Table 3.

Prior licensing and strains’ change procedures for pandemic vaccines.

Regulatory Authority	FDA	EMA
Statutory articles and guidance	Guidance for industry: Clinical data needed to support the licensing of pandemic influenza vaccines	Article 21 of Regulation 1234/2008/EC
Procedure 1
Same subtypes	Supplement application
Data requirement	Same as annual supplement for seasonal influenza vaccines
Procedure 2
Novel subtypes	Traditional pathway + supplement	Pre-pandemic procedures + supplement
	Accelerated approval + supplement
Data requirement	Clinical trials for safety and immunogenicity of the selected dose and schedule	Non-clinical quality and clinical data; case-by-case communications may be needed