FDA Approves Novel Pandemic Influenza A (H5N1) Vaccine

February 3, 2020

Seqirus’ influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz) is the first-ever adjuvanted, cell-based vaccine to protect against pandemic influenza A (H5N1). 

Officials with the FDA have approved Seqirus’ influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz), the first-ever adjuvanted, cell-based vaccine to protect against pandemic influenza A (H5N1), according to a press release.

The novel vaccine is indicated for use in individuals 6 months of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.

According to the World Health Organization, the influenza A H5N1 strain can cause severe disease and has a high mortality rate.  

Related: CDC Stresses Flu Vaccine as Deaths, Hospitalizations Rise

Combining 2 leading-edge technologies (MF59 adjuvant and cell-based manufacturing), the vaccine is designed to be rapidly deployed and stockpiled to protect the US population in the event of 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. 

According to Seqirus, “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.

The FDA previously granted Fast Track designation for the aH5N1c vaccine for the prevention of illness related to pandemic influenza caused by A (H5N1) virus in December 2015.

"Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives," Rick Bright, PhD, BARDA director, said in a statement. "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."

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