Study including more than 1,800 infants showed Bexsero™ induces an immune response in 79 per cent to 99 per cent when given
alone or with other routine vaccines in different vaccination schedules2.
Current meningococcal vaccines do not provide protection against
meningococcal B disease (MenB) which is easily misdiagnosed and can kill within 24 hours; infants are
at highest risk3.
MenB in Canada represents 82% of all meningococcal cases in infants
below 1 year, 72% in children 1-4 years and 68% of all cases in
Health Canada is currently reviewing the first ever meningitis B vaccine
for approval and use for Canadians.
DORVAL, QC, Feb. 9, 2012 /CNW/ - The Journal of the American Medical Association (JAMA) published a study today that shows Bexsero™ induced a sufficient immune response against meningococcal B disease in
the vast majority of infants vaccinated2. In addition, these results show that Bexsero™ can fit into various vaccination schedules in the first year of life
when the likelihood of contracting this often-deadly disease is
greatest. The study also demonstrated that Bexsero™ has an acceptable tolerability profile.
These data were first presented in 2011 at the 29th Annual Meeting of the European Society of Paediatric Infectious
"The publication of these results in JAMA adds to the growing body of evidence supporting Bexsero's potential to
help protect all age groups, from infants to adults, against this
devastating disease," said Andrin Oswald, Head of Novartis Vaccines and
Diagnostics Division. "Bexsero holds great promise in providing a
solution to a major public health concern - the lack of a routine
vaccine providing broad protection against MenB."
In Canada, MenB causes 82 per cent (82%) of meningococcal meningitis
cases in infants under 1 year of age and 68 per cent (68%) of the cases
In general, approximately one in ten of people who contract
meningococcal disease will die despite appropriate treatment2,5,6. Of those surviving, around one in five suffers permanent disabilities
such as brain damage, hearing loss, or learning difficulties5,6. The majority of cases in some of the developed world are due to
serogroup B (MenB)6, with a disproportionate disease burden in infants7. Meningococcal disease most commonly affects otherwise healthy persons,
and in many cases physicians cannot diagnose and treat an infected
child soon enough to avoid serious outcomes, therefore prevention
through vaccination is a means to counter meningococcal disease.
"The development of a broadly protective vaccine against MenB disease
has been a formidable challenge and, if successful, would represent an
enormous step forward in the prevention of childhood meningitis," said
Dr. Matthew Snape, Consultant in Vaccinology and General Paediatrics,
University of Oxford, UK. "This study provides important data on how
well infants' immune systems respond to this new MenB vaccine when
given in a variety of schedules. This information is vital when
considering how the vaccine could be incorporated into different
immunization regimens around the world."
Study Design and Results
This pivotal Phase IIb open-label immunogenicity study1 randomized 1,885 infants to receive Bexsero at 2, 4, 6 months together
with routine infant vaccines; at 2, 4, 6 months with routine vaccines
given separately at 3, 5, 7 months; or at 2, 3, 4 months together with
routine infant vaccines. A control group received the routine vaccines
only at 2, 3, 4 months. The routine vaccines used were 7-valent
pneumococcal glycoconjugate vaccine and a combined diphtheria, tetanus,
acellular pertussis, inactivated polio, hepatitis B and Haemophilus influenzae type b vaccine.
Immune response was measured using the human serum bactericidal antibody
(hSBA) assay with a titer ≥ 1:5, which is the accepted level that
correlates with protection. The study met all of its primary endpoints,
and showed that the majority of infants vaccinated with Bexsero, at
either dosing schedule with or without routine vaccines, achieved hSBA
≥ 1:5 against all vaccine antigens in tested MenB strains (H44/76,
5/99, NZ98/254). More than 99% of participants receiving Bexsero at 2,
4, 6 months (with or without routine vaccines) or at 2, 3 and 4 months
(with routine vaccines) developed hSBA titers ≥ 1:5 against the
reference strains 44/76 and 5/99. For NZ98/254 the ≥ 1:5 result was
reached or exceeded in 79% (2, 4, 6 months with routine vaccines), 87%
(2, 4, 6 months without routine vaccines) and 81% (2, 3, 4 months with
routine vaccines) of patients on the corresponding schedules.
