Novartis announced today that its meningococcal serogroup B (MenB) vaccine, Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]), will be used as part of a vaccination program at the University of California Santa Barbara (UCSB) that began today and will end on March 7. In the last three months, the Food and Drug Administration (FDA) has approved the use of Bexsero twice in response to MenB outbreaks at US college campuses. More than 5,000 students were vaccinated at Princeton University and 20,000 students will be offered vaccination at UCSB.
Bexsero is the only licensed broad coverage vaccine approved in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B. It was approved for use in the US under a treatment Investigational New Drug (IND) designation. Under this process, many weeks are required to gain administrative approvals, organize supply and delivery of the vaccine from countries where it is being used, and decide how vaccination programs will be managed at local sites.
Granting a US license for Bexsero for use in all adolescents and young adults would enable immediate response to future outbreaks and allow US families to have access to a vaccine to help protect against MenB.
"Having lost my son to meningitis, I know how dangerous the disease is and how quickly it can strike someone," said Lynn Bozof, President of the National Meningitis Association. "Because it is impossible to know who will be affected and when, we look forward to the day when there is a licensed MenB vaccine in the US, which could help prevent other families from experiencing the devastation this disease causes." "These recent outbreaks remind us how unpredictable the disease can be and demonstrate the need to license Bexsero in the US. 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 the disease," said Andrin Oswald, Division Head, Novartis Vaccines. "We will continue to work with the FDA to pursue a potential license for Bexsero in the US to help fulfill this public health need."