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FDA Approves 2 New Vaccines

February 28, 2010
On February 24, 2010, the U.S. Food and Drug Administration (FDA) approved Pfizer's Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children 6 weeks through 5 years of age. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

On February 16, 2010, the FDA approved the vaccine Menveo by Novartis to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 when administered to individuals 11 through 55 years of age.

Click on the following links for additional information on these two new vaccines:

Pfizer payment policy for Prevnar 13 and amended return policy for Prevnar 7
FDA approval letter, package insert, and press release for Prevnar 13
FDA approval letter and package insert for Menveo

The AAP's Red Book OnlineVaccine Status Table has been updated to include the new licensure of both Prevnar 13 and Menveo.

FDA Approves 2 New Vaccines has been found in News

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