Meningitis Vaccine Bexsero® Receives EU Approval

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Meningitis Vaccine Bexsero® Receives EU Approval

Main Category: Immune System / Vaccines
Also Included In: Infectious Diseases / Bacteria / Viruses | Regulatory Affairs / Drug Approvals
Article Date: 29 Jan 2013

Bexsero is indicated to help protect all age groups against meningococcal serogroup B (MenB) disease, including infants who are the most vulnerablei. MenB disease is associated with a high human toll for families and communities, as it can be fatal or may cause serious, life-long disabilities in survivorsii,iii

Novartis announced on January 22 that the European Commission has approved Bexsero® (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) for use in individuals from 2 months of age and older. Novartis is committed to making Bexsero available as soon as possible.

MenB disease is a bacterial infection and is the leading cause of meningitis across Europeiv, particularly in infants1. Although rare, one reason this disease is so feared is that it affects healthy people rapidly and without warning2,3. Symptoms can often resemble the flu, making this disease easily misdiagnosed in its early stagesv. In many cases, doctors simply cannot treat infected patients soon enough to avoid serious outcomes. About one in ten of those who contract the disease will die despite appropriate treatment3. Up to one in five survivors may suffer from devastating, life-long disabilities such as brain damage, hearing impairment or limb loss3. Prevention through vaccination is therefore the best defense against this aggressive disease.

"Each year, thousands of parents see their children die or left with severe disabilities as a result of this devastating disease. Through the combined efforts of many people over two decades, we are closer than ever to seeing an end to this suffering," said Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics. "Our vision is a world without meningitis, and our priority is to work with decision makers across Europe to ensure there is broad and timely access to vaccination."

Following today's approval, EU member states will evaluate Bexsero for potential inclusion into national immunization programs and, where relevant, reimbursement schemes. Novartis is already engaging with governments interested in the early adoption of the vaccine.

Bexsero is the result of more than 20 years of pioneering vaccine researchvi, and its tolerability profile and immunogenicity have been established through a comprehensive clinical program involving infants, children, adolescents and adultsvii,viii,ix,x,xi,xii. Starting at two months of age, Bexsero offers several immunization schedule options that could fit with routine vaccination visits.

The approval of Bexsero underscores the unique leadership position of Novartis in the global fight against devastating meningococcal disease. Together, Bexsero and Menveo® help to protect against all five main serogroups of meningococcal bacteria (A, C, W-135, Y and now B) that cause the majority of cases around the worldxiii.

Original article posted on Medical News Today.
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