The immune response to routine vaccine antigens when co-administered
with Bexsero was similar to that in the control group2, except for slightly lower immune responses to pneumococcal serotype 6B
and pertactin, comparable with other authorized vaccines. The data also
showed that Bexsero, when administered alone, had a reactogenicity
profile that was comparable to those of the routine vaccines2. Fever, which is a common event following routine childhood
immunizations, was observed more frequently in infants who received
Bexsero together with routine infant vaccines compared to infants
receiving routine vaccines alone2. Fever was generally mild-to-moderate and of short duration, with more
than 95% of cases resolving within 24-48 hours2.
Bexsero is the result of more than 20 years of pioneering research in
the fight to protect infants and other populations at risk of infection
from MenB8,9. To address the unpredictable and changing nature of meningococcus
bacteria over time, Bexsero - comprising four key components that
independently are highly immunogenic10 - was designed to protect against the majority of disease-causing
strains worldwide. The immunogenicity and tolerability of Bexsero has
been demonstrated in large Phase III clinical trials involving more
than 8,000 infants, adolescents and adults with post-vaccination
reactions comparable to those of other routine vaccines11,12. In December 2010, a Marketing Authorization Application (MAA) for
Bexsero was submitted in Europe and in other countries, including a
proposed infant vaccination schedule consisting of three doses for the
primary series. Regulatory action is expected later in 2012.
The study was published in the February 8, 2012 issue of JAMA2 with the title of "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" by Nicoletta Gossger MD, Matthew D Snape
FRCPCH MD, et al.
The Novartis Pharmaceuticals Canada Inc., Vaccines and Diagnostics'
Bexsero vaccine (also known as 4CMenB) was developed using a pioneering
approach known as "reverse vaccinology8." This was necessary because the approach used to produce a conjugate
meningococcal vaccine against serogroups A, C, W-135 and Y could not be
used for MenB. The capsular polysaccharide of MenB is identical to a
polysaccharide component present in the human body and is therefore not
immunogenic. In contrast to conventional methods of developing
vaccines, reverse vaccinology was used to decode the genetic makeup
(genome sequence) of MenB and select those proteins that were most
likely to be broadly effective vaccine candidates8. Bexsero contains multiple components, which are highly immunogenic
independently and, taken together, have the potential to protect
against a broad range of disease-causing MenB strains10. To date, more than 8,000 infants, toddlers, and adults have been
enrolled in studies of Bexsero1,13,14,15,16,17. Bexsero is not currently authorized for use in any country, including
Canada. However, Health Canada is currently reviewing Bexsero, the
first ever meningitis B vaccine for approval and use for Canadians.
Authorized vaccines are available to protect against meningococcal
disease caused by serogroups A, C, W-135 and Y6; however, MenB remains an important unmet public health challenge6.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "would," "could," "will," "promise,"
"potential," "proposal," or similar expressions, or by express or
implied discussions regarding potential future marketing approvals for
Bexsero or regarding potential future revenues from Bexsero. You should
not place undue reliance on these statements. Such forward-looking
statements reflect the current views of management regarding future
events, and involve known and unknown risks, uncertainties and other
factors that may cause actual results with Bexsero to be materially
different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that
Bexsero will be approved for sale in any market, or at any particular
time. Nor can there be any guarantee that Bexsero will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding Bexsero could be affected by, among other
things, unexpected regulatory actions or delays or government
regulation generally; unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of
existing clinical data; government, industry and general public pricing
pressures; unexpected manufacturing issues; the company's ability to
obtain or maintain patent or other proprietary intellectual property
protection; competition in general; the impact that the foregoing
factors could have on the values attributed to the Novartis Group's
assets and liabilities as recorded in the Group's consolidated balance
sheet, and other risks and factors referred to in Novartis AG's current
Form 20-F on file with the US Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected.
