FDA Approves Seqirus’ Adjuvanted, Cell-Based Pandemic Influenza Vaccine

February 4, 2020

The vaccine is designed to provide active immunity against the influenza A (H5N1) strain and can be easily deployed in a pandemic event.

FDA has approved Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) by Seqirus to aid in protecting individuals six months of age and older against the influenza A (H5N1) strain. The vaccine is the first adjuvanted, cell-based influenza vaccine designed to provide active immunization against this influenza strain in the event of a pandemic, Seqirus announced in a Feb. 3, 2020 press release.

Audenz combines two technologies-MF59 adjuvant and cell-based antigen manufacturing. 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 reduces the amount of antigen required to produce an immune response, increasing the number of doses of vaccine developed, so that a large number of people can be protected as quickly as possible, according to the company.

The cell-based vaccine antigen, MF59 adjuvant, and formulated prefilled syringes used for the vaccine are all produced at Seqirus’ production facility in Holly Springs, NC. The facility was built and supported through a multi-year public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services. Audenz can be rapidly deployed to help protect the US population and can be stockpiled for first responders in the event of 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, in the company press release. "This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency."

"Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives," said BARDA Director Rick Bright, PhD, in the press release. "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."

An influenza pandemic is a global epidemic caused by the emergence of a new influenza virus to which there is little or no pre-existing immunity in the human population. Pandemics are impossible to predict and can cause catastrophic morbidity and mortality globally. The World Health Organization (WHO) Global Influenza Strategy for 2019-2030 states that a severe pandemic can result in widespread social and economic effects, including a loss of national economic productivity and severe economic burdens on affected citizens and communities.

Source: Seqirus