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National Center for Immunization & Respiratory Diseases
Work Group Interpretation of Pfizer’s
MenABCWY Vaccine Clinical Trials Data
Sam Crowe, PhD, MPH
Meningococcal Vaccines Work Group Lead
February 23, 2023
Policy Questions for Each Pentavalent Vaccine
Should the pentavalent vaccine be included as an option for
MenACWY/MenB vaccination in people currently recommended to receive both vaccines?
– For e
xample, 16 year olds1
Should the pentavalent vaccine be included as an option for people currently recommended to receive MenACWY only?
– For e
xample, 11–12 year olds
Should the pentavalent vaccine be included as an option for people currently recommended to receive MenB only?
– For e
xample, during a serogroup B outbreak
116 year olds who decide to receive the MenB vaccine based on shared clinical decision-making 2
Pfizer MenABCWY Vaccine and Trials Overview
Comprised of Nimenrix (serogroups ACWY) and Trumenba (serogroup B)
– Trumenba currently licensed and available in US, 10y through 25y
– Nimenrix not licensed in US but used extensively elsewhere, 6w and older
Two clinical trials completed (NCT03135834, NCT04440163)
– Assessed safety and immunogenicity of pentavalent vaccine
– Compared to Trumenba (MenB) and Menveo (MenACWY)
– Included participants 10 through 25 years of age
– Studied single and two dose (0, 6m) schedules
– 4-year persistence and booster dose were evaluated
Extended interval study underway (NCT04440176)
– Study arm 1 — 0, 12m (data available)
– Study arm 2 — 0, 36m
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Safety
Assessed by monitoring for and comparing local reactions, systemic events,
medically attended adverse events, serious adverse events, and newly diagnosed chronic medical conditions
Local reactions within 7 days after vaccination
– Includes pain, redness, swelling
– Comp
arison between pentavalent and MenB vaccine only
– Slig
htly higher percentage of participants had a local reaction to pentavalent vaccine for
both 1st and 2nd doses
Systemic events within 7 days after vaccination
– Includes fatigue, headache, muscle pain, joint pain, chills, diarrhea, vomiting, fever
– Simi
lar percentage of participants experienced systemic events in pentavalent vaccine
group and in MenACWY+MenB group
– Perc
entage varied slightly between groups by systemic event and by dose
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Safety, Continued
Medically attended adverse events
– Sim
ilar percentages between study groups (both <15%)
Serious adverse events
– Mor
e reported for pentavalent group (0.4% vs. 0%)
– Non
e assessed to be related to pentavalent vaccine (e.g., hospitalization due to other
medical conditions)
Newly diagnosed chronic medical conditions (NDCMC)
– Mor
e reported for pentavalent group (1.1% vs. 0.3%)
– Hig
her number of participants with attention-deficit/hyperactivity disorder (ADHD) in
pentavalent group – most with related symptoms before entering study
Higher risk patients (e.g., complement deficiency) not included in trials
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Immunogenicity Standards
Serogroups A, C, W, and Y
– Percen
tage of participants achieving MenACWY seroresponse in hSBA
titer 1 month after 1 dose and 1 month after 2 doses
– Seroresponse is defined as a 4-fold increase in titer over baseline
Serogroup B
– Perc
entage of participants achieving MenB seroresponse in hSBA 1
month after 2 doses
– Composite response provided
– Seroresponse is defined as a 4-fold increase in titer over baseline
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Immunogenicity for Serogroups A, C, W, Y
1 dose of the pentavalent vaccine is noninferior to 1 dose of MenACWY in both
ACWY-naïve and ACWY-primed participants 1 month after administration
ACWY-Naive ACWY-Primed
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Immunogenicity for Serogroups A, C, W, Y
2 doses of the pentavalent vaccine given 6 months apart are noninferior to 1 dose
of MenACWY in both naïve and primed participants 1 month after administration
ACWY-Naive ACWY-Primed
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Seroprotection for ACWY-Naïve Participants after 4 Years
Seroprotection persists up to 4 years in naïve participants after a 2-dose series
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Seroprotection for ACWY-Primed Participants after 4 Years
Seroprotection persists up to 4 years in primed participants after a 2-dose series
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Immunogenicity for Serogroup B
2 doses of the pentavalent vaccine given 6 months apart are noninferior to 2 doses
of MenB in naïve participants (primed not assessed)
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Seroprotection for Serogroup B-Naïve Participants
Waning of immunity for the pentavalent vaccine is very similar to that observed
with MenB, dropping substantially by 12 months post-dose 2
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Additional Work Group Reflections
Data not presented on 3-dose schedule of pentavalent vaccine
–
3
-dose schedule of Trumenba currently recommended for certain
high-risk groups (e.g., people affected by a serogroup B outbreak)
Data not available in people older than 25 years
–
M
enB vaccines licensed for 10–25 years
–
M
enACWY vaccines licensed up to 55 years or older depending on
vaccine
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Final Reflections and Next Steps
Pfizer’s MenABCWY vaccine appears to be noninferior to MenACWY+MenB based
on clinical trial data presented
Data gaps
–
3-dose schedule for high-risk populations
– Adults older than 25 years
Next steps
–
Reviewing additional immunologic persistence data for a single dose
– GRADE and EtR — will focus on pentavalent vaccine studies
– Cost effectiveness study will be conducted
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For more information, contact CDC
1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.