PNEUMOVAX® 23
PNEUMOVAX 23 consist of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae types (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).
Advisory Board:
There were no issues in this supplement that required input from an Advisory Committee.
Indications: For active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F) in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease
Key Regulatory Milestones:
10/27/2011 – PDUFA Goal Date
11/26/2019 – FDA approval date