EU CHMP recommends Trumenba (Meningococcal Group B Vaccine) immunization of individuals 10 years and older to prevent invasive meningococcal disease . - Pfizer

Pfizer Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that Trumenba (Meningococcal Group B Vaccine) be granted marketing authorization in the European Union (EU) for active immunization of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB). The CHMP’s opinion will now be sent to the European Commission (EC) for final decision.

Pfizer conducted a global clinical development program for Trumenba, evaluating more than 20,000 adolescents and adults, approximately 15,000 of whom received Trumenba. These data, which were reviewed by the CHMP, demonstrate that the benefits of Trumenba are its ability to induce protective serum bactericidal antibody responses to diverse meningococcal serogroup B strains expressing fHBP variants that are representative of MenB strains causing invasive disease, and that Trumenba is a well-tolerated vaccine.