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
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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
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.
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