04 Meningococcal Collins 508

Summary of EtRand proposed
recommendations for Pfizer’s MenABCWY
vaccine
Jennifer Collins MD, MSc
Interim Co -Lead, ACIP Meningococcal Vaccines Work Group
October 25, 2023National Center for Immunization & Respiratory Diseases
ACIP Recommendations for Meningococcal Vaccines
▪ Routine schedule
–MenACWY : dose 1 at age 11 –12 years, booster dose at age 16 years
–MenB (shared clinical decision -making): two doses at age 16–23 years (preferred age 16 –18 years)
▪ Special situations
IndicationMenACWY
(age ≥2 months)MenB
(age ≥10 years)
Medical conditionsAsplenia X X
Complement Deficiency X X
Complement inhibitor use X X
HIV infection X
OtherSome microbiologists X X
Exposure during an outbreak X X
Travel to hyperendemic areas X
First -year college students X
Military recruits X2
Meningococcal vaccines licensed and
available in the United States
▪MenACWY vaccines are interchangeable
▪MenB vaccines are NOT interchangeableVaccine Trade Name Manufacturer Minimum age
MenACWY -CRM Menveo GSK 2 months
MenACWY -TT MenQuadfi Sanofi Pasteur 2 years
3Vaccine Trade Name Manufacturer Minimum age
MenB -4C Bexsero GSK 10 years
MenB -FHbp Trumenba Pfizer 10 years
Pfizer’s MenABCWY Vaccine
▪Licensed as a 2 -dose series (6-month interval) for individuals aged 10 –25 years
▪Comprised of Trumenba (serogroup B) and Nimenrix (serogroups ACWY)
–Trumenba
•Consists of two purified recombinant lipidated FHbp antigens, one from
each FHbp subfamily (A and B)
•Currently licensed and available in U.S. (10 –25 years)
–Nimenrix
•Meningococcal group A, C, W, and Y polysaccharide tetanus toxoid
conjugate vaccine
•Not licensed in U.S. but used extensively in Europe and elsewhere for more
than a decade
4
Policy Questions for 3 PICOs
▪Should the pentavalent vaccine be included as an option for
MenACWY/MenB vaccination in people currently recommended to
receive both vaccines ?
▪Should the pentavalent vaccine be included as an option for people
currently recommended to receive MenACWY only ?
▪Should the pentavalent vaccine be included as an option for people
currently recommended to receive MenB only ? PICO 1
PICO 2
PICO 3
5
GRADE Table 1: Combined Policy Question and PICO
Policy QuestionShould the pentavalent vaccine be included as an option for people currently recommended to
receive MenACWY and MenB, MenACWY only, or MenB only ?
PopulationAll individuals aged 10 years or older currently recommended to receive MenACWY+MenB,
MenACWY , or MenB vaccine
Intervention Vaccination with Pfizer’s pentavalent ( MenABCWY ) vaccine
Comparison Vaccination with currently licensed MenACWY+MenB, MenACWY , or MenB vaccine
Outcomes•Meningococcal disease caused by serogroups A, B, C, W, and Y ( as appropriate by PICO )
•Short -term immunity
•Persistent immunity
•Interference with other recommended vaccines administered concurrently
•Serious adverse events
•Non -serious adverse events
6
How PICOs Translate into Schedule Options for Healthy
Adolescents –assuming MenB #1 at age 16 years
Legend
Q = MenACWY (quadrivalent)
B = MenB
P = MenABCWY (pentavalent)Options11–12 year
olddose16 year old
dose #116 year old
dose #2
Standard of care (MenACWY only) Q Q –
Standard of care (MenACWY + MenB) Q Q+B B
PICO 1 (MenABCWY as option for MenACWY + MenB) Q P B
PICO 2 (MenABCWY as option for MenACWY) P P ±B
PICO 3 (MenABCWY as option for MenB) Q P P
Combination of all 3 PICOs P P P
7
Schedule options presented in June
Legend
Q = MenACWY (quadrivalent)
B = MenB
P = MenABCWY (pentavalent)Options11–12 year
olddose16 year old
dose #116 year old
dose #2WG
Proposal
Standard of care (MenACWY only) Q Q – N/A
Standard of care (MenACWY + MenB) Q Q+B B N/A
PICO 1 (MenABCWY as option for MenACWY + MenB) Q P B
PICO 2 (MenABCWY as option for MenACWY) P P B
PICO 3 (MenABCWY as option for MenB) Q P P
Combination of all 3 PICOs P P P
8
Since June, the WG has refined the EtRand further
considered possible implications of each PICO
(especially PICO 3) based on
▪ACIP members’ concerns raised during the June meeting
–Cost effectiveness
–Concerns about increasing exposure to B component related to reactogenicity, low
burden of disease, and limitations to protection
–Optimal timing of B component is often not age16 years
–Fidelity to clinical trial data and licensure
–Stocking and administration considerations
▪Cost effectiveness analysis
–Updates to quoted price of the pentavalent vaccine
–Refinements to the CDC model
9
Summary of updated EtR
PUBLIC HEALTH PROBLEM
Is meningococcal disease a problem of public health importance?
▪Incidence of meningococcal
disease is low and decreasing
▪Causes very severe disease
▪Poor outcomes even with
treatment
–Case fatality 10 –15%
–10–20% of survivors have
permanent sequelae
11WG interpretationPICO 1
MenABCWY vs. MenACWY + MenBPICO 2
MenABCWY vs. MenACWYPICO 3
MenABCWY vs. Men B
Yes Yes Yes

