USDA Accepts Field Safety Data for ECO’s ECOVAXXIN MS, Clearing Path to US Approval by Year End

The USDA’s Center for Veterinary Biologics has confirmed that field safety trial data for ECO Animal Health’s Mycoplasma synoviae poultry vaccine meets the requirements to support US licensure, following trials in more than 170,000 commercial laying pullets. ECO now expects US marketing authorisation by the end of the calendar year for the first product to emerge from its proprietary R&D pipeline.

The field safety programme ran across three sites in Michigan, Indiana and Wisconsin, generating data the USDA-CVB has now accepted as fulfilling its safety requirements for licensure. The milestone follows earlier internal risk assessments demonstrating that the vaccine strain does not revert to or increase in virulence after passage through poultry — a prerequisite for US registration.

Mycoplasma synoviae causes respiratory disease and infectious synovitis in chickens and can significantly depress egg production, making it a persistent economic burden for commercial layer operations. ECOVAXXIN MS uses a non-pathogenic M. synoviae isolate previously shown to be free of antimicrobial resistance genes, developed in collaboration with Professor Naola Ferguson-Noel at the University of Georgia’s Poultry Diagnostic and Research Center.

The product launched commercially in the European Union in July 2026, with ECO securing distribution partnerships covering more than 220 million layer birds annually across the EU’s seven largest layer-producing markets — leveraging the established channels built around its Aivlosin franchise.

Chief executive David Hallas described the acceptance as an important step forward in the US regulatory review.
A second Mycoplasma vaccine, ECOVAXXIN MG, targeting Mycoplasma gallisepticum, received a favourable USDA safety assessment in March 2026, with final regulatory submission anticipated in 2028. ECO’s broader pipeline comprises up to nine products, including a PCV2/Mhyo bivalent swine vaccine targeted for marketing authorisation in 2028 and a PRRS monoclonal antibody programme aiming for approval in 2030.