9.2 Response Implemented

9.2.1 Committees

The CMO’s Vaccine Advisory Group (VAG) provided advice on the recommended quantity of vaccinations required to protect the vulnerable and reduce transmission in the community. The CMO’s Scientific Pandemic Advisory Group (SPAG) convened to provide advice on priority groups and vaccine formulation. Immunisation advice was also sought from the CMO’s GPRT.

The AHPCNIC operated as the key logistical coordinators for the rollout of the Pandemic (H1N1) Vaccination Program. Membership included at least one representative from each state and territory, and largely comprised the same membership as the standing Jurisdictional Immunisation Coordinators (JIC) group of immunisation program managers who are responsible for the logistics of the routine National Immunisation Program.

The Australian Technical Advisory Group on Immunisation (ATAGI) provided technical advice on the use of multi-dose vials and other vaccine administration issues when required. This role was not envisaged during planning and became of key importance during the response.

9.2.2 Purchase of a customised pandemic (H1N1) 2009 vaccine

The Australian Government held discussions early in the response with the two contracted influenza vaccine manufacturers, CSL Limited and Sanofi Pasteur. CSL Limited was selected to supply the pandemic vaccine, as it had the capacity to supply the vaccine in a timely manner at a reasonable price. Separate discussions were also held with six vaccine manufacturers, including CSL Limited, to establish capacity to supply additional pandemic vaccine if further doses were required. The need for further supplies did not eventuate.

The Australian Government purchased 21 million doses of pandemic vaccine, which ensured vaccine supply for Australia. The order was placed in May 2009 (see Figure 4 for a timeline of vaccine availability). Australia’s order was based on expert advice in Australia and internationally that two doses of vaccine would most likely be needed to achieve a good level of immunity. The initial order was intended to provide enough vaccine to meet the two objectives of reducing transmission and protecting the vulnerable. The aim was to cover those most at risk of severe outcomes from influenza (approximately 3.35 million people, including Indigenous Australians, those with compromised immunity, pregnant women and older Australians) and a sufficient number of the population to control the spread of infection (33 per cent of the population or 7 million people) – a total of 10.5 million courses. Clinical trials provided a clear indication in September 2009 that adults would only require one dose. This enabled the vaccine to be offered to all Australians as part of the national Pandemic (H1N1) Vaccination Program.

The majority of the vaccine was supplied in MDVs as planned. The Royal Australian College of General Practitioners (RACGP) developed guidelines, in consultation with ATAGI, on the safe administration of vaccine from MDVs. This information was disseminated to GPs and other immunisation providers at the commencement of the vaccination program, and was included with every vaccine order. Single-dose preservative (thiomersal)–free pre-filled syringes (PFSs) were purchased for use in children aged from six months to under three years. PFSs made it easier to administer the smaller dose required in this age group, and also provided parents with the choice of obtaining thiomersal-free product for their young children should they desire. Concern about the safety of thiomersal had been linked to MDVs. ATAGI was commissioned to review the clinical evidence, and advice was provided to reassure clinicians and the public of its safety.

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9.2.3 Testing and registration

Clinical trials are not normally conducted in the southern hemisphere for changes in strains in seasonal influenza vaccine. To ensure timely availability of seasonal influenza vaccine in Australia each year, the Therapeutic Goods Administration (TGA) processes applications for registration of such vaccines as a strain change rather than as a new product where there are no changes to the manufacturing process other than the virus strain. However, the pandemic (H1N1) 2009 virus was a novel virus and a monovalent vaccine was to be manufactured. The TGA therefore requested clinical trials prior to registration.

The Australian Government funded adult and paediatric clinical trials to assess the safety and efficacy of the pandemic (H1N1) 2009 vaccine and to determine the number of doses required to produce an effective immune response. The adult trial commenced on 22 July 2009, with interim results available in early September 2009 that confirmed that the vaccine was effective and provided clarification that only one dose was required for adults and children over 10 years of age.³¹ The paediatric trial commenced on 3 August 2009, with preliminary results in November 2009 indicating that one dose achieved a good level of immunity but a second dose was recommended to ensure a sustained response. The results of the US paediatric clinical trials were also used to inform the range of paediatric dosage in Australia.

