Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) is a sterile suspension 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 linked to non-toxic diphtheria CRM197 protein. Each serotype is grown in soy peptone broth.
09/19/2012 -The original protocol for study B1851138 was submitted to IND 13142
03/02/2013 - CBER provided comments regarding the proposed study protocol on
03/26/2013 - teleconference
11/04/2013 - revised protocol incorporating CBER comments was submitted
09/18/2014 - Study enrollment began.
11/23/2015 - final clinical study report was submitted to STN 125324/1376.0.
01/22/2016 - submitted an amendment to the final clinical study report due to administrative changes to STN 125324/1376.1.
03/26/2017 - PDUFA Goal Date
08/22/2017 - FDA approval date
There were no issues pertaining to this supplement that required input from the Vaccines and Related Biological Products Advisory Committee. However, On November 16, 2011, the Center for Biologics Evaluation and Research (CBER) convened a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to seek input on the immunogenicity and safety data submitted to STN 125324/262. The Committee noted both the diminished antibody responses following concomitantly administered PCV13 and inactivated TIV in Pneumovax 23 (PPSV23)-naïve adults ≥ 50 years of age and the lack of data on the concomitant administration of PCV13 and inactivated influenza vaccine in PPSV23 preimmunized adults ≥ 50 years of age. The concern was whether the data in the PPSV23-naïve group could be extrapolated to PPSV23 pre-immunized adults, or if there is a need for a study in PPSV23 pre-immunized adults. There did not appear to be support for extrapolation at the meeting.