TRUMENBA Has Been Studied in a Global Clinical
Development Program Evaluating the Vaccine in Adolescents and
Adults1
The Majority of Meningococcal Disease Cases in
Europe are Caused by Meningococcal Group B (MenB), with Adolescents
and Young Adults at Increased Risk2
Pfizer Inc. (NYSE:PFE) today announced that the European
Medicines Agency’s Committee for Medicinal Products for Human Use
(CHMP) has adopted a positive opinion recommending that TRUMENBA®
(Meningococcal Group B Vaccine) be granted marketing authorization
in the European Union (EU) for active immunization of individuals
10 years and older to prevent invasive meningococcal disease caused
by Neisseria meningitidis serogroup B (MenB).3 The CHMP’s opinion
will now be sent to the European Commission (EC) for final
decision.
“This positive opinion by the CHMP to recommend marketing
authorization of TRUMENBA in the EU is an additional step toward
the fight to help protect individuals over 10 years of age from
meningococcal disease caused by serogroup B, an uncommon yet
devastating and life-threatening disease,” said Kathrin Jansen,
Ph.D., senior vice president and head of Vaccine Research and
Development for Pfizer Inc. “This decision further affirms the
effectiveness and robust safety profile of TRUMENBA.”
Pfizer conducted a global clinical development program for
TRUMENBA, evaluating more than 20,000 adolescents and adults,
approximately 15,000 of whom received TRUMENBA. These data, which
were reviewed by the CHMP, demonstrate that the benefits of
TRUMENBA are its ability to induce protective serum bactericidal
antibody responses to diverse meningococcal serogroup B strains
expressing fHBP variants that are representative of MenB strains
causing invasive disease, and that TRUMENBA is a well-tolerated
vaccine.1
Meningococcal disease is an uncommon, yet devastating condition
that can strike quickly without warning at any age. The most common
clinical presentations of meningococcal disease are meningitis and
meningococcal septicaemia (also known as meningococcemia), a
bloodstream infection.4 Despite appropriate care, as many as 10
percent of those who develop the disease die from it2 and of those
who survive, up to 20 percent may experience significant medical
disabilities including limb amputation, vision or hearing
impairment, mental and motor skill impairment and poorer quality of
life.5,6,7 Adolescents and young adults are at an increased risk of
meningococcal disease due to inherent environmental and behavioral
factors such as living in close quarters and sharing drinks, cups
or utensils.8,9
The majority of meningococcal disease cases worldwide can be
attributed to six Neisseria meningitidis serogroups (A, B, C, W, X
and Y).10,11 In Europe, the majority of cases are caused by
serogroup B strains.2
Vaccines are one of the greatest public health advances,
resulting in the control, elimination or near-elimination of
numerous vaccine-preventable infectious diseases. Pfizer’s
Meningococcal Vaccines portfolio is built with vaccines that help
protect against five of the most common disease-causing serogroups
– A, C, W, Y and B (approvals varying by country) – which can
threaten the health of people at various points in their
lives.1
About TRUMENBA
TRUMENBA was first introduced in the United States in October
2014 for active immunization to prevent invasive disease caused by
Neisseria meningitidis serogroup B in individuals 10 through 25
years of age.12
TRUMENBA is a sterile suspension composed of two recombinant
lipidated factor H binding protein (fHBP) variants from N.
meningitidis serogroup B, one from fHBP subfamily A and one
from subfamily B (A05 and B01, respectively). fHBP is one of many
proteins found on the surface of meningococci and contributes to
the ability of the bacterium to avoid host defenses. fHBPs can be
categorized into two immunologically distinct subfamilies, A and
B.13 The susceptibility of serogroup B meningococci to
complement-mediated, antibody-dependent killing following
vaccination with TRUMENBA is dependent on both the antigenic
similarity of the bacterial and vaccine fHBPs, as well as the
amount of fHBP expressed on the surface of the invading
meningococci.14
As with any vaccine, TRUMENBA may not prevent disease in all
vaccinated individuals. The frequency of meningococcal disease
caused by serogroup B varies geographically, and could influence
the ability to evaluate effectiveness of the vaccine in any given
country. Based on the low incidence of meningococcal disease,
placebo-controlled clinical trials for TRUMENBA were considered
unfeasible due to the size of the study that would be required and
were not performed. Licensure of TRUMENBA was based on
demonstration of immune responses measured using a serum
bactericidal assay with human complement (hSBA).
U.S. Indication for TRUMENBA
TRUMENBA® (Meningococcal Group B Vaccine) is indicated for
individuals 10 through 25 years of age for active immunization to
prevent invasive disease caused by Neisseria meningitidis group
B.
The effectiveness of the two-dose schedule of Trumenba against
diverse Neisseria meningitidis serogroup B strains has not been
confirmed.
Important Safety Information
TRUMENBA® (Meningococcal Group B Vaccine) should not be given to
anyone with a history of a severe allergic reaction after a
previous dose of TRUMENBA.
Individuals with weakened immune systems may have a reduced
immune response.
