Understanding conditional licensure.
Vaccines are regulated under the Virus-Serum-Toxin Act and must be shown
to be pure, safe, potent and efficacious before a full license may be
issued. However, the U.S. Department of Agriculture (USDA) may grant
a conditional license under certain situations. The USDA issued a conditional
license for the ESCHERICHIA COLI BACTERIAL EXTRACT VACCINE* on Feb.
26, 2009, when it confirmed an unmet need for such a product.
The ESCHERICHIA COLI BACTERIAL EXTRACT VACCINE meets the same safety
testing and purity requirements as fully licensed products. Test studies
confirming the product’s efficacy have since been completed. The USDA
has accepted and approved the efficacy results. Zoetis
is now in the process of providing a fully validated potency test.
Find more information on the conditional license