Merck receives positive European regulatory opinion for Bovilis Cryptium

First cattle maternal vaccine effectively proven to protect against Cryptosporidium parvum in calves.

October 6, 2023

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Merck Animal Health announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) issued a positive opinion for Bovilis Cryptium, a vaccine to protect cattle against Cryptosporidium parvum (C. parvum) infection.

Bovilis Cryptium is indicated for the active immunization of pregnant cows to raise antibodies in colostrum against gp40 of C. parvum.  Bovilis Cryptium is the first C. parvum maternal vaccine for cattle. C. parvum is a highly infectious zoonotic parasite that causes cryptosporidiosis, one of the most significant gastrointestinal diseases in cattle.

C. parvum is a relentlessly challenging pathogen for cattle producers across Europe and worldwide. It is highly contagious and fast-spreading, and its contamination can be unavoidable in environments where cattle, goats and sheep live,” said Philippe Houffschmitt, DVM, MBA, associate vice president of the global ruminant business at Merck Animal Health. “We are pleased the CVMP recognizes the vaccine’s capability to help solve such a significant problem. We look forward to working with European regulators to potentially expand the preventive neonatal vaccine market with this new therapeutic category.”

Vaccinating pregnant heifers and cows can provide protection for calves at birth – when they are most vulnerable. The parasite plays a major role in the development of calf scour, the most common cause of death in young calves, and can have longer term effects on weight gain and production efficiency in severe cases.

The efficacy of Bovilis Cryptium was previously established in various field studies which showed that the therapy elicits a strong immune response against C. parvum in newborn calves fed with colostrum from vaccinated pregnant heifers or cows, significantly reducing clinical signs (i.e. diarrhea) caused by C. parvum.

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