2 (0.5%)
BMI (kg/m2)
Mean (SD) 27.3 (3.98) 27.6 (3.90) 27.5 (3.94)

13Rapid induction of robust anti -CHIKV seroresponse  rates and GMT in
adolescents and adults 12 to <65 years of age
(immunogenicity evaluable population)
* Seroresponse  rate (considered the presumptive seroprotection  rate) was defined as the percentage of participants who achieved an anti -CHIK SNA NT80 titer ≥100
** Success criterion met: lower bound of the two -sided 95% CI on the difference in seroresponse  rates between CHIKV VLP vaccine and placebo groups ≥70%;
Vertical bars denote 95% confidence interval; CI = confidence interval; GMT = geometric mean titer; IEP  = immunogenicity evaluable population; SNA = serum neutralizing antibody; LLOQ =
Note: 15 was the lower limit of quantitation (LLOQ) for the human SNA assay, so results <LLOQ were set to a titer of LLOQ/2 o r 7.5 for analysis
Data presented at IDWeek  2023, Data not yet published in a peer -reviewed article.Anti-CHIKV SNA GMT Anti-CHIKV SNA seroresponse rate
P < 0.0001 for all time
points beyond Day 1P < 0.0001 for all time points beyond Day 1
115 183 228931,0961,618
338
788 8
1101001,00010,000
CHIKV VLP (N=2,559)
Placebo (N=424)SNA GMT (NT80)
Study day115 183 228479798
86
020406080100
CHIKV VLP (n=2,559)
Placebo (N=424)Seroresponse  rate* (%)
Study day
•All co -primary endpoints were met:
•At Day 22, the seroresponse rate difference between vaccine and placebo group was 96.6% (95% CI: 95.0%, 97.5%)**
•At Day 22, the vaccine group GMT was significantly higher than that for placebo (1618 vs. 8; P<0.0001, ANOVA)
•The pairwise lot comparison of SNA response to CHIKV VLP vaccine in adults aged 18 to 45 years demonstrated equivalence
•All key secondary endpoints were metSeroresponse threshold
14Rapid induction of robust anti -CHIKV seroresponse  rates and GMT
in adults ≥65 years of age
(immunogenicity evaluable population)
Anti-CHIKV SNA GMT
378724
233
898 8
1101001,00010,000
CHIKV VLP (n=189)
Placebo (n=183)SNA GMT (NT80)Seroresponse  rate* (%)
Study day Study dayAnti-CHIKV SNA seroresponse rate
P < 0.0001 for all time
points beyond Day 1
P < 0.0001 for all time points beyond Day 1
115 183 22 115 183 228287
76
020406080100
CHIKV VLP (n=189)
Placebo (n=183)
* Seroresponse  rate (considered the presumptive seroprotection  rate) was defined as the percentage of participants who achieved an anti -CHIK SNA NT80 titer ≥100
Vertical bars denote 95% confidence interval; CI = confidence interval; GMT = geometric mean titer; IEP  = immunogenicity evaluable population; SNA = serum neutralizing antibody; LLOQ = lower limit of quantitation
Note: 15 was the LLOQ for the human SNA assay, so results <LLOQ were set to a titer of LLOQ/2 or 7.5 for analysis
Data presented at IDWeek  2023, Data not yet published in a peer -reviewed article.Seroresponse  threshold
•All co -primary endpoints were met
•At Day 22, the seroresponse rate difference between vaccine and placebo group was 86.2% (95% CI: 72.3%, 84.6%) **
•At Day 22, the vaccine group GMT was significantly higher than that for placebo (724 vs. 8; P<0.0001, ANOVA)
•All key secondary endpoints were met
CHIKV VLP vaccine was well -tolerated in individuals 12 to <65 years of age
Placebo CHIKV VLP Placebo CHIKV VLP Placebo CHIKV VLP21.9 10.0 0.3 0.0 0.3 0.01.7 0.7 0.1 0.10.1 0.0 0.04 0.0
020406080100
Injection site redness Injection site pain Injection site swellingIncidence (%)
10.8 10.7 11.9 10.5 13.16.3 6.4 2.2 5.4 4.4 4.8 4.60.4 0.28.4 6.1 5.8 5.74.1 2.8 2.1 1.1 2.1 2.6 2.3 2.0 0.2 0.00.7 0.2 0.3 0.4 0.4 0.4 0.1 0.0 0.3 0.2 0.4 0.0 0.2 0.0
020406080100
Fatigue Headache Myalgia Chills Arthralgia Nausea FeverLocal  solicited AEs Days 1 -8 (safety population)
Systemic  solicited AEs Days 1 -8 (safety population)
•Grade 3 (severe) local solicited AEs occurred in 5 (0.2%) CHIKV VLP vaccine recipients (4 injection site pain and 1 injection  site redness);
no placebo recipients reported ≥Grade 3 events.
•Grade 3 (severe) systemic solicited AEs occurred in 41 (1.5%) CHIKV VLP vaccine recipients and in 2 (0.4%) placebo recipients.
15
Incidence (%)
AEs = adverse events
Note: One grade 4 (potentially life- threatening) systemic solicited AE of 105ºF fever was recorded in the electronic diary by a CHIKV VLP vaccine recipient, but the site deemed this entry an error.
16Incidence of AESI and MAAE did not differ between the CHIKV VLP vaccine
group and the placebo group  in individuals 12 to <65 years of age
AE = adverse event; AESI = adverse event of special interest; MAAE = medically attended adverse event; SAE = serious adverse eve nt; SMC = safety monitoring committee; PT = preferred term.
Data presented at IDWeek  2023, Data not yet published in a peer -reviewed article.Unsolicited AEs Day 1 -29, and AESI, MAAEs and SAEs Day 1 -183 (safety population)
15.8
1.1 0.28.9
0.813.4
0.2 0.29.1
0.2
020406080100
Unsolicited AE Unsolicited AE
≥ Grade 3  AESI MAAE SAEIncidence (%)
•AESI defined as defined as new onset or worsening arthralgia that was medically attended
•One participant in the CHIKV VLP vaccine group had a severe (Grade 3) treatment-related unsolicited AE of dehydration, which
resolved without medical intervention
•There was one investigator assessed possibly related SAE (PT: retinal detachment) in the CHIKV VLP vaccine group that was assessed by the sponsor and independent SMC Chair as unrelated due to prior medical history of seeing ‘black spots’ in the right eye ( the
same eye with the retinal detachment) 1 month pre -study CHIKV VLP (n=2790)
Placebo (n=464)

