Recommendation provides updated guidance for
administering a two- or a three-dose series
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers
for Disease Control and Prevention’s (CDC) Advisory Committee on
Immunization Practices (ACIP) voted to recommend that:
- For persons at increased risk for
meningococcal disease and for use during serogroup B outbreaks, 3
doses of TRUMENBA should be administered at 0, 1-2, and 6
months
- When given to healthy adolescents who
are not at increased risk for meningococcal disease, 2 doses of
TRUMENBA should be administered at 0 and 6 months
- If the second dose is given at an
interval of less than 6 months, a third dose should be given at
least 6 months after the first dose
“Today’s ACIP recommendation is an important update that offers
clear guidance to healthcare providers administering TRUMENBA to
help prevent meningococcal group B disease, also known as MenB, in
healthy adolescents and young adults, as well as those at increased
risk for the disease,” said Dr. Laura York, Global Medical Lead for
Meningococcal Vaccines, Pfizer Vaccines. “This new recommendation
enables flexible vaccination dosing intervals depending on one’s
risk of exposure to MenB, which makes it easier for healthcare
providers to help protect individuals from this uncommon but
life-threatening disease.”
The ACIP recommendation will be forwarded to the director of the
CDC and the U.S. Department of Health and Human Services for review
and approval. Once approved, the recommendations are published in
the Morbidity and Mortality Weekly Report (MMWR). The Affordable
Care Act (ACA) and Vaccines for Children (VFC) program ensure
coverage for all vaccines administered in accordance with ACIP
recommendations. Healthcare providers should contact their
individual plan to determine specific coverage and reimbursement
requirements.
In 2015, the CDC’s ACIP recommended serogroup B meningococcal
vaccination for certain persons aged 10 years and older at
increased risk for meningococcal disease.1 They also recommended
that a MenB vaccine series may be administered to adolescents and
young adults 16 through 23 years of age (preferred age 16 through
18) to provide short-term protection against most strains of MenB
disease.2 In October 2014, TRUMENBA 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.
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 and Europe. The effectiveness of TRUMENBA against
diverse 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 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® (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.3
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.
In April 2016, the FDA approved a revised dosing schedule for
TRUMENBA based on data from the U.S. and European Phase 2
trials.
TRUMENBA is now approved to be administered in two dosing
schedules:
- Three-Dose Schedule: Administer
a dose (0.5 mL) at 0, 1-2, and 6 months; or
- Two-Dose Schedule: Administer a
dose (0.5 mL) at 0 and 6 months.
- The choice of dosing schedule may
depend on the risk of exposure and the patient’s susceptibility to
meningococcal serogroup B disease.3
About Group B Meningococcal (MenB) Disease
The majority of invasive meningococcal disease cases worldwide
can be attributed to five Neisseria meningitidis serogroups (A, B,
C, W and Y).4 MenB affects all age groups in the U.S., but
incidence is highest among infants younger than one year,
adolescents and young adults.5 MenB accounts for nearly 50 percent
of all U.S. meningococcal cases in 17-23 year olds.6
Although uncommon, MenB may result in life-altering, significant
long-term and permanent medical disabilities.7,8,9 However, even
with antibiotic treatment, 10 to 15 percent of patients with MenB
die and many of those who survive are afflicted with long-term
disabilities, such as brain damage, hearing loss, learning
disabilities or limb amputations.10,11,12
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
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Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this
release is as of October 19, 2016. 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 recommendations 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 additional jurisdictions
for TRUMENBA; whether and when any applications that are pending or
that may be filed 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, 2015 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 Folaranmi T, Rubin L, Martin S, Patel M, MacNeil J. Use of
Serogroup B Meningococcal Vaccines in Persons Aged ≥10 Years at
Increased Risk for Serogroup B Meningococcal Disease:
recommendations of the Advisory Committee on Immunization
Practices, 2015. MMWR. June 12, 2015; 64(22): 608-612.
2 MacNeil JR, Rubin L, Folaranmi T, Ortega-Sanchez IR, Patel M,
Martin SW. Use of Serogroup B Meningococcal Vaccines in Adolescents
and Young Adults: Recommendations of the Advisory Committee on
Immunization Practices, 2015. MMWR Morb Mortal Wkly Rep. 2015;
64(41): 1171-1176.
3 TRUMENBA (Meningococcal Group B Vaccine) Prescribing
Information. Philadelphia, PA: Pfizer, Inc. 2016.
4 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.
5 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.
6 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.
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 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.
9 Brigham KS, Sandora TJ. Neisseria meningitidis:
epidemiology, treatment and prevention in adolescents. Curr
Opin Pediatr. 2009; 21: 437-443.
10 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.
11 Centers for Disease Control and Prevention. Meningococcal
Vaccines for Preteens, Teens.ast updated April 18, 2016. Accessed
June 1, 2016.
12 Centers for Disease Control and Prevention. Epidemiology and
Prevention of Vaccine-Preventable Diseases: Meningitis.
http://www.cdc.gov/vaccines/pubs/pinkbook/mening.html. Last updated
July 24, 2015. Accessed September 30, 2016.
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Pfizer Inc.Media:Sally Beatty, +1 (347)
330-7867sally.beatty@pfizer.comorInvestor:Ryan Crowe, +1 (212)
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