01 Sugerman measles 508

U.S. Measles Update
April 15, 2025Centers for Disease Control and Prevention
National Center for Immunization & Respiratory Diseases
CAPT David Sugerman, MD MPH FACEP, USPHS
Senior Scientist, 2025 Measles Response
Division of Viral Diseases / National Center for Immunization and Respiratory Diseases
US Centers for Disease Control and Prevention (CDC)
History of measles cases in the U.S., 1962 –2023
†Measles was declared eliminated in the U.S. in 2000 by WHO/PAHO. Elimination is defined as the absence of endemic measles
transmission in a region for ≥ 12 months in the presence of a well -performing surveillance system
Texas:
2025: 541 cases*
MMR % unknown Measles outbreaks with 50+ cases and MMR vaccine coverage among affected populations – U.S. 2001 –2025
*As of April 11th, 2025

National and State Level 2 -dose MMR Coverage among
Kindergartners: 2023 –2024
https://www.cdc.gov/mmwr/volumes/73/wr/mm7341a3.htm
MMR (2 doses)
2019 -20 95.2%
2020 -21 93.9%
2021 -22 93.0%
2022 -23 93.1%
2023 -24 92.7%
County -level coverage with ≥ 1 dose of MMR vaccine
Seeskin , ZH et al.  Estimating county -level vaccination coverage using small area estimation with the National
Immunization Survey -Child, Vaccine, Vol 42, Issue 3,2024, Pages 418 -425.

U.S. monthly measles cases by rash onset, 2023 –2025
YearConfirmed measles
cases
2023 59
2024 285
2025 712*
*As of April 10th, 2025.050100150200250300350400
Jan Feb Mar Apr May Jun JulAug Sep Oct Nov Dec Jan Feb Mar Apr May Jun JulAug Sep Oct Nov Dec Jan Feb Mar Apr
2023 2024 2025
U.S. measles outbreaks, 2023 –2025
Year No. outbreaksNo. (%) cases
associated
with outbreaks / total
cases Outbreak size,
median cases
(maximum)Outbreak duration,
median days
(maximum)
2023 4 28/58 (48%) 7 (10) 22 (31)
2024 16 194/285 (68%) 4 (58) 17.5 (131)
2025 7 660/712 (93%) 5 (591)12.5 (5 outbreaks
ongoing)
•As of April 10 , 2025, Texas, New Mexico, and Oklahoma have reported 591 confirmed cases associated with this
single outbreak (528 in Texas ,56 in New Mexico , and 7 in Oklahoma ).
As of April 10, 712 confirmed measles cases have been
reported by 25 states in 2025

National and Southwest Outbreak Measles Cases, 2025
(As of April 10th, 2025)*

•Age
-Under 5 years: 225 (32%)
-5-19 years: 274 (38%)
-20+ years: 198 (28%)
-Age unknown: 15 (2%)
•Vaccination Status:
-Unvaccinated or Unknown: 97%
-One MMR dose: 1%
-Two MMR doses: 2%
•Hospitalizations
-11% of cases (79 of 712) for management of measles
complications
•Deaths - 2 in Texas and 1 in New Mexico  Epidemiology of U.S. measles cases in 2025 (n=712)

Distribution of Distinct Sequence Identifiers ( DSIds ) for measles
genotypes B3 and D8 detected in the U.S. by epidemiological week
in 2025
D8-9171
0510152025303540
1 2 3 4 5 6 7 8 9 10 11 12# Genotyped Cases
Epidemiological Week
B3-9260 B3-8777 B3-9259 B3-8841 B3-8661 D8-9171
D8-9274 D8-9304 D8-9322 D8-9323 D8-5963Green: B3
Blue:    D8
•Texas Epi -Aid: 15 deployers from CDC provided on -site technical  assistance  in Texas
during 3/4 -4/1, with another team deploying this week.
-Provided infection prevention control support for 7 healthcare facilities with ventilation
assessments by NIOSH
-Review ed school infection control activities and risk mitigation strategies
-Developed an int ernal dashboard for TX to track cases by location and exposure location
•Provide remote technical assistance to multiple state health departments
•Biweekly national measles calls with public health partners
•Biweekly trilateral calls with Canada and Mexico to share updates and lessons learned
•Continue to make additional, outbreak -related MMR vaccine doses available for
health departments to order at their requestCDC 2025 measles outbreak response efforts
•Provider Outreach
-Health Alert Network (HAN) released - Expanding Measles Outbreak in Texas and New
Mexico and Guidance for the Upcoming Travel Season
-Clinician Outreach and Communication Activity (COCA) and Epi -X alerts
-Shared a provider letter summarizing routine and outbreak -related MMR vaccination
recommendations
•Laboratory Support
-Coordination with the APHL Vaccine Preventable Disease Reference Centers (VPD -RCs) for
genotyping and  sequencing
-Expanded and standardized testing for wastewater surveillance for measles with the
National Wastewater Surveillance System (NWSS) and Center of Excellence in Texas.
•Ongoing modeling work to determine risk CDC 2025 measles outbreak response efforts (continued)
For more information, contact CDC/ATSDR
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov           www.atsdr.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position
of the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Thank you