17CHIKV VLP vaccine was well -tolerated in individuals ≥65 years of age
AEs = adverse events5.4 1.00.5 0.0 0.00.50.0
020406080100
Placebo CHIKV VLP Placebo CHIKV VLP Placebo CHIKV VLP Injection site pain Injection site redness Injection site swellingIncidence  (%)
3.9 5.0 2.4 5.0 2.9 7.0 1.5 2.0 2.4 3.0 2.0 1.5 0.0 0.52.4 1.5 3.4 1.0 1.0 0.5 1.5 2.0 0.5 1.0 0.50.5 0.5
020406080100
Myalgia Fatigue Headache Arthralgia Chills Nausea Fever
•No participants experienced a grade 3 (severe) or higher local solicited AE
•Solicited AEs occurred at similar rates between groups and were of grade 1 (mild) or 2 (moderate) intensity, except for one
participant in the vaccine group who experienced two grade 3 (severe) systemic solicited AEs (headache and fatigue)Solicited  local AEs Days 1 -8 (safety population)
Solicited  systemic  AEs Days 1 -8 (safety population)Incidence  (%)

18Incidence of AESI and MAAE did not differ between the CHIKV VLP vaccine
group and the placebo group  in individuals ≥65 years of age
Unsolicited  AEs Days 1 -29, and AESI, MAAEs and SAEs Days 1 -183 (safety population)
12.6
1.9 0.09.2
1.916.4
1.4 0.511.1
1.4
020406080100
Unsolicited AE Unsolicited AE
≥ Grade 3 AESI MAAE SAEIncidence (%)
•AESI defined as defined as new onset or worsening arthralgia that was medically attended
•Fatigue and myalgia were the only treatment -related unsolicited AEs that each occurred in more than one participant
•No SAE was considered treatment -related
AE = adverse event; AESI = adverse event of special interest; MAAE = medically attended adverse event; SAE  = serious adverse event; SMC  = safety monitoring committee
Data presented at IDWeek  2023, Data not yet published in a peer -reviewed article.CHIKV VLP vaccine (n=206)
Placebo (n=207)

19Analysis of serious adverse events, arthralgia, arthritis and osteoarthritis
across clinical trials1 reveals no safety signal
1 Study PXVX- CV-317-001 Groups 8 and 10: 40 μg dose with 300 μg adjuvant single dose; studies EBSI -CV-317-002, EBSI -CV-317-010, EBSI -CV-317-004, and EBSI -CV-317-005. 2 There was 1 SAE (PT: retinal detachment) in the
CHIKV VLP vaccine group that was considered possibly treatment -related by the study investigator but was assessed by the sponsor  and independent SMC Chair as unrelated due to prior medical historyEventCHIKV VLP vaccine
40/300 µg  (N=3141)
n (%)Placebo
(N=675)
n (%)
Any Serious AEs 31/3141 (0.99) 4/675 (0.59)
Related Serious AEs2 0 0
Solicited AE of arthralgia 230/3114 (7.39) 41/661 (6.20)
Arthralgia Grade 3 7/3114 (0.22) 1/661 (0.15)
Arthralgia duration >15 days 0 0
Unsolicited Arthritis 1 (0.03) 0
Related arthritis 0 0
Unsolicited osteoarthritis 1 (0.03) 0
Related osteoarthritis 0 0

Summary: CHIKV VLP vaccine
20
•Single dose vaccine based on VLP technology, suitable for broad populations
•PDUFA target action date: Feb 14th, 2025
•Proposed indication: prevention of disease caused by CHIKV infection in individuals 12 years of age and older
PDUFA, FDA Prescription Drug User Free Act •Well-tolerated
•No treatment related SAEs as determined by sponsor
•Most solicited and unsolicited adverse events mild or moderate in intensity•Phase 3 trials demonstrated rapid and robust immune response in individuals 12 years of age and older
•Durable and boostable  immune response in a phase 2 trial

Summary: CHIKV VLP vaccine Bavarian Nordic’s chikungunya vaccine candidate October 2024 Victoria Jenkins, PhD, MBA VP Regulatory Affairs & CHIKV Program LeadBavarian Nordic vije@bavarian -nordic.com 2E protein Membrane Capsid shell RNA CHIKV VLP vaccine Chikungunya virus3CHIKV virus -like particle vaccine (CHIKV VLP)1 CHIKV, chikungunya virus; VLP, virus -like particle ; BLA, Biologics License Application; PDUFA, Prescription Drug User Free Act   1. Bennett SR, et al. Lancet Infect Dis.…


