First vaccine for deadly form of meningitis approved in U.S.

© Reuters/Harrison McClary A medical technician, prepares samples in the specimen set-up area of the Vanderbilt Clinical Microbiology Lab for patient care, where the fungal meningitis outbreak was first diagnosed, in Nashville, Tennessee on…
When meningitis outbreaks sickened students at Princeton and at the University of California at Santa Barbara last year, the schools had to seek special permission to vaccinate their students, using a vaccine that was not yet approved for use in the United States.
On Wednesday, the Food and Drug Administration approved a vaccine for the first time for the deadly type of meningitis that affected the students. The vaccine, Trumenba, protects against serogroup B, one of five forms of bacterial meningitis. It is manufactured by Pfizer.
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, Dr. Karen Midthun said in a conference call with reporters Thursday.
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 United States.
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 for all preteens and adolescents. Many schools and colleges require students to receive a meningitis vaccine before enrolling.
The CDC did not immediately respond to questions on Thursday about whether it would start recommending Trumenba for all adolescents or just for use in locations where a meningitis outbreak is occurring.
Serogroup B meningitis caused 160 of the 500 cases of meningococcal disease in the country in 2012, according to the CDC. The agency said that 10 to 15 percent of these cases are fatal. Among those who survive, 11 to 19 percent suffer permanent disabilities, including limb loss, hearing loss and brain damage.
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 percent 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.
Midthun, of the FDA, said that manufacturers might eventually develop one shot containing the vaccines for all five types of bacterial meningitis. But 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.