BENEFITS & HARMS
▪ Three randomized control trials studied
–MenABCWY 2 doses (0, 6 months and 0, 12 months) vs. MenACWY -CRM 1 dose + MenB -FHbp 2 doses
(0, 6 months)
–Among ACWY -naïve and ACWY -primed participants
–Available data facilitated assessment of select outcomes through GRADE
•Short -term immunity
•Persistent immunity
•Serious adverse events
•Non -serious adverse events
▪ Othe r important benefits and harms were not assessed through GRADE but factored into WG
interpretations
–Increased r eactogenicity of MenB relative to MenACWY
–Limitations to B protection
•Low VE expected following a single dose
•Rapidly waning protection following 2 -dose series
•Multiple studies demonstrating MenB vaccination has no effect on meningococcal carriage
12
BENEFITS AND HARMS: Summary of GRADE
Type Outcome ImportanceDesign
(# studies)FindingsEvidence type*
Healthy Increased risk
BenefitsMeningococcal disease
caused by serogroups, A, B,
C, W, and YCritical n/a No data available ND ND
Short -term immunity Critical RCT (1)Serogroup -specific seroresponses one month after
the first trial dose of ACWY -or B-containing vaccine
occurred as often or more often in the pentavalent
group compared with the control groupModerate Low
Persistent immunity Important RCT (2)Seroresponse rates by serogroup were similar:
-48 months after 2 doses pentavalent vs. 54
months after 1 dose MenACWY -CRM
-48 months after 2 doses pentavalent vs. 2 doses
MenB -FHbpLow─
moderateLow
HarmsSerious adverse events Critical RCT (3)Significantly more SAEs occurred in the pentavalent
group vs. comparison group; none were attributed
to the vaccineLow Very low
Non -serious adverse
eventsImportant RCT (3)Significantly more non -serious adverse events
occurred in the pentavalent group vs. comparison
groupLow Very low
Interference with other
recommended vaccines
administered concurrentlyImportant n/a No data available ND ND
13 *Downgrades primarily related to indirectness of intervention and comparison groups relative to PICOs, people at increased ri sk not being included, and wide confidence intervals for adverse events
BENEFITS & HARMS –Work Group interpretations
14QuestionPICO 1
MenABCWY vs. MenACWY +
MenBPICO 2
MenABCWY vs.
MenACWYPICO 3
MenABCWY vs. Men B
How substantial are the
desirable anticipated
effects?SmallMinimal, small, or
moderateMinimal
How substantial are the
undesirable anticipated
effectsSmall Minimal or small Minimal or small
Do the desirable effects
outweigh the
undesirable effects?Favors interventionFavors intervention,
comparison, or bothFavors intervention or
comparison
What is the overall
certainty?Varies by group Varies by group Varies by group
15VALUES
▪Limited data were available
–Among adolescents during 2021, vaccination coverage of at least 1 dose
•89% for MenACWY
•31% for MenB
–Limited data are available on vaccine uptake in other individuals recommended to receive
MenACWY or MenB vaccine
▪Use of combination vaccines can reduce number of injections and is generally preferred over
separate injections of the equivalent component vaccines1,2
13
1 General Best Practice Guidelines for Immunization. Best Practice Guidance of the ACIP. https://www.cdc.gov/vaccines/hcp/acip -recs/general -recs/downloads/general -recs.pdf
2 American Academy of Pediatrics. Red Book 2018. Report of the Committee on Infectious Diseases. 31stEd. https://seciss.facmed.unam.mx/wp -content/uploads/2021/02/Red -Book -31th -Edition.pdf15QuestionPICO 1
MenABCWY vs. MenACWY + MenBPICO 2
MenABCWY vs. MenACWYPICO 3
MenABCWY vs. Men B
Does the target population feel
that desirable effects are large
relative to undesirable effects?Probably yes Probably yesProbably yes or don’t
know
Important uncertainty or
variability in how much people
value the main outcomes?Probably no Probably yes Probably yes
16ACCEPTABILITY
Is the intervention acceptable to key stakeholders?
▪Limited data were available
▪Acceptability likely depends on PICO and balance of stakeholder values
–Health care providers likely supportive of options that allow stocking fewer vaccines1,2
–Potential to increase vaccination rates against serogroup B disease
–Reduces number of injections from 4 to 3 for some patients
–Potential to incentivize MenB administration at age 16 years with waning immunity by peak risk for some
patients
•Many vaccine providers prefer waiting until closer to exposure to congregate settings (college/military)
–Concerns about increasing exposure to MenB (which is more reactogenic than MenACWY ) when burden of
MenB disease is already low despite low vaccine coverage
•31% single dose
•<12% second dose
1CDC. Timing and Spacing of Immunobiologics : General Best Practice Guidelines for Immunization. ACIP Timing and Spacing Guidelines for Immunization | CDC .
2Hall E, Odafe S, Madden J, Schillie S. Qualitative Conceptual Content Analysis of COVID -19 Vaccine Administration Error Inquiries. Vaccines . 2023; 11(2):254.16WG interpretationPICO 1
MenABCWY vs. MenACWY + MenBPICO 2
MenABCWY vs. MenACWYPICO 3
MenABCWY vs. Men B
Probably yes or yes Probably yes or yes Don’t know
RESOURCE USE
Is the intervention a reasonable and efficient allocation of resources?
▪All proposed meningococcal
vaccine strategies are
expensive, including currently
recommended options for
adolescents (QQ and QQBB)
▪With new price estimates, QPP
is the most cost -effective
option when MenB protection
is desired
17WG interpretationPICO 1
MenABCWY vs. MenACWY + MenBPICO 2
MenABCWY vs. MenACWYPICO 3
MenABCWY vs. Men B
Probably yes or yes Probably no or no Probably yes or yesStrategy Cost/person
Public sector QQ 241.2
QQBB 554.88
QPB 479.94
QPP 465.6
QQPP 586.2
Private sector QQ 372.0
QQBB 854.64
QPB 707.32
QPP 666.0
QQPP 852.0
EQUITY
What would be the impact on health equity?
▪Limited data were available
▪The pentavalent vaccine is not expected to negatively impact equity
▪It could potentially reduce disparities among those who might be interested in being
vaccinated against serogroup B but who might not receive clinical care that includes
discussion of the MenB vaccine
▪Possible risk of clinics not stocking monovalent B vaccines with some policy options, which
could affect availability for
–Outbreaks
–People at increased risk recommended to receive 3 doses of MenB -FHbp
18WG interpretationPICO 1
MenABCWY vs. MenACWY + MenBPICO 2
MenABCWY vs. MenACWYPICO 3
MenABCWY vs. Men B
Probably no impact or variesProbably increased, varies, or
don’t knowDon’t know
FEASIBILITY
Is the intervention feasible to implement?
▪Challenges with insurance coverage specific to the pentavalent vaccine not expected
▪Substantial financial burdens for providers or health systems not expected
▪Pentavalent vaccine would provide additional option in current schedule and may reduce
number of doses for some people
▪Administration requires reconstitution, which may lead to administration errors1
▪Stocking three different meningococcal vaccine types may be prohibitive for some
providers
▪Lack of B vaccines interchangeability complicates stocking considerations
19WG
interpretationPICO 1
MenABCWY vs. MenACWY + MenBPICO 2
MenABCWY vs. MenACWYPICO 3
MenABCWY vs. Men B
Probably yes or yes Probably yes or yes Probably yes or yes
1https://www.cdc.gov/mmwr/volumes/65/wr/mm6506a4.htm
20DomainPICO 1
MenABCWY vs. MenACWY + MenBPICO 2
MenABCWY vs. MenACWYPICO 3
MenABCWY vs. Men B
Public health problem Yes Yes Yes
Benefits
&
harmsDesirable anticipated effects Small Minimal, small, or moderate Minimal
Undesirable anticipated
effectsSmall Minimal or small Minimal or small
Desirable effects > undesirable
effects?Favors interventionFavors intervention, comparison, or
bothFavors intervention or comparison
Overall certainty Varies by group Varies by group Varies by group
ValuesAre desirable effects large
relative to undesirable
effects?Probably yes Probably yes Probably yes or don’t know
Important uncertainty or
variability?Probably no Probably yes Probably yes
Acceptability Probably yes or yes Probably yes or yes Don’t know
Resource use Probably yes or yes Probably no or no Probably yes or yes
Equity Probably no impact or variesProbably increased, varies, or don’t
knowDon’t know
Feasibility Probably yes or yes Probably yes or yes Probably yes or yesEtRsummary –all 3 PICOs
20Favorable Somewhat favorable Uncertain Unfavorable
Summary of work group consensus and
debate
21▪Strong consensus in favor of PICO 1: MenABCWY as an option for MenACWY + MenB (QPB)
▪Strong consensus a gainst PICO 2: MenABCWY as an option for MenACWY only (PPB )
▪Limited consensus regarding PICO 3: MenABCWY as an option for MenB only
▪Options debated for PICO 3
Option Preference
A Reject outright
B Accept with limitations (i.e., QPP only)
C Accept fully (i.e., QPP , QQPP , QQPB)
Q
11–12       16          17          18          19          20          21          22          23
Age (years) BB
QYes
(age >16
years)
22Existing recommendations for routine schedule
incorporating SCDM
QBBYes
(age 16 years)Serogroup B
vaccine
desired based
on shared
clinical
decision -
making?
No
Q
Q
11–12       16          17          18          19          20          21          22          23
Age (years) BB
QYes
(age >16
years)
23QBBYes
(age 16 years)Serogroup B
vaccine
desired based
on shared
clinical
decision -
making?
No
QPB
B POption A adds QPB to the existing options
Lack of dataNeither option is consistent
with licensure (i.e., 2 -dose
MenABCWY series)
Q
11–12       16          17          18          19          20          21          22          23
Age (years) BB
QYes
(age >16
years)
24QBBYes
(age 16 years)Serogroup B
vaccine
desired based
on shared
clinical
decision -
making?
No
QPB
B POption B adds QPP to Option A
PP
Q
11–12       16          17          18          19          20          21          22          23
Age (years) BB
QYes
(age >16
years)
25QBBYes
(age 16 years)Serogroup B
vaccine
desired based
on shared
clinical
decision -
making?
No
QPB
B P Option C adds QQPP and QQPB to option B
PPQQ PP
PB•Higher cost
•Lack of data
26Summary of routine schedule interpretation
for 3 options
26All options would permit current standard of care (i.e., QQ vs. QQBB under SCDM)
Option* Preference for PICO 3 Schedule options incorporating
SCDM for MenB
A Reject outright QPB
B Accept with limitations QPB + QPP
C Accept fully QPB + QPP + QQPP + QQPB
*All options include a recommendation in favor of PICO 1 and against PICO 2
27WG deliberations regarding 3 most favored options
CONSIDERATIONOption A
PICO 1 (QPB)Option B
PICO 1 + PICO 3 (QPP only)Option C
PICO 1 + PICO 3 (QPP , QQPP , QQPB)
CLINICAL
Alignment with clinical trial dataNot directly assessed; however,
second pentavalent dose is
primarily for additional B
protectionDirectly assessed in clinical trial (6 -
or 12 -month interval between
pentavalent doses)Options with additional antigenic
exposures for which safety and
immunogenicity have not been assessed
(QQPP , QQPB)
Alignment with licensure Off-label Yes Yes
Excess doses for ≥1 serogroup No Yes (1 dose) Yes (multiple doses)
STOCKING AND ADMINISTRATION
Flexibility (especially for under -
resourced clinics)Least Intermediate Most
Minimum # vaccines to stock if using
MenABCWY for routine indications*3 2 2
ECONOMIC
Projected cost effectiveness Unclear cost effectiveness Most cost -effective option based
on recent price update from PfizerIncludes more expensive options not
assessed in CE model (e.g., QQPP)
Potential for insurance reimbursement
issuesYes No No
Most favorable Somewhat favorable Least favorable27*All options would require stocking 3 vaccines for special situations if using MenABCWY . Minimum number of vaccines to stock will remain 2 ( MenACWY , MenB ) if not using MenABCWY .