04 Chikungunya Hills 508

Work Group interpretation of data for
virus -like particle chikungunya vaccineNational Center for Emerging and Zoonotic Infectious Diseases
Susan Hills MBBS MTH
CDC Lead , Chikungunya Vaccines Work Group
Arboviral Diseases Branch
Division of Vector -Borne Diseases
Fort Collins , Colorado
ACIP Meeting, October 23, 2024
•No vaccine effectiveness data
•Short -term* immunogenicity data available from ~2,750
vaccinated subjects in two Phase 3 studies
-Majority adults aged 18 –64 years (~2350 subjects)
-Smaller numbers of adolescents aged 12 –17 years and older adults
aged ≥65 years (~200 subjects in each group)Vaccine effectiveness (immunogenicity) data availability
*Seroresponse  rates at 21 days after vaccination
2
•Robust response to vaccination with seroresponse  rates* at 21 days
after vaccination of 98% in adolescents/younger adults vs. 87% in
older adults
•Relatively good seroresponse  rates maintained at 6 months after
vaccination with rates in younger and older age groups of 86% vs. 76%
•No longer -term (>6 months) data available from Phase 3 studies so
need for booster dose unknownKey immunogenicity results
*Percent of subjects with anti -chikungunya virus 80% serum neutralizing antibody titer ≥100 3
•Safety data available from ~3,000 vaccinated subjects in
two Phase 3 studies
-Majority adults aged 18 –64 years (~2,580 subjects)
-Smaller numbers of adolescents aged 12 –17 years and older adults
aged ≥65 years (~210 subjects in each group)Safety data availability
4
•Solicited adverse events within 8 days of vaccination
-Local: 24%; severe in 0.2%; m ostly injection site pain
-Systemic: 32%; severe in 1.5%; fatigue, headache, and myalgia in 1 8%–20%
•New onset or worsening arthralgia requiring medical attention in 0.2%
•One serious adverse event (i.e., retinal detachment) assessed as related
by investigator but unrelated by safety monitoring committee chair
•All rates lower in older adults aged ≥65 yearsKey safety results in adolescents and adults aged 12 –64 years
5
•Will provide option, in addition to the licensed live attenuated vaccine, for
vaccination of adults aged ≥18 years
•Will provide option for adolescents aged 12 –17 years
•Immunogenic vaccine but no vaccine effectiveness data which will be gathered post -licensure, and need for booster dose currently unknown
•No apparent safety concerns but safety data only from ~3,000 people so
insufficient to detect rare events, and post -marketing surveillance important
•Work Group to conduct comprehensive data review and present GRADE assessment as part of Evidence to Recommendations framework at future meetingWork Group summary for chikungunya virus- like
particle vaccine
6
Chikungunya Vaccines Work Group plans
Anticipated votes on vaccine recommendations, 2025
Population Live attenuated vaccine Virus -like particle vaccine
Travelers≥18 years completed
YES†
YES*
Laboratory workers Completed YES
Residents of U.S. territories
with transmission risk YES YES
Residents of U.S. states with transmission risk YES YES
*12– 17 years  †≥12 years
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: Work Group interpretation of data for  virus -like particle chikungunya vaccineNational Center for Emerging and Zoonotic Infectious Diseases Susan Hills MBBS MTH CDC Lead , Chikungunya Vaccines Work Group Arboviral Diseases Branch Division of Vector -Borne Diseases Fort Collins , Colorado ACIP Meeting, October 23, 2024 •No vaccine effectiveness data •Short -term* immunogenicity data available from ~2,750  vaccinated subjects in two Phase 3 studies -Majority adults aged 18 –64 years (~2350…


01 COVID Schechter 508

ACIP COVID -19 Vaccines Work Group
Robert Schechter, MD
COVID -19 ACIP Work Group Chair
Advisory Committee on Immunization Practices Meeting
October 23, 2024National Center for Immunization and Respiratory Diseases

•To protect against COVID -19 disease, caused by SARS -CoV-2, ACIP recommended at its June 2024
meeting the 2024 –2025 COVID -19 vaccines, as authorized or approved by FDA:
-Moderna COVID -19 vaccine in persons ≥6 months
-Pfizer -BioNTech COVID -19 vaccine in persons ≥6 months
-Novavax COVID -19 vaccine in persons ≥ 12 years*
•Everyone aged 5 years and older should get 1 dose of a 2024 –2025 COVID -19 vaccine
•Children aged 6 months– 4 years need multiple doses of COVID- 19 vaccines to be up to date,
including at least 1 dose of 2024 –2025 COVID -19 vaccine
•People who are moderately or severely immune compromised may receive additional doses of
2024 –2025 COVID -19 vaccines under shared clinical decision making
•No recommendation for additional doses of 2024 –2025 COVID -19 vaccine for older adultsCurrent 2024– 2025 COVID -19 vaccine recommendations
*People who are previously unvaccinated for COVID -19 and are receiving Novavax should complete a 2 -dose initial series
•To protect against COVID -19 disease, caused by SARS -CoV-2, ACIP recommended at its June 2024
meeting the 2024 –2025 COVID -19 vaccines, as authorized or approved by FDA:
-Moderna COVID -19 vaccine in persons ≥6 months
-Pfizer -BioNTech COVID -19 vaccine in persons ≥6 months
-Novavax COVID -19 vaccine in persons ≥ 12 years*
•Everyone aged 5 years and older should get 1 dose of a 2024 –2025 COVID -19 vaccine
•Children aged 6 months– 4 years need multiple doses of COVID- 19 vaccines to be up to date,
including at least 1 dose of 2024 –2025 COVID -19 vaccine
•People who are moderately or severely immune compromised may receive additional doses of
2024 –2025 COVID -19 vaccines under shared clinical decision making
•No recommendation for additional doses of 2024 –2025 COVID -19 vaccine for older adultsCurrent 2024– 2025 COVID -19 vaccine recommendations
*People who are previously unvaccinated for COVID -19 and are receiving Novavax should complete a 2 -dose initial series
ACIP COVID -19 Work Group Meeting Review
July – October 2024
•Seasonality of SARS- CoV-2
•Epidemiology of COVID -19
in older adults and persons
with immunocompromise
•SARS -CoV-2 variant updates
•Vaccine safety updateRegarding additional doses of COVID -19 vaccine:
•Vaccine effectiveness
•Uptake and intent survey data
•Economic analyses
•Implementation
Agenda: October 23, 2024
Introduction Dr. Robert Schechter (ACIP, WG Chair)
COVID -19 vaccine uptake and implementation Dr. Georgina Peacock (CDC/NCIRD)
COVID -19 epidemiology Dr. Christopher Taylor (CDC/NCIRD)
COVID -19 vaccine effectiveness Dr. Ruth Link -Gelles (CDC/NCIRD)
Economic analysis of an additional dose of the
2024 -2025 COVID -19 vaccineDr. Lisa Prosser (University of Michigan)
Evidence to Recommendations Ms. Lauren Roper (CDC/NCIRD)
Clinical considerations Dr. Lakshmi Panagiotakopoulos (CDC/NCIRD)
Vote Ms. Lauren Roper (CDC/NCIRD)
In addition to previously recommended 2024 –2025 vaccination:
•ACIP recommends a second dose* of 2024– 2025 COVID -19 vaccine for adults ages
≥65 years
•ACIP recommends a second dose**  of 2024– 2025 COVID -19 vaccine for people
ages 6 months –64 years who are moderately or severely immunocompromised
•ACIP recommends additional doses (i.e., 3 or more doses) of 2024– 2025 COVID -19
vaccine for people ages ≥6 months who are moderately or severely
immunocompromised under shared clinical decision makingVote language
*If previously unvaccinated and receiving Novavax, 2 doses are recommended as initial vaccination series followed by a third dose of any age -
appropriate 2024 -2025 COVID -19vaccine 6 months (minimum interval 2 months) after second dose.
**If previously unvaccinated or receiving initial vaccination series, at least 2 doses of 2024 –2025 vaccine are recommended, and  depending on
vaccination history more may be needed. This additional 2024– 2025 vaccine dose is recommended 6 months (minimum interval 2 month s) after
completion of initial vaccination series.
•During October 2023– April 2024, adults aged ≥65 years accounted for 70%
of all COVID- 19–associated hospitalizations among adults.
-Most hospitalized adults had multiple underlying medical conditions.
-12% had received the recommended COVID -19 2023– 2024 formula vaccine.
•During October 2022– April 2024, COVID- 19–associated hospitalization rates
in infants aged <6 months were similar to those in adults aged 65 –74 years.
-The percentage of hospitalized infants whose mothers had been vaccinated
during pregnancy was 18% during October 2022 –September 2023 and decreased
to <5% during October 2023 –April 2024.Recent COVID -NET Reports Describe
Low Immunization Rates in Hospitalized, High- Risk Populations
www.cdc.gov/mmwr/volumes/73/wr/mm7339a2.htm?s_cid=mm7339a2_w
www.cdc.gov/mmwr/volumes/73/wr/mm7338a1.htm?s_cid=mm7338a1_w
Work Group members
ACIP members
•Robert Schechter  (chair)
•Noel Brewer
•Oliver Brooks
•George Kuchel
•Keipp Talbot
Ex-officio/government members
•BARDA: Christine Oshansky
•CDC: Alan Lam
•FDA: Adam Spanier, Rachel Zhang
•IHS: Uzo Chukwuma
•NIH: Chris Roberts
CDC co -Leads
•Lakshmi Panagiotakopoulos
•Lauren RoperLiaisons
•AAFP: Jonathan Temte
•AAP: Sean O’Leary
•ACOG: Naima Joseph (primary),
Laura Riley (alternate)
•ACP: Jason Goldman
•AGS: Ken Schmader
•AIM: Heather Roth
•AMA: Sandra Fryhofer
•ANA: Ruth Francis
•APhA: Richard Dang
•ASTHO: Marcus Plescia
•CSTE: Paul Cieslak, Christine Hahn
•IDSA: James McAuley Liaisons, cont’d
•NACCHO: Matt Zahn
•NACI: Eva Wong (primary), Matthew Tunis (alternate)
•NFID: Robert Hopkins (primary),   Bill Schaffner (alternate)
•SHEA: Preeti Mehrotra (primary),
Marci Drees (alternate)

