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European Commission approves Trumenba for meningococcal B disease
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The European Commission has approved the use of the MenB-FHbp meningococcal group B vaccine for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B among patients aged 10 years and older, according to a manufacturer press release.
Since nearly 25% of adolescents could be asymptomatic carriers of Neisseria meningitidis, the approval for Trumenba (MenB-FHbp, Pfizer) represents a significant preventive measure for a demographic at increased risk for meningococcal B disease, due to social risk factors such as close-quartered living and sharing behaviors.
“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,” Luis Jodar, PhD, chief medical and scientific affairs officer for Pfizer, said in a press release. “Though uncommon, MenB 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 preventative measure.”
The European Commission based its approval, in part, on the results of a clinical development program in which more than 20,000 adolescents and adults were evaluated, approximately 15,000 of whom received Trumenba. According to research data, Trumenba induced protective serum bactericidal antibody responses to diverse meningococcal B test strains that are representative of disease causing strains; additionally, the vaccine has an established safety profile.
Approval of Trumenba by the European Commission grants marketing authorization within all countries that are members of the European Union as well as Iceland, Liechtenstein and Norway.
“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,” Susan Silbermann, president and general manager of Pfizer Vaccines, said in the release. “With the European Commission 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 most common adverse reaction among patients receiving Trumenba included pain, redness and swelling at the injection site, headache, fatigue, chills, diarrhea, muscle pain, joint pain and nausea.