The US Food and Drug Administration (FDA) has approved a novel vaccine to help protect patients as young as 6 months old against influenza A (H5N1), according to a press release from Seqirus.
With approval, influenza A monovalent vaccine, adjuvanted (Audenz™) becomes the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A in the event of a pandemic.
Influenza A monovalent vaccine, adjuvanted is an inactivated vaccine indicated for active immunization and is designed with the capability to be rapidly deployed and to be stockpiled for first responders in the event of a pandemic, according to the release from Seqirus.
The cell-based vaccine antigen, MF59® adjuvant, and formulated prefilled syringe, had previously received Fast Track Designation from the FDA in 2015, is approved for use in people 6 months of age and older who are at increased risk of exposure to the influenza A virus H5N1 subtype.
Safety information for influenza A monovalent vaccine, adjuvanted from Seqirus noted use in patients between the ages of 6 months and 17 years is approved under accelerated approval based on immune response elicited by the vaccine. The safety information also noted that continued approval for use in this age group may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Leave a Reply