Bexsero* is indicated to help protect individuals from two months
through 17 years of age against meningococcal B disease, including
infants, children one to four years and adolescents who are at the
greatest risk of infection2,3
MenB is the most common type of meningitis in Canada4. It is responsible for 80 per cent of meningococcal cases in infants
under one year of age, 67 per cent in one to four year olds and 62 per
cent of the cases in adolescents aged 15 to 193
MenB invasive meningococcal infections cause substantial morbidity and
mortality and are the leading cause of invasive meningococcal disease
DORVAL, QC, Dec. 9, 2013 /CNW/ - Novartis announced today that Health
Canada has approved Bexsero* (Multicomponent Meningococcal B Vaccine
[recombinant, adsorbed]) for use in individuals from two months through
17 years of age2. Bexsero* is the first broad coverage vaccine to help protect against
meningococcal serogroup B (MenB) disease, including infants, toddlers
and adolescents who are at the greatest risk of infection1,2,3.
MenB infection is the leading cause of meningococcal disease across
Canada, particularly in infants3,4. Although rare, this disease is feared as it affects healthy people
rapidly and without warning5,6. Meningococcal disease can cause significant mortality in 24 - 48 hours and early symptoms can often resemble the flu, making this disease
initially misdiagnosed in its early stages5.
"Until now, we have had no vaccine against MenB that could be used
routinely to protect infants, children, teens against this devastating
disease," said Dr. Ron Gold, Senior Medical Advisor of the Meningitis
Research Foundation of Canada and retired Chief of Infectious Disease
at The Hospital for Sick Children in Toronto. "The MenB vaccine is
designed to reduce the risk of disease in those most at risk and
provide parents with peace of mind. The new MenB vaccine has the
potential to fill the last remaining gap in vaccines to prevent all of
the major causes of bacterial meningitis outside of the newborn period.
I encourage parents to talk to their doctor about meningitis and how
they can protect their children with vaccines. I also hope that the new
MenB vaccine will rapidly be added to the routine immunization programs
About 10 per cent to 14 per cent of people who contract the disease will
die despite appropriate treatment5. Up to 20 per cent of survivors may suffer from devastating, life-long
disabilities such as neurological disabilities, hearing loss or limb
loss5. Prevention through vaccination is considered the best control strategy
against an aggressive disease that leaves little time for intervention5.
Novartis is dedicated to providing healthcare solutions that address the
evolving needs of patients and societies. Novartis is working with
health authorities to provide access to Bexsero* as soon as possible.
Meningococcal disease is caused by Neisseria meningitidis5. Five main groups of meningococcal bacteria (A, B, C, W and Y) cause
virtually all cases around the world5. Prior to Bexsero*, vaccines were available to help protect only
against A, C, W and Y strains6.
Bexsero* is the result of more than 40 years of pioneering vaccine
research and its tolerability profile and immunogenicity have been
established through a comprehensive clinical program involving infants,
children, adolescents and adults2,7.
Bexsero* is the first broad coverage meningococcal MenB vaccine to
demonstrate an immune response in infants, for use in individuals from
two months through 17 years of age, the population at greatest risk for
developing this devastating disease1,2,3. Bexsero* provides a flexible option that can fit into various
vaccination schedules8,9. When given with other childhood vaccinations there is little impact on
immunogenicity of Bexsero* or the other vaccines8,9.
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, Y and now B) that cause
virtually all cases around the world6.
Bexsero* will be available for sale in early 2014.
About Novartis Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. In 2012, the
company invested close to $100 million in research and development in
Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600
people in Canada. For further information, please consult www.novartis.ca.
Novartis Pharmaceuticals Canada Inc. is an affiliate of Novartis AG,
which provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel,
Switzerland, Novartis offers a diversified portfolio to best meet these
needs: innovative medicines, eye care, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools,
over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2012, the
Group achieved net sales of USD 56.7 billion, while R&D throughout the
Group amounted to approximately USD 9.3 billion (USD 9.1 billion
excluding impairment and amortization charges). Novartis Group
companies employ approximately 129,000 full-time-equivalent associates
and operate in more than 140 countries around the world. For more
information, please visit http://www.novartis.com.
* Bexsero and Menveo are registered trademarks.
1 Novartis Bexsero EU Approval Press Release. Available at: http://www.novartis.com/newsroom/media-releases/en/2013/1672036.shtml. Accessed November 2013.
2 BEXSERO* Product Monograph. Novartis Pharmaceuticals Canada Inc.,
3 National Advisory Committee on Immunization. (2013) Update on the use
of Quadrivalent Conjugate
Meningococcal Vaccines. Canada Communicable Disease Report. January
2013; Vol. 39, ACS-1: 1-40.
4 Bettinger, J et al. for IMPACT. The Disease Burden of Invasive
Meningococcal Serogroup B Disease in Canada. The Pediatric Infectious
Disease Journal, January 2013; Vol. 32 (1) e20-e25.
5 Harrison LH. Prospects for vaccine prevention of meningococcal
infection. Clin Microbiol Rev. 2006; 19(1):142-1643. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360272/pdf/002.
6 Perrett KP, Pollard AJ. Towards an improved serogroup B Neisseria
meningitidis vaccine. Expert Opin Biol Ther. 2005;5:1611-1625.
Available at: http://informahealthcare.com/doi/abs/10.1517/147125188.8.131.521. Accessed on August 24, 2013.
7 Rappuoli, R. Reverse vaccinology, a genome-based approach to vaccine
development. Vaccine. 2001; 19: 2688-2691. Available at: http://www.ncbi.nlm.nih.gov/pubmed/11257410.
8 Gossger N et al. (2012) Immunogenicity of recombinant serogroup B
meningococcal vaccine administered with or without routine infant
vaccinations according to different immunization schedules: a
randomized controlled trial. JAMA 307(6):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, 2012; Vol 381. Available at: http://dx.doi.org/10.1016/S0140-6736(12)61961-8.
SOURCE: Novartis Pharmaceuticals Canada Inc.
For further information:
Novartis Media Relations:
Novartis Pharma Communications
+1 514 633 7873
416 642 7909