Summary: U.S. Measles Update April 15, 2025Centers for Disease Control and Prevention National Center for Immunization & Respiratory Diseases CAPT David Sugerman, MD MPH FACEP, USPHS Senior Scientist, 2025 Measles Response Division of Viral Diseases / National Center for Immunization and Respiratory Diseases US Centers for Disease Control and Prevention (CDC) History of measles cases in the U.S., 1962 –2023 †Measles was declared eliminated in the U.S. in 2000 by WHO/PAHO. Elimination is defined as the…


01 Loehr mening 508

Introduction to Meningococcal Vaccines
Session
Jamie Loehr, MD
Advisory Committee on Immunization Practices
April 16, 2025National Center for Immunization & Respiratory Diseases
1
3 Terms of Reference
GSK Pentavalent (MenABCWY) Vaccine
MenQuadfi Use in Infants
Adolescent Schedule Change
2 of 8
3 Terms of Reference
GSK Pentavalent (MenABCWY) Vaccine
–Licensure:  February 14, 2025
–ACIP Vote:  April 16, 2025 (today)
MenQuadfi Use in Infants
–Licensure:  May 2025 (anticipated)
–ACIP Vote:  June 2025 (anticipated)
Adolescent Schedule Change
–WG deliberations ongoing
3 of 8
Today
GSK Pentavalent (MenABCWY) Vaccine:  Update of EtR and
Work Group Considerations
Updates to Meningococcal Vaccines VFC Resolution
Introduction to MenQuadfi Label Change for Infants
MenQuadfi in Infants:  Safety and Immunogenicity
Work Group Considerations Regarding MenQuadfi in Infants
4 of 8
Today
GSK Pentavalent (MenABCWY) Vaccine:  Update of EtR and
Work Group Considerations
Updates to Meningococcal Vaccines VFC Resolution
–VOTE (including VFC Vote)
Introduction to MenQuadfi Label Change for Infants
MenQuadfi in Infants:  Safety and Immunogenicity
Work Group Considerations Regarding MenQuadfi in Infants
5 of 8
GSK Pentavalent Vaccine
After immunogenicity data presented to ACIP , Bexsero
(comparator) label changed from 0, ≥1 month to 0, 6 months
Longer intervals between vaccine doses associated with higher immunogenicity
–As a result, pentavalent now has comparatively lower
immunogenicity than MenB
Some data points in label have also been updated
WG members voiced need for ACIP to review updated data in
consideration of vote, although WG recommendation has not changed
6 of 8
ACIP Meningococcal Vaccines Work Group
ACIP Members on the WG
 Jamie Loehr (Chair)
 Charlotte Moser
Ex Officio WG Members
 Margaret Bash (FDA)
 Xin-Xing Gu (NIH)
7 of 8WG Liaisons and Consultants
 Amra Resic (AAFP)
 Mary Healy (AAP)
 Barb Fluty (ACHA)
 Karyn Lyons (AIM)
 Stephanie Schauer (AIM)
 Paul Cieslak (CSTE)
 Kathy Hsu (IDSA)
 Joseline Zafack (NACI)
 Jeff Goad (NFID)
 Jessica Cataldi (PIDS)
 Amy Middleman (SAHM)
 Kathy Poehling (Wake Forest)
 Lynn Bahta (Minnesota Department of Health)
 David Stephens (Emory)
Acknowledgements
CDC Contributors
 Sarah Schillie (DBD/NCIRD) – Meningococcal Lead
 Jennifer Collins (DBD/NCIRD) – Hib Lead
 Lucy McNamara (DBD/NCIRD)
 Avnika Amin (DBD/NCIRD)
 LeAnne Fox (DBD/NCIRD)
 Susan Hariri (DBD/NCIRD)
 Amy Rubis (DBD/NCIRD)
 Jenny Thomas (DBD/NCIRD)
 Noele Nelson (DBD/NCIRD)
 Alison Albert (DBD/NCIRD)
 Shelby Miller (DBD/NCIRD)
 Michael Williams (DBD/NCIRD)
 Michelle Hughes (DBD/NCIRD)
 Madhura Vachon (DBD/NCIRD)
 Gabrielle Cooper (DBD/NCIRD)
 Xiaoyu Dong (ISD/NCIRD)
 Andrew Leidner (ISD/NCIRD)
 Katherine Lean (DBD/NCIRD)
 Ismael Ortega- Sanchez (CORVD/NCIRD)
 Jonathan Duffy (DHQP/NCEZID)
 Pedro Moro (DHQP/NCEZID)
 Tanya Myers (DHQP/NCEZID)
 Madeleine Valier (ISD/NCIRD)
 Sam Graitcer (ISD/NCIRD)
 Leslie Lee (OD/NCIRD)
 Manisha (Mo) Patel (OD/NCIRD)
 Jessica MacNeil (ACIP Secretariat)
 Hannah Rosenblum (ACIP Secretariat)
 Melinda Wharton (ACIP Secretariat)
8 of 8

Summary: Introduction to Meningococcal Vaccines  Session Jamie Loehr, MD Advisory Committee on Immunization Practices April 16, 2025National Center for Immunization & Respiratory Diseases 1 3 Terms of Reference GSK Pentavalent (MenABCWY) Vaccine MenQuadfi Use in Infants Adolescent Schedule Change 2 of 8 3 Terms of Reference GSK Pentavalent (MenABCWY) Vaccine –Licensure:  February 14, 2025 –ACIP Vote:  April 16, 2025 (today) MenQuadfi Use in Infants –Licensure:  May 2025 (anticipated) –ACIP Vote: …


