Download the Influenza Flu Kit Here

Influenza.
Don’t get it.
Don’t give it.
Everything you need to know
ABOUT INFLUENZA
2014
2014 Seasonal Influenza Campaign
resource order form enclosed
Refer to back pocket
for samples
National Influenza
Specialist Group
National Influenza
Specialist Group
Section one – quick reference material
Key messages
1.1
Eligibility criteria
1.3
Vaccine order form (order form overleaf)
1.5
2014 seasonal influenza vaccine order form
1.6
Patient consent form
1.7
Claiming funded vaccine
1.8
Useful contacts
1.9
Websites
1.10
Section two – clinical information
Influenza the disease 2.1
New Zealand immunisation strategy 2.1
Should healthcare workers be immunised?
2.2
2014 seasonal influenza vaccines
2.3
Effectiveness of inactivated influenza vaccines
2.5
Safety of influenza vaccines
2.7
Contraindications to receiving influenza vaccines
2.8
Influenza and children
2.9
Influenza and other special patient groups
(immune compromised & international travel)
2.10
Related diseases
2.11
Use of antivirals 2.15
Section three – influenza and pregnancy
Help protect our mums-to-be
3.1
The importance of recommendation/discussion with pregnant women
3.1
The negative impact of influenza infection during pregnancy
3.2
Immunise to protect pregnant women and their babies
3.4
Vaccination and breastfeeding
3.5
Protect yourself to protect pregnant women and their unborn baby
3.5
Section four – technical information/
data sheets
Ordering, delivery and storage
4.1
Vaccine comparison chart
4.3
Vaccine data sheets
4.5
References
4.9
Section one – quick reference material
Key messages 1.1
Eligibility criteria 1.3
Vaccine order form (order form overleaf) 1.5
2014 seasonal influenza vaccine order form
1.6
Patient consent form 1.7
Claiming funded vaccine 1.8
Useful contacts 1.9
Websites
1.10
Key messages
Your regular use and support of the following messages plays an
essential role in increasing influenza immunisation and lowering
infection rates this year.
1. Influenza is a serious illness with severe effects including
hospitalisation, complications and even death
Influenza is more than just a ‘bad cold’. Although some of the symptoms are the same, influenza is usually
much more severe. Symptoms of influenza include a cough, headache, fever or chills, body aches and
pains, fatigue and generally feeling miserable.
Influenza can lead to serious complications, particularly in people with some existing medical conditions
such as heart or lung conditions. Complications include pneumonia, heart failure, and worsening asthma.
Deaths directly attributable to influenza have decreased in the past decade. There has been an
average annual mortality rate of 0.3 per 100,000 from 1997-2003. In some years, however, this rate is
considerably higher.1
2. Y
ou can spread the flu to people, including your family/whanau
and friends, who are at most risk of complications
While general health affects the severity of an infection, influenza is highly contagious and anyone can
become infected.
3. Influenza can affect anyone, no matter how fit, active and
healthy they may be
Although people with underlying health conditions are most at risk from influenza-associated complications,
previously healthy people can still become seriously ill and even die.
1.1
4. Pregnant women and newborn babies are at particularly high
risk of severe outcomes from flu
The influenza vaccine has an excellent safety profile and has been proven to provide effective protection
both for pregnant women and for their newborn babies.
5. Influenza immunisation cannot give you the flu
Influenza immunisation contains no live viruses. Therefore it cannot cause influenza.
The seasonal influenza vaccine contains fragments of disrupted (inactivated) virus. It stimulates the immune
system to produce antibodies that naturally protect against circulating influenza viruses. Many other viruses
are also present throughout the year, so people may catch a different respiratory infection with ‘flu-like’
symptoms around the time the vaccine is given and mistakenly blame the influenza vaccine or influenza
virus. The vaccine itself can cause mild aches and pains for up to a day or two after vaccination. Sometimes
this is mistaken as early symptoms of the flu.
6. T
he immunity provided through influenza vaccination
is completely natural
The process of developing immunity by vaccination is natural.
Protective immunity following influenza vaccination develops in the same way as natural infection. The
immunity generated by influenza vaccination is generally less diverse and shorter lived than that triggered by
natural influenza infection.
1.2
Eligibility for funded seasonal vaccine
INFLUVAC® and FLUARIX® are free if administered to eligible people by July 31st, 2014.
Note: INFLUVAC® and FLUARIX® are Prescription Medicines. For full prescribing information please refer
to the data sheets pages 4.5 and 4.7 or visit www.medsafe.govt.nz.
Eligibility criteria for FREE seasonal influenza vaccination for 2014:
1. Anyone aged 65 years or over
2.Anyone under 65 years with any of the
medical conditions listed overleaf – page 1.4
3. Pregnant women
The following conditions are excluded from funding:
• Asthma not requiring regular preventive therapy
• Hypertension and/or dyslipidaemia without evidence
of end-organ disease
Patient eligibility and clinical queries contact:
Immunisation Advisory Centre (IMAC)
University of Auckland
Phone: 0800 IMMUNE (0800 466 863)
Email: [email protected]
1.3
Eligible medical conditions for funded
influenza vaccine
List of eligible medical conditions for free influenza immunisation (adults and children).
For eligibility queries call 0800 IMMUNE (0800 466 863).
Cardiovascular disease/
cerebrovascular disease
Pregnant women
• Congenital heart disease
Cancer
• Ischaemic heart disease
• Congestive heart failure
• Rheumatic heart disease
• Coronary artery disease
• Angina
• Heart attack
• Stroke
• Other heart conditions and
cerebrovascular disease
Chronic respiratory disease
• Asthma if on regular preventive therapy
• Emphysema
• Chronic obstructive airways disease
• Cystic fibrosis
• Chronic bronchitis
•Other chronic respiratory disease with
impaired lung function
Certain infants & children
•Children under the age of 5 years who have
been hospitalised for a respiratory illness,
or have a history of significant respiratory
illness
Diabetes
• Type I & Type II diabetes
1.4
• In all trimesters
•Cancer (current), excluding basal and
squamous skin cancers if not invasive
Other conditions
• Autoimmune disease
• Cerebral palsy
• Children on long-term aspirin
• Chronic renal disease
• Congenital myopathy
• Epilepsy
• Haemoglobinopathies
• Human immunodeficiency virus (HIV)
• Hydrocephaly
• Immune suppression
• Motor neurone disease
• Multiple sclerosis
• Muscular dystrophy
• Myasthenia gravis
• Neuromuscular and central nervous
system diseases
• Parkinson’s disease
• Rheumatoid arthritis
• Sickle cell anaemia
• Transplant recipients
Vaccine order form
The back of this page is a fax back order form for influenza vaccine.
Ordering vaccine
You can order seasonal influenza vaccine (INFLUVAC® and FLUARIX®) in two ways:
1.Fax: 0508 408 358
2.Online: www.hconline.co.nz
Enquiries can be made by calling customer services on
0508 425 358. Please have your Healthcare Logistics
Customer Number ready. Additional copies of the fax
order form can be found at www.influenza.org.nz in
the resources section.
For questions about ordering and returning vaccine
stock please refer to the ordering, delivery and storage
information in page 4.1 of this kit.
1.5
2014 Seasonal influenza vaccine order form
(Failing to complete in full may affect the processing of your request)
TO: Healthcare Logistics TOLL-FREE FAX: 0508 408 358
Date:
Healthcare Logistics Customer Number:
Surgery name:
Contact name:
Delivery address:
Contact phone:
Email address for invoice:
(Email address for invoicing only needs to be provided once)
Customer purchase order number (if applicable):
I would like to order:
DOSES [1122908], Seasonal Influenza Vaccine 2014 (only available in multiples of 10).
You will be supplied the doses that you commit to in writing (please remember we cannot split boxes).
Influenza chilly bins cannot be recycled. To reduce wastage when ordering, please consider your
expected usage.
A small bin holds 60 doses, a medium chilly bin holds up to 120 doses, a large bin holds up to 180 doses,
the extra-large bin holds up to 500 doses.
Depending on your fridge capacity, please try to order every two weeks (the same as you order for funded
schedule vaccines).
Note: Due to demand, please allow up to 48 hours before dispatch. Please do not book your
clinics before the stock has arrived.
Minimum order quantities apply as follows:
February
March
April
May
June
July
Min 60 doses
Min 60 doses
Min 30 doses
Min 30 doses
Min 20 doses
Min 10 doses
NOTE: Some orders may have a temperature logging device included with the shipment. Do not be concerned if your shipment does not contain a temperature
logging device.
Refund for unused stock
A refund will be available for a total of 10 units of unused stock of seasonal influenza vaccine either
INFLUVAC® or FLUARIX®, (for 2014, only one brand, not both) from any one account. Unused stock must
be returned by August 31st, 2014 to be eligible for a refund. Thereafter surgeries should contact their
immunisation coordinator for information on safe disposal.
For any further information on ordering, please phone Healthcare Logistics Customer Services
0508 425 358.
For online ordering go to www.hconline.co.nz.
1.6
Patient consent form
Patient/Guardian
Surname:
Phone:
First name:
Date of birth: M F NHI
Name of guardian (if applicable):
Address:
Your doctor’s name / surgery address: This form confirms that you have given your consent to have the influenza vaccine for our records.
If any of the following apply to you then please consult your healthcare professional:
I am currently unwell with a high fever
I have had a previous severe reaction to an influenza vaccine
I have a history of a bleeding disorder
I have a severe allergy to eggs and / or any poultry products
Possible reactions to influenza immunisation:
Influenza immunisation is usually well tolerated. Possible reactions include redness, tenderness or hardness
at the injection site for a day or two; a mild fever, muscle ache or headache within the first two days. Rarely,
an allergic reaction can occur.
You should remain under observation to watch for allergic reactions
for 20 minutes after your immunisation.
Influenza immunisation is highly effective but cannot guarantee complete protection against catching
influenza. Influenza vaccine does not protect against other respiratory viruses such as the common cold.
For more information on the influenza vaccine please refer to the Consumer Medicine Information located at
www.medsafe.govt.nz.
The Ministry of Health keeps a record of influenza immunisation on the National Immunisation Register so
that authorised health professionals can find out what immunisations have been given. It helps them identify
people who are due for immunisation or who have missed out. Talk to your GP or health professional for more
information about privacy. If you do not want your immunisation recorded on the National Immunisation Register
please advise your doctor or healthcare professional.
I have read or have had explained to me information about influenza vaccine, and I have had a chance to ask
questions that were answered to my satisfaction. I believe I understand the benefits and risks of influenza
vaccination. I understand getting the vaccine is my choice. I agree to get the vaccine and that it is recommended
that I wait here for 20 minutes after my vaccination.
I consent to this information being given to my healthcare provider to update applicable records.
Signed: Date:
Signed/Guardian (if applicable): Relationship to the child/patient: Immunisation Record (for Clinic Use Only)
Vaccine:
Administered: Left / Right Arm
Vaccine Batch Number: Vaccinator:
The influenza vaccine is a
Prescription Medicine. Talk to your
healthcare professional about the
benefits and possible risks.
