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
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
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.
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The information contained in this release is as of January 8, 2013. 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 potential indications for Prevnar 13/Prevenar 13 in age groups for which it has not
received regulatory approval in various jurisdictions. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities in jurisdictions in which applications have been or may be filed for such potential indications regarding whether and when to approve such applications, as well as their decisions regarding labeling and other matters that could affect the availability and commercial potential of such indications; 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.