FDA Approves First-Ever Cell-Based Influenza Vaccine

The US Food and Drug Administration (FDA) has approved a multi-dose vial (MDV) platform for Influenza A(H5N1) Monovalent Vaccine, Adjuvanted(AUDENZ) for patients 6 months and older against influenza A(H5N1) in the event of a pandemic.

The approval, awarded to Seqirus, represents the first-ever adjuvanted, cell-based influenza vaccine for this patient population. The vaccine was originally approved in 2020 as a single dose, prefilled syringe (PFS) presentation.

The Vaccine

The vaccine utilizes MF59 adjuvant technology with a cell-based manufacturing platform, an alternative to traditional egg-based manufacturing. This allows influenza vaccines to enhance and broaden the body’s immune response by creating broad, cross-reactive antibodies.

This reduces the amount of antigen required to produce an immune response, increasing the number of doses that can be developed.

Pandemic Response

In 2009, Seqirus entered into a partnership with the Biomedical Advanced Research and Development Authority (BARDA), which comes under the auspice of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS).

The partnership allows Seqirus to deliver 150 million vaccine doses to the US government to support an influenza pandemic response within 6 months.

"Producing AUDENZ in multi-dose vials allows for increased speed and efficiency, which is absolutely critical to help protect public health in the case of an influenza pandemic," said Marc Lacey, Executive Director, Pandemic Response Solutions, Seqirus, in a statement. "According to the CDC, the influenza A(H5N1) virus is highly pathogenic and has high pandemic potential, so it's critical to be prepared. Seqirus is committed to partnering with key stakeholders to develop adequate and effective influenza pandemic preparedness plans."