Expiry Date: 1.7
Claiming funded vaccine
The patient’s correct NHI number is essential to process the claim - an incorrect NHI number
(often adding the letter ‘o’ rather than a zero ‘0’) is the most common reason for rejected claims.
If you do not know your patient’s NHI number, phone Sector Services on 0800 855 151. You will need:
1. Your payee number
2. Patient’s surname, first name and middle name
3. Patient’s gender and date of birth
4. Patient’s previous address
5. Any other name/s the patient has been known as
Electronic forms
Available via most Practice Management Systems.
Manual forms
Download the form at: http://www.health.govt.nz/
system/files/documents/pages/immunisation-benefitclaim-details-form.pdf. Please note manual claims
require District Health Board written approval. The
written approval must accompany manual claims when
sent to Sector Services.
For assistance call Sector Services Contact Centre
on 0800 458 448.
Please select correct coding box.
Funded vaccines eligible for payment need
to be submitted within eight months from the
date the patient received the influenza vaccine.
Funded vaccines eligible for payment must be
administered within the subsidised period. Note
that claiming for the second dose for children
under 9 years will be available until 31 August only
when the first dose is administered within the
subsidised period and only when prior approval
has been given from your DHB.
For payment queries call 0800 458 448.
1.8
Useful contact information
All the information and contacts you may need are here
Ordering vaccine:
All influenza vaccine ordering is handled by Healthcare
Logistics (HCL). You can order in two ways:
Online: www.hconline.co.nz
Fax order forms to: 0508 408 358
For questions about ordering vaccine contact HCL,
on their Customer Service line 0508 425 358.
Ordering surgery resources:
Use the fax form supplied in the front pocket
of this kit.
Medical queries:
For medical questions about the vaccine contact
the distributing companies:
or questions on INFLUVAC® contact
F
Abbott Laboratories NZ
Phone: 0800 737 271
or questions on FLUARIX® contact
F
GlaxoSmithKline
Phone: 0800 808 500
(ask for medical information)
For manual forms download the form at: http://
www.health.govt.nz/system/files/documents/
pages/immunisation-benefit-claim-details-form.pdf
Phone: 0800 458 448
If you do not know your patient’s NHI number
contact Sector Services on
Phone: 0800 855 151
Information on the
national influenza
immunisation campaign:
National Influenza Immunisation Coordinator
Email: [email protected]
or
Phone: (09) 373 7599 ext. 82075
or
Website: www.influenza.org.nz
Your local immunisation coordinator may
be able to assist with more information
General information
on immunisation:
or questions about antiviral medication contact
F
Roche Products
Phone: 0800 656 464
The Immunisation Advisory Centre (IMAC)
Phone: 0800 IMMUNE (0800 466 863)
or
Website: www.immune.org.nz
Patient eligibility and
clinical queries:
Centre for adverse reactions
monitoring (CARM):
Immunisation Advisory Centre (IMAC),
University of Auckland
Phone: 0800 Immune (0800 466 863)
Email: [email protected]
Health professionals can report any adverse
reaction to influenza vaccination online at CARM’s
website: www.otago.ac.nz/carm (use your practice
number as login) or on the standard CARM
reporting form (also available online)
Phone: (03) 479 7247
Fax: (03) 479 7150
Email: [email protected]
Post: NZPhvC, University of Otago Medical School
PO Box 913, Dunedin 9054
Information on claiming
funded vaccine:
all Sector Services Help Desk
C
Phone: 0800 458 448
1.9
Websites
New Zealand:
Centre for Adverse Reactions Monitoring (CARM)
www.otago.ac.nz/carm
Immunisation Advisory Centre (IMAC), University of Auckland
www.immune.org.nz
Medsafe
www.medsafe.govt.nz
Ministry of Health
www.health.govt.nz
National Influenza Specialist Group (NISG)
www.influenza.org.nz & www.fightflu.co.nz
Sector Services
www.health.govt.nz/new-zealand-health-system
Influenza vaccine pharmaceutical companies:
Abbott Laboratories NZ
www.abbott.com
GlaxoSmithKline
www.gsk.co.nz
International:
Australian Influenza Vaccine Committee (AIVC) – Department of Health,
Therapeutic Goods Administration
www.tga.gov/about/committees-aivc.htm
Centres for Disease Control and Prevention (CDC)
Seasonal Influenza (Flu) (Flu Basics; Health Professionals; Prevention - Flu Vaccine;
Free Resources; Treatment - Antiviral Drugs; Information for Partners; News & Highlights;
PHIL Influenza Images) www.cdc.gov/flu/
Influenza Specialist Group (ISG)
www.isg.org.au
National Health and Medical Research Council - Institute of Clinical Studies (NICS)
www.nhmrc.gov.au/nics
World Health Organization (WHO)
www.who.int/en
WHO Collaborating Centre for Reference and Research on Influenza (Australia)
www.influenzacentre.org
WHO recommendations for influenza vaccine composition for the northern hemisphere (2013-2014)
www.who.int/influenza/vaccines/virus/recommendations/2013_14_north/en/
1.10
WHO recommendations for influenza vaccine composition for the southern hemisphere 2014
www.who.int/influenza/vaccines/virus/recommendations/2014_south/en/index.html
Section two – clinical information
Influenza the disease 2.1
New Zealand immunisation strategy 2.1
Should healthcare workers be immunised?
2.2
2014 seasonal influenza vaccines
2.3
Effectiveness of inactivated influenza vaccines
2.5
Safety of influenza vaccines
2.7
Contraindications to receiving influenza vaccines
2.8
Influenza and children
2.9
Influenza and other special patient groups
(immune compromised & international travel)
2.10
Related diseases
2.11
Use of antivirals 2.15
Influenza the disease
Influenza illness can include any or all of these symptoms: fever, muscle aches, headache, lack of energy,
dry cough, sore throat, and possibly a runny nose. The fever and body aches can last 3-5 days and the
cough and lack of energy may last for two or more weeks. Influenza can be difficult to diagnose based
on clinical symptoms alone because the symptoms of influenza can be similar to those caused by other
infectious agents including, but not limited to, Mycoplasma pneumoniae, adenovirus, respiratory syncytial
virus, rhinovirus, parainfluenza viruses, and Legionella.2
With seasonal outbreaks most influenza is diagnosed on symptomatology. The definitive diagnosis of
influenza is made in the laboratory, usually from PCR testing of a nasopharyngeal swab or aspirate. Samples
should be collected within the first four days of illness.
New Zealand immunisation strategy
Who should be immunised?
Influenza continues to be a major threat to public health worldwide because of its ability to spread rapidly
through populations. Anyone over 6 months of age can be immunised against influenza.
The vaccine is fully funded by the Ministry of Health for certain groups of people who are considered to be
at higher risk of severe outcomes.
Who is eligible for free seasonal influenza vaccination?
Seasonal influenza vaccine is free if administered before July 31st, 2014 to eligible people who fall into the
following criteria:
1. Anyone aged 65 years or over
2. Anyone aged 6 months to 65 years with one or more of the following medical conditions:
•Cardiovascular disease (ischaemic heart disease, congestive heart failure, rheumatic heart disease,
congenital heart disease, cerebrovascular disease)
•Chronic respiratory disease (asthma if on regular preventive therapy; other chronic respiratory disease
with impaired lung function)
• Diabetes
• Chronic renal disease
• Cancer (current), excluding basal and squamous skin cancers if not invasive
• Other conditions (autoimmune disease, immune suppression, human immunodeficiency virus,
transplant recipients, neuromuscular and central nervous systems diseases, haemoglobinopathies,
children on long term aspirin)
•Children under the age of 5 years who have been hospitalised for a respiratory illness, or have a
history of significant respiratory illness
3. Pregnant women
Please see page 1.4 for full eligibility criteria.
2.1
Should healthcare workers be immunised?
YES. Annual influenza immunisation is strongly recommended for all healthcare workers to
help reduce spread of the virus and to protect those patients at greater risk of developing
complications following influenza illness.3
Healthcare workers have a responsibility to protect vulnerable patients from the serious health threat of
influenza illness.
• Studies demonstrate that annual influenza vaccine for healthcare workers is likely to reduce illness
among the patients they care for4
• There are concerns about rates of influenza vaccine uptake among New Zealand health professionals
(uptake data is for DHB health care workers only and does not currently include other health
professionals in New Zealand). While rates have been steadily improving from 45% in 2010 to 58%
in 2013 many staff continue to work when sick, thereby exposing influenza illness to patients, coworkers and to family members.5 For 2013 Workforce Influenza Immunisation Coverage Rates
by District Health Board - http://www.health.govt.nz/our-work/preventative-health-wellness/
immunisation/updates-immunisation.
• Annual influenza immunisation results in improved patient safety, improved employee safety and
decreased healthcare expenditure6
• While healthcare workers are not covered by the national immunisation programme, most
organisations offer subsidised influenza vaccine for staff
When should people be vaccinated?
The best time to vaccinate is prior to influenza entering the community. Influenza vaccines can be given
even when influenza virus activity has been identified, as protective antibody levels have been observed to
develop rapidly from four days after immunisation.7,8
Why influenza immunisation is needed every year?
Annual immunisation is required for two important reasons: Protection lessens over time and influenza can
be caused by different strains of influenza viruses that are not always included in the previous year’s vaccine.
This year the influenza vaccine includes two new strains.
2.2
2014 seasonal influenza vaccines
What are the seasonal strains for 2014?
This year’s seasonal influenza vaccine will offer protection against the following strains:
• A/California/7/2009 (H1N1)-like virus
• A/Texas/50/2012 (H3N2)-like virus
• B/Massachusetts/2/2012-like virus
What are the funded seasonal influenza vaccines for 2014?
INFLUVAC® (Abbott Laboratories NZ) and FLUARIX® (GlaxoSmithKline) are the funded vaccines for 2014.
For more information on both these vaccines, please refer to the Vaccine Data Sheets on page 4.5 & 4.7
and Vaccine Comparison Chart on page 4.3 of this kit.
How are INFLUVAC® and FLUARIX® produced?
INFLUVAC® is a subunit vaccine which contains only viral surface antigens (or protein haemagglutinins).
FLUARIX® is a split virion (split virus) vaccine. The virus is concentrated, inactivated and “split” by disrupting
its membranes. Both vaccines are purified and inactivated. Influenza virus is grown in embryonated hens’
eggs from disease-free flocks. The haemagglutinin protein for each of the strains are harvested for use in
influenza vaccine.9
Both vaccines conform in safety and sterility to the requirements of the British Pharmacopoeia.
What are the differences between INFLUVAC® and FLUARIX®?
The vaccines produced by different companies have essentially the same effectiveness profile. Either of
the vaccines can be given for influenza protection to eligible people and the immunisation subsidy can be
claimed. Please refer to page 4.5 for the Data Sheets and 4.3 for Comparison Chart for more information.
Can INFLUVAC® and FLUARIX® be given to people with egg allergies?
