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H1N1 - Panvax

Swine Flu Vaccination

Vince Rettura

Delivering a Healthy WA
Goal

• The goal of the pandemic vaccination


program is to provide protection to the
pandemic virus by vaccinating as many
people as quickly as possible, using an
approach which targets specific population
groups

11 September Slide 2
2009
Rationale
The underlying principles for targeting groups in Australia
include:
• To prevent severe disease in those vulnerable to more
severe outcomes
• To prevent spread of disease to the vulnerable by
vaccinating their contacts
• To protect those at high risk of exposure because of their
work
• To protect health care services and reduce healthcare
worker staff absenteeism
• To mitigate potential economic impact on the Australian
pig industry
• To provide herd immunity
11 September Slide 3
2009
Priority Tiers

First Tier Second Tier (early 2010)


•Pregnant women •Children not covered by 1st tier
aged 6 months < 10years
Some women who have caught
H1N1 have miscarried or gone •School aged children
into premature labour
•Medically at risk- vulnerable
population
•Health care workers
•Indigenous

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2009
Age cut offs in Priority Tier One

• Indigenous People - All people aged 6 months and


older will be included

• Vulnerable (including medically at risk) - All people


aged 6 months and older will be included

There is no older age cut off proposed.

11 September Slide 5
2009
Defining of Health care workers
• HCW: An employee, student or volunteer who has direct contact
with patients, either in the community or at a dedicated health
service sited, in both public and private sectors limited to the
following:
• Aboriginal medical services
• General practice
• Ambulance services (includes RFDS)
• Remote or community health clinics and nursing posts
• Hospitals
• Prisons
• Satellite dialysis units
• Post acute care services in the home (eg silver chain)

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2009
• Community care workers: an employee,
student or volunteer who has direct contact
with patients, either in the community or at a
dedicated site, limited to the following:
• Aged care
• Disability services

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2009
Who gets the vaccine directly?
•Metropolitan Public •Residential Aged Care
Hospitals Facilities
•Regional Hospitals •Disability Service
•Private Hospitals and Day Facilities
Surgeries
•RFDS
•St Johns Ambulance
•Private satellite Dialysis
•Prisons Units
•Community Health •Public Satellite Dialysis
Clinics Units
•GP surgeries
•Aboriginal Medical
11 September Slide 8 Services
2009
• Vaccine ordering and delivery is as per usual
ordering mechanisms for those recipients
listed under “who gets the vaccine directly”.

11 September Slide 9
2009
Why do people need to be
vaccinated

• As this is a new strain of the influenza A virus,


most people do not have any natural immunity
so they are more likely to catch this new ‘flu’
then they are to catch the seasonal flu.
• This vaccine will prevent those with
underlying medical conditions from
developing severe illness

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2009
Product Information

•Information provided may change!


•You will be notified of the changes
by the State Government
Which vaccine is to be used to treat
H1N1 Pandemic Influenza?

11 September Slide 12
2009
Panvax H1N1 monovalent
Vaccine - CSL

Panvax is a vaccine which


has been made to provide
immunity to the pandemic
2009 influenza strain of
the influenza A virus – a
new strain of the
influenza A virus

11 September Slide 13
2009
Product Description
Panvax is supplied as:
• a clear liquid in
• 10ml Multi dose vials with a latex free rubber
stopper
• Vaccine for children 6 months to 10 years of
age will be provided in single dose pre-filled
syringes (thiomersal free)
• Boxes of 10 vials or may come to start with
boxes of 50 vials .
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2009
11 September Slide 15
2009
What’s in Panvax?

