Vaxneuvance Description

VAXNEUVANCE is a suspension for injection available in 0.5 mL single-dose prefilled syringes.
The vaccine is an opalescent suspension.
Composition: Active Ingredient: Each 0.5 mL dose contains 32 mcg of total pneumococcal polysaccharide (2.0 mcg each of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4.0 mcg of polysaccharide serotype 6B) conjugated to 30 mcg of CRM₁₉₇ carrier protein.
Chemistry: VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine [CRM₁₉₇ Protein], adsorbed) is a sterile suspension of purified capsular polysaccharides from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F individually conjugated to CRM₁₉₇. Each pneumococcal capsular polysaccharide is activated via sodium metaperiodate oxidation and then individually conjugated to CRM₁₉₇ carrier protein via reductive amination. CRM₁₉₇ is a nontoxic mutant of diphtheria toxin (originating from Corynebacterium diphtheriae C7) expressed recombinantly in Pseudomonas fluorescens.
Each of the fifteen serotypes is manufactured independently using a common manufacturing platform with slight variations to accommodate for differences in strains, polysaccharides and process stream properties. The process consists of the fermentation steps to produce the inactivated pneumococcal bacteria and the purification process which consists of clarification, ultrafiltration, polishing and recovery to produce purified polysaccharides. Each activated polysaccharide is conjugated to lysine groups on the CRM₁₉₇ carrier protein using reductive amination. The pneumococcal polysaccharide powder is dissolved, size reduced to a target molecular mass, chemically activated, and buffer-exchanged by ultrafiltration. The CRM₁₉₇ protein carrier is then conjugated to the activated pneumococcal polysaccharide. The final vaccine is prepared by blending the fifteen conjugates with aluminum phosphate adjuvant in a final buffer containing histidine, polysorbate 20 and sodium chloride.
Excipients/Inactive Ingredients: Each 0.5 mL dose contains 1.55 mg L-histidine, 1 mg of polysorbate 20, 4.50 mg sodium chloride, water for injection and 125 mcg of aluminum (as aluminum phosphate adjuvant).