02 Schillie mening 508

GSK Pentavalent ( MenABCWY ) Vaccine:
Review of Updated EtR and Work Group
Considerations
Sarah Schillie, MD, MPH, MBA
Advisory Committee on Immunization Practices
April 16, 2025National Center for Immunization & Respiratory Diseases
1
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position o f
the U. S. Centers for Disease Control and Prevention.
Meningococcal Vaccine Recommendations
2 of 56One MenACWY  dose at
age 11 –12 years and a
booster dose at age 16
years (routine)
Two MenB  doses at age
16–23 years (shared
clinical decision -making
[SCDM])
–Preferred age range: 16–18 years

Risk-Based Meningococcal Vaccine Recommendations
2MenACWY  (≥2 months) MenB  (≥10 years)
Asplenia (functional or anatomic) √ √
Complement deficiency/
complement inhibitor use√ √
HIV infection √
Some microbiologists √ √
Exposure during outbreak √ √
Travel to hyperendemic areas √
First -year college students (if not
previously vaccinated at ≥16 years) √
Interchangeability of Vaccine Products
MenACWY
–Brands are interchangeable
–Same brand is preferred, but not required, for all doses in a series
MenB
–Brands are not interchangeable
–Same brand must be used for all doses in a series (including booster
doses)
4 of 56
Two Pentavalent MenABCWY  Vaccines
Pfizer (Penbraya) GSK ( Penmenvy )
ACWY component Nimenrix (not licensed in U.S.) Menveo
B component Trumenba Bexsero
Schedule 2 doses, 6 months apart 2 doses, 6 months apart
Age 10–25 years 10–25 years
Licensed October 20, 2023 February 14, 2025
ACIP Vote October 25, 2023 Today
5 of 56
Pfizer Pentavalent Vaccine
6 of 56May be used when both MenACWY  and MenB
are indicated at the same visit for:
 1) Healthy persons aged 16 –23 years
(routine schedule) when shared clinical decision-
making favors administration of MenB  vaccine
and
 2) Persons aged ≥10 years who are at
increased risk for meningococcal disease (e.g.,
because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia)