28WG deliberations regarding 3 most favored options
CONSIDERATIONOption A
PICO 1 (QPB)Option B
PICO 1 + PICO 3 (QPP only)Option C
PICO 1 + PICO 3 (QPP , QQPP , QQPB)
CLINICAL
Alignment with clinical trial dataNot directly assessed; however,
second pentavalent dose is
primarily for additional B
protectionDirectly assessed in clinical trial (6 -
or 12 -month interval between
pentavalent doses)Options with additional antigenic
exposures for which safety and
immunogenicity have not been assessed
(QQPP , QQPB)
Alignment with licensure Off-label Yes Yes
Excess doses for ≥1 serogroup No Yes (1 dose) Yes (multiple doses)
STOCKING AND ADMINISTRATION
Flexibility (especially for under -
resourced clinics)Least Intermediate Most
Minimum # vaccines to stock if using
MenABCWY for routine indications*3 2 2
ECONOMIC
Projected cost effectiveness Unclear cost effectiveness Most cost -effective option based
on recent price update from PfizerIncludes more expensive options not
assessed in CE model (e.g., QQPP)
Potential for insurance reimbursement
issuesYes No No
Most favorable Somewhat favorable Least favorable28*All options would require stocking 3 vaccines for special situations if using MenABCWY . Minimum number of vaccines to stock will remain 2 ( MenACWY , MenB ) if not using MenABCWY .
29WG deliberations regarding 3 most favored options
CONSIDERATIONOption A
PICO 1 (QPB)Option B
PICO 1 + PICO 3 (QPP only)Option C
PICO 1 + PICO 3 (QPP , QQPP , QQPB)
CLINICAL
Alignment with clinical trial dataNot directly assessed; however,
second pentavalent dose is
primarily for additional B
protectionDirectly assessed in clinical trial (6 -
or 12 -month interval between
pentavalent doses)Options with additional antigenic
exposures for which safety and
immunogenicity have not been assessed
(QQPP , QQPB)
Alignment with licensure Off-label Yes Yes
Excess doses for ≥1 serogroup No Yes (1 dose) Yes (multiple doses)
STOCKING AND ADMINISTRATION
Flexibility (especially for under -
resourced clinics)Least Intermediate Most
Minimum # vaccines to stock if using
MenABCWY for routine indications*3 2 2
ECONOMIC
Projected cost effectiveness Unclear cost effectiveness Most cost -effective option based
on recent price update from PfizerIncludes more expensive options not
assessed in CE model (e.g., QQPP)
Potential for insurance reimbursement
issuesYes No No
Most favorable Somewhat favorable Least favorable29*All options would require stocking 3 vaccines for special situations if using MenABCWY . Minimum number of vaccines to stock will remain 2 ( MenACWY , MenB ) if not using MenABCWY .
30WG deliberations regarding 3 most favored options
CONSIDERATIONOption A
PICO 1 (QPB)Option B
PICO 1 + PICO 3 (QPP only)Option C
PICO 1 + PICO 3 (QPP , QQPP , QQPB)
CLINICAL
Alignment with clinical trial dataNot directly assessed; however,
second pentavalent dose is
primarily for additional B
protectionDirectly assessed in clinical trial (6 -
or 12 -month interval between
pentavalent doses)Options with additional antigenic
exposures for which safety and
immunogenicity have not been assessed
(QQPP , QQPB)
Alignment with licensure Off-label Yes Yes
Excess doses for ≥1 serogroup No Yes (1 dose) Yes (multiple doses)
STOCKING AND ADMINISTRATION
Flexibility (especially for under -
resourced clinics)Least Intermediate Most
Minimum # vaccines to stock if using
MenABCWY for routine indications*3 2 2
ECONOMIC
Projected cost effectiveness Unclear cost effectiveness Most cost -effective option based
on recent price update from PfizerIncludes more expensive options not
assessed in CE model (e.g., QQPP)
Potential for insurance reimbursement
issuesYes No No
Most favorable Somewhat favorable Least favorable30*All options would require stocking 3 vaccines for special situations if using MenABCWY . Minimum number of vaccines to stock will remain 2 ( MenACWY , MenB ) if not using MenABCWY .
31Balance of Consequences —PICO 1
MenABCWY as an option for MenACWY+MenB
Undesirable
consequences
clearly outweigh
desirable
consequences in
most settings Undesirable
consequences
probably outweigh
desirable
consequences in
most settingsThe balance
between
desirable and
undesirable
consequences is
closely balanced
or uncertainDesirable
consequences
probably outweigh
undesirable
consequences in
most settingsDesirable
consequences
clearly outweigh
undesirable
consequences in
most settingsThere is
insufficient
evidence to
determine the
balance of
consequences
31Majority of WG members think desirable consequences probably
or clearly outweigh undesirable consequences in most settings
Most common 2ndmost common 3rdmost common
32 Most common 2ndmost commonWork Group Interpretation —PICO 1
We do not recommend the intervention, but it may be used within FDA licensed indications
We recommend the intervention for individuals based on shared clinical decision -making
We recommend the interventionShould the pentavalent vaccine be included as an option for
MenACWY/MenB vaccination in people currently recommended to
receive both vaccines ?
32Majority of WG members favored recommending the intervention
33Balance of Consequences —PICO 2
MenABCWY as an option for MenACWY
Undesirable
consequences
clearly outweigh
desirable
consequences in
most settings Undesirable
consequences
probably outweigh
desirable
consequences in
most settingsThe balance
between
desirable and
undesirable
consequences is
closely balanced
or uncertain Desirable
consequences
probably outweigh
undesirable
consequences in
most settingsDesirable
consequences
clearly outweigh
undesirable
consequences in
most settingsThere is
insufficient
evidence to
determine the
balance of
consequences
33 Most common 2ndmost common 3rdmost commonMajority of WG members think undesirable consequences probably or
clearly outweigh desirable consequences in most settings
34Work Group Interpretation —PICO 2
We do not recommend the intervention, but it may be used within FDA licensed indications
We recommend the intervention for individuals based on shared clinical decision -making
We recommend the interventionShould the pentavalent vaccine be included as an option for
people currently recommended to receive MenACWY only ?
34Most common 2ndmost commonMajority of WG members favored not recommending the intervention
35 Most common 2ndmost commonBalance of Consequences —PICO 3
MenABCWY as an option for MenB
Undesirable
consequences
clearly outweigh
desirable
consequences in
most settings Undesirable
consequences
probably outweigh
desirable
consequences in
most settingsThe balance
between
desirable and
undesirable
consequences is
closely balanced
or uncertain Desirable
consequences
probably outweigh
undesirable
consequences in
most settings Desirable
consequences
clearly outweigh
undesirable
consequences in
most settings There is
insufficient
evidence to
determine the
balance of
consequences
35The WG did not reach a majority consensus on the balance of
consequences
36Work Group Interpretation —PICO 3
We do not recommend the intervention, but it may be used within FDA licensed indications
We recommend the intervention for individuals based on shared clinical decision -making
We recommend the intervention but only in certain circumstances (i.e., QPP)
We recommend the intervention in all circumstancesShould the pentavalent vaccine be included as an option for
people currently recommended to receive MenB only ?
36Added an additional option because some WG members favored QPP only
37Work Group Interpretation —PICO 3
We do not recommend the intervention, but it may be used within FDA licensed indications
We recommend the intervention for individuals based on shared clinical decision -making
We recommend the intervention but only in certain circumstances (i.e., QPP)
We recommend the intervention in all circumstancesShould the pentavalent vaccine be included as an option for
people currently recommended to receive MenB only ?
▪WG was divided regarding PICO 3
▪Majority favored PICO 3 in some form
▪Substantial minority of work group members favored not recommending the intervention
37Most common 2ndmost common 3rdmost common 4thmost common
3838PICO 1 (QPB)
PICO 2 (PPB)
PICO 3 (QPP only)
Pfizer’s MenABCWY vaccine may be used when both MenACWY and MenB are indicated at the
same visit.* If MenABCWY is administered in this way, a second dose of MenABCWY may be
administered 6 months later to complete the series.
*1) Healthy individuals aged 16 –23 years (routine schedule) when shared clinical decision -
making favors administration of MenB vaccination, 2) individuals aged 10 years and older at
increased risk of meningococcal disease (e.g., due to persistent complement deficiencies,
complement inhibitor use, or functional or anatomic asplenia) due for both vaccines.
▪Remarks:
•for Pfizer’s MenABCWY vaccine, data are not available regarding safety or immunogenicity of dosing intervals exceeding
12 months
•the licensed B component vaccines are not interchangeable by manufacturer. Administration of a B component vaccine
(MenB or MenABCWY ) requires that subsequent B component vaccine doses be from the same manufacturer
•the minimum interval for Pfizer’s MenABCWY vaccine is 6 months. Individuals at increased risk of meningococcal disease
who are recommended to receive additional doses of MenACWY and MenB less than 6 months after a dose of
pentavalent meningococcal vaccine should instead receive separate MenACWY and MenB -FHbp vaccines
Combined draft proposal for option B
39Rationale in favor of combined draft proposal
▪Aligns with clinical trial data and licensure
▪Allows for f ewer injections than QQBB
▪Provides flexibility with vaccine inventory, including for clinics that prefer to stock
2 vaccines for routine indications
▪Stocking fewer vaccines may increase equity (e.g., if under -resourced clinics are
less likely to stock 3 vaccines )
▪Most cost -effective option based on recent price update from Pfizer
39
40Rationale against combined draft proposal
▪Unnecessary ACWY antigen exposure for second pentavalent dose in routine schedule
(i.e., when only MenB is indicated)
▪Not as much flexibility for providers as Option 3
General considerations (all options):
▪Potential to incentivize MenB at age 16 years with waning immunity by peak risk (i.e.,
college/military) for some patients
▪Uncertainty regarding cost estimates
▪If using MenABCWY , it will be necessary to stock 3 vaccines to cover all indications
(routine schedule + special situations), which may be challenging for some vaccine
providers
40
Acknowledgments
▪ ACIP Members on the WG
– Kathy Poehling (Chair)
– Lynn Bahta
– Jamie Loehr
▪ Ex Officio WG Members
– Margaret Bash (FDA)
– Mark Connelly (FDA)
– Francisco Leyva (NIH)
▪ WG Liaisons and Consultants
– Amra Resic (AAFP)
– Samir Shah (AAP)
– Sharon McMullen (ACHA)
– Cacky Tate / Karyn Lyons (AIM)
– Paul Cieslak (CSTE)
– Kathy Hsu (IDSA)
– Joseline Zafack (NACI)
– Jeff Goad (NFID)
– Jessica Cataldi (PIDS)
– Amy Middleman (SAHM)
– David Stephens (Emory)▪ CDC Contributors
– Sam Crowe (DBD/NCIRD)
– Lucy McNamara (DBD/NCIRD)
– Ismael Ortega -Sanchez (DVD/NCIRD)
– Andrew Leidner (ISD/NCIRD)
– LeAnne Fox (DBD/NCIRD)
– Susan Hariri (DBD/NCIRD)
– Amy Rubis (DBD/NCIRD)
– Noele Nelson (DBD/NCIRD)
– Alison Albert (DBD/NCIRD)
– Angela Jiles (DBD/NCIRD)
– Jonathan Duffy (DHQP/NCEZID)
– Tanya Myers (DHQP/NCEZID)
– Liz Velazquez (ISD/NCIRD)
– Jessica MacNeil (ACIP Secretariat)
– Melinda Wharton (ACIP Secretariat)
▪ GRADE/EtR Support
– Doug Campos -Outcalt (Arizona)
– Rebecca Morgan (Case Western Reserve)
41
Thank you!
Questions?

