Pfizer Presents Detailed Results From Landmark Community-Acquired Pneumonia Immunization Trial In Adults (CAPiTA) Evaluating

  Pfizer Presents Detailed Results From Landmark Community-Acquired Pneumonia
  Immunization Trial In Adults (CAPiTA) Evaluating Efficacy Of Prevenar 13*

 Study Findings, Presented at ISPPD, Demonstrate that Prevenar 13 Can Prevent
                  Vaccine-Type Community-Acquired Pneumonia

Business Wire

NEW YORK -- March 12, 2014

Pfizer Inc. (NYSE:PFE) today presented detailed results of the
Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the
landmark study of approximately 85,000 subjects, demonstrating that Prevenar
13^* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed])
prevented a first episode of vaccine-type community-acquired pneumonia (CAP)
in adults 65 years of age and older, the study’s primary objective. This trial
is the first in adults to clearly demonstrate a significant reduction in
vaccine-type pneumococcal CAP, and importantly, non-bacteremic/non-invasive
vaccine-type pneumococcal CAP. Results were presented during the late-breaker
session at the 9th International Symposium on Pneumococci and Pneumococcal
Diseases (ISPPD) in Hyderabad, India, on March 12, 2014.

CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) also met
both of its secondary study objectives –significant reduction in (i)
non-bacteremic/non-invasive vaccine-type pneumococcal CAP and (ii)
vaccine-type invasive pneumococcal disease (IPD).

Regarding the study’s primary objective, there were 45.56 percentfewer first
episodes of vaccine-type CAP among Prevenar 13-vaccinated subjects than in
subjects who received placebo (P=0.0006). Regarding the study’s secondary
objectives, the Prevenar 13 group experienced45.00 percent fewer first
episodes of non-bacteremic/non-invasive vaccine-type CAP (P=0.0067) and 75.00
percent fewer first episodes of vaccine-type IPD (P=0.0005) compared with the
placebo group. The safety profile of Prevenar 13 in this study was consistent
with studies previously conducted in adults.

Additional data showed reductions in vaccine-type CAP,
non-bacteremic/non-invasive vaccine-type CAP, and vaccine-type IPD for up to
four years after vaccination among subjects who received Prevenar 13.

“With the aging of the population, hospitalizations due to pneumococcal
pneumonia represent a growing burden to public health systems. Evidence from
this study is particularly important for a population in which age-related
decline of the immune system makes it difficult to prevent disease,” said Dr.
Emilio A. Emini, senior vice president, Vaccine Research and Development,

“This study demonstrated that vaccination with Prevenar 13 can prevent a
significant portion of pneumococcal community-acquired pneumonia in adults
aged 65 and older, which is an important global public health goal,” said
principal investigator Prof. Marc Bonten, professor of Molecular Epidemiology
of Infectious Diseases, Department of Medical Microbiology, Julius Center for
Health Sciences & Primary Care, University Medical Center Utrecht in the

The CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) study
data will be an important part of any consideration of potential new or
updated recommendations for Prevenar 13 in adults. Other key factors also are
expected to be taken into consideration, including the current burden of
pneumococcal disease in adults.

About CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults)

In 2011, Prevnar 13 was licensed by the U.S. Food and Drug Administration
under an accelerated approval process to address an unmet medical need in
older adults. As a requirement of the accelerated approval pathway, Pfizer
conducted CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults)
to verify clinical benefit.

This was a parallel-group, randomized, placebo-controlled, double-blind,
single-center trial in which subjects aged 65 years and older were randomly
assigned to receive a single dose of either Prevnar 13 or placebo. A total of
84,496 subjects were enrolled. The trial was conducted by Julius Clinical, a
spin-off of the Julius Center for Health Sciences and Primary Care, a division
of the University Medical Center Utrecht in the Netherlands. Fifty-eight
sentinel hospitals were used for the surveillance of CAP and IPD.

Vaccine-type CAP (VT-CAP) was defined as CAP caused by any Streptococcus
pneumoniae serotype included in the vaccine. Non-bacteremic/noninvasive VT-CAP
was defined as CAP in which vaccine-type S. pneumoniae caused the pneumonia,
but was not detected concurrently in the bloodstream or any other normally
sterile site. Vaccine-type IPD was defined as a case in which vaccine-type S.
pneumoniae was present in the bloodstream or any other normally sterile site,
with or without pneumonia.

