In a groundbreaking development, Pfizer Inc. has received FDA approval for Penbraya, a revolutionary pentavalent vaccine that promises to transform the landscape of meningitis protection.
This pioneering vaccine, known as Penbraya, offers comprehensive coverage against the five most common serogroups causing meningococcal disease—A, B, C, W, and Y—streamlining the vaccination process and providing greater protection.
The condition carries a significant mortality rate, even with advancements in healthcare, with figures close to 25% reported
What is Meningitis?
Meningitis is a severe medical condition characterised by the inflammation of the meninges, which are the protective membranes covering the brain and spinal cord. This inflammation can be primarily caused by bacterial or viral infections, although other factors might also contribute. Meningitis is a life-threatening disorder, especially in its bacterial form, and demands immediate medical attention.
Survivors may endure life-altering disabilities. Adolescents and young adults currently receive multiple vaccines to guard against various meningococcal serogroups.
However, Penbraya aims to simplify this complex vaccination schedule by reducing the number of required doses for full coverage. This aligns with the U.S. Centers for Disease Control and Prevention’s mission to promote timely vaccination, minimise delays in protection against serious diseases, and potentially reduce the incidence of meningococcal disease cases and related costs.
Clinical Development and FDA Approval
Dr. Annaliesa Anderson, Senior Vice President and Head of Vaccine Research and Development at Pfizer, emphasised the significance of this achievement.
“Today marks an important step forward in the prevention of meningococcal disease in the U.S. In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.”
This milestone resulted from rigorous clinical trials. This included Phase 2 and Phase 3 studies, demonstrating Penbraya’s robust immunogenicity, comparable to Trumenba + Menveo for all serogroups. The vaccine also exhibited a favourable safety profile. The Phase 3 trial involved over 2,400 patients from the U.S. and Europe, forming a solid foundation for the FDA’s approval.
Future Considerations: CDC Advisory Committee
Looking ahead, the CDC Advisory Committee on Immunization Practices (ACIP) is set to convene on October 25, 2023, to deliberate on recommendations for Penbraya’s utilisation in adolescents and young adults.
Administration and Eligibility of Penbraya
Penbraya is administered as a two-dose series, with doses spaced six months apart. However, individuals with a history of severe allergic reactions to any of its components should not receive Penbraya. Precautions are necessary to prevent fainting after injectable vaccines. Moreover, those with weakened immune systems may exhibit reduced immune responses to Penbraya.
Limitations of Penbraya
It’s important to note that vaccination with Penbraya may not provide absolute protection against all N. meningitis is group A, B, C, W, and Y infections. Therefore, individuals should consult their healthcare providers to assess Penbraya’s suitability for them or their children.
Pfizer’s Meningococcal Vaccine Expertise
Penbraya represents a significant leap in Pfizer’s vaccine portfolio. Drawing on over two decades of expertise in meningococcal disease prevention, this vaccine has the potential to revolutionise vaccination strategies. Additionally, it offers broader protection with fewer shots, contributing to improved public health outcomes.
- FDA Approves PENBRAYATM, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents | Pfizer. (n.d.). https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-penbrayatm-first-and-only-vaccine-prevention
- Hersi, K. (2023, August 12). Meningitis. StatPearls – NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK459360/#:~:text=Meningitis%20is%20a%20life,as%20inflammation%20of%20the%20meninges