In most cases the vaccine can be safely administered to people with a history of allergy to egg.10,11
If a patient has a high-risk of complications from influenza and has a history of egg anaphylaxis, it is
important to seek additional specialist advice. The risk of anaphylaxis needs to be considered against the
benefits of being protected from influenza or its complications. As the vaccine virus is grown in hens’ eggs
it may contain minute amounts of egg protein. Other allergies to eggs that are non-anaphylactic are not
a contraindication.
Do INFLUVAC® or FLUARIX® contain blood products?
No blood products are used in the manufacturing process of INFLUVAC® and FLUARIX®.
Do INFLUVAC® or FLUARIX® contain thiomersal?
No. INFLUVAC® and FLUARIX® are preservative free. Neither of the vaccines contain thiomersal.
2.3
Do INFLUVAC® or FLUARIX® contain gentamicin?
Yes. Both INFLUVAC® and FLUARIX® vaccines contain traces of gentamicin due to the use of these
substances during production. INFLUVAC® and FLUARIX® should be used with caution in people with a
hypersensitivity to gentamicin. However, these vaccines should not be used in people who have had an
anaphylactic reaction to gentamicin.
Vaccine data sheets may vary in their recommendations on contraindications. Regarding hypersensitivity
and contraindications, current best evidence for influenza vaccines and recommendations by the
Immunisation Advisory Centre (IMAC) and Australasian Society of Clinical Immunology and Allergy (ASCIA)
are that individuals with anaphylaxis to any ingredient in the vaccine are contraindicated except egg allergy
and should not receive a vaccine that includes them.
Are INFLUVAC® and FLUARIX® latex free?
INFLUVAC® syringes do not contain any latex components. However, the manufacturer (Abbott Laboratories
NZ) is unable to confirm that the product did not come in contact with any latex materials during the
manufacturing and packaging process. Patients highly sensitive to latex, who have a history of severe
hypersensitivity reaction to this material are advised that they should consult their doctor. With regard to
FLUARIX® some prefilled syringe models have a pre-attached needle and a typical skirted needle shield.
This needle shield contains approximately 43% of dry natural rubber (DNR). These prefilled syringes with
pre-attached needles are not considered latex-free.
Can INFLUVAC® or FLUARIX® be administered simultaneously
with other vaccines?
Yes, however the vaccines must be given at different injection sites.12
Can you get influenza from INFLUVAC® and FLUARIX®?
No. The vaccines have been made from influenza virus that has been concentrated, inactivated, then broken
apart. Immunisation cannot cause influenza as the vaccine does not contain any live viruses.
Sometimes immunisation is accused of causing the flu. There are two possible reasons for this. Firstly when
vaccinated, the body responds to the vaccine by producing an immune response. This can include systemic
symptoms such as fever, malaise and muscle aches which may mistakenly be assumed to be early signs
of flu. Secondly other respiratory viruses circulate during the winter months and influenza vaccines do not
protect against these. Most of these viruses cause milder infections (e.g. the common cold) and do not
pose the same threat, particularly to those at higher risk. However certain other infections may on occasion
produce influenza-like symptoms and quite severe illness which can lead to the suggestion that the vaccine
is ineffective. They should not be confused with influenza.
2.4
Effectiveness of inactivated influenza
vaccines
How effective is the trivalent inactivated influenza vaccine?
The efficacy (prevention of illness among vaccinated persons in controlled trials) and effectiveness
(prevention of illness in vaccinated populations) of influenza vaccines depends on several factors. The age
and immune status of the recipient are important as well as the match between circulating viral strains and
the vaccine. Randomised controlled trials comparing vaccinated with unvaccinated participants show that
outcome measures that include laboratory-confirmed infection with influenza virus provide the most robust
evidence of vaccine efficacy.
Inactivated seasonal influenza vaccine effectiveness against influenza in recent meta-analyses and
systematic reviews ranges from 59% (95% CI 51-67)13 to 73% (54-84)14 in healthy adults for years when
circulating and vaccine strains are well matched. Recently a re-analysis of the Cochrane Review on
effectiveness of influenza vaccines in the elderly was conducted using different methods that enabled
the utilisation of the same information, but viewed from a biological perspective, and were less likely to
miss a real effect finding that influenza vaccination in the elderly is often protective. The following table
summarises selected current estimates of both vaccine efficacy and vaccine effectiveness against a range
of clinical outcomes.
Level of protection
(95% confidence intervals)
Population
Type of Outcome
Infants under 6-months whose
mothers received influenza vaccine
during pregnancy
Efficacy against laboratory
confirmed influenza
41% - 48%15,16
Healthy children under 2 years of age
Efficacy against laboratory
confirmed influenza
Insufficient data13,17
Effectiveness against laboratory
confirmed influenza
66% (9% - 88%)18
Healthy children aged 6-35 months
Effectiveness against laboratory
confirmed influenza
66% (29% - 84%)18
Healthy children under 16 years
of age
TIV vaccine efficacy in
prevention of laboratory
confirmed influenza in
Randomised Controlled Trials
59% (41% - 71%)17
Healthy adults (18-65 years)
Effectiveness against influenzalike-illness
30% (17% - 41%)14
Efficacy against
influenza symptoms
73% (54% - 84%)14
Efficacy against laboratoryconfirmed influenza
59% (51% - 67%)13
2.5
Level of protection
(95% confidence intervals)
Population
Type of Outcome
Elderly aged 65 years and over
(Cochrane review 2010)
Effectiveness in preventing
influenza, influenza-like-illness,
hospitalisations, complications
and mortality
Inconclusive due to poor
quality of studies19
Elderly aged 65 years and
over (Rearranged analysis of
Cochrane studies)
Effectiveness against non-fatal
and fatal complications
28% (26%-30%)20
Influenza-like illness
39% (35%-43%)20
Laboratory confirmed influenza
49% (33% - 62%)20
Influenza vaccines are effective in children; however there is less evidence available for children under 2
years. In healthy adults, influenza vaccines are effective in reducing cases of influenza particularly when
the vaccine and circulating virus strains are well matched. Evidence suggests the effectiveness of influenza
vaccination in the community-dwelling elderly is modest. There is some evidence that in long-term care
facilities, influenza vaccination is effective against complications.
Is the vaccine useful in older adults?
Although older people may have a reduced immune response to influenza vaccine compared with younger
adults, they may still benefit from influenza vaccination. Older people are more likely to have a condition that
places them at higher risk of complications from influenza.
How long after immunisation does it take for antibodies to
be produced?
It takes up to two weeks for the vaccine to start providing protection. Some studies have observed
protective levels of antibodies developing as early as 4-6 days.
How effective is the immunisation against influenza strains not
included in the vaccine?
Effectiveness can be reduced by the difference between circulating virus strains and vaccine strains. The
influenza virus keeps changing and new vaccines are formulated for each northern and southern hemisphere
season. There may be some cross protection against an influenza virus not in the vaccine.
Why does a child need two doses if vaccinated for the first time?
Younger children have a better immune response after two doses for the first influenza vaccination.
This may be because they are more likely to be immunologically naive to influenza.
Are INFLUVAC® or FLUARIX® a single dose vaccine?
Yes.
2.6
Safety of influenza vaccines
Influenza vaccine is generally well tolerated
Common reactions associated with inactivated influenza vaccines include pain and redness at the injection
site. These are likely to occur in around 1 in 3 of adult vaccinees and are almost always mild.
Systemic events such as aches and pains may occur in about 1 in 10 adult vaccinees and are generally
mild and of short duration and not necessarily caused by the vaccine. Less common systemic events such
as fever, feeling unwell or tired, or muscle aches may appear influenza-like. However, the influenza vaccine
used in New Zealand does not contain live viruses and cannot cause the disease. Systemic reactions are
generally of short duration (1-2 days). In placebo controlled trials there is very little difference in rates of
systemic events in vaccinated compared with unvaccinated subjects.14
Children are more likely to experience a fever following influenza vaccine than adults. This is, however,
normally in less than 1 in 10 of vaccinees. The most commonly reported reactions in children other than
local injection site reactions are fever, appetite loss, irritability and drowsiness.
Serious events associated with influenza vaccine
The most significant serious reaction associated with influenza vaccination is anaphylaxis, a serious allergic
reaction that usually comes on within minutes of receiving the vaccine. This occurs in approximately 1.5 per
million doses.4 Other serious events following influenza vaccination are extremely rare. Many studies have
looked at a range of both acute and chronic conditions and have found no association with the inactivated
influenza vaccines currently used in New Zealand.4,14
Guillain-Barre Syndrome and influenza vaccine
Guillain-Barre Syndrome (GBS) has an annual incidence of around 10-20 cases per one million adults.
During a specific swine influenza immunisation campaign in the United States in the 1970s, an increase in
GBS was observed in vaccine recipients (around 1/100,000 additional cases) and the vaccination campaign
was halted. A meta-analysis of data in the US from the use of a monovalent pandemic A(H1N1) ‘swine flu’
vaccine used in 2009 reported a modest increase in GBS of around 1.6 excess cases per million people
vaccinated.21 An Australian study did not show any additional risk for GBS associated with the recent
pandemic vaccines.22
Epidemiological studies suggest there is either no increased risk or possibly a slightly increased risk
of around one case per million adult vaccines with the use of seasonal influenza vaccine.23
A United Kingdom population study showed that the relative incidence of GBS within 90 days of influenza
vaccination was not increased; however the risk of GBS within 90 days of an influenza-like illness was seven
times higher.23
2.7
Febrile adverse events
Fever is a common adverse event in children after immunisation. Febrile convulsions can occur in
susceptible children who have a fever. The background risk of febrile convulsions is highest in children
aged between 16 and 23 months estimated at up to 48 cases per 1000 person years.24 A higher risk
was associated with FLUVAX® in 2010 resulting in the recommendation not to use this vaccine in children
under 9 years.
In 2014 the funded vaccines are INFLUVAC® and FLUARIX®.
For further information please refer to the vaccine data sheets www.medsafe.govt.nz.
Reporting adverse events following influenza immunisation
Health professionals/vaccinators should report any serious or unexpected adverse events regardless
of whether or not they consider the event to have been caused by the vaccination.
Information should include:
• individual’s details
• the vaccine administered
• vaccine batch number
• date of onset of symptoms
• type and duration of adverse event
• treatment required
• outcome if known but do not delay reporting whilst waiting outcome information
A copy of the form for reporting adverse events following immunisation can be downloaded from the CARM website
www.otago.ac.nz/carm. A copy of the form is also available on page 75 of the 2011 Immunisation Handbook.
Contraindications to receiving influenza vaccines
Who should not have the vaccine?
The general contraindication to receiving any vaccine is a history of anaphylaxis to a previous
dose or any constituent of the vaccine.
Immunisation should be deferred for anyone who is acutely unwell with a fever or other systemic illness.
