February 25, 2014
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FDA grants special use of meningitis B vaccine at UCSB

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A meningococcal serogroup B vaccine developed by Novartis will be used in a vaccination program at the University of California, Santa Barbara, according to a press release.

The FDA has approved the use of Bexsero twice in the past 3 months in response to outbreaks of meningitis serogroup B on college campuses in the United States. More than 5,000 students were vaccinated at Princeton University, and 20,000 students will be offered the vaccine at the University of California, Santa Barbara (UCSB).

Bexsero has been approved for use outside of the United States, based on data from numerous clinical studies conducted by Novartis, involving about 8,000 infants, adolescents and adults.

Meningitis serogroup B can be difficult to diagnose because initial symptoms are unspecific and flu-like. The bacterial infection can lead to death or permanent disability within 24 hours of symptom onset. Adolescents and young adults have an increased risk for contracting the infection and are more likely to be carriers of the bacteria compared with other age groups. Further, adolescents and young adults have a high fatality case rate from this particular strain of meningitis.

“These recent outbreaks remind us how unpredictable the disease can be and demonstrate the need to license Bexsero in the United States. This would enable us to quickly respond to future outbreaks, while also having a vaccine available for those who might pre-emptively choose to protect themselves against this disease. We will continue to work with the FDA to pursue a potential license for Bexsero in the United States to help fulfill this public health need,” Andrin Oswald, the division head of Novartis Vaccines, said in the release.