Bad news for all haters of Staphylococcus aureus disease. Pfizer just announced their large Phase 2b clinical trial for a S. aureus vaccine to prevent post-operative infections with S. aureus among spinal surgery patients was futile to continue.
Exactly what this means for the Pfizer staph vaccine program is unclear. according to the press release, there was no indication of any safety concerns, but rather a low likelihood of the study to reach statistical significance of any of their primary clinical endpoints:
- S aureus BSI and/or deep incisional or organ/space SSI occurring within 90 days of elective open posterior spinal fusion procedures with multilevel instrumentation.
STRIVE was evaluating a Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine. I have to admit I did provide some consultation to Pfizer's advisory group on this study, including a modest one time consulting fee (full disclosure!); however I have no insider information on the trial itself. As an advocate for making the public health case for a S. aureus vaccine, I (again) find this development extremely disappointing.
We hear reports that MRSA incidence is improving, mostly from NHSN type reporting - but to be honest I can't really find contemporary data to tell a clear story about S. aureus incidence in past few years. I know we are all making good progress with HAI prevention, hospital-onset MRSA, probably even S. aureus HAIs in general - is there room for clinical trial work in this arena?! or is S. aureus just a problematic pathogen to develop a vaccine! Well a big thank you to Pfizer and NIH and the other Pharma companies rising and investing to develop an efficient S. aureus vaccine - I am sorry STRIVE has ended, I hope the healthcare epidemiology community can continue to produce data to help make a rational argument for companies to invest in such development!.
happy new year!