Pfizer Inc. (NYSE: PFE) welcomes today's announcement from the GAVI
Alliance that Pfizer's pneumococcal conjugate vaccine, Prevenar 13*
(pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]),
is now included in the expanded pediatric immunization program in
Tanzania. Pneumococcal disease is one of the leading causes of
vaccine-preventable deaths worldwide in children younger than 5 years of
age and results in more than one out of every five deaths in children
younger than 5 years of age in Tanzania.2,3
The availability of Prevenar 13 in Tanzania is made possible by the
Advance Market Commitment (AMC), an innovative funding mechanism that
provides newer vaccines on a sustainable, affordable and accelerated
basis to the world's poorest countries. In just two years, 20 countries,
including Tanzania, have introduced Prevenar 13 into their immunization
programs as part of the AMC. This potentially lifesaving vaccine is
being offered to help protect an estimated 10.5 million infants and
children in these developing countries from pneumococcal pneumonia and
invasive disease caused by the serotypes in the vaccine.1,4
"Pfizer is accelerating access to Prevenar 13 to infants and children
who are most vulnerable, and our partnership with the GAVI Alliance
helps ensure that this goal is realized," says Susan Silbermann,
president, vaccines, Pfizer. "Since pneumococcal pneumonia continues to
be a major threat to young children in Tanzania, the AMC has the
potential to significantly contribute to the achievement of the United
Nation's fourth Millennium Development Goal of reducing infant mortality
two-thirds by 2015."5
While public health interventions have helped to decrease infant
mortality in Tanzania by 47 percent between 1990 and 2010,5
mortality rates are still among the highest in the world. There are more
than 100,000 deaths of Tanzanian children under the age of 5 every year.6
On Dec. 6, 2012, representatives from the GAVI Alliance, including board
chair Dagfinn Høybråten; the United Nations; government officials,
including Tanzania's Minister of Health and Social Welfare, Hussein Ali
Mwinyi; and the country's first lady, Salma Kikwete, will gather at a
health and vaccination center in Morogoro, outside Dar es Salaam, for
the official launch and immunization of the first Tanzanian child with
Pfizer will supply up to 480 million doses of Prevenar 13 under the AMC
to help expand immunization programs against pneumococcal disease by
About the Advance Market Commitment (AMC)
Pfizer has been a long-standing partner of the GAVI Alliance, since
March 2010, when the Company entered into the first 10-year agreement to
provide Prevenar 13 to infants and young children in the world's poorest
countries under the AMC framework. Pneumococcal vaccines are expected to
reach more than 50 GAVI-supported countries by 2015.
In December 2010, Nicaragua became the first GAVI-eligible country to
launch a pneumococcal conjugate vaccine, Prevenar 13, through the AMC.
To date, Prevenar 13 has been introduced into the national immunization
programs of the following GAVI-eligible countries: Benin, Burundi,
Cameroon, Central African Republic, Congo, Democratic Republic of Congo,
Djibouti, Gambia, Ghana, Guyana, Honduras, Malawi, Mali, Nicaragua,
Rwanda, Sao Tome, Sierra Leone, Tanzania, Yemen and Zimbabwe.7
To meet the growing global need for Prevenar 13, Pfizer is increasing
its manufacturing capabilities through a combination of capital
investment, process improvements and efficiency measures throughout its
supply network. Additionally, Pfizer is engaged in the development of a
preserved, multi-dose vial which, subject to the required regulatory
approval, World Health Organization prequalification and AMC eligibility
requirements, would provide an alternative option for developing world
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. It is already the most widely used
pneumococcal conjugate vaccine in the world, and more than 500 million
doses of Prevenar/Prevenar 13 have already been distributed worldwide.7
Currently, Prevenar 13 is included as part of a national
immunization program in more than 60 countries, offering coverage
against invasive pneumococcal disease to more than 30 million children
Prevenar 13 offers the broadest serotype coverage of any currently
available pneumococcal conjugate vaccine for prevention of pneumococcal
disease including invasive pneumococcal disease, pneumonia and otitis
media.8 The 13 pneumococcal serotypes in Prevenar 13 (1, 3,
4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are among the most
prevalent invasive-disease causing strains in children worldwide.8,9
Prevenar 13 is also approved for use in adults 50 years of age and older
in more than 100 countries, and is the first and only pneumococcal
vaccine to be granted World Health Organization prequalification in the
Prevenar 13 is marketed in the United States as Prevnar 13®
(Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197
Pneumococcal disease is a group of illnesses caused by the bacterium Streptococcus
pneumoniae (S. pneumoniae), also known as pneumococcus.11
It includes invasive infections such as bacteremia and meningitis, as
well as non-invasive disease such as pneumonia and acute otitis media.11
While pneumococcus can infect people of all ages, infants and young
children and the elderly are at heightened risk.12 The World
Health Organization estimates that more than 1.6 million people -
including more than 800,000 children under 5 years of age - die every
year from pneumococcal infections. Nearly all these deaths occur in the
world's poorest countries.13
Indications for Prevnar 13 in the United States
In the United States, Prevnar 13 is indicated for use in children six
weeks through 5 years of age for the prevention of invasive disease
(e.g., meningitis, bacteremia) caused by 13 Streptococcus pneumoniae
serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The
vaccine is also indicated in adults 50 years of age and older for active
immunization for the prevention of pneumonia and invasive disease caused
by the 13 Streptococcus pneumoniae serotypes contained in the
vaccine (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
Indication is based on immune responses.
