Novartis has announced the initial results of a large-scale vaccination campaign with Bexsero® (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) to help protect against meningitis B within the Saguenay-Lac-Saint-Jean region of Québec, Canada. This public program adds to the growing real-world experience of Bexsero, which is approved in 34 countries, including the European Union, Australia and Canada.

Neisseria meningitidis  Image/CDC
Neisseria meningitidis

This regional program is the first of its kind globally and has reached 81% of the campaign’s target population within the first three months. This encompasses more than 45,000 infants, young children and adolescents from 2 months to 20 years of age. The high rate of uptake in this public vaccination program with Bexsero demonstrates the value placed on preventing meningitis B within communities that are afforded access.

“A high level of uptake through a public vaccination program is critical to achieving community-wide protection against a devastating and unpredictable disease like meningitis B,” said Andrin Oswald, Division Head, Novartis Vaccines. “Thanks to the decisive leadership and urgency with which the public health officials in Québec have acted, lives will likely be saved. We are committed to continuing to work with health authorities globally to ensure public access to Bexsero.”

Ninety-four percent of Québec’s invasive meningococcal disease cases in those aged 1-24 years old were caused by meningitis B between 2009 and 2011. In the past few years, the number of people infected with meningitis B has been higher in the Saguenay-Lac-Saint-Jean region than in other Québec regions, relative to the population. The decision to implement this vaccination campaign in the region was based on experts’ recommendations, following Bexsero’s approval in Canada in December 2013 for use in individuals from 2 months to 17 years of age. Second doses of Bexsero will be available in the fall of this year and the program will conclude on December 31, 2014.

Bexsero is the first broad coverage vaccine to help protect against meningitis B. Since its launch in 2013, over half a million doses have been shipped worldwide[9]. Bexsero was also recently provided in the US to students at Princeton University and the University of California, Santa Barbara (UCSB) under a treatment Investigational New Drug (IND) designation from the US Food and Drug Administration (FDA) in response to local meningitis B outbreaks on both campuses. In June 2014, Novartis submitted a Biologic License Application (BLA) to the FDA for US marketing approval of Bexsero, which initiated a rolling submission process, following the receipt of a Breakthrough Therapy designation in April 2014.

Meningitis B is a rare but aggressive disease and is the leading cause of meningococcal disease and septicemia in the developed world. Meningitis B can kill or cause serious, life-long disabilities within 24 hours of symptom onset, leaving little time for intervention[12]. Vaccination is therefore the best defense against this devastating disease.

Meningococcal disease is most commonly caused by one of the five main serogroups of meningococcal bacteria (A, B, C, W-135 and Y). Prior to the development of Bexsero, vaccines were only available for four of these serogroups, and a vaccine to protect against serogroup B was the remaining piece needed to provide populations with broad-spectrum protection against all five serogroups, which together cause the majority of cases in the world.