Pfizer Inc. 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 approval of TRUMENBA reflects our dedication to advancing novel vaccines that can help protect adolescents and young adults, a population at an increased risk for meningococcal disease caused by MenB,” said Luis Jodar, Chief Medical and Scientific Affairs Officer, Medicines Development, Scientific and Clinical Affairs, Pfizer Vaccines. “Though uncommon, MenB disease is unpredictable, can progress rapidly and is associated with a significant risk of death and long-term disability, demonstrating the value of immunization as a preventive measure.”
“We are steadfast in our commitment to progress and shape the future of vaccines to help address serious health threats worldwide and make the greatest public impact,” said Susan Silbermann, President and General Manager, Pfizer Vaccines. “We are also focused on consistent, reliable supply for all the vaccines we manufacture, including a full 36-month shelf life with TRUMENBA. With the EC approval of TRUMENBA, Pfizer now has a comprehensive portfolio of vaccines to help prevent five of the most common disease-causing meningococcal serogroups in this region.”
Pfizer continues to invest significantly in manufacturing processes and facilities to ensure a sufficient supply of TRUMENBA in Europe, where the majority of meningococcal disease cases (60 percent) among adolescents and young adults are caused by serogroup B.1
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.6,7,8,9,10,11,12 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.13 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 member states, plus Iceland, Liechtenstein and Norway. Additional marketing authorization application reviews for TRUMENBA are under way in other countries.