Influenza A Vaccine Approved to Combat Pandemics

North Carolina based Seqirus announced that the U.S. Food and Drug Administration has approved the flu vaccine Audenz™ to help protect individuals 6 months of age and older against influenza A.

The Audenz vaccine combines 2 leading-edge technologies—MF59® adjuvant and cell-based antigen manufacturing.

According to a Seqirus press release, Audenz is the 1st ever adjuvanted, cell-based influenza vaccine designed to protect people against influenza A (H5N1) in the event of a pandemic.

This announcement is important since if the A (H5N1) virus were to become easily transmissible from person to person while retaining its capacity to cause severe disease, the consequences for public health could be very serious, with approximately 60 percent mortality rate.

This means Audenz was designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first-responders in the event of an influenza pandemic.

Influenza pandemics are impossible to predict and can cause catastrophic morbidity and mortality globally.

Four influenza pandemics have occurred over the past 100 years, with the 1918 pandemic being the most severe, estimated to have killed up to 50 million people worldwide.

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 as it reduces the amount of antigen required to produce an immune response, increasing the number of doses of the vaccine developed, so that a large number of people can be protected as quickly as possible.

The cell-based vaccine antigen, MF59® adjuvant, and formulated prefilled syringes used in the Audenz vaccine are all produced in the state-of-the-art Seqirus production facility in N.C.

This 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 U.S. Department of Health and Human Services.

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

The World Health Organization 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.

"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 February 3, 2020, press release.

Audenz™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) is a pandemic influenza vaccine developed by Seqirus. This is the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.

Seqirus is part of CSL Limited (ASX: CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 22,000 people with operations in more than 60 countries.

Influenza Vaccine news published by Precision Vaccinations.