Trumenba: Meningitis vaccine approved in US
The Food and Drug Administration (FDA) approved a vaccine for the first time for the deadly type of meningitis that affected the students at Princeton and at the University of California in 2013.
Pfizer’s vaccine Trumenba protects against serogroup B, one of five forms of bacterial meningitis.
The FDA accelerated the approval of Trumenba, completing the approval process in “well under six months,” the typical time frame for completing even a priority review of a new drug, FDA’s Dr. Karen Midthun said in a conference call with reporters on October 30.
Karen Midthun, the director of the FDA’s Center for Biologics Evaluation and Research, said that the 2013 outbreaks “underscored the urgent public health need” for a vaccine for serogroup B meningcoccal disease in the US.
Two existing vaccines, Menactra and Menveo, prevent the other four types of bacterial meningitis and are currently recommended by the Centers for Disease Control and Prevention (CDC) for all preteens and adolescents. Many schools and colleges require students to receive a meningitis vaccine before enrolling.
Serogroup B meningitis caused 160 of the 500 cases of meningococcal disease in the US in 2012, according to the CDC. The agency said that 10 to 15% of these cases are fatal. Among those who survive, 11 to 19% suffer permanent disabilities, including limb loss, hearing loss and brain damage.
Pfizer’s vaccine Trumenba protects against serogroup B, one of five forms of bacterial meningitis
The outbreaks on the two university campuses in 2013 killed one student at Drexel University, who had come into contact with Princeton students, and caused a student in California to lose both of his feet. In September, a Georgetown University sophomore died of serogroup B, in what the university said was an isolated case.
Viral meningitis, though less serious than the bacterial form of the disease, also causes inflammation of the tissue around the brain and spinal cord. There is no vaccine for the illness, which is rarely fatal. Viral meningitis has been reported this month in up to 19 students at the University of Maryland at College Park and a teacher at a District preschool.
Bexsero, the Novartis vaccine administered at the universities last year with special FDA permission, had been approved for use in Europe and Australia, while the U.S. had no serogroup B vaccine.
As part of getting speedy approval, Pfizer has agreed to keep testing the vaccine. Three studies in the U.S. and Europe, involving about 2,800 adolescents, demonstrated that the vaccine generated antibodies in the blood of 82% of participants. The antibodies can kill four strains of serogroup B, according to the FDA.
The further testing will evaluate whether the vaccine is effective at creating antibodies that kill additional strains.
Pfizer said in a press release that the new vaccine must be administered in three doses over the course of six months. It is approved for use in people ages 10 to 25, a key group for meningitis cases, which can easily spread among students living in close quarters in dormitories.
Karen Midthun said that manufacturers might eventually develop one shot containing the vaccines for all five types of bacterial meningitis.
Right now, full protection would require three doses of Trumenba in addition to an existing meningitis vaccine, for which the CDC recommends an initial shot and a later booster.