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Bexsero Safe and Effective

Updated: Aug 18

14 January 2013


Results from a pivotal clinical trial show the highly anticipated Bexsero vaccine against meningococcal B disease (MenB) can be safely and effectively administered with routine vaccines.

Results from a pivotal Phase 3 clinical trial of Bexsero, the highly anticipated vaccine to protect against meningococcal B, were published in The Lancet and showed that Bexsero demonstrated a protective immune response and has an acceptable safety profile when administered as a three-dose primary series when administered with routine vaccines.The investigators also observed a robust booster response in toddlers to a fourth dose administered at 12 months, which may contribute to an extended duration of protection.

“As a practicing paediatrician, I see how devastating MenB is for infants and toddlers, as well as the agony for their families. It is a disease that can strike with little warning and progress very rapidly, even when parents are quick to respond,” said Professor Susanna Esposito from the Università degli Studi di Milano in Italy, a committee member of the European Society for Paediatric Infectious Disease. “The prospect of a new vaccine that helps to prevent MenB is the advance that we have been awaiting for decades.”

In November 2012, Bexsero was recommended for European licensure by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months, which will be applicable to all European Union (EU) and European Economic Area (EEA) countries. Novartis, manufacturer of Bexseco, is committed to making Bexsero available as soon as possible and is already engaging with governments interested in the early adoption of the vaccine.

Meningococcal disease is easily misdiagnosed and kills approximately one in ten people within 24 hours of onset despite appropriate treatment[1],[2]. Of the survivors, around one in five suffers permanent disabilities such as brain damage, hearing impairment or limb loss[3]. Therefore prevention through vaccination is the best means to reduce the burden of meningococcal disease. The majority of cases in the developed world are due to MenB[4], with a disproportionate disease burden in infants[5].


References


1. Thompson MJ, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet 2006;367:397-403.

2. World Health Organisation. Meningococcal meningitis. Fact sheet #141. December 2011 update.

3. Rosenstein NE, et al. Meningococcal disease. N Engl J Med 2001;344:1378-88.

4. Perrett KP, Pollard AJ. Towards an improved serogroup B Neisseria meningitidis vaccine. Expert Opin Biol Ther 2005;5:1611-25.

5. Centers for Disease Control and Prevention. Meningococcal Disease – Age as a risk factor.


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