Vaccine
Specifications:

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2009
The basic vaccine formulation is as
follows:
• Monovalent vaccine
• 15ug of antigen per 0.5mls
• Unadjuvanted (Adjuvants are compounds used to
enhance the immune response to vaccination – The
use of adjuvanted vaccines on a large scale carries
the risk that previously unrecognised side effects will
not occur. That the risk is increased if the adjuvant
has not been widely used in man or has not
previously been combined with influenza antigens)

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2009
• 10ml Multi Dose Vials (containing thiomersal
– compound partly composed of mercury and
ethylmercury.
- Used to prevent bacterial and fungal
contamination of vaccines

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2009
Causes a toxic effect after it reaches a
certain level in the body
• Whether or not it reaches a toxic effect after it
reaches a certain level in the body depends on
- the amount of mercury consumed and
- the persons body weight.
• Individuals with very low body weight are usually
more susceptible to toxic effects from a certain
intake of mercury. HENCE…….
• Vaccine for children 6 months to 10 years of age will
be provided in single dose pre-filled syringes
(thiomersal free)

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2009
According to the Commonwealth

• There is no evidence that thiomersal has


caused any developmental or neurological
abnormalities, such as ADHD or Autism

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2009
Other components According to
Product Information– Each 0.5mls
contains
• Sub units of A/California/7/2009 (H1N1) v-like
virus
• 15ug haemagglutinin
• As stated – 0.01%w/v Thiomersal as a
preservative

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2009
Each 0.5mls also contains

• Sodium Chloride 4.1mg


• Sodium phosphate –dibasic anhydrous 0.3mg
• Sodium phosphate- monobasic 80ug
• Potassium chloride 20 ug
• Potassium phosphate – monobasic 20 ug
• Calcium chloride 1.5ug
Explanation of contents in Appendices in 9th ed
handbook under Vaccine Content

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2009
The following are present per dose:

• Taurodeoxycholate ≤ 5ug (Bile salt-related, anionic


detergent) (can give red eyes, blurred vision etc)
• Ovalbumin ≤ 1.0ug
• Sucrose <10ug
• Neomycin ≤ 0.7ug – check for allergies to this antibiotic
• Polymyxin B sulfate ≤0.11ng– check for allergies to this antibiotic
• Beta-propiolactone ≤1.4ng

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2009
Dosage and Administration

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2009
Take note……..
• Previously -- The vaccination course
consists of 2 doses of 15ug of antigen
at least 21 days apart. … This now no
longer applies
• The vaccination course consists of
1 dose of 15ug of antigen for those
aged 9 years of age and older

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2009
• Children aged 6 months to <9years of
age require 2 doses with a minimal
interval of 21 days

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2009
Name Doses Tier of 1st dose 2nd dose Minimum
administration interval
between
doses

Panvax 1 (One) IM TIER 1 ≥21days 21 days


dose
Pregnant Pregnant Can give
(0.5ml/dose)
women women in in 1st
>9years their 2nd and Trimester
It is given Medically at
3rd trimester
IM not 2 (Two) IM risk (>6 That is for
subcut dose months) Individuals eg. given
like
aged 10 accidently
seasonal (0.25ml/dose) Health care
flu. years old and not
workers
There is 6mths-<3yrs over will be knowing if
a greater Indigenous able to client was
chance 2 (Two) IM
of side receive this pregnant
dose ( >6 months)
effects if formulation
given
Or if client
(0.5ml/dose) of 15ug of
sub cut. requests
antigen per
3-9years it.
11 September Slide 27 0.5ml
2009
Please Note -- CHANGES

• It is recommended that all children under 10


years of age wait for the thiomersal free
vaccine
• Yes the vaccine is available to those ≥ 6
months of age and so if clients request the
vaccine and are aware of the vaccine content
they may receive the thiomersal vaccine with
out waiting for the thiomersal free vaccine

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2009
Use with other vaccines?

• Panvax can be given with other vaccines


• It is not a live vaccine so no special waiting
times when administering other vaccines

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2009
How much is given?

