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 toxoid–containing vaccine
•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 (0.9%) •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 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, 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. References 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. 2008;83(42):373-384. 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.
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