ImmuCell achieves USDA approval of new product claim

First calf-level scours preventative granted claims against all three newborn calf scours (diarrhea) causing pathogens: E. coli, coronavirus and rotavirus.

ImmuCell Corp., a growing animal health company that develops, manufactures and markets scientifically-proven products that improve the health and productivity of dairy and beef cattle, announced Nov. 13 that the U.S. Department of Agriculture's Center for Veterinary Biologics approved licensure for the first calf-level scours preventative with claims against all three newborn calf scours (diarrhea) causing pathogens: Escherichia coli, coronavirus and rotavirus.

The new product, First Defense Tri-Shield, combines the E. coli and coronavirus antibodies contained in ImmuCell’s legacy product, First Defense, with a guaranteed minimum level of rotavirus antibody content in one preventative dose.

This unique breadth of claims further differentiates the ImmuCell product from competitive products on the market that have claims against both coronavirus and rotavirus or just E. coli or just coronavirus, but not all three, the company said. Preventing scours in newborn calves reduces the need to use treatment antibiotics later in life. This new product will be available in a gel tube delivery format.

“This is a very important achievement by our development and manufacturing teams after many years of challenging work,” ImmuCell president and chief executive officer Michael F. Brigham said. “Generating a consistent level of rotavirus antibodies through our proprietary hyper-immunization program is not easy. This result utilizes the novel technology that we have exclusively licensed from the Baylor College of Medicine in Houston (Texas).”

No other calf-level product contains all three important health claims in a one-time preventative dose, ImmuCell said. With this expanded claim set, the company can compete more effectively against dam-level scours vaccine products that are given to the cow to improve the quality of her colostrum (first milk) that is fed to the newborn. However, it is generally believed that only 80% of animals respond to a vaccine, which leaves about 20% of calves unprotected. Additionally, ImmuCell's research suggests that treatment protocols for dam-level vaccine programs are not always followed, leaving even more calves compromised.

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