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).
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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.
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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.
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By GlobalData"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.
