Penbraya is a pentavalent conjugate vaccine developed by Pfizer for the prevention of invasive meningococcal disease in people 10 through 25 years of age.[2] Invasive meningococcal disease, caused by the bacterium Neisseria meningitidis, can lead to serious conditions such as meningitis (inflammation of the brain and spinal cord lining) and septicemia (bloodstream infection).[3] Penbraya is approved for use by the US Food and Drug Administration (FDA).[1] Penbraya is the first pentavalent vaccine that provides coverage against the five most common serogroups causing meningococcal disease.[4]
| Vaccine description | |
|---|---|
| Target | MenABCWY |
| Vaccine type | Conjugate |
| Clinical data | |
| Trade names | Penbraya |
| AHFS/Drugs.com | Monograph |
| License data | |
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| Legal status | |
| Legal status | |
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Composition
editPenbraya is a vaccine that combines components of two previously licensed meningococcal vaccines:
- Trumenba: A serogroup B meningococcal vaccine that targets outer membrane protein antigens (factor H binding proteins) of Neisseria meningitidis.[5]
- Nimenrix: A quadrivalent conjugate vaccine that protects against Neisseria meningitidis serogroups A, C, W-135, and Y.[6]
Mechanism of action
editPenbraya works by stimulating the body's immune system to produce antibodies that specifically target the Neisseria meningitidis bacteria.[7] Antibodies against fHbp specifically block this protein's function, preventing the bacteria from evading immune defenses (serogroup B).[8]
Clinical Studies
editPenbraya's efficacy was established through a randomized, active-controlled, observer-blinded multicenter phase III study that assessed Penbraya's immunogenicity.[9] The trial compared Penbraya, administered at 0 and 6 months, with Trumenba, another meningococcal serogroup B vaccine, and MenACWY-CRM, a meningococcal conjugate vaccine. The primary measure of effectiveness was the increase in serum bactericidal activity using human complement (hSBA) against various strains of Neisseria meningitidis. The results demonstrated that Penbraya's seroresponse rates for serogroups A, C, W, and Y were non-inferior to those following a single dose of MenACWY-CRM. Moreover, the seroresponse to serogroup B primary strains among participants who received two doses of Penbraya was shown to be non-inferior to those following two doses of Trumenba.[10]
Society and culture
editLegal status
editIn September 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Penbraya, intended for protection against invasive meningococcal disease caused by meningococcal bacteria of the serogroups A, B, C, W and Y.[11] The applicant for this medicinal product is Pfizer Europe MA EEIG.[11]
References
edit- ^ a b "Penbraya". U.S. Food and Drug Administration (FDA). 27 November 2023.
- ^ "FDA Approves Pentavalent Meningococcal Vaccine from Pfizer for Ages 10 to 25 years". Patient Care Online. 24 October 2023. Retrieved 25 February 2024.
- ^ "Meningococcal Disease". U.S. Centers for Disease Control and Prevention (CDC). 1 September 2023. Retrieved 25 February 2024.
- ^ "Approval-first for meningococcal vaccine". European Pharmaceutical Review. Retrieved 26 February 2024.
- ^ "Trumenba". U.S. Food and Drug Administration (FDA). 9 March 2023.
- ^ Dhillon S, Pace D (November 2017). "Meningococcal Quadrivalent Tetanus Toxoid Conjugate Vaccine (MenACWY-TT; Nimenrix®): A Review". Drugs. 77 (17): 1881–1896. doi:10.1007/s40265-017-0828-8. PMID 29094312. S2CID 24522214.
- ^ "Penbraya: Uses, Dosage, Side Effects, Warnings". Drugs.com. Retrieved 25 February 2024.
- ^ Beernink PT (March 2020). "Effect of complement Factor H on antibody repertoire and protection elicited by meningococcal capsular group B vaccines containing Factor H binding protein". Human Vaccines & Immunotherapeutics. 16 (3): 703–712. doi:10.1080/21645515.2019.1664241. PMC 7227650. PMID 31526219.
- ^ "Penbraya (meningococcal groups A, B, C, W, and Y vaccine) FDA Approval History". Drugs.com. Retrieved 25 February 2024.
- ^ "Penbraya (meningococcal groups A, B, C, W, and Y vaccine) – New vaccine approval". Optum Rx. Retrieved 26 February 2024.
- ^ a b "Penbraya EPAR". European Medicines Agency (EMA). 19 September 2024. Retrieved 21 September 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
