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FDA Approves New Vaccine for Influenza A (H5N1)

Seqirus announced approval of influenza A monovalent vaccine, adjuvanted (Audenz™) for protection against influenza A in a release on Monday morning.

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.

"The approval of AUDENZ represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge cell-based manufacturing and adjuvant technologies," said Russell Basser, MD, chief scientist and senior vice president of Research and Development at Seqirus. "This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency."

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 vaccine was developed through a partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health of Human Services.

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.

"Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives," said Rick Bright, PhD, director of BARDA, in the release from Seqirus. "With this licensure—the latest FDA-approved vaccine to prevent H5N1 influenza—we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic."