Designation Will Enable Increased Access to
Vaccine in World’s Poorest Countries
Pfizer Inc. (NYSE: PFE) announced today that the World Health
Organization (WHO) has prequalified its four-dose, multi-dose vial
(MDV) presentation of Prevenar 13®* (pneumococcal polysaccharide
conjugate vaccine [13 – valent, adsorbed]). WHO prequalification
allows for the global use of Prevenar 13® MDV by United Nations
agencies and countries worldwide that require WHO
prequalification.
“It is unconscionable that children in developing countries are
still falling ill, or dying, by the hundreds of thousands every
year from preventable diseases like invasive pneumococcal disease
and meningitis,” said Orin Levine, director of the vaccine delivery
team at the Bill & Melinda Gates Foundation. “We need a range
of tools to save children's lives and welcome advances like this
one that help improve our ability to prevent life-threatening
invasive pneumococcal disease.”
“We are pleased that the WHO has prequalified the MDV
presentation of Prevenar 13®, another crucial step in providing
broader global access to this important vaccine for those who need
it,” said Susan Silbermann, President and General Manager, Pfizer
Vaccines. “Pfizer is committed to continued innovation aimed at
meeting the challenges of the developing world and helping to
prevent invasive pneumococcal disease by providing a path for
children in resource-limited countries to access a reliable supply
of Prevenar 13®.”
The MDV presentation of Prevenar 13® offers significant
benefits to developing countries, including a 75 percent reduction
in:
- Temperature-controlled supply chain
requirements,
- United Nations Children’s Fund (UNICEF)
shipping costs, and
- Storage requirements at the national,
regional, district, and community levels.
The Prevenar 13® MDV presentation includes the preservative
2-Phenoxyethanol, which enables use of the vaccine over a 28-day
period following its first use, provided it is stored at 2-8
degrees Celsius. This presentation has been approved in the
European Union following the positive opinion from the Committee
for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) in April 2016.
“It is encouraging to see vaccine manufacturers committed to
addressing the unique conditions and challenges experienced by
those of us working in communities whose health systems are still
developing,” said Dawda Sowe, Program Manager, Expanded Program on
Immunization, The Gambia. “The MDV presentation is expected to aid
in increasing availability of Prevenar 13®, thereby allowing us to
help protect more infants and children against invasive
pneumococcal disease.”
The prequalified MDV presentation is expected to be introduced
under the Advance Market Commitment (AMC) program in early 2017,
for shipment to countries supported by Gavi, the Vaccine Alliance
(Gavi). In January 2015, during Gavi’s pledging conference, Pfizer
began to prepare for the potential introduction of Prevenar 13® in
the MDV presentation by announcing a 20 cent reduction in cost,
from $3.30 per-dose to $3.10 per-dose, in its MDV per-dose price
for Gavi-eligible countries. Once the MDV presentation is
introduced under the AMC, this pricing is expected to be available
to all Gavi-eligible countries. In addition, expanded availability
will enable Gavi-graduated countries to access the same pricing
until 2025.
Pfizer Vaccines in the Developing World
Accelerating the availability of potentially life-saving
vaccines around the world is a key component of Pfizer’s commitment
to making true inroads toward global healthcare access. Through its
participation in international public-private programs, Pfizer
provides its 13-valent pneumococcal conjugate vaccine, Prevenar
13®, to infants and young children in the developing world to help
protect against invasive pneumococcal disease. Since 2010, more
than 40 low- and lower middle-income countries have launched
pneumococcal immunization programs with Prevenar 13®, via the
Advance Market Commitment, an innovative program by Gavi, the
Vaccine Alliance.1 With continued investment in research and
development, Pfizer has helped meet the challenges of the
developing world by providing innovative manufacturing, storage,
inventory management, and supply chain solutions. Pfizer also
continues to develop and deliver educational materials to aid
healthcare workers in the field and supports surveillance studies
to understand the impact of pneumococcal immunization programs on
reducing the burden of disease. For more information on Pfizer
Vaccines in the Developing World, go to
http://www.pfizer.com/health/vaccines/developing_world.
About Prevenar 13®
Prevenar 13®*(pneumococcal polysaccharide conjugate vaccine [13
– valent, adsorbed]) was first approved in the European Union (EU)
in December 2009 for use in infants and young children to help
protect against invasive pneumococcal disease. Prevenar 13® is
approved for such use in more than 150 countries worldwide,
including the United States, Canada, Australia and Japan. Prevenar
13® is the most widely used pneumococcal conjugate vaccine in the
world, and is included in the pediatric National Immunization
Programs in 102 countries.2,3 It is approved in the United States,
EU and other countries for use in infants, older children and
adolescents aged 6 to 17 years.
