Regulatory Decision Summary for Influvac Tetra

Influvac Tetra (quadrivalent inactivated vaccine [QIV]) with an alternate-lineage B strain provides additional benefits on immunogenicity without substantial immuno-interference with the other three existing strains, as compared to Influvac (trivalent inactivated vaccine [TIV]). The immunogenicity of QIV has been demonstrated for all four tested influenza strains in adults of 18 years of age and older.

QIV showed comparable reactogenicity and overall safety profile with TIV in a pivotal study. The previous safety data collected with Influvac TIV is considered supportive for the QIV in view of the same production process of QIV as TIV and alternative use of both B-strain lineages in the TIV formulation over the years. Influvac TIV has shown a favorable safety profile in both healthy and at-risk populations.

However, no efficacy studies on Influvac Tetra are available in adults and the efficacy of Influvac Tetra was inferred from immunogenicity. There are limited safety data available for Influvac Tetra.

Overall, the benefits of Influvac-Tetra (QIV) outweigh the risks in the prevention of influenza infection caused by the specific strains contained in the vaccine, in adults of 18 years of age and older.