PURCHASE FLUADPURCHASE FLUAD: flu.seqirus.com
Search Burden

Clinical overview of FLUAD

FLUAD is a next-generation flu shot for the 65+ generation

Flu protection for patients aged 65 years and older
FLUAD is a trivalent inactivated influenza vaccine for adults aged 65 years and older.1 It contains the 3 flu strains (2 A strains, 1 B strain) recommended for the current flu season, plus something more: a proprietary adjuvant called MF59®.1 MF59 is an emulsion of the oil squalene, which is a naturally occurring substance in the body.2 Studies in humans and animals suggest that MF59 recruits immune cells to the injection site and enhances their uptake of antigen.3

In a clinical study vs AGRIFLU (influenza vaccine), FLUAD was shown to provide a strong immune response.1 FLUAD was also found to be immunogenic against the A/H3N2 strain, which typically exhibits faster antigenic drift and is often the causative agent in influenza outbreaks.1,4

Indications and Usage
FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older. Approval is based on the immune response elicited by FLUAD. Data demonstrating a decrease in influenza disease after vaccination with FLUAD are not available.1

Contraindications
Do not administer FLUAD to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine.1

CPT Code: 90653


Immunogenicity:

In a large pivotal trial, FLUAD was shown to elicit a strong immune response in adults aged 65+1

Immunogenicity against flu strains contained in the vaccine1,a

Seroconversionb rates: FLUAD established noninferiority vs AGRIFLU at day 221
 Chart  Chart
GMTs and GMT ratios: FLUAD established noninferiority vs AGRIFLU at day 221
 Chart  Chart

CI = confidence interval; GMT = geometric mean antibody titer.

a Results obtained following vaccination with influenza vaccine formulated for the 2010-2011 season. b Seroconversion was defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI from prevaccination HI titer ≥10. c N = 3225-3227, the number of vaccinated participants with available data for the immunologic endpoint listed. d N = 3256-3259, the number of vaccinated participants with available data for the immunologic endpoint listed. e FLUAD met noninferiority criteria based on seroconversion rate differences if the lower limit of the 95% CI [FLUAD – AGRIFLU] for each strain was >-10%. f FLUAD met noninferiority criteria based on GMT ratios if the lower limit of the 95% CI [FLUAD: AGRIFLU] for each strain was >0.67.

Arrow

Study design: Study 1 (NCT01162122) was a multicenter, observer-blind, randomized controlled study that evaluated the safety and immunogenicity of FLUAD in comparison to AGRIFLU. A total of 7082 subjects aged 65 years and older were randomized and vaccinated with FLUAD (N = 3541) or AGRIFLU (N = 3541). The primary immunogenicity analysis was performed on all vaccinated subjects who had a blood sample collected at Day 22 (N = 3225-3227 [91%] and 3256-3259 [92%] in the FLUAD and AGRIFLU groups, respectively).

A determination of noninferiority was made on the basis of predefined thresholds for seroconversion rate differences and GMT ratios. The safety analysis included subjects (N = 3545 FLUAD, 3537 AGRIFLU) from Study 1 who completed a symptom diary card for 7 days following vaccination. Additional safety data were derived from 15 randomized controlled studies involving 10,952 adults aged 65 years and older who received FLUAD (N = 5754) or other US-licensed vaccines (N = 5198).1

Arrow

Takeaway: Subjects receiving FLUAD demonstrated noninferiority to AGRIFLU in all 3 influenza strains.1

For more information, please see US Full Prescribing Information for FLUAD.

FLUAD: Safety data from the pivotal trial
The most common (≥10%) solicited local adverse reactions observed were injection site pain and tenderness.1

FLUAD: Solicited local adverse reactions1

Table

a AGRIFLU (influenza vaccine) is a US-licensed nonadjuvanted influenza vaccine. b N = number of subjects with safety data.
c Moderate: injection site pain, tenderness, myalgia, fatigue, headache, arthralgia, chills, nausea, vomiting defined as “some limitation in normal daily activity,” diarrhea defined as “4 to 5 stools a day.” d Severe: pain, tenderness, myalgia, fatigue, headache, arthralgia, chills, nausea, vomiting defined as “unable to perform normal daily activity,” diarrhea defined as “6 or more watery stools a day.”