World Health Organization Indication for
The World Health Organization prequalified Prevenar 13 for active
immunization of infants and children from 6 weeks through five years of
age against invasive disease, pneumonia and otitis media and for active
immunization of adults 50 years of age and older against pneumonia and
invasive disease caused by the 13 pneumococcal serotypes (1, 3, 4, 5,
6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) contained in the vaccine. The
World Health Organization prequalification allows for the procurement of
Prevenar 13 by United Nations agencies. The prequalification is for
global use of the vaccine in a single-dose vial.
Important Safety Information for Prevnar 13
•Prevnar 13 should not be given to anyone with a history of severe
allergic reaction to any component of Prevnar 13 or any diphtheria
•Children and adults with weakened immune systems (e.g., HIV infection,
leukemia) may have a reduced immune response
•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
•In adults, immune responses to Prevnar 13 were reduced when given with
injected seasonal flu vaccine
•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 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
For the full prescribing information for Prevnar 13 in the U.S., please
click here http://www.pfizer.com/products/#prevnar13.
Pfizer Inc: Working together for a healthier
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, 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 release
is as of December 5, 2012. 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 that involves
substantial risks and uncertainties regarding Prevenar 13, including its
potential benefits and the success of the AMC project for vaccines. Such
risks and uncertainties include, among other things, the uncertainties
inherent in research and development; whether and when regulatory
authorities in countries where applications for Prevenar
13 and/or for the preserved, multi-dose vial for Prevenar 13 have been
or may be submitted will approve such applications and their decisions
regarding labeling and other matters that could affect its availability
or commercial potential; 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.
1. State of Worlds Midwifery 2011. "Country Information." Chapter 4.
Available at http://www.unfpa.org/sowmy/resources/en/country_info.htm.
Accessed November 29, 2012.
2. World Health Organization (WHO). 23-valent pneumococcal
polysaccharide vaccine. WHO Position Paper. Wkly Epidemiol Rec.
3. Samarasekera U. Tanzania to introduce vaccines to tackle childhood
pneumonia. The Lancet Infectious Diseases. 2008;8 (7):408.
4. Central Intelligence Agency (CIA). World Fact Book. "Population" and
"Birth Rates." 2012. Available at https://www.cia.gov/library/publications/the-world-factbook/index.html.
Accessed November 29, 2012.
5. Millennium Development Goals Report 2012: Assessing Progress in
Africa Toward the Millennium Development Goals. 2012.
6. UNICEF. Tanzania Statistics. 2010. Available at http://www.unicef.org/infobycountry/tanzania_statistics.html p=printme.
Accessed November 29, 2012.
7. Pfizer Data on File (DOF).
8. Prevenar 13 Global Summary of Product Characteristics (SmPC). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001104/WC500057247.pdf.
9. Johnson, H. et al. Systematic Evaluation of Serotypes Causing
Invasive Pneumococcal Disease among Children Under Five: The
Pneumococcal Global Serotype Project. PLoS Medicine, 2010: Vol 7, Issue
10. Adult Prevnar 13 USPI. 2011. http://labeling.pfizer.com/showlabeling.aspx id=501.
11. Centers for Disease Control and Prevention. Prevention of
Pneumococcal Disease: Recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR Recommendations and Reports.
12. World Health Organization (WHO). Pneumococcal Vaccines. 2003.
Available at http://www.who.int/vaccines/en/pneumococcus.shtml.
Accessed February 9, 2011.
13. National Institute of Allergy and Infectious Diseases (NIAID).
Pneumococcal Disease. 2009. Available at http://www.niaid.nih.gov/topics/pneumococal/Pages/PneumococcalDisease.aspx.
Accessed November 29, 2012.
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