FDA Approves Adjuvanted Vaccine for H5N1 Influenza

The first adjuvanted, cell-based influenza vaccine is designed to protect against influenza A (H5N1) in the event of a pandemic.

The FDA has approved an influenza (H5N1) monovalent adjuvanted vaccine (Audenz, Seqirus) to help protect individuals aged 6 months and older against H5N1 influenza. It is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against H5N1 in the event of a pandemic.

The novel vaccine combines 2 leading-edge technologies: MF59 adjuvant and cell-based antigen manufacturing. It is designed to be rapidly deployed to help protect the US population and can be stockpiled for first responders in the event of pandemic, according to a press release.

“The approval 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 of Seqirus. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”

An influenza pandemic is a global epidemic caused by the emergence of a new influenza for which there is little or no pre-existing immunity in the human population. Pandemics are impossible to predict and can cause catastrophic global morbidity and mortality, according to the press release.

Influenza vaccines using the MF59 adjuvant may enhance and broaden the body’s immune response by inducing antibodies against virus strains that have mutated. This adjuvant is an important part of pandemic preparedness planning because it reduces the amount of antigen required to produce an immune response, increasing the number of doses of vaccine developed.

“Pandemic influenza vaccines can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives. 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 up the availability of influenza vaccines. Ultimately, this latest licensure means we can protect more people in an influenza pandemic,” said Rick Bright, PhD, director of Biomedical Advanced Research and Development Authority.


Seqirus Announces US FDA Approval of its First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine [news release]. PR Newswire website. Published February 3, 2020. https://www.prnewswire.com/news-releases/seqirus-announces-us-fda-approval-of-its-first-ever-adjuvanted-cell-based-pandemic-influenza-a-h5n1-vaccine-300997595.html?tc=eml_cleartime. Accessed February 3, 2020.

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