Pneumococcal Vaccine with Broader Protection Cleared

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The FDA has approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and children aged six weeks through five years. Prevnar 13 will be the successor to Prevnar, the pneumococcal seven-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

Prevnar 13 is approved for the prevention of invasive disease caused by 13 different serotypes of Streptococcus pneumoniae. It also is approved for the prevention of otitis media caused by the seven serotypes shared with Prevnar.

“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,” Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research, said in a news release. “The availability of Prevnar 13 will help prevent pneumococcal disease caused by the six additional serotypes.”

Prevnar 13 is manufactured by Wyeth Pharmaceuticals Inc. of Collegeville, Pa., a wholly owned subsidiary of Pfizer Inc.

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