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New data from a pivotal study in more than 1,800 infants show that Novartis candidate vaccine Bexsero® (Multicomponent Meningococcal Serogroup B Vaccine) induces a robust immune response to meningococcal serogroup B when given alone or when co-administered with other routine vaccines. These results also show that Bexsero can fit into various vaccination schedules in the first year of life, when the likelihood of contracting this often-deadly disease is greatest. The study also demonstrated that Bexsero has an acceptable tolerability profile.
Data from another pivotal study in more than 1,500 toddlers shows that Bexsero provides protective immune response when used as a booster in toddlers already primed, or after two doses in those not previously vaccinated with Bexsero. A third study presented showed that Bexsero induces a strong immune response in adolescents against meningococcal serogroup B (MenB). The data were presented at The European Society for Paediatric Infectious Diseases (ESPID) in The Hague, the Netherlands.
These data are included in the comprehensive clinical program with Bexsero in more than 8,000 infants, toddlers, adolescents and adults which served as the basis of the registration file submitted to the European Medicines Agency (EMA) in December 2010.
“MenB disease poses a significant burden to people around the world, particularly infants, the population at greatest risk for the disease,” said Andrin Oswald, Head of Novartis Vaccines and Diagnostics Division. “The data show that Bexsero, our innovative multicomponent MenB vaccine, holds great promise in providing a solution to a major public health concern that can have a devastating impact on vulnerable populations.”
MenB is the most common cause of bacterial meningitis for which there is no effective routine vaccine, and it is responsible for up to 90% of meningococcal disease cases in Europe, and over 80% of meningococcal cases in infants in Canada. Survivors may suffer permanent brain damage, learning disabilities, hearing loss, and limb loss.
“The serious and long-term effects of MenB are often devastating to its victim, family members and the community at large,” said Jamie Findlow PhD, Deputy Head of the Health Protection Agency, Vaccine Evaluation Unit, Manchester, UK. “The rapid disease progression and flu-like symptoms of MenB can be difficult to recognise, particularly in infants, making prevention through vaccination the most effective way to control this disease.”
Bexsero has the potential to provide protection against a broad range of MenB strains. If licensed, Bexsero could fill a public health need across multiple regions that is not met by currently available vaccines. Recent data have shown that Bexsero could be expected to provide protection against approximately 80% of more than 1,000 disease-causing MenBstrains isolated in Europe in 2007–2008.