Summary: Summary of EtRand proposed  recommendations for Pfizer’s MenABCWY vaccine  Jennifer Collins MD, MSc Interim Co -Lead, ACIP Meningococcal Vaccines Work Group October 25, 2023National Center for Immunization & Respiratory Diseases ACIP Recommendations for Meningococcal Vaccines ▪ Routine schedule  –MenACWY : dose 1 at age 11 –12 years, booster dose at age 16 years –MenB (shared clinical decision -making): two doses at age 16–23 years (preferred age 16 –18 years) ▪ Special situations…


01 MPOX Sanchez 508

National Center for Emerging and Zoonotic Infectiou s Diseases
Mpox Vaccine Work Group:  Introduction
ACIP Meeting October 25, 2023 Pablo Sanchez MD /uni00YJhe Ohio State /uni00YYni/uni00-6ersit/uni00-9/uni2212Na/gJ1Yon/uni00--ide Children/uni2019s /uni00J8osp ital
Chair, ACIP Mpox Work Group
Global mpox outbreak, 2022
First case in this outbreak identified in the Unite d Kingdom in May 2022
Primarily affecting gay, bisexual, and other men wh o have sex with men
(MSM)
Associated with person-to-person spread via close s kin-to-skin contact
including sex
Deaths have occurred, primarily among persons with severe
immunocompromise from advanced HIV
U.S. case counts and deaths comprising 1/3 of cases  and deaths
–>30,800 cases
–54 deaths
Current global cases reported to WHO, September, 2023
https://worldhealthorg.shinyapps.io/mpx_global/
JYNNEOS
Comprised of replication-deficient vaccinia virus
Administered subcutaneously* via 2 vaccine doses, 28 day s apart
Effectiveness assessed by comparing immunologic response  to that for
ACAM2000
Licensed for prevention of both smallpox and mpox
Is recommended for persons with HIV and other immunoc ompromising
conditions
Licensed for persons ≥ 18 years of age; an NIH trial is  underway to evaluate
safety and immunogenicity for persons 12-17 years of a ge
*During the 2022 mpox outbreak, it was also administ ered intradermally because of limited vaccine avail ability; it is currently available
in enough supply
Outbreak recommendation: February and June ACIP meetings
Vote: ACIP recommends the 2-dose* JYNNEOS vaccine s eries for
persons aged 18 years and older at risk of mpox during  an mpox
outbreak †
*Dose 2 administered one month after dose 1 †Public health authorities determine whether there i s an mpox outbreak; a single case may be considered an
mpox outbreak at the discretion of public health aut horities. Other circumstances in which a public hea lth
response may be indicated including ongoing risk of  introduction of mpox into a community due to diseas e
activity in another geographic area
Outbreak recommendations intended for any U.S. mpox outbreak,
regardless of whether associated with male-to-male sexual contact
Clinical guidance, including about use of vaccine i n children during
outbreaks discussed
National mpox vaccination strategy for pre-exposure
vaccination during current outbreak*
*https://www.cdc.gov/poxvirus/monkeypox/interim-con siderations/overview.html Vaccination before exposure to mpox virus
-Gay, bisexual, and other MSM, transgender or nonbi nary people (including adolescents
who fall into the aforementioned categories) who in  the past 6 months have had:
•New diagnosis of ≥ 1 sexually transmitted disease
•More than one sex partner
-People with the following in the last 6 months: •Sex at commercial sex venue
•Sex in association with large public event in geogr aphic area where mpox transmission
is occurring
-Sexual partners of people with the above risks -People who anticipate experiencing above risks -People with HIV or other causes of immunosuppressi on who have had recent or
anticipate potential mpox exposure
Elimination of human-to-human transmission
WHO strategy in development; additional resources a nd data needed
Immunization may be one component of the strategy
Elimination is a complex issue not addressed by WG;  however, a
recommendation that persons at-risk for mpox during the ongoing
outbreak receive the vaccines if they have not alre ady, may support any
upcoming WHO strategy
Recommendation that will be proposed during today’s
meeting
ACIP recommends vaccination* with the 2-dose †JYNNEOS vaccine series for
persons aged 18 years and older at risk for mpox §?
*Interim recommendation to be revisited in 2-3 year s
† Dose 2 administered 28 days after dose 1
§Persons at risk:
•Gay, bisexual, and other men who have sex with men,  transgender or nonbinary people who
in the past 6 months have had one of the following:
•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
•Sexual partners of persons with the risks described  in above
•Persons who anticipate experiencing any of the abov e
Potential implications of interim routine recommendation
Increase vaccine coverage and prevent or minimize o utbreaks
Remove some stigma and facilitate 1:1 consultation with clinician during
appointments
Potential commercialization of JYNNEOS
Product sponsor (Bavarian Nordic) has indicated they will attempt to
commercialize the vaccine if it is on a routine schedule
This will transition vaccine from U.S. government stockpiles  (which were
intended for smallpox preparedness) to the commercial se ctor
Tentative timeline for ACIP discussions and votes*
Interim routine recommendation and clinical guidance
October 2023 Early 2024 Possibly 2024 Publication of 2 MMWRs: 1) Use of JYNNEOS during mpox
outbreaks
2) Use of JYNNEOS among
persons at risk during the ongoing mpox outbreak Consider results from NIH trial about use of JYNNEOS in persons aged 12-18 years
*February 2023 and June 2023 votes do not impact ex isting recommendations for the current mpox outbrea k.
8uni0067https://www.cdc.gov/poxvirus/monkeypox/interim-cons iderations/overview.html TBD Review epidemiology, cost-effectiveness analysis, and other data to determine if routine recommendation should be continued
Proposed recommendation
ACIP recommends vaccination* with the 2-dose †JYNNEOS vaccine series for
persons aged 18 years and older at risk for mpox §?
*Interim recommendation to be revisited in 2-3 year s
† Dose 2 administered 28 days after dose 1
§Persons at risk:
•Gay, bisexual, and other men who have sex with men,  transgender or nonbinary people who
in the past 6 months have had one of the following:
•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
•Sexual partners of persons with the risks described  in above
•Persons who anticipate experiencing any of the abov e
Goal for today’s meeting
Updates from the ongoing outbreak
–Epidemiology:  Dr. Faisal Minhaj
–Evidence to recommendations framework:  Dr. Agam Ra o
–Clinical guidance and next steps:  Dr. Agam Rao
Vote
–Mpox vote
–Mpox Vaccines for Children vote
WG members
ACIP Member
Pablo Sánchez Beth Bell
Ex Officio and Liaison Members
CSTE: Chris Hahn / Paul Cieslak
ASTHO: Ericka McGowan
NACHO: Philip Huang FDA: Sixun Yang, Clement
Meseda & Alonzo García
ACOG: Howard Minkoff AAP: Jim Campbell
HRSA:  Vikram Krishnasamy AIM: Rob Schechter / Jane Zucker APHL:  Jafar Razeq
NIH: Janet Lathey / Kimberly Taylor IHS: Matthew Clark NACI: Nicole Forbes / Joshua Montroy IDSA: Shireesha Dhanireddy / Rajesh Gandhi
Invited Consultants
Subject matter experts: Inger Damon, Stuart Isaacs, Mike Merchlinsky & Amanda
Zarrabian (HHS/BARDA)
Clinician experts in STIs, HIV, pediatrics, maternal vaccination, vaccine safety, health equity, smallpox vaccination strategies, occupational health
Clinician experts
STIs, HIV, and mpox
(adult and peds):
Jason Zucker
Pablo Tebas Vince Marconi Kim Workowski Bonnie Maldonado
Immunizations (including for special
populations) and vaccine safety:
Ruth Karron Flor Munoz-Rivas Kathy Edwards Health equity, vaccination strategies
including for smallpox:
Joel Breman
Gerard Vong
Occupational Medicine and worker safety:
Mark Russi
CDC contributors
Mpox epi, lab, and vaccine experts
Andrea McCollum
Christy Hutson Sathesh Panayampalli
Infection control, worker safety:
Marie de Perio David Kuhar Vaccine safety
Jonathan Duffy
Michael McNeil Regulatory Affairs
Yon Yu
STIs and HIV
Laura Bachmann Leandro Mena
John Brooks Alexa Oster Drug Services
Julian Jolly
Vaccine
implementation
Laura Daniel
James Lee
DoD Liaison to CDC
Alan Lam
Work group lead
Agam Rao
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 tho se of the authors and do not necessarily represent the
official position of the Centers for Disease Contro l and Prevention. Thank you!

Summary: National Center for Emerging and Zoonotic Infectiou s Diseases  Mpox Vaccine Work Group:  Introduction  ACIP Meeting October 25, 2023 Pablo Sanchez MD /uni00YJhe Ohio State /uni00YYni/uni00-6ersit/uni00-9/uni2212Na/gJ1Yon/uni00--ide Children/uni2019s /uni00J8osp ital  Chair, ACIP Mpox Work Group  Global mpox outbreak, 2022  First case in this outbreak identified in the Unite d Kingdom in May 2022  Primarily affecting gay, bisexual, and other men wh o have sex with men  (MSM)  Associated…


02 MPOX Minhaj 508

National Center for Emerging and Zoonotic Infectiou s Diseases
2022/2023 Mpox Outbreak: Situational Awareness and Updates
ACIP Meeting October 25, 2023 Faisal Syed Minhaj, PharmD, MPH, DABAT Epidemiologist
Poxvirus and Rabies Branch Division of High Consequence Pathogens and Patholog y
United States Mpox Case Counts May 2022–Sept 28, 202 3
https://www.cdc.gov/poxvirus/mpox/response/2022/mpx -trends.html /uni004D/uni0061/uni0079/uni002D/uni0032/uni0033
/uni004A/uni0075/uni006E/uni002D/uni0036
/uni004A/uni0075/uni006E/uni002D/uni0032/uni0030
/uni004A/uni0075/uni006C/uni002D/uni0034
/uni004A/uni0075
/uni006C/uni002D/uni0031/uni0038/uni0041/uni0075/uni0067/uni002D/uni0031
/uni0041/uni0075
/uni0067/uni002D/uni0031/uni0035/uni0041/uni0075
/uni0067/uni002D/uni0032/uni0039/uni0053/uni0065
/uni0070/uni002D/uni0031/uni0032/uni0053/uni0065
/uni0070/uni002D/uni0032/uni0036/uni004F/uni0063/uni0074/uni002D/uni0031/uni0030
/uni004F/uni0063/uni0074
/uni002D/uni0032/uni0034/uni004E/uni006F/uni0076/uni002D
/uni0037/uni004E/uni006F/uni0076/uni002D/uni0032/uni0031
/uni0044/uni0065
/uni0063/uni002D/uni0035/uni0044/uni0065/uni0063
/uni002D/uni0031/uni0039/uni004A/uni0061/uni006E/uni002D/uni0032
/uni004A/uni0061/uni006E/uni002D/uni0031/uni0036
/uni004A/uni0061/uni006E/uni002D/uni0033/uni0030
/uni0046/uni0065/uni0062/uni002D/uni0031/uni0033
/uni0046/uni0065/uni0062/uni002D/uni0032/uni0037
/uni004D/uni0061/uni0072
/uni002D/uni0031/uni0033/uni004D/uni0061/uni0072
/uni002D/uni0032/uni0037/uni0041/uni0070/uni0072/uni002D/uni0031/uni0030
/uni0041/uni0070/uni0072/uni002D/uni0032/uni0034
/uni004D/uni0061/uni0079/uni002D/uni0038
/uni004D/uni0061/uni0079/uni002D/uni0032/uni0032
/uni004A/uni0075/uni006E/uni002D/uni0035
/uni004A/uni0075/uni006E/uni002D/uni0031/uni0039
/uni004A/uni0075/uni006C/uni002D/uni0033
/uni004A/uni0075/uni006C/uni002D/uni0031/uni0037/uni004A/uni0075/uni006C/uni002D/uni0033/uni0031/uni0041/uni0075
/uni0067/uni002D/uni0031/uni0034/uni0041/uni0075/uni0067/uni002D
/uni0032/uni0038/uni0053/uni0065
/uni0070/uni002D/uni0031/uni0031/uni0053/uni0065/uni0070/uni002D/uni0032/uni0035/uni0030/uni0031/uni0030/uni0030 /uni0032/uni0030/uni0030 /uni0033/uni0030/uni0030 /uni0034/uni0030/uni0030 /uni0035/uni0030/uni0030 /uni0036/uni0030/uni0030 /uni0037/uni0030/uni0030 /uni0043/uni0061/uni0073/uni0065/uni0020/uni0020/uni0043/uni006F/uni0075/uni006E/uni0074/uni0037/uni002D/uni0064/uni0061/uni0079/uni0020/uni0041/uni0076/uni0065/uni0072/uni0061/uni0067/uni0065
/uni0032/uni0030/uni0032/uni0032 /uni0032/uni0030/uni0032/uni0033
Subject to reporting irregularities Subject to reporting irregularities N = 30,681
United States Mpox Case Counts Jan 1–Sept 28, 2023
https://www.cdc.gov/poxvirus/mpox/response/2022/mpx -trends.html
N = 785
Subject to reporting irregularities 7-day average of daily cases reported
United States Mpox Case Counts Jan 1–Sept 28, 2023
https://www.cdc.gov/poxvirus/mpox/response/2022/mpx -trends.html
Subject to reporting irregularities 5–7
N = 785
7-day average of daily cases reported
X7-day daily average case range
United States Mpox Case Counts Jan 1–Sept 28, 2023
https://www.cdc.gov/poxvirus/mpox/response/2022/mpx -trends.html
Subject to reporting irregularities 5–7 1–3
N = 785
7-day average of daily cases reported
X7-day daily average case range
United States Mpox Case Counts Jan 1–Sept 28, 2023
https://www.cdc.gov/poxvirus/mpox/response/2022/mpx -trends.html
Subject to reporting irregularities 5–7 2–5 1–3
N = 785
7-day average of daily cases reported
X7-day daily average case range
United States Mpox Case Counts Jan 1–Sept 28, 2023
https://www.cdc.gov/poxvirus/mpox/response/2022/mpx -trends.html
Subject to reporting irregularities 5–7 2–5 1–3 1–4
N = 785
7-day average of daily cases reported
X
7-day daily average case range
Cases Following Vaccination
Reported since the outbreak started, including clusters
Generally, most have had mild illness
–Few requiring hospitalization
–Many did not need any treatment
–Low number of lesions
Hazra A. Lancet Infect Dis . 2023 Sep 4:S1473-3099(23)00492-9.