Considerations
Each pentavalent vaccine assessed separately by Work Group
—Lack of data directly comparing the two vaccines
The MenACWY  and MenB vaccine indications have not
changed with the availability of pentavalent vaccine
ACIP previously voiced preference to harmonize
recommendations between the Pfizer and GSK pentavalent vaccines
–Unless a vaccine -specific reason to have a different
recommendation exists 7 of 56
Assessing Immunogenicity
Exogenous complement (“traditional” hSBA assays)
Seroprotection
Seroresponse *
GMTs
Endogenous complement
Immunologic Vaccine Effectiveness:  Immune response against diverse
serogroup B strains
Serologic correlate of protection exists only for serogroup C
*E.g.:  a post- vaccination hSBA  titer at least 4 -fold the LOD or ≥LLOQ, whichever is greater, for participants with pre -vaccination hSBA  titer
<LOD, a post -vaccination hSBA  titer at least 4 -fold the LLOQ for participants with pre -vaccination hSBA  titer ≥LOD and <LLOQ, and a post -
vaccination hSBA  titer at least 4 -fold the pre -vaccination hSBA  titer for participants with pre -vaccination hSBA  titer ≥ LLOQ
LOD, limit of detection; LLOQ, lower limit of quantitation
PICO Questions:  GSK Pentavalent Vaccine
PICO 1:
Should the GSK pentavalent vaccine be included as an option for MenACWY /MenB
vaccination in people currently recommended to receive both vaccines at the same
visit?
– For example, 16 year- olds*
PICO 2:
Should the GSK pentavalent vaccine be included as an option for people currently recommended to receive MenACWY  only?
–For example, 11 –12 year -olds
PICO 3:
Should the GSK pentavalent vaccine be included as an option for people currently recommended to receive MenB  only?
– For example, during a serogroup B outbreak
*16 year -olds who decide to receive MenB  vaccine based on shared clinical decision -making9 of 56
Acronyms
Q=Quadrivalent ( MenACWY  vaccine)
B=MenB  vaccine
P=Pentavalent ( MenABCWY  vaccine)
10 of 56
Acronyms
Current Recommendation:  Q-QB-B or Q -Q
PICO 1:
 Should the GSK pentavalent vaccine be included as an option for MenACWY /MenB  vaccination in
people currently recommended to receive both vaccines at the same visit?  Q -P-B
PICO 2:
 Should the GSK pentavalent vaccine be included as an option for people currently recommended to
receive MenACWY  only?  P-P
PICO 3:
 Should the GSK pentavalent vaccine be included as an option for people currently recommended to receive MenB  only?  Q-P-PQ=Quadrivalent ( MenACWY  vaccine)
B=MenB  vaccine
P=Pentavalent ( MenABCWY  vaccine)
11 of 56
Acronyms
Current Recommendation:  Q-QB-B or Q -Q
PICO 1:  “Yes” for Pfizer pentavalent vaccine
 Should the GSK pentavalent vaccine be included as an option for MenACWY /MenB  vaccination in
people currently recommended to receive both vaccines at the same visit?  Q -P-B
PICO 2:  “No” for Pfizer pentavalent vaccine
 Should the GSK pentavalent vaccine be included as an option for people currently recommended to
receive MenACWY  only?  P-P
PICO 3:  “No” for Pfizer pentavalent vaccine
 Should the GSK pentavalent vaccine be included as an option for people currently recommended to receive MenB  only?  Q-P-PQ=Quadrivalent ( MenACWY  vaccine)
B=MenB  vaccine
P=Pentavalent ( MenABCWY  vaccine)
12 of 56
Updated Evidence-to-Recommendations
Framework:  GSK Pentavalent Vaccine
EtR Domain QuestionWork Group
Determination –
PICO 1Work Group
Determination –
PICO 2Work Group
Determination –
PICO 3
Public health
problemIs invasive meningococcal disease a problem of public health importance?Yes Yes Yes
Benefits and harmsHow substantial are the desirable anticipated effects? Small Small Small
How substantial are the undesirable anticipated effects? Minimal Small Minimal
Do the desirable anticipated effects outweigh the undesirable effects?Favors
intervention/
favors comparisonFavors intervention/
comparison/bothFavors
intervention/
comparison/both
What is the overall certainty of evidence? Low Low Low
Values Does the target population feel the desirable effects are large relative to the undesirable effects?Yes Probably yes Probably yes/yes/
don’t know
Is there important variability in how patients value the
outcome?Probably not/no Probably/probably
notProbably/probably
not
Acceptability Is the intervention acceptable to key stakeholders? Yes Probably yes Probably yes/yes
Resource use Is the intervention a reasonable and efficient allocation of
resources?Yes Probably no/varies Varies
Health equity What would be the impact of the intervention on health equity?Probably
increasedProbably
increased/increasedProbably increased
Feasibility Is the intervention feasible to implement? Yes Probably yes/yes Yes
Public health problem
0.000.200.400.600.801.001.201.40
1996 2000 2005 2010 2015 2020 2024Incidence per 100,000
YearMeningococcal Disease Incidence –
United States, 1996 –2024*
Abbreviations: MenACWY vaccine = quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccine; MenB  vaccine = serogroup B meningococcal vaccine
Source: 1996– 2024 NNDSS Data. *2024 NNDSS data are preliminary.0.15 cases/100,000 populationMenACWY vaccine1.2 cases/100,000
population
MenB  vaccine
Public Health Problem
Is invasive meningococcal disease a problem of public health importance?
No Probably
noProbably
yesYes VariesDon’t
know
PICO 1 (QPB vs. QQBB):
MenABCWY vs. MenACWY + MenBX
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY vs. MenACWYX
PICO 3 (QPP vs. QQBB):
MenABCWY vs. MenB  X
PICO 1 (QPB vs. QQBB):
MenABCWY vs. MenACWY + MenBX
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY vs. MenACWYX
PICO 3 (QPP vs. QQBB):
MenABCWY vs. MenB  X
17 of 56
Benefits and harms
Serogroup B Immunogenicity Lower than
Previously Shared with ACIP
Comparator of Bexsero at 0, 2 month interval
–August 2024:  Bexsero label changed from 0, ≥1 month to
0, 6 months
Longer intervals between vaccine doses associated with
higher immunogenicity
Additionally, some data points in label have been updated
19 of 56
Work Group Assessment
Clinical significance of comparatively lower
immunogenicity uncertain
–Serologic correlate of protection lacking for serogroup B disease
The Work Group’s recommendation for the GSK pentavalent vaccine remains unchanged
–ACIP to weigh the change in immunogenicity in their deliberations
20 of 56
Previous Synthesis to ACIP
(Remains Unchanged from June 2024):
For “traditional” exogenous hSBA  titers against 4 vaccine indicator strains,
MenABCWY  was:
–Non -inferior to MenB  0, 2 months for 3 strains
–Non -inferior to MenB  0, 6 months for 2 strains
Endogenous complement hSBA  assay against a broad range of strains
(Immunologic Vaccine Effectiveness):  Success criteria met
–Although MenABCWY  had lower point estimates (especially compared to MenB  0,6)
21 of 56
Previous Synthesis Unchanged Regarding:
ACWY Immunogenicity  and Safety
MenABCWY  non- inferior to MenACWY  in most study groups
–Except serogroup A for 1 dose MenABCWY  vs. 1 dose MenACWY  in
naïve recipients
•Serogroup A disease very rare in the United States
MenABCWY  safety profile similar to MenB , except slightly more unsolicited
adverse events with MenABCWY
–More adverse events than with MenACWY
22 of 56
23 of 56
Presentation to
ACIP , Jun 2024Package Insert,Feb 2025•Poorer immunogenicity when comparing to 0,6 month schedule
•Success criterion not met for all strains (unchanged since June ACIP)
•Some change in numbersComposite response= hSBA
≥LLOQ for all 4 indicator strains
24 of 56
Presentation to
ACIP , Jun 2024Package Insert,Feb 2025•Poorer immunogenicity when comparing to 0,6 month schedule
•Success criterion not met for all strains (unchanged since June ACIP)
•Some change in numbers
PorA
Non-inferiority not demonstrated for PorA  strain for 0, 2 or 0, 6
month comparison
–PorA  indicator strain is important because it represents the outer
membrane vesicle (OMV) component of the vaccine and has bearing on
cross -protection
25 of 56
Penmenvy (GSK)
Package Insert Composite response= hSBA
≥LLOQ for all 4 indicator strains
Penmenvy (GSK)
Package Insert
Penbraya  (Pfizer)
Package InsertComposite response= hSBA
≥LLOQ for all 4 indicator strains
2
Presentation to
ACIP , Jun 2024
Package Insert,Feb 2025•Poorer immunogenicity when comparing to 0,6 month schedule
•Success criterion met
•Minimal change in numbers
28 of 56
8GSK presentation
to ACIP , Jun 2024
Integrated FDA Review, Mar 2025•Poorer immunogenicity when comparing to 0,6 month schedule
•Success criterion met
•No change in numbers