Influenza vaccine is produced in hen's eggs and may contain residual egg protein. Patients who have had a
confirmed anaphylactic reaction to egg protein may still be able to receive the vaccine but it is recommended to
do so under specialist supervision. Non-anaphylactic reactions to eggs are not a contraindication.
Refer Australasian Society of Clinical Immunology and Allergy (ASCIA) 2010 guidelines on influenza
vaccination in egg allergic individuals www.allergy.org.au/images/stories/pospapers/ascia_
guidelines_influenza_ vaccination_egg_allergic_individual_2010.pdf.
Neomycin, polymyxin and gentamicin are also residual in some influenza vaccines and patients with known
anaphylaxis to these should not receive a vaccine that includes them as residual ingredients.
2.8
Influenza and children
Influenza immunisation: use in children
Influenza vaccination recommendations vary between countries. The United States of America recommends
annual vaccination for all persons from 6 months of age.26 Cost-benefit analysis to date identifies in
particular vaccinating high-risk children as providing the greatest gains,27 hence the current New Zealand
strategy is to offer free immunisation to children with certain medical conditions most likely to lead to higher
risk of severe outcomes. However, influenza infection rates are generally highest in children28,29 and healthy
children are the major cause of the spread of influenza viruses in the community.30
Vaccination of healthy children aged 2-5 years have the potential to substantially reduce influenza-like illness
and related costs in both the children themselves and their families.30
The United Kingdom has just announced a plan to vaccinate all children aged 2 – 17 years annually from
2014 with a live attenuated nasal spray influenza vaccine: this vaccine is expected to be more effective in
children but this type of vaccine is not currently available in New Zealand.
New Zealand current strategy
Children aged 6 months to 9 years of age who are receiving the influenza vaccine for the first time should
receive two doses four weeks apart, as they are likely to be immunologically naive and hence get better
response from a two dose priming regime.31 Children who have received a previous influenza vaccine need
only a single dose.
Age
Dose
Number of doses
6-35 months
0.25 mL
1 or 2*
3-8 years
0.5 mL
1 or 2*
>9 years
0.5 mL
1
*Two doses separated by at least four weeks if an influenza vaccine is being used for the first time.
Use of paracetamol following immunisation
The routine prophylactic use of paracetamol to control fever either prior to or following vaccine administration
is not recommended. Evidence shows that the immune response to some antigens can be reduced.9
The current recommendations are as follows:
• Do not use routine prophylactic paracetamol or other antipyretics pre or post vaccination in the
absence of pain or significant discomfort
• Infants who are uncomfortable with fever should first be managed with appropriate removal of
clothing and other cooling measures such as cool drinks or tepid sponging
• Only use analgesics (paracetamol or ibuprofen) for relief of pain or significant discomfort post vaccination
Anyone with concerns following immunisation should seek medical advice.
* NOTE that treatment advice may differ for other groups. For example, it is important to
manage fever carefully in pregnant women because of the potential risks to mother and
baby. Seek specialist advice as appropriate.
2.9
Influenza and other special patient groups
Immune-compromised
Severely immune-compromised people are at high-risk of severe influenza and its
complications. It is important to offer immunisation prior to the initiation of chemotherapy or radiation
treatment. Following cessation of chemotherapy, normal immune responses return after about 30 days.
A medical specialist’s advice should be sought when considering the repeat influenza vaccination of a
patient following bone marrow transplantation.
The protective effectiveness of influenza vaccination in those with very poorly functioning immune systems
is likely to be low, thus additional preventative strategies are needed. ‘Ring-fencing’ of such patients by
immunising family members, other close contacts and hospital staff should be considered.
International travel
Studies have indicated that influenza is the most commonly caught vaccine-preventable disease amongst
international travellers.32,33 Influenza outbreaks have been linked to travellers.34,35 Certain types of travel
where large numbers of people are likely to be in close proximity, such as cruise ship voyages36 or events
that include mass gatherings37 are particularly high-risk. For these reasons, all people travelling outside New
Zealand should consider influenza vaccination pre-travel. This is especially important for those who are at
higher risk of influenza complications, many of whom will be eligible for subsidised vaccine.
In tropical countries, influenza activity can occur throughout the year, so immunisation is worthwhile
regardless of season. In temperate climates in the northern hemisphere activity is more common between
the months of December and March. If a traveller has received the southern hemisphere vaccine in the
preceding New Zealand autumn or winter and the same strains are circulating in the northern hemisphere,
they should remain protected. If they haven’t been immunised the preceeding autumn or winter or it is
getting close to 12 months since their last immunisation, vaccination is recommended prior to travel.
If the southern and northern hemisphere strains differ significantly, it would be preferable to obtain the local
vaccine on arrival. However, vaccination with the southern hemisphere vaccine may offer some protection
and would be preferable to having none. The northern hemisphere vaccine is not available in New Zealand.
The influenza strains covered by the northern hemisphere influenza vaccine for (2013-2014) are:
• A/California/7/2009 (H1N1)-like virus
• A/Victoria/361/2011 (H3N2)-like virus
• B/Massachusetts/2/2012-like virus
Quadrivalent vaccines will also include an additional vaccine virus strain
• B/Brisbane/60/2008 – like virus
Are there any circumstances where people may consider
re-immunising within a year, e.g. prior to travel?
Yes. When the available vaccine gives protection against influenza viruses circulating in the northern
hemisphere, travellers - particularly those in ‘high-risk’ groups - who will be exposed to a northern
hemisphere influenza season should consider immunisation or re-immunisation prior to travel.33
Protective antibodies peak one week to one month after vaccination and then begin to wane.
By 6-8 months after vaccination, protective levels are lower and may not be sufficient to provide
good protection.
2.10
Related diseases
Additive protection with pneumococcal immunisation
The risk of invasive pneumococcal disease is much higher in infants and older people and more frequent
in individuals with predisposing conditions such as viral respiratory tract infections, including influenza, or
underlying conditions such as immune deficiency states. Mortality is highest in patients with underlying
medical conditions.
Pneumovax® 23
It has been demonstrated, particularly in older people over 65 years with chronic lung disease, that giving
both influenza and pneumococcal polysaccharide 23-valent (23PPV) vaccines during the influenza season
has an additive benefit in reducing hospitalisations for pneumonia and death.
The 23PPV vaccine offers some protection against invasive pneumococcal disease in the general elderly
population and a reduced level of protection in the high-risk elderly. There is limited evidence to support
efficacy against pneumonia in older adults in the community. The vaccine appears to provide some
protection against all cause pneumonia and pneumococcal pneumonia in nursing home residents.
Protection from the polysaccharide type of pneumococcal vaccine is relatively short lasting. The general
consensus is that most high-risk people will require a second vaccination after approximately 3-5
years in children under 10 years and after 5 years in older children and adults.42,43 The polysaccharide
pneumococcal vaccine should not be given more than 2-3 times in a lifetime.
Adult groups (16 years and over) who are RECOMMENDED, but NOT funded, to have
pneumococcal vaccination:*
• Adults 65 years and over
• Adults with chronic illness
- cardiac and renal disease
- pulmonary disease (COPD, asthma)
- diabetes
- alcoholism
- cigarette smoking
• CSF leaks, cochlear implants
• Immune compromised
- nephrotic syndrome
- myeloma
- lymphoma and Hodgkin’s disease
- post organ transplant
• HIV infection
• Previous pneumococcal invasive disease
*Ministry of Health. Immunisation Handbook 2011.
2.11
Conjugate pneumococcal vaccines
SYNFLORIX®
SYNFLORIX® is funded for primary and booster vaccination of all infants and children up to their 5th birthday
to protect against disease caused by 10 types of Streptococcus pneumoniae.
PREVENAR 13®
PREVENAR 13® is used for primary and booster vaccination to protect against disease caused by 13 types
of S. pneumoniae. The vaccine is licensed for use in infants and children up to their 5th birthday and for
adults from 50 years of age. PREVENAR 13® is recommended and funded for those who have medical
conditions which make them more likely to be at higher risk from pneumococcal diseases.44
For the SYNFLORIX® and PREVENAR 13® Datasheets, please refer to the Medsafe website
www.medsafe.govt.nz.
NB. Prevenar 13 will gradually be replacing Synflorix.
Can high-risk adults be further protected by using a conjugate pneumococcal vaccine?
Conjugate pneumococcal vaccines show good immunogenicity results in older adults, and studies are
currently underway on effectiveness. PCV-13 was approved for used in adults aged 50 years and older by
the US FDA in October 2011 on the data supporting clinical benefit from studies indicating superior immune
responses over the PPV-23.44 A prior dose of a polysaccharide vaccine (PPV23) is likely to attenuate the
response to a subsequent dose of a conjugate (PCV-13). Hence PCV-13 is likely to be of clinical benefit
in at-risk older adult age groups. When used it is preferential to offer it prior to PPV23 to avoid potential
hyporesponsiveness associated with the use of PPV23.45 There is a recommended two month interval
between use of the two vaccines.
Can pneumococcal and influenza vaccine be given at the same time?
Yes. Concurrent administration of all pneumococcal vaccines and influenza vaccine is safe and is not
associated with increased rates of side effects as long as given in separate injection sites.46 If not given at
the same time there is no need for any minimum interval space. Co-administration of PCV-13 and influenza
vaccine does result in lower influenza mean antibody titres but it is still considered satisfactory from both
a safety and immunogenicity perspective.47 For further information on pneumococcal disease, refer to the
2011 Immunisation Handbook.
For the PNEUMOVAX® 23, SYNFLORIX® and PREVENAR 13® Datasheets please refer to the Medsafe
website www.medsafe.govt.nz.
2.12
Meningococcal disease
When you are assessing patients with flu symptoms,
be alert for meningococcal disease.
Infection with meningococcus results in a wide range of presentations, but most commonly meningitis
and / or septicaemia. Approximately two-thirds of cases have a rash, which may be petechial, purpuric
or, less commonly, maculopapular and urticarial.
The presence of a petechial or purpuric (non-blanching) rash must be taken very seriously
Those particularly at risk of meningococcal disease are children aged less than 5 years, although all age
groups may be infected and there is a higher case fatality rate in adults. The presentation may be nonspecific in young infants.
Symptoms
Be alert for patients who may present with flu-like symptoms. It usually has a sudden onset with:
• A high fever
•Headache
•Sleepiness
• Joint and muscle pains
There are also more specific symptoms, such as:
• A stiff neck
• Dislike of bright lights
•Vomiting
•Crying
• Refusal to feed (in infants)
• A rash consisting of reddish-purple pin-prick spots or bruises
For more information refer to the Immunisation Handbook 2011 pg 286 or
www.health.govt.nz/our-work/diseases- and-conditions/meningococcal
2.13
Pertussis
Current pertussis epidemic
There has been a major increase in the number of cases of whooping cough around the world; including
New Zealand, where outbreaks of the disease usually happen every three to five years. The most recent
outbreak began in August 2011 and is still ongoing.
PHARMAC has made the decision to extend the National Immunisation Schedule to fund BOOSTRIX®
(Tdap) vaccine during the current pertussis epidemic for pregnant women (between gestational weeks 28
and 38). This position is in line with other countries.