The most common (≥10%) solicited systemic adverse reactions observed were myalgia, headache, and fatigue.1

FLUAD: Solicited systemic adverse reactions1

FLUAD: Solicited systemic adverse reactions

a AGRIFLU (influenza vaccine) is a US-licensed nonadjuvanted influenza vaccine. b N = number of subjects with safety data.
c Moderate: pain, tenderness, myalgia, fatigue, headache, arthralgia, chills, nausea, vomiting defined as “some limitation in normal daily activity,” diarrhea defined as “4 to 5 stools a day.” d Severe: pain, tenderness, myalgia, fatigue, headache, arthralgia, chills, nausea, vomiting defined as “unable to perform normal daily activity,” diarrhea defined as “6 or more watery stools a day.”
e Potentially life-threatening (PLT) reaction defined as requiring emergency room visit or hospitalization.

Takeaway: While higher solicited adverse reactions were noted for FLUAD, they were typically mild to moderate.1

FLUAD: Safety data from 15 randomized controlled studies in more than 10,000 adults 65+
Unsolicited Adverse Events and Adverse Events of Special Interest

The clinical safety of FLUAD was assessed in 15 randomized controlled studies. The total safety population in these trials included 10,952 adults 65 years and older, 5754 who received FLUAD and 5198 who received other US-licensed influenza vaccines. The percentage of subjects with an unsolicited adverse event (AE) within 30 days following vaccination was similar between vaccine groups.1 In addition, rates of new onset neuroinflammatory and immune mediated diseases were assessed in a post hoc analysis of the 15 randomized controlled studies over 1 year. The percentage of subjects with an adverse event of special interest (AESI) at any time after vaccination was also similar between vaccine groups. There were no notable imbalances for specific AESIs.1

Unsolicited AEs and AESIs in 15 randomized controlled trials1

Table

a Other US-licensed influenza vaccines.

Serious Adverse Events and Deaths

Subjects in Study 1 were followed for 1 year following vaccination. The percentages of subjects with an SAE were similar between vaccine groups. Four SAEs (1 FLUAD and 3 AGRIFLU) were considered to be related to study vaccination over 1 year of observation; 2 of these occurred (1 FLUAD, 1 AGRIFLU) within 21 days of vaccination. There were 98 deaths (n = 52 FLUAD, n = 46 AGRIFLU) over 1 year (none occurred within the first 21 days following vaccination).1

SAEs and deaths in Study 11

Table

The number of SAEs and deaths was also monitored in 14 additional randomized controlled studies. The percentages of SAEs and deaths within 30 days and within 6 months were similar between vaccine groups.1

SAEs and deaths in 14 randomized controlled studies1

Table

a The comparator for SAEs was AGRIFLU; the comparator for deaths was other US-licensed vaccines.

Safety of Annual Revaccination

In 5 of the randomized controlled trials, subjects were followed for SAEs and deaths for 6 months following revaccination. The percentages of subjects with an SAE reported after the second annual revaccination was similar between groups. None of the 23 reported deaths were considered to be related to study vaccination.1

SAEs and deaths reported after second annual vaccination with FLUAD or comparator influenza vaccines1

Table

a US-licensed and non—US-licensed influenza vaccines.

Dosing and Administration of FLUAD1

  • For intramuscular injection only.
  • Administer FLUAD as a single 0.5-mL intramuscular injection in adults 65 years of age and older.
  • Gently shake each syringe. FLUAD has a milky white appearance. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
    • If either condition exists, FLUAD should not be administered.
  • The vaccine should be administered by intramuscular injection, preferably in the region of the deltoid muscle of the upper arm.
    • Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk.
  • FLUAD does not contain latex but the tip caps of the prefilled syringes contain natural rubber latex.
  • FLUAD does not contain a preservative.
Dosing and Administration of FLUAD
 
 

Storage and Handling of FLUAD

FLUAD is supplied as a 0.5-mL prefilled, needleless syringe in the following presentation1:

  • Package of 10 prefilled syringes per carton
    (NDC number: 66521-000-01)

Store FLUAD refrigerated at 2°C to 8°C (36°F-46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date.1

Store FLUAD refrigerated at 2°C to 8°C (36°F-46°F). Do not freeze. Discard if the vaccine has been frozen. Protect from light. Do not use after expiration date.1