Pfizer Presents Phase 3 Safety And Immunogenicity Data On Prevenar 13 In Adults Aged 18 To 49 Years

  Pfizer Presents Phase 3 Safety And Immunogenicity Data On Prevenar 13 In
  Adults Aged 18 To 49 Years

Business Wire

NEW YORK -- April 28, 2013

Pfizer Inc. (NYSE:PFE) presented today the results from a Phase 3 study
investigating immunogenicity, tolerability and safety of Prevenar 13*
(Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in
adults 18 to 49 years of age. The study met all primary and secondary
objectives and provides the clinical foundation for the Company’s regulatory
submission in the European Union (EU) and planned regulatory submissions in
the United States (U.S.) and other countries around the world to seek
expansion of the use of Prevenar 13 to include adults 18 to 49 years of age.
These results were presented at the 23^rd European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID) in Berlin, Germany.

Data from this study showed that Prevenar 13 was at least as immunogenic in
adults 18 to 49 years of age as it is in adults 60 to 64 years of age, as
measured one month after vaccination; for adults 18 to 49 years of age,
functional antibody responses to all 13 serotypes included in the vaccine were
non-inferior to responses in adults 60 to 64 years of age. ^ In the study,
Prevenar 13 showed a favorable safety profile and was generally well
tolerated. Pain at the injection site was the most frequently observed local
reaction. Muscle pain, headache and fatigue were the most common systemic

“This important analysis shows the immunogenicity and safety profile following
vaccination with Prevenar 13 in adults aged 18 to 49 years. This vaccine has
the potential to help prevent pneumococcal disease caused by the Streptococcus
pneumoniae serotypes contained in the vaccine,” said lead investigator Dr.
Kristina Bryant, associate professor of Pediatrics at the University of

Currently, Prevenar 13, or Prevnar 13 as it is called in the U.S., Canada and
Taiwan, is approved in more than 120 countries worldwide for use in infants
and young children and in more than 80 countries for use in adults 50 years of
age and older.

“Pfizer is committed to developing vaccines with the goal of preventing
serious disease through every stage of life,” said Dr. William Gruber, senior
vice president, Pfizer Vaccine Clinical Research and Development. “We continue
to further investigate the use of Prevenar 13 with the aim of broadening
prevention efforts to additional populations.”

This study, titled “Immunogenicity and safety of a 13-valent pneumococcal
conjugate vaccine in adults 18-49 years, naïve to 23-valent pneumococcal
polysaccharide vaccine,” was presented as an ePoster during the session
“Streptococcus pneumoniae: Serotypes and Vaccination,” at ECCMID 2013 on April
28 at 1:30 p.m. CEST.

Pneumococcal Disease (PD)

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

E.U. Indication for Prevenar 13

Prevenar 13 is approved in the EU for the prevention of invasive disease,
pneumonia and acute otitis media caused by S. pneumoniae serotypes (1, 3, 4,
5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in children and adolescents
aged 6 weeks to 17 years. It is also approved in the EU for the prevention of
invasive disease caused by 13 S. pneumoniae serotypes (single dose) in adults
50 years and older.

U.S. Indication for Prevnar 13

  *Prevnar 13 is a vaccine approved for children 6 weeks through 17 years of
    age 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), and for
    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
  *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. Most commonly
    reported side effects in children 5 years through 17 years also included
    hives 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 you or
    your child

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

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DISCLOSURE NOTICE: The information contained in this release is as of April
28, 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 a regulatory submission in the European
Union (EU) and planned regulatory submissions in other countries to include
data on adults 18 to 49 years of age in the Prevnar 13/Prevenar 13 label,
including its potential benefits. Such risks and uncertainties include, among
other things, the uncertainties inherent in research and development; whether
and when regulatory submissions may be made in jurisdictions other than the EU
for this potential label update for Prevnar 13/Prevenar 13; decisions by the
European Medicines Agency and regulatory authorities in other jurisdictions in
which submissions may be made regarding whether and when to approve this
potential label update for Prevnar 13/Prevenar 13 as well as their other
decisions regarding labeling and other matters that could affect the
availability and commercial potential of Prevnar 13/Prevenar 13 for adults 18
to 49 years of age; 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 reports on Form 10-Q and Form 8-K.

*Trademark. Prevenar 13 is referred to as Prevnar 13 in the United States.


Pfizer Inc.
Victoria Davis, +1 484-865-5194(o)
Suzanne Harnett, +1 212-733-8009(o)
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