Reverse Cumulative Distribution of hSBA
Against Indicator Strains
28
pentavalent
30 of 56
Reverse Cumulative Distribution of hSBA
Against Indicator Strains
28
pentavalentMenB
31 of 56
Enc-hSBA  against 110 Isolates by Clonal
Complex
For PorA /OMV:  enc -hSBA
likely most reflective of U.S.
strains and exogenous assay
likely most reflective of New Zealand strain
CC 41/44 represents 72/179
(40.2%) of U.S. isolates from
2020 -2024
•For serogroups CWY , 1 dose
pentavalent immunogenicity
greater than 1 dose Menveo
for naïve recipients
•For serogroup A, 1 dose
pentavalent immunogenicity
lower than 1 dose Menveo for
naïve recipients (Serogroup A
does not circulate in U.S.)
•For primed recipients, 1 -dose
immunogenicity similar for serogroups A, C, W, and Y
Serious Adverse Events Assessed as Possibly Related to Vaccination
34 of 56StudyNumber
Pentavalent MenACWY MenB MenACWY/MenB
Saez -Llorens 201510 0 -- --
Block 2015 0 0 0 --
Welsch 2018 0 0 -- --
Vesikari 20212
(seizure, connective
tissue disorder)-- 0 --
Beran 2021 0 01
(syncope)0
v72_722 1
(neuromyelitis optica)1
(pyrexia)1
(ulcerative colitis)--
MenABCWY_019 0 0 -- --
1One related event during extension study in a recipient of a MenABCWY that contained ¼ of the usual OMV component
2These were reported as related to vaccination by investigators; however, they were not considered adverse drug reactions rela ted to vaccination after GSK and independent evaluation
Serogroup B Immunogenicity Summary
MenABCWY  immunogenicity slightly lower than MenB
–Clinical significance uncertain as serologic correlate of protection is lacking
For “traditional” exogenous hSBA  titers against 4 vaccine indicator strains,
MenABCWY  was:
–Non -inferior to MenB  0, 2 months for 3 strains
–Non -inferior to MenB  0, 6 months for 2 strains
Endogenous complement hSBA  assay against a broad range of strains
(Immunologic Vaccine Effectiveness):  Success criteria met
Work Group’s interpretation has not changed
ACIP to consider the magnitude of the difference in immunogenicity in their
deliberations35 of 56
How substantial are the desirable  anticipated effects?Benefits and Harms
Minimal Small Moderate Large VariesDon’t
know
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX X X
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X
36 of 56
How substantial are the undesirable  anticipated effects?Benefits and Harms
Minimal Small Moderate Large VariesDon’t
know
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX X
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X X
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X
37 of 56
Do the desirable effects outweigh the undesirable effects?Benefits and Harms
Favors
interventionFavors
comparisonFavors
bothFavors
neitherVariesDon’t
know
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX X X
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X X
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX X*
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX X X
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X X X
38 of 56*Represents minority opinion added since last presented to ACIP
What is the overall certainty of this evidence for the critical outcomes?Benefits and Harms:  Short -term Immunity
No studies
foundVery low Low Moderate High
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX X
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX X
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X X
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX X
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX X
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X X
39 of 56
What is the overall certainty of this evidence for the critical outcomes?Benefits and Harms:  Serious Adverse Events
No studies
foundVery low Low Moderate High
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX X
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX X
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X X
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX X
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX X
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X X
40 of 56
Resource use
Pediatric Price Per Dose
Public Private
MenACWYMenveo $119.986* $166.747
MenQuadfi $114.36* $171.972
MenBTrumenba $142.73* $207.32*
Bexsero $154.504* $237.126
MenABCWYPenbraya $189.35 $230.75
Penmenvy *$181.00* (final price:
pending negotiation)$241.00** (final
price:  $230- 255)
42 of 56https://www.cdc.gov/vaccines -for-children/php/awardees/current -cdc-vaccine -price -list.html*Updated contract price **Value used in CDC cost- effectiveness model
Pediatric Price Per Dose
Public Private
MenACWYMenveo $119.986* $166.747
MenQuadfi $114.36* $171.972
MenBTrumenba $142.73* $207.32*
Bexsero $154.504* $237.126
MenABCWYPenbraya $189.35 $230.75
Penmenvy *$181.00* (final price:
pending negotiation)$241.00** (final
price:  $230- 255)
43 of 56https://www.cdc.gov/vaccines -for-children/php/awardees/current -cdc-vaccine -price -list.html*Updated contract price **Value used in CDC cost- effectiveness model
Pediatric Price Per Dose
Public Private
MenACWYMenveo $119.986* $166.747
MenQuadfi $114.36* $171.972
MenBTrumenba $142.73* $207.32*
Bexsero $154.504* $237.126
MenABCWYPenbraya $189.35 $230.75
Penmenvy *$181.00* (final price:
pending negotiation)$241.00** (final
price:  $230- 255)
44 of 56https://www.cdc.gov/vaccines -for-children/php/awardees/current -cdc-vaccine -price -list.html*Updated contract price **Value used in CDC cost- effectiveness model
