Pfizer Inc (NYSE: PFE) issued the following statement in response to
today’s Centers for Disease Control and Prevention’s (CDC) Advisory
Committee on Immunization Practices (ACIP) vote to recommend the use of
Pfizer’s Prevnar 13® (Pneumococcal 13-valent Conjugate
Vaccine [Diphtheria CRM197 Protein]) for adults 19 years of
age and older with immunocompromising conditions. The ACIP defines
immunocompromised as those people who have functional or anatomic
asplenia, HIV infection, cancer, advanced kidney disease, or other
immunocompromising conditions.
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Pfizer believes that Prevnar 13 offers a significant health benefit and
compelling value proposition for the U.S. health care system. We are
committed to continuing discussions with the ACIP with the aim of
expanding the recommendations to include all adults 50 years of age and
older – a population rapidly increasing in the United States and at risk
for developing vaccine-type pneumococcal pneumonia and invasive disease.
In December 2011, Prevnar 13 was approved by the U.S. Food and Drug
Administration (FDA) under an accelerated approval pathway for adults 50
years of age and older for active immunization for the prevention of
pneumococcal pneumonia and invasive disease caused by the 13 serotypes
contained in the vaccine. This indication is based on immune responses
elicited by Prevnar 13. There have been no controlled trials in adults
demonstrating a decrease in pneumococcal pneumonia or invasive disease
after vaccination with Prevnar 13. Prevnar 13 is not FDA-approved for
patients 6 through 49 years of age.
Pfizer is conducting a variety of clinical studies using Prevnar 13 in
immunocompromised individuals and expects results at the end of 2012 and
into 2013. Data on the safety and effectiveness of Prevnar 13 when
administered to immunocompromised individuals are not available. These
individuals may have reduced antibody response to active immunization
due to impaired immune responsiveness.
Pfizer is conducting the Community-Acquired Pneumonia Immunization Trial
in Adults (CAPiTA) and will share results with the ACIP once complete.
The ACIP will consider these results and other available evidence before
developing a recommendation regarding routine use of Prevnar 13 in
adults aged 50 years of age and older. CAPiTA is an efficacy trial
involving more than 84,000 subjects 65 years of age and older designed
to evaluate whether Prevnar 13 is effective in preventing the first
episode of community-acquired pneumonia (CAP) caused by the 13
pneumococcal serotypes contained in the vaccine. Pfizer estimates that
the primary outcome measures for this event-driven study will be
available in 2013.
Prevnar 13 is available commercially for adults 50 years of age and
older in the United States, as well as many other countries around the
world. Prevnar 13 was first approved in the United States in February
2010 for the prevention of invasive pneumococcal disease caused by the
13 serotypes included in the vaccine in infants and young children from
6 weeks through 5 years of age.
INDICATIONS FOR PREVNAR 13
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Prevnar 13 is a vaccine indicated 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.
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In children 6 weeks through 5 years of age, Prevnar 13 is indicated
for the prevention of invasive disease caused by these same strains,
and for the prevention of ear infection caused by 7 of the 13 strains
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Prevnar 13 is not 100% effective and will only help protect against
the 13 strains included in the vaccine
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Effectiveness when given less than 5 years after a pneumococcal
polysaccharide vaccine is not known
IMPORTANT SAFETY INFORMATION
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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
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Children and adults with weakened immune systems (eg, HIV infection,
leukemia) may have a reduced immune response
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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
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In adults, immune responses to Prevnar 13 were reduced when given with
injected seasonal flu vaccine
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A temporary pause of breathing following vaccination has been observed
in some infants born prematurely
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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 (0.9%)
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In infants and toddlers, the most common side effects were tenderness,
redness or swelling at the injection site, irritability, decreased
appetite, decreased or increased sleep, and fever
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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™
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, as well as nutritional products
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 www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this statement is as
of June 20, 2012. Pfizer assumes no obligation to update forward-looking
statements contained in this statement as the result of new information
or future events or developments.
This statement contains forward-looking information that involves
substantial risks and uncertainties regarding the use of Prevnar 13 for
adults 50 years of age and older (the Prevnar 13 Adult indication),
including its potential benefits. Such risks and uncertainties include,
among other things, the uncertainties inherent in research and
development, including uncertainty regarding the results of and the
anticipated completion dates of the CAPiTA trial and of ongoing trials
of Prevnar 13 in immunocompromised individuals as well as the impact of
those trial results on the commercial potential of the Prevnar 13 Adult
indication; uncertainty regarding whether and when ACIP will recommend
the routine use of Prevnar 13 by all adults 50 years of age and older
and the impact of ACIP’s decision on the commercial potential of the
Prevnar 13 Adult indication; 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.
