FLUAD- influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (formaldehyde inactivated) and influenza b virus b/victoria/705/2018 bvr-11 antigen (formaldehyde inactivated) injection, suspension
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. This indication is approved under accelerated approval based on the immune response elicited by FLUAD [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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 [see Description (11)]. If either condition exists, FLUAD should not be administered.
- To use a pre-filled syringe fitted with a Luer Lok system, remove the tip cap by unscrewing it in a counter-clockwise direction. Once the tip cap is removed, attach a needle to the syringe by screwing it on in a clockwise direction until it locks. Once the needle is locked in place, remove the needle protector and administer the vaccine.
- 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 is a sterile injectable emulsion supplied in 0.5 mL single-dose pre-filled syringes.
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 [see Description (11)] , or to a previous influenza vaccine.
If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks. The 1976 swine influenza vaccine was associated with an elevated risk of GBS. [see References (1)] Evidence for a causal relationship of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
The immune response to FLUAD in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals. [see Concurrent Use With Immunosuppressive Therapies (7.2)]
Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD. Ensure procedures are in place to avoid injury from falling associated with syncope.
Vaccination with FLUAD may not protect all vaccine recipients against influenza disease.
The most common (≥ 10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%).
The most common (≥ 10%) systemic adverse reactions observed in clinical studies were myalgia
(15%), headache (13%) and fatigue (13%).
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect rates observed in clinical practice.
Solicited adverse reactions were assessed in a multicenter, observer-blind, randomized controlled study (Study 1) conducted in the United States, Colombia, Panama and the Philippines. The safety analysis set included 3545 FLUAD recipients and 3537 AGRIFLU (Influenza Vaccine) recipients. The enrolled subject population in Study 1 was 65 to 97 years of age (mean 72 years) and 64% were female. Within each treatment group, 53% were Asian, 28% were Caucasian, 18% were Hispanic, 1% were Black, and fewer than 1% each were Native American/Alaskan, Pacific Islander/Hawaiian, or Other.
Solicited local (injection site) and systemic adverse reactions were collected from subjects in Study 1 who completed a symptom diary card for seven days following vaccination. The reported frequencies of solicited local adverse events from Study 1 are presented in Table 1a and systemic adverse events from Study 1 are presented in Table 1b.
a N = number of subjects with safety data.
b Moderate: pain, tenderness, defined as “some limitation in normal daily activity”
c Severe: pain, tenderness, defined as “unable to perform normal daily activity”
|Solicited Local Adverse Reactions||FLUAD (N a =3418-3496) Percentage||AGRIFLU (N a =3420-3488) Percentage|
|Injection site Pain: Any||25.0||12.2|
|Injection site Pain: Moderateb||3.9||1.9|
|Injection site Pain: Severec||0.3||0.2|
|Erythema: 25 to ≤ 50 mm||1.1||0.5|
|Erythema: 51 to ≤ 100 mm||0.2||<0.1|
|Erythema: > 100 mm||0.0||0.0|
|Induration: 25 to ≤ 50 mm||1.0||0.5|
|Induration: 51 to ≤ 100 mm||0.3||0.0|
|Induration: > 100 mm||0.0||0.0|
|Swelling: 25 to ≤ 50 mm||1.0||0.4|
|Swelling: 51 to ≤ 100 mm||0.2||<0.1|
|Swelling: > 100 mm||<0.1||0.0|
a N = number of subjects with safety data.
b Moderate: myalgia, fatigue, headache, arthralgia, chills, nausea, vomiting defined as “some limitation in normal daily activity”, diarrhea defined as “4 to 5 stools a day”.
c Severe: 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”.
d Potentially life threatening (PLT) reaction defined as requiring emergency room visit or hospitalization.
|Solicited Systemic Adverse Reactions||FLUAD (N a =3418-3496) Percentage||AGRIFLU (N a =3420-3488) Percentage|
|Fever: ≥38.0°C to ≤ 38.4°C||1.8||1.7|
|Fever: ≥ 38.5°C to ≤ 38.9°C||1.3||1.3|
|Fever: 39.0°C to ≤ 40.0°C||0.4||0.4|
|Fever: ≥ 40.0°C||0.1||0.0|
Unsolicited Adverse Events (AEs): The clinical safety of FLUAD was assessed in fifteen (15) randomized, controlled studies. The total safety population in these trials included 10,952 adults 65 years of age and older, comprising 5,754 who received FLUAD and 5,198 who received other US licensed influenza vaccines. The percentage of subjects with an unsolicited AE within 30 days following vaccination was similar between vaccine groups (16.9% FLUAD vs. 18.0% active comparator).
Serious Adverse Events (SAEs) and Deaths: In Study 1, in which subjects were followed for SAEs and deaths for one year following vaccination (N=3,545 FLUAD, N=3,537 AGRIFLU), the percentages of subjects with an SAE were similar between vaccine groups (7% FLUAD vs. 7% AGRIFLU). Four SAEs (1 FLUAD and 3 AGRIFLU) were assessed as related to study vaccination over one year of observation and 2 of these occurred (1 FLUAD and 1 AGRIFLU) within 21 days following study vaccination. There were 98 deaths (N=52 FLUAD, N=46 AGRIFLU) over one year of which none occurred within the first 21 days following vaccination.
In 14 additional randomized, controlled studies, SAEs were collected over a 3 to 4-week period in 4 studies, over a 8-week period in 1 study, and over a 6-month period in 9 studies (N= 2,209 FLUAD, N=1,661 US licensed influenza vaccines). The percentages of subjects with an SAE within 30 days (1.1% FLUAD vs. 1.8% AGRIFLU) or within 6 months (4.3% FLUAD vs. 5.9% AGRIFLU) were similar between vaccine groups. The percentages of deaths within 30 days (0.3% FLUAD vs. 0.6% active comparator) or within 6 months (1.0% FLUAD vs. 1.5% active comparator) were also similar.
Adverse Events of Special Interest (AESIs): Rates of new onset neuroinflammatory and immune mediated diseases were assessed in a post hoc analysis of the 15 randomized controlled studies over the time periods specified above for SAEs. The percentage of subjects with an AESI at any time after vaccination was similar between vaccine groups (0.9% FLUAD vs. 0.9% active comparator). There were no notable imbalances for specific AESIs.
Safety of Annual Revaccination: In 5 of the randomized, controlled trials, subjects were followed for SAEs and deaths for 6 months following revaccination (N=492 FLUAD, N=330 US licensed and non-US licensed influenza vaccines). After the second annual vaccination, the percentages of subjects with an SAE were similar between vaccine groups (6.1% FLUAD vs. 5.5% comparator influenza vaccines); 23 deaths (N=17 FLUAD, N=6 comparator influenza vaccines) were reported. Causes of death included cardiovascular events, malignancy, trauma, gastrointestinal disorders, and respiratory failure. Clinical characteristics of the deaths, including the variable causes, timing since vaccination, and underlying medical conditions, do not provide evidence for a causal relationship with FLUAD.
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