FDA/CDC

MenB vaccine receives breakthrough therapy designation for children aged 1-9 years


 

Trumenba (meningococcal group B vaccine) received the Food and Drug Administration’s breakthrough therapy designation for immunizing children aged 1-9 years, 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.

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The breakthrough therapy designation is given to some drugs or treatments for serious or life-threating diseases or conditions; specifically, these drugs or treatments have preliminary clinical evidence suggesting that they may prove to be a substantial improvement over existing drugs or treatments.

For more information, read Pfizer’s full press statement.

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