EU approves Trumenba (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease- Pfizer

Pfizer announced that the European Commission (EC) has approved Trumenba (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older.

The EC decision is based on results from a clinical development program in which more than 20,000 adolescents and adults were evaluated, approximately 15,000 of whom received Trumenba. The data demonstrate that Trumenba induces protective serum bactericidal antibody responses to diverse MenB test strains that are representative of disease causing strains, and the vaccine has an established safety profile. In clinical studies, the most common adverse reactions observed were injection site pain, redness and swelling at the vaccination site, headache, fatigue, chills, diarrhea, muscle pain, joint pain and nausea. The posology includes both two- and three-dose schedules, providing flexibility for healthcare professionals to administer the vaccine depending on individuals’ risk of exposure and susceptibility to MenB.

The marketing authorization granted by the EC is valid in all European Union (EU) member states, plus Iceland, Liechtenstein and Norway. Additional marketing authorization application reviews for Trumenba are under way in other countries.