In a report released this month, the Government Accountability Office (GAO) is recommending that USDA provide more specific public guidance on the license approval requirements of shiga toxin-producing E. coli (STEC) vaccines. The recommendations come after extensive research by GAO officials who visited cattle feedlots and a slaughter plant and interviewed agency officials, researchers as well as industry and consumer group representatives with expertise in STEC in cattle.

“Few manufacturers have submitted applications for pre-slaughter intervention products to target STEC, but at least two have submitted applications for STEC vaccines,” according to the report. “However, the approval requirements are unclear. In 2005, USDA’s APHIS clarified its responsibility for vaccines, but it still has not provided specific guidance to approve a vaccine for STEC. Without guidance that gives manufacturers clear and more specific information they need to submit an acceptable application, the approval requirements for STEC vaccines could face delays.”

Of the available technology, the one with the most footing is the SRP vaccine, developed by Epitopix and licensed to Pfizer Animal Health, which calls it the only conditionally licensed product that can help reduce E. coli in the live animal.