Elanco Animal Health Incorporated (NYSE: ELAN) announced that the U.S. Department of Agriculture approved TruCan Ultra Lyme-L4, a combination vaccine for dogs that protects against both Lyme disease and leptospirosis in a 1/2 mL dose.

The vaccine combines protection against two diseases in a single injection, reducing the number of shots required during veterinary visits. The product uses Elanco's PureFil Technology, which the company states is designed to reduce vaccination reactions associated with unwanted protein.

"USDA approval of TruCan Ultra Lyme-L4 is a testament to our commitment to vaccine innovation," said Bobby Modi, Executive Vice President, U.S. Pet Health and Global Digital Transformation. "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."

According to the company, leptospirosis vaccination is now considered core for dogs by American Animal Hospital Association guidelines, meaning all dogs should receive the vaccine. The company cited data showing over 40% of at-risk dogs in Lyme-endemic states lack current Lyme vaccination despite receiving core vaccines.

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

The vaccine expands Elanco's TruCan Ultra Portfolio, which includes other low-volume vaccines recently approved by the USDA, including TruCan Ultra B (Oral), a 1/2 mL oral Bordetella vaccine, and TruCan Ultra CIV H3N2/H3N8, a 1/2 mL bivalent canine influenza vaccine.

TruCan Ultra Lyme-L4 is expected to begin shipping within 30 days, according to the company's announcement.