Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children - Advisory Committee on Immunization Practices (ACIP), 2010.

On February 24, 2010, a 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.]) was licensed by the Food and Drug Administration (FDA) for prevention of invasive pneumococcal disease (IPD) caused by the 13 pneumococcal serotypes covered by the vaccine and for prevention of otitis media caused by serotypes in the 7-valent pneumococcal conjugate vaccine formulation (PCV7 [Prevnar, Wyeth]). PCV13 is approved for use among children aged 6 weeks-71 months and succeeds PCV7, which was licensed by FDA in 2000. The Pneumococcal Vaccines Work Group of the Advisory Committee on Immunization Practices (ACIP) reviewed available data on the immunogenicity, safety, and cost-effectiveness of PCV13, and on estimates of the vaccine-preventable pneumococcal disease burden. The working group then presented policy options for consideration of the full ACIP. This report summarizes recommendations approved by ACIP on February 24, 2010, for 1) routine vaccination of all children aged 2-59 months with PCV13, 2) vaccination with PCV13 of children aged 60-71 months with underlying medical conditions that increase their risk for pneumococcal disease or complications, and 3) PCV13 vaccination of children who previously received 1 or more doses of PCV7. CDC guidance for vaccination providers regarding transition from PCV7 to the PCV13 immunization program also is included.