Pfizer’s application was based a clinical trial dataset of about 20,800 adolescents, as well as adults aged 10 years and older, studied across the globe.
The company noted that the dataset demonstrated the consistency of vaccine-induced immune responses to diverse disease-causing MnB strains and the well-studied safety and tolerability profile.
Pfizer senior vice president and head of vaccine research and development Kathrin Jansen said: "The EMA’s acceptance of Trumenba’s Marketing Authorization Application brings us one step closer to fighting this uncommon yet life-threatening disease worldwide, by helping to protect adolescents and adults who are at risk to contract meningococcal disease caused by serogroup B."
Trumenba, which is currently approved in the US, is a sterile suspension featuring two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively).
It showed immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the US.
The effectiveness of Trumenba against different serogroup B strains has not been confirmed.
Pfizer warned that Trumenba should not be given to anyone with allergic reaction history after an earlier dose.
Image: Pfizer World Headquarters New York City. Photo: courtesy of Norbert Nagel, Mörfelden-Walldorf, Germany.