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GSK Pentavalent MenABCWY Vaccine: Term of Reference
Sarah Schillie, MD, MPH, MBA
February 29, 2024National Center for Immunization & Respiratory Diseases
The findings and conclusions in this presentation are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
▪Two new MenABCWY vaccines:
–Pfizer (“ Penbraya ,” ACIP voted October 2023)
–GSK (clinical trials)
▪Each vaccine is a combination of an existing:
–MenACWY vaccine and
–MenB vaccine
▪Each vaccine assessed separately by Work Group
–Lack of data directly comparing Pfizer and GSK Pentavalent vaccinesPentavalent MenABCWY Vaccines
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Pfizer ( Penbraya ) GSK*
ACWY
componentNimenrix (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*
Clinical trial
participantsStudied in MenACWY primed
and naive subjects; all MenB
naiveStudied in MenACWY primed
and naive subjects; MenB
naïve in phase 3 trials
Future studiesLonger interval studies
underwayLonger interval studies
underway
Gonorrhea
protectionNo Yes/some
*Vaccine not yet licensed in U.S. and this slide represents anticipated schedule and age indications Pfizer’s and GSK’s MenABCWY Vaccines
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Policy Questions for GSK’s Pentavalent Vaccine
▪Should the 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*
▪Should the pentavalent vaccine be included as an option for people currently
recommended to receive MenACWY only?
–For example, 11 –12 year olds
▪Should the 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 the MenB vaccine based on shared clinical decision making4 of 10
Outcomes Table
Outcome Importance* To be Included in Evidence Profile
Meningococcal disease caused by
serogroups A, B, C, W, and YCritical Yes
Persistent immunity Important Yes
Short -term immunity Critical Yes
Interference with other
recommended vaccines
administered concurrentlyImportant Yes
Serious adverse events Critical Yes
Non -serious adverse events Important Yes
Gonorrhea prevention Important Yes
* Three options: critical, important but not critical, of limited importance for decision making. 5 of 10
PICO policy question #1 (of 3) — 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?
Population All individuals aged 10 years or older currently recommended to receive
MenACWY and MenB vaccines at the same visit
Intervention Vaccination with GSK’s pentavalent vaccine
Comparison Vaccination with a currently licensed MenACWY vaccine and a MenB vaccine
Outcomes •Meningococcal disease caused by serogroups A, B, C, W, and Y
•Short -term immunity
•Persistent immunity
•Interference with other recommended vaccines administered concurrently
•Serious adverse events
•Non -serious adverse events
•Gonorrhea prevention6 of 10
PICO policy question #2 (of 3) — Should the GSK pentavalent vaccine be included
as an option for people currently recommended to receive MenACWY only ?
Population All individuals aged 10 years or older currently recommended to receive
MenACWY vaccine only
Intervention Vaccination with GSK’s pentavalent vaccine
Comparison Vaccination with a currently licensed MenACWY vaccine
Outcomes •Meningococcal disease caused by serogroups A, C, W, and Y
•Short -term immunity
•Persistent immunity
•Interference with other recommended vaccines administered concurrently
•Serious adverse events
•Non -serious adverse events
•Gonorrhea prevention 7 of 10
PICO policy question #3 (of 3) — Should the GSK pentavalent vaccine be included
as an option for people currently recommended to receive MenB only ?
Population All individuals aged 10 years or older currently recommended to receive MenB
vaccine only
Intervention Vaccination with GSK’s pentavalent vaccine
Comparison Vaccination with a currently licensed MenB vaccine
Outcomes •Meningococcal disease caused by serogroup B
•Short -term immunity
•Persistent immunity
•Interference with other recommended vaccines administered concurrently
•Serious adverse events
•Non -serious adverse events
•Gonorrhea prevention 8 of 10
Discussion
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Acknowledgements
▪Lucy McNamara
▪Jennifer Collins
▪Samuel Crowe
▪Sancta St. Cyr▪CDC Division of STD
Prevention
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