Pfizer's TRUMENBA moves closer to European approval

Pfizer Inc.'s meningococcal group B vaccine TRUMENBA has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
The European Commission will make the final decision on the vaccine's marketing authorization.
During the development program for TRUMENBA, Pfizer evaluated more than 20,000 participants. Approximately 15,000 received the vaccine, and the data showed that TRUMENBA produced a protective serum antibody response to meningococcal group B strains and it was well-tolerated by the participants.
“This positive opinion by the CHMP to recommend marketing authorization of TRUMENBA in the E.U. 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,” Pfizer Senior Vice President and head of Vaccine Research and Development Kathrin Jansen said. “This decision further affirms the effectiveness and robust safety profile of TRUMENBA.”
The majority of meningococcal disease cases in Europe are caused by Group B strains, which often result in meningitis and meningococcal septicaemia -- a bloodstream infection. Up to 10 percent of infected patients die from the disease and 20 percent of the survivors suffer from disabilities ranging from amputations to mental and motor skill impairments.