In response to the outbreak, the CDC has moved forward with an Investigational New Drug application, filed with the Food and Drug Administration, to execute the vaccination campaign.
The IND is a federal requirement for pharmaceutical companies to ship drugs before they have been granted formal approval. The vaccine is currently licensed in Europe, Canada and Australia, but not the United States.
UCSB students and their parents were notified of this plan of action on Dec. 23, when health officials sent out a community-wide email stating that the IND process had been initiated.
“Following a CDC site visit to campus earlier this month and a careful review of the historical epidemiology of the disease at our University and in the local community, the CDC … will be moving forward with an Investigational New Drug application (IND) with the Food and Drug Administration (FDA),” the email read.
“It’s still an unlicensed vaccine, and just because it was done at Princeton, it doesn’t make the process any easier,” Dr. Thomas Clark,head of Meningitis and Vaccine Preventable Diseases Branch of the CDC, told the Daily Princetonian. “So a lot of stuff needs to happen, but again, we are working to make the vaccines available.”
The meningitis outbreak at UCSB was not caused by the same strain of meningitis found at Princeton, according to the CDC. While both strains were identified as meningococcal bacteria type B, CDC experts have found their "genetic fingerprints" do not match.
The announcement comes after a series of complaints from UCSB students and their families who requested the vaccine. Dr. Cristina Lete, an obstetrician-gynecologist in Massachusetts whose son attends UCSB told NBC News, “The government’s response at UCSB … is baffling.” She sent her son to London during the school’s winter break to acquire the vaccine.
The IND application in response to Princeton’s outbreak, which had eight confirmed cases since March 2013, was filed in October and received final approval on Nov. 18 of last year. UCSB is awaiting final decisions prior to officially administering the vaccine. With over 20,000 full-time undergraduate and graduate students, the vaccination campaign could be significantly larger than Princeton’s.