Health Emergency
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Previous advice from the Chief Medical Officer

2 November 2009: Letter to General Practitioners on pregnant and postpartum women

General Practitioners

Dear Colleagues,

I am writing to update you on the severe impact that pandemic (H1N1) 2009 has had upon pregnant and postpartum women and to advise you to encourage your patients who are pregnant, or who are planning a pregnancy, that they be vaccinated against pandemic (H1N1) 2009. I also want to tell you about a mechanism we have put in place through the Therapeutic Goods Administration and CSL Limited to monitor pregnant women who receive the pandemic vaccine.

Our experience in Australia has been that the first wave of the pandemic lasted around 18 weeks. It was a moderate illness overall with a hospitalisation rate above 1% (around 4,900 admissions or 22/100,000 population to 28th October), 13% of these were admitted to ICU with 186 deaths confirmed to be associated with the virus. This activity stretched our health system, particularly our intensive care services peaking in late July.

Experience from history and from other countries with this virus shows that, unlike seasonal influenza, pandemic influenza is not just a winter infection. In the next few months a number of possible scenarios could occur. As has happened over the Northern Hemisphere summer, we may continue to have ongoing outbreaks of various sizes and spread in our communities. We may face a major out-of-season influenza outbreak due to importation of the virus back into Australia from infected travellers. Thus a second wave may occur at any time or the virus may mutate and become more virulent, causing another large outbreak now or next winter. Vaccination now will protect the community against all the scenarios possible with this unpredictable pandemic virus.

Whilst the pandemic influenza has been moderate overall, some population groups have experienced severe disease. One of these groups is pregnant women and their infants. Let me summarise some of our Australian data for the impact of the pandemic on pregnant women:

• 16% of ICU cases have been pregnant women;
• 32% (62/191) of women aged 15 – 44 years admitted to ICU for pandemic H1N1 were pregnant. Of the women aged 20 – 29 years, 47 % were pregnant;
• Of all pregnant women admitted to ICU, 56% did not have any co-morbidities such as asthma or diabetes;
• Pregnant women stayed an average of 15 days in hospital (Range 1 – 63 days).
• Three pregnant women have died.

These Australian data are consistent with what is known about the previous impacts of pandemic influenza and with data that have emerged from overseas. We do not have equivalent ICU data for pregnant women for seasonal influenza for comparison but our information from the Australian and New Zealand Intensive Care Society is that the impact of pandemic (H1N1) 2009 on Australian pregnant women has been much more severe than that of seasonal influenza.

The Australian Technical Advisory Group on Immunisation (ATAGI) recommended in the 9th Edition of The Australian Immunisation Handbook 2008 that pregnant women have trivalent inactivated influenza (TIV) against seasonal influenza because of the risks that seasonal influenza poses to the woman and her foetus. Likewise ATAGI has considered that pregnant women should be in the highest priority group to have the monovalent vaccine against pandemic H1N1 2009, Panvax™.

The monovalent CSL Ltd vaccine Panvax™ is made using the same techniques that have been used to make seasonal vaccine for over 40 years. It has been registered by the Therapeutic Goods Administration (TGA) and meets all the relevant standards for safety and efficacy. Unlike TIV it does contain thiomersal, but the risk posed by the presence of a small quantity of this preservative has been assessed by expert groups who consider this to be safe. ATAGI have conducted a detailed analysis of the use of influenza vaccines containing thiomersal and advise that the pandemic vaccine is safe for infants, children, adolescents and adults including pregnant and breastfeeding women. The ATAGI advice is on the health emergency website at www.healthemergency.gov.au.

The consistent recommendations by ATAGI, the Institute of Medicine (IOM), the Centres for Disease Control and Prevention (CDC) and the World Health Organisation (WHO) are that the benefits of vaccination against pandemic (H1N1) 2009 far outweigh any theoretical risks associated with the vaccine. In addition, there is increasing evidence that influenza vaccination of a pregnant woman will provide the neonate with some protection against influenza for the first six months of life. (Vaccination of infants younger than six months is not currently recommended by any specialist body.) This intervention may be life saving for both mother and baby.

Finally, I want to advise you that as part of the safety monitoring activities being undertaken by CSL Limited for Panvax ™, CSL Limited is developing a voluntary pregnancy register. CSL will follow up any report of a pregnant woman receiving the vaccine that is notified to them to the outcome of the pregnancy. This will provide important safety information on influenza vaccines as well as the Panvax™ vaccine specifically.

