FOI release

Studies for new avian influenza vaccines showing bioequivalence to Aflunov

Some or all of the information requested was not provided because we didn't hold it.

Case reference FOI2025/00320

Received 29 March 2025

Published 30 May 2025

Request

on the 7th March you kindly informed me that Aflunov licensed in November 2010 is the predicate vaccine for Incellipan, Adjuvanted Zoonotic Influenza Vaccine Sequirus and Celldemic. According to Regulation 56 of Human Medicines Regulations, you must have licensed the 3 newer vaccines as bioequivalents to ensure "the same qualitative and quantitative composition". You must have done this on the basis of their bioequivalence given the different composition and production process of each vaccine. Please point me to or send me the bioequivalence studies.

Response

see attached

Documents

• FOI2025_00320 redacted for publication.pdf (156.9 KB)

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