Sanofi calls on FDA to review competitor's flu vaccine labelling

French pharma major Sanofi (Euronext: SAN) has filed a Citizen’s Petition calling on the US Food and Drug Administration to review the labels for influenza vaccines from Seqirus, a subsidiary of Australia’s CSL Limited (ASX: CSL).

The Seqirus unit recorded sales of $1.74 billion, in the last fiscal year, of which over $1 billion came from US seasonal flu vaccine sales. Sanofi’s total flu vaccine sales in 2021 were 2.63 billion euros ($2.9 billion)./

The petition requests that the FDA Commissioner immediately require revision of the labelling for the influenza vaccine products Fluad and Fluad Quadrivalent, both manufactured by Seqirus and approved under the same Biologics License Application (BLA) (BL125510) via the FDA’s accelerated approval pathway. Fluad and Fluad Quadrivalent received accelerated approval, in 20151 and 2020, respectively, for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine for use in persons ≥ 65 years of age.