FDA NewsPerspective

FDA approves pandemic H5N1 flu vaccine Audenz

The FDA announced the approval of a vaccine to protect against pandemic influenza A(H5N1).

Audenz (Seqirus) is the first-ever adjuvanted, cell-based vaccine designed to protect against H5N1 in the event of a pandemic, according to Seqirus. It was approved for children aged 6 months or older.

“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge cell-based manufacturing and adjuvant technologies,” Seqirus Chief Scientist and Senior Vice President of Research and Development Russell Basser, MD, said in a news release. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”

The MF59-adjuvanted vaccine is designed to be rapidly deployed to help protect the U.S. population from H5N1 and can be stockpiled for first responders in the event of a pandemic, Seqirus noted.

Influenza pandemics can occur when a novel influenza virus emerges in the human population. Experts have identified H5N1 — a highly pathogenic virus in poultry — as one of the likeliest potential threats.

According to Seqirus, Audenz will be produced in a Holly Springs, North Carolina, facility that was built and supported through a multiyear public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA). Seqirus said it can produce the vaccine on a pandemic scale because of its partnership with BARDA.

“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives. . . ,” BARDA Director Rick Bright, PhD, said in the release. “Ultimately, this latest licensure means we can protect more people in an influenza pandemic.” – by Ken Downey Jr.

References:

Sequirus. Sequirus announced U.S. FDA approval of its first-ever adjuvanted, cell-based pandemic influenza A (H5N1) vaccine. https://www.seqirus.us/news/seqirus-announces-us-fda-approval-of-pandemic-influenza-vaccine. Accessed February 3, 2020.

The FDA announced the approval of a vaccine to protect against pandemic influenza A(H5N1).

Audenz (Seqirus) is the first-ever adjuvanted, cell-based vaccine designed to protect against H5N1 in the event of a pandemic, according to Seqirus. It was approved for children aged 6 months or older.

“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge cell-based manufacturing and adjuvant technologies,” Seqirus Chief Scientist and Senior Vice President of Research and Development Russell Basser, MD, said in a news release. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”

The MF59-adjuvanted vaccine is designed to be rapidly deployed to help protect the U.S. population from H5N1 and can be stockpiled for first responders in the event of a pandemic, Seqirus noted.

Influenza pandemics can occur when a novel influenza virus emerges in the human population. Experts have identified H5N1 — a highly pathogenic virus in poultry — as one of the likeliest potential threats.

According to Seqirus, Audenz will be produced in a Holly Springs, North Carolina, facility that was built and supported through a multiyear public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA). Seqirus said it can produce the vaccine on a pandemic scale because of its partnership with BARDA.

“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives. . . ,” BARDA Director Rick Bright, PhD, said in the release. “Ultimately, this latest licensure means we can protect more people in an influenza pandemic.” – by Ken Downey Jr.

References:

Sequirus. Sequirus announced U.S. FDA approval of its first-ever adjuvanted, cell-based pandemic influenza A (H5N1) vaccine. https://www.seqirus.us/news/seqirus-announces-us-fda-approval-of-pandemic-influenza-vaccine. Accessed February 3, 2020.

    Perspective
    Amesh A. Adalja

    Amesh A. Adalja

    Although not in the headlines any longer, avian influenza remains a major pandemic threat and it is essential to develop countermeasures to be used in the event of sustained human-to-human spread of these viruses. That an adjuvanted vaccine against H5N1 — one of the [deadliest] avian influenza viruses — has been approved by the FDA is a major milestone in increasing our resiliency to this strain of avian influenza. 

    • Amesh A. Adalja, MD
    • Senior scholar
      Johns Hopkins Center for Health Security

    Disclosures: Adalja reports no relevant financial disclosures.