In addition, Prevenar 13® is approved for use in adults 50 years
of age and older in more than 100 countries. Prevenar 13® is now
approved in the U.S., the EU and 44 other countries for use in
adults 18 to 49 years of age.
*Trademark. Prevnar 13® is the trade name in the United
States, Canada, and Taiwan.
U.S. INDICATIONS FOR PREVNAR 13®
- Prevnar 13® is a vaccine approved
for adults 18 years of age and older for the prevention of
pneumococcal pneumonia and invasive disease caused by
13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B,
7F, 9V, 14, 18C, 19A, 19F, and 23F)
- In children 6 weeks through 17 years of
age (prior to the 18th birthday), Prevnar 13® is indicated for
the prevention of invasive disease caused by S
pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,
19F, and 23F
- In children 6 weeks through 5 years of
age (prior to the 6th birthday), Prevnar 13® is indicated for
the prevention of otitis media caused by S
pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
- Prevnar 13® is not 100% effective
and will only help protect against the 13 strains included in the
vaccine
IMPORTANT SAFETY INFORMATION
- Prevnar 13® should not be given to
anyone with a history of severe allergic reaction to any component
of Prevnar 13® or any diphtheria toxoid–containing
vaccine
- Children and adults with weakened
immune systems (eg, HIV infection, leukemia) may have a reduced
immune response
- In adults, immune responses to Prevnar
13® were reduced when given with injected seasonal flu
vaccine
- In adults, the common side effects were
pain, redness, or swelling at the injection site, limitation of arm
movement, fatigue, headache, muscle pain, vomiting, joint pain,
decreased appetite, chills, or rash
- A temporary pause of breathing
following vaccination has been observed in some infants born
prematurely
- The most commonly reported serious
adverse events in infants and toddlers were bronchiolitis (an
infection of the lungs) (0.9%), gastroenteritis (inflammation of
the stomach and small intestine) (0.9%), and pneumonia (0.9%)
- In children 6 weeks through 17 years,
the most common side effects were tenderness, redness, or swelling
at the injection site, irritability, decreased appetite, decreased
or increased sleep, and fever
- Ask your healthcare provider about the
risks and benefits of Prevnar 13®. Only a healthcare provider can
decide if Prevnar 13® is right for you or your child
For the full prescribing information for Prevnar 13®, please
click
here http://www.pfizer.com/products/product-detail/prevnar_13.
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. For more information, please visit us
at www.pfizer.com. In addition, to learn more, follow us on
Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of July 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 regarding
Prevnar 13®/Prevenar 13®, including its potential benefits and the
expected timing of the introduction of the four-dose, multi-dose
vial (MDV) presentation under the Advance Market Commitment, 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 MDV
presentation of Prevenar 13®; uncertainty regarding whether the
anticipated benefits of the WHO prequalification will be realized;
whether and when regulatory submissions may be made in additional
jurisdictions for the Prevnar 13®/Prevenar 13® MDV presentation,
and whether and when regulatory authorities in jurisdictions where
such applications are pending or submitted will approve any such
submissions, as well as their decisions regarding labeling and
other matters that could affect the availability or commercial
potential of the Prevnar 13®/Prevenar 13® MDV presentation in those
jurisdictions; 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 our 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 Gavi, the Vaccine Alliance. Advance Market Commitment for
Pneumococcal Vaccines: Annual Report. April 1, 2014-March 31, 2015.
http://www.gavi.org/library/documents/amc/2015-pneumococcal-amc-annual-report/.
Accessed March 2, 2016.
2 Data on file. Pfizer Inc, New York, NY. [Total Prevenar 13V
Doses Through May 2016]
3 GlaxoSmithKline. GSK’s Synflorix™ receives CHMP positive
opinion for major label extension. July 27,
2015. http://www.gsk.com/en-gb/media/press-releases/2015/gsk-s-synflorix-receives-chmp-positive-opinion-for-major-label-extension/.
Accessed July 7, 2016.
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version on businesswire.com: http://www.businesswire.com/news/home/20160719005745/en/
Pfizer Inc.Media:Dawn Carty, 00353
876711651dawn.carty@pfizer.comorSally Beatty,
347-330-7867sally.beatty@pfizer.com
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