On November 7th, the Vaccines and Related Biological Products Committee (VRBPAC) met to discuss and make recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine (SA4Ag) intended for pre-surgical prophylaxis in elective orthopedic surgical populations.
Specifically, the FDA sought the committee’s input regarding the clinical data necessary to support the indication. The committee discussed whether efficacy data for SA4Ag in spinal surgery patients may could support approval in other types of orthopedic surgery patients.
Pfizer’s STRIVE is a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of a single intramuscular dose of the four-antigen vaccine in preventing postoperative invasive S. aureus disease in adults ages 18-85 years of age scheduled to undergo elective open, posterior approach, multilevel, instrumented, spinal fusion surgery. The trial began in July 2015 and approximately 1,900 subjects have been randomized from about 100 clinical sites.
Some VRBPAC members believe that if SA4Ag is efficacious in the 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. Others expressed that more safety data in other orthopedic surgical populations is needed prior to approval.
Although STRIVE is currently a Phase IIb study, the sponsor is in discussions with FDA about converting it to a Phase III study that would enroll a total of 6,000 subjects. The sponsor acknowledged willingness to expand the trial to secure a broad indication for use. However, if FDA concludes a broader claim could not be supported by STRIVE beyond the spinal surgical setting, the company may consider terminating the study.
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