Novartis provides UCSB with meningitis vaccine
The U.S. Food and Drug Administration previously approved the use of Bexsero in response to MenB outbreaks at Princeton University, where more than 5,000 students were vaccinated against the disease. Approximately 20,000 students will be offered vaccination at UCSB.
Bexsero is the only licensed broad coverage vaccine approved in Australia, Canada and Europe to protect against invasive meningococcal disease caused by serogroup B. The vaccine was approved for use in the U.S. under an investigational new drug designation, which requires many weeks to gain administrative approvals, organize supply and delivery and decide how vaccination programs will be managed.
Novartis said that granting a U.S. license for Bexsero for use in all young adults and adolescents would allow for immediate response to future outbreaks.
"These recent outbreaks remind us how unpredictable the disease can be and demonstrate the need to license Bexsero in the U.S.," Andrin Oswald, the division head of Novartis Vaccines, said. "This would enable us to quickly respond to future outbreaks, while also having a vaccine available for those who might preemptively choose to protect themselves against the disease. We will continue to work with the FDA to pursue a potential license for Bexsero in the U.S. to help fulfill this public health need."
Novartis submitted data from Bexsero's clinical program to the FDA. The same data supported the licensure of the vaccine in Australia, Canada and Europe.
MenB is a rare bacterial infection that progresses rapidly and can cause permanent disability or death within 24 hours of symptom onset. Adolescents and young adults are at an increased risk of contracting meningococcal disease.
According to a study published in Clinical Infectious Diseases in 2006, there were 69 outbreaks of invasive meningococcal disease in the U.S. between 1992 and 2002.