The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is currently conducting a systematic review of approved enhanced seasonal influenza vaccines to inform a potential recommendation for adults 65 years of age and older, recommendations that have not changed since 2010.
In a meeting on February 23, ACIP for the first time officially acknowledged benefits of an Enhanced Influenza Vaccine (EIV) compared to standard egg-based influenza vaccines.1 Seqirus’ FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) is one of three vaccines classified by ACIP as an EIV and is part of its review. ACIP clearly stated that the overall evidence directly comparing EIVs with one another – based on data including millions of patients and multiple seasons – does not indicate superiority of one EIV over the others.1 ACIP’s presentation can be found here.1
While the ACIP has not yet decided on whether a change in the current recommendation is warranted, ACIP has classified FLUAD QUADRIVALENT as an EIV based on data from multiple observational studies indicating that FLUAD QUADRIVALENT may perform better than standard influenza vaccines in patients 65 years of age and older.
“Seqirus applauds the immense efforts and scientific review that ACIP has undertaken over the past two years to evaluate the Enhanced Influenza Vaccine category,” said Gregg Sylvester, Chief Medical Officer, Seqirus. “According to the CDC, older adults have an increased risk of influenza-related complications and severe outcomes.2 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.”
FLUAD QUADRIVALENT is specifically designed with MF59® adjuvant to address some of the factors impacting vaccine effectiveness in older adults.3,4 In addition to clinical trial data, more than 20 years of real-world evidence supports the clinical effectiveness of FLUAD in adults 65 years and older across different influenza seasons with different study designs, clinical outcomes, and study limitations.5 More information from the CDC on adjuvanted flu vaccines can be found here.6
FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted)
IMPORTANT SAFETY INFORMATION
What is FLUAD® QUADRIVALENT?
FLUAD QUADRIVALENT is a vaccine that helps protect against flu. FLUAD QUADRIVALENT is for people age 65 years and older. Vaccination with FLUAD QUADRIVALENT may not protect all people who receive the vaccine.
Who should not get FLUAD QUADRIVALENT?
You should not get FLUAD QUADRIVALENT if you 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.
Before receiving FLUAD QUADRIVALENT, tell your healthcare provider about all medical conditions, including if you:
- have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu shot. The decision to give FLUAD QUADRIVALENT should be made by your healthcare provider, based on careful consideration of the potential benefits and risks.
- have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine
- have ever fainted when receiving a vaccine
What are the most common side effects of FLUAD QUADRIVALENT?
- Pain or tenderness where the shot was given
These are not all of the possible side effects of FLUAD QUADRIVALENT. You can ask your healthcare provider for a complete list of possible side effects.
What do I do if I have side effects?
Ask your healthcare provider for advice about any side effects that concern you. To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Before receiving vaccine, please see the full Prescribing Information for FLUAD QUADRIVALENT. The information provided here is not comprehensive. To learn more, talk about FLUAD QUADRIVALENT with your healthcare provider or pharmacist.
FLUAD® QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.
1 National Center for Immunization & Respiratory Diseases. Advisory Committee on Influenza Practices. Influenza Vaccines for Older Adults: GRADE Summary. Accessed March 2022.
2 Centers for Disease Control and Prevention (CDC). Flu & People 65 Years and Older. Retrieved from: https://www.cdc.gov/flu/highrisk/65over.htm. Accessed March 2022.
3 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: Seqirus Inc; 2019.
4 Banzhoff A, Pellegrini M, Del Giudice G, Fragapane E, Groth N, Podda A. (2008). MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respir Viruses: 2008;2(6):243-249.
5 O’Hagan DT, Ott GS, Nest GV, Rappuoli R, Giudice GD. (2013). The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines: 2013;12(1): 13-3.
6 CDC. (2021). Adjuvated Flu Vaccine. Retrieved from: https://www.cdc.gov/flu/prevent/adjuvant.htm. Accessed March 2022.