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Pfizer Inc. has received approval from the US Food and Drug Administration (FDA) for Penbraya, a groundbreaking pentavalent vaccine designed to combat meningococcal groups A, B, C, W, and Y. This vaccine is the first of its kind, offering comprehensive protection against the most prevalent serogroups responsible for meningococcal disease in individuals aged 10 to 25.
Penbraya merges the components of two existing meningococcal vaccines, Trumenba (targeting meningococcal group B) and Nimenrix (addressing meningococcal groups A, C, W-135, and Y), providing defense against the five primary meningococcal serogroups responsible for the majority of global invasive meningococcal disease (IMD). Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research and Development at Pfizer, stated, “As pioneers in the field of vaccines, our aim is to deliver vaccines that redefine standards of care in the US.”
Anderson continued, “Today marks a significant stride in preventing meningococcal disease in the US. With Penbraya, we have the potential to shield a greater number of adolescents and young adults from this severe and unpredictable ailment in a single vaccine, offering the broadest meningococcal coverage in the fewest shots.”
Meningococcal disease, though rare, is a grave condition that can lead to death within a day and, for survivors, result in debilitating, long-term consequences. Penbraya reduces the overall number of doses required for full vaccination against the five most common serogroups, streamlining the standard of care and potentially increasing vaccination rates among adolescents and young adults. According to the US Centers for Disease Control and Prevention (CDC), consolidating vaccines into fewer shots could lead to more timely administration of recommended vaccines, resulting in fewer delays in protection against severe diseases. Routine use of Penbraya could also lower IMD cases, associated mortality rates, sequelae in survivors, and costs related to outbreak control.
“Nearly nine out of 10 adolescents lack complete protection against invasive meningococcal disease caused by the predominant serogroups,” remarked Dr. Jana Shaw, Pediatrics Infectious Disease Specialist at Upstate Golisano Children’s Hospital in Syracuse, NY. “For the first time, we have a single vaccine that guards against the five most common serogroups, potentially enhancing coverage and fortifying protection for adolescents and young adults.”
The FDA’s approval is based on favorable outcomes from both phase 2 and phase 3 trials, including a randomized, active-controlled, and observer-blinded phase 3 trial that assessed the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate in comparison to currently licensed US meningococcal vaccines. The primary objective was to establish immunologic noninferiority. The phase 3 trial (NCT04440163) involved over 2,400 patients from the US and Europe.
The CDC Advisory Committee on Immunization Practices (ACIP) is scheduled to convene on October 25, 2023, to deliberate on recommendations for the appropriate utilization of Penbraya in adolescents and young adults. In September 2022, Pfizer announced encouraging results from a randomized, active-controlled, and observer-blinded phase 3 trial comparing Penbraya with currently licensed meningococcal vaccines, with the aim of determining immunologic noninferiority. The phase 3 trial (NCT04440163) included over 2,400 patients from the US and Europe. This trial was followed by the FDA’s acceptance of Penbraya’s Biologics License Application (BLA) in December 2022.
Penbraya is administered as a two-dose series, spaced six months apart, and is indicated for active immunization against invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. It is approved for use in individuals aged 10 to 25 years.
