BRIEF—FDA approval for Fluad Quadrivalent for adults 65 years and older

24 February 2020

The US Food and Drug Administration has approved the first adjuvanted quadrivalent influenza vaccine, Fluad Quadrivalent (influenza vaccine, adjuvanted), to help protect adults 65 years and older against seasonal influenza from Seqirus.

Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), was approved by the FDA for the prevention of seasonal influenza in people 65 years of age and older in 2015.

"Adults 65 years and older are at high risk for influenza-related complications each season and it is important to have influenza vaccines to help protect this vulnerable population," said Anjana Narain, executive vice president and general manager at Seqirus, part of Australia’s CSL Limited, adding: "As part of our leading role on the front line of influenza prevention, we are pleased to offer Fluad Quadrivalent as another seasonal vaccine option for healthcare providers and their patients in the fight against influenza."

In the USA, influenza impacts adults 65 years and older with higher hospitalization and death rates compared to young, healthy adults. During the 2017/18 influenza season, 70% of influenza-related hospitalizations and 90% of influenza-related deaths occurred in this age group. Influenza vaccine effectiveness also tends to be lower in this population due to age-related immune decline, which reduces the body's ability to produce a sufficient, protective immune response to the vaccine.

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