Novartis receives EU approval for Bexsero®

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].

References

1. Rosenstein NE, et al. Meningococcal disease. N Engl J Med 2001;344:1378-88.
2. Thompson MJ, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet 2006;367:397-403.
3. World Health Organization. Meningococcal meningitis. Fact sheet #141. November 2012 update. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/. Last accessed 15 Jan 2013.
4. World Health Organization. Meningococcal, staphylococcal and streptococcal infections. Available at: http://www.who.int/vaccine_research/documents/Meningo20091103.pdf. Last accessed 15 Jan 2013.
5. Mayo Foundation for Medical Education and Research. Meningitis. April 2011. Available at: http://www.mayoclinic.com/health/meningitis/DS00118/DSECTION=symptoms. Last accessed 15 Jan 2013.
6. Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine development. Vaccine 2001;19:2688-91.
7. Santolaya ME, et al. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile. Lancet 2012;379:617-24.
8. Gossger N, et al. Immunogenicity and tolerability of recombinant meningococcal serogroup B vaccine administered with or without routine infant vaccinations according to different immunization schedules: A randomized controlled trial. JAMA 2012;307:573-82.
9. Vesikari T, et al. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet 2013 Jan 14. [Epub ahead of print].
10. Findlow J, et al. Multicenter, open-label, randomized phase II controlled trial of an investigational recombinant meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy. Clin Infect Dis 2010;51:1127-37.
11. Snape MD, et al. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J 2010;29:e71-9.
12. Prymula R, et al. Catch-up vaccination of healthy toddlers with an investigational multicomponent meningococcal serogroup B vaccine (4CMenB) – exploration of a two-dose schedule. Presented at 29th ESPID Meeting, 7-11 June 2011; The Hague, The Netherlands.
13. World Health Organization. Meningococcal position paper. Weekly epidemiological record No. 44, 2002, 77, 329-40. Available at: http://www.who.int/immunization/wer7740meningococcal_Oct02_position_paper.pdf. Last accessed 15 Jan 2013.