FDA allows emergency use of still-unapproved vaccine against deadly meningitis amid Princeton University outbreak

CAMBRIDGE, Mass. — Swiss drug maker Novartis is providing a vaccine to Princeton University amid an outbreak of potentially fatal meningitis that has affected at least eight students, the university said Monday.

Princeton said it had started a vaccination program with Novartis' Bexsero (meningococcal group B vaccine [rDNA, component, adsorbed]). Bexsero currently has approval in Canada, Europe and Australia, and the Food and Drug Administration gave it conditional approval in response to an application from the Centers for Disease Control and Prevention for its use on the Princeton campus to protect students against the infection. It is currently in phase-1 and phase-2 clinical trials in the United States, but is being recommended for all Princeton undergraduate students, whether they live on- or off-campus, as well as graduate students living in dormitories.

Meningococcal serogroup B, also known as MenB, is a rare but devastating infection that progresses rapidly and can lead to death or permanent disability within 24 hours of symptom onset. It can be difficult for healthcare professionals to diagnose in its early stages because symptoms are often non-specific and flu-like, but one-tenth of those with the disease die despite treatment, and among those who survive, one-fifth suffer from lifelong disabilities such as brain damage, hearing loss and limb loss.