Pfizer's Staph Vaccine: Can Narrow Trial Population Support Broader Claim?
US FDA advisory committee will weigh in on clinical development plan for SA4Ag, an S. aureus vaccine for prophylactic use, including whether safety and efficacy data from an ongoing, Phase II trial in spinal surgery patients are generalizable to other elective orthopedic surgical populations.
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The big pharma has two vaccines that have progressed to late-stage development, one for Clostridium difficile infection and the other for Staph aureus. Both represent big commercial opportunities, but bringing a new vaccine to market is a slow process.
If Pfizer doesn't get regulatory clarity that Phase IIb/III STRIVE study data could support broad indication in elective orthopedic surgeries, company says it would have to reassess resources needed to continue current development program, with study termination a possible outcome.
US FDA advisory committee members say if SA4Ag is efficacious in ongoing trial of spinal surgery patients, efficacy data could support a broader claim encompassing limited number of other orthopedic procedures with similar pathophysiology and infection risk, such as hip and knee replacement surgeries.