Pfizer Staph Vaccine Trial May Support Claim For Some, But Not All, Orthopedic Surgeries

 
• By Sue Sutter

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.

FDA Advisory Committee Feature image

Efficacy data for Pfizer Inc.'s Staphylococcus aureus vaccine SA4Ag in spinal surgery patients potentially could support approval in other types of orthopedic surgery patients, but not as many as the sponsor has proposed, US FDA advisory committee members concluded Nov. 7.

The majority of FDA's Vaccines and Related Biological Products Advisory Committee said that the S. aureus vaccine's efficacy could be generalized to patients undergoing elective orthopedic surgeries that are similar in scope, duration or infection risk to the spinal surgeries in Pifzer's ongoing Phase IIb STRIVE trial

SA4Ag Proposed Indication And Dose
  • Active immunization for the prevention of postoperative invasive disease caused by Staphylococcus aureus in adults 18 years of age and older undergoing elective orthopedic surgery

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