Legal News

Will a cow shot cure our national difficulties combating E. coli? It just might. Vaccines like the one recently approved by the Department of Agriculture may not totally wipe out the dangerous strain of E. coli bacterium called O157:H7, but in combination with the other safeguards already in place, it could substantially lessen the outbreaks that can sicken and kill. Since January of 2007, there were 52 recalls of beef due to E. coli, compared with only 20 in the three previous years.

Unfortunately for consumers, the approval of the vaccine by governmental agencies progressed at a truly bovine pace. Two vaccines have been developed commercially, one, made in the U.S. by a Minnesota company called Epitopix, and a second developed by Bioniche Life Sciences, a Canadian company. Both vaccines have been tied down by red tape pending approval, mainly because they straddle the border between animal and human health.

To illustrate, the Agriculture Department received its first application for an E. coli vaccine in 2001 and took until 2003 to declare it did not have jurisdiction to approve the medicine. The FDA did not feel it had jurisdiction either because it is not technically responsible for animal vaccines under federal law.

Finally in 2005, the Dept. of Agriculture agreed to oversee the approval process. Initially, the Department set an usually high success rate requirement of 90% on the vaccine, but relaxed its requirements after recalls of beef due to E. coli contamination spiked in 2007.

Dr. Kent McClure, general counsel of the Animal Health Institute, a pharmaceutical industry group, said that while the review took longer than the industry would have liked, the new legal clarity could pave the way for other food safety vaccines.

A large scale test of the vaccine is underway.

Related Resources:

• After Delays, Vaccine to Counter Bad Beef Is Being Tested (New York Times)
• Food and Nutrition - Food Safety (FindLaw)
• Food Safety: BBB - Escherichia coli O157:H7 (FDA)
• Beef: From Farm to Table (USDA)
• Product Recall and PI News (provided by Warner Law Offices PA)
• Personal Injuries from Dangerous or Def. Products (provided by Warner Law Offices PLLC)