Prevnar 13 receives FDA approval

ROCKVILLE, Md. The Food and Drug Administration has approved a vaccine for preventing pneumococcal disease in children, the agency announced Wednesday.

The FDA approved Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]), manufactured by Pfizer subsidiary Wyeth Pharmaceuticals. Prevnar 13, approved for preventing pneumococcal disease in children ages 6 weeks to 5 years, prevents against 13 types of the bacterium Streptococcus pneumoniae, compared to the original Prevnar, which prevented against seven types.

“Although the rates of invasive pneumococcal disease have declined dramatically, there are still children in the United States who are suffering with this serious illness,” FDA Center for Biologics Evaluation and Research acting director Karen Midthun stated. “The availability of Prevnar 13 will help prevent pneumococcal disease caused by the six additional serotypes.”

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