20-Valent Pneumococcal Conjugate Vaccine Candidate Eligible for FDA’s Fast Track Designation Program
Pfizer announced that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the Food and Drug Administration (FDA).
The 20vPnC vaccine candidate is used for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes, in adults aged 18 years and older.
Streptococcus pneumoniae is a gram-positive bacteria that cause a variety of infectious diseases, including invasive disease (bacteremia and meningitis) and infections of the respiratory tract (pneumonia and otitis media), says the Mayo Clinic.
More than 90 serotypes of Streptococcus pneumoniae have been identified, based on varying polysaccharides that are found in the bacterial cell wall. The serotypes responsible for disease vary with age and geographic location.
The FDA decision is based upon the results of the 20vPnC Phase 2 randomized, double-blind clinical trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in adults 60 through 64 years of age.
The FDA previously granted Fast Track designation for 20vPnC in October 2017.
Pfizer said in this press release it expects to start Phase 3 trials in a few months.
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Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer, said “There continues to be a global health need to protect against the potentially devastating effects of invasive pneumococcal disease and pneumonia caused by additional serotypes, and we are dedicated to continue to build on our expertise in pneumococcal conjugate vaccines with this vaccine candidate.”
FDA 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 the 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.