The European Medicines Agency (EMA) has accepted to review the marketing authorisation application (MAA) for the American pharmaceutical company Pfizer’s Trumenba (Meningococcal Group B Vaccine).
With the EMA acceptance, the regulatory review process for this Trumenba vaccine begins in the European Union (EU).
Trumenba is used to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in people of ten years of age and above.
The drug is a sterile suspension that comprises two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and the other from subfamily B (A05 and B01, respectively).
fHBP is a type of protein found on the surface of meningococci and helps of the bacterium to avoid host defences.
Pfizer vaccine research and development senior vice-president and head Kathrin Jansen said: "The EMA’s acceptance of Trumenba’s marketing authorisation 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.
"At Pfizer we are committed to providing innovative vaccines that help people live the longest, healthiest lives possible."
The MAA for Trumenba is dependent on a clinical trial dataset of about 20,800 adolescents, as well as adults who belong to the age group of ten or above.
This dataset reveals the consistency of vaccine-induced immune responses to various disease-causing MnB strains, along with the well-studied safety and tolerability profile.
Trumenba is currently approved in the US.
Image: Meningococcal disease is an infection caused by a bacterium called N. meningitidis or the meningococcus. Photo: courtesy of Dr. Brodsky / Centers for Disease Control and Prevention.