The US Department of Agriculture (USDA) has approved the safety of four new, ready-to-use ENABL adjuvants from VaxLiant that can be added to vaccines to help improve the resulting immune response in cattle and swine.
This follows approval of six ENABL adjuvants for swine and cattle vaccines in 2014. All of these approvals include a 21-day withdrawal period when ENABL is used in vaccines administered either subcutaneously (SQ) or intramuscularly (IM).USDA
"A 21-day withdrawal period — which is the shortest allowed by USDA for food-animal vaccines — is especially important when developing vaccines for practical use in cattle and pigs," says Steve Schram, VaxLiant co-founder. "Beyond that, having access to innovative adjuvants that already are approved for safety means manufacturers can reference existing withdrawal studies that meet stringent USDA standards. This can reduce the development time needed to bring new vaccines to market."
The USDA's review of the submitted research resulted in approval of two additional ENABL formulations for swine vaccines and two for cattle vaccines. With a total of 10 USDA-safety-approved ENABL adjuvants now available for these two species, researchers have more options for developing cutting-edge vaccines to protect against disease.
"Until recently, a key hurdle to using DNA, gene-vector and other next-generation technologies to develop vaccines has been access to adjuvants that are versatile enough to accommodate these unique platforms," says Tim Miller, Ph.D., VaxLiant-co-founder. "Access to a variety of ENABL formulations has eliminated that hurdle by offering never-seen-before stability and strong immune response, while enabling new approaches for antigen recovery in product-release assays."
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