FDA OKs First Quadrivalent, Adjuvanted Flu Vaccine for Older Adults

Megan Brooks

February 24, 2020

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

Fluad Quadrivalent uses the same MF59 adjuvant as Seqirus's trivalent Fluad vaccine, "which has an extensive clinical legacy, with 114+ million doses distributed and licensure in 29 countries since it was first approved in 1997," the company said in a news release.

The adjuvant is designed to generate a strong, broad, durable immune response.

The approval of the quadrivalent version of Fluad is supported by data from multiple clinical studies that demonstrated safety and efficacy in adults aged 65 years or older against influenza strains included in the vaccine, the company said.

Fluad and Fluad Quadrivalent are inactivated vaccines indicated for immunization against influenza caused by A and B virus subtypes contained in the vaccine.

During the 2018–2019 influenza season, up to 647,000 people in the United States were hospitalized because of influenza-related complications, according to preliminary estimates from the Centers for Disease Control and Prevention (CDC).

Rates of hospitalization and deaths from seasonal flu are higher in older adults compared to young, healthy adults. During the 2017–2018 influenza season, 70% of influenza-related hospitalizations and 90% of influenza-related deaths occurred in this age group, according to the CDC.

The effectiveness of influenza vaccine tends to be lower in older people, owing to age-related decline in immunity.

"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," Anjana Narain, Seqirus's executive vice president and general manager, said in the release.

Fluad Quadrivalent offers "another seasonal vaccine option for healthcare providers and their patients in the fight against influenza," Narain said.

The CDC recommends that everyone aged 6 months or older receive an annual flu shot, but it is particularly important for those 65 years and older who are at risk of developing serious complications from influenza.

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