Questions and Answers for vaccination providers

Healthcare professionals

This document will be updated or amended as and when the situation demands or information becomes available. Medical Practitioners should also consult the Community Questions & Answers and Kid’s Vaccine Question and Answers for information dealing with potential patient enquiries

Panvax® H1N1 vaccine and ordering | Administering Panvax® H1N1 vaccine | Vaccine safety | Residential Aged Care | Indemnity | Program information

Panvax® H1N1 vaccine and ordering

When was Panvax® H1N1 vaccine registered by the TGA?

The Therapeutic Goods Administration registered Panvax® H1N1 vaccine on 18 September 2009 for people 10 years and older. On 3 December 2009 the vaccine was approved for use in children six months to nine years.

What is the presentation of Panvax® H1N1 vaccine?

Panvax® H1N1 vaccine has been formulated in multi-dose vials containing the preservative, thiomersal, and a small quantity of pre-filled syringes, which do not contain thiomersal for use in children 6 to 35 months of age.

How many doses are in a multi-dose vial?

Panvax® H1N1 vaccine packed in blue boxes with blue labels contains 18 doses per vial. Panvax® H1N1 vaccine packed in red boxes with red labels contains 10 doses per vial. Pre-filled syringes will be single use, and packed individually.

When should I discard the multi-dose vial contents?

The multi-dose vial, including contents, should be discarded 24 hours after it is opened to ensure patient safety.

How do I order Panvax® H1N1 vaccine?

Panvax® H1N1 vaccine is ordered through your State or Territory health department on the following numbers:

• WA: 08 9388 4383
• SA: 08 8226 7177
• VIC: 1300 882 008
• Tas: 03 6222 7724
• ACT: 02 6205 2300
• NSW: Call your local Public Health Unit
• QLD: 07 3328 9888
• NT: 08 8922 8044

Can I order individual vials rather than a full ten-pack box?

No. The minimum multi-dose vial order is a red box of 10 vials (100 doses). Pre-filled syringes can be ordered individually (once they are available).

How is Panvax® H1N1 vaccine be distributed?

Panvax® H1N1 vaccine is distributed via the usual ordering and distribution processes used for other vaccine supplies as part of the National Immunisation Program. Contact your State or Territory health department for more details.

What about wastage?

Every effort should be made to ensure wastage of multi-dose vials is limited as much as possible. If you have opened a vial for a patient, and do not have scheduled vaccinations to ensure the remainder of the MDV is used, consider offering vaccination to subsequent patients attending your surgery.
What other equipment will I get to help me deliver Panvax® H1N1 vaccine?
The Australian Government is supplying State and Territory health authorities with vaccination equipment (such as needles and syringes) from the National Medical Stockpile. This equipment will be available in packs (Vac Pacs) for both GPs and community vaccination clinics. Each pack will contain enough equipment to give 200 doses of Panvax® H1N1 vaccine.
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Administering Panvax® H1N1 vaccine

Are there guidelines and other information to help me administer the vaccination?

Yes. Guidance has been developed by the Australian Technical Advisory Group on Immunisation (ATAGI) for the administration of pandemic (H1N1) influenza vaccine from multi-dose vials (MDV). These provide more detail on how to safely handle, store and administer vaccines from MDVs. The document is available on www.flupandemic.gov.au Further advice is available from your local Division of General Practice.

For further information about the administration of vaccines please consult the Australian Immunisation Handbook 2000 (Section 1.4). The handbook is available online at www.immunise.health.gov.au

ATAGI advice on administering seasonal and pandemic vaccine in children under 10 years of age is also available at www.healthemergency.gov.au

How many hours can Panvax® remain drawn up in the syringe?

It is recommended that that drawn up syringes can be kept for no more than four hours provided cold chain requirements are maintained. ATAGI guidelines for the administration of pandemic (H1N1) influenza vaccine from multi-dose vials (MDV) provide more detail on the safe handling and storage.

What is the dosage?

The Therapeutic Goods Administration has recommended two doses of vaccine be given to children aged 6 months to 9 years of age. These doses should be given at least 28 days apart.

Specifically, the dosages are:

• Children aged 6-35 months: Two doses of 0.25mL per dose (7.5 micrograms) at least 28 days apart
• Children aged 36 months-9years: Two doses of 0.5mL per dose (15 micrograms) at least 28 days apart
• People 10 years and older: One dose of 0.5mL (15 micrograms)

Are there any contraindications for the vaccine?

Panvax® H1N1 vaccine is contraindicated in anyone who has experienced anaphylaxis following a previous dose of any influenza vaccine, or who has experienced anaphylaxis following any vaccine component, including the antibiotics neomycin or polymyxin.

Panvax® H1N1 vaccine should not be used in anyone who has experienced anaphylaxis to eggs or chicken protein.

