Pfizer Persists: Big Opportunities And Challenges In Vaccines
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.
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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.
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.