On October 20, 2023, the United States FDA approved Pfizer’s PENBRAYA™, first and only pentavalent meningococcal vaccine.
Meningococcal disease, a potentially devastating condition, is caused by the bacterium Neisseria meningitidis. It encompasses various clinical forms, the most recognized of which is meningitis, an inflammation of the protective membranes covering the brain and spinal cord. This disease is notorious for its rapid onset and can lead to death within hours.
An article published in Infectious Diseases and Therapy discussed why a meningococcal vaccine is necessary. It highlights IMD’s severe and long-lasting effects, particularly in adolescents and young adults.
One study referenced in the article reveals that those who have had IMD between the ages of 15 and 19 can experience poorer mental health, reduced social support, and negative educational and quality-of-life outcomes. Notably, over half of these individuals reported sequelae, including skin scarring, vertigo, mobility and speech problems, and hearing deficits. Furthermore, IMD can impact various aspects of daily life, including leisure activities, academic achievement, friendships, and vocational choices.
The article also underscores the financial resources required for outbreak control, highlighting the substantial costs associated with emergency vaccination efforts. The financial burden incurred during outbreak responses, including expenses for vaccination and healthcare services, is a crucial factor to consider in the overall cost-effectiveness of vaccination strategies.
While the economic costs are substantial, the human cost is immeasurable. The article suggests that reducing the number of vaccine-preventable deaths, particularly among young people, should be a key consideration in determining vaccination recommendations.
In light of these challenges, the article suggests (and now, the FDA officially agrees) that a pentavalent meningococcal vaccine (MenABCWY) could offer a comprehensive solution. This vaccine protects against multiple serogroups, simplifying vaccination schedules and potentially increasing compliance, particularly among infants.
The Phase 2 & 3 clinical trials that the FDA based their approval on had thousands of participants from around the world. This vaccine has been demonstrated to be safe and effective, and it is a highly anticipated player in the future of meningitis treatment and prevention.
Sources: Infectious Diseases and Therapy, Pfizer, Pediatrics, ClinicalTrials,gov
