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. 2023 Oct 9;11(10):1573. doi: 10.3390/vaccines11101573

Table 2.

Annual update procedures for seasonal influenza vaccines.

Regulatory Authority FDA EMA
Procedures Supplement application Strain change
supplement application
Statutory articles and guidance 21 CFR 601.2 Reg. (EC) No. 1234/2008
Article 18
Supplemental data requirement
  • ♦

    For IIV and RIV, no new clinical data are required.

  • ♦

    For LAIV, new clinical data of approximately 300 adults are required.
  • ♦

    For same-subtype substitutions, no pre-market clinical data, but quality-related data for the new strain, are required.