The Department of Health in the United Kingdom has widened access to pertussis containing vaccine to
include pregnant women (between gestational 28 and 38 weeks). Its advice is that the vaccine may provide
maternally acquired immunity in newborn children until they can initiate the childhood vaccine schedule
(http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1287142671506).
The United Kingdom's Joint Committee On Vaccination and Immunisation (JCVI) considered that
immunisation could be offered at one of the routine antenatal appointments within weeks 28 to 32 of
pregnancy. The JCVI noted antibody levels in adults’ peak around two weeks after a pertussis booster with
significant decline over the following months. Transplacental antibody transfer is minimal until week 34 of
pregnancy.
Offering immunisation from 28 weeks would provide some protection to infants born prematurely who may
be particularly vulnerable to complications from pertussis.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (United
States of America) has also recommended vaccination in the third trimester.
For best protection
To protect infants from severe disease please continue to encourage on time immunisation at ages
six weeks, three months and five months and immunisation of pregnant women between 28 and 38
weeks gestation.
BOOSTRIX® is recommended and funded in every pregnancy between 28 and 38 weeks gestation
regardless of the interval since a previous Tdap or Td vaccine. This is to maximise maternal protection
against pertussis and maximise transplacental pertussis antibody transfer and protection of the newborn
from severe pertussis for four to six weeks after birth.
For the BOOSTRIX® Datasheet please refer to the Medsafe website www.medsafe.govt.nz.
2.14
Use of antivirals for influenza treatment
and/or prevention
Antiviral medications for influenza
Antiviral medications are available and effective for the treatment and prevention of influenza, however they
do not replace influenza vaccination as the recommended strategy for the control of influenza.48
The neuraminidase inhibitors are the preferred class of antivirals approved for use in New Zealand. They
include TAMIFLU® (oseltamivir) and RELENZA® (zanamivir) which are active against influenza A and B
viruses.
Antiviral resistance to both oseltamivir and zanamivir in circulating influenza viruses is currently low, however
resistance may emerge in some patients (e.g. the immunocompromised) in association with treatment.
Guidance on influenza prevalence can be obtained from regional influenza surveillance reports, these are
updated weekly and available at http://www.surv.esr.cri.nz/virology/influenza_weekly_update.php during
the season. Antiviral resistance data is included in the report at the end of October and the annual report in
March the following year.
Antiviral treatment
TAMIFLU® is approved for the treatment of persons 1 year and older. RELENZA® is approved for the
treatment of persons 5 years and older; however it is not recommended for people with underlying
respiratory disease (e.g. asthma, COPD).
Limited information regarding the use of TAMIFLU® in children from birth to <1 year old is available, although
it was approved for use during the 2009 pandemic.
Clinical benefit is greatest when antiviral treatment is commenced EARLY, especially within 2 days of
influenza illness onset. Clinical trials show that early antiviral treatment can shorten the duration of fever
and influenza symptoms, reduces viral shedding and may reduce the risk of complications from influenza
including otitis media in children, pneumonia and respiratory failure.49,50 Observational studies during the
2009 pandemic have shown that antiviral treatment commenced within 2-4 days in comparison with
5 or more days may still be beneficial in patients with severe or complicated influenza. Reductions in
hospitalisation, respiratory failure, intensive care admission, and mortality have been demonstrated.51-53
Treatment indications
Treatment is recommended as early as possible for patients with suspected or confirmed influenza who are
hospitalised, have severe influenza, progressive illness or are at higher risk of severe outcomes.
• Persons at higher risk for influenza complications include those ≥65 years, all ages with chronic
respiratory disease, immunosuppression, women who are pregnant or postpartum and residents of
nursing homes or chronic care facilities
• Treatment should start immediately, rather than wait for the results of a virology test
Seek specialist advice as appropriate, especially for patients with severe or deteriorating influenza.
2.15
TAMIFLU® is recommended as the first-line antiviral treatment. Standard adult treatment courses are:
• TAMIFLU® 1 x 75mg capsule twice daily for 5 days
• RELENZA® 2 x 5mg, two inhalations twice a day (a total daily dose of 20mg) for 5 days
Recomendations for the second-line use of RELENZA® are:
• An inability to take or tolerate TAMIFLU® e.g. due to nausea or vomiting
• Moderate to severe renal impairment
For paediatric doses and other information see medicine data sheets:
www.medsafe.govt.nz/profs/Datasheet/t/Tamiflucapsusp.pdf
www.medsafe.govt.nz/profs/Datasheet/relenzarotadisk.pdf
TAMIFLU® is a Prescription Medicine and must be prescribed by a doctor. However, during the influenza
season (April to November) Tamiflu may be prescribed by a pharmacist for the treatment of influenza,
provided the patient is ≥12 years old and has been assessed by a pharmacist.
www.medsafe.govt.nz/profs/class/classification.asp.
Antiviral chemoprophylaxis
TAMIFLU® is approved for the prophylaxis of persons 1 year and older and RELENZA® for the prophylaxis of
persons 5 years and older; however RELENZA® is not recommended for people with underlying respiratory
disease (e.g. asthma, COPD).
While annual influenza vaccination, given well before the influenza season, is the recommended strategy/
approach to prevention and control of influenza, clinical trials have reported that both TAMIFLU® and
RELENZA® were effective in preventing influenza illness in persons following exposure to a household
member or other close contact with laboratory confirmed influenza (TAMIFLU® 68%-89%; RELENZA®
72%-82%).48
Post-exposure indications for use
Routine use of antivirals for pre-exposure or post exposure chemoprophylaxis is not recommended,
however there are situations where post-exposure use is indicated.
• On a case by case basis e.g. for pregnant or postpartum women who have had close contact with
an influenza case or other persons at high risk of severe illness
• For outbreak control among high risk persons in institutional settings e.g. hospitals, residents
of nursing homes and other closed institutions54
Chemoprophylaxis should occur within 48 hours of exposure to an influenza infected person.
Standard adult chemoprophylaxis courses are:
• TAMIFLU® 1 x 75mg capsule daily for 10 days
• RELENZA® 2 x 5mg, two inhalations a day (a total daily dose of 10mg) for 10 days
2.16
Section three –influenza and pregnancy
Help protect our mums-to-be
3.1
The importance of recommendation/discussion with pregnant women
3.1
The negative impact of Influenza infection during pregnancy
3.2
Immunise to protect pregnant women and their babies
3.4
Vaccination and breastfeeding
3.5
Protect yourself to protect pregnant women and their unborn baby
3.5
Help protect our mums-to-be
Influenza circulates in New Zealand seasonally each year and the proportion of the population infected and
the severity of infection is unpredictable.
Influenza affects different population groups disproportionality with the very young and the very
old and people who have certain underlying health conditions among the groups at highest risk for
serious complications.
One other important group at high risk of severe disease and complications are pregnant women and their
babies (up to 6 months). This has been recognised since the 1918 pandemic.
The World Health Organization recommends influenza vaccination for pregnant women regardless
of any trimester and that they be given the highest priority.
Vaccination of pregnant women has been found to be highly effective in preventing influenza and its
complications in women and, for a short time after birth, her baby.
As an inactivated vaccine there are no concerns about the safety of influenza vaccine used in
pregnant women.
The importance of recommendation/
discussion with pregnant women
There is considerable research to show that patients value the recommendation of their health professional.
Studies have indicated that an explanation covering the following three aspects is important:
1. The risk of disease for the woman, the pregnancy outcome
and fetal development
2. S
afety and efficacy of the trivalent inactivated vaccine
3. Two for one benefit for the woman and her baby as newborns
cannot receive influenza vaccine until they reach the age
of 6 months
3.1
The negative impact of influenza infection
during pregnancy
It has been estimated that in a routine influenza season around one in ten pregnant women are exposed to
influenza and during pandemics this will be much higher. It is well established that some of the physiological
changes that occur during pregnancy leave pregnant women and fetuses at greater risk for influenza and
associated complications. Influenza infection during pregnancy can have catastrophic consequences for
both mother and baby including premature birth, stillbirth, small for gestational age and perinatal death.
Physiological changes during pregnancy that can lead to complications from influenza include the following:
• I mmune system: While humoral (antibody mediated) immunity appears to be enhanced, the cellular
arm of the immune system is temporarily altered. This is to prevent harmful immune responses
directed at the pregnancy, which is genetically foreign to the mother. Generally, during pregnancy
inflammatory responses are dampened and anti-inflammatory responses are enhanced. However
this change also leaves the women more vulnerable to some intracellular pathogens including viral
infections which require inflammatory responses for the initial control and the clearance of infection.55
• Physical changes: Changes in the pelvic region, abdominal and thoracic cavities place pressure
on surrounding organs. Lung capacity is decreased and oxygen consumption increased. The heart
increases its output and rate, blood volume increases and associated blood pumped per contraction
(stroke volume) are increased. As a result pregnant women have an increased risk of pneumonia and
more severe complications.
Risk to the women
Pregnant women who contract influenza have significantly higher rates of hospital admissions than women
who are not pregnant. A Canadian study which investigated the rates of influenza-attributable hospitalisation
for healthy pregnant and non-pregnant women for six years between 1994 and 2000 found that pregnancy
was associated with an 18-fold greater rate of hospitalisation.56 When pre-existing medical conditions are
superimposed on pregnancy the risks become even higher. A normally healthy woman who is pregnant has
a similar risk for complications from influenza as non-pregnant women who has co-morbidities. This risk
increases with gestation.
Evidence suggests that pregnant women are even more vulnerable during pandemics.
Pregnant women in Australia and New Zealand who had pandemic influenza in 2009 were 13 times more
likely to be admitted to hospital with a critical illness than non-pregnant women who had pandemic influenza
2009. Nearly 70% of these women admitted to Intensive Care needed mechanical ventilation. Of those
admitted to Intensive Care, 11% of mothers and 12% of babies died despite modern obstetric and Intensive
Care management.57
At the time pregnant women represented around 1% of the total population of Australia and New Zealand.
Of all the patients admitted to Intensive Care in these countries, over 9% were pregnant. Pregnancy was
also an independent risk factor for death.58
3.2
Risk to the fetus
Direct vertical transmission of the influenza virus to the fetus is thought to be extremely rare, therefore the
adverse effects observed on the fetus in mothers who have influenza are likely to be indirect i.e. as a result
of the mother’s response to the virus. One mechanism by which maternal influenza infection is associated
with congenital abnormalities is via the induction of fever. Fever in pregnancy is associated with neural
tube defects when it occurs in early pregnancy59 and infants born to mothers infected with influenza during
pregnancy are more likely to have babies with congenital abnormalities than uninfected matched controls.60
Overall there is an increase of general pregnancy complications in women who have influenza.61
Maternal influenza infection is also associated with an increased risk for cancers in the infant, including
neoplasms of lymphatic and haematopoietic tissue (noted in the 1957 pandemic)62 and neuroblastomas.63
The increased risk of developing a neoplasm in a child born to a
mother who had influenza is estimated to be not less than fourfold64
but depends on the epidemic or pandemic year. Note however the
absolute risk is still low as these are rare cancers.
