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CDC: 'Process Is Underway' to Get Approval to Use Bexsero at UCSB

Source: Examiner.com (NY)

By: Herriman, Robert

01/01/2014

The Centers for Disease Control and Prevention (CDC) is proceeding with an Investigational New Drug (IND) application that could help get the unlicensed serogroup B meningococcal vaccine to students at the University of California, Santa Barbara (UCSB). Four cases of Neisseria meningitidis B meningitis were reported among undergraduate students between Nov. 11 and Nov. 21, 2013. One case in an 18-year-old freshman required the amputation of his feet. The CDC reported that, with support of the university and state and county health departments, it is moving forward with an IND application with the U.S. Food and Drug Administration to use a serogroup B meningococcal vaccine licensed for use in Europe, Canada, and Australia. The IND would give high-risk individuals access to this vaccine during the outbreak. The CDC reports that the process to get the vaccine approved for use at UCSB includes analyzing the number of cases and duration of time between cases and establishing that the vaccine would help protect against the outbreak-causing strain. Because of the length of this process, the CDC recommends other steps to help protect students, such as prophylactic antibiotics and personal hygienic practices that include not sharing cups or other eating utensils.



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