The European Medicines Agency (EMA) has revised its guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines, aligning with recommendations from the World Organisation for Animal Health (WOAH). The revision, adopted by the Committee for Medicinal Products for Veterinary Use (CVMP) on 16 July 2026 and published on 24 July 2026, updates terminology and legal references to comply with Regulation (EU) 2019/6, without altering scientific content.
The guideline, first adopted in November 2014, sets out the quality, safety, efficacy, and field data that manufacturers must provide when updating vaccine strains to match circulating equine influenza viruses. The revision, agreed by the Immunologicals Working Party on 22 April 2026, introduces administrative changes to align with new definitions under Article 4 of Regulation (EU) 2019/6 and updates references to applicable legislation and other scientific guidelines. No public consultation was conducted as the scientific content remains unchanged.
The updated guideline will come into effect on 16 January 2027. It applies to all authorised equine influenza vaccines in the EU and aims to facilitate timely updates of vaccine strains in response to WOAH recommendations, ensuring continued protection against evolving viral strains. The revision clarifies data requirements for strain changes, including quality data on antigen content, safety data from target animal studies, and efficacy data from challenge or serological studies. It also addresses the removal of a strain from a multivalent vaccine.
Vaccine manufacturers will benefit from clearer regulatory pathways for strain updates, reducing administrative burden and enabling faster responses to epidemiological changes. Equine owners and veterinarians gain from improved vaccine effectiveness against circulating strains. National competent authorities will have harmonised criteria for evaluating strain-change applications. However, the administrative update does not alter scientific expectations, so manufacturers must still generate appropriate data, which may involve costs for quality and efficacy studies.