FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine
HOLLY SPRINGS, N.C., Feb. 3, 2020 /PRNewswire/ -- Seqirus, a global leader in influenza prevention and pandemic response, today announced that the U.S. Food and Drug Administration (FDA) has approved Audenz™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) to help protect individuals six months of age and older against influenza A (H5N1).1 Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.2
The novel vaccine combines two leading-edge technologies—MF59® adjuvant and cell-based antigen manufacturing. Audenz is designed to be rapidly deployed to help protect the U.S. population1,3 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. "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 virus to which there is little or no pre-existing immunity in the human population.4 Pandemics are impossible to predict and can cause catastrophic morbidity and mortality globally.3 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.5
Influenza vaccines using the MF59® adjuvant may enhance and broaden the body's immune response by inducing antibodies against virus strains that have mutated.6,7,8 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 vaccine developed, so that a large number of people can be protected as quickly as possible.9,10 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 Holly Springs, N.C., 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.11
"Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives," said BARDA Director Rick Bright, Ph.D. "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."
Seqirus is uniquely positioned to manufacture cell-based vaccines on a pandemic scale as a result of its public-private partnership with the BARDA.11
About Pandemic Influenza
Pandemic influenza, as with seasonal influenza, is a contagious airborne respiratory disease which is unpredictable and can occur in any age group or any population worldwide.4 The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because of little or no pre-existing immunity to the virus in the human population.3 Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, estimated to have killed up to 50 million people worldwide.12 According to the World Health Organization (WHO), A (H5N1) influenza strain can cause severe disease and has a high mortality rate. If the A (H5N1) virus were to change and 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 an approximate 60% mortality rate.13
Audenz™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) is a pandemic influenza vaccine developed by Seqirus.1 This is the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.2 Seqirus has combined two leading-edge technologies—MF59® adjuvant and cell-based antigen manufacturing—to create this pandemic influenza vaccine.2 The U.S. Food and Drug Administration granted Fast Track designation for the aH5N1c vaccine for prevention of illness related to pandemic influenza caused by A (H5N1) virus in December 2015.14 Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.15 (Article from : www.drugs.com)