USDA approves canine vaccination for Lyme disease and leptospirosis

A canine vaccine for protecting dogs against both Lyme disease and leptospirosis was recently approved by the USDA. TruCan Ultra Lyme-L4 from Elanco Animal Health protects against 2 increasingly prevalent threats to canine health with a new 1/2 mL formulation, according to the company.¹

An expansion of the Elanco’s TruCan Ultra line, the new vaccine provides the same broad protection as the category-exclusive 1 mL version but in half the volume and allows veterinarians to provide protection against Lyme disease and leptospirosis without the need for multiple injections. TruCan Ultra Lyme-L4 is engineered with Elanco’s proprietary PureFilTM Technology, which aims to reduce vaccination reactions associated with unwanted protein.¹

“USDA approval of TruCan Ultra Lyme-L4 is a testament to our commitment to vaccine innovation,” Bobby Modi, executive vice president for US pet health and global digital transformation, said in a news release.¹ “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.”

This approval comes at a critical time for canine wellness as all dogs are at risk for leptospirosis regardless of breed, size, lifestyle, or geographic location.² “Leptospirosis and Lyme disease remain important infectious threats for dogs in the US,” Jessica Pritchard, VMD, MS, DACVIM (SAIM), clinical assistant professor in small animal internal medicine at the University of Wisconsin-Madison School of Veterinary Medicine, said in the release.¹ “Leptospirosis vaccination is now considered core for dogs because the exposure risk exists nationwide, including in suburban and urban environments. Vaccination, along with risk-based lifestyle discussions between veterinarians and pet owners, plays an important role in protecting dogs from these preventable diseases.”

In a dvm360 interview, Jane Sykes, BVSc, PhD, MPH, MBA, FNAP, also addressed leptospirosis vaccination. She encouraged veterinarians to speak with their clients about annual vaccination against the disease and to be prepared for address questions about safety and rationale.³

“When communicating with clients, use stories and examples. Tell them that the dogs developing leptospirosis are often unvaccinated dogs, including small breed dogs, geriatric dogs, and very young puppies. Explain that leptospirosis can be a fatal disease, that treatment costs can be in the thousands of dollars, and that some dogs might not survive. It is now one of the more common vaccine preventable diseases we see. If an owner chooses not to vaccinate their dog, that decision should be documented in the medical record,” Sykes said.³

Additionally, Lyme disease is a primary focus of the CAPC’s 2026 forecast on increasing parasite risks. CAPC said black-legged ticks continue to expand geographically, with the Upper Midwest and Northeast still representing high-risk regions with its projected spread into Ohio, Kentucky, West Virginia, Tennessee, North Carolina, Indiana, Illinois, and Michigan, as well as into the Northern Plains. The organization noted that areas of higher canine Lyme risk often mirror areas where people contract Lyme disease, reinforcing the One Health connection between pets, people, and the environment.⁴

Kathryn E. Reif, PhD, MSPH, an associate professor of parasitology at Auburn University, a CAPC board member, and the lead author of the forecast, said that vector-borne disease risk is shifting in response to land use changes, pet travel, wildlife movement, and climate-related warming and extreme weather. The forecasts were intended to help veterinarians strengthen year-round prevention, tailor vaccination strategies based on local risk, and reinforce annual testing, she said.⁴

TruCan Ultra Lyme vaccines have demonstrated 92.2% efficacy against natural infection in highly endemic areasvii and 100% efficacy in laboratory studies, according to Elanco. By reducing the required number of injections, the combination vaccine aims to improve the overall wellness visit for pets, their owners and veterinary staff.¹

References

1. Elanco announces USDA approval of TruCanTM Ultra Lyme-L4, the first and only 1/2 mL combination vaccine for lyme and leptospirosis for dogs. News release. USDA. June 15, 2026. Accessed June 15, 2026. https://www.prnewswire.com/news-releases/elanco-announces-usda-approval-of-trucan-ultra-lyme-l4-the-first-and-only-12-ml-combination-vaccine-for-lyme-and-leptospirosis-for-dogs-302800250.html
2. Sykes JE, Francey T, Schuller S, Stoddard RA, Cowgill LD, Moore GE. Updated ACVIM consensus statement on leptospirosis in dogs. J Vet Intern Med. 2023 Nov-Dec;37(6):1966-1982. doi: 10.1111/jvim.16903
3. Alaburda B, Sykes J. Make leptospirosis vaccination part of the annual conversation. dvm360. December 16, 2025. Accessed June 15, 2026. https://www.dvm360.com/view/lepto-consensus-statement
4. CAPC forecasts expanding parasite risk in 2026, including Lyme disease, heartworm, ehrlichiosis, and anaplasmosis. dvm360. March 23, 2026. Accessed June 15, 2026. https://www.dvm360.com/view/capc-forecasts-expanding-parasite-risk-in-2026-including-lyme-disease-heartworm-ehrlichiosis-and-anaplasmosis