Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to FOI2025/00320, for what reason the Adjuvanted Zoonotic Influenza Vaccine was authorised via UK Regulation 56.

Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in a pre‐filled syringe (PLGB 47991/0013) was authorised by the Medicines and Healthcare products Regulatory Agency via UK Regulation 56 of The Human Medicines Regulations 2012 on 6 October 2023. This created a duplicate unbranded licence that was identical to Aflunov suspension for injection in a pre-filled syringe (PLGB 47991/0004), which was authorised in the United Kingdom on 29 November 2010 by a European Commission decision, following a centralised procedure by the European Medicines Agency (EMA; EMEA/H/C/002094). Subsequent to the granting of this duplicate unbranded licence, further lifecycle management actions were authorised for this licence.