Consultants
•Ed Belongia
•Hank Bernstein
•Matthew Daley
•Kathy Edwards
•Lisa Jackson•Dayna Matthew
•Jennifer Nelson
•Stanley Perlman
•Peter Szilagyi
CDC participants
•Amadea Britton
•Mary Chamberland
•Fatimah Dawood
•Jonathan Duffy
•Katherine Fleming -Dutra
•Kristen Folsom
•Julianne Gee
•Monica Godfrey
•Susan Goldstein
•Lisa Grohskopf
•Aron Hall
•Elisha Hall
•Demorah Hayes•Suzanne Heitfeld
•Rita Helfand
•Michele Hlavsa
•Jefferson Jones
•Ruth Link -Gelles
•Jessica MacNeil
•Josephine Mak
•Seth Abram Meador
•Michael Melgar
•Sarah Meyer
•Noelle -Angelique Molinari
•Danielle Moulia
•Ismael Ortega -Sanchez•Manisha Patel
•Amanda Payne
•Jamison Pike
•Hannah Rosenblum
•Sierra Scarbrough
•John Su
•Diya Surie
•Natalie Thornburg
•David Wentworth
•Melinda Wharton
•Trang Wisard
•JoEllen Wolicki
For more information, contact CDC
1-800- CDC -INFO (232- 4636)
TTY:  1 -888- 232- 6348    cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. Centers for Disease Control and Prevention.

Summary: ACIP COVID -19 Vaccines Work Group Robert Schechter, MD COVID -19 ACIP Work Group Chair Advisory Committee on Immunization Practices Meeting October 23, 2024National Center for Immunization and Respiratory Diseases  •To protect against COVID -19 disease, caused by SARS -CoV-2, ACIP recommended at its June 2024  meeting the 2024 –2025 COVID -19 vaccines, as authorized or approved by FDA:  -Moderna COVID -19 vaccine in persons ≥6 months  -Pfizer -BioNTech COVID -19 vaccine in persons ≥6 months…


02 COVID Peacock 508

Implementation Considerations for Additional
COVID -19 Vaccine Doses
Georgina Peacock, MD, MPH
Immunization Services Division
Centers for Disease Control and Prevention
October 23, 2024National Center for Immunization and Respiratory Diseases

COVID -19 Vaccination Coverage and Intent for 2 Doses,
National Immunization Survey -Adult COVID Module
2023 -2024 Data
2-Dose Coverage and Intent Among Adults 65 Years
and Older
COVID -19Vaccination Coverage (≥1 Dose and ≥2 Doses) A mong Adults 65Years
and Older, 2023 -2024
National Immunization Survey -Adult COVID Module  (NIS- ACM)

