Seqirus has begun shipping FLUAD™ (Influenza Vaccine, Adjuvanted) for the 2016-2017 flu season since gaining approval from the Food and Drug Administration (FDA) late November last year. FLUAD is the first and only adjuvanted seasonal influenza vaccine approved in the United States and was specifically developed to help protect adults aged 65 and older from the flu.1
“As the first vaccine of its kind approved in the U.S. for the adult population aged 65 and older, FLUAD represents an important new option for those at the highest risk for serious complications from the flu,” said Brent MacGregor, Senior Vice President, Commercial Operations. “At Seqirus, we are proud to further fulfill our mission of securing health for everyone, including those who need the greatest protection, by delivering the first shipment of FLUAD to our valued customers in the U.S. this year.”
The CDC recognizes that annual flu vaccination is the best way to prevent influenza, and is especially important for people 65 years and older because human immune defenses weaken with age. Adults 65 years and older account for more than half of all influenza related hospitalizations and up to 90 percent of all seasonal flu deaths in the U.S.3
The FDA approval of FLUAD was based on the results of a pivotal Phase III study of more than 7,000 adults aged 65 and older.2 In addition to demonstrating safety, tolerability and a strong immune response in patients, FLUAD was shown to be non-inferior in relation to the comparator vaccine for all three vaccine strains based on pre-defined thresholds for seroconversion rate differences and geometric mean titer (GMT) ratios.2
“Adults aged 65 years and older are at the greatest risk of serious complications from influenza because the immune system weakens with age,” said William Schaffner, M.D., Professor of Medicine and Preventive Medicine at Vanderbilt University, Nashville, Tennessee. “The flu can also trigger a worsening of chronic health problems, such as heart, kidney or liver disorders. The availability of an adjuvanted trivalent influenza vaccine provides a new vaccine option to help protect older adults against the flu.”
FLUAD was first licensed for use in Italy in 1997. Now approved in more than 30 countries, including the U.S., 81 million doses of FLUAD have been distributed worldwide.4 This 2016-2017 flu season is the first year that FLUAD will be available in the U.S.
- U.S. Food and Drug Administration. “FDA Approves First Seasonal Influenza Vaccine Containing an Adjuvant.” Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474295.htm. Accessed June 2016.
- FLUAD [package insert] Cambridge, MA: Seqirus Inc.; 2016.
- U.S. Centers for Disease Control and Prevention (CDC). “What You Should Know and Do this Flu Season If You Are 65 Years and Older.” Available at: http://www.cdc.gov/flu/about/disease/65over.htm. Accessed June 2016.
- Seqirus Inc. “About Fluad.” Available at: http://flu.seqirus.com/fluad/about-fluad.html. Accessed June 2016.