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Prevnar 13 is a sterile solution of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F individually conjugated by reductive amination to nontoxic diphtheria CRM197 protein. The polysaccharides are chemically activated and then covalently linked to the protein carrier CRM197 to form the glycoconjugate.
Individual conjugates are compounded and then polysorbate 80, succinate buffer 5 mM and aluminum phosphate are added to formulate the vaccine. The potency of the vaccine is determined by the quantity of the saccharide antigens and the saccharide-to-protein ratios in the individual glycoconjugates.
Each 0.5-mL dose contains approximately 2.2 mcg of each saccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F and approximately saccharide 4.4 mcg for serotype 6B, conjugated to CRM197 carrier protein, 0.02% polysorbate 80 and aluminum 0.125 mg as aluminum phosphate adjuvant.