COVID -19Vaccination Coverage A mong Adults 65Years and O lder, ≥2 Doses of
the 2023 -2024 Vaccine by End of June 2024
National Immunization Survey -Adult COVID Module  (NIS- ACM)
21.813.516.29.011.18.112.76.78.311.17.49.09.210.69.18.78.9
0.0 10.0 20.0 30.0 40.0 50.0 60.0AI/ANOther/multiple, non-…NH/OPIHispanicBlack, non-HispanicWhite, non-HispanicAsianRuralSuburbanUrban65-6970-7475-7980+MaleFemaleOverall 65+
W eighted % (95% C I )9.48.48.510.510.78.818.011.17.87.76.88.97.39.38.08.4
0.010.0 20.0 30.0 40.0 50.0 60.0Income unknownAbove poverty, >=$75KAbove poverty, <$75KBelow povertyUninsuredInsuredHHS Region 10HHS Region 9HHS Region 8HHS Region 7HHS Region 6HHS Region 5HHS Region 4HHS Region 3HHS Region 2HHS Region 1
W eighted % (95% C I )*
**
AI/AN: American Indian or Alaska Native; NH/OPI: Native Hawaiian or Other Pacific Islander.
*Statistically significant at p<0.05 (referent categories: Age 65 -69, Rural, White non- Hispanic, HHS Region 1).*

7.213.68.79.713.97.710.38.69.38.7
0.0 10.0 20.0 30.0 40.0 50.0 60.0No provider recommendationHealth care provider recommended…Does not have any disabilityHas a disabilityImmunocompromisedNo health conditionHas health conditionHigh SVIModerate SVILow SVI
W eighted % (95% C I )COVID -19Vaccination Coverage A mong Adults 65Years and O lder, ≥2 Doses of
the 2023 -2024 Vaccine by End of June 2024
National Immunization Survey -Adult COVID Module  (NIS- ACM)
*
*
*Statistically significant at p<0.05 (referent categories: No health condition, No provider
recommendation).
36.8
0.0 10.0 20.0 30.0 40.0 50.0 60.0Overall 65+
Weighted % (95% CI)
20.0 44.3 30.9 4.7
0.0 50.0 100.0
W eighted %COVID -19Vaccination Coverage and Intent for Second Dose A mong Adults 65
Years and Older, April -June 2024
National Immunization Survey -Adult COVID Module  (NIS- ACM)
Percent of adults 65+ who received
≥1 dose of 2023 -24 Covid vaccine
Among adults 65+ who received
≥1 dose of 2023- 24 Covid vaccine:
Receipt /intent to receive 2nd dose
Probably or definitely will not get another dose
Probably will get another dose or unsureDefinitely will get another doseVaccinated with ≥2 doses of 2023- 24 Covid vaccine
27.432.740.327.928.017.819.817.319.122.817.819.319.225.8
41.034.627.235.238.046.638.545.444.743.245.843.745.441.2
30.026.327.031.029.531.237.832.831.030.030.433.330.928.3
1.56.45.55.94.44.53.94.55.24.16.03.74.64.7
0.0 20.0 40.0 60.0 80.0 100.0AI/ANNH/OPIBlack, non-HispanicAsianRuralUrban65-6975-79
W eighted %COVID -19Vaccination Coverage and Intent for Second Dose A mong Adults 65
Years and Older, April -June 2024
National Immunization Survey -Adult COVID Module  (NIS- ACM)
Among adults 65+ who received ≥1 dose of 2023- 24 Covid vaccine:
Receipt  and intent to receive 2nd dose
AI/AN: American Indian or Alaska Native; NH/OPI: Native Hawaiian or Other Pacific
Islander .
Probably or definitely will not get another dose
Probably will get another dose or unsureDefinitely will get another doseVaccinated with ≥2 doses of 2023- 24 Covid vaccine
COVID -19Vaccination Coverage and Intent for Second Dose A mong Adults 65
Years and Older, April -June 2024
National Immunization Survey -Adult COVID Module  (NIS- ACM)
Among adults 65+ who received ≥1 dose of 2023- 24 Covid vaccine:
Receipt  and intent to receive 2nd dose
16.8 17.4 21.2 24.744.4 43.045.244.533.8 34.329.0 26.85.1 5.3 4.6 4.0
0.020.040.060.080.0100.0
Apr-24 May-24 Jun-24 Jul-24W eighted %
Survey month
Probably or definitely will not get another dose
Probably will get another dose or unsureDefinitely will get another doseVaccinated with ≥2 doses of 2023- 24 Covid vaccine
2-Dose Coverage Among Adults 18 Years and Older
Who Are Immunocompromised
COVID -19Vaccination Coverage (≥2 Doses) A mong Adults 65Years and O lder
and Adults 18 Years and Older Who Are Immunocompromised , 2024
National Immunization Survey -Adult COVID Module  (NIS- ACM)

COVID -19Vaccination Coverage A mong Adults 18 Years and Older Who Are Immunocompromised , ≥2
Doses of the 2023 -2024 Vaccine by End of June 2024
National Immunization Survey -Adult COVID Module  (NIS-ACM)
NA: estimate not reported because denominator is <30; AI/AN: American Indian or Alaska Native; NH/OPI: Native
Hawaiian or Other Pacific Islander.
*Statistically significant at p<0.05 (referent categories: Age 18 -49, Rural, White non- Hispanic, No Provider
Recommendation, Insured).