Following the 2009 pandemic, in New Zealand the eligibility criteria
for free influenza immunisation were extended in 2010 to include
pregnant women due to the significant risk for pregnant women that
was observed during the pandemic. In 2011 a policy decision was
made to continue to subsidise influenza immunisation for pregnant
women as research has clearly shown that pregnant women and
their fetuses are particularly susceptible to more severe outcomes
from influenza.
Risk to the baby
Infants are at higher risk of being hospitalised with influenza than
other age groups. New Zealand research on the burden of influenza,
based on hospitalisation rates in Auckland revealed that in 2013,
infants under a year of age had an incidence of 122/100,000
compared to 10 /100 000 for midlife adults and 69/100 000 for
those over 80 years of age (http://www.esr.cri.nz/competencies/
shivers/Pages/default.aspx). Those from Pacific background are
at particularly high risk. Infants of Maori ethnicity, and those from
backgrounds of socioeconomic hardship also have higher rates of
hospitalisation with influenza.
Infants are unable to receive the influenza vaccine until they are
6 months of age. An effective way of reducing influenza for young
babies is to vaccinate the pregnant woman. Passive transfer of
antibodies to the fetus offers significant short term protection to the
baby. Pregnancy vaccination reduces the risk of influenza in infants
less than 6 months of age by more than 90%.65
3.3
Immunise to protect pregnant women and
their babies
Effectiveness
The immune response to influenza vaccine in pregnant women is similar to that of non-pregnant women
and it is expected that the effectiveness in preventing influenza is no different.66 The inactivated vaccines
used in New Zealand are estimated to prevent around two thirds of serologically confirmed influenza in
non-pregnant healthy women.67 Among pregnant women influenza vaccination is around 28% effective
in preventing any febrile illness. In addition to preventing influenza in the pregnant women, there is
transplacental transfer of influenza-specific antibodies which have a half-life in the newborn baby of around
43-53 days. These antibodies are protective for around eight weeks in about 61% of babies.68,69
Safety of influenza vaccine in pregnant women and their babies
Influenza vaccines have been recommended for and used in pregnant women since the 1960s and there
is considerable safety data. There is no evidence for risks to the developing fetus associated with maternal
influenza vaccination using subunit vaccines, inactivated vaccines or non-live whole cell vaccines of any
kind. While there are theoretical risks to the developing fetus associated with the use of live vaccines there is
no existing evidence of harm . The influenza vaccines used in New Zealand are inactivated vaccines and as
such their activity and the immune response they induce occur locally, not systemically.
A review of the available data supports a good safety profile of influenza vaccines in pregnant women and
no concerns with regard to fetal and neonatal outcomes have been identified.70 Influenza vaccination in
early pregnancy is not associated with any increase in major malformations but has been associated with a
decrease in the overall stillbirth rate.71 There is a range of studies looking at the safety of influenza vaccine in
pregnant women that have been conducted over the past 40 years. Below are the key points from a few:
• In a cohort of 51,000 pregnant women there was no evidence for an excess of childhood
malignancies in children born to vaccinated mothers (n=2291) compared with unvaccinated mothers.72
• Influenza vaccine during pregnancy was not associated with increased risk of adverse events in the
42 days after vaccination among 75,906 vaccinated and 147,992 matched unvaccinated women.73
To date there has been no study showing any increased risk for either maternal or fetal adverse outcomes
associated with inactivated influenza vaccination.
Within New Zealand influenza vaccine uptake amongst pregnant women has, to date, been very modest
with many concerns raised around safety of the influenza vaccine and the potential effect on the fetus. In a
recent survey conducted, it was highlighted that pregnant women were regularly having appointments with
their midwife / LMC but only two in five were being recommended vaccination (Ministry of Health 2013).
The research also highlighted the importance of reassuring pregnant women of the excellent safety record
of influenza immunisation while stressing that the potential complications from catching influenza pose a
greater threat to them and their baby than immunisation (Ministry of Health 2013).
3.4
Vaccination and breastfeeding
The influenza vaccine can be given to a breastfeeding woman. Protecting the mother can help prevent her
becoming infected and transmitting influenza to her baby. There is no evidence that breastfeeding protects
against influenza.74
Protect yourself to protect pregnant
women and their unborn baby
By immunising yourself against influenza you are less likely
to become infected and transmit the virus to women in
your care.
The WHO strongly recommends Health Care Workers as a
priority group for influenza vaccination, not only for their own
protection and ability to maintain services but also to reduce
the spread of influenza to their vulnerable patients.
You can transmit influenza without knowing you are infected.
For further information relating to Pertussis please refer to page 2.14.
3.5
Section four – technical information/
data sheets
Ordering, delivery and storage
4.1
Vaccine comparison chart
4.3
Vaccine data sheets
4.5
References
4.12
Ordering, delivery and storage
Seasonal influenza vaccine ordering is handled by Healthcare Logistics (HCL). You can order in two ways:
Online: www.hconline.co.nz
Fax order form to: 0508 408 358
Enquiries can be made by calling: 0508 425 358
Cost of the influenza vaccine
The vaccine costs $9.00 (excl. GST) per dose. For patients eligible for funded vaccines, the vaccine is free.
PHARMAC in conjunction with the Ministry of Health (Please refer to the Eligibility Criteria on page 1.4 of this
kit) both INFLUVAC® and FLUARIX® can be used for patients eligible for subsidised vaccination and patients
who are privately funded. The programme runs from when the vaccine becomes available (late February,
early March), through to July 31st, 2014. Claiming will be via the usual Sector Services process. Influenza
vaccine is still available following the funded period, however, all patients will have to pay for it.
How much is the immunisation subsidy?
$19.59 (excl. GST)
Delivery charges?
There are no delivery charges.
Minimum order requirements?
The following minimum order quantities apply:
February
March
April
May
June
July
Min 60 doses
Min 60 doses
Min 30 doses
Min 30 doses
Min 20 doses
Min 10 doses
Influenza chilly bins
Influenza chilly bins cannot be recycled. To reduce wastage when ordering, please consider your expected
usage. A small bin holds 60 doses, a medium chilly bin holds up to 120 doses, a large bin holds up to 180
doses, the extra-large bin holds up to 500 doses.
Vaccine availability at the start of the season
Orders will be dispatched as soon as the vaccine is available from the supplier (late February, early March).
Please do not organise clinics until you are certain you will have sufficient vaccine available in your
refrigerator to meet demand.
Influenza vaccine stock damaged in transit
Influenza vaccine damaged in transit may be returned to Healthcare Logistics for destruction.
4.1
Expired influenza vaccine
Expired influenza vaccine can be returned using the normal process for expired / damaged paediatric
vaccines to your local ProPharma vaccine warehouse. If unsure of the process, contact your local
immunisation coordinator.
Refund for unused stock?
It can be difficult to determine exact requirements towards the end of the influenza season. A refund will be
available for a total of 10 units of unused stock of seasonal influenza vaccine either INFLUVAC® or FLUARIX®,
(for 2014, only one brand, not both) from any one account. Unused stock must be returned by August
31st, 2014 to be eligible for a refund. Thereafter surgeries should contact their immunisation coordinator for
information on safe disposal.
The shelf life of INFLUVAC® and FLUARIX®?
Twelve months from date of manufacture, if stored between
2ºC and 8ºC (refrigerated). All pre-filled syringes are marked
with an expiry date which should be checked before
vaccine administration.
Cold Chain
The vaccine should be stored between 2ºC and 8ºC.
It must not be frozen. If the vaccine has been inadvertently
left out of refrigeration or has frozen, please contact your
local immunisation coordinator for advice.
Temperature
Some orders may have a temperature logging device included
with the shipment. Do not be concerned if your shipment does
not contain a temperature logging device. If your order includes
a temperature logging device, further details will be provided
with the shipment.
4.2
0.25 mL
0.5 mL
0.5 mL
6-35 months
3-8 years
>9 years
1
1 or 2*
1 or 2*
Number of doses
0.25ml
0.5ml
6-35 3-8 years &
months > 9 years
Influenza vaccine
total dose = 0.5ml
• Those with immunodeficiency disorders may require two doses
Precautions needing further
information:
Abbott Laboratories NZ: 0800 737 271
Fully funded for eligible groups
Healthcare Logistics (HCL) • Phone: 0508 425 358 • Fax: 0508 408 358 • www.hconline.co.nz
Phone regarding clinical information:
Funding status:
Order from:
INFLUVAC®, and FLUARIX® are Prescription Only Medicines.
Please refer to manufacturers Data Sheet for further details www.medsafe.govt.nz.
•V
accines must be stored, protected from light, at +2°C to +8°C. DO NOT FREEZE. Discard if vaccine has been frozen
Storage:
GlaxoSmithKline: 0800 808 500
Pre-filled syringes: 0.5mL
Presentation:
• Those with acute illness or fever over 38°C
www.influenza.org.nz
0800 IMMUNE
(0800 466 863)
www.immune.org
• Those who have had anaphylactic reaction (with respiratory and/or cardiac involvement) to hen eggs or chicken proteins, gentamicin or any other
vaccine component
Contradictions:
• Gentamicin
• Gentamicin
Components of special note:
• Those with previous hypersensitivity to any component in the vaccine
• Reports have been published of patients on warfarin, theophylline, carbamazepine, phenobarbitone and phenytoin developing temporary toxicity
following influenza immunisation. Prescribers are advised to be alert for signs of toxicity. However the possible risk of interaction should not preclude
patients from being administered an influenza vaccine (Prescriber Update 2004;25(2);23-24 Potential for Flu Vaccine interaction exists)
Intramuscular or deep subcutaneous injection
Route of administration:
*Two doses separated by at least four weeks if an influenza vaccine is being used for the first time. INFLUVAC® & FLUARIX® are single dose
vaccines.
Dose
Where the recommendation differs from the Manufacturer’s datasheet, the latest Ministry of Health Immunisation Handbook takes preference:
Dosage:
Age
• A/California/7/2009 (H1N1)-like virus • A/Texas/50/2012 (H3N2)-like virus • B/Massachusetts/2/2012-like virus
Influenza strains for 2014:
GlaxoSmithKline NZ Ltd
National Influenza
Specialist Group
Abbott Laboratories NZ
FLUARIX®
www.influenza.org.nz
Manufacturer:
INFLUVAC®
Table comparing influenza vaccines for 2014 season
National Influenza
Specialist Group
4.4
INFLUVAC® Data Sheet
NAME OF THE MEDICINE
Influvac inactivated influenza vaccine (surface antigen)
DESCRIPTION
Influvac is a clear colourless suspension for injection. It is an egg-grown,
inactivated influenza virus vaccine based on isolated surface antigens of A and B
strains of myxovirus influenza. The type and amount of viral antigens in Influvac
conform to the requirements of the Australian Influenza Vaccine Committee
(AIVC) and the New Zealand Ministry of Health for the winter of 2014. The
strains chosen for vaccine manufacture are endorsed by the AIVC as being
antigenically equivalent to the reference virus.
