Meningococcal Group B (MenB) is Responsible for 60 Percent of
Meningococcal Disease Cases in Adolescents and Young Adults in Europe1
TRUMENBA Approved in Europe with Option for a Two- or Three-Dose
Schedule
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC)
has approved TRUMENBA® (Meningococcal Group B Vaccine) for
the prevention of invasive meningococcal disease caused by Neisseria
meningitidis serogroup B (MenB) in individuals 10 years of age and
older. Adolescents and young adults are a critical demographic for
vaccination against MenB due to inherent environmental and social risk
factors such as close-quartered living and sharing behaviors.2
“The approval of TRUMENBA reflects our dedication to advancing novel
vaccines that can help protect adolescents and young adults, a
population at an increased risk for meningococcal disease caused by
MenB,” said Luis Jodar, Chief Medical and Scientific Affairs Officer,
Medicines Development, Scientific and Clinical Affairs, Pfizer Vaccines.
“Though uncommon, MenB disease is unpredictable, can progress rapidly
and is associated with a significant risk of death and long-term
disability, demonstrating the value of immunization as a preventive
measure.”
Early symptoms can be misinterpreted as the flu, but meningococcal
disease can lead to death within 24 hours.3 Despite
antibiotic treatment, 10 to 15 percent of people with meningococcal
disease will die.3 Of those adolescents who survive, three in
five experience significant physical and mental disabilities.4
Adolescents remain a very important group for vaccination, as up to a
quarter may be asymptomatic carriers of Neisseria meningitidis.5
“We are steadfast in our commitment to progress and shape the future of
vaccines to help address serious health threats worldwide and make the
greatest public impact,” said Susan Silbermann, President and General
Manager, Pfizer Vaccines. “We are also focused on consistent, reliable
supply for all the vaccines we manufacture, including a full 36-month
shelf life with TRUMENBA. With the EC approval of TRUMENBA, Pfizer now
has a comprehensive portfolio of vaccines to help prevent five of the
most common disease-causing meningococcal serogroups in this region.”
Pfizer continues to invest significantly in manufacturing processes and
facilities to ensure a sufficient supply of TRUMENBA in Europe, where
the majority of meningococcal disease cases (60 percent) among
adolescents and young adults are caused by serogroup B.1
The EC decision is based on results from a clinical development program
in which more than 20,000 adolescents and adults were evaluated,
approximately 15,000 of whom received TRUMENBA.6,7,8,9,10,11,12
The data demonstrate that TRUMENBA induces protective serum bactericidal
antibody responses to diverse MenB test strains that are representative
of disease causing strains, and the vaccine has an established safety
profile.13 In clinical studies, the most common adverse
reactions observed were injection site pain, redness and swelling at the
vaccination site, headache, fatigue, chills, diarrhea, muscle pain,
joint pain and nausea. The posology includes both two- and three-dose
schedules, providing flexibility for healthcare professionals to
administer the vaccine depending on individuals’ risk of exposure and
susceptibility to MenB. The marketing authorization granted by the EC is
valid in all European Union (EU) member states, plus Iceland,
Liechtenstein and Norway. Additional marketing authorization application
reviews for TRUMENBA are under way in other countries.
Pfizer’s Meningococcal Vaccines portfolio includes vaccines that help
protect against five of the most common disease-causing serogroups — A,
B, C, W, and Y (approvals varying by country) — which can threaten the
health of people at various points in their lives.14 Since
its first approval in the U.S. in 2014, TRUMENBA has been administered
to an estimated 600,000 adolescents and young adults.15 The
risk of contracting meningococcal disease varies year to year, by age
group, and by the country one travels to or lives in.16
EU Indication for TRUMENBA® (Meningococcal
Group B Vaccine)
TRUMENBA® (Meningococcal Group B Vaccine) is indicated for
active immunization of individuals 10 years and older to prevent
invasive meningococcal disease caused by Neisseria meningitidis serogroup
B.
EU Important Safety Information
Hypersensitivity to the active substances or to any of the excipients is
a contraindication.
Severe allergic reaction (e.g., anaphylaxis) after any previous dose of
TRUMENBA or to any component of this vaccine is a contraindication.
Immunocompromised persons, including individuals receiving
immunosuppressant therapy, may have a diminished immune response to
TRUMENBA.
As with any vaccine, vaccination with TRUMENBA may not protect all
vaccine recipients.
In clinical studies, the most common adverse reactions observed were
injection site pain, redness and swelling at the vaccination site,
headache, fatigue, chills, diarrhea, muscle pain, joint pain and nausea.
There are no data from the use of TRUMENBA in pregnant women. TRUMENBA
should be used during pregnancy only if clearly needed.
U.S. Indication for TRUMENBA® (Meningococcal
Group B Vaccine)
TRUMENBA® (Meningococcal Group B Vaccine) is a vaccine
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.
U.S. 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.
About TRUMENBA® (Meningococcal Group B
Vaccine)
TRUMENBA® (Meningococcal Group B Vaccine) 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.