Mpox Reinfection
Potential reinfection cases have been published in the literature, but only a few with convincing evidence of true reinfection
CDC is aware of <10 cases of probable reinfection
Probable reinfection cases seem to be milder than initial infection
Hazra A. Lancet Infect Dis . 2023 Sep 4:S1473-3099(23)00492-9.

CDC Continues to Consult on Severe Mpox Cases and
Deaths
https://www.cdc.gov/mmwr/volumes/71/wr/mm7144e1.htmCDC’s mpox clinical consult service continues to consult on  2-6 new cases
monthly over the last 6 months
Repeat consultations are more frequent, and include seve re cases with
infections ongoing for months
54 people have died from mpox in the United States since  May 2022, with 2
just this September
Black persons, people living with HIV (mostly advanced HIV  [AIDS]), and people
experiencing homelessness are disproportionately affected
Mpox Cases Reported to CDC by Age and Gender May 17, 2022–Sept 28, 2023
https://www.cdc.gov/poxvirus/mpox/response/2022/dem ographics.html Data were available for /uni200999.4%
of cases reported to CDC
Mpox Cases Reported to CDC by Race and Ethnicity May 17, 2022–Jun 14, 2023
57     1095   9233 10965  4739  1748   686     297    159      61       57       43       90      108    105     82        21 Count within columns
https://www.cdc.gov/poxvirus/mpox/response/2022/dem ographics.html Subject to reporting irregularities
Data were available for /uni200994.5%
of cases reported to CDC

Mpox Cases Globally Apr–Sept 2023
15

https://worldhealthorg.shinyapps.io/mpx_global/
First and Second Doses of JYNNEOS Vaccine /uni0041d/uni006Dinistra/g415ons/uni2212/uni0055nited States/uni002C /uni004Da/uni0079 /uni0032/uni0030/uni0032/uni0032/uni2212Se/uni0070t /uni0032/uni0030/uni0032/uni0033
Overall vaccine coverage*
1-dose: 38.8% and 2-dose: 24.3%
*Coverage is the estimated proportion who have recei ved vaccination divided by the population recommend ed to receive the vaccine,which is estimated
using 2021 data for MSM with HIV pre-exposure proph ylaxis (PrEP) indications and 2020 data for HIV pre valence among MSM from CDC AtlasPlus . These
estimates are increased by 25% to account for addit ional vaccine eligible people not captured by these  data sources totaling approximately 2 million peop le.
Shift in Vaccine Administration Sites From Public Health Clinics to Medical Centers
•Public health providers administered 40% of all vaccines through Mar 2023
•Medical care providers administered an increasing proportion of vaccines since the start of the outbreak
•Pharmacies consistently provided 3-4% of all vaccines
Public Health
Provider or
Clinic Medical
Center
Provider Commercial
Vaccination
Service
Provider Pharmacy Other Percentage of Doses Administered
Categories of Medical Providers Administering Vaccin es
From 2022 to 2023, there were statistically significant increases in vaccines provided by •Primary care offices
•Federally qualifying health centers (FQHC)
•Other health centers
Primary
Care Hospital FQHC Health
Center -
Other Health
Center -
STD/HIV Percentage of Doses Administered
Modeling
Estimating Averted Cases from Vaccination and Behavioral Adaptation in DC
https://www.medrxiv.org/content/10.1101/2023.02.10. 23285772v1.full.pdf
Lines and shaded regions reflect median and interqu artile range from 120 simulations
Estimated prevalent infections over time with no vaccination or behavioral adaptation.
Estimating Averted Cases from Vaccination and Behavioral Adaptation in DC
https://www.medrxiv.org/content/10.1101/2023.02.10. 23285772v1.full.pdf
Lines and shaded regions reflect median and interqu artile range from 120 simulations
Behavioral adaptation alone would have had early impact on the curve and flattened it
Estimating Averted Cases from Vaccination and Behavioral Adaptation in DC
https://www.medrxiv.org/content/10.1101/2023.02.10. 23285772v1.full.pdf Lines and shaded regions reflect median and interqu artile range from 120 simulations
Behavioral adaptation alone would have had early impact on the curve and flattened it
Vaccination alone would have had a later impact, but would have ended the outbreak within 1 year
Estimating Averted Cases from Vaccination and Behavioral Adaptation in DC
https://www.medrxiv.org/content/10.1101/2023.02.10. 23285772v1.full.pdf Lines and shaded regions reflect median and interqu artile range from 120 simulations
Behavioral adaptation alone would have had early impact on the curve and flattened it
Vaccination alone would have had a later impact, but would have ended the outbreak within 1 year
Combined, behavioral adaptation and vaccination averted 80% of cases 1 year into the outbreak
Risk for Recurrent Mpox Outbreak Lasting >3 Months, by Immunity Level — United States, 2023
Pollock ED. MMWR MorbMortal WklyRep 2023;72:568–573 .% Risk of
Recurrence
% Population at increased mpox risk with partial or  full immunity Risk of recurrence increases linearly as the percent of the high-risk population with full or partial protection decreases
Cumulative Monkeypox virus I nfections Relative to
2022, by Immunity Level — United States, 2023
Pollock ED. MMWR MorbMortal WklyRep 2023;72:568–573 .Cumulative
monkeypox
virus infections,
relative to 2022
% Population at increased mpox risk with partial or  full immunity
Cumulative Monkeypox virus I nfections Relative to
2022, by Immunity Level — United States, 2023
Pollock ED. MMWR MorbMortal WklyRep 2023;72:568–573 .>50% is needed to
significantly decrease
the risk of large
outbreaks Cumulative
monkeypox
virus infections,
relative to 2022
% Population at increased mpox risk with partial or  full immunity
Vaccine: Effectiveness and Safety Updates
Vaccine effectiveness of JYNNEOS against mpox ranges  from 36%–75%
for 1-dose vaccination and 66%–89% for 2-dose vaccination
Cases Controls Adjusted* VE (95% CI)
1-dose JYNNEOS
Epic Cosmos case-control study 146 1000 36% (22–47)
Multi-jurisdictional case-control study 58 237 75% (61–84)
New York State case-control study 10 23 68% (25–86)
.
2-dose JYNNEOS
Epic Cosmos case-control study 25 335 66% (47–78)
Multi-jurisdictional case-control study 14 122 86% (74–89)
New York State case-control study 2 19 89% (44–98)
Vaccine Effectiveness (%) 0 20 40 60 80 100
Vaccine effectiveness of JYNNEOS against mpox ranges  from 36%–75%
for 1-dose vaccination and 66%–89% for 2-dose vaccination
Cases Controls Adjusted* VE (95% CI)
1-dose JYNNEOS
Epic Cosmos case-control study 146 1000 36% (22–47)
Multi-jurisdictional case-control study 58 237 75% (61–84)
New York State case-control study 10 23 68% (25–86)
.
2-dose JYNNEOS
Epic Cosmos case-control study 25 335 66% (47–78)
Multi-jurisdictional case-control study 14 122 86% (74–89)
New York State case-control study 2 19 89% (44–98)
Vaccine Effectiveness (%) 0 20 40 60 80 100
Vaccine effectiveness of JYNNEOS against mpox ranges  from 36%–75%
for 1-dose vaccination and 66%–89% for 2-dose vaccination
Cases Controls Adjusted* VE (95% CI)
1-dose JYNNEOS
Epic Cosmos case-control study 146 1000 36% (22–47)
Multi-jurisdictional case-control study 58 237 75% (61–84)
New York State case-control study 10 23 68% (25–86)
.
2-dose JYNNEOS
Epic Cosmos case-control study 25 335 66% (47–78)
Multi-jurisdictional case-control study 14 122 86% (74–89)
New York State case-control study 2 19 89% (44–98)
Vaccine Effectiveness (%) 0 20 40 60 80 100
Multi-jurisdictional Case-Control Study: Methods
–Population: Men who have sex with men; ages 18-49; 12 U.S. juri sdictions
–Time Period: August 19, 2022, to September 27, 2023
–Methods:
–Cases identified from jurisdictions’ probable and confirm ed mpox case lists
–Controls identified from healthcare settings providing HIV P rEP or sexually
transmitted infection (STI) clinics
–Demographics, immunocompromised status, exposure hi story, and
vaccination history collected using electronic surv eys
–Vaccination status confirmed by state immunization registries
–Analysis:
–VE estimated using conditional logistic regression
–Adjusted for age, race/ethnicity, immunocompromising conditions
–Stratified by route of administration and immunocompromised statu s
Both partial and full vaccination with JYNNEOS showed
effectiveness against mpox, regardless of administr ation
route
*Adjusted for age, race/ethnicity, immunocompromise d status, reported close contact with a
confirmed/suspected mpox case in 3 weeks prior to i ndex event
Both partial and full vaccination with JYNNEOS showed
effectiveness against mpox, regardless of administr ation
route
*Adjusted for age, race/ethnicity, immunocompromise d status, reported close contact with a
confirmed/suspected mpox case in 3 weeks prior to i ndex event
VE trended higher for immunocompetent participants
compared to self-reported immunocompromised
participants
*Adjusted for age, race/ethnicity, immunocompromise d status, reported close contact with a
confirmed/suspected mpox case in 3 weeks prior to i ndex event
 Confidence interval remains very wide
 More work is needed to understand VE in objectively confirmed immunocompromised people
JYNNEOS Vaccine Safety Monitoring
CDC vaccine safety monitoring is ongoing using two surveillance systems:
–Vaccine Adverse Event Reporting System (VAERS)
–Vaccine Safety Datalink (VSD)
V-safe data collection for mpox vaccines was availa ble from
November 2022 through March 21, 2023
JYNNEOS Vaccine Safety Findings Summary
90% of VAERS reports were submitted in 2022
The adverse events most commonly reported to VAERS h ave been injection
site symptoms (redness, swelling, pain, itching)
Myocarditis and pericarditis are adverse events of specia l interest
–Observed rates are consistent with expected backgroun d rates
JYNNEOS Vaccine Safety Conclusions
VAERS and VSD data do not suggest an increased risk f or myocarditis or
pericarditis following JYNNEOS, but the possibility of a small risk cannot be
excluded
The frequencies of local and systemic reactions reported  to v-safe after
mpox vaccine were similar to those reported in clinical trials
No new or unexpected safety concerns have been ident ified
Summary
Mpox cases and deaths continue to be reported domest ically and globally
Need to improve our overall vaccine coverage; <25% of t he eligible
population is fully vaccinated with 2 doses
Modeling suggests that without vaccination, transmission o f mpox will
continue with sporadic outbreaks
No new safety signals from VAERS or VSD
VE appears stable for immunocompetent people
Acknowledgements
Sarah Guagliardo
Agam Rao
Rosalind Carter
Andrea McCollum
Ian Kracalik
Allie Tuttle
Jonathan Duffy
Eunice Kimunai
Katrina Byrd Victoria Shelus
Christine Hughes
Christina Hutson
Ian Spicknall
Patrick Clay
Emily Pollock
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 tho se of the authors and do not necessarily represent the
official position of the Centers for Disease Contro l and Prevention.
National Center for Emerging and Zoonotic Infectiou s Diseases
Division of High-Consequence Pathogens and Patholog y Questions?

