By IDSE News Staff
The FDA approved the first vaccine against a strain of bird flu that has the potential to cause a pandemic.
Audenz (aH5N1c, Seqirus) is the first adjuvanted, cell-based, monovalent vaccine designed to protect against influenza A(H5N1) in the event of a pandemic.
The novel vaccine combines two leading-edge technologies: MF59adjuvant and cell-based antigen manufacturing. The aH5N1c vaccine is designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders during a pandemic.
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 because 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.
The cell-based vaccine antigen, MF59 adjuvant, and formulated prefilled syringes used in the aH5N1c vaccine are all produced in the Seqirus production facility in Holly Springs, N.C., built and supported through a multiple-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 Department of Health and Human Services.
“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. “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 risk for influenza-associated morbidity and mortality is greater with pandemic influenza than seasonal influenza because of little or no preexisting immunity to the virus in the human population. 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. According to the World Health Organization, the 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.
The FDA granted fast track designation for the aH5N1c vaccine for prevention of illness related to pandemic influenza caused by the A(H5N1) virus in December 2015.