Data Consistent with Immunogenicity and
Safety Data from Previous Studies
Pfizer Inc. (NYSE:PFE) announced today positive topline results
of two Phase 3 studies of TRUMENBA® (Meningococcal Group B
Vaccine). One study included approximately 3,600 healthy
individuals 10 through 18 years of age, and the other study
included approximately 3,300 healthy individuals 18 through 25
years of age. Both studies met all primary immunogenicity
endpoints, demonstrating robust immune responses against certain
invasive meningococcal B strains after the vaccine dose series.
Safety and tolerability data from both studies were also consistent
with data from previous studies.
“We are very pleased with these Phase 3 data that show
immunogenicity and safety data consistent with findings that formed
the basis for the accelerated FDA approval of TRUMENBA,” said
Kathrin Jansen, Ph.D., senior vice president of Vaccine Research
and Development for Pfizer Inc. “The Phase 3 data extend the body
of evidence that supports vaccination of adolescents and young
adults with TRUMENBA to help prevent serogroup B meningococcal
disease.”
In October 2014, Pfizer’s TRUMENBA® (Meningococcal Group B
Vaccine) was granted accelerated approval by the U.S. Food and Drug
Administration (FDA) for active immunization to prevent invasive
disease caused by Neisseria meningitidis serogroup B in individuals
10 through 25 years of age.
Pfizer plans to present the full results of both studies at an
upcoming scientific congress.
Phase 3 Study Designs
Vaccine safety and immunogenicity were evaluated in these two
Phase 3 studies.
One Phase 3 study was a randomized, active-controlled,
observer-blinded study that included approximately 3,600 healthy
individuals 10 through 18 years of age in the United States and
Europe. Individuals were randomized to receive one of three
different lots of TRUMENBA® in a 0, 2, 6 month schedule or a
control. The control group received a licensed hepatitis A (HAV)
vaccine at 0 and 6 months and saline at 2 months. The primary
endpoints assessed immunogenicity, lot consistency and safety.
- Immunogenicity: Demonstration of an
immune response measured by serum bactericidal assays with human
complement (hSBA) for 4 primary test strains 1 month after the
third vaccination with TRUMENBA
- Lot consistency: hSBA geometric mean
titers (GMTs) for 2 primary test strains (A22 and B24) measured 1
month after the third vaccination for individuals receiving one of
three different lots of TRUMENBA
- Safety: Proportion of subjects who
reported local and systemic reactions, adverse events (AE), serious
adverse events (SAE), newly diagnosed chronic medical conditions
(NDCMC), medically-attended adverse events (MAE), autoimmune
diseases and neuroinflammatory conditions following vaccination
with TRUMENBA or a control
A second Phase 3 study was a randomized, placebo-controlled,
observer-blinded study that included approximately 3,300 healthy
individuals 18 through 25 years of age in the United States and
Europe. Individuals were randomized to receive TRUMENBA® or a
saline control in a 0, 2, 6 month schedule. The primary endpoints
assessed immunogenicity and safety.
- Immunogenicity: Demonstration of an
immune response measured by hSBA for 4 primary test strains 1 month
after the third vaccination with TRUMENBA
- Safety: Proportion of subjects who
reported local and systemic reactions, AEs, SAEs, NDCMCs, MAEs,
autoimmune diseases and neuroinflammatory conditions following
vaccination with TRUMENBA or placebo
U.S. Indication for TRUMENBA® (Meningococcal
Group B Vaccine)
TRUMENBA® (Meningococcal Group B Vaccine) is indicated for
active immunization to prevent invasive disease caused by Neisseria
meningitidis serogroup B in individuals 10 through 25 years of
age.
Approval of TRUMENBA is based on the demonstration of immune
response, as measured by serum bactericidal activity against four
serogroup B strains representative of prevalent strains in the
United States. The effectiveness of TRUMENBA against diverse
serogroup 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.
Individuals with weakened immune systems may have a reduced
immune response.
The most common adverse reactions were pain at the injection
site, fatigue, headache, muscle pain, and chills.
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® 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.1
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).
In 2014, TRUMENBA was reviewed and received accelerated approval
under the FDA's Breakthrough Therapy designation and Priority
Review programs.
About Serogroup B Meningococcal Disease
The majority of invasive meningococcal disease cases worldwide
can be attributed to five Neisseria meningitidis serogroups (A, B,
C, W and Y).2 Meningococcal serogroup B disease affects all age
groups in the U.S., but incidence is highest among infants younger
than one year, adolescents and young adults.3 In 2013,
approximately 500 cases of meningococcal disease occurred in the
United States, more than 30 percent of which were caused by
serogroup B.4
Serogroup B meningococcal disease may result in life-altering,
significant long-term and permanent medical disabilities.5,6,7
Despite the availability of antibiotic treatment, 12.5 percent of
patients with meningococcal serogroup B disease die and many of
those who survive are afflicted with long-term disabilities, such
as brain damage, hearing loss, learning disabilities or limb
amputations.8,9
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. To learn more, please visit us at
www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this
release is as of August 21, 2015. 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), 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 commercial
impact of the ACIP’s recommendation regarding TRUMENBA;
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 jurisdictions other than
the United States for TRUMENBA; whether and when any such other
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; 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, 2014 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 SEC and available at www.sec.gov and
www.pfizer.com.
1 TRUMENBA® (Meningococcal Group B Vaccine) Prescribing
Information. Philadelphia, PA: Pfizer, Inc. 2015.
2 Pinto VB, Burden R, Wagner A, Moran EE, Lee C. The Development
of an Experimental Multiple Serogroups Vaccine for Neisseria
meningitidis. PLoS ONE. 2013; 8(11): 1-10.
3 Cohn A, MacNeil JR, Harrison LH, et al. Changes
in Neisseria meningitidis disease epidemiology in the
United States, 1998-2007: implications for prevention of
meningococcal disease. Clin Infect Dis. 2010; 50: 184-191.
4 Centers for Disease Control and Prevention. Active Bacterial
Core Surveillance (ABCs) Report: emerging infections program
network, Neisseria meningitidis, 2013.
http://www.cdc.gov/abcs/reports-findings/survreports/mening13.pdf.
Accessed August 6, 2015.
5 Sabatini C, Bosis S, Semino M, Senatore L, Principi N,
Esposito S. Clinical Presentation of Meningococcal Disease in
Childhood. J Prev Med Hyg. 2012; 53: 116-119.
6 Brigham KS, Sandora TJ. Neisseria meningitidis:
epidemiology, treatment and prevention in adolescents. Curr
Opin Pediatr. 2009; 21: 437-443.
7 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.
8 MacNeil J. Epidemiology of Serogroup B Meningococcal Disease,
United States. Presented at the Advisory Committee on Immunization
Practices, Centers for Disease Control and Prevention. October 30,
2014. Centers for Disease Control and Prevention website:
http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2014-10/mening-02-MacNeil.pdf.
Accessed August 6, 2015.
9 Centers for Disease Control and Prevention. Preteens, Teens
Need Meningococcal Vaccine.
http://www.cdc.gov/features/meningococcal/. Last updated April 30,
2015. Accessed August 6, 2015.
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Pfizer Inc.Media:Sally Beatty,
+1-347-330-7867sally.beatty@pfizer.comorInvestors:Ryan Crowe,
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