Pfizer receives positive CHMP opinion for Trumenba for prevention of meningococcal group B disease

Trumenba has been studied in a global clinical development program evaluating the vaccine in adolescents and adults.

Pfizer has 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.

"This positive opinion by the CHMP to recommend marketing authorization of TRUMENBA in the EU is an additional step toward the fight to help protect individuals over 10 years of age from meningococcal disease caused by serogroup B, an uncommon yet devastating and life-threatening disease," said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. "This decision further affirms the effectiveness and robust safety profile of Trumenba."

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.

The majority of meningococcal disease cases worldwide can be attributed to six Neisseria meningitidis serogroups (A, B, C, W, X and Y).10,11 In Europe, the majority of cases are caused by serogroup B strains.