Seqirus announces FDA approval of Fluad for seasonal influenza

Seqirus announced today that the US Food and Drug Administration (FDA) has approved Fluad^™ (Influenza Vaccine, Adjuvanted) to help protect those aged 65 years and older against seasonal influenza. Fluad is the first adjuvanted seasonal influenza vaccine approved in the United States; it was specifically developed for the adult population aged 65 and older.

Fluad is an inactivated influenza vaccine indicated for active immunization of adults aged 65 and older caused by influenza virus subtypes A and B contained in the vaccine.

"While it's important to vaccinate people against the flu throughout their lives, the FDA approval of Fluad offers healthcare providers and their patients 65 years of age and older, who are at high risk for serious complications, a new option to help protect against influenza," said Gordon Naylor, President of Seqirus. "Not only is Fluad the first adjuvanted seasonal influenza vaccine approved for this population in the US, it is the first approval for Seqirus, the combined organization of bioCSL and the influenza vaccines business of Novartis. The name Seqirus is derived from the phrase 'securing health for all of us.'"

According to the Centers for Disease Control and Prevention (CDC), high-risk groups, including people 65 years and older who are at risk of developing serious complications should ensure that they are vaccinated each year. Adults 65 years and older account for more than half of all influenza-related hospitalizations and approximately 90 percent of influenza-associated deaths in the US. Furthermore, the CDC reports that in the US, the annual direct costs (e.g., hospitalization, doctors' office visits, medications) of influenza are estimated at $4.6 billion.

"Adults aged 65 years and older are at the greatest risk of serious complications from influenza compared with young, healthy adults because the immune system weakens with age," said William Schaffner, M.D., Medical Director at the National Foundation for Infectious Diseases and Professor of Medicine and Preventive Medicine at Vanderbilt University, Nashville, Tennessee. "The approval of an adjuvanted trivalent influenza vaccine provides a new vaccine alternative."

The FDA approval of Fluad was based on the results of the pivotal Phase III study of more than 7,000 adults aged 65 and older and demonstrated an acceptable safety profile. Fluad demonstrated a strong immune response and was shown to be non-inferior in relation to the comparator vaccine for all three vaccine strains on the basis of both seroconversion rates and geometric mean titers (GMTs).

Fluad is licensed in more than 30 countries, in which 81 million doses have been distributed since it was first approved in 1997.