The vaccine, Panvax™ H1N1, was not released until it had been registered by the TGA. The TGA approved registration for use in adults and children 10 years and older on 18 September 2009, and in children aged six months to under ten years on 3 December 2009. The national Pandemic (H1N1) Vaccination Program commenced on 30 September 2009 for people aged 10 years and over and on 4 December 2009 for children aged six months to under 10 years. It concluded on 31 December 2010 when the remaining stockpiled vaccine expired.

Figure 4: Timeline of vaccine availability

Description of Figure 4: Timeline of vaccine availability

This is a timeline of the key dates in the pandemic vaccination program. The timeline starts at April 2009 and finishes at December 2010, with an axis break between December 2009 and December 2010. The timeline is divided into months and has ten information boxes that are divided into three themes: Key dates, the “adult” vaccination program (greater than and equal to 10 years of age) and the “children” vaccination program.

From left to right:

• In the “Key dates” section, 24 April 2009, is when the World Health Organization notified the world of an outbreak of a novel influenza virus.
• In the “Key dates” section, 9 May 2009 is when the first confirmed case of H1N1 in Australia.
• In the “Key dates” section, 29 May 2009, is the point at which 21 million vaccine doses were ordered.
• In the “Adult vaccination program” section, 22 July 2009, is the commencement of the Australian clinical trial, in adults, of the pandemic (H1N1) influenza 2009 vaccine.
• In the “Children vaccination program” section, 3 August 2009 is the commencement of the Australian clinical trial, in children, of the pandemic (H1N1) influenza 2009 vaccine.
• In the “Adult vaccination program” section, 18 September 2009 is the registration of the vaccine in Australia for use by people aged 10 years and older.
• In the “Adult vaccination program” section, 30 September 2009 is the commencement of the vaccination program in adults and children aged 10 years and older.
• In the “Children” vaccination program section, 3 December 2009 is the registration of the vaccine in Australia for children aged six months to under 10 years.
• In the “Children” vaccination program section, 4 December 2009, indicates the commencement of the vaccination program in children aged six months to under 10 years.

9.2.4 Vaccination program rollout

The objective of the Pandemic (H1N1) 2009 Vaccination Program was to prevent further spread of the current wave of pandemic (H1N1) 2009 influenza in the Australian community and protect the Australian community against possible future waves of a similar or more severe variant of the pandemic virus. During program rollout planning it was agreed that the vaccine would initially be offered as a priority to certain groups at higher risk of exposure (such as healthcare workers) and those vulnerable to more severe outcomes (including pregnant women, Indigenous Australians and people with underlying medical conditions). Confirmation that a single dose was sufficient resulted in enough vaccine being available to offer free of charge to all Australians from the commencement of the program.

Pandemic vaccine distribution reflected the National Immunisation Program arrangements. In all the states, CSL Limited managed the distribution of vaccine from jurisdictional repositories to immunisation providers. The Australian Capital Territory and the Northern Territory managed their own distribution requirements. The quantity of vaccine distributed was driven by demand from immunisation providers.

In addition, CSL Limited agreed to distribute patient consent forms, information sheets and MDV guidelines with the vaccine, as well as the vaccination equipment packs (PanFlu VacPacks).

The vaccine was primarily administered through GP surgeries and not mass vaccination clinics as had been anticipated in pandemic planning. Vaccination was also administered in hospitals (mainly for healthcare workers) and through Aboriginal Medical Services, state-run clinics and aged-care services. Some jurisdictions also operated clinics at school premises on weekends, at festivals and through vaccination programs in schools for students with disabilities and outreach clinics to remote Indigenous communities, to facilitate availability of the vaccine to the community.

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9.2.5 Vaccine uptake

Vaccinations were recorded by providers for each individual. Systematic collection of these records was not implemented. Four of the eight jurisdictions provided estimated vaccine uptake figures based on the number of doses of vaccine distributed to immunisation providers, changes in immunity detected in routine blood collections, and individual self-reporting of vaccination collected by telephone surveys.

9.2.5.1 Adult Vaccination Survey

The Adult Vaccination Survey (AVS) is routinely conducted by Computer Assisted Telephone Interview (CATI) through the Australian Institute of Health and Welfare (AIHW). A question regarding the pandemic (H1N1) 2009 vaccine was added to the 2009 Adult Vaccination Survey.

