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# Pfizer Breakthrough Therapy Designation for Pneumococcal Vaccine
- URL: https://www.fdaweb.com/pfizer-breakthrough-therapy-designation-for-pneumococcal-vaccine/
- Published: 2018-09-21T12:00:00.000Z
- Updated: 2026-09-15T00:33:30.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5142414

FDA has granted Pfizer a Breakthrough Therapy designation for its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, indicated for preventing invasive disease and pneumonia caused by *Streptococcus pneumoniae* serotypes in adults aged 18 years and older. The company expects to start Phase 3 trials in a few months. FDA’s designation is based on data from a 20vPnC Phase 2 randomized, double-blind trial that evaluated safety and immunogenicity of the vaccine. The agency previously granted a fast track designation for the product 10/2017.