The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pfizer’s (NYSE: PFE) 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, for the prevention of invasive disease and pneumonia in adults.
Following on from the FDA’s fast track designation of PF-06482077, the status has been granted based on a Phase II trial, with a Phase III study set to start in a few months.
Kathrin Jansen, senior vice president and head of vaccine R&D, 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.”
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