H1n1 Swine Flu Vaccine Panvax Manufacturer Listed Guillian Barre Syndrome As Vaccine Side Effect

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

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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 2009

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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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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.

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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) 11 September 2009

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• 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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Who gets the vaccine directly? •Metropolitan Public Hospitals

•Residential Aged Care Facilities

•Regional Hospitals

•Disability Service Facilities

•Private Hospitals and Day Surgeries •St Johns Ambulance

•RFDS

•Prisons

•Private satellite Dialysis Units

•Community Health Clinics

•Public Satellite Dialysis Units

•GP surgeries 11 September 2009

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•Aboriginal Medical Services

• Vaccine ordering and delivery is as per usual ordering mechanisms for those recipients listed under “who gets the vaccine directly”.

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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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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?

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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

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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 . 11 September 2009

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What’s in Panvax? Vaccine Specifications:

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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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• 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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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) 11 September 2009

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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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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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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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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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Dosage and Administration

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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 11 September 2009

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

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Name

Doses

Tier of administration

Panvax 1 (One) IM dose (0.5ml/dose) >9years It is given IM not subcut like seasonal flu. There is a greater chance of side effects if given sub cut.

Pregnant women

(0.25ml/dose) 6mths-<3yrs

Health care workers Indigenous

2 (Two) IM dose

( >6 months)

(0.5ml/dose) 3-9years

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2nd dose

≥21days

TIER 1

Medically at risk (>6 months)

2 (Two) IM dose

1st dose

Pregnant women in their 2nd and 3rd trimester

Can give in 1st Trimester

That is for eg. given Individuals accidently aged 10 years old and not knowing if over will be client was able to pregnant receive this formulation Or if client of 15ug of requests antigen per it. 0.5ml

Minimum interval between doses 21 days

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 11 September 2009

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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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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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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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• 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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Preparing Panvax

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•Record the date and time of opening on 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

ONE

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

THREE

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 11 September 2009

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SIX

FIVE

•When the required number of doses have been extracted, remove the drawing up needle and dispose in appropriate sharps container •If contents of the MDV are not all used, refrigerate the MDV (+2-8°C) 11 September 2009

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NB: Unused vaccine should be discarded through normal medical waste mechanisms

• 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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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 2009

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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.

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• 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. 11 September 2009

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Common Questions

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If I had Human Swine flu do I need to be vaccinated?

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• 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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If someone was on Tamiflu can they be vaccinated?

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Yes • Tamiflu is an antiviral working on infections

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How long after the vaccination am I protected

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• On average it takes about 2-4 weeks to fully develop protection against Human Swine Flu

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How long am I protected??

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• 1 year protection

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Is the vaccine safe???

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• 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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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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Can Thiomersal be given to pregnant women?

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• 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 2009

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If I had the seasonal flu do I need to get this additional vaccine (even during pregnancy?) ?

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• 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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Who should not get the vaccine?

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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 2009

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• 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

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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

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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 11 September 2009

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What about other medication??

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• 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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What are the side effects from the vaccine?

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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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Very rare side effects • Severe allergic reaction (anaphylaxis) • Guillian-Barre Syndrome (nervous system disorder featuring paralysis)

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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 2009

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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

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Hasn’t the pandemic flu peaked – isn’t it too late for me to benefit from the vaccine??

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• 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

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Pandemic (H1N1) 2009 Influenza Vaccination Packs

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• 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:

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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 devices

2 individual bags and closures

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

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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

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1 box x 40 needles

• 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. 11 September 2009

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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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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

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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

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• 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 2009

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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 11 September 2009

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Trivalent vaccine • To be included in the seasonal influenza vaccine • ?? Next year

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You will receive with each vaccine order: • Your vaccine • Vacpacks • Consent forms • ADRAC (adverse events form)

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