I encourage you both to support your patients to have this vaccine and would suggest also that you seek the consent of your patient to advise CSL on 1800 024 204 that your patient has received the vaccine.

Yours sincerely
Professor Jim Bishop AO
MD MMed MBBS FRACP FRCPA

2nd November 2009

Printable version of CMO advice 2 November 2009 (PDF 85 KB)

12 October 2009: Letter to General Practitioners on the Latex Allergy

General Practitioners

Dear Colleagues.
Thank you for your continuing support for the roll out of the pandemic (H1N1) 2009 influenza (swine flu) vaccine. I would like to update you on medical and scientific developments.

Firstly our experience with the first wave of this epidemic lasted around 18 weeks and the natural history of the illness is now quite clear. It was moderate in most with a hospitalisation rate above 1% (around 4,800 admissions or 22/100,000 population), 13% of these (735) admitted to intensive care and sadly 185 deaths confirmed to be associated with the virus. This activity stretched our health system peaking in late July. Our national intensive care experience this winter has recently been reported in the New England Journal of Medicine . The next step in this epidemic remains unclear with the possibility of a second wave before next winter, a return next winter or the return of a more virulent form.

Secondly it has been speculated that the latex in the syringes supplied could lead to hypersensitivity reactions. We now have expert opinions from allergy specialists, the Therapeutics Goods Administration (TGA) and the Australian Technical Advisory Group on Immunisation (ATAGI) on this issue.

Latex is derived from the sap of the rubber tree that also contains a number of allergenic proteins. There is no latex in the Panvax® H1N1 vaccine or vaccine multi-dose vials. However the 1ml syringes provided in the vaccination packs contain latex in the syringe plunger. The manufacturing process for this type of latex involves prolonged treatment at high temperatures resulting in degradation of the latex proteins responsible for sensitisation. In this form we are advised that latex is most unlikely to be allergenic. The plunger in the syringe is also coated with silicone and this provides an impervious barrier between the latex in the plunger and the contents of the syringe. The Therapeutics Goods Administration (TGA) has examined the syringes in the vaccination pack and confirms the integrity of the silicone barrier. There are many millions of syringes used in Australia each year. These have been used safely. These include syringes that are latex free and those with silicone-coated latex plungers.
The vaccination programs in the USA and UK routinely suggest the precautionary use of non latex equipment in individuals who have proven latex reactions. ATAGI advice is similar (attached). It is a reasonable and precautionary approach. Before vaccinating we would suggest checking for a history of hypersensitivity as per the ATAGI advice. Otherwise our best advice is that the syringes can continue to be safely used for all other people without latex sensitivity.

The vaccine product information advises that 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 non mandatory patient consent form contains a question that checks for any severe allergy of any kind. This would include severe allergy to latex. As with routine practice all syringes should be checked prior to use for faults or damage.

The vaccination program will continue over the next few months. The Department and I hope this information will be useful to you and we will continue to update you with any new information. Current information is updated on the internet at www.healthemergency.gov.au/

Yours sincerely
Professor Jim Bishop AO
MD MMed MBBS FRACP FRCPA
12 October 2009

Printable version of CMO advice 12 October 2009 (PDF 72 KB)
ATAGI guidance on use of latex-containing 1 mL syringes from pandemic vaccination packs (PDF 31 KB)

7 October 2009: Latex Allergy Update

A short term adverse reaction has occurred at the time of vaccination in a person with an allergy to latex. However, the true cause of this event has not been determined and is currently being investigated by the TGA through their normal process.

The pandemic H1N1 2009 influenza vaccine and vial is latex free. The Department of Health and Ageing has investigated the 1mL syringe in the vaccination packs and confirmed it contains latex.

In line with the Australasian Society of Clinical Immunology and Allergy (ASCIA) guidelines for hospital management of patients with latex allergies, while the association is not proven a prudent approach is to use a syringe that you know to be latex free for those who have a latex allergy.

We will continue to investigate this issue and will keep you informed of progress.

21 September 2009: Letter to General Practitioners on the National Vaccination Program

General Practitioners

Dear Colleagues.
This letter is to update you on Australia’s response to the world-wide outbreak of pandemic (H1N1) 2009 influenza and the national rollout of a new specific vaccine to protect the Australian community.

