Pfizer receives EC approval for Trumenba to prevent MenB disease in adolescents and young adults
The European Commission (EC) has approved Pfizer’s Trumenba (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease in people aged ten and above.
Invasive meningococcal disease is caused by Neisseria meningitidis serogroup B (MenB) whereby early symptoms are difficult to be distinguished from common flu-like symptoms, such as headache, nausea and vomiting.
Meningococcal disease can cause patient death within 24 hours.
The vaccination may not be successful in preventing MenB in all vaccinated patients as a result of inherent environmental and social risk factors, such as close-quartered living and sharing behaviour.
Pfizer Vaccines scientific and clinical affairs medicines development chief medical and scientific affairs officer Luis Jodar said: “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.
“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 immunisation as a preventive measure.”
Pfizer’s Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively).
fHBP is one of many proteins found on the surface of meningococci and helps the bacterium to avoid host defences.
Pfizer Vaccines president and general manager Susan Silbermann said: “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.”
The EC approval is based on results from a clinical development programme in which more than 20,000 adolescents and adults were studied, approximately 15,000 of whom received Trumenba.
The study demonstrates that the treatment induces protective serum bactericidal antibody responses to various MenB test strains representative of disease-causing strains, and that the vaccine has an established safety profile.