Summary: National Center for Emerging and Zoonotic Infectiou s Diseases  2022/2023 Mpox Outbreak: Situational Awareness and Updates  ACIP Meeting October 25, 2023 Faisal Syed Minhaj, PharmD, MPH, DABAT Epidemiologist  Poxvirus and Rabies Branch Division of High Consequence Pathogens and Patholog y  United States Mpox Case Counts May 2022–Sept 28, 202 3  https://www.cdc.gov/poxvirus/mpox/response/2022/mpx -trends.html /uni004D/uni0061/uni0079/uni002D/uni0032/uni0033…


03 MPOX Rao 508

National Center for Emerging and Zoonotic Infectiou s Diseases
Evidence to Recommendations Framework:  Vaccination with JYNNEOS for Persons At Risk of Mpo x
Advisory Committee on Immunization Practices October 25, 2023 Agam Rao, MD CAPT, US Public Health Service Poxvirus and Rabies Branch Centers for Disease Control and Prevention
Evidence to Recommendations (EtR) Framework
Structure to describe information considered in moving fr om evidence to
ACIP vaccine recommendations
Provides transparency around the impact of additional fa ctors on
deliberations when considering a recommendation
EtR question
Does ACIP recommend vaccination with the 2-dose* JYN NEOS vaccine series
for persons aged 18 years and older at risk †for mpox?
*Dose 2 administered 28 days after dose 1
†Persons at risk:
•Gay, bisexual, and other men who have sex with men,  transgender or nonbinary people who in the past
6 months have had one of the following:
•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
•Sexual partners of persons with the risks described in above
•Persons who anticipate experiencing any of the above
Policy question: Should the 2 dose JYNNEOS vaccine s eries* be recommended
for persons aged 18 years and older at risk †for mpox ?
Population Persons aged 18 years and older at risk for mpox
Intervention Vaccination with JYNNEOS®
Comparison No vaccination
Outcome a) Prevention of disease
b) Severity of disease
c) Serious adverse events d) Myo-/ peri- carditis
*Dose 2 administered 28 days after dose 1
†Persons at risk:
• Gay, bisexual, and other men who have sex with men,  transgender or nonbinary people who in the past 6 months have had one of the following:
• 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
• Sexual partners of persons with the risks described in above
• Persons who anticipate experiencing any of the above
EtR Domains
EtR Domain Question(s) Public Health Problem •Is the problem of public health importance?
Benefits and Harms •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?
Values •Does the target population feel the desirable effec ts are large relative to the undesirable
effects?
•Is there important variability in how patients valu e the outcome?
Acceptability •Is the intervention acceptable to key stakeholders?
Equity •What would be the impact of the intervention on hea lth equity?
Feasibility •Is the intervention feasible to implement?
Resource Use •Is the intervention a reasonable and efficient allo cation of resources?
Public Health Problem
Are continued mpox cases of public health importance?
>1.25 million doses of JYNNEOS have been administered in t he United States
However, national vaccine coverage remains lower than ide al, possibly
because of lower perceived risk in the last 6 months
Mpox cases continue to occur domestically and internation ally, including in
clusters
Modeling data suggests larger outbreaks may occur if va ccine coverage
remains <50% nationally for persons at risk of mpox
Severe disease and deaths continue to occur

Benefits and Harms
Main source of VE data has been three U.S. studies
CDC EPIC study
CDC Multi-jurisdictional study
New York State study
Estimated VE for preventing mpox disease has ranged from 66-89% for the 2-dose vaccine series
Multi-jurisdictional study:  estimate of VE for preventing infections among immunocompetent vs. self-reported immunocompromised persons
*Adjusted for age, race/ethnicity, immunocompromise d status, reported close contact with a
confirmed/suspected mpox case in 3 weeks prior to i ndex event
•Only recently able to evaluate VE of self-reported immunocompromised, confidence interval is still wid e
•Modifications in protocol needed to evaluate VE for  objectively confirmed immunocompromised persons
How substantial are desirable anticipated effects o f
JYNNEOS?
ACIP previously recommended use of JYNNEOS
–Persons at increased risk of occupational exposure to orthopoxviruses
–Persons at-risk for mpox during mpox outbreaks
Subsequent data has supported its effectiveness for  the population
impacted by the ongoing outbreak
How substantial are desirable anticipated effects o f
JYNNEOS?
ACIP previously recommended use of JYNNEOS
–Persons at increased risk of occupational exposure to orthopoxviruses
–Persons at-risk for mpox during mpox outbreaks
No new safety signals identified from pre-licensure  studies
The adverse events most commonly reported to VAERS have been
injection site symptoms (redness, swelling, pain, i tching)

Balance between desirable effects relative to undesirable effects of JYNNEOS
Desirable anticipated effects considered large
Undesirable anticipated effects considered small Do the desirable effects outweigh the undesirable e ffects?
Favors intervention        Favors comparison        Favors both         Favors neither         Unclear

EtR Domain:  Values
Early in outbreak response: National surveys indica ted
strong interest in vaccine
During Aug-Nov 2022, >85% of respondents in the Ame rican
Transformative HIV Study (AMETHST) were interested in vaccine, and
uptake doubled from August to September
During August-Dec 2022, 50% of Porter-Novelli survey  responders who
identified as LGBTQ+ felt the vaccination is import ant to protect from mpox
During Oct-Nov 2022, >70% of MSM in a San Francisco  survey of persons
experiencing homelessness reported that they would accept or have
accepted vaccination
During October-December 2022, an American Men’s Int erest Survey
(AMIS) showed that those who were concerned about m pox were 3.5x
more likely to be vaccinated
https://grants.nih.gov/grants/guide/rfa-files/RFA-A I-21-018.html
https://emoryamis.org/wp-content/uploads/2022/08/20 22-Monkeypox-Survey.pdf
https://www.cdc.gov/mmwr/volumes/71/wr/mm7135e1.htm
Filardo TD. Vaccine. 2023 Sep 7;41(39):5673-5677.
Early in outbreak: Persons seeking vaccination were ,
as expected, supportive of the JYNNEOS vaccine
DC PEP ++ Study: CDC and DC Health collaboration to follo w cohort of
persons at elevated risk of mpox exposure in Washington D.C. who
presented for JYNNEOS vaccination, Aug 2022-Oct 2022
–Survey with 866 adults
–>85% agreed or strongly agreed that vaccines for mp ox should be available to
anyone who wants the vaccine
–82% were likely or very likely to get a third dose if it was recommended
Qualitative interviews August and September 2022 am ong adults
presenting for JYNNEOS vaccine in Washington DC
–Many participants grateful that LGBTQ+ were given p riority vaccine access
(suggests interest in vaccine)
Hassan, R. (in press). Sexually Transmitted Diseases
Early in outbreak: Studies indicated conflicting fe elings
about receiving JYNNEOS vaccines
Curtis et al. Survey with 320 persons, primarily MS M living in Illinois and at
risk for mpox. September 2022
–24.1% received 2 vaccine doses, 27.5% received one dose, 47.5% no doses
–Persons who were vaccinated were more likely to hav e higher education, know
someone with mpox, express concern about their safe ty, and less likely to
report recent food insecurity
Turpin et al. Qualitative interviews with 24 Black MSM attending HIV
prevention-related events in greater D.C. area, May  2022
–Lack of availability of mpox vaccines was common co ncern suggesting interest
–Vaccine  hesitancy was also common
https://pubmed.ncbi.nlm.nih.gov/37236817/
https://pubmed.ncbi.nlm.nih.gov/37510557/
More recent:  State of vaccine confidence report, J une
2023
Review of mpox-related discussions on 23 news and social media outlets in the Chicago area during the
month following the CDPH media release indicating a n
increase in mpox cases, particularly among previous ly
vaccinated persons
Findings:
–Mpox vaccine hesitancy among general public and LGB TQ-
affiliated groups noted
–Questions raised
•Effectiveness and safety of the vaccine (e.g., sent iment expressed
that vaccine is experimental)
•Distrust in reporting (e.g., Suspicion that mpox re porting is
exaggerated)
https://www.cdc.gov/vaccines/covid-19/downloads/SoV C-MPOX-062723.pdf
More recent: Interviews with 18 patients associated
with mpox cluster in Chicago, May 2023
Fully vaccinated, partially vaccinated, unvaccinated intervie wed
Most stated they would recommend vaccine to others
Most vaccinated persons felt vaccine was effective in re ducing severity
Some assumed it would prevent infection
Unvaccinated reported initial interest in vaccine when supp ly was limited
and they were unable to receive it; they reported they  did not seek it again
because case counts decreased so they assumed diminish ed risk
More recent: Online focus group used by CDC to develop communication material, July 12, 2023
Session conducted with 52 persons
–Participant inclusion criteria:
•Identify as men (including transgender men and tran sgender women)
•Unvaccinated for mpox and never diagnosed with mpox
•18-45 years of age
•Sex with 2 or more men within past 6 months
–Participant demographics: average age 30-34 years; 48% Black, 37% White, 27%
Hispanic/Latino; 75% gay, 21% bisexual
Exposure to communication materials increased intere st in receiving mpox vaccine
–Information about mpox vaccine safety, effectiveness , and current threat of mpox
affected interest
–Current risk of mpox and protecting community were m otivating
Some people did not change their minds
Target population sentiments
Vaccine demand was high early in the outbreak response
National surveys with the affected population indicate ove rall interest in
JYNNEOS vaccinations

