Penbraya approval sparks shift to pentavalent meningococcal vaccines in US: GlobalData

Pfizer has recently announced the FDA approval of Penbraya, the first and only pentavalent vaccine for coverage against the most common serogroups causing meningococcal disease in people aged 10 to 25 years. The pentavalent vaccine has potential to enhance the level of protection against serious and life-threatening meningococcal infections in adolescents and young adults, says GlobalData.

Reportedly, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has also recommended administering Penbraya when both meningococcal groups A, C, W and Y (MenACWY) and meningococcal group B (MenB) vaccines are indicated at the same visit for healthy patients ages 16 to 23 years and patients ages 10 years and older who have certain underlying health conditions.

Anaelle Tannen, Infectious Disease Analyst at GlobalData comments, “It is likely that we will see big changes to the meningococcal vaccine market landscape with the launch of Penbraya, as this vaccine provides the broadest serogroup coverage yet.”

Neisseria meningitidis, a gram-negative, encapsulated diplococcal bacterium is the causative agent for invasive meningococcal disease. The two most common invasive meningococcal diseases are meningitis and septicaemia, rare infections that can be deadly in a matter of hours if untreated.

The high mortality rate associated with such diseases, in combination with complications which often cause long-term health-problems among survivors, has led many countries to implement routine immunizations against specific serogroups of N. meningitidis.

Six serotypes of N. meningitidis — A, B, C, W, X, and Y —cause most disease worldwide, with B, C, and Y causing most disease in the US. Penbraya, administered as a two-dose series given six months apart, is the first vaccine to provide coverage against five common serogroups, A, B, C, W and Y.

Tannen adds, “Keeping up to date with recommended vaccines is the best protection against meningococcal disease but administration schedules for these vaccines can be time consuming and inconvenient. Penbraya has the potential to help simplify complex vaccination schedules by providing broader serogroup coverage with fewer doses.”

GSK is also in the process of developing a pentavalent vaccine, and positive Phase III data were announced earlier this year. GlobalData projects the collective revenue for these two pentavalent vaccines to reach approximately $555 million in the US by 2029.

Tannen concludes, “The US market is expected to experience a shift towards the usage of pentavalent vaccines over the next few years, resulting in the loss of patient share for MenB vaccines like GSK’s Bexsero and conjugate vaccines such as Sanofi’s tetravalent vaccine Menactra.”