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HomeAbout AboutWhy PENBRAYA?Risks of Meningococcal DiseaseGaps in Vaccination CoverageDosing & Recommendations Effectiveness & Safety Effectiveness
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Prescribing InformationIndicationsPatient SiteRequest a RepLoading
PENBRAYA elicited a robust immune response for serogroups A, B, C, W, and Y1*†PENBRAYA demonstrated a similar seroresponse to MenACWY-CRM1,2‡Study 1 results: ACWY-exposed participantsMenACWY seroresponse rate* 1-month post-vaccination
2 doses of PENBRAYA vs 1 dose of Menveo®§
PENBRAYA at age 16 provides non-inferior ACWY responses in patients who have previously received ACWY vaccinations1
PENBRAYA at age 16 provides non-inferior ACWY
responses in patients who have previously received ACWY vaccinations1
The LLOQ is an hSBA titer = 1:8 for serogroups A, C, W, and Y. Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥LOD and <LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer.1Evaluable immunogenicity populations.1Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination groups.1MenACWY-CRM is sold and licensed under the tradename Menveo®. Menveo® is a registered trademark of GSK.3Two doses of PENBRAYA demonstrated similar immunogenic responses to MenB primary strains (representative of US disease-causing strains) compared to two doses of Trumenba (Meningococcal Group B Vaccine)1,2||¶‡‡Study 1 results: MenB-naïve participantsMenB seroresponse|| and composite response** 1-month post-vaccination
2 doses of PENBRAYA vs 2 doses of Trumenba††
In ACWY-exposed individuals, PENBRAYA at age 16
combines the ACWY booster with the first injection of the MenB series. Help more patients start their MenB series.1,4,5
In ACWY-exposed individuals, PENBRAYA at age 16 combines the
ACWY booster with the
first injection of the MenB series. Help more patients start their MenB series.1,4,5
The LLOQ is an hSBA titer = 1:16 for A22 and 1:8 for A56, B24, and B44. Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥LOD and <LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer.1Evaluable immunogenicity populations.1Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination groups.1Composite response = hSBA ≥LLOQ for all 4 primary meningococcal B strains combined.1The MenB vaccine component of PENBRAYA is licensed and sold as Trumenba by Pfizer and is licensed for use in the United States.6​​​​​​​Statistically higher.1CI=confidence interval; hSBA=human serum bactericidal assay; LLOQ=lower limit of quantitation; LOD=limit of detection.Study description1,2 PENBRAYA clinical studyStudy 1 was a Phase 3, randomized, active-controlled, observer-blinded, multicenter study.
  • The effectiveness of PENBRAYA was assessed by measuring antibodies with assays that used human complement to assess serum bactericidal activity (hSBA)
     
    • The proportions of subjects with a 4-fold or greater increase in hSBA titer for each strain (seroresponse), and the proportion of subjects with a titer greater than or equal to the lower limit of quantitation (LLOQ) of the assay for all 4 serogroup B strains (composite response) were assessed
       
    • For serogroups A, C, W, and Y, one strain was utilized per group
       
    • For serogroup B, 4 meningococcal serogroup B strains expressing different fHbp variants (subfamilies A and B) that represent strains causing invasive disease in the United States and Europe were utilized
       
  • Safety was evaluated including local and systemic adverse reactions
     
  • Participants were 10 through 25 years of age in the United States and Europe
     
    • Participants received either PENBRAYA at 0 and 6 months or Trumenba (Meningococcal Group B Vaccine) at 0 and 6 months and MenACWY-CRM at 0 months
       
    • All participants were MenB vaccine-naïve
       
    • Both MenACWY conjugate vaccine-naïve (N=821) and MenACWY conjugate vaccine-exposed (N=786) participants (received 1 dose of MenACWY conjugate vaccine at least 4 years prior to enrollment) were part of the study
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PENBRAYA elicited a robust immune response for serogroups A, B, C, W, and Y 

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PENBRAYA elicited a robust 
immune response for 
serogroups A, B, C, W, and Y 

 See clinical data LoadingCircle icon of document representing ACIP recommendations ACIP Recommendations

See the full ACIP recommendations 

 Read recommendations LoadingCircle icon with shield representing the safety profile for PENBRAYA (meningococcal groups A, B, C, W, and Y vaccine) Safety Profile

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 Go to safety profile LoadingReferences: 1. PENBRAYA [prescribing information]. New York, NY: Pfizer Inc.; 2023. 2. MenABCWY noninferiority study in healthy participants ≥10 to <26 years of age. ClinicalTrials.gov identifier: NCT04440163. Updated April 18, 2023. Accessed October 27, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT04440163 3. MENVEO [prescribing information]. Durham, NC: GlaxoSmithKline; 2022. 4. Advisory Committee on Immunization Practices (ACIP): ACIP recommendations. Centers for Disease Control and Prevention. Last reviewed October 27, 2023. Accessed October 27, 2023. https://www.cdc.gov/vaccines/acip/recommendations.html 5. Collins J. Summary of EtR and proposed recommendations for Pfizer’s MenABCWY vaccine. Presented at: Advisory Committee on Immunization Practices (ACIP); October 25, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-10-25-26/04-Meningococcal-Collins-508.pdf 6. TRUMENBA [prescribing information]. Philadelphia, PA: Pfizer Inc.; 2021.

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Indications
  • PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age
  • TRUMENBA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. TRUMENBA is approved for use in individuals 10 through 25 years of age 
Important Safety Information
  • Do not administer PENBRAYA or TRUMENBA to individuals with a history of severe allergic reaction (eg, anaphylaxis) to any component of PENBRAYA or TRUMENBA. Appropriate medical treatment used to manage allergic reactions must be available in the event an anaphylactic reaction occurs immediately following administration of PENBRAYA or TRUMENBA
  • Syncope (fainting) may occur in association with administration of injectable vaccines, including PENBRAYA or TRUMENBA. Procedures should be in place to avoid injury from fainting
  • Some individuals with altered immunocompetence may have reduced immune responses to PENBRAYA or TRUMENBA
  • Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis groups A, B, C, W, and Y, even if they develop antibodies following vaccination with PENBRAYA
  • Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis group B, even if they develop antibodies following vaccination with TRUMENBA
  • Vaccination with PENBRAYA or TRUMENBA may not protect all vaccine recipients
  • Vaccination with PENBRAYA does not substitute for vaccination with a tetanus toxoid–containing vaccine to prevent tetanus
  • Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer PENBRAYA to individuals with a history of GBS should take into account the expected benefits and potential risks 
  • For PENBRAYA, the most commonly reported (≥15%) solicited adverse reactions after Dose 1 and Dose 2, respectively, were pain at the injection site (89% and 84%), fatigue (52% and 48%), headache (47% and 40%), muscle pain (26% and 23%), injection site redness (26% and 23%), injection site swelling (25% and 24%), joint pain (20% and 18%), and chills (20% and 16%)
  • For TRUMENBA, the most common solicited adverse reactions in adolescents and young adults were pain at injection site (≥85%), fatigue (≥60%), headache (≥55%), and muscle pain (≥35%)
  • Data are not available on the safety and effectiveness of using TRUMENBA and other meningococcal group B vaccines interchangeably to complete the vaccination series
  • The safety and effectiveness of PENBRAYA or TRUMENBA have not been established in pregnant individuals
     
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.

Please see full Prescribing Information for PENBRAYA and full Prescribing Information for TRUMENBA.Indications
  • PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age
  • TRUMENBA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. TRUMENBA is approved for use in individuals 10 through 25 years of age