• 1 (One) IM dose (0.5ml/dose)


>9years
• 2 (Two) IM dose
(0.25ml/dose)
6mths-<3yrs
• 2 (Two) IM dose
(0.5ml/dose)
3-9 years

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2009
Administration and instructions for
use and handling

• Panvax is for IM injection


• Vaccine that has been drawn into syringes in
preparation for administration must be used on the
day they are drawn
• Hence – same day use (end of clinic, surgery or day)
in drawn up syringe
• Punctured Multi Dose Vials can remain in the fridge
for up to 24hours since date of first opening (may
change)

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2009
• Check and observe vial for clear fluid
• The contents of the vial should be inspected visually
before and after shaking for any foreign particulate
matter and or abnormal physical appearance prior to
administration
• Once drawn up into a syringe it is for single use only
• ALSO - once drawn up into syringe – must be
discarded at the end of the day/clinic etc DO NOT
STORE DRAWN UP SYRINGES FOR NEXT CLINIC
DAYS AND DO NOT DRAW UP VACCINE FOR THE
WHOLE WEEK OR FOR NUMEROUS VACCINATION
CLINICS!

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2009
Preparing Panvax

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2009
•Record the date and time of opening on
ONE the MDV
DO NOT USE MDV if:
-sterility is breached
-cold chain is breached (outside 2-8°C)
-expiry date reached
-More than 24 hours since date of first
opening (may change again) and
contact_________________________
for advice on how to discard (see cold
chain section)

TWO
•Wipe the diaphragm of the MDV
with an alcohol swap
•If taking doses from an already
opened MDV, check opening date
and then wipe the diaphragm with
alcohol prior to use

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2009
THREE
•Using an aseptic ‘no-touch’
technique, insert into the diaphragm a
new single use sterile drawing up
needle for the extraction of doses

FOUR

•Draw up each single dose required


into separate new sterile syringes
and attached a new sterile
administration needle
•Each single dose vaccine must be
used (within 7 hours of drawing up
vaccine) and/discarded at the end
of clinic session

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2009
SIX
FIVE

•When the required number


of doses have been NB: Unused vaccine
extracted, remove the should be discarded
drawing up needle and through normal medical
dispose in appropriate waste mechanisms
sharps container
•If contents of the MDV are
not all used, refrigerate the
MDV (+2-8°C)
11 September Slide 36
2009
• Gloves are not recommended for routine
immunisation service providers. However, in
a pandemic influenza environment, PPE -
mask, eyewear, gloves and gown may be
indicated for protection of the vaccine
administrator if need be.

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2009
Vaccine distribution

• First delivery of vaccines – Contact the 9388


number on the order form if you require more
vaccines on your first order
• 50 pack of 10ml vials = 18-20 doses per vial
• 10 pack of 10ml vials = 18-20 doses per vial
• End of September delivery changes
• 10 pack of 5ml vials = 10 doses per vial

11 September Slide 38
2009
Cold Chain
• As per Strive for 5 Guidelines
• Store at +2-+8oC
• Refrigerate do not Freeze and protect from light
• If the vaccine has been exposed to a cold chain breach, do not
discard but isolate vaccines, inform other staff and label them
“Do not use”. Keep the vaccines stored at +2-+8°C and contact
________________________ for advice
• Cold chain breaches are to be reported through normal
channels of reporting. For eg. contacting the divisions of
general practice, Regional Immunisation Coordinators, the
Central Immunisation clinic etc in order to obtain advice.

11 September Slide 39
2009
• If MDV is to be used throughout an immunisation clinic and left
on a work bench for easy access so you do not have to go into
the fridge repeatedly -
• - ensure that the MDV is placed within a kidney dish, protected
from light and the kidney dish is placed on top of an ice block to
maintain the cold chain.
• - drawn up vaccines can remain within the kidney dish whilst
vaccinating
• NB: always check the coldness of the cold pack an the cold
pack must be ‘sweated’ first upon removal from the freezer.

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2009
Common Questions

11 September Slide 41
2009
If I had Human Swine flu do I need to
be vaccinated?

11 September Slide 42
2009
• If you have been diagnosed with swine flu –
confirmed by testing, then No vaccination is
required
• If you have been told you had swine flu but
not confirmed testing then you can get
vaccinated

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2009
If someone was on Tamiflu can they
be vaccinated?

11 September Slide 44
2009
Yes

• Tamiflu is an antiviral working on infections

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2009
How long after the vaccination am I
protected

11 September Slide 46
2009
• On average it takes about 2-4 weeks to fully
develop protection against Human Swine Flu

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2009
How long am I protected??

