EMA To Review Pfizer’s Meningococcal VaccineBy
The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for Pfizer’s Trumenba (Meningococcal Group B Vaccine) for review. Trumenba has been developed for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10 years and older. The acceptance marks the beginning of the regulatory review process for this vaccine in the European Union.
Trumenba is currently approved in the US. It is approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age.