21 September 2018 - - US-based biopharmaceutical company Pfizer Inc.'s (NYSE: PFE) 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older, the company said.

Pfizer said it expects to start Phase 3 trials in a few months.

The FDA decision is informed by the results of the 20vPnC Phase 2 randomized, double-blind trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in adults 60 through 64 years of age. Pfizer will seek to present and publish outcomes from this clinical trial at a future date.

Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA's Fast Track designation, which may include more frequent communication with the FDA about the drug's development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.

The FDA previously granted Fast Track designation for 20vPnC in October 2017 for use in adults aged 18 years and older.

The FDA's Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.