Pfizer has announced the US Food and Drug Administration’s approval of Penbraya, the first and only pentavalent vaccine for coverage against the most common serogroups causing meningococcal disease in people aged ten to 25 years.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices has also recommended administering Penbraya when both MenACWY (meningococcal groups A, C, W, and Y) and MenB (meningococcal group B) vaccines are indicated at the same visit for healthy patients aged 16 to 23 years and patients aged ten years and older who have certain underlying health conditions.
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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.
This new vaccine combines components from two other meningococcal vaccines, Trumenba (meningococcal group B) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate).
Penbraya has the potential to enhance the level of protection against serious and life-threatening meningococcal infections in adolescents and young adults.
Neisseria (N.) meningitidis, a gram-negative, encapsulated diplococcal bacterium, is the causative agent for invasive meningococcal disease.
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By GlobalDataThe two most common invasive meningococcal diseases are meningitis and septicemia, rare infections that can be deadly in a matter of hours if untreated.
Approximately 10% of individuals carry N. meningitidis asymptomatically in their nasopharynx, and close contact such as coughing or kissing, is typically required for the bacteria to spread person-to-person.
Symptoms include high fever, headache, nausea, fatigue, and stiff neck, among others, yet the relatively non-specific nature of the disease makes it difficult to diagnose.
The high mortality rate associated with such diseases, in combination with complications that often cause long-term health problems among survivors such as deafness, motor deficits, and other neurological conditions, has led many countries to implement routine immunisations against specific serogroups of N. meningitidis, as keeping up to date with recommended vaccines is the best protection against the meningococcal disease.
13 distinct serogroups of N. meningitidis exist; however, six serogroups – A, B, C, W-135, X, and Y – cause most diseases worldwide, with B, C, and Y causing most diseases in the US.
Penbraya has the potential to help simplify complex vaccination schedules by providing broader serogroup coverage with fewer doses.
It is likely that we will see significant changes to the meningococcal vaccine market landscape with the launch of the pentavalent vaccine.
GSK is also in the process of developing a pentavalent vaccine, a combination of its licensed meningococcal vaccines – Bexsero (MenB) and Menveo (MenACWY) – and positive Phase III data was announced earlier this year.
Consequently, 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 such as GSK’s Bexsero and conjugate vaccines, including Sanofi’s tetravalent vaccine Menactra.
The projected collective revenue for the two pentavalent vaccines in the US is expected to reach approximately $555m by 2029.
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