Elanco Secures USDA Approval for TruCan Ultra Lyme-L4 Combination Vaccine for Dogs

The newly approved vaccine is the first and only 0.5 mL combination vaccine protecting against both Lyme disease and leptospirosis in dogs, reducing the number of injections required during wellness visits.
Photo provided by Elanco
  • USDA has approved Elanco’s TruCan Ultra Lyme-L4 for use in dogs.
  • The vaccine is the first and only 0.5 mL combination vaccine covering both Lyme disease and leptospirosis.
  • Elanco says the product combines protection against two significant canine infectious diseases into a single injection.
  • The vaccine utilizes the company’s proprietary PureFil™ Technology, designed to reduce vaccination reactions associated with unwanted proteins.
  • Product shipments are expected to begin within the next 30 days.

Elanco Animal Health has received U.S. Department of Agriculture (USDA) approval for TruCan™ Ultra Lyme-L4, a new canine vaccine that combines protection against Lyme disease and leptospirosis in a single 0.5 mL dose.

The approval expands Elanco’s TruCan Ultra vaccine portfolio and introduces what the company describes as the first and only low-volume combination vaccine designed to protect against both diseases.

Addressing Emerging Disease Risks

According to Elanco, the new formulation provides the same level of protection as the company’s existing 1 mL Lyme-L4 vaccine while reducing injection volume by half. By combining Lyme and leptospirosis protection into a single administration, veterinarians can reduce the number of injections required during preventive care visits.

The approval comes as veterinary organizations continue to emphasize the importance of leptospirosis vaccination. The American Animal Hospital Association (AAHA) currently considers leptospirosis a core vaccine for dogs, reflecting the disease’s widespread geographic distribution and risk across diverse lifestyles and environments.

At the same time, Lyme disease continues to expand into new regions of the United States. Elanco cited data indicating that more than 40% of at-risk dogs in endemic states do not have current Lyme vaccination protection despite receiving core vaccines.

Focus on Patient Comfort

TruCan Ultra Lyme-L4 incorporates Elanco’s proprietary PureFil™ Technology, which is designed to reduce vaccination reactions associated with unwanted proteins while maintaining immunologic protection.

“USDA approval of TruCan Ultra Lyme-L4 is a testament to our commitment to vaccine innovation,” said Bobby Modi, executive vice president of U.S. Pet Health and Global Digital Transformation at Elanco. “By offering a low-volume, highly-purified combination vaccine, we are providing veterinarians with a powerful tool to help close critical protection gaps while encouraging a comfortable, low-stress experience.”

Dr. Jessica Pritchard, clinical assistant professor in small animal internal medicine at the University of Wisconsin-Madison School of Veterinary Medicine, noted that both diseases remain important infectious threats for dogs.

“Leptospirosis vaccination is now considered core for dogs because the exposure risk exists nationwide, including in suburban and urban environments,” Pritchard said. “Vaccination, along with risk-based lifestyle discussions between veterinarians and pet owners, plays an important role in protecting dogs from these preventable diseases.”

Expanding the TruCan Ultra Portfolio

Elanco stated that TruCan Ultra Lyme vaccines have demonstrated 92.2% efficacy against natural infection in highly endemic areas and 100% efficacy in laboratory studies.

The approval follows recent USDA clearances for TruCan Ultra B (Oral), a 0.5 mL oral Bordetella vaccine, and TruCan Ultra CIV H3N2/H3N8, a 0.5 mL bivalent canine influenza vaccine.

TruCan Ultra Lyme-L4 is expected to begin shipping to veterinary practices within the next 30 days.

Information sourced from Elanco Animal Health’s press release.

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