Pfizer Inc. (NYSE:PFE) announced today that the European Medicines
Agency’s Committee for Medicinal Products for Human Use (CHMP) has
adopted a positive opinion recommending that the indication for Prevenar
13* (pneumococcal polysaccharide conjugate vaccine
[13-valent, adsorbed]) be expanded to include the prevention of
pneumonia caused by the 13 pneumococcal serotypes in the vaccine in
adults 18 years and older. Prevenar 13 is currently approved in Europe
for the prevention of invasive pneumococcal disease (IPD) in the same
population. The CHMP’s positive opinion will now be reviewed by the
European Commission (EC). The decision on whether to approve Prevenar
13 for this indication will be made by the EC and will be applicable to
all European Union member states plus Iceland, Lichtenstein and Norway.
The CHMP opinion was granted following review of the results from the
Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA).
Pfizer conducted this study as part of its regulatory commitments to
global regulatory authorities, including the European Medicines Agency.
The study achieved its primary and secondary objectives. The primary
endpoint evaluated the efficacy of Prevenar 13 for the prevention of a
first episode of vaccine-type community-acquired pneumonia (CAP) in
adults 65 years of age and older. Secondary endpoints were the
prevention of a first episode of vaccine-type
non-invasive/non-bacteremic CAP, and prevention of a first episode of
vaccine-type IPD in adults aged 65 and older.
This study is one of the largest double-blind, randomized,
placebo-controlled vaccine efficacy trials ever conducted in older
adults. It involved approximately 85,000 subjects aged 65 years and
older and 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-nine
sentinel hospitals were used for the surveillance of CAP and IPD.
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, Canada, Australia
and Japan. It is the most widely used pneumococcal conjugate vaccine
(PCV) in the world, and more than 750 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 it is also approved in the United States,
European Union (EU) and other countries for use in older children and
adolescents aged 6 to 17 years. Prevenar 13 is also approved in the EU
for use in adults 18 to 49 years of age.
U.S. INDICATIONS FOR PREVNAR 13®
-
Prevnar 13® is a vaccine approved in the U.S. 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
in the U.S. 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
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 (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 (0.9%)
-
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 you
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®
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to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
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more than 150 years, Pfizer has worked to make a difference for all who
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DISCLOSURE NOTICE: The information contained in this release is as of
January 22, 2015. 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 regarding Prevnar
13/Prevenar 13 and a potential expanded indication in the European Union
to include the prevention of pneumonia caused by the 13 pneumococcal
serotypes in the vaccine in adults 18 years and older, including their
potential benefits, that involves substantial risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied by such statements. Risks and uncertainties
include, among other things, whether and when the European Commission
(the “EC”) may approve the potential expanded indication, as well as the
EC’s decisions regarding labeling and other matters that could affect
the availability or commercial potential of the potential expanded
indication; uncertainties concerning the commercial impact of the
results of the CAPiTA (Community-Acquired Pneumonia Immunization Trial
in Adults) trial and the potential expanded indication; uncertainty
concerning whether and when regulatory authorities in various
jurisdictions will update the label and vaccine technical committees in
various jurisdictions (other than the U.S. Centers for Disease Control
and Prevention’s Advisory Committee on Immunization Practices) 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
additional jurisdictions 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 jurisdictions where
such applications are pending or submitted will approve any such
submissions, as well as their decisions regarding labeling and other
matters that could affect the availability or 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 our subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information That May Affect Future Results”, as well as in its
subsequent reports on Form 8-K, all of which are filed with the SEC and
available at www.sec.gov and
www.pfizer.com.
* Trademark. Prevnar 13® is the trade name in the
United States, Canada, and Taiwan.
Copyright Business Wire 2015