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2009
• 1 year protection

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2009
Is the vaccine safe???

11 September Slide 50
2009
• Clinical trials have shown that the vaccine is
safe on those who participated. The
Australian Government has granted
exemption from registration for this vaccine
to make it available for use as soon as
possible.
• Ongoing assessment of the vaccine will
continue to monitor its safety and also
identify if a booster dose (a second shot) is
required to provide you with immunity to the
virus.

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2009
According to the vaccine trials
group and CSL on adults and now
kids
• Only common side effects have occurred –
eg pain, swelling and redness at the injection
site

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2009
Can Thiomersal be given to pregnant
women?

11 September Slide 53
2009
• Thiomersal has a very long safety record and
has not been shown to have any long term
problems
• Influenza vaccines are safe during pregnancy
and are normally recommended for pregnant
women. The Panvax® H1N1 vaccine is not a
‘live’ vaccine and is not a risk to unborn
babies.
• Expectant mothers may have some side
effects from vaccination but this is usually
only a sore, red arm, or slight headache.
11 September Slide 54
2009
If I had the seasonal flu do I need to
get this additional vaccine (even
during pregnancy?) ?

11 September Slide 55
2009
• Yes
• This new vaccine protects people against
pandemic influenza – Human Swine Flu.
• The seasonal vaccine gives no protection
against this new strain

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2009
Who should not get the vaccine?

11 September Slide 57
2009
People with a known severe allergy to eggs
should not be given the vaccine ---
(anaphylactic hypersensitivity)
Characterised by
• Generalised hives
• Swelling of the mouth and throat
• Difficulty in breathing, wheeze
• Low BP and
• Shock

11 September Slide 58
2009
• And as usual:
- Anaphylaxis following a previous dose of the
relevant vaccine, and
- Anaphylaxis following any component of the relevant
vaccine
• Also check allergies to:
- Neomycin
- Polymyxin B
- Especially if the client has had an anaphylactic
hypersensitivity to the above anti biotics

11 September Slide 59
2009
Be aware of false contraindications
to vaccinations

• Conditions listed in Table 1.3.4 page 21 in the


Immunisation hand book outlines false
contraindications.
• People with these conditions should be
vaccinated with all recommended vaccines

11 September Slide 60
2009
Corticosteroids – just take note...

• Clients on daily doses of corticosteroids (Adults in excess of


60mgof prednisilone; Children in excess of either 2mg/kg per
day for more than a week or 1mg/kg daily for 4 weeks) will
greatly suppress the immune system
• which means that not only is the vaccine unlikely to be
effective, but there is an increased chance of adverse events
occurring as a result of immunosuppression
• just like any vaccine you can still vaccinate however the
protection offered will be greatly reduced…….
- Partial protection is better than no protection. If the client
was to catch swine flu and was vaccinated --- the
symptoms may not be as severe

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2009
What about other medication??

11 September Slide 62
2009
• Some medications may interfere with
influenza vaccines as discussed.
• Others include:
- Some treatments for cancer (including
radiation therapy)
- Cyclosporine- immunosuppressant drug

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2009
What are the side effects from the
vaccine?

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2009
Common side effects include:
- Pain and redness at the injection site
- Drowsiness or tiredness
- Muscle aches
- Low grade fever
- Malaise
- Headache
- General Public can report side effects by calling the
Adverse Medicine Events Line on 1300 134 237.

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2009
Very rare side effects

• Severe allergic reaction (anaphylaxis)


• Guillian-Barre Syndrome (nervous system
disorder featuring paralysis)

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2009
History of Guillian-Barre Syndrome
(GBS)

• Risks and benefits of the influenza and H1N1


pandemic influenza vaccine should be
weighed against the potential risk of GBS
recurrence
• Specialist advice advised
• NB People with a history of GBS may be at
risk of recurrence of the condition following
influenza vaccine

11 September Slide 67
2009
Will I get GBS from this vaccine?

• From the evidence collected by experts:


