Pfizer Announces Positive Top-Line Results Of Landmark Community-Acquired Pneumonia Immunization Trial In Adults (CAPiTA)

  Pfizer Announces Positive Top-Line Results Of Landmark Community-Acquired
  Pneumonia Immunization Trial In Adults (CAPiTA) Evaluating Efficacy Of
  Prevenar 13*

    Data to Be Presented at 9th International Symposium on Pneumococci and
               Pneumococcal Diseases (ISPPD) on March 12, 2014

Business Wire

NEW YORK -- February 24, 2014

Pfizer Inc. (NYSE:PFE) today announced that the Community-Acquired Pneumonia
Immunization Trial in Adults (CAPiTA), the landmark study of approximately
85,000 subjects evaluating the efficacy of Prevenar 13^* (pneumococcal
polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults 65 years of
age and older, achieved its primary clinical objective and both secondary
clinical objectives. CAPiTA is the largest double-blind, randomized,
placebo-controlled vaccine efficacy trial ever conducted in adults.

The primary objective of the study was to demonstrate efficacy of Prevenar 13
against a first episode of vaccine-type community-acquired pneumonia (CAP).
The CAPiTA study also met both secondary objectives, which were efficacy
against (i) a first episode of non-bacteremic/non-invasive vaccine-type CAP
and (ii) a first episode of vaccine-type invasive pneumococcal disease (IPD).

Vaccine-type CAP (VT-CAP) was defined as CAP caused by any S. pneumoniae
serotype included in the vaccine. Non-bacteremic/non-invasive 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.

“We are pleased with the outcome of the CAPiTA study, which demonstrated that
Prevenar 13 can prevent vaccine-type pneumococcal community-acquired pneumonia
in adults,” said Dr. William Gruber, senior vice president, Vaccine Clinical
Research, Pfizer.

“Pneumococcal pneumonia is a significant cause of illness and death in adults
around the world, and the potential to reduce the burden of this disease
through direct vaccination of adults represents a meaningful public health
benefit,” said Dr. Emilio A. Emini, senior vice president, Vaccine Research
and Development, Pfizer. “Pfizer looks forward to sharing the CAPiTA data with
U.S. and worldwide regulatory authorities, and vaccine technical committees,
to help inform decisions regarding potential Prevenar 13 label and
recommendation updates.”

The CAPiTA data will be an important component in any consideration of
potential new or updated Prevenar 13 recommendations for adults. In addition,
other key factors will be taken into consideration, such as the current burden
of pneumococcal disease in adults.

Prevnar 13 was licensed by the FDA 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 to verify clinical

Detailed results will be presented at the 9th International Symposium on
Pneumococci and Pneumococcal Diseases (ISPPD) in Hyderabad, India, on March
12, 2014, during the late-breaker session from 2:30 p.m. to 4:10 p.m. IST/5
a.m. to 6:40 a.m. EDT.

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 CAPiTA

As part of its regulatory commitments under the FDA’s accelerated approval
program, Pfizer conducted the CAPiTA study, which was designed to evaluate the
efficacy of Prevnar 13 in the prevention of vaccine-type pneumococcal
pneumonia. CAPiTA is the largest double-blind, randomized, placebo-controlled
vaccine efficacy trial ever conducted in adults. It involved approximately
85,000 subjects aged 65 years and older. 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.
The safety profile of Prevenar 13 observed in CAPiTA was consistent with
studies previously conducted in adults. The safety data will be included in
the presentation at ISPPD.

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

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DISCLOSURE NOTICE: The information contained in this release is as of February
24, 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 trial. Such risks and uncertainties
include, among other things, uncertainty concerning the commercial impact of
the results of the CAPiTA 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 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/A for the fiscal year ended December 31, 2012 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.
Pneumoccocal Vaccines. 2003.


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