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Figure 1. Pneumococcal serotypes included in the currently licensed 7-valent and 13-valent pneumococcal conjugate vaccines.
(Figure omitted. See article PDF.)
Figure 2. Rank order and cumulative worldwide distribution of Streptococcus pneumoniae serotypes covered by the 13-valent pneumococcal conjugate vaccine (PCV13). Serotype distribution derived from McIntosh and Reinert [Manuscript in Preparation].
(Figure omitted. See article PDF.)
The 13-valent pneumococcal conjugate (PCV13, Prevenar 13®® , Pfizer Inc., NY, USA) was developed as a successor to the currently registered 7-valent pneumococcal conjugate vaccine (PCV7, which contains serotypes 4, 6B, 9V, 14, 18C, 19F and 23F; Prevnar®® /Prevenar®® , Pfizer Inc.), for use in infants and young children to prevent disease such as invasive pneumococcal disease (IPD), nonbacteremic pneumonia and acute otitis media (AOM), caused by the 13 pneumococcal serotypes contained in the vaccine. In addition to the serotypes in PCV7, PCV13 contains serotypes 1, 3, 5, 6A, 7F and 19A [1].
For PCV13, the global pediatric filings were initiated in late 2008 and, to date, regulatory applications for PCV13 have been submitted in more than 50 countries spanning six continents. The first country to approve PCV13 was Chile on 14th July 2009. PCV13 has been granted priority review in the USA, Canada, Australia and South Africa. In Europe, this vaccine received positive feedback from the Committee for Medicinal Products for Human Use (CHMP) on 24th September 2009 and received market authorization on 11th December 2009.
Streptococcus pneumoniae is a major source of morbidity and mortality worldwide. It is estimated by the WHO that approximately one million children die of pneumococcal disease every year, mostly in developing countries [2]. Pneumococcal infections are the leading cause of death from a vaccine-preventable illness in children younger than 5 years of age [3,4]. Invasive diseases caused by pneumococci include meningitis, bacteremia, and pneumonia with bacteremia and/or empyema [5].
PCV7 was licensed in the USA in the year 2000 and in Europe in 2001. By December 2009, PCV7 was licensed in approximately 100 of 193 member states of the WHO. In addition, it had been included in the routine or national immunization programs or was widely used in 42 of these countries.
The achievements of the PCV7 vaccination programs were recently reviewed in detail in this journal [6,7], and...