• GBS is 4 to 7 times more likely after an attack
of the actual flu than after the influenza
vaccine
• There have been reports overseas of a
possible association between influenza
vaccinations and GBS

11 September Slide 68
2009
Hasn’t the pandemic flu peaked –
isn’t it too late for me to benefit from
the vaccine??

11 September Slide 69
2009
• We don’t know that the pandemic has peaked
• Its never too late to gain immunity
• Experience from countries in the northern
hemisphere this year has also shown that
pandemic influenza can continue to spread in
the summer months
• Vaccination will protect you through summer
and into the flu season next year

11 September Slide 70
2009
Pandemic (H1N1) 2009 Influenza
Vaccination Packs

11 September Slide 71
2009
• This Pandemic (H1N1) 2009 VacPac (VacPac)
contains equipment sufficient for the
administration of 200 doses of pandemic
H1N1 2009 influenza vaccine (vaccine).
• A mini VacPac is only available for GP
surgeries and only includes syringes and
needles only
• The components of each VacPac are listed
below:

11 September Slide 72
2009
Item Quantity/Packaging
1mL syringes 1 box x 220 syringes
Drawing up needles 19g x 38mm 1 box x 220 needles
Injection needles 23g x 25mm 1 box x 200 needles
Injection needles 23g x 38mm 1 box x 40 needles
Alcohol Swabs 1 box x 220 swabs
Sharps containers 3 individual sharps containers
Disposable dishes 6 individual dishes
Disposable Gloves 1 box x 110 gloves
Clinical waste bags and closure 2 individual bags and closures
devices
Sticking Plaster 1 box x 110 plasters
Alcohol Hand Rub 2 x 500mL bottles with
dispensers
Cotton Wool Balls 1 bag x 220 cotton wool balls
11 September Slide 73
2009
GP mini VacPac

Item Quantity/Packaging
1mL syringes 1 box x 220 syringes
Drawing up needles 19g x 38mm 1 box x 200 needles
Injection needles 23g x 25mm 1 box x 200 needles
Injection needles 23g x 38mm 1 box x 40 needles

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2009
• Some additional quantities of each
component are provided to cover normal
levels of wastage that may occur in a mass
vaccination situation.
• The 19g x 38mm needles have been included
for drawing up. 23g x 25mm needles can be
used for administering the vaccine to the
majority of the population.
• A quantity of 23g x 38mm needles has also
been provided for use with obese adults.

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2009
AND FINALLY

•Consent
•Consent is needed because the
vaccine is not registered
• Please note when the vaccine becomes
registered – there is no need to use the
Commonwealths consent form

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2009
Child and Adult consent form
Containing the following:
- Fact sheet on the vaccine and what pandemic
influenza 2009 is
- Effects of the disease, possible side effects of
vaccination, contraindications and what to do to
reduce side effects
- Care after vaccination
- Pre vaccination checklist
- Client record following vaccination

11 September Slide 78
2009
Consent forms – data uptake
only if the vaccine is unregistered
• Completed consent cards will need to be
faxed or scanned to the Department of Health
Communicable Disease Control Directorate
to be entered on the data base
• For this reason we will be able to monitor
dosages and organise the help desk

11 September Slide 79
2009
• For GP surgeries and all other
clinics/hospitals you will need to fax/scan or
email consent cards and send it to a 1800:
Number to be advised
• A call centre will be organised which will act
as a help line to check to see if people have
been vaccinated i.e. which doses they have
had. This number is for health staff only!
• 1800 243 522
• 180 2007 – is for the general public

11 September Slide 80
2009
Quick Consent – just a thought!

• It may be best to get clients together and do a group


consent prior to vaccination.
• I.E. 1 nurse to go through consent
- 1 admin to check to see it is filled and direct
any errors back to consent nurse (optional)
- then clients can see the vaccinator
• That way the vaccinator does not have to go through
the consent

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2009
Trivalent vaccine

• To be included in the seasonal influenza


vaccine
• ?? Next year

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2009
You will receive with each vaccine
order:

• Your vaccine
• Vacpacks
• Consent forms
• ADRAC (adverse events form)

11 September Slide 83
2009