Committee’s Recommendation Allows for
Individual Clinical Decision
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 decisions to
vaccinate adolescents and young adults 16 through 23 years of age
against serogroup B meningococcal disease should be made at the
individual level with healthcare providers. Specifically, the ACIP
voted that a serogroup B meningococcal (MenB) vaccine series may be
administered to adolescents and young adults 16 through 23 years of
age to provide short term protection against most strains of
serogroup B meningococcal disease. The preferred age for MenB
vaccination is 16 through 18 years of age.
Pfizer’s TRUMENBA® (Meningococcal Group B Vaccine) is
FDA-approved for active immunization to prevent invasive disease
caused by Neisseria meningitidis serogroup B in individuals 10
through 25 years of age.
“Healthcare providers should understand the importance of
today’s ACIP recommendation to help protect adolescents and young
adults,” said Dr. Laura York, Global Medical Lead for Meningococcal
Vaccines, Pfizer Vaccines. “This recommendation is an important
step forward that provides guidance that serogroup B meningococcal
disease vaccination may be administered between the ages of 16
through 23, with preferred timing for vaccination between ages 16
through 18.”
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.
“Serogroup B meningococcal disease is an uncommon but serious
illness that attacks without warning and may become
life-threatening within 24 hours,” said Susan Silbermann,
President, Pfizer Vaccines. “Parents and healthcare providers
should take action now and consider vaccination particularly for
those aged 16 through 23. No one in this age group should lack
access to potentially life-saving vaccines.”
This recommendation expands the CDC’s ACIP February 2015
recommendation for serogroup B meningococcal vaccination.
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 Serogroup B meningococcal 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 serogroup B meningococcal 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 June 24, 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;
uncertainties regarding whether and when the CDC will make any
Category A recommendations regarding serogroup B meningococcal
vaccination; 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 efficacy 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 June 5, 2015.
5 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.
6 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.
7 Brigham KS, Sandora TJ. Neisseria meningitidis: epidemiology,
treatment and prevention in adolescents. Curr Opin Pediatr. 2009;
21: 437-443.
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 June 5, 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 June 5, 2015.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150624006209/en/
Media:Pfizer Inc.Sally Beatty,
+1-347-330-7867sally.beatty@pfizer.comorInvestors:Ryan Crowe,
+1-212-733-8160ryan.crowe@pfizer.com
Pfizer (NYSE:PFE)
Historical Stock Chart
From Apr 2024 to May 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From May 2023 to May 2024