Pfizer’s Trumenba has been cleared by European regulators to help prevent infection with meningococcal group B disease in adolescents and adults.
The approval by the European Commission covers the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older, in either or two-dose or three-dose regimen.
Meningococcal disease can lead to death within 24 hours. Despite available treatment with antibiotics, 10 to 15 percent of people with meningococcal disease will die, highlighting the severity of the disease.
Adolescents and young adults are a key demographic for vaccination against MenB because of environmental and social risk factors such as close-quartered living and sharing behaviours, and up to a quarter may be asymptotic carriers of Neisseria meningitidis.
Of those adolescents who do show symptoms and survive the illness, three in five experience significant physical and mental disabilities.
In clinical trials involving more than 20,000 adolescents and adults, Trumenba induced protective serum bactericidal antibody responses to diverse MenB test strains, and exhibited an acceptable safety profile, the most common adverse events being injection site pain, redness and swelling, headache, fatigue, chills, diarrhoea, muscle pain, joint pain and nausea.
The vaccine was approved in the US back in 2014, and has since been administered to around 600,000 adolescents and young adults, the firm notes.
“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,” noted Susan Silbermann, president and general manager, Pfizer Vaccines.