Pfizer gets FDA breakthrough therapy designation for pneumococcal conjugate vaccine
Pfizer's 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the Food and Drug Administration for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults age 18 years old and older.
Pfizer 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 age 60-to-64 years of age. Pfizer will seek to present and publish outcomes from this clinical trial at a future date.
“We look forward to continuing our dialogue with the FDA so that we can accelerate the development program of the adult indication of Pfizer’s 20-valent next-generation pneumococcal vaccine candidate,” Pfizer senior vice president and head of vaccine research and development Kathrin Jansen said in a statement. “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.”
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).
Pfizer 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 age 60-to-64 years of age. Pfizer will seek to present and publish outcomes from this clinical trial at a future date.
“We look forward to continuing our dialogue with the FDA so that we can accelerate the development program of the adult indication of Pfizer’s 20-valent next-generation pneumococcal vaccine candidate,” Pfizer senior vice president and head of vaccine research and development Kathrin Jansen said in a statement. “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.”
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).