Interviews were conducted between 20 November 2009 and 23 December 2009, after the national Pandemic (H1N1) Vaccination Program had commenced. The survey was administered to 10,231 randomly selected households across Australia. Questions were included about awareness of the vaccine and actual vaccination. Results have been extrapolated as a representation of the Australian population.³² An estimated 15.9 million adult Australians had heard of the ‘swine flu’ vaccine (representing 96 per cent of the 16.6 million adults in scope for the survey). Of these, 19 per cent, or an estimated three million adults, had received the vaccine.

A second survey involving adults and children, the Pandemic Vaccination Survey, was conducted by the AIHW in January and February 2010. The results of this survey³³ indicate that approximately 3.9 million Australians, or approximately 18 per cent of Australians of all ages, had been vaccinated against the pandemic (H1N1) 2009 virus by the end of February 2010 (which is prior to the commencement of the 2010 influenza season), including 21 per cent of adults. The percentage varied across jurisdictions.

9.2.5.2 Serosurveillance

While serosurveillance studies were conducted to gain an understanding of immunity to pandemic influenza in the community, they can also provide a measure of immunity due to vaccination.

A National Serosurveillance Study was carried out using blood collected from Red Cross donors aged 18 and over from seven cities in Australia. Donors are typically healthy adults. Comparisons were made with 500 samples collected in Cairns and Townsville in May 2009; that is, before the pandemic had emerged in Australia. In these baseline blood samples, the proportion of blood from donors that showed immunity to the pandemic (H1N1) 2009 virus was 12 per cent (range 5–15 per cent).

In October 2009 to November 2009, after the initial stage of infection in Australia, the seropositivity in 779 blood samples from major city centres across Australia was 22 per cent (range 20–30 per cent). This suggests that exposure to the novel pandemic (H1N1) 2009 strain during the 2009 winter was relatively uncommon among the healthy adult population, in the order of 10 per cent.

In March 2010 to April 2010, following distribution of the pandemic (H1N1) 2009 vaccine, seropositivity in 986 blood samples collected from major city centres across Australia was 43 per cent (range 40–50 per cent). This rise was observed across all age groups and jurisdictions.

The increase in the seropositive proportion observed between October 2009 and April 2010 is likely attributable to vaccination, given the absence of observed outbreaks and very few notified cases of pandemic (H1N1) 2009 over the period. This level of immunity would be anticipated to constrain transmission of the pandemic strain of influenza in the community among members of the adult population.

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9.2.6 Adverse events

Recording of any adverse events is important after a vaccine is administered. Rare reactions to vaccines may only be apparent after a large number of people have been immunised. These need to be identified to determine preventative measures and ensure ongoing safety of the vaccination program.

Adverse events for the pandemic (H1N1) 2009 vaccine were collected by the TGA through the existing mechanisms used for the National Immunisation Program. This is a passive surveillance reporting system that relies on immunisation providers and consumers reporting reactions to the vaccine. Reports can be made to state and territory health departments, to the vaccine manufacturer or directly to the TGA. Expert committees examine these reports and compile and respond appropriately to the adverse event data.

9.2.7 Donation of vaccine to WHO

The Australian Government made two separate donations of vaccine to assist the WHO initiative to provide pandemic (H1N1) 2009 vaccine to developing countries in need that faced difficulty in accessing limited global supplies of the vaccine. The first donation, of 2.1 million doses, was provided to the Comoros, the Cook Islands, East Timor, Fiji, Kiribati, Laos, Nauru, Niue, Papua New Guinea, Samoa, the Solomon Islands, Sri Lanka, Tokelau, Tonga, Tuvalu and Vanuatu. Recipient countries of the second donation, of 1.7 million doses, were Equatorial Guinea, Samoa, Somalia and Sri Lanka.

As Australia’s pandemic planning did not incorporate processes for donating vaccine to WHO, these arrangements were established during the pandemic response.

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³¹ Interim results of the adult clinical trial were published online in the New England Journal of Medicine on 10 September 2009.
³² Australian Institute of Health and Welfare (2011). 2009 Adult Vaccination Survey: summary results, cat. no. PHE135, available from www.aihw.gov.au/publication-detail/?id=10737418409
³³ AIHW (2010). 2010 Pandemic Vaccination Survey: summary results, cat. no. PHE128, available from www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=6442460016