The most common adverse reactions in adolescents and young
adults were pain at the injection site, fatigue, headache, and
muscle pain.
Data are not available on the safety and effectiveness of using
TRUMENBA and other meningococcal group B vaccines interchangeably
to complete the vaccination series.
Tell your healthcare provider if you are pregnant, or plan to
become pregnant.
Ask your healthcare provider about the risks and benefits of
TRUMENBA. Only a healthcare provider can decide if TRUMENBA is
right for you or your child.
You are encouraged to report negative side effects of vaccines
to the U.S. Food and Drug Administration (FDA) and the Centers for
Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or
call 1-800-822-7967.
For the full prescribing information for TRUMENBA, please visit
www.trumenba.com.
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. We routinely post information that may be
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DISCLOSURE NOTICE: The information contained in this
release is as of March 24, 2017. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information about
TRUMENBA® (Meningococcal Group B Vaccine) and the opinion of the
CHMP of the EMA regarding the filed marketing authorization
application for TRUMENBA, including their potential benefits, that
involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Risks and uncertainties include, among other
things, uncertainties regarding the commercial success of TRUMENBA;
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical trial completion dates and
regulatory submission dates, as well as the possibility of
unfavorable clinical trial results; whether and when any biologics
license applications may be filed in any other jurisdictions for
TRUMENBA; whether and when the EMA or regulatory authorities in any
other jurisdictions where applications for TRUMENBA may be pending
or filed may approve any such applications, which will depend on
the assessment by such regulatory authorities of the benefit-risk
profile suggested by the totality of the immunogenicity and safety
information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of TRUMENBA; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results,” as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
_____________________________________
1 Pfizer Data on File.2 World Health Organization. Meningococcal
vaccines: WHO position paper, 2011. Wkly Epidemiol Rec. 2011;
86(47); 521-540. Available at:
http://www.who.int/wer/2011/wer8647.pdf?ua=1. Published 2011.
Accessed March 2017.3 European Medicines Agency. CHMP Agendas and
outcomes. Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/03/news_detail_002712.jsp&mid=WC0b01ac058004d5c1.
Accessed March 2017.4 Meningitis Research Foundation. Meningococcal
meningitis and septicaemia: guidance notes: diagnosis and treatment
in general practice, 2014 edition. Available at:
http://www.meningitis.org/assets/x/50631. Accessed March 2017.5
Meningococcal Disease. In: Hamborsky J, Kroger A, Wolfe S. ed.
Centers for Disease Control and Prevention (CDC). The Pink Book.
Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th
ed. Washington D.C.: Public Health Foundation; 2015: 231-246.
Available at:
https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/mening.pdf.
Accessed March 2017.6 Vyse A, Anonychuk A, Jakel A, et al. The
burden and impact of severe and long-term sequelae of meningococcal
disease. Expert Rev Anti Infect Ther. 2013; 11(6): 597-604.
Available at: https://www.ncbi.nlm.nih.gov/pubmed/23750731.
Accessed March 2017.7 Al-Janabi H, Van Exel J, Brouwer W, et al.
Measuring health spillovers for economic evaluation: a case study
in meningitis. Health Economics. 2015; 25(12): 1529–1544. Available
at: http://onlinelibrary.wiley.com/doi/10.1002/hec.3259/full.
Accessed March 2017.8 Memish ZA, Goubeaud A, Br�ker M, et al.
Invasive meningococcal disease and travel. J Infect Pub Health.
2010; 3: 143-151. Available at:
http://www.sciencedirect.com/science/article/pii/S187603411000078X?np=y.
Accessed March 2017.9 MacLennan J, Kafatos G, Neal K, et al. Social
behavior and meningococcal carriage in British teenagers. Emerg
Infect Dis. 2006; 12(6): 950-957. Available at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3373034/. Accessed
March 2017.10 Halperin SA, et al. The changing and dynamic
epidemiology of meningococcal disease. Vaccine. 2012;30(2):B26–3611
Pinto VB, Burden R, Wagner A, et al. The development of an
experimental multiple serogroups vaccine for Neisseria
meningitidis. PLoS ONE. 2013; 8(11):1-10. Available at
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0079304;
Accessed March 2017.12 U.S. Food & Drug Administration. October
29, 2014 Approval Letter – TRUMENBA. Available at:
https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm421034.htm.
Accessed March 2017.13 Shirley M, Dhillon S. Bivalent rLP2086
vaccine (Trumenba((R))): a review in active immunization against
invasive meningococcal group B disease in individuals aged 10–25
years. BioDrugs. 2015 Oct; 29(5): 353-61. Available at:
http://link.springer.com/article/10.1007%2Fs40259-015-0139-0.
Accessed March 2017.14 Murphy E, Andrew L, Lee KL et al. Sequence
diversity of the factor H binding protein vaccine candidate in
epidemiologically relevant strains of serogroup B Neisseria
meningitidis. J Infect Dis. 2009 Aug 1; 200(3): 379-89. Available
at https://doi.org/10.1086/600141. Accessed March 2017.
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