Pivotal study in The Lancet shows potential of Novartis vaccine Bexsero to help provide broad protection to infants against MenB
• Phase III results show that Bexsero induced a robust
immune response when administered concomitantly with routine
vaccines, and also as a booster dose[1]
• Data confirm Bexsero's acceptable safety and tolerability
profile in infants, who are among the most vulnerable to MenB, a
leading cause of meningitis
• Bexsero was recommended for European licensure in November
2012; upon approval, Bexsero will be the first and only broad
coverage vaccine against MenB
Basel, January 14, 2013 - The Lancet published findings online
today from a pivotal Phase III clinical trial of Bexsero®
(Meningococcal Group B Vaccine [rDNA, component, adsorbed])
involving 3,630 infants from two months of age. The study showed
that Bexsero demonstrated a protective immune response and has an
acceptable safety profile when administered as a three-dose primary
series concomitantly 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. These data were first presented in 2010 at
the 17th International Pathogenic Neisseria Conference
(IPNC)[2].
"As a practicing pediatrician, 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 Prof.
Susanna Esposito, Pediatric Clinic 1, Fondazione IRCCS Ca' Granda
Ospedale Maggiore Policlinico, Department of Pathophysiology and
Transplantation, Università degli Studi di Milano, Italy,
and Committee Member of the European Society for Pediatric
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 is committed to making Bexsero available as soon as
possible and is already engaging with governments interested in the
early adoption of the vaccine.
"Our company has made a strong commitment to addressing the public
health need for a vaccine that can provide broad protection against
MenB. The findings from this and other studies have built a
substantial body of evidence showing that Bexsero can be an
effective vaccine against this deadly disease," said Andrin Oswald,
Division Head, Novartis Vaccines and Diagnostics. "Upon the
licensure of Bexsero, Novartis will be able to offer vaccines to
help prevent all five of the most common and most virulent
meningococcal serogroups."
Meningococcal disease is easily misdiagnosed and kills
approximately one in ten people within 24 hours of onset despite
appropriate treatment[3],[4]. Of the survivors, around one in five
suffers permanent disabilities such as brain damage, hearing
impairment or limb loss[5]. 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[6], with a disproportionate disease burden in
infants[7].
Study Design and Results
This pivotal (Phase III) immunogenicity study randomized 3,630
infants to receive routine vaccines at 2, 4 and 6 months, either
alone or concomitantly with either Bexsero or a serogroup C
conjugate vaccine. The routine vaccines administered were 7-valent
pneumococcal glycoconjugate vaccine and a combined diphtheria,
tetanus, acellular pertussis, inactivated polio, hepatitis B and
Haemophilus influenzae type b vaccine[1].
Immune response against each of the four vaccine components (fHbp,
NadA, OMV, and NHBA) was measured using the human serum
bactericidal antibody (hSBA) assay with a pre-defined threshold
titer of >=1:5, the accepted correlate for protection[1].
A total of 1,555 toddlers were enrolled in the booster phase of the
study and randomized to receive either a Bexsero booster dose at
the same time as measles-mumps-rubella-varicella (MMRV) vaccine, or
given the Bexsero booster alone at 12 months and MMRV given one
month later.
Following the booster dose of Bexsero at 12 months, more than 95%
of recipients showed a protective response to all four vaccine
components. Furthermore, one month after the third dose, all
infants in the study showed a 100% protective antibody response
against two vaccine components (fHbp, NadA) and 84% against the
other two components (NHBA, OMV). These findings are important
given that the burden of disease is highest in infants and
toddlers[1].
In this study, Bexsero was shown not to interfere with the
immunogenicity of any other vaccine it was administered with,
except for a slightly lower immune response to polio vaccine that
the investigators concluded was not to be clinically
meaningful[1].
Bexsero had an acceptable tolerability profile when co-administered
with other routine infant vaccinations. During the primary series,
local injection site reactions (e.g., tenderness) and fever
occurred more frequently when Bexsero was co-administered with
routine vaccines than when the routine vaccines were given alone.
When fever occurred, it was generally mild-to-moderate in severity
and of short duration, with the majority of cases resolving within
24 hours. During the booster phase, the frequency of fever was
similar when Bexsero was administered alone to when it was
co-administered with MMRV[1].
About Bexsero
Bexsero, an investigational multicomponent meningococcal group B
(MenB) vaccine, is the result of more than 20 years of pioneering
research in vaccine development[8]. MenB has been a particularly
elusive target because the outer coating of the bacteria is not
well recognized by the immune system, making it especially
challenging to develop a broadly effective vaccine until recent
advances in scientific knowledge[9]. Bexsero was developed using an
award-winning scientific approach that involved decoding the
genetic makeup (genome sequence) of MenB[8],[9].This innovative
approach provides the foundation for the potential development of a
new generation of vaccines that may help prevent other diseases
with a significant diversity of disease-causing strains.
Upon regulatory approval, Bexsero will be the first and only
licensed vaccine with the potential to protect against a broad
range of strains that cause MenB disease worldwide[10]. The
tolerability profile and immunogenicity of Bexsero have been
established through a comprehensive clinical program including data
from large Phase II/III clinical trials involving almost 8,000
patients[1],[11],[12],[13],[14],[15], including infants, the age
group at the greatest risk of infection. Starting from two months
of age, Bexsero offers several immunization schedule options that
can fit with routine vaccination visits.
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by terminology such as "potential," "recommended,"
"will," "prospect," "generally follows . and delivers,"
"committed," "commitment," "can," "may," or similar expressions, or
by express or implied discussions regarding potential marketing
approvals for Bexsero or any other vaccines, or the timing of any
such approvals, or regarding potential future revenues from any
such vaccines. 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 or any
other vaccines will be approved for sale in any market, or at any
particular time. Nor can there be any guarantee that Bexsero or any
other vaccines will achieve any particular levels of revenue in the
future. In particular, management's expectations 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; competition in general;
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; 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
Novartis 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 2011, the
Group achieved net sales of USD 58.6 billion, while approximately
USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group.
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References
1. 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].
2. 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 the 17th International
Pathogenic Neisseria Conference, 11-16 September 2010; Banff,
Canada.
3. Thompson MJ, et al. Clinical recognition of meningococcal
disease in children and adolescents. Lancet 2006;367:397-403.
4. World Health Organization. Meningococcal meningitis. Fact sheet
#141. November 2012 update. Available at:
http://www.who.int/mediacentre/factsheets/fs141/en/. Last accessed
10 Dec 2012.
5. Rosenstein NE, et al. Meningococcal disease. N Engl J Med
2001;344:1378-88.
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. Meningococcal
Disease - Age as a risk factor. Available at:
http://www.cdc.gov/meningococcal/about/risk-age.html. Last accessed
10 Dec 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. 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.
12. 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.
13. 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.
14. 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.
15. 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.
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Posted: January 2013
