Vaccine Info

Fluad Influenza Vaccine

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Last reviewed
January 24, 2021

Fluad Vaccine Description

Fluad consists of an inactivated, trivalent influenza virus antigen produced in eggs and an oil-in-water emulsion adjuvant, MF59. Adding MF59 adjuvant to an influenza vaccine is designed to enhance the immune response to the influenza strains contained in the vaccine in adults 65 years and older.

Fluad was the first FDA-approved seasonal flu shot that contains an adjuvant, which is an immune-enhancing ingredient.

For 2020-2021, trivalent (three-component) egg-based vaccines are recommended to contain:

A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like virus (updated)

A/Hong Kong/2671/2019 (H3N2)-like virus (updated)

B/Washington/02/2019 (B/Victoria lineage)-like virus (updated)

The immune-enhancing ingredient in Fluad is an oil derived from squalene. Squalene is a naturally occurring substance found in humans, animals, and plants.

Squalene, the immune-enhancing ingredient, is proven to provide a strong immune response to help adults' immune systems of 65 and older to recognize and respond to the flu virus.

Fluad vaccine has an extensive clinical legacy, with 144+ million doses distributed and licensure in 30 countries since it was first approved in 1997.

Seqirus is part of CSL Limited. As one of the largest influenza vaccine providers globally, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. 

Fluad Vaccine Indication

Fluad is indicated for active immunization against influenza viruses caused by influenza virus subtypes A and type B in the vaccine.

Fluad helps protect against the same flu strains as other seasonal flu shots, but it has something they don’t have: an immune-enhancing ingredient that can help provide a strong immune response to the flu in adults 65 and older. Seniors who have an aging immune system might have a lower immune response to traditional flu vaccines than younger adults.

Fluad Vaccine Dosage

Fluad is administered as an intramuscular injection in adults 65 years of age and older.

Fluad Vaccine Adverse Events

Some adverse events (reported after regular flu vaccines) were reported more frequently after vaccination with Fluad. The most adverse events experienced during clinical studies were mild to moderate and temporary: pain, redness at the injection site, headache, muscle aches, and malaise.

Fluad Vaccine News

January 5, 2021 - Adjuvanted influenza vaccine and influenza outbreaks in U.S. nursing homes: Results from a pragmatic cluster-randomized clinical trial. Among 777 facilities, the adjuvant group experienced a 17% reduction in suspected and laboratory-confirmed influenza outbreaks, reported Vincent Mor, Ph.D. a renowned nursing home researcher. The estimated reduction in outbreaks rose further — to 22% for laboratory-confirmed outbreaks — when the researchers adjusted for facility-level vaccination rates and resident characteristics.

December 7, 2020 - Seqirus Presents New Late-Breaking Data at ESWI 2020 Highlighting Benefits of MF59®-Adjuvanted Seasonal Influenza Vaccine. "Adults age 65 years and older are at higher risk for complications from seasonal influenza. At Seqirus, we're focused on utilizing advanced technology like the MF59® adjuvant to potentially offer better protection against influenza for those most vulnerable, like adults in this age group," said Gregg Sylvester, MD, Chief Medical Officer at Seqirus.

September 21, 2020 - Seqirus, a global leader in influenza prevention, today announced the publication of new real-world evidence that demonstrated an MF59® adjuvanted, trivalent influenza vaccine was more effective than a standard-dose non-adjuvanted trivalent seasonal vaccine in preventing influenza-related medical office visits and hospitalizations in adults 65 years and older during the 2017/18 U.S. influenza season.

August 7, 2020 - Study: Evaluating the Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to High-Dose Trivalent and Other Egg-Based Influenza Vaccines among Older Adults in the US during the 2017–2018 Influenza Season.

February 24, 2020 - Seqirus Receives FDA Approval for FLUAD QUADRIVALENT for Adults 65 Years and Older.

July 20, 2017 - Seqirus Begins Shipping 2017-2018 Influenza Vaccines to the U.S. Market. 

Fluad Vaccine Clinical Trials

Clinical Trial NCT02882100Adjuvanted Influenza Vaccination in U.S. Nursing Homes Last Update Posted on June 12, 2020.

This study is powered to prospectively evaluate the relative effectiveness of adjuvanted trivalent influenza vaccine (aTIV; FLUAD) in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the commercially available, standard dose trivalent seasonal influenza vaccine (TIV; Fluvirin).

Clinical Trial NCT03603509:  Influenza Vaccine Responses last Update Posted on December 21, 2020.

The purpose of this research study is to better understand the immune response to the Adjuvanted Subunit flu vaccine (MF59) and the High Dose flu vaccine (HDFlu) in people 65 years of age and older. The research team will be studying why immune response diminishes as people get older in both men and women.

The ultimate goal is to understand how flu immunity develops after vaccination. This information may lead to the development of more effective flu vaccines in the future.