Pfizer on Wednesday announced that the FDA cleared Trumenba (meningococcal group B vaccine) as the first vaccine licensed in the US for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroup B in subjects aged 10 to 25 years. Emilio Emini, Pfizer's senior vice president of vaccine research and development, stated "we look forward to participating in discussions with the [US Centers for Disease Control and Prevention] regarding potential meningococcal group B vaccination recommendations."
According to the FDA, the safety of the vaccine was supported by studies involving a total of about 4500 subjects. The agency noted that in three clinical trials involving a total of about 2800 adolescents, immunisation with three doses of Trumenba resulted in the production of antibodies that eradicated four different Neisseria meningitidis serogroup B strains in 82 percent of subjects, versus less than 1 percent prior to vaccination.
Trumenba was cleared under the FDA's breakthrough therapy and priority review programmes. As part of the accelerated approval process, Pfizer plans to finish ongoing studies of the vaccine to confirm its effectiveness against a number of serotype B strains.
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