This is a purified, inactivated influenza vaccine (surface antigen), each 0.5 mL
of which contains antigens representative of the following type:
A/California/7/2009 NYMC X-181 (A/California/7/2009 (H1N1)-like) 15 µg
haemagglutinin/dose
A/Texas/50/2012 NYMC X-223A (A/Texas/50/2012 (H3N2)-like) 15 µg
haemagglutinin/dose
B/Massachusetts/2/2012 NYMC BX-51B (B/Massachusetts/2/2012-like) 15
µg haemagglutinin/dose
Inactive:
Potassium chloride, potassium phosphate monobasic, sodium phosphatedibasic dihydrate, sodium chloride, calcium chloride, magnesium chloride and
water for injections.
PHARMACOLOGY
The vaccine stimulates production of antibodies with a specific capacity against
influenza. Protection is only against those strains of the virus from which the
vaccine is prepared or closely related strains.
Seroprotection is obtained within 2-3 weeks. The duration of post-vaccination
immunity varies, between 6-12 months.
INDICATIONS
For the prevention of influenza caused by influenza virus, types A and B in adults
and children older than 6 months in accordance with the recommendations in
the National Immunisation Guideline.
CONTRAINDICATIONS
Hypersensitivity to the active substances, to any of the excipients and to residues
of eggs, chicken protein, formaldehyde, cetrimonium bromide, polysorbate 80,
or gentamicin.
Immunisation should be postponed in patients with an acute febrile illness.
The presence of a minor illness with or without fever should not contraindicate
the use of Influvac.
PRECAUTIONS
As with all injectable vaccines, appropriate medical treatment and supervision
should always be readily available in case of a rare anaphylactic event following
the administration of the vaccine.
Influvac should not be administered intravascularly.
Influvac should be administered subcutaneously to subjects with
thrombocytopenia or a bleeding disorder, since bleeding may occur following
an intramuscular injection.
Patients with impaired immune responsiveness, whether due to the use of
immunosuppressive therapy, a genetic defect, human immunodeficiency virus
(HIV) infection, or other causes, may have a reduced antibody response in active
immunisation procedures.
Patients with a history of Guillain-Barre syndrome (GBS) with an onset related
in time to influenza vaccination may be at increased risk of again developing
GBS if given influenza vaccine. While this risk should be weighed against the
benefits to the individual patient of influenza vaccination, it would seem prudent
to avoid subsequent influenza vaccination in this group. Because patients with
a history of GBS have an increased likelihood of again developing the syndrome,
the chance of them coincidentally developing the syndrome following influenza
vaccination may be higher than in individuals with no history of GBS.
INTERACTIONS WITH OTHER MEDICINES
Influenza vaccine can impair the metabolism of warfarin, theophylline, phenytoin,
phenobarbitone and carbamazepine by the hepatic P450 system. Results from
studies have been variable in degree of interaction and time after vaccination
for the interaction to take effect. The interaction may be idiosyncratic. Patients
taking warfarin, theophylline, phenytoin, phenobarbitone, or carbamazepine
should be advised of the possibility of an interaction and told to look out for
signs of elevated levels of medication.
The immunological response may be diminished in patients taking
immunosuppressant treatment.
Influvac should not be mixed with other vaccines in the same syringe. Influvac
may be given at the same time as other vaccines. Immunisation should be
carried out in separate limbs. Adverse reactions may be intensified.
Effects on laboratory tests
Following influenza vaccination, false positive results in serology tests using
the ELISA method to detect antibodies against HIV1, Hepatitis C and especially
HTLV1 have been observed. The Western Blot technique disproves the results.
The transient false positive reactions could be due to the IgM response by
the vaccine.
Carcinogenesis, mutagenesis, impairment of fertility
Animal studies have not been conducted and therefore the effects of vaccination
are unknown.
No fertility data are available.
Use in pregnancy
Category B2.
No relevant animal data is available. There is no convincing evidence of risk
to the foetus from immunisation of pregnant women using inactivated virus
vaccines, bacterial vaccines, or toxoids. In pregnant high risk patients the
possible risks of clinical influenza infection should be weighed against the
possible risks of vaccination.
There is evidence from a number of studies that pregnant women, particularly
during the second and third trimester, are at increased risk of influenza
associated complications. It is therefore recommended that all women who will
be in the second or third trimester of pregnancy during the influenza season be
vaccinated in advance, so they are protected during that season.
Use in lactation
No relevant animal data is available. There are no known contraindications to
the use of Influvac by lactating women.
Effects on ability to drive and use machines
Influvac has no or negligible influence on the ability to drive and use machines.
ADVERSE EFFECTS
In clinical studies Influvac was administered to 1101 subjects. No serious
adverse reactions attributable to vaccine administration were reported. Local
and general symptoms were recorded for a period of 3 days following vaccination
and reactions usually disappeared within 1-2 days without treatment.
During clinical studies, local and general signs and symptoms reported by the
vaccinee were recorded.
The events are categorised by frequency according to the following definitions:
Very common: (frequency ≥ 10 %)
Common (frequency ≥ 1 and < 10 %)
4.5
Uncommon (frequency ≥ 0.1% and < 1 %)
Rare (frequency ≥ 0.01% and < 0.1 %)
Very rare (frequency < 0.01 %)
Local reactions.Very common: redness, swelling, pain.
Common: ecchymosis, induration.
Body as a whole.Very common: headache.
Common: fever, malaise.
Uncommon: shivering, fatigue, sweating,
myalgia, arthralgia.
Very rare: neuralgia, paraesthesia, convulsions,
transient thrombocytopenia, allergic reactions
(such as angioedema) leading to shock.
As with most biological products very rare post-vaccination neurological
disorders such as encephalomyelitis, neuritis and Guillain-Barre syndrome
(GBS) have been reported. Guillain-Barre syndrome (GBS) has been very rarely
reported in temporal association with administration of influenza vaccines. In
the 1976 swine influenza vaccination program, the US Public Health Advisory
Committee on Immunization Procedures (ACIP) found that GBS occurred at
an incidence of approximately 1 in 100,000 after immunisation and that the
death rate in this 'series' was approximately 1 in 2,000,000. Such an excess
incidence of GBS was not demonstrated in subsequent years when recipients of
the 1978 or 1979 vaccines were studied. However, in 1998, ACIP reported that
a study of the 1992-93 and 1993-94 seasons found an elevation in the overall
relative risk for GBS which represents an excess of an estimated one to two
cases of GBS per million persons vaccinated.
Post-marketing Experience
Adverse reactions reported from post marketing surveillance are, next to the
reactions which have also been observed during the clinical trials, the following:
Blood and lymphatic system disorders:
Transient thrombocytopenia, transient lymphadenopathy
Immune system disorders:
Allergic reactions, in rare cases leading to shock, angioedema
Nervous system disorders:
Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as
encephalomyelitis, neuritis and Guillain Barre syndrome.
Vascular disorders:
Vasculitis associated in very rare cases with transient renal involvement.
Skin and subcutaneous tissue disorders:
Generalised skin reactions including pruritus, urticaria or non-specific rash.
DOSAGE AND ADMINISTRATION
One dose is sufficient for persons previously exposed to viruses of similar
antigenic composition to the strain(s) present in the vaccine. In those with
some impairment of immune mechanisms, two doses separated by an interval
of at least four weeks are recommended.
Adults and children 3 years of age and older: 0.5 mL
Children from 6 months up to 35 months of age: Clinical data are limited.
A 0.25 mL dose is recommended.
For children who have not previously been vaccinated, a second dose may be
given after an interval of at least four weeks.
Children less than 6 months: The safety and efficacy of Influvac in children
less than 6 months has not been established. No data are available.
Administration
Influvac should be administered by intramuscular or deep subcutaneous
injection. Influvac should not be administered intravenously.
Influvac should not be mixed with other injection fluids.
Data on the administration of Influvac with other vaccines is not available.
For administration of a 0.25 mL dose from a syringe, push the front side of
the plunger exactly to the edge of the hub (the knurled polypropylene ring); a
reproducible volume of vaccine remains in the syringe suitable for administration.
4.6
The syringe is for use in a single patient on one occasion only. Remaining
contents should be discarded.
Instructions for use/handling
Influvac should be allowed to reach room temperature and shaken well
before use.
Vaccination schedule
Influvac should be administered before the beginning of the influenza
season or as required by the epidemiological situation. Vaccination should
be repeated every year with an age appropriate dose of vaccine of updated
antigen composition.
OVERDOSAGE
Given the nature of the product and mode of administration the probability of
overdosage is negligible.
PRESENTATION AND STORAGE CONDITIONS
Single-dose 0.5 mL pre-filled glass syringe, 1’s and 10’s (AUST R: 81465)
Keep out of reach and sight of children.
Store between 2 and 8 degrees Celsius. Refrigerate, Do not freeze. Store in the
original package in order to protect from light.
NAME AND ADDRESS OF THE SPONSOR
In New Zealand:
Abbott Laboratories NZ Ltd
4 Pacific Rise
Mt Wellington
Auckland
New Zealand
In Australia:
Abbott Australasia Pty Ltd
32-34 Lord Street
Botany NSW 2019
Australia
DATE OF PREPARATION
16 December 2011
DATE OF MOST RECENT AMENDMENT
7 November 2013
FLUARIX® Data Sheet
NAME OF MEDICINAL PRODUCT
FLUARIX Inactivated split influenza vaccine
PRESENTATION
FLUARIX is an inactivated and purified split influenza vaccine, prepared in
embryonated eggs.
The antigen composition and strains for the approaching influenza season are
determined by the World Health Organisation (WHO). This corresponds to the
following types and subtypes:
A/California/7/2009 (H1N1)-like virus,
A/Texas/50/2012 (H3N2)-like virus*,
B/Massachusetts/02/2012-like virus
*
an (H3N2) virus antigenically like the cell-propagated prototype virus A/
Victoria/361/2011.
Each 0.5 mL vaccine dose contains 15 μg haemagglutinin of each of the
recommended strains, in phosphate buffered saline. The vaccine preparation
also contains other excipients including saccharose, d-alpha-tocopheryl acid
succinate and traces of formaldehyde and gentamicin sulphate.
Fluarix meets the WHO requirements for biological substances and influenza
vaccines.
CLINICAL PARTICULARS
Therapeutic indications
Fluarix is indicated for prophylaxis against influenza in adults and children
older than six months of age. Because of the possibility of increased morbidity
and mortality from complications of influenza, vaccination is especially
recommended for the following:
• Persons over 60 years of age,
• Persons who suffer from diseases of the cardiovascular system, metabolic
diseases (diabetes), cystic fibrosis, chronic respiratory diseases, and chronic
renal insufficiency,
• Persons with congenital or acquired immune deficiency.
Vaccination can be recommended for individuals exposed to increased risk of
infection because of their occupation, such as medical personnel. In addition,
prevention of disease in the workforce could lead to substantial economic benefits.
