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诺华B型脑膜炎球菌疫苗Bexsero获EC批准

来源:生物谷 2013-01-23 16:58

2013年1月23日讯 /生物谷BIOON/ --诺华宣布,B型脑膜炎球菌疫苗Bexsero获欧盟委员会(EC)批准,用于年龄在2个月以上的人群。该疫苗是欧洲首个获批用于预防B型脑膜炎的疫苗。(生物谷bioon.com)

英文原文:Novartis receives EU approval for Bexsero®, first vaccine to prevent the leading cause of life-threatening meningitis across Europe

    Bexsero is indicated to help protect all age groups against meningococcal serogroup B (MenB) disease, including infants who are the most vulnerable[1]
    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 survivors[2],[3]
    Novartis is working with health authorities to provide access to Bexsero as soon as possible
Basel, January 22, 2013 - Novartis announced today 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.

"This meningitis B vaccine is the most important medical breakthrough in the 30 years since I lost my son to the disease," said Meningitis UK Founder Steve Dayman MBE. "It could save thousands of lives and prevent other parents suffering the same tragedy. The vaccine must be made widely available through the immunisation schedule as soon as possible - any delay could mean lives lost."

MenB disease is a bacterial infection and is the leading cause of meningitis across Europe[4], particularly in infants[1]. Although rare, one reason this disease is so feared is that it affects healthy people rapidly and without warning[2],[3]. Symptoms can often resemble the flu, making this disease easily misdiagnosed in its early stages[5]. 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 treatment[3]. Up to one in five survivors may suffer from devastating, life-long disabilities such as brain damage, hearing impairment or limb loss[3]. 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 research[6], and its tolerability profile and immunogenicity have been established through a comprehensive clinical program involving infants, children, adolescents and adults[7],[8],[9],[10],[11],[12]. 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 world[13].

 

 

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