Pfizer Inc. (NYSE: PFE) today announced that TRUMENBA®
(Meningococcal Group B Vaccine) received Breakthrough Therapy
designation from the U.S. Food and Drug Administration (FDA) for
active immunization to prevent invasive disease caused by Neisseria
meningitidis group B (MenB) in children ages 1 through 9 years.
This is the first Breakthrough Therapy designation for a MenB
vaccine to help protect children as young as 1 year of age.
TRUMENBA previously received Breakthrough Therapy designation in
2014 for the prevention of MenB in adolescents and young adults
ages 10 through 25 years, and later the same year received FDA
approval as the first MenB vaccine approved in the U.S.
As noted in the October 2014 Approval Letter, Pfizer was
required to assess the safety and effectiveness of TRUMENBA in
children down to 1 year of age. Pfizer has successfully completed
Phase 2 studies in this investigational age group and these data
have been submitted to the FDA. These data supported Pfizer’s
request for Breakthrough Therapy designation.
“Despite the occurrence of invasive serogroup B disease in
children ages 1 through 9 years, and the potential life-altering
and long-term consequences that may result from this uncommon
disease, there is no MenB vaccine licensed in the U.S. for this age
group,” said Dr. Luis Jodar, Chief Medical and Scientific Affairs
Officer, Vaccines Medical Development, Scientific and Clinical
Affairs, Pfizer Inc. “We look forward to working closely with the
FDA toward our goal to extend the range of individuals who may
benefit from immunization with TRUMENBA.”
In April 2017, TRUMENBA received traditional approval from the
FDA in individuals 10 to 25 years of age for the three-dose
schedule based on Phase 3 data, making it the only MenB vaccine in
the U.S. with this full approval. TRUMENBA can be administered as a
two‐ or three‐dose schedule to adolescents and young adults 10
through 25 years of age depending on an individual’s risk of
exposure and susceptibility to MenB. A study to confirm the
effectiveness of the two-dose schedule is ongoing.
The majority of invasive meningococcal disease cases worldwide
can be attributed to six Neisseria meningitidis serogroups (A, B,
C, W, X, and Y). Together, serogroups A, B, C, W, and Y account for
90% of all invasive meningococcal disease (IMD)1, with MenB
accounting for the majority of disease in adolescents and young
adults in the U.S. and Europe.2 As of 2016, the burden of MenB is
highest in adolescents/young adults (32%) and infants (20%),
followed by children ages 1 to 4 years (12%) and children ages 5 to
10 years (4%).3
Breakthrough Therapy designation was initiated as part of the
Food and Drug Administration Safety and Innovation Act (FDASIA)
signed in 2012. As defined by the FDA, a breakthrough therapy is a
drug intended to be used alone or in combination with one or more
other drugs to treat a serious or life-threatening disease or
condition and preliminary clinical evidence indicates that the drug
may demonstrate substantial improvement over existing therapies on
one or more clinically significant endpoints, such as substantial
treatment effects observed early in clinical development. If a drug
is designated as a breakthrough therapy, the FDA may expedite the
development and review of such drug.4
U.S. Indication for TRUMENBA® (Meningococcal
Group B Vaccine)
TRUMENBA is a vaccine indicated for individuals 10 through 25
years of age for active immunization to prevent invasive disease
caused by Neisseria meningitidis (N meningitidis) group B. The
effectiveness of the two-dose schedule of TRUMENBA against diverse
N meningitidis group B strains has not been confirmed.
IMPORTANT SAFETY INFORMATION
TRUMENBA should not be given to anyone with a history of a
severe allergic reaction after a previous dose of TRUMENBA. Some
individuals with weakened immune systems may have a reduced immune
response.
As with any vaccine, vaccination with TRUMENBA may not protect
all vaccine recipients against N meningitidis group B
infections.
The most common adverse reactions in adolescents and young
adults were pain at injection site, fatigue, headache, and muscle
pain. Nausea was reported in adolescents in early phase
studies.
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 health care provider if you are pregnant, or plan to
become pregnant. Ask your health care provider about the risks and
benefits of TRUMENBA. Only a health care 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
http://labeling.pfizer.com/ShowLabeling.aspx?id=1796.
About TRUMENBA® (Meningococcal Group B
Vaccine)
TRUMENBA® (Meningococcal Group B Vaccine) 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. 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.5
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).
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, we have worked to make a difference for
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DISCLOSURE NOTICE: The information contained in this
release is as of April 23, 2018. 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 a potential expanded
indication to prevent invasive disease caused by MenB in children
ages 1 through 9 years, including its 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 ability to obtain
recommendations from vaccine technical committees and other public
health authorities regarding TRUMENBA and uncertainties regarding
the commercial impact of any such recommendations; 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 or
additional analyses of existing clinical data; the risk that
clinical trial data are subject to differing interpretations, and,
even when we view data as sufficient to support the safety and/or
effectiveness of a product candidate, regulatory authorities may
not share our views and may require additional data or may deny
approval altogether; whether regulatory authorities will be
satisfied with the design of and results from our clinical studies;
whether and when any supplemental biologics license applications
may be filed in any jurisdictions for the potential expanded
indication for TRUMENBA or in any other jurisdictions for any other
potential indications for TRUMENBA; whether and when any such
applications may be approved by regulatory authorities, 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 and, if approved,
whether TRUMENBA will be commercially successful; decisions by
regulatory authorities regarding labeling and other matters that
could affect the availability or commercial potential of TRUMENBA,
including the potential expanded indication; 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, 2017 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 Kieny MP, Excier J,
Girard M. Research and development of new vaccines against
infectious diseases. Am J Public Health. 2004;94(11):1931-1935.2
Soeters HM, McNamara LA, Whaley M, Wang X, Alexander-Scott N,
Kanadanian, KV, et al. Serogroup B meningococcal disease outbreak
and carriage evaluation at a college – Rhode Island, 2015. MMWR
Morb Mortal Wkly Rep. 2015;64(22):606-607.3 US CDC Enhanced
Meningococcal Disease Surveillance Report, 2016. Available at:
https://www.cdc.gov/meningococcal/downloads/NCIRD-EMS-Report.pdf4
Food and Drug Administration Fact Sheet Breakthrough Therapies at
https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm5
TRUMENBA (meningococcal group B vaccine) prescribing information.
Philadelphia, PA: Pfizer, Inc. 2017.
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Pfizer Inc.Media:Jessica Smith,
212-733-6123jessica.m.smith@pfizer.comorInvestors:Ryan Crowe,
212-733-8160ryan.crowe@pfizer.com
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