Fluarix should be administered before the beginning of the influenza season or as
required by the epidemiological situations. Vaccination should be repeated every
year with an age-appropriate dose of vaccine of updated antigen composition.
Posology and method of administration
Posology
The following dosage schedule is recommended.
Age
Dose
Number of doses
6-35 months
3-8 years
>9 years
0.25mL
0.5mL
0.5mL
1 or 2*
1 or 2*
1
*Two doses separated by at least four weeks if the vaccine is being administered
for the first time.
Method of administration
FLUARIX can be administered intramuscularly or subcutaneously.
FLUARIX should be administered subcutaneously to subjects with
thrombocytopenia or a bleeding disorder since bleeding may occur following an
intramuscular administration to these subjects.
FLUARIX should under no circumstances be administered intravenously.
Contraindications
FLUARIX should not be administered to subjects with known hypersensitivity to
egg proteins, to gentamicin or to any other constituent of the vaccine.
Special warnings and special precautions for use
As with other vaccines, the administration of FLUARIX should be postponed in
subjects suffering from acute severe febrile illness. The presence of a minor
illness with or without fever should not contraindicate the use of FLUARIX.
FLUARIX will only prevent disease caused by influenza viruses.
Infections with other agents causing flu-like symptoms are not prevented by
the vaccine.
As with all injectable vaccines, appropriate medical treatment and supervision
should always be readily available in case of a rare anaphylactic reaction
following the administration of the vaccine.
Syncope (fainting) can occur following, or even before, any vaccination as a
psychogenic response to the needle injection. It is important that procedures
are in place to avoid injury from faints.
Interaction with other medicaments and other forms of interaction
Immunisation can be affected by concomitant immunosuppressive therapy or an
existing immunodeficiency.
FLUARIX can be administered simultaneously with other vaccines. However,
different injection sites must be selected.
False positive ELISA serologic tests for HIV-1, Hepatitis C, and especially HTLV-1
may occur following influenza vaccination. These transient false-positive results
may be due to cross-reactive IgM elicited by the vaccine. For this reason, a
definitive diagnosis of HIV-1, Hepatitis C, or HTLV-1 infection requires a positive
result from a virus-specific confirmatory test (e.g,Western Blot or immunoblot).
Pregnancy and lactation
Adequate human data on use during pregnancy are not available. Animal studies
do not indicate direct or indirect harmful effects with respect to reproductive and
developmental toxicity. However, as with all inactivated viral vaccines, the risks
to the foetus are considered to be negligible. FLUARIX should be used during
pregnancy only when clearly needed, and the possible advantages outweigh the
potential risks for the foetus.
Adequate human data on use during lactation and adequate animal reproduction
studies are not available. There is no known contraindication in the use of
FLUARIX during lactation.
Effects on ability to drive and use machines
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
Latex
The removable rubber needle shield of the prefilled syringes contains natural
rubber latex, and therefore Fluarix cannot be considered latex-free.
UNDESIRABLE EFFECTS
Clinical trial data
In controlled clinical studies, Fluarix was administered to more than 22,000
subjects aged 18 to over 60 years and to more than 2,000 subjects from 6
months to 18 years of age. Signs and symptoms were solicited in all subjects
for seven days following the administration of the vaccine. A checklist was used
for this purpose. The vaccinees were also requested to report any clinical events
occurring during the 30 days study period.
Undesirable effects reported are listed according to the following frequency:
Very common: Common: Uncommon: Rare: Very rare: ≥ 1/10
≥1/100 to <1/10
≥1/1,000 to <1/100
≥1/10,000 to <1/1,000
<1/10,000
Metabolism and nutrition disorders
Very common: appetite loss1
Psychiatric disorders
Very common: irritability1
4.7
Nervous system disorders
Very common: drowsiness1, headache
Uncommon: dizziness
Skin and subcutaneous tissue disorders
Common: sweating
defined as at least one general symptom (fever ≥37.8°C and/or myalgia) and at
least one respiratory symptom (cough and/or sore throat).
Table: Attack rates and Vaccine Efficacy against Illness associated
with evidence of influenza A or B Infection in adults 18 to 64 years of
age (Total Vaccinated Cohort)
AttackRates
(n/N)1
Musculoskeletal and connective tissue disorders
Very common: myalgia
Common: arthralgia
General disorders and administration site conditions
Very common: pain at the injection site, fatigue
Common: redness , swelling and induration at the injection site, shivering
Uncommon: fever3, ecchymosis
2
2
N
n
Vaccine Efficacy
(95% CI2)
%
%
LL3
UL
Antigenically matched, culture-confirmed Influenza
4
FLUARIX
5,103
49
1.0
66.9
51.9
77.4
Placebo
2,549
74
2.9
-
-
-
All culture-confirmed Influenza (Matched, Unmatched and Untyped) 5
1
FLUARIX
5,103
63
1.2
61.6
46.0
72.8
2
Placebo
2,549
82
3.2
-
-
-
reported in subjects 6 months to 5 years old
very common in subjects 6 months to 18 years of age
3
common in subjects 6 months to 18 years of age
Post marketing data
Blood and lymphatic system disorders
Rare: transient lymphadenopathy, transient thromocytopenia
Immune system disorders
Rare: allergic reactions (including anaphylactic reactions)
Nervous system disorders
Rare: neuritis, acute disseminated encephalomyelitis, neuralgia, paraesthesia,
febrile convulsions, rigours, Guillan Barré syndrome*
*Spontaneous reports of Guillain-Barré syndrome have been received following
vaccination with Fluarix; however, a causal association between vaccination
and Guillain-Barré syndrome has not been established.
Gastrointestinal disorders
Rare: vomiting, diarrhoea
Skin and subcutaneous tissue disorders
Rare: urticaria, pruritus, erythema, rash, angioedoema
Vascular disorders:
Vasculitis associated in very rare cases with transient renal involvement
General disorders and administration site conditions
Rare: influenza-like illness, malaise
Overdose
Not applicable.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
FLUARIX induces humoral antibodies against the haemagglutinins. These
antibodies neutralise influenza viruses.
A haemagglutinin inhibition titre equal to or greater than 1 : 40 in the serum is
considered to be protective.
FLUARIX provides protection for the ongoing influenza season.
The seroconversion rates of FLUARIX have been assessed for each influenza
vaccine season. The seroprotection rates following vaccination were in excess
of the requirements from the European Committee for Medicinal Products for
Human Use (CHMP) criteria for influenza vaccines (> 70% for adults 18-60
years and > 60% for adults 60 years and above).
Significant increases in serum titres of antibodies cross-reacting with Influenza
A and B drift variants have been observed after vaccine with FLUARIX.
1.n/N: number of case/total number of subjects
2.CI: Confidence Interval
3.LL: Lower Limit
4.
There were no vaccine matched culture-confirmed cases of A/New
Caledonia/20/1999 (H1N1) or B/Malaysia/2506/2004 influenza strains with
Fluarix or placebo
5.Of the 22 additional cases, 18 were unmatched and 4 were untyped; 15 of the
22 cases were A (H3N2) (11 cases with Fluarix and 4 cases with placebo).
Pharmacokinetic properties
Evaluation of pharmacokinetic properties is not required for vaccines.
Preclinical safety data
Non-clinical data reveal no special hazards for humans based on conventional
studies of acute toxicity, local tolerance, repeated dose toxicity, reproductive/
developmental toxicity, and safety pharmacology.
PHARMACEUTICAL PARTICULARS
Incompatibilities
FLUARIX should not be mixed with other vaccines in the same syringe.
Special precautions for storage
Fluarix must be stored between +2°C and +8°C.
DO NOT FREEZE. Discard if vaccine has been frozen.
Instructions for use/handling
Vaccines should be inspected visually for any foreign particulate matter and/
or variation of physical aspects prior to administration. Before use, the vaccine
should be well shaken to obtain a colourless to slight opalescent liquid. Discard
if the content appears otherwise.
Any unused product or waste material should be disposed of in accordance with
local requirements.
Shelf life
The expiry date of the vaccine is indicated on the label and packaging.
When stored under the prescribed conditions, the shelf life is 12 months.
MEDICINE CLASSIFICATION
Prescription Medicine.
Package Quantities
Prefilled syringes: 0.5mL in packs of 1 and 10.
A clinical study performed in more than 7,600 subjects in the Czech Republic
and Finland evaluated the efficacy of Fluarix to prevent culture-confirmed
influenza A and/or B cases for vaccine antigenically matched strains.
Sponsor Details
GlaxoSmithKline NZ Ltd Private Bag 106600
Downtown Auckland 1143 NEW ZEALAND
Telephone: (09) 367 2900
Fax: (09) 367 2910
Subjects were monitored for influenza-like illnesses followed by cultureconfirmed influenza (see below table for results). Influenza-like illness was
Date of Preparation: 22 October 2013
Version: 9.0
4.8
References:
1.Huang, Q.S., et al., Influenza surveillance and immunisation in New
Zealand, 1997-2006. Influenza Other Respi Viruses, 2008. 2(4):
p. 139-45.
22.Crawford, N.W., et al., Guillain-Barre syndrome following pandemic
(H1N1) 2009 influenza A immunisation in Victoria: a self-controlled
case series. Medical Journal of Australia, 2012. 197(10): p. 574-578.
2.Centres for Disease Control and Prevention. Influenza Symptoms and
the Role of Laboratory Diagnostics. 2013 [cited 2013 22 October
2013]; Available from: http://www.cdc.gov/flu/professionals/
diagnosis/labrolesprocedures.htm.
23.Stowe, J., et al., Investigation of the Temporal Association of GuillainBarre Syndrome With Influenza Vaccine and Influenzalike Illness Using
the United Kingdom General Practice Research Database. American
Journal of Epidemiology, 2009. 169(3): p. 382-388.
3.Shefer, A., et al., Immunization of Health-Care Personnel. MMWR
Recomm Rep, 2011. 60: p. 1-45.
24.Verburgh, M. E., et al. "Incidence of febrile seizures in The
Netherlands." Neuroepidemiology 11.4-6 (1992): 169-172.
4.Fiore, A.E., et al., Prevention and control of influenza with vaccines:
recommendations of the Advisory Committee on Immunization
Practices (ACIP), 2010. MMWR Recomm Rep, 2010. 59(RR-8):
p. 1-62.
26.Centers for Disease, C. and Prevention, Prevention and control of
seasonal influenza with vaccines. Recommendations of the Advisory
Committee on Immunization Practices--United States, 2013-2014.
MMWR Recomm Rep, 2013. 62(RR-07): p. 1-43.
5.Ministry of Health, 2013 Workforce Influenza Immunisation Coverage
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2014 Influenza Campaign resource
samples enclosed
Protect yourself and your patients
AGAINST INFLUENZA
The influenza vaccines are a prescription medicine. For more information please refer to the data sheets enclosed. TAPS CH3843
National Influenza
Specialist Group
INSIGHT 5839
Immunise now