Target population sentiments
Interest and intent to get vaccinated varies among the  affected population
Lower perceived risk of mpox may contribute to reduced  interest in vaccine
later in the outbreak

EtR Domain:  Acceptability
Stakeholder perceptions:  Health departments
Health departments requested JYNNEOS and organized va ccination
campaigns
https://aspr.hhs.gov/SNS/Pages/JYNNEOS-Distribution .aspx
Stakeholder perceptions:  Sermo survey of clinicians
Sermo*: Online community of >1.3 million clinicians
July 31 - August 1, 2022 survey results of U.S. clinicians (n=415): 69% felt U.S. without enough mpox vaccine to handle outbreak
September 12, 2022 survey of U.S. clinicians (n=62)
•66% had treated at least one mpox patient
•76% knew where a patient could get JYNNEOS vaccination
•86% wanted to be able to provide vaccination in their office
*https://app.sermo.com/barometer/unitedstates
Porter-Novelli Survey of Pediatricians (n=102) and Family Practice (FP) Practitioners (n=104)
Added 3 mpox vaccine questions to survey on pediatri c COVID-19 vaccine
attitudes and behaviors
Description of respondents' clinical practices:
–85% of FP and 88% of Pediatricians cared for children 12-17 years
–70% of FP and 60% of Pediatricians cared for patien ts 18+ years
–Majority (75%) in private practice; 14% practiced i n FQHC
–54% had >1500 patients in their practice
Porter Novelli Survey: Preference to provide JYNNEOS  within medical practice,
PN survey of Pediatricians (N=102) and Family Practitioners (n=104), August
2023

Shift in vaccine administration sites from public h ealth
clinics to medical centers
•Public health providers administered 40% of all vaccines through Mar 2023
•Medical care providers administered an increasing proportion of vaccines since the start of the outbreak
•Pharmacies consistently provided 3-4% of all vaccines
Public Health
Provider or
Clinic Medical
Center
Provider Commercial
Vaccination
Service
Provider Pharmacy Other Percentage of Doses Administered
Categories of medical providers administering vacci nes
From 2022 to 2023, there were statistically significant increases in vaccines provided by •Primary care offices
•Federally qualifying health centers (FQHCs)
•Other health centers
Primary
Care Hospital FQHC Health
Center -
Other Health
Center -
STD/HIV Percentage of Doses Administered
FQHC: Federally qualifying health center
Online focus group by CDC: Healthcare provider perceptions of sexual health and mpox
Conducted to explore provider knowledge, attitudes,  and practices related to
service delivery, including those specific to mpox
Recruitment targeting 50 providers via external rec ruiting firm
41 total participants – diverse by gender, race/ethn icity, practice setting, payment
methods for patients (e.g., private insurance plans , Medicaid, Medicare,
government programs), and clinical profession
61% reported spending ≥60% of their time providing sexual health services
59% private healthcare setting, 29% private and pub licly funded, 10% publicly
funded
54% in private practice, 20% STD/HIV/family plannin g clinic, 10% FQHC, 25% in ED
or urgent care
Responses from healthcare provider participants (N= 41)
68% had never managed an mpox case
34% believe mpox is a threat to public health
32% reported mpox is important to their patient popu lations
51% believe that mpox services (e.g., counseling) sh ould be integrated into
standard care for the following reasons
–Increase access to vaccine
–Improve education and awareness for patients
–Ensure STI screening is comprehensive
Is the intervention acceptable to key stakeholders
Is the intervention acceptable to key stakeholders
No            Probably no           Uncertain           Probably yes           Yes Varies
Health departments and clinicians are supportive of mpox v accines even if
pediatricians would prefer to refer patients to other clin ics to receive
JYNNEOS
Family practitioners would like to be able to provide JYNNEO S in their own
clinics
There has been a shift from JYNNEOS provided by public health providers to
JYNNEOS provided by medical center providers, including ST I and HIV clinics
EtR Domain:  Resource Use
Is the intervention a reasonable and efficient allocation of resources
Current resources
–Vaccine only available via national government stoc kpiles
–JYNNEOS stockpiled for smallpox preparedness
–Doses used need to be replenished
–Significant use of resources (e.g., shipments, tran sportation, personnel) during
the outbreak and routine recommendation could be fu rther drain
Potential resources in the future:  Uncertain wheth er it will be
commercialized but if so, unknown costs associated with commercialization

EtR Domain:  Equity
Mpox and health equity
Disproportionate impact of mpox
–Gay, bisexual, and other MSM
–Black and Hispanic persons
–Persons experiencing homelessness
Any vaccine administered may decrease the disparity betw een the affected
population and others
Impact on health equity
Will facilitate 1:1 counseling and information shar ing in the privacy of a
clinic; vaccine recommendation from a clinician is associated with
increased vaccine uptake
$5,000,000 allocated to community-based organizations (C BOs) in
September 2023 to advance mpox prevention and vaccinat ion efforts*
–CBOS essential to increasing vaccination coverage a mong those at highest risk
and provided pivotal role during 2022
–42 CBOs funded so far
If commercialized, there may be an impact on primar y sites of vaccination
and on health departments
Recommendation might facilitate broad acceptance of  vaccination (e.g., by
insurance companies, patients) because endorsed by ACIP after rigorous review
*https://www.cdcfoundation.org/pr/2023/mpox-vaccina tion-CBO-outreach
What would be the impact on health equity
What would be the impact on health equity?
Reduced                  Probably Reduced                Probably no impact            Probably increa sed
Increased                 Varies                                    Don’t know
Access to vaccine (vs. no vaccine) may improve the health of persons who
are at risk for mpox
Routine recommendation may facilitate vaccinations
EtR Domain:  Feasibility
Access to JYNNEOS vaccination if ACIP recommends it
Continue via national stockpiles free of cost to patients and providers
Mpox provider agreements* do not have a termination da te; they will
continue as long as vaccine is acquired via the US govern ment program and
can include new providers
Funding † provided to CBOs may improve feasibility
If commercialized §
–Via Medicare, Medicaid, commercial plans without copay
–Uninsured children via Vaccines for Children Program
–Some uninsured and underinsured adults might have difficu lty
*https://www.cdc.gov/poxvirus/mpox/clinicians/provi der-agreement.html
† https://www.cdcfoundation.org/pr/2023/mpox-vaccinat ion-CBO-outreach
§Uncertain whether it will be commercialized
Is the intervention feasible to implement?
Is the intervention feasible to implement
No            Probably no           Uncertain           Probably yes           Yes Varies
Subcutaneous vaccine; easy to administer
Standing orders available; JYNNEOS can be stored ref rigerated for 8 weeks
Recent analysis of shift in vaccine providers demon strates the continued
successful integration of JYNNEOS into providers’ pra ctices (e.g., STI and HIV care
settings, HIV care pharmacies, LGBTQ+ affirming pri mary care practices)
STI, HIV, and most family medicine/internal medicin e providers comfortable
providing vaccines but some pediatricians may prefe r referring patient to other
clinics
If commercialized, similar to other vaccines, cost of vaccine might impact access to
some populations
Summary of EtR
Domains Domains Domains
Benefits:  How substantial are the desired anticipated effects Large Values:  Does the target population feel desirable effects are large Probably Yes Impact on health equity Probably increased
Harms:  How substantial are undesirable anticipated effects? Small Is there important uncertainty about or variability in values? Possibly important uncertainty or variability Feasible to implement ? Probably Yes
Benefit / Harm:  Favors intervention Acceptable to stakeholders? Yes Balance of consequences:
Reasonable and efficient allocation of resources? Uncertain
Balance of Consequences
Undesirable                                        Undesirable                                   Balan ce between
consequences clearly                       conseque nces probably               desirable and undesirab le
outweigh desirable                           outwei gh desirable                       consequences is closely
consequences in most                      consequen ces in most                 balanced or uncertain
settings settings Desirable consequences                   Desirable consequences             There is insufficient evid ence
probably outweigh                             clear ly outweigh to determine the balance of
undesirable consequences               undesirable consequences consequences
in most settings                                  i n most settings X
Proposed recommendation
ACIP recommends vaccination* with the 2-dose †JYNNEOS vaccine series for
persons aged 18 years and older at risk for mpox §?
*Interim recommendation that ACIP will revisit in 2 -3 years
† Dose 2 administered 28 days after dose 1
§Persons at risk:
•Gay, bisexual, and other men who have sex with men,  transgender or nonbinary people who in the past
6 months have had one of the following:
•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
•Sexual partners of persons with the risks described  in above
•Persons who anticipate experiencing any of the abov e
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 tho se of the authors and do not necessarily represent the
official position of the Centers for Disease Contro l and Prevention.
National Center for Emerging and Zoonotic Infectiou s Diseases
Division of High-Consequence Pathogens and Patholog y Questions?

Summary: National Center for Emerging and Zoonotic Infectiou s Diseases  Evidence to Recommendations Framework:  Vaccination with JYNNEOS for Persons At Risk of Mpo x  Advisory Committee on Immunization Practices October 25, 2023 Agam Rao, MD CAPT, US Public Health Service Poxvirus and Rabies Branch Centers for Disease Control and Prevention  Evidence to Recommendations (EtR) Framework  Structure to describe information considered in moving fr om evidence to  ACIP vaccine recommendations  Provides…


04 MPOX Rao 508

National Center for Emerging and Zoonotic Infectiou s Diseases
Clinical guidance and next steps
Advisory Committee on Immunization Practices October 25, 2023 Agam Rao, MD CAPT, US Public Health Service Poxvirus and Rabies Branch Centers for Disease Control and Prevention
Guidance about vaccination before exposures to mpox
Similar to what has previously been presented to ACIP
Specific to pre-exposure vaccination
Specific to the population at risk for mpox*
*Interim recommendation to be revisited in 2-3 year s
† Dose 2 administered 28 days after dose 1
§Persons at risk:
•Gay, bisexual, and other men who have sex with men,  transgender or nonbinary people who
in the past 6 months have had one of the following:
•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
•Sexual partners of persons with the risks described  in above
•Persons who anticipate experiencing any of the abov e
Persons <18 years of age at risk for mpox
JYNNEOS is not licensed for persons <18 years of age
No pre-licensure studies in this population; however, no safety signals identified during the current outbreak
NIH clinical trial in progress:  Safety and immunogenicity of JYNNEOS in persons aged 12-17 years
Adolescents at risk for mpox* may receive the JYNNEOS vaccine before an exposure
*See slide 2 for description of population at risk for mpox
Pregnant or breastfeeding persons
Pregnancy
–Available human data insufficient to determine vacc ine associated risks
–However, animal models including in rats have shown  no evidence of harm to
the developing fetus
–No adverse events reported via vaccine safety surve illance systems
Safety in breastfeeding persons
–Has not been evaluated
–No adverse events reported via vaccine safety surve illance systems
JYNNEOS is not contraindicated in pregnancy or whil e breastfeeding
Pregnant or breastfeeding persons at risk for mpox*  may receive the JYNNEOS
vaccine before an exposure
*See slide 2 for description of population at risk for mpox
Healthcare personnel
Healthcare-associated mpox infections have been rare , typically
associated with sharps injuries or exposure in the absence of personal
protective equipment
Healthcare personnel at risk for mpox because of the  risk factors
described (e.g., MSM with more than one sexual part ner) should be
vaccinated; however, this recommendation is not bec ause of
occupational risk
JYNNEOS is not recommended as a routine vaccination  for healthcare
personnel unless sexual risk factors are present

