FDA
26th November 2017

FDA Advisory Committee Makes Recommendations for Pfizer Staph Vaccine Trial

On November 7th, the Vaccines and Related Biological Products Committee (VRBPAC) met to discuss and make recommendations on the clinical.

FDA Advisory Committee Makes Recommendations for Pfizer Staph Vaccine Trial

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.

ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

Do you have an upcoming Advisory Committee Meeting?

  • This field is for validation purposes and should be left unchanged.

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us