Penbraya

Penbraya (styled PENBRAYA) is a pentavalent conjugate vaccine developed by Pfizer for the prevention of invasive meningococcal disease (IMD) in individuals 10 through 25 years of age. 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). Penbraya is approved for use by the U.S. Food and Drug Administration (FDA). Penbraya is the first and only pentavalent vaccine that provides coverage against the five most common serogroups causing meningococcal disease in adolescents and young adults.

Composition

Penbraya is a unique 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.
• Nimenrix: A quadrivalent conjugate vaccine that protects against Neisseria meningitidis serogroups A, C, W-135, and Y.

By combining these components, Penbraya offers broader protection against the five most common serogroups responsible for invasive meningococcal disease worldwide.

Mechanism of action

Penbraya works by stimulating the body's immune system to produce antibodies that specifically target the Neisseria meningitidis bacteria. Antibodies against fHbp specifically block this protein's function, preventing the bacteria from evading immune defenses (serogroup B).

Clinical Studies

Penbraya's efficacy was established through comprehensive clinical trials. The critical studies involved a randomized, active-controlled, observer-blinded multicenter Phase 3 trial that assessed Penbraya's immunogenicity. 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.