FDA Grants Breakthrough Therapy Designation for Pfizer's MenB Vaccine in Children


This is the first Breakthrough Therapy designation for a MenB vaccine to help protect children as young as 1 year of age.

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pfizer Inc.’s Trumenba, a meningococcal group B (MenB) vaccine, to protect children between the ages of 1 and 9 years against invasive disease.

This is the first Breakthrough Therapy designation for a MenB vaccine to protect children as young as 1 year of age, according to Pfizer’s recent media statement.

“Despite the occurrence of invasive serogroup B disease in children ages 1 through 9 years, and the potential life-altering and long-term consequences that may result from this uncommon disease, there is no MenB vaccine licensed in the United States for this age group,” Dr. Luis Jodar, Chief Medical and Scientific Affairs Officer, Vaccines Medical Development, Scientific and Clinical Affairs, Pfizer Inc., said in a recent statement.

Trumenba is a sterile suspension comprised of 2 recombinant lipidated factor H binding protein (fHBP) variants from Neisseria meningitidis serogroup B. Currently, 5 types of bacteria cause the most meningococcal disease in the United States: A, C, Y, W, and B. Meningitis B can become deadly within just 24 hours. According to the Centers for Disease Control and Prevention (CDC), even when the disease is treated, it is estimated to kill 10 to 15 infected individuals out of 100. Ten to 20 of those who survive out of every 100 run the risk of suffering from disabilities including, but not limited to, loss of hearing, brain or kidney damage, amputations, and nervous system-associated complications.

In 2014, the FDA granted Breakthrough designation to the MenB vaccine for the prevention of the disease in adolescents and young adults between 10 and 25 years of age. Later that year, Trumenba received the green light from the FDA, making it the first MenB vaccine approved in the United States.

In April 2017, the FDA approved Trumenba for use in adolescents between 10 and 25 years of age for the 3-dose schedule based on phase 3 data. Depending on each individual’s risk of exposure and susceptibility to MenB, the vaccine is designated to be administered in either 2- or 3-dose schedules for the aforementioned population. There is currently a study being conducted to assess the effectiveness of the 2-dose schedule.

The CDC recommends that preteens and teenagers should receive the serogroup B meningococcal vaccine if they have a rare type of disorder, are taking Soliris, have a damaged spleen or had it removed, or have been identified as someone who is at increased risk due to an MenB outbreak.

In fact, when 2 undergraduates attending Rutgers University in New Brunswick, New Jersey, were diagnosed with MenB and an outbreak occurred, the CDC recommended the brand Trumenba specifically to be administered to over 35,000 individuals at the university rather than GlaxoSmithKline’s Bexsero, after whole genome sequencing showed that there was a mismatch between outbreak strain antigens and those targeted by Bexsero.

In an October 2014 approval letter, Pfizer was instructed to look into how safe and effective the vaccine would be in children 1 year of age. After completing phase 2 studies in this population, Pfizer submitted their data to the FDA.

“These data supported Pfizer’s request for Breakthrough Therapy designation,” according to the statement.

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