Pfizer's Staph Vaccine: Can Narrow Trial Population Support Broader Claim?

03 Nov 2017

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.

The US FDA seeks advisory committee input on whether a Phase II study of Pfizer Inc.'s investigational Staphylococcus aureus vaccine SA4Ag in spinal surgery patients could support approval for prophylactic use in other elective orthopedic surgical populations, as the sponsor asserts.

On Nov. 7, the Vaccines and Related Biological Products Advisory Committee will discuss the clinical data needed to support an...