Myopericarditis
Known risk after ACAM2000, a different orthopoxviru s vaccine; mechanism
unknown so theoretical risk with JYNNEOS has not be en ruled out
Known risk after COVID-19 vaccines, particularly in  adolescent and young adult
males
CDC websites for COVID-19 and mpox vaccines provide interim guidance for
coadministration
CDC guidance for coadministration of JYNNEOS with COVID-19 vaccines
There is no required minimum interval between recei ving any COVID-19
vaccine and JYNNEOS vaccine (e.g., for mpox prevent ion), regardless of
which vaccine is administered first
People, particularly adolescent and young adult mal es, who are
recommended to receive both vaccines might consider  waiting 4 weeks
between vaccines. This is because of the observed r isk for myocarditis and
pericarditis after receipt of ACAM2000 orthopoxviru s vaccine and COVID-
19 vaccines and the hypothetical risk for myocardit is and pericarditis after
JYNNEOS vaccine. However, if a patient’s risk for mp ox or severe disease
due to COVID-19 is increased, administration of JYN NEOS and COVID-19
vaccines should not be delayed
https://www.cdc.gov/vaccines/covid-19/clinical-cons iderations/interim-considerations-us.html
Clinical guidance when JYNNEOS and immunoglobulin products are temporally administered
Most immunoglobulin products: No precautions are necessa ry if JYNNEOS
is administered in close temporal proximity to Intravenous immunoglobulin
(IVIG)
Vaccinia immune globulin intravenous (VIGIV)
–Could interfere with immune response to JYNNEOS
•Ideally, administration of JYNNEOS should be delayed  if VIGIV was recently administered
•The duration for which it should be delayed is unkn own; public health consultation
should be obtained for case specific guidance
–Unlikely that VIGIV would be administered in close proximity to JYNNEOS
Contraindications and precautions
JYNNEOS was licensed* for prevention of smallpox in addition to
prevention of mpox
Because smallpox is nearly always life-threatening, there are no absolute
contraindications; however, for mpox, considerations  may be different
Consistent with contraindications in ACIP routine s chedules, WG proposed
–JYNNEOS contraindicated in patients with a severe a llergic reaction (e.g.,
anaphylaxis) after a previous dose or to a vaccine component
–Precautions: Moderate or severe acute illness, with or without fever
*https://www.fda.gov/media/131078/download
Other administration guidance
Completion of the 2-dose series should be encouraged
As much as possible, the 2 nd dose of JYNNEOS should be administered ~28
days after the first dose
Unintentional delays in receiving the 2 nd dose does not require restarting
the series; the second dose should be administered as s oon as possible
even if >1 year has elapsed
Next steps
Tentative timeline for ACIP discussions and votes*
Interim routine recommendation and clinical guidance
October 2023 Early 2024 Possibly 2024 Publication of 2 MMWRs: 1) Use of JYNNEOS during mpox
outbreaks
2) Use of JYNNEOS among
persons at risk during the ongoing mpox outbreak Consider results from NIH trial about use of JYNNEOS in persons aged 12-18 years
*February 2023 and June 2023 votes do not impact ex isting recommendations for the current mpox outbrea k.
JuniYYT7https://www.cdc.gov/poxvirus/monkeypox/interim-cons iderations/overview.html ~2025/2026 Review epidemiology, cost-effectiveness analysis, and other data to determine if routine recommendation should be continued
Proposed recommendation is interim recommendation
If passed, recommendations will be revisited in 2-3 years
Epidemiology at the time may inform decision about continuin g routine
vaccinations
Vaccine may be commercialized by that time
Cost-effectiveness analysis will be performed
Acknowledgements
ACIP Work Group
Howard Minkoff
Jane Zucker
Jim Campbell
Sathesh Panayampalli
Alli Tuttle
Jonathan Duffy
Rosalind Carter
Neil Murthy
Patricia Wodi Mark Russi
Marie de Perio
Jason Zucker
John Brooks
David Kuhar
Evelyn Twentyman
Sara Oliver
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 tho se of the authors and do not necessarily represent the
official position of the Centers for Disease Contro l and Prevention.
National Center for Emerging and Zoonotic Infectiou s Diseases
Division of High-Consequence Pathogens and Patholog y Questions?

Summary: National Center for Emerging and Zoonotic Infectiou s Diseases  Clinical guidance and next steps  Advisory Committee on Immunization Practices October 25, 2023 Agam Rao, MD CAPT, US Public Health Service Poxvirus and Rabies Branch Centers for Disease Control and Prevention  Guidance about vaccination before exposures to mpox Similar to what has previously been presented to ACIP  Specific to pre-exposure vaccination  Specific to the population at risk for mpox*  *Interim recommendation to be…


01 Kotton Adult RSV 508

Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Di seases
Photographs and images included in this presentation a re licensed solely for CDC/NCIRD online and present ation
use. No rights are implied or extended for use in pr inting or any use by other CDC CIOs or any external audiences.
Adult Respiratory Syncytial Virus (RSV) Session
Camille Kotton, MD Chair, Adult RSV Work Group
Advisory Committee on Immunization Practices (ACIP)October 25, 2023
RSVPreF3 (Arexvy, GSK) is a 1-dose adjuvanted (AS01 E)
recombinant prefusion F protein (preF) vaccine.
RSVpreF (Abrysvo, Pfizer) is a 1-dose recombinant preF vacci ne. In June 2023, CDC’s Advisory Committee on Immunizat ion
Practices (ACIP) voted to recommend that adults age s 60
years and older may receive a single dose of RSV va ccine
using shared clinical decision making.
https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm2
The Work Group reviewed CDC vaccine safety surveill ance plans for RSV vaccination in
adults ≥60 years.
GSK shared with the Work Group results of an immuno -bridging study showing non-
inferior humoral immune responses to RSV vaccinatio n in immunocompetent adults
50–59, compared with immunocompetent adults ≥60 (in  whom efficacy was
demonstrated).
The Work Group discussed the potential role of RSV vaccination in adults younger than
60 years, including subpopulations that would benef it most from vaccination and
equity implications. Issues under discussion since the June meeting
3
The Work Group reviewed CDC vaccine safety surveillan ce plans for RSV
vaccination in adults ≥60 years.
–V-safe ( https://vsafe.cdc.gov ) has launched for older adult RSV vaccination
–Today’s session will not include RSV vaccine uptake  data or safety surveillance data;
data are premature this early into the vaccination program
–Uptake and safety results will be shared at a futur e ACIP meeting Issues under discussion since the June meeting
4
Agenda: Wednesday October 25, 2023
RSVPreF3 safety and immunogenicity in adults aged 50–59 years, compared with adults aged ≥60 years
Epidemiology of RSV hospitalization in adults, with  a
focus on adults aged 50–59 years
Work Group considerations regarding RSV vaccination in adults aged 50–59 years Dr. Susan Gerber (GSK) Dr. Monica Patton (CDC) Dr. Amadea Britton (CDC)
5
Adult RSV Work Group Membership
6ACIP Voting Members
Camille Kotton (Chair) Keipp Talbot Sarah Long Ex Officio Members
Rachel Zhang (FDA) Judy Beeler (FDA) Nicholas Geagan (FDA) Nadine Peart Akindele (FDA) Sonnie Kim (NIH/NIAID) Jeffrey Kelman (CMS) Michelle Juaneza (HRSA/VICP)Uzo Chukwuma (IHS) Valerie Marshal (OIDP) Consultants
Robert Atmar (Baylor Coll. of Medicine) Helen Chu (U Washington) Peter Donofrio (Vanderbilt University) Marie Griffin (Vanderbilt University) Cynthia Lucero-Obusan (VHA) Tracy Ruckwardt (NIH/NIAID) Jonathan Temte (U Wisconsin) Rebecca Morgan (Case Western) Doug Campos-Outcalt (U Arizona)
Liaisons
Kenneth Schmader (AGS) Vidya Sundareshan (ACP) Gretchen LaSalle (AAFP) April Killikelly (NACI/PHAC) Winnie Su (NACI/PHAC) Katherine Williams (APTR) Ruth Lynfield (NFID) Bindy Crouch (AIM) Steven Pergam (IDSA) Elizabeth Skoy (APhA)
CDC Contributors
Amadea Britton (co-lead) Michael Melgar (co-lead) Lauren Roper Fiona Havers Chris Taylor Monica Patton Meredith McMorrow Diya Surie Jennifer DeCuir Mila Prill Monica Godfrey Ruth Link-Gelles Amanda Payne Danielle Moulia Megan Wallace Natalie Thornburg Melissa Coughlin Jefferson Jones Katherine Fleming-Dutra Ismael Ortega Sanchez Noelle Molinari Pragna Patel Aron Hall Hannah Rosenblum Derrell Powers Raigan Wheeler Jarrett Gartin Elizabeth Greene Manisha Patel Lisa Grohskopf Anne Hause David Shay Christine Olson Tom Shimabukuro Karen Broder Neil Murthy Patricia Wodi Andrew Leidner Jamison Pike Sarah Meyer Nicole Dowling
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position of the Centers for Disease Control and Pre vention.
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use. No rights are implied or extended for use in p rinting or any use by other CDC CIOs or any externa l audiences.

Summary: Centers for Disease Control and Prevention  National Center for Immunization and Respiratory Di seases  Photographs and images included in this presentation a re licensed solely for CDC/NCIRD online and present ation  use. No rights are implied or extended for use in pr inting or any use by other CDC CIOs or any external audiences.  Adult Respiratory Syncytial Virus (RSV) Session  Camille Kotton, MD Chair, Adult RSV Work Group  Advisory Committee on Immunization Practices (ACIP)October 25,…