Download Influenza Vaccine Trivalent Inactivated Adjuvanted FLUAD

Alberta Health, Public Health and Compliance Division
Alberta Immunization Policy - Biological Products
Influenza Vaccine FLUAD®
July 29, 2016
Influenza Vaccine Trivalent Inactivated Adjuvanted: FLUAD®
2016–2017
Revision Date: July 29, 2016
1
Please consult the Product Monograph for further information about the vaccine.
Manufacturer
Novartis Vaccines and Diagnostics, Inc. distributed by Novartis
Pharmaceuticals Canada Inc.
Off-license use
None
Influenza strains
for 2016-2017
season
A/California/7/2009 (H1N1)pdm09-like virus
A/Hong Kong/4801/2014 (H3N2)-like virus
B/Brisbane/60/2008-like virus
1,2
1,2
1,2
Indications for
use of
provincially
funded vaccine
Albertans 65 years of age and older: this is the vaccine of choice for 65
years of age and older.
Use in individuals
younger than 65
years of age
Not recommended for individuals younger than 65 years of age.
Dose
0.5 mL
Route
Intramuscular injection
Schedule
65 years of age and older:
1
 1 dose
Contraindications
Precautions
•
Known severe hypersensitivity to any component of FLUAD with the
3
exception of egg. (see Precautions below).
•
Anaphylactic or other allergic reaction to a previous dose of influenza
1
vaccine.
•
Avoiding subsequent immunization of individuals known to have had
Guillain-Barré Syndrome (GBS) within six weeks of a previous
3
influenza immunization appears prudent at this time. However, the
potential risk of GBS recurrence associated with influenza vaccine
must be balanced against the risk of GBS associated with influenza
3
infection itself and the other benefits of influenza immunization. The
relative and attributable risks of GBS after seasonal influenza
4
immunization are lower than those after influenza illness.
•
Egg-allergic individuals may be immunized against influenza using
trivalent inactivated adjuvanted vaccine without a prior influenza
vaccine skin test and with the full dose of vaccine, irrespective of a
3
past severe reaction to egg. Egg-allergic vaccine recipients should
be kept under observation for 30 minutes following the administration
of inactivated influenza vaccine.
®
© 2007–2016 Government of Alberta
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Alberta Health, Public Health and Compliance Division
Alberta Immunization Policy - Biological Products
Influenza Vaccine FLUAD®
Possible adverse
events following
immunization
July 29, 2016
•
Expert review of the risks and benefits of influenza immunization should
be sought for individuals who previously experienced severe lowerrespiratory symptoms (wheeze, chest tightness, dyspnea) within 24
hours of influenza immunization, an apparent significant allergic
reaction to the vaccine or any other symptoms (e.g. throat constriction
or dysphagia) that raise concern regarding the safety of re3
immunization. This advice may be obtained from the local Medical
Officer of Health or other experts in infectious disease,
allergy/immunology and/or public health or any combination of these
3
specialities.
•
Individuals who have experienced oculorespiratory syndrome (ORS)
including those with a severe presentation (bilateral red eyes, cough,
sore throat, hoarseness, facial swelling) but without lower respiratory
3
tract symptoms, may be safely re-immunized. Advise of an expert
should be sought before immunizing individuals who experienced ORS
3
with lower respiratory tract symptoms.
•
Although influenza vaccine can inhibit the clearance of warfarin and
theophylline, clinical studies have not shown any adverse effects
3
attributable to these drugs in people receiving influenza vaccine.
•
Immunization with FLUAD cannot cause influenza because the
1
vaccine does not contain live virus.
•
In clinical trials, the incidence of reported systemic reactions was
®
1
generally slightly higher in FLUAD than in the comparator group.
•
Adverse events following immunization are generally mild or moderate
1
and of limited duration.
®
Local:
•
Injection site pain, erythema, swelling, induration and temperature at
1
the injection site.
Systemic:
•
Headache, fatigue, malaise, myalgia, chills, nausea, rash, sweating,
1
arthralgia and fever.
•
The following additional adverse events have been reported through
post-market surveillance: Injection-site cellutitis-like reaction, extensive
swelling of injected limb lasting more than one week, allergic reactions
leading to shock, angioedema, vasculitis, thrombocytopenia,
lymphadenopathy, muscular weakness, neuralgia, paraesthesia,
convulsion, myelitis, neuritis, GBS, pruritus, urticaria and non-specific
1
rash.
•
Refer to: Adverse Events Following Immunization (AEFI), Policy for
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Alberta Immunization Providers.
®
Pregnancy
FLUAD is not recommended for pregnant women.
Lactation
FLUAD is not recommended for breastfeeding women.
®
© 2007–2016 Government of Alberta
Page 2 of 3
Alberta Health, Public Health and Compliance Division
Alberta Immunization Policy - Biological Products
Influenza Vaccine FLUAD®
July 29, 2016
References
1
Novartis Vaccines and Diagnostics, Inc. (2016, June 6). FLUAD Pediatric™ and FLUAD : Influenza
vaccine, surface antigen, inactivated, adjuvanted with MF59C.1. Product Monograph.
®
2
World Health Organization. (2016). Recommended composition of influenza virus vaccines for use in the
2016-2017 northern hemisphere influenza season. Retrieved from:
www.who.int/influenza/vaccines/virus/recommendations/2016_17_north/en/
3
National Advisory Committee on Immunization. (2016). Statement on seasonal influenza vaccine for 20162017.
4
Kwong, J. C., Vasa, P. P., Campitelli, S. H., et al. (2013). Risk of Guillain-Barré syndrome after seasonal
influenza vaccination and influenza health-care encounter: a self-controlled study. Lancet Infectious
Disease, 13, 769-76.
5
Alberta Health. (2015, February). Adverse Events Following Immunization (AEFI), Policy for Alberta
Immunization Providers. www.health.alberta.ca/documents/AIP-AEFI-Policy-2015.pdf
© 2007–2016 Government of Alberta
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