Pfizer secures European approval for MenB vaccine
- Pfizer said Tuesday its meningococcal group B vaccine Trumenba won European approval for prevention of meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in adolescents over 10 years and adults.
- The approval, which follows a positive opinion from the European Medicines Agency's CHMP committee in March, will be for a two- or a three-dose schedule.
- Pfizer said it would continue to invest in its manufacturing capacity to ensure "sufficient supply", a problem which hurt GlaxoSmithKline after its launch of its meningitis B vaccine Bexsero.
Trumenba secured approval from the Food and Drug Administration back in 2014, making it the first vaccine OK'd for the prevention of meningitis B in the U.S. It was also the first biologic approved through the regulator's Breakthrough Therapy Designation program.
This new approval gives Pfizer access to Europe, where around 60% of cases of meningococcal disease are caused by serogroup B, and will be supported by continued investment in manufacturing.
Adolescents and young adults are particularly at risk from meningitis B, as up to a quarter may be asymptomatic carriers, and many live, work and study within close quarters. While rare, meningitis B can kill within 24 hours in 10%-15% of patients who acquire meningococcal disease. As many as three in five adolescent survivors are left with physical and mental disabilities.
"With the EC approval of Trumenba, Pfizer now has a comprehensive portfolio of vaccines to help prevent five of the most common disease-causing meningococcal serogroups in this region," said Susan Silbermann, general manager of Pfizer Vaccines.
The approval pits Trumenba directly against GlaxoSmithKline's Bexsero for serogroup B, which has been approved in Europe for years. The two companies recently settled a legal battler over the U.K. pharma's claim that Pfizer's shot infringes its patent.
- Pfizer Press release
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