Pfizer’s Trumenba vaccine accepted for EU regulatory review

Pfizer has announced that its meningococcal group B vaccine Trumenba has been accepted for review by the European Medicines Agency.

The regulator has accepted the marketing authorisation application for the vaccine, which has been developed for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged ten years and older.

This application is based on clinical trial dataset comprising around 20,800 adolescents and adults, which has demonstrated the consistency of the immune responses to diverse disease-causing strains, as well as underlining the vaccine's safety and tolerability.

Trumenba is already approved in the US, having demonstrated efficacy against four serogroup B categories representative of the most prevalent strains in the country.

Dr Kathrin Jansen, senior vice-president and head of vaccine research and development for Pfizer, 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."

This comes after the firm announced clinical data showing the effectiveness of Trumenba in protecting adolescents and young adults earlier this month.