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.17 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.18
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).
About Meningococcal Disease
Meningococcal disease can affect anyone, at any age. The reported
incidence of invasive meningococcal disease (IMD) varies by region,
ranging from less than 0.5 cases per 100,000 in North America and just
under 1 case per 100,000 in Europe, and up to 10-1,000 cases per 100,000
during epidemic years in Africa.19 The majority of invasive
meningococcal disease cases worldwide can be attributed to six Neisseria
meningitidis serogroups (A, B, C, W-135, X and Y).19
Together serogroups A, B, C, W-135, and Y account for 90% of all
invasive meningococcal disease.14
Meningococcal disease can progress rapidly, and symptoms are difficult
to distinguish from other more common infections, with flu-like symptoms
such as headache, nausea and vomiting among the earliest signs.3
The most common clinical presentations of meningococcal disease are
meningitis and septicemia.3
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
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DISCLOSURE NOTICE: The information contained in this release
is as of May 30, 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 an approval for TRUMENBA in Europe
for the prevention of meningococcal disease caused by Neisseria
meningitidis serogroup B in individuals 10 years of age and older,
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, including unfavorable
new clinical data and additional analyses of existing clinical data;
whether and when any biologics license applications may be filed in any
other jurisdictions for TRUMENBA; whether and when 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 European Centre for Disease Prevention and Control. Annual
Epidemiological Report 2016 – Invasive meningococcal disease. Stockholm:
ECDC; 2016.
2 Poland GA. Prevention of meningococcal
disease: current use of polysaccharide and conjugate vaccines. Clin
Infect Dis. 2010; 50; S45-S53.
3 Centers for Disease
Control and Prevention. Meningococcal Vaccines for Preteens, Teens. http://www.cdc.gov/features/meningococcal/.
Last Updated April 18, 2016. Accessed May 2017.
4 Borg
J, Christie D, Coen PG, Pooy R, Viner RM. Outcomes of meningococcal
disease in adolescence: prospective, matched-cohort study. Pediatrics.
2009; 123: e502-e509.
5 Christensen H, May M, Bowen L,
Hickman M, Trotter C. Meningococcal carriage by age: a systematic review
and meta-analysis. Lancet Infect Dis. 2010; 10(12):853-861.
6
ClinicalTrials.gov. A Trial to Assess the Safety, Tolerability and
Immunogenicity of Repevax® and rLP2086 Vaccine When Given Together in
Healthy Subjects Aged >=11 to <19 Years.http://clinicaltrials.gov/ct2/show/NCT01323270?term=B1971010&rank=1.
Accessed March 12, 2015.
7 ClinicalTrials.gov. A
Clinical Trial to Study the Safety, Tolerance and Immunogenic Response
to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to
Children Between the Ages of 11 and 17. http://clinicaltrials.gov/ct2/show/NCT01461993?term=B1971011&rank=1.
Accessed March 12, 2015.
8 ClinicalTrials.gov. A Trial
To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086
Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy
Subjects Aged ≥11 To <19 Years. http://clinicaltrials.gov/ct2/show/NCT01299480?term=B1971012&rank=1.
Accessed March 12, 2015.
9 ClinicalTrials.gov. A
Clinical Trial to Study the Safety, Tolerance and Immunogenic Response
to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time
to Children Between the Ages of 10 Through 12 Years of Age. http://clinicaltrials.gov/ct2/show/NCT01461980?term=B1971015&rank=1.
Accessed March 12, 2015.
10 ClinicalTrials.gov. A Trial
to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity
of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to
<19 years.http://clinicaltrials.gov/ct2/show/NCT01830855?term=B1971009&rank=1.
Accessed March 12, 2015.
11 ClinicalTrials.gov. A Global
Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young
Adults Aged 10 to 25 Years. http://clinicaltrials.gov/ct2/show/NCT01352793?term=B1971014&rank=1.
Accessed March 12, 2015.
12 ClinicalTrials.gov. A Trial
to Assess the Safety, Tolerability, and Immunogenicity of Bivalent
rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26
Years. (B1971016).http://clinicaltrials.gov/ct2/show/NCT01352845?term=B1971016&rank=1.
Accessed March 12, 2015.
13 Pfizer Data on File.
14
Kieny MP, Excier J, Girard M. Research and development of new vaccines
against infectious diseases. Am J Public Health. 2004; 94(11): 1931-1935.
15
Internal calculations based on Quintiles IMS database. QuintilesIMS
LifeLink Patient Data, including Rx, Dx and Specialty Pharmacy, full
year 2014-2016.
16 Rouphael NG, Stephens DS. Neisseria
meningitidis: biology, microbiology, and epidemiology. Methods Mol Biol.
2012; 799:1-20.
17 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 May 2017.
18 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 May 2017.
19 Halperin SA, et al. Vaccine
2012;30(2):B26–36.
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Source: Pfizer Inc.