About Pneumococcal Disease

Pneumococcal disease refers to a group of illnesses caused byS. pneumoniae
bacteria.^1 Invasive pneumococcal disease occurs when bacteria enter the
bloodstream, or another site that is normally sterile.^2 Non-invasive
pneumococcal pneumonia occurs when the bacteria cause infection in the lungs
but are not detected in the blood concurrently.^1 In adults, pneumonia is the
most common presentation of pneumococcal disease.^1 For every one case of
invasive pneumococcal pneumonia in adults, it is estimated that at least three
cases of non-invasive pneumococcal pneumonia occur.^3 While non-invasive forms
of pneumococcal disease are typically more common, the invasive types of
disease are generally more severe.^4

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, including the United States and Japan. It is the most
widely used pneumococcal conjugate vaccine (PCV) in the world, and more than
640 million doses of Prevenar 7-valent/Prevenar 13 have been distributed
worldwide. In addition, Prevenar 13 is approved for use in adults 50 years of
age and older in more than 90 countries, and is also approved in the United
States and European Union (EU) for use in older children and adolescents aged
6 to 17 years. Recently, Prevenar 13 was also approved in the EU for use in
adults 18 to 49 years of age.


  *Prevnar 13^® is a vaccine approved for adults 50 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). This indication is based upon immune responses to
    the vaccine
  *For children 6 weeks through 17 years of age, Prevnar 13^® is approved for
    the prevention of invasive disease caused by the 13 vaccine strains, and
    for children 6 weeks through 5 years for the prevention of otitis media
    caused by 7 of the 13 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


  *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, 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
  *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 health care provider about the risks and benefits of Prevnar
    13^®. Only a health care provider can decide if Prevnar 13^® is right for

For the full prescribing information for Prevnar 13, please click here

Pfizer Inc.: Working together for a healthier world®

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DISCLOSURE NOTICE: The information contained in this release is as of March
12, 2014. 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 Prevnar 13/Prevenar 13, including its
potential benefits, and about the CAPiTA (Community-Acquired Pneumonia
Immunization Trial in Adults) trial. Such risks and uncertainties include,
among other things, uncertainty concerning the commercial impact of the
results of the trial; uncertainty concerning whether and when regulatory
authorities in various jurisdictions will update the label and vaccine
technical committees in various jurisdictions will update their
recommendations with respect to the use of Prevnar 13/Prevenar 13 in adults
based on the results of the CAPiTA (Community-Acquired Pneumonia Immunization
Trial in Adults) trial and other factors; whether and when regulatory
submissions may be made in jurisdictions other than the U.S. for Prevenar 13
for the prevention of pneumococcal pneumonia in adults caused by the 13
serotypes in Prevenar 13, and whether and when regulatory authorities in such
jurisdictions will approve any such submissions, as well as their decisions
regarding labeling and other matters that could affect the availability and
commercial potential of that additional indication for Prevenar 13 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, 2013 and in
its subsequent reports on Form 10-Q and Form 8-K.

^* Trademark. Prevnar 13^® is the trade name in the United States, Canada, and

^1 Centers for Disease Control and Prevention. Pneumococcal disease. In:
Atkinson W, Wolfe S, Hamborsky J, eds. Epidemiology and Prevention of
Vaccine-Preventable Diseases. 12th ed., second printing. Washington DC: Public
Health Foundation, 2012.

^2 Musher DM. Streptococcus pneumoniae. In: Mandell GL, Douglas JE, Dolin R,
eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious
Diseases. 7^th ed. Elsevier: 2010.

^3 Said MA, Johnson HL, Nonyane BAS, et al. Estimating the burden of
pneumococcal disease among adults: a systematic review and meta-analysis of
diagnostic techniques. PLoS ONE. 2013;8(4):e60273.

^4 World Health Organization (WHO).Immunization, vaccines and biologicals.
Pneumococcalvaccines. 2003.


Pfizer Inc.
Sally Beatty, 212-733-6566
Chuck Triano, 212-733-3901
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