Prevention of influenza A (H5N1)! The first adjuvant, cell-based pandemic influenza A (H5N1) vaccine, audenz, has been approved by the US FDA!

February 6, 2020 / BIOON / -- seqirus is the global leader in influenza prevention Recently, the company announced that the U.S Food and Drug Administration (FDA) has approved its audenz (monovalent influenza A [H5N1] vaccine, adjuvant) for active immunization of people with 6 months or more, to help protect against influenza A (H5N1) It is worth mentioning that audenz is the first adjuvant, cell-based influenza vaccine designed to prevent influenza A (H5N1) during a pandemic In December 2015, the FDA granted audenz the fast track qualification (FTD) to prevent influenza A (H5N1) pandemic influenza Audenz is a new vaccine that combines two cutting-edge technologies - MF59 adjuvant and cell-based antigen manufacturing The vaccine is designed to be deployed quickly to protect the American population and can be stockpiled in response to a pandemic Russell Basser, MD, chief scientist and senior vice president of research and development at sequirus, said: "audenz's approval marks a major advance in influenza prevention and pandemic preparedness, which combines advanced cell manufacturing and adjuvant technology This pandemic vaccine demonstrates our commitment to developing innovative technologies to help provide a rapid response in the event of a pandemic emergency " Influenza pandemic is a global epidemic caused by a new influenza virus, which has little or no pre-existing immunity in human beings Pandemic diseases are impossible to predict and can cause catastrophic incidence rate and mortality worldwide The World Health Organization (who) global influenza strategy 2019-2030 points out that severe epidemics can have a wide range of social and economic impacts, including the loss of national economic productivity and the severe economic burden on affected citizens and communities Influenza vaccines using MF59 ® adjuvants can enhance and expand the immune response of the body by inducing antibodies against mutated virus strains This adjuvant is an important part of the pandemic prevention program because it reduces the amount of antigens needed to produce an immune response and increases the dose of vaccine development in order to protect a large number of people as soon as possible Cell based vaccine antigens, MF59 ® adjuvants, and formulation prefilled syringes used in audenz vaccines are all produced at the state-of-the-art sequirus manufacturing facility in Holly Springs, North Carolina, supported by a multi-year public-private partnership between sequirus and the biomedical advanced research and Development Agency (BARDA), the U.S Department of health and human services Part of the office of the assistant minister responsible for preparation and response "Pandemic influenza viruses can be deadly and spread rapidly, so the production of safe and effective vaccines is crucial to saving lives," said Rick bright, director of BARDA With this License - the latest FDA approved vaccine against H5N1 - we celebrate a decade long partnership to achieve the health and safety goals set out in the national pandemic influenza strategy and the executive order to speed up the supply of influenza vaccines in 2019 In the end, this latest license means that we can protect more people in an influenza pandemic " Original source: seqrus announcements U.S FDA app roval of its first ever adjusted, cell based pandemical influenza A (H5N1) vaccine