While this pandemic (H1N1) 2009 has generally been a moderate disease in most there have been severe outcomes in those with underlying medical disease and in some otherwise fit and healthy people, including pregnant women , young children and healthy young adults. The pandemic has been associated with 172 deaths in Australia thus far. The average age of deaths associated with pandemic (H1N1) 2009 is 56 years, compared with 83 years for seasonal flu. There have been more than 4700 people hospitalised by pandemic influenza to date with over 15% of hospitalisations in ICU. Fortunately the intensity of this wave of the epidemic is diminishing.
Experience from history and from other countries with this virus shows that, unlike seasonal influenza, pandemic influenza is not just a winter infection. In the next few months a number of possible scenarios could occur. As has happened over the Northern Hemisphere summer, we may continue to have ongoing outbreaks of various sizes and spread in our communities. We may face a major out-of-season influenza outbreak due to importation of the virus back into Australia from infected travellers from the large number of new cases now expected in the Northern Hemisphere. Thus a second wave may occur at any time or the virus may mutate and become more virulent, causing another large outbreak now or next winter. Vaccination will protect the community against all the scenarios possible with this unpredictable pandemic virus.

The WHO has said that safe and effective vaccines are “the most important intervention for reducing morbidity and mortality” in an influenza pandemic. Australians are therefore fortunate that a vaccine for pandemic (H1N1) 2009 has now been approved for registration by the Therapeutic Goods Administration for people 10 years and older. The vaccine is made by CSL Limited, which has been producing seasonal vaccines in Australia in the same way for 40 years, and it has undergone
additional clinical testing and trials. Early data from these trials were published in the New England Journal of Medicine on 10 September 2009 and the vaccine was subsequently registered by the Food and Drug Administration in the USA.

The data indicates that the pandemic influenza vaccine has a similar safety profile to seasonal influenza vaccine. One dose is sufficient for protection. The vaccine is currently not registered for use in children under 10 years pending receipt of satisfactory clinical trials data expected in the near future. As with seasonal flu vaccine, the TGA will monitor post-vaccination adverse events and we ask you to notify in the usual way.

The pandemic vaccination program will be initially focused on vaccinating certain priority groups at higher risk of exposure (for example, health care workers) and those vulnerable to more severe outcomes. This includes pregnant women, Indigenous Australians, severely obese individuals and people with underlying medical conditions. While emphasis will be on targeting these priority groups, the opportunistic vaccination of friends, family, and carers of vulnerable people or anyone who wishes to protect themselves from pandemic influenza is also encouraged leading to more generalised vaccination as supplies increase.

The presentation of the vaccine is different from that of the seasonal influenza vaccine. In order to provide sufficient vaccine to respond to this health emergency, the vaccine is packaged in multi dose vials (MDVs). This has also been the usual practice in dealing with this pandemic world-wide in developed countries including the USA, UK and Canada. The RACGP and the Australian Technical Advisory Group on Immunisation (ATAGI) have developed specific guidelines on the best use of MDVs for this program. Additional information to assist you in implementing the vaccination program is provided in the fact sheet attached to this letter.

The situation in a pandemic may change especially as the Northern Hemisphere develops more cases and our scientific knowledge expands. The Department and I understand that we need to continue to update you. We will ensure that current information is available on the internet at www.healthemergency.gov.au/

Yours sincerely
Professor Jim Bishop AO
MD MMed MBBS FRACP FRCPA
September 2009

Printable version of CMO Advice 21 September 2009 (PDF 78 KB)

17 June 2009: Australia has developed a new response phase to manage the outbreak of pandemic (H1N1) 2009 called PROTECT. This is a measured, reasonable and proportionate health response to the risk that the virus poses to the Australian community.
Read more

17 June 2009: CMO’s discussion paper - Medical and Scientific Data on pandemic H1N1 2009 influenza: Over the last seven weeks, the delay of the virus entering Australia and the containment of small outbreaks has allowed time to better understand its key scientific and clinical characteristics.
Read more (PDF 123 KB)

9 June 2009: On 3 June 2009 Victoria moved to a modified Sustain Phase on advice from the Australian Health Protection Committee and the Commonwealth’s Chief Medical Officer.

24 May 2009: CMO‘s letter to GPs (PDF 161 KB)

22 May 2009: Today Australia is moving our pandemic response phase from DELAY to CONTAIN. This change follows the Chief Medical Officer's recommendation to the Minister for Health and Ageing and the Prime Minister, and it is based on the evidence that the infection has spread in Australia. Further information will be provided to GP's shortly.

5 May 2009: CMO’s Update (PDF 110 KB)

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