Pfizer Receives FDA Approval For The Use Of Prevnar 13 In Vaccine-Naive Children And Adolescents Aged 6 Years Through 17 Years For The Prevention Of Invasive Pneumococcal Disease

Fri Jan 25, 2013 4:22pm EST

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Prevnar 13 is the First and Only Pneumococcal Conjugate Vaccine Approved for
This Age Group
NEW YORK--(Business Wire)--
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug
Administration (FDA) has granted approval for the expansion of the company`s
pneumococcal conjugate vaccine, Prevnar 13®* (Pneumococcal 13-valent Conjugate
Vaccine [Diphtheria CRM197 Protein]), for use in older children and adolescents
aged 6 years through 17 years for active immunization for the prevention of
invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained
in the vaccine. For this age group, Prevnar 13 is administered as a one-time
dose to patients who have never received Prevnar 13.1

"As a global leader in pneumococcal disease prevention, extending the impact of
Prevnar 13 to older children and adolescents aged 6 through 17 years is a
reflection of our dedication to improving public health worldwide," said Susan
Silbermann, president, vaccines, Pfizer. "We continue to work tirelessly to make
this vaccine available to people at risk for invasive pneumococcal disease." 

The FDA approval followed submission and review of a Phase 3, open-label trial
of Prevnar 13 in 592 older children and adolescents, including those with
asthma.2 The study met all endpoints, demonstrating immunogenicity and
establishing a safety profile in children aged 6 years through 17 years
consistent with the safety profile established in previous trials in infants and
young children.2

About Prevnar 13

Prevnar 13 was first introduced for use in infants and young children in
December 2009 in Europe and in February 2010 in the U.S., and it is now approved
for such use in nearly 120 countries worldwide. It is the most widely used
pneumococcal conjugate vaccine in the world, and more than 500 million doses of
Prevnar/Prevnar 13 have been distributed worldwide. Currently, Prevnar 13 is
included as part of a national or regional immunization program in more than 60
countries, offering coverage against invasive pneumococcal disease to nearly 30
million children per year.3

Prevnar 13 is also approved for use in adults 50 years of age and older in more
than 80 countries and it is the first and only pneumococcal vaccine to be
granted World Health Organization prequalification in the adult population.3

About Pneumococcal Disease

Pneumococcal disease (PD) is a group of illnesses caused by the bacterium
Streptococcus pneumoniae (S. pneumoniae), also known as pneumococcus.4 PD is
associated with significant morbidity and mortality.4 Invasive manifestations of
the disease include bacteremia (bacteria in the blood) and meningitis (infection
of the tissues surrounding the brain and spinal cord).4 Invasive pneumococcal
disease can affect people of all ages, although older adults and young children
are at heightened risk.4,5,6

U.S. Indication for Prevnar 13

* Prevnar 13 is a vaccine approved for the prevention of invasive disease caused
by 13 S. 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, and in children 6 weeks
through 5 years for the prevention of otitis media caused by 7 of the 13 strains
(4, 6B, 9V, 14, 18C, 19F, and 23F) 
* Based upon immune responses to the vaccine, Prevnar 13 is also approved for
adults 50 years of age and older for the prevention of pneumococcal pneumonia
and invasive disease caused by the 13 vaccine strains 
* Prevnar 13 is not 100% effective and will only help protect against the 13
strains included in the vaccine 
* Effectiveness when given less than 5 years after a pneumococcal polysaccharide
vaccine is not known

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 (e.g., HIV infection,
leukemia) may have a reduced immune response 
* A temporary pause of breathing following vaccination has been observed in some
infants born prematurely 
* The most commonly reported serious adverse events in children were
bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation
of the stomach and small intestine) (0.9%), and pneumonia (0.9%) 
* In infants and toddlers, the most common side effects were tenderness, redness
or swelling at the injection site, irritability, decreased appetite, decreased
or increased sleep, and fever 
* 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,
joint pain, decreased appetite, chills, or rash 
* Ask your health care provider about the risks and benefits of Prevnar 13. Only
a health care provider can decide if Prevnar 13 is right for your child

For the full prescribing information for Prevnar 13, please click here
http://www.pfizer.com/products/#prevnar13

Pfizer Inc.: Working together for a healthier world

At Pfizer, we apply science and our global resources to improve health and
well-being at every stage of life. We strive to set the standard for quality,
safety and value in the discovery, development and manufacturing of medicines
for people and animals. Our diversified global health care portfolio includes
human and animal biologic and small molecule medicines and vaccines, and many of
the world's best-known consumer 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 the world's leading biopharmaceutical
company, we also 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 about our commitments, please
visit us at www.pfizer.com. 

DISCLOSURE NOTICE:The information contained in this release is as of January 25,
2013. 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 that involves substantial
risks and uncertainties regarding potential indications for Prevnar 13/Prevenar
13 in age groups for which it has notreceived regulatory approval in various
jurisdictions. Such risks and uncertainties include, among other things, the
uncertainties inherent in research and development; decisions by regulatory
authorities in jurisdictions in which applications have been or may be filed for
such potential indications regarding whether and when to approve such
applications, as well as their decisions regarding labelling and other matters
that could affect the availability and commercial potential of such indications;
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, 2011, and in its
reports on Form 10-Q and Form 8-K.

References

1
        Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine 
        [Diphtheria CRM197 Protein]) DRAFT Prescribing Information, 
        Wyeth Pharmaceuticals Inc.
      2
        Data on File (DOF). 13vPnC-Infant Clinical Study Report. Final Report 
        For Groups 3 And 4: A Phase 3, Open Label Trial Evaluating The Safety, 
        Tolerability, And Immunogenicity Of 13 Valent Pneumococcal Conjugate 
        Vaccine In Healthy Children Aged 15 Months To 17 Years In The United 
        States.
      3
        Pfizer Data on File (DOF).
      4
        World Health Organization (WHO). 23-valent pneumococcal polysaccharide 
        vaccine. WHO Position Paper. Wkly Epidemiol Rec. 
        2008;83(42):373-384.
      5
        Centers for Disease Control and Prevention. Updated recommendations 
        for prevention of invasive pneumococcal disease among adults using the 
        23-valent pneumococcal polysaccharide vaccine (PPSV23). MMWR. 
        2010;59(34):1102-1106.
      6
        Centers for Disease Control and Prevention. Prevention of pneumococcal 
        disease among infants and children – use of 13-valent pneumococcal 
        conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine. 
        Recommendations of the Advisory Committee on Immunization Practices 
        (ACIP). 2010;59(RR-11):1-19.

*Prevnar 13 is referred to as Prevenar 13 in most countries outside the United
States.

Pfizer Inc.
Media:
Jennifer Kokell, 917-741-4254
jennifer.kokell@pfizer.com
or
Investors:
Jennifer Davis, 212-733-0717
Jennifer.m.davis@pfizer.com

Copyright Business Wire 2013

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