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Pfizer Receives European Approval To Expand Use Of Prevenar 13 To Older Children And Adolescents Aged 6 To 17 Years For The

  Pfizer Receives European Approval To Expand Use Of Prevenar 13 To Older
  Children And Adolescents Aged 6 To 17 Years For The Prevention Of
  Pneumococcal Disease

Prevenar 13 is the First and Only Pneumococcal Conjugate Vaccine Approved for
                                This Age Group

Business Wire

NEW YORK -- January 8, 2013

Pfizer Inc. (NYSE: PFE) announced today that the European Commission has
approved expanding the use of the company’s pneumococcal conjugate vaccine,
Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent,
adsorbed]), to older children and adolescents aged 6 to 17 years for active
immunization for the prevention of invasive disease, pneumonia and acute
otitis media caused by vaccine-type Streptococcus pneumoniae. Children in this
age group who have not previously received Prevenar 13 may receive a single
dose of the vaccine.

“Prevenar 13 has been administered to millions of infants and young children
around the world and helps protect against the often fatal effects of
pneumococcal disease,” said Emilio Emini, Ph.D., chief scientific officer,
Vaccine Research, Pfizer. “As the global leader in pneumococcal disease
prevention, Pfizer continues to study the use of this life-saving vaccine
across all ages.”

The European Commission’s decision to approve this expanded indication
followed submission and review of a Phase 3, open-label trial of Prevenar 13
in 592 healthy children and adolescents, including those with underlying
medical conditions such as asthma (17.4% of the study population). The study
met all endpoints, demonstrating immunogenicity and establishing a safety
profile in children and adolescents aged 6 to 17 years consistent with the
safety profile established in previous trials in infants and young children.

“Children and adolescents aged 6 to 17 with underlying medical conditions have
an increased risk of pneumococcal disease,” said Luis Jodar, Ph.D., vice
president, Vaccines Global Medicines Development Group, Pfizer. “Pfizer will
continue working with health authorities worldwide in an effort to provide
access to Prevenar 13 to those at risk of disease.”

About Prevenar 13

Prevenar 13 was first introduced for use in infants and young children in
December 2009 in Europe and is now approved for such use in more than 120
countries worldwide. It is the most widely used pneumococcal conjugate
vaccine, with more than 500 million doses of Prevenar/Prevenar 13 having been
distributed worldwide. ^ Currently, Prevenar 13 is included as part of a
national or regional immunization program in more than 60 countries, helping
to protect more than 30 million children per year against invasive
pneumococcal disease.

Prevenar 13 offers the broadest serotype coverage of any currently available
pneumococcal conjugate vaccine for prevention of pneumococcal disease
including invasive pneumococcal disease, pneumonia and otitis media. The 13
pneumococcal serotypes in Prevenar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C,
19A, 19F and 23F) are among the most prevalent invasive-disease-causing
strains in children worldwide.

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

Prevenar 13 is marketed in the United States as Prevnar 13^® (Pneumococcal
13-valent Conjugate Vaccine [Diphtheria CRM[197] Protein]). In the United
States, Prevnar 13 is not indicated for the prevention of pneumococcal
pneumonia in the pediatric population.

Pneumococcal Disease

Pneumococcal Disease (PD) is a group of illnesses caused by the bacterium
Streptococcus pneumoniae (S. pneumoniae), also known as pneumococcus. While
pneumococcus can infect people of all ages, infants, and young children and
individuals with certain underlying chronic conditions, are at heightened
risk. Certain underlying medical conditions, such as asthma and illnesses that
impact a person’s immune system, can increase an individual’s risk of PD. PD
is associated with significant morbidity and mortality.

Indication for Prevenar 13 in Europe

Prevenar 13 is approved in the EU for active immunization for the prevention
of invasive disease, pneumonia and acute otitis media caused by  vaccine-type
S. pneumoniae in infants and children from 6 weeks to 17 years of age and
invasive pneumococcal disease in adults aged 50 years and older.

Important Safety Information for Prevenar 13

The use of Prevenar 13 should be determined on the basis of official
recommendations taking into consideration the impact of invasive disease in
different age groups as well as the variability of serotype epidemiology in
different geographical areas.

In clinical studies, the most commonly reported adverse reactions were
injection-site reactions, fever, irritability, decreased appetite, and
increased and/or decreased sleep.

Risks are associated with all vaccines, including Prevenar 13.
Hypersensitivity to any component, including diphtheria toxoid, is a
contraindication to its use. As with other vaccines, the administration of
Prevenar 13 should be postponed in subjects suffering from acute, severe
febrile illness. However, the presence of a minor infection, such as a cold,
should not result in the deferral of vaccination. Prevenar 13 does not provide
100 percent protection against vaccine serotypes or protect against
non-vaccine serotypes.

Indications for Prevnar 13 in the United States

In the United States, Prevnar 13 is indicated for use in children six weeks
through 5 years of age for the prevention of invasive disease (e.g.,
meningitis, bacteremia) caused by 13 Streptococcus pneumoniae serotypes (1, 3,
4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The vaccine is also
indicated in adults 50 years of age and older for active immunization for the
prevention of pneumonia and invasive disease caused by the 13 Streptococcus
pneumoniae serotypes contained in the vaccine (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14,
18C, 19A, 19F and 23F). Indication is based on immune responses.

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

DISCLOSURE NOTICE: The information contained in this release is as of January
8, 2013. Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future events or

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 not received 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 labeling 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.



Pfizer Inc.
Media Contact:
Victoria Davis, 347-558-3455
Investor Contact:
Jennifer Davis, 212-733-0717
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