Health Outcomes*: Cumulative Number of IMD Cases and
Deaths for a Single Birth Cohort from Ages 11 through 29 Years
*All numbers are cumulative over the analytical horizon of the model for a single cohort of 11 -year -olds. For example, in the “No  Vaccination” strategy, there were a
total of 233 undiscounted episodes of IMD among about 4 million individuals, who started in the model at 11 years old and age d to 29 years old.45PICO 1
Q=Quadrivalent ( MenACWY ) vaccine; B= MenB  vaccine; P=Pentavalent ( MenABCWY ) vaccine; IMD=Invasive meningococcal disease.
45 of 56
Cost -Effectiveness
PICO Intervention Comparator Diff. in QALYs* Diff. in Cost*ICER
 ($/QALY)
1 Q-P-B Q-QB-B 0 -$175 million Cost -saving**
2 P-P Q-Q 33 $373 million $11,332,778
3 Q-P-PQ-QB-B 2 -$166 million Cost -saving
Q-P-B 2 $9 million $4,510,830
*Annual discount is 3%; 2024$; **In this comparison, costs are reduced, but health outcomes remain the same when comparing Q -P-B to Q -QB-B.46
Q=Quadrivalent ( MenACWY ) vaccine; B= MenB  vaccine; P=Pentavalent ( MenABCWY ) vaccine; QALY=Quality -adjusted life year.•In a sensitivity analysis, with the updated price assumptions, PICO
#1 (Q -P-B) remained cost -saving (when compared to Q -QB-B).
46 of 56
Resource Use
Is the intervention a reasonable and efficient allocation of resources?
No Probably
noProbably
yesYes VariesDon’t
know
PICO 1 (QPB vs. QQBB):
MenABCWY vs. MenACWY + MenBX X
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY vs. MenACWYX X
PICO 3 (QPP vs. QQBB):
MenABCWY vs. MenB  X X
PICO 1 (QPB vs. QQBB):
MenABCWY vs. MenACWY + MenBX
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY vs. MenACWYX X
PICO 3 (QPP vs. QQBB):
MenABCWY vs. MenB  X*
*WG sentiment varied from no to yes 4747 of 56
Evidence-to-Recommendations
Framework
EtR Domain QuestionWork Group
Determination –
PICO 1Work Group
Determination –
PICO 2Work Group
Determination –
PICO 3
Public health
problemIs invasive meningococcal disease a problem of public health importance?Yes Yes Yes
Benefits and harmsHow substantial are the desirable anticipated effects? Small Small Small
How substantial are the undesirable anticipated effects? Minimal Small Minimal
Do the desirable anticipated effects outweigh the undesirable effects?Favors
intervention/
favors comparison*Favors intervention/
comparison/bothFavors
intervention/
comparison/both
What is the overall certainty of evidence? Low Low Low
Values Does the target population feel the desirable effects are large relative to the undesirable effects?Yes Probably yes Probably yes/yes/
don’t know
Is there important variability in how patients value the
outcome?Probably not/no Probably/probably
notProbably/probably
not
Acceptability Is the intervention acceptable to key stakeholders? Yes Probably yes Probably yes/yes
Resource use Is the intervention a reasonable and efficient allocation of
resources?Yes Probably no/varies Varies
Health equity What would be the impact of the intervention on health equity?Probably increased Probably
increased/increasedProbably increased
Feasibility Is the intervention feasible to implement? Yes Probably yes/yes Yes
*Added since last presented to ACIP
Balance of Consequences
Undesirable
consequences
clearly outweigh
desirable
consequences in
most settingsUndesirable
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
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX X
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X X X
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX* X
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX X X
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X X X X
*Added since last presented to ACIP
Work Group Interpretation
Is there sufficient information to move forward with a recommendation?
Yes No
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  +
MenBX
PICO 2 (PPB vs. QQBB or PP
vs. QQ):
MenABCWY  vs. MenACWYX
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X
6251 of 56
Work Group Interpretation
We do not
recommend the
interventionWe do
recommend the
intervention
PICO 1 (QPB vs. QQBB):
MenABCWY  vs. MenACWY  + MenBX
PICO 2 (PPB vs. QQBB or PP vs. QQ):
MenABCWY  vs. MenACWYX
PICO 3 (QPP vs. QQBB):
MenABCWY  vs. MenB   X X
6352 of 56
53Comments Regarding Proposed Recommendation
PICO 1 would typically involve 1 dose of
pentavalent vaccine (and 1 dose of MenB vaccine)
–Studies evaluated 2 doses of pentavalent vaccine
Recommendations for use of both pentavalent vaccines could be revisited as part of future adolescent schedule deliberations if desired
53 of 56
Vote Language
ACIP recommends GSK’s MenABCWY  vaccine may be used when both
MenACWY  and MenB  are indicated at the same visit*
*1) healthy persons aged 16 –23 years (routine schedule) when shared clinical decision-
making favors administration of MenB  vaccine and 2) persons aged ≥10 years who are
at increased risk for meningococcal disease (e.g., because of persistent complement
deficiencies, complement inhibitor use, or functional or anatomic asplenia) PICO 1 (QPB) √
PICO 2 (PP) X
PICO 3 (QPP) X
54 of 56
55Acknowledgements
Avnika Amin
Lucy McNamara
Xiaoyu Dong
Andrew Leidner
Rebecca Morgan
Doug Campos -Outcalt
Noele Nelson
Alison Albert
Susan Hariri
LeAnne Fox
Jennifer Collins
Amy Rubis
61 of 6255 of 56
Thank you!
For more information, contact CDC
1-800- CDC- INFO (232- 4636)
TTY:  1 -888- 232- 6348    cdc.gov
Follow us on X (Twitter) @CDCgov & @CDCEnvironment
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position o f
the U. S. Centers for Disease Control and Prevention.