The Product Information for Panvax® H1N1 vaccine states that immunisation must be postponed in people who have febrile illness or acute infection.

What interactions with other medicines are there?

The immunological response may be diminished if the patient is undergoing corticosteroid or immunosuppressant treatment.

Can I give the vaccine with other vaccines?

There are no data to assess the concomitant administration of Panvax® H1N1 vaccine with other vaccines. If Panvax® H1N1 vaccine is to be given at the same time as another injectable vaccine, the vaccines should be administered at different injection sites.
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Residential Aged Care

Can a Registered Nurse working in a Residential Aged Care facility (RACF) administer the vaccine prescribed by the resident’s GP?

As a Registered Nurse you are required to comply with your State’s legal requirements regarding the administration of any medication and to comply with the competencies required by your Nursing Board. The requirements would be the same as for giving any other vaccine in an RACF.

What should I do if the resident cannot provide consent?

If the resident is unable to give their own consent, the same processes apply as for seasonal influenza vaccination, that is, consent must be sought from the person who has the authority to make medical decisions on their behalf. This person should give or refuse the consent, including signing the consent form where one is used. Consent should be documented in accordance with your facility's normal practice.

What do I do if the resident’s GP instructs me to administer the vaccine but the person authorised to make medical decisions for the resident says no?

If the person(s) holds a valid enduring power of attorney which provides for that person to make medical decisions on behalf of the resident, and they have advised that they do not wish the resident to be vaccinated, the vaccine should not be administered. The decision should be documented in accordance with your facility's normal practice.
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Vaccine safety

What are the possible short-term adverse events following pandemic (H1N1) 2009 influenza vaccination?

Short-term adverse events following pandemic (H1N1) 2009 influenza vaccination are similar to those following seasonal influenza vaccinations.
Common

• Local reactions, including pain, swelling and induration at the injection site.
• Minor systemic reactions, including malaise, headache, myalgia, nausea and vomiting, mild fever and children and young infants may be more irritable and unsettled.
• Other systemic reactions, including fainting may occur in adolescents, particularly when vaccinated in groups, and in people with needle phobias.

Rare
People with an allergy or hypersensitivity to one or more of the components of the vaccine may have anaphylaxis.

People receiving the vaccine should be observed for 15 minutes post vaccination in case an immediate reaction occurs. This will ensure the event can be managed in the health care setting.

What are the treatment options to address adverse events?

Immunisation service providers should refer to the Australian Immunisation Handbook 9th Edition 2008 (Page 58, Post Vaccination Procedures) for complete information on the identification and management of adverse events, including anaphylaxis. The handbook is available online at www.immunise.health.gov.au

What are the longer term possible adverse events?

Inactivated seasonal influenza vaccines have no known long-term adverse events associated with them. There have been reports of a possible association with the development of Guillain-Barré syndrome (GBS). Whether this is causal or only a temporal association is unclear. Viral and bacterial infections, especially Campylobacter jejuni and acute respiratory tract infections are the commonest antecedents of GBS. The estimated frequency of influenza-related GBS is four to seven times higher than the estimated frequency of influenza-vaccine-associated GBS. If there is a causal association with influenza vaccine it is of the order of 1-2 per million people vaccinated.

During the 1976 swine influenza vaccination campaign in the USA, about 10 persons per million vaccinated persons developed GBS. The reason why GBS developed in association with that specific vaccine has never been firmly established. Manufacturing processes for influenza vaccines have been significantly improved since then.

How do I report adverse events after pandemic (H1N1) 2009 influenza vaccination?

Immunisation service providers should report any serious or unexpected adverse event following pandemic (H1N1) 2009 influenza vaccination just as they would report similar events associated with any other vaccine.

In most States and Territories, there is a requirement that serious or unexpected adverse events be notified to the relevant health authority. In Tasmania, it is requested that reports be made directly to the Therapeutic Goods Administration (TGA).

For the pandemic (H1N1) 2009 influenza vaccination program, immunisation service providers may report in their usual way and/or may elect to report directly to TGA. Information provided to TGA will be passed on to the State and Territory health authorities for any necessary follow up to be undertaken.

Reporting to TGA can be web-based at http://www.tga.gov.au or through the “Blue Card” form which is available on the TGA website at http://www.tga.gov.au/adr/bluecard.htm

In Queensland you should fax the Adverse Event Form Following Immunisation - Initial Report to Queensland on 3328 9434.

What adverse events should I report?

Any adverse event that the immunisation service provider considers to be serious or unexpected should be reported. Serious adverse events are listed in Appendix 6 of the Australian Immunisation Handbook 9th Edition http://www.health.gov.au/internet/immunise/publishing.nsf/Content/handbook-appendix6 .

Can patients report adverse events?

Patients wanting to report an adverse event can do so to the Therapeutic Goods Administration online at www.tga.gov.au or by calling the Pandemic Hotline on 180 2007.

