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CDC: 'Process is underway' to get approval to use Bexsero at UCSB

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After calls from parent of students at the University of California, Santa Barbara (UCSB) and local health officials to get the unlicensed serogroup B meningococcal vaccine available for students, the Centers for Disease Control and Prevention (CDC) announced they are moving forward with an Investigational New Drug (IND) application to hopefully make that happen, according to a CDC outbreak update Dec. 31.

UCSB has reported four Neisseria meningitidis B meningitis cases in undergraduate students between November 11 and November 21, 2013. One case, that of 18-year-old freshman, Aaron Loy resulted in the amputation of his feet.

In mid-December, the university said, just as the vaccine clinics at Princeton opened, “The CDC will work to make the serogroup B meningococcal vaccine available at UCSB if the circumstances of this outbreak warrant its use."

Dr. Charity Thoman, MD, MPH, Deputy Health Officer for the Santa Barbara County Public Health Department wrote in The Independent last week, "Immediately after the fourth case was confirmed, I invited CDC and CDPH investigators to come to Santa Barbara for an on-site visit at UCSB. We all agreed that we should work under the assumption that the vaccine would be needed at UCSB, and a site visit was the first step in moving the vaccine issue forward."

The CDC now says, with the support of the university, the state and county health departments, "they are moving forward with an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) with the goal of being able to use a serogroup B meningococcal vaccine that is licensed for use in Europe, Canada, and Australia in response to the UCSB outbreak.

"The IND would allow access to the serogroup B meningococcal vaccine during the UCSB outbreak for those identified as being at increased risk. There are still many steps that need to take place before the campaign can be implemented, but the process is underway."

CDC Expert: Use Of Unlicensed Vaccine, Bexsero, ‘Highly Unusual’

According to the CDC, the weeks long process to get the vaccine approved for use at UCSB is multi-step that include analyzing the number of cases and duration of time between cases, establishing that the vaccine would help protect against the outbreak-causing strain (based on genetic fingerprinting, the UCSB outbreak is serogroup B strain ST32, and the Princeton outbreak is serogroup B strain ST409) and logistics, among others.

The CDC advises that since the process to gain access to an unlicensed vaccine can take several weeks, it is critical that other steps are taken to help protect students right now, which can include prophylactic antibiotics, changing behaviors of students to help prevent transmission (sharing drinking cups, etc.) and other personal hygienic practices.

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