Summary: GSK Pentavalent ( MenABCWY ) Vaccine:   Review of Updated EtR and Work Group  Considerations Sarah Schillie, MD, MPH, MBA Advisory Committee on Immunization Practices April 16, 2025National Center for Immunization & Respiratory Diseases 1 The findings and conclusions in this report are those of the authors and do not necessarily represent the official position o f  the U. S. Centers for Disease Control and Prevention. Meningococcal Vaccine Recommendations  2 of 56One MenACWY  dose at  age 11…


03 Santoli mening 508

VFC Resolution Update:  Meningococcal Vaccines
Jeanne Santoli, MD, MPH
April 16, 2025National Center for Immunization & Respiratory Diseases

•Orange font/highlight in the presentation is used to indicate changes to
the resolution in comparison to the prior approved version.Note
•The purpose of this resolution is to update the resolution to incorporate a
new combination pentavalent vaccine. Purpose of the Resolution
Eligible Groups
•  Children aged 2 months through 10 years who are at increased risk for meningococcal
disease attributable to serogroups A, C, W, and Y, including:
-Children who have persistent complement component deficiencies (including inherited or
chronic deficiencies in C3, C5 -C9, properdin, factor H, or factor D)
-Children taking a complement inhibitor (e.g., eculizumab [Soliris], ravulizumab [Ultomiris ])
-Children who have anatomic or functional asplenia, including sickle cell disease
-Children infected with human immunodeficiency virus (HIV)
-Children traveling to or residing in countries in which meningococcal disease is hyperendemic or epidemic, particularly if contact with local population will be prolonged
-Children identified to be at increased risk because of a meningococcal disease outbreak
attributable to serogroups A, C, W, or Y
•  All children aged 11 through 18 yearsMeningococcal Conjugate Vaccines ( MenACWY)
Recommended Vaccination Schedule and Intervals
•The table below lists meningococcal conjugate vaccines currently available to prevent
meningococcal disease attributable to serogroups A, C, W, and Y. Meningococcal Conjugate Vaccines ( MenACWY)
Vaccine Type Brand
(1)Age
indication
(pediatric)Children at increased riskChildren not at
increased risk
2m through 23m 2ythrough 18y Booster Doses
Primary:  1 dose
at age 11 -12y
(or 13y  -18y) if
not vaccinated
previously
Booster:  1 dose
at age 16y (if
vaccinated at
11y  -12y) or 1
dose at 16y -
18y (if
vaccinated at
13y -15y)Men-ACWY -
CRM
(lyophilized)Menveo
Two-Vial  2m –18y Initiating at 2m : 4
doses, at 2, 4, 6, and 12m
Initiating at 7 -
23m:  2 doses, 12
wksapartFor children with persistent complement deficiencies,
complement
inhibitor use (2), functional or anatomic asplenia, or
HIV: 2 doses,
≥8 wksapart
Other children
at increased
risk: 1 doseFor children who
remain at increased
ri sk and compl eted
the primary dose or
series at age:
< 7y:  ad d itional d ose
3 years after primary;
boosters should be
repeated every 5
years
>7y:  ad d itional d ose
5 yrs after primary;
boosters should be
repeated every 5
yearsMen-ACWY -
CRM (liquid)M enveo One-Via l10y –18y Not ind icated
Men-ACWY -TT M enQuadfi 2y –18y Not ind icated
Table Notes
(1) Use of brand names is not meant to preclude the use of other comparable US licensed
vaccines
(2) Includes eculizumab (Soliris) and ravulizumab (Ultomiris )
Recommended schedules and intervals for meningococcal conjugate vaccines can be found at
Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization
Practices, United States, 2020 | MMWR
Recommended dosage Refer to product package inserts.
Contraindications and Precautions
Contraindications and Precautions can be found in the package inserts available at Vaccines
Licensed for Use in the United States | FDAMeningococcal Conjugate Vaccines ( MenACWY)
Eligible Groups
•  Children aged 10 through 18 years at increased risk for serogroup B meningococcal
disease, including:
-Children who have persistent complement component deficiencies (including inherited or
chronic deficiencies in C3, C5 -C9, properdin, factor H, or factor D)
-Children taking a complement inhibitor (e.g., eculizumab [Soliris], ravulizumab [Ultomiris ])
-Children who have anatomic or functional asplenia, including sickle cell disease
-Children identified to be at increased risk because of a meningococcal disease outbreak
attributable to serogroup B
•  Children aged 16 through 18 years who are not at increased risk for serogroup B
meningococcal disease may also be vaccinated when shared clinical decision -making
favors administration of MenB . Serogroup B Meningococcal Vaccines ( MenB )
Recommended Vaccination Schedule and IntervalsSerogroup B Meningococcal Vaccines ( MenB )
Vaccine (1), (3) Age Group Dosing Schedule (Primary
Series)Dosing Schedule (Booster Dose)
MenB -4C
(Bexsero, GSK)
MenB -FHbp
(Trumenba , Pfizer)10y -18y -Persons at increased risk
for meningococcal disease
including during
serogroup B outbreaks:
Three doses (0, 1 -2, and 6
month schedule)
-Adolescents who are not
at increased risk for
meningococcal disease: Two doses (0, 6 month schedule) (2)-For children at increased risk due to
complement deficiency, complement inhibitor
