Fluad® Influenza Vaccine Clinical Trials, Dosage, Indication, Side Effects

CSL Seqirus, Inc. Fluad® Influenza Vaccine (Fluad Tetra) consists of an inactivated influenza virus antigen produced in eggs and an oil-in-water emulsion adjuvant, MF59. Fluad is a U.S. FDA-approved seasonal flu shot containing an adjuvant, an immune-enhancing ingredient. Fluad is indicated for active immunization against influenza disease caused by influenza virus subtypes A and B contained in the vaccine. Compared to Fluad, FLUAD QUADRIVALENT includes an additional B virus strain to help prevent disease caused by all four influenza strains in the vaccine.

The immune-enhancing ingredient in Fluad is an oil derived from squalene. Squalene is a naturally occurring substance in humans, animals, and plants. Adults aged 65 and older with an aging immune system might have a lower immune response to traditional flu vaccines than younger adults. Squalene, the immune-enhancing ingredient, provides a robust immune response to help adults' immune systems recognize and respond to the flu virus, says the U.S. Centers for Disease Control and Prevention (CDC). Fluad has an extensive clinical legacy, with millions of vaccine doses distributed and licensure in 30 countries since it was first approved in 1997.

On November 24, 2015, the U.S. FDA sent an approval letter authorizing Seqirus, Inc. to introduce and deliver Fluad into interstate commerce. STN: 125510. On March 30, 2021, the FDA issued a supplement Biologics License Application (STN: BL 125510/236) for Influenza Vaccine, Adjuvanted (FLUAD), manufactured at your Holly Springs, NC facility. STN: 125510 was published in July 2023. This adjuvanted inactivated influenza vaccine (IIV-Adj) is currently authorized in Canada and Europe under the Fluad Tetra brand: EMEA/H/C/004993. The U.S. CDC recognized FLUAD® as a preferentially recommended seasonal vaccine option for adults aged 65+. As of December 20, 2023, Canada's National Advisory Committee on Immunization preferentially recommended FLUAD® Influenza vaccine for adults 65 and older. Influenza activity in Canada for the previous year's flu seasons is posted at this link.

New Jersey-based CSL Seqirus (CSL.AX) is a leader in the fight against influenza with an innovative portfolio of influenza products. CSL Seqirus is the only influenza vaccine manufacturer that offers differentiated vaccine options for individuals six months of age and older. On February 12, 2024, CSL Seqirus reported Fluad's revenues increased 14% during the last half year.

Fluad Quadrivalent Vaccine Price

Seqirus provides a coding and billing guide for healthcare providers. CMS.gov provides seasonal influenza pricing. For the 2022-2023 Flu season, the Fluad Quadrivalent payment allowance is $71.68.

Fluad Trivalent Vaccine Description

Fluad (aTIV) 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. For 2021-2022, the FDA has recommended the trivalent (three-component) egg-based vaccine that includes these components. For the 2024-2025 flu season, the FDA has directed manufacturers to remove the B/Yamagata influenza virus strain from all influenza vaccines distributed in the U.S.

Fluad Vaccine Pediatric Description

Fluad Pediatric® contains 7.5 µg HA per strain administered as a 0.25 mL dose by IM injection for children 6-23 months of age and is currently authorized in Canada.

Fluad Vaccine Indication

The Fluad egg-based vaccine 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 immune response to the flu in adults 65 and older. Seniors with 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.

Fluad Vaccine Adverse Events

Some adverse events (reported after regular flu vaccines) were reported more frequently after vaccination with FLUAD. During clinical studies, the adverse events were mild to moderate and temporary: pain, redness at the injection site, headache, muscle aches, and malaise. People should not get FLUAD or FLUAD QUADRIVALENT if they have had a severe allergic reaction to any of the ingredients in the vaccine in the past, including egg protein, or a severe allergic reaction to a previous influenza vaccine.

Fluad Vaccine News

August 16, 2024 - A study demonstrated comparable effectiveness of aTIV and HD-TIV among individuals with no identified risk factors and higher effectiveness of aTIV compared with HD-TIV in preventing any IRMEs, outpatient IRMEs, and influenza- or pneumonia-related hospitalizations among those with at least one or multiple high-risk factors in adults ≥65 years old.

December 21, 2023 - "The 2022/23 influenza season was especially challenging for Canadians and added to the already significant strain being experienced by our healthcare systems," said Bertrand Roy, Ph.D., Country Head of Medical Affairs Canada at CSL Seqirus. "We are pleased that NACI's thorough review and recommendation will help immunizers optimize the delivery of annual influenza immunizations to help mitigate other potentially difficult flu seasons."

July 17, 2023 - CSL Seqirus stated it is the only manufacturer to offer differentiated influenza vaccine options approved for use in individuals six months of age and older for the 2023/24 U.S. influenza season.

September 26, 2022—Seqirus announced real-world evidence showing that adults 65 years of age and older had fewer influenza-related hospitalizations during the 2019/20 U.S. influenza season when vaccinated with FLUAD® (Influenza Vaccine, Adjuvanted), an MF59®-adjuvanted trivalent vaccine (aTIV), compared to quadrivalent inactivated influenza vaccine (QIVe) or a high-dose trivalent vaccine (HD-TIV).

June 22, 2022 - The CDC ACIP committee recommends adults 65 years of age and older receive an enhanced flu vaccine, such as FLUAD® QUADRIVALENT, to help protect against four seasonal influenza strains annually.

March 4, 2022 - Gregg Sylvester, Chief Medical Officer, Seqirus. "According to the CDC, older adults have an increased risk of influenza-related complications and severe outcomes. Data from the recent ACIP systematic review support the benefit of an Enhanced Influenza Vaccine for this population. Seqirus is proud to support the public health benefit that an EIV category recommendation for older adults would provide."

April 20, 2021 - Real-World-Evidence published in the journal Clinical Infectious Diseases indicates that Seqirus' aTIV was more effective in reducing influenza-related medical encounters compared with standard egg-based quadrivalent influenza vaccine (QIVe) and high-dose trivalent influenza vaccine (TIV-HD) among adults 65 years and older during the 2017/18 and 2018/19 U.S. influenza seasons.

December 14, 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.

September 21, 2020 - Seqirus announced the publication of new real-world evidence (RWE) that demonstrated an MF59® adjuvanted, trivalent influenza vaccine (aTIV) 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.

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

Fluad Clinical Trials

Seqirus continues participating in clinical trials for its family of Fluad influenza vaccines.