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FDA approves 1st vaccine for deadly form of meningitis

WASHINGTON - When meningitis outbreaks sickened students at Princeton and 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.

WASHINGTON - When meningitis outbreaks sickened students at Princeton and 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, Karen Midthun said in a conference call.

Midthun, 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 four other 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 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.

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.