use, or functional or anatomic asplenia:
A booster dose is recommended if it has been a
least one year since primary series; repeat every
2-3 years as long as risk remains.
-For children at increased risk due to a
serogroup B outbreak:
A booster dose is recommended if it has been a
least one year since primary series. If recommended by public health officials,
booster dose may be given if it has been at leas
6 months since primary series.
-Booster doses are not recommended for
adolescents who are not at increased risk for
meningococcal disease.
Table Notes
(1)  Use of brand names is not meant to preclude the use of other comparable US licensed vaccines.
(2)  If the second dose is administered earlier than 6 months after the first dose, a third dose should
be administered at least 4 months after the second dose.
(3)  MenB vaccines are not interchangeable by manufacturer. Administration of a B component
vaccine ( MenB or MenACWY -TT/MenB -FHbp or MenACWY -CRM/MenB -4C) requires that
subsequent B component vaccine doses be from the same manufacturer.
Recommended dosage Refer to product package inserts.
Contraindications and Precautions
Contraindications and Precautions can be found in the package inserts available at Vaccines
Licensed for Use in the United States | FDASerogroup B Meningococcal Vaccines ( MenB )
Eligible Groups
Children who are indicated to receive MenACWY and MenB vaccines, including:
•Children aged 10 through 18 years who are at increased risk for meningococcal
disease attributable to serogroups A, C, W, Y , and B, including:
-Children who have persistent complement component deficiencies (including
inherited or chronic deficiencies in C3, C5 -C9, properdin, factor H, or factor D)
-Children taking a complement inhibitor (e.g., eculizumab [Soliris], ravulizumab
[Ultomiris ])
-Children who have anatomic or functional asplenia, including sickle cell disease
•Children aged 16 through 18 years for whom both MenACWY and MenB are
indicated to be given at the same time and shared clinical decision -making favors
administration of MenB vaccine.Combination Pentavalent Serogroup A, C, W, Y , and B
Meningococcal Vaccines ( MenACWY -MenB )
The table below displays dosing schedules for the combination pentavalent vaccines
MenACWY -TT/MenB -FHbp (Penbraya ) and MenACWY -CRM/MenB -4C (Penmenvy) (1).Combination Pentavalent Serogroup A, C, W, Y , and B
Meningococcal Vaccines ( MenACWY -MenB )
Children at Increased Risk (10y through 18y)
Children not at Increased RiskDosing Schedule
(Primary Series) Dosing Schedule (Boosters)
For children with persistent complement
deficiencies, complement inhibitor use (2),
or functional or anatomic asplenia who are
due for both MenACWY and MenB
vaccination: 1 dose may be given in lieu of
MenACWY and MenB .
If subsequent doses of MenACWY and/or
MenB (3) are indicated less than 6 months
after a dose of combination pentavalent
vaccine ,  the vaccines should be given
separately according to the MenACWY and
MenB tables above. For subsequent doses, where both MenACWY and MenB are
indicated and at least 6 months
have passed since administration of a previous dose of combination pentavalent vaccine, a second
dose of combination pentavalent vaccine from the same manufacturer may be
used (3). Initial dose:
May be given in lieu of MenACWY and MenB when
both vaccines are indicated at the same visit (e.g., age 16 years) and shared clinical decision -making
favors administration of MenB .
Second dose: The MenB series should then be completed with a
MenB component from the same manufacturer (3).
Table Notes
(1) Use of brand names is not meant to preclude the use of other comparable US licensed vaccines.
(2) Includes eculizumab (Soliris) and ravulizumab (Ultomiris ).
(3) MenB vaccines are not interchangeable by manufacturer. Administration of a B component
vaccine ( MenB , MenACWY -TT/MenB -FHbp , or MenACWY -CRM/MenB -4C ) requires that subsequent
B component vaccine doses be from the same manufacturer.
Recommended dosage Refer to product package inserts.
Contraindications and Precautions
Contraindications and Precautions can be found in the package inserts available at Vaccines Licensed
for Use in the United States | FDACombination Pentavalent Serogroup A, C, W, Y , and B
Meningococcal Vaccines ( MenACWY- MenB )
•[If an ACIP recommendation or notice regarding meningococcal vaccination is
published within 6 months following this resolution, the relevant language above (except in the eligible groups sections) will be replaced with the language in the
recommendation and incorporated by reference to the publication URL.]Statement Regarding Update Based on Published  Documents

Summary: VFC Resolution Update:  Meningococcal Vaccines Jeanne Santoli, MD, MPH April 16, 2025National Center for Immunization & Respiratory Diseases  •Orange font/highlight in the presentation is used to indicate changes to  the resolution in comparison to the prior approved version.Note •The purpose of this resolution is to update the resolution to incorporate a  new combination pentavalent vaccine. Purpose of the Resolution Eligible Groups •  Children aged 2 months through 10 years who are at…