Intent to Receive 1, 2 or 3+ doses of 2024 -2025 COVID -
19 vaccine if recommended
Omnibus Surveys,  August 2024
•Data are collected through the IPSOS KnowledgePanel  and NORC AmeriSpeak
Omnibus Surveys, which use probability -based panels to survey a nationally
representative sample of U.S. adults ≥18 years of age on a set monthly
schedule.
•C DC  fields questions about vaccination status,  intent,  knowledge,  attitudes,  beliefs,  and behaviors on each survey for 2 waves each month,  for a combined
sample size of ~4,000 per month.
-These slides present combined results from August 2024 (N=4,224).
•Data were weighted to represent the non -institutionalized U .S.  population and
m itigate possible non -response bias.  All responses are self -reported.Omnibus Survey Methods
https://www.ipsos.com/sites/default/files/ipsosknowledgepanelmethodology.pdf
https://amerispeak.norc.org/content/dam/amerispeak/research/pdf/AmeriSpeak%20Technical%20Overview%202019%2002%2018.pdf
32.6 19.2 16.4 10.9 20.9
25.0
34.517.0
19.819.0
15.811.2
10.827.8
19.1
36.7
33.5
23.920.3
19.6
16.814.7
16.9
18.211.3
11.0
10.217.0
19.2
30.9
0 25 50 75 100Overall (N=1,263)
Age 65+ (N=1,012)Age 18 -64 with health
Condition (N=251)
Rural (N=265)Suburban (N=590)Urban (N=408)
Weighted %47.5 28.0 20.6
7.3 29.7 63.1
30.9
45.2
35.8
21.518.8
23.3
16.4
23.915.4
15.7
18.5
27.511.1
10.9
10.8
8.823.8
4.8
18.6
18.3
34.1
12.918.8
25.716.6
12.910.8
8.919.8
39.6
0 25 50 75 100Definitely/probably would not
get first dose (N=408)Definitely/probably would or unsure
if would get first dose  (N=855)
Other, non- Hispanic (N=56)Hispanic (N=121)Black, non- Hispanic (N=109)White, non- Hispanic (N=977)
Uninsured (N=42)Insured (N=1,160)
Weighted %
*Health condition includes cancer (excluding basal cell carcinoma and squamous cell carcinoma), solid organ or blood stem cell  transplant, HIV, and immunocompromised state. †NORC and Ipsos base urbanicity on different, but comparable
measures. NORC uses Census tract -based RUCA (Rural -Urban- Commuting Area) codes, whereas Ipsos uses Office of Management and Budg et's CBSA (Core Based Statistical Area) classification. §Insured group includes plans purchased through
employer, insurance companies, marketplaces, military insurance, Medicare, Medicaid, VA, IHS, and "other".
¶42 respondents excluded from analysis due to inconsistent answers.Intent to receive second 2024 -25 Covid -19 vaccination if recommended
among adults ≥18 years of age with health conditions or ≥65 years of age, by
demographics ,*†§Omnibus Surveys, August 8 -26, 2024 (N=  1,263)¶
•Based on data from the NIS -ACM, as of June 29, 2024, 8.9% of adults ≥65
years reported receipt of ≥2 doses of the 2023 -24 COVID -19 vaccine
-Among adults 65 years and older who received ≥1 dose of the 2023 -24 COVID -19
vaccine, 20.0% reported receiving a second dose
•Based on Omnibus surveys fielded between August 8 -26, 2024, 34.5% of
adults ≥65 years reported that they would definitely get two doses of the
2024 -25 COVID -19 vaccine if recommendedTopline Summary
Implementation considerations
•Should an additional dose* of 2024 –2025 COVID -19 vaccine be
recommended for adults ages ≥65 years?
•Should additional dose(s) of 2024 -2025 COVID -19 vaccine be
recommended for people ages ≥6 months who are moderately or severely
immunocompromised?Proposed policy questions
*Recommended interval: 6 months since last 2024 -2025 dose, minimal interval: 2 months since last 2024- 2025 dose
•Recommendations would not be
overly burdensome to implement.
-Additional dose recommendations
would be the same formula (2024 -
2025) of COVID -19 vaccine currently
available.
-Existing COVID -19 vaccine
administration infrastructure and product can be used.
-The recommendation could be easily
integrated into existing systems and
structures (e.g., standing orders,
CDSi ).Implementation considerations

“Should” vs “may” recommendations
Behavioral interventions for vaccination uptake: A systematic review and meta -analysis - PubM ed (nih.gov)“Should”
E asier to communicate
Strong call to action
F ramed as normativeR emoves cognitive decision work“May”
Difficult to communicate
Weaker call to action
Flexibility in decision makingAdds cognitive work
•Minimum interval vs. Recommended interval
•Recommended interval for vaccination
-“Recommended” interval is consistent with language used for other vaccines,
sowill be familiar to healthcare providers.
-A recommended interval of 6 months is consistent with previous recommendations for additional doses for ages 65+.
-Standardizing this interval across both 65+ and
immunocompromised populations will simplify schedule complexity.
•Minimum interval for vaccination
-A minimum interval of 2 months allows for flexibility of vaccine administration
when accounting for individual risk and circumstances.Intervals for vaccination
6.92.05.7
0.2 0.481.9
0.4 1.8 0.1 0.6
0102030405060708090100 Percent (95% CI)Reported place of updated COVID -19 vaccination, adults aged ≥18 years,
United States, National Immunization Survey -Adult COVID Module*
*Among persons who reported receiving an updated 2024 -2025 COVID -19 vaccination since August 22, 2024 (n=2,943). Data collected September 1 -28, 2024.Place of 2024- 2025 COVID -19 Vaccination
6.82.56.2
0.1 0.382.8
0.1 0.5 0.1 0.6
0102030405060708090100 Percent (95% CI)Reported place of updated COVID -19 vaccination, adults aged ≥65 years,
United States, National Immunization Survey -Adult COVID Module*
*Among persons who reported receiving an updated 2024 -2025 COVID -19 vaccination since August 22, 2024 (n=1,715). Data collected September 1 -28, 2024.Place of 2024- 2025 COVID -19 Vaccination
•“May” recommendations can be particularly challenging in these settings.
-Current recommendation for further additional doses are “informed by the
clinical judgment of a healthcare provider and personal preferences and
circumstances.”
•Some challenges reported from pharmacy organizations or pharmacists:
-Not all pharmacists feel this is within their scope of practice.
-There is some discomfort with the patient conversations to make a vaccination
decision.
•Some pharmacists feel they lack the time for these conversations.
-Not all pharmacists have a clear understanding of moderate or severely immunocompromising conditions.
-There are concerns about vaccinating the right patients for adequate
reimbursement, which can lead to hesitation giving additional doses.Additional doses in pharmacy settings
•Reports of people being denied vaccination tend to increase when there
are changes to the guidance. More reports of denied vaccination occur
with additional doses.
-For example, in February 2024 after recommendations for 65+ additional doses,
reports of people who are immunocompromised being denied additional doses
increased.
•CDC will work to assure recommendations are widely communicated to
reduce confusion and avoid missed opportunities for vaccination.
-Dedicated fall/winter workstream on healthcare provider engagement
-Education and communications on recommendations and the importance of self -
attestation to reduce barriers to vaccination
-Wide array of partnershipsDenial of vaccination with frequent guidance changes
•Social Determinants of Health drive differences in vaccine access creating
disparities in uptake.
•Additional dose recommendations may further increase these disparities.
For e xample:
-Insurance: decreased access with the end of the Bridge Access Program
-Disability:  increased prevalence with age creating potential challenges getting to
vaccination sites
-Setting: decreased access in setting with existing challenges (e.g., long- term care)
•In the absence of an ACIP recommendation, decreased access if required to
pay out -of-pocket.Vaccine equity considerations
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: Implementation Considerations for Additional  COVID -19 Vaccine Doses Georgina Peacock, MD, MPH Immunization Services Division Centers for Disease Control and Prevention October 23, 2024National Center for Immunization and Respiratory Diseases  COVID -19 Vaccination Coverage and Intent for 2 Doses,  National Immunization Survey -Adult COVID Module 2023 -2024 Data 2-Dose Coverage and Intent Among Adults 65 Years  and Older COVID -19Vaccination Coverage (≥1 Dose and ≥2 Doses) A mong Adults…


