according to an April 23, 2018, press statement from the vaccine’s manufacturer.
Trumenba is the first Neisseria meningitidis group B (MenB) vaccine to receive this designation for children as young as 1 year in the United States. In 2014, it became the first MenB vaccine to receive approval in the United States for older patients – aged 10-25 years. “As of 2016, the burden of MenB is highest in adolescents/young adults (32%) and infants (20%), followed by children ages 1 to 4 years (12%) and children ages 5 to 10 years (4%),” according to the statement.
The 2014 approval letter required the vaccine’s manufacturer, Pfizer, to assess the efficacy and safety of Trumenba among children aged 1-9 years. Data from the resulting phase 2 studies supported Pfizer’s request for a breakthrough therapy designation for use of the MenB vaccine in that age group.
For more information, read Pfizer’s full press.