How should I report errors in administration of the multi-dose Panvax® H1N1 vaccine?

Errors in administration of the multi-dose Panvax® H1N1 vaccine should be reported to your State or Territory health department.

Will safety of Panvax® H1N1 vaccine be monitored?

Yes. Monitoring of pharmaceutical products in Australia is ongoing. Some extremely rare adverse events may occur at a frequency of one in a million or even less. These rare adverse events cannot be detected by clinical trials.

Data collected through ongoing monitoring will be continually assessed by the Therapeutic Goods Administration.

The Australian Chief Medical Officer, Professor Jim Bishop, will continue to provide advice, updates and information directly to medical professionals and clinicians. Advice provided by the CMO is posted on www.healthemergency.gov.au .

People who suspect they have experienced an adverse reaction can report it to the Therapeutic Goods Administration online at www.tga.gov.au or by calling the Pandemic Hotline on 180 2007.
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Indemnity

Have the medical indemnity insurers confirmed they will cover GPs administering the vaccine?

Yes. All medical indemnity insurer organisations (MDA National, Medical Indemnity Protection Society, Avant, Invivo and MIGA) have confirmed that they will insure members involved in the pandemic (H1N1) 2009 vaccination program.

What about nurses’ insurance? Are they also covered?

Yes. Vero Insurance and Guild Insurance, which primarily offer insurance to nurses, have also confirmed that they will continue to provide cover to their members under the policies they sell.
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Program information

As a GP, do I have to provide records of the number of people I vaccinate?

There is no Australian Government requirement for private general practitioners to provide records of the number of people vaccinated. However, State or Territory health departments will advise GPs if there are local reporting requirements. Requirements for data recording by other immunisation service providers will be determined by the respective State or Territory health department.

GPs should provide patients with a record of the vaccination.

Where can I obtain a consent form?

Consent forms can be downloaded or ordered from the www.flupandemic.gov.au website under the health professionals menu.

Where do health professionals send their consent forms?

Use of the consent form is optional. The Australian Government does not require a copy of completed forms but individual State and Territory Health Department requirements may vary. Check with your jurisdiction for local requirements. Patient information about the vaccination, including forms, should be kept in the patient’s record.

Who can I refer patients to if I don’t provide Panvax® H1N1 vaccine in my practice?

Practices not providing vaccination services may wish to make arrangements with other practices in their area to provide vaccination to patients. In some areas there may also be public vaccination clinics that people can refer patients to. For information on local clinics contact your local health department.

Health department websites and phone numbers

WA: call 1800 186 815 or visit http://www.health.wa.gov.au/swine_flu/home/
SA: call 1800 022 222 or visit www.flu.sa.gov.au
VIC: call: 1300 882 008 or visit www.humanswineflu.health.vic.gov.au
TAS: 1800 358 362 (1800 FLU DOC) or visit www.pandemic.tas.gov.au
ACT: call 02 6205 2300 or visit www.health.act.gov.au/flupandemic
NSW: visit www.emergency.health.nsw.gov.au/swineflu/vaccination/index.asp, or call 180 2007 for your local Public Health Unit contact - please check link as the link provided was broken.
QLD: 13HEALTH (13 43 25 84) or vist www.health.qld.gov.au/swineflu/html/vacc.asp
NT: call 08 8922 8044 or visit www.swinefluvax.nt.gov.au

Is the pandemic (H1N1) 2009 influenza strain included in the 2010 trivalent vaccine?

Yes, the Australian 2010 seasonal trivalent influenza vaccine will provide protection against the pandemic (H1N1) 2009 influenza strain.

If there is a major change in the pandemic (H1N1) 2009 influenza virus, will the immunisation program be stopped?

It is unlikely that the virus will change dramatically in the immediate future. If that happens, the immunisation program will be reviewed in line with how different the virus is from the vaccine strain. Even if Panvax® H1N1 vaccine is no longer a perfect match to the new strain, it may still give some cross-protection against an altered strain. Our experience with seasonal flu and its vaccine tells us that this is the case.

Will I be informed of developments or issues that arise during the vaccination program?

Yes. The Australian Chief Medical Officer, Professor Jim Bishop, will continue to provide advice, updates and information directly to medical professionals and clinicians. These communications have been widely disseminated by the major medical peak bodies and colleges throughout the pandemic (H1N1) 2009 influenza outbreak. This will continue and the advice posted on www.flupandemic.gov.au

Is there a local contact number health professionals can call for more information?

Yes. You can call your local unit on the contact below.

WA: 1800 243 522
SA: 08 8226 7177
VIC: 1300 882 008
TAS: 1800 358 362
ACT: 02 6205 2300
NSW: Contact your local Public Health Unit
QLD: Contact your local Population Health Unit
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This information is current for 17 May, 2012
This information was issued on 06 January, 2011