03 COVID Taylor 508

COVID -19–Associated Hospitalizations Update —
COVID -NET, July 2023– September 2024
Adults Ages ≥65 Years and Persons with Immunocompromising Conditions
Christopher A. Taylor, PhD
RESP -NET Hospitalization Surveillance Team
Coronavirus and Other Respiratory Viruses Division
Meeting of the Advisory Committee on Immunization Practices (ACIP)
October 23, 2024National Center for Immunization and Respiratory Diseases
1
COVID -NET is a population -based hospitalization
surveillance platform.
•RESP -NET: COVID -NET, RSV -NET, FluSurv -NET
•>300 acute -care hospitals
•98 counties in 13 states
-90 counties in 12 states for this analysis
due to incomplete data
•Approx. 10% of the U.S. population
•Positive SARS -CoV-2 test ≤14 days
before admission or during
hospitalization
•Screening or clinician -driven testing
•Clinical data: stratified random sample
2

COVID -19–Associated Hospitalizations
Among Adults Ages ≥65 Years
3
Adults ages ≥65 years comprise 2/3 of all COVID- 19–
associated hospitalizations among adults.
during this same period of October 2023 through August 2024, children and adolescents ages 17 years and younger comprised 4% of all COVID -19-associated hospitalizations. 40%10%20%30%40%50%60%70%80%90%100%Percent of adults hospitalized with COVID -19
Surveillance week end datePercent of weekly COVID -19–associated hospitalizations, by age group —
COVID -NET, March 2020 –September 2024
18–49 years 50–64 years 65–74 years ≥75 years≥75 years=50%
≥65 years=70%
Rates of COVID -19 hospitalizations are highest among
adults ages ≥75 years.
5020406080100120140160Rate per 100,000 population
Surveillance week end dateWeekly rates of COVID -19–associated hospitalizations — COVID -NET, March 2020 –September 2024
<6 months 6 months –4 years 5–11 years 12–17 years
18–49 years 50–64 years 65–74 years ≥75 years
Among adults, rates of COVID- 19–associated
hospitalizations increase with age.
6581624191410
02004006008001000120014001600
10/7/2023
10/21/2023
11/4/2023
11/18/2023
12/2/2023
12/16/2023
12/30/2023
1/13/2024
1/27/2024
2/10/20242/24/2024
3/9/2024
3/23/2024
4/6/2024
4/20/2024
5/4/2024
5/18/2024
6/1/2024
6/15/2024
6/29/2024
7/13/20247/27/2024
8/10/2024
8/24/2024
9/7/2024
9/21/2024R ate per 100,000 population
Surveillance  week end dateCumulative rates of COVID -19–associated hospitalizations — COVID -NET,
October 1, 2023 –September 28, 2024
18–49 years 50–64 years 65–74 years ≥75 yearsAge groupRate ratio of
≥75 years
relative to
adult age
groups
18–49 24.4
50–64 8.7
65–74 3.4
≥75 1.0
Rates among adults ages
≥75 years are many times
higher compared to
younger adults.
Rates of COVID -19–associated hospitalizations among
adults ages ≥65 years have decreased over time.
* The 2019– 2020 surveillance period includes March 2020 –September 2021.
7050010001500200025003000
*2019 –2020
2020–2021
2021–20222022–2023
2023–2024
*2019–2020
2020–2021
2021–20222022–20232023–2024
*2019–2020
2020–20212021–20222022–20232023–2024
*2019–2020
2020–20212021–2022
2022–2023
2023–2024
*2019–2020
2020–2021
2021–2022
2022–2023
2023–202418–49 50–64 65–74 ≥75 ≥18R ate per 100,000 population
A ge group and surveillance periodCumulative rates of COVID -19–associated hospitalizations — COVID -NET, March 2020 –September 2024
Most adults ages ≥65 years hospitalized with COVID- 19
have underlying medical conditions.
•Among adults ages ≥65 years :
-19% are residents of a long -term care facility (LTCF)
-83% have ≥2 underlying medical conditions.
•Among adults ages ≥75 years :
-24% are residents of a LTCF
-86% have ≥2 underlying conditions
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission during October 2023 –May 2024.8
Adults ages ≥65 years remain at risk for severe
outcomes during COVID- 19–associated hospitalization.
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission. 9Percent of outcomes and interventions among COVID -19–associated hospitalizations, by age group —
COVID -NET, October 2023 –May 2024
18–49 50–64 ≥65
L ength of stay ,  days (median) 2.9 3.4 3.5
L ength of stay ,  days (I QR ) 1.4–5.5 1.9–7.9 1.9–7.1
ICU adm ission 17.9% 21.5% 17.7%
Invasive m echanical ventilation 5.9% 12.8% 8.1%
In-hospital death 2.1% 11.3% 7.7%
During this period, 80% of all adults hospitalized with COVID -19 who died in -hospital were ages ≥65 years.
Fewer than half of adults ages ≥65 years hospitalized with
COVID -19 received any COVID -19 vaccine since September 2022.
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission. 1075
7067
4753
2124 243733
4 6101715
01020304050607080
18–49 50–64 65–74 ≥75 ≥65Percent of adults hospitalized with C OV I D -19
A ge groupVaccination status among adults with COVID -19–associated hospitalization, by age group —
COVID -NET, October 2023 –May 2024
No record of 2022–2023 (bivalent) or 2023–2024 formula
R eceived 2022–2023 (bivalent), but not 2023–2024 formula
R eceived 2023–2024 formula
COVID -19–Associated Hospitalizations
Among Persons with
Immunocompromising Conditions
11
Immunocompromising conditions among patients
hospitalized with COVID- 19 include:
•AIDS or CD4 count <200
•Complement deficiency
•Graft vs. host disease
•HIV infection
•Immunoglobulin deficiency
