Multivalent Pneumococcal Conjugate Vaccine Gets Breakthrough Tx Designation
Pfizer's 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, has received Breakthrough Therapy designation from the Food and Drug Administration (FDA). The designation was granted specifically for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ≥18 years old.
The Breakthrough designation follows an FDA examination of results from a Phase 2 randomized, double-blind trial which evaluated the safety and immunogenicity of the 20vPnC in adults aged 60 to 64 years. The findings of this trial will be published at a future date. The Company expects to begin Phase 3 trials of the vaccine within "a few months".
"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," said Kathrin U. Jansen, PhD, SVP and Head of Vaccine R&D, Pfizer.
For more information visit Pfizer.com.