What makes FLUAD different? It's adjuvanted.1
FLUAD is the first FDA-approved seasonal influenza vaccine made with MF59®, an immune-enhancing adjuvant derived from squalene: a naturally occurring substance found in humans, plants, and animals, which is proven to help provide a strong immune response to the influenza for adults 65 and older.1,2
102 plus million
doses distributed in countries where FLUAD® is licensed3
29
countries approve FLUAD3
MORE THAN 20
years of FLUAD heritage use4
As we age, influenza can be more serious for people 65 and older.5
Influenza-related deaths estimated for adults 65 and older as compared to all other age groups.6
Adults 65 and older account for approximately 54-70% of seasonal influenza-related hospitalization, each season in the United States.5
Increased risk of heart attack for adults 65 and older in the first few weeks after infection6
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Review FLUAD information here.
FLUAD® is an influenza vaccine that is clinically proven to generate a strong immune response in adults 65 and older. FLUAD is the first FDA-approved seasonal influenza vaccine in the United States. made with an immune-enhancing adjuvant, MF59®, for people 65 and older. MF59® is derived from squalene, a naturally occurring substance found in humans, plants and animals. Studies suggest MF59® recruits immune cells to the site of injections and enhances their uptake of antigen.1,2,4
The CDC recommends FLUAD® as an acceptable option to other vaccines licensed (or indicated) for people 65 years of age and older for immunization against influenza.5
The CDC has not made a preferential recommendation for any influenza vaccine formulation directed toward this age group.2
In a large pivotal trialb (N=7082), FLUAD elicited a strong immune response in adults 65 and older1,c
Seroconversiond rates:
FLUAD established noninferiority vs AGRIFLUTM (influenza vaccine) at Day 22
| A/H1N1 | A/H3N2 | B | Differences in seroconversion ratesg (95% CI) | 9.8% (7.5%-12.1%) | 13.9% (11.7%-16.1%) | 3.2% (1.1%-5.3%) |
|---|
GMTs and GMT rates:
FLUAD established noninferiority vs AGRIFLUTM at Day 22
| A/H1N1 | A/H3N2 | B | GMT ratioh (95%) | 1.4 (1.32-1.49) | 1.61 (1.52-1.7) | 1.15 (1.08-1.21) |
|---|
CI = confidence interval; GMT = geometric mean
antibody titer.
bStudy 1 (NCT01162122) was a multicenter,
observer-blind, randomized, controlled study that evaluated
the safety and immunogenicity of FLUAD in comparison to
AGRIFLU, a US-licensed nonadjuvanted trivalent influenza
vaccine. 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. cResults obtained following
vaccination with influenza vaccine formulated for the 2010 to
2011 season. dSeroconversion was defined as
prevaccination hemagglutination inhibition (HI) titer <10
and postvaccination HI titer ≥40 or at least a 4-fold
increase in HI from prevaccination HI titer ≥10. 3n
= 3225-3227, the number of vaccinated participants with
available data for the immunologic endpoint listed. fn
= 3256-3259, the number of vaccinated participants with
available data for the immunologic endpoint listed. gFLUAD
met noninferiority criteria based on seroconversion rate
differences if the lower limit of the 95% CI [FLUAD :
AGRIFLU] for each strain was >-10%. hFLUAD met
noninferiority criteria based on GMT ratios if the lower
limit of the 95% CI [FLUAD: AGRIFLU] for each strain was
>0.67.
A demonstrated safety profilea
In the pivotal trial, the most common (≥10%) adverse reactions in subjects receiving FLUAD were1:
Injection Site Pain (25%)
Tenderness (21%)
Myalgia (15%)
Fatigue (13%)
Headache (13%)
While higher rates of solicited adverse reactions were noted with FLUAD, they were typically mild to moderate1
Thea safety analysis included subjects (n = 3545 FLUAD; n = 3537 AGRIFLU) from Study 1 who completed a symptom diary card for 7 days following vaccination.
- For intramuscular injection only
- FLUAD is supplied as a package of ten, 0.5-mL prefilled needleless syringes
- Administer FLUAD as a single 0.5-mL intramuscular injection in adults 65 years of age and older
- Each 0.5-mL dose of FLUAD is preservative free. The syringe, syringe plunger stopper, and tip cap are not made with natural rubber latex.
Store FLUAD at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date.
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