•Immunosuppressive therapy*
•Leukemia**
•Lymphoma**
•Malignancy (solid organ)**•Bone marrow transplant
•Metastatic cancer**
•Multiple myeloma**
•Steroid therapy***
•Solid organ transplant
•Other conditions typically associated
with immunocompromised status
upon review
* Within the 12 months before admission
** Current/in treatment or diagnosed in the 12 months before admission
*** Within 2 weeks before admission. Does not include inhaled, intranasal steroids or intramuscular or intra -articular injection  of steroids.12
About 1 in 6 (15.6%) persons hospitalized with COVID- 19
have an immunocompromising condition.
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission. 1316314 162215
0%10%20%30%40%50%60%70%80%90%100%
Total 0–4 5–17 18–49 50–64 ≥65Percent of persons hospitalized with C OV I D -19
A ge group (years)Immunocompromising condition among persons with COVID -19–associated hospitalization, by age group —
COVID -NET, July 2023 –May 2024
Immunocompromising condition No immunocompromising condition
The most common immunocompromising conditions
among persons hospitalized with COVID- 19 include:
* Within the 12 months before admission
** Current/in treatment or diagnosed in the 12 months before admission
***  Within 2 weeks before admission. Does not include inhaled, intranasal steroids or intramuscular or intra -articular injectio n of steroids.
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission. 1446
34
26
22
9
6
5
4
3
2
1
0.8
0.1
10 10 20 30 40 50
* Immunosuppressive therapy
** Solid organ malignancy
*** Steroid therapy
** Metastatic cancer
Solid organ transplant
** Lymphoma/Hodgkins/Non-Hodgkins
HIV infection
** Leukemia
Bone marrow transplant
Immunoglobulin deficiency
** Multiple myeloma
AIDS or CD4 count <200
Graft vs. host disease
Other immunocompromising conditionsPercent of persons hospitalized with C OV I D -19Prevalence of immunocompromising conditions among persons hospitalized with COVID -19 with
immunocompromised status — COVID -NET, July 2023 –May 2024
Prevalence  of conditions among
the 16% of hospitalized persons
with immunocompromising
conditions
Few persons with an immunocompromising condition hospitalized with
COVID -19 received any COVID -19 vaccine since September 2022.
1567
191470
19
11
01020304050607080
No record of 2022–2023 (bivalent) or 2023–
2024 formula doseR eceived 2022–2023 (bivalent) dose, but no
2023–2024 formula doseR eceived 2023–2024 formula dosePercent of persons hospitalized with C OV I D -19
V accination statusVaccination status among persons hospitalized with COVID -19, by immunocompromising status —
COVID -NET, October 2023 –May 2024
Immunocompromising condition No immunocompromising condition
Time since receipt of most recent COVID -19 vaccine
varies little by immunocompromising condition status.
Limited to persons hospitalized with COVID -19 who received either a 2022– 2023 (bivalent) or 2023– 2024 formula COVID -19 vaccine s ince September 1, 2022. Data are limited to hospitalizations
where COVID- 19 is a likely primary reason for admission. 1621322
757
5619
961
010203040506070
≤30 days 31–60 days 61–120 days 121–180 days ≥180 daysPercent of persons hospitalized with C OV I D -19
Days since vaccinationTime since receipt of most recent COVID -19 vaccine among persons hospitalized with COVID -19, by
immunocompromising status — COVID -NET, October 2023 –May 2024
Immunocompromising condition No immunocompromising condition
Risk for severe outcomes during COVID -19–associated
hospitalization among children and adolescents varies little by
immunocompromising condition status.
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission. 1719
6
0.923
5
0.6
0510152025
ICU admission Invasive mechanical ventilation In-hospital deathPercent of persons hospitalized with C OV I D -19Prevalence of outcomes and interventions among children and adolescents
aged ≤17 years hospitalized with COVID -19, by immunocompromising
condition status — COVID -NET, July 2023 –May 2024
Immunocompromising condition No immunocompromising conditionSample size with I.C. condition = 103
Risk for severe outcomes during COVID -19–associated
hospitalization among adults varies by immunocompromising
condition status.
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission. 1827
18
15 15
64
051015202530
ICU admission Invasive mechanical ventilation In-hospital deathPercent of persons hospitalized with C OV I D -19Prevalence of outcomes and interventions among adults ages ≥18 years
hospitalized with COVID -19, by immunocompromising condition status —
COVID -NET, July 2023 –May 2024
Immunocompromising condition No immunocompromising conditionSample size with I.C. condition = 512
Questions
19

Summary: COVID -19–Associated Hospitalizations Update —   COVID -NET, July 2023– September 2024 Adults Ages ≥65 Years and Persons with Immunocompromising Conditions Christopher A. Taylor, PhD RESP -NET Hospitalization Surveillance Team Coronavirus and Other Respiratory Viruses Division Meeting of the Advisory Committee on Immunization Practices (ACIP) October 23, 2024National Center for Immunization and Respiratory Diseases 1 COVID -NET is a population -based hospitalization  surveillance platform.…