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MedImmune submits sBLA for quadrivalent nasal spray

MedImmune has submitted supplemental biologics license application (sBLA) for quadrivalent (four-strain) version of FluMist (Influenza Vaccine Live, Intranasal).

FluMist is indicated for the prevention of influenza and for the active immunization of patients from 2 years to 49 years of age against influenza disease linked with influenza virus subtypes A and B contained in the vaccine.

Quadrivalent vaccine is intended to provide protection against B strains.

The results from previous clinical studies demonstrated that when compared to two trivalent formulations of MedImmune’s FluMist, quadrivalent live attenuated influenza vaccine (Q/LAIV) induced immune responses to both B strains and the immune responses for all of the four strains in the vaccine were comparable to the immune responses induced by the trivalent vaccines.

MedImmune Clinical Development vice president Filip Dubovsky said they believe that the inclusion of an additional B strain in an annual influenza vaccine could provide a direct health benefit to individual vaccine recipients in the event that the correct B lineage either is not selected for inclusion in a trivalent vaccine, or if both lineages co-circulate.