Novartis is providing the information in this press release as of this
date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result
of new information, future events or otherwise.
About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc. provides healthcare solutions that
address the evolving needs of patients and societies. Focused solely on
healthcare, Novartis offers a diversified portfolio to best meet these
needs: innovative medicines, cost-saving generic pharmaceuticals,
preventive vaccines, diagnostic tools and consumer health products.
Novartis is the only company with leading positions in these areas. In
2010, the Company invested close to $100 million in research and
development and conducted clinical trials across the country seeking
new treatments in Ophthalmology, Respiratory diseases, Neurosciences
(including MS), Immunology and Infectious diseases, Cardiovascular,
Oncology (including Hematology) and organ transplantation. In addition
to Novartis Pharmaceuticals Canada Inc., the Novartis Group consists of
Novartis Animal Health Canada Inc., Novartis Consumer Health Canada
Inc., Alcon Canada Inc. and Sandoz Canada Inc. For further information
about Novartis Canada, please consult www.novartis.ca.
™Bexsero is a trademark.
1 Novartis Pharmaceuticals Canada Inc., Vaccines and Diagnostics
2 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.
3 Thompson MJ, et al. Clinical recognition of meningococcal disease in
children and adolescents. Lancet 2006;367:397-403.
4 Gossger N, et al. Immunogenicity of an investigational multicomponent
meningococcal serogroup B vaccine (4CMenB) administered with or without
routine infant vaccinations in different schedules. Presented at 29th
ESPID Meeting, June 7-10, 2011; The Hague, The Netherlands. Poster
5 Health Protection Agency. Infectious Diseases: Meningococcal disease.
Meningococcal Reference Unit isolates of Neisseria Menengitidis:
England and Wales, by serogroup & epidemiological year,
1998/99-2008/09. Available and Canadian Communicable Disease Report (CCDR), April 2009, Volume 36,
6 Perrett KP, Pollard AJ. Towards an improved serogroup B Neisseria
meningitidis vaccine. Expert Opin Biol Ther 2005;5:1611-25.
7 Centers for Disease Control and Prevention. Meningitis: Signs and
Symptoms. June 2009. Available at: http://www.cdc.gov/meningitis/about/symptoms.html. Last accessed on 9 Jan 2012.
8 Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine
development. Vaccine 2001;19:2688-91.
9 Giuliani MM, et al. A universal vaccine for serogroup B meningococcus.
Proc Natl Acad Sci USA 2006;103:10834-9.
10 Donnelly, J et al. Qualitative and quantitative assessment of
meningococcal antigens to evaluate the potential strain coverage of
protein-based vaccines. Proc Natl Acad Sci USA 2010;107:19490-5.
11 Beeretz, I et al. Reactogenicity and Safety of Multicomponent
Meningococcal Serogroup B Vaccine (4CMenB) Administered With or Without
Routine Infant Vaccinations in Different Schedules, presented at the
29th European Society for Paediatric Infectious Diseases Conference,
June 7-11, 2011, The Hague, The Netherlands
12 Esposito S, et al. Tolerability of a three-dose schedule of an
investigational, multicomponent, meningococcal serogroup B vaccine and
routine infant vaccines in a lot consistency trial. Presented at IPNC,
Sept 11-16, 2010. Banff, Canada. Poster #182.
13 Santolaya ME, et al. Immunogenicity and tolerability of a
multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy
adolescents in Chile. Lancet 2012 Jan 17. [ePub ahead of print].
14 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.
15 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.
16 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, June 7-11, 2011; The Hague, The Netherlands. Poster #706.
17 Vesikari T, et al. Immunogenicity of an investigational,
multicomponent, meningococcal serogroup b vaccine in healthy infants at
2, 4, and 6 months of age. Presented at IPNC, Sept 11-16, 2010; Banff, Canada. Poster #180.
SOURCE Novartis Pharmaceuticals Canada Inc.
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