9.3 Key Issues and Lessons Identified

The national Pandemic (H1N1) Vaccination Program was the biggest vaccination program undertaken in Australian history, and contributed to the substantially lower than expected levels of circulating pandemic influenza virus during Australia’s 2010 influenza season and the low impact of influenza on the Australian population in 2010.

9.3.1 Committees

The committees responsible for providing advice on pandemic vaccine and vaccination need to be streamlined and their functions made clear. Concerns have been raised regarding the number of committees supporting the CMO and the need for greater transparency and accountability of these groups. The input from committees that routinely advise on vaccination and procedures for immunisation, in particular ATAGI, was valued and these committees should be used in the future rather than new or separate pandemic structures. There was some concern regarding having two national operational immunisation committees with the same jurisdictional members operating at the same time (the AHPCNIC and the JIC).

The forums that were established during the response to engage with the primary care sector were also valuable. The GP Roundtable and the Indigenous Flu Network worked well to ensure an open dialogue between governments and the primary care sector.

Pandemic committee structures are discussed in Chapter 1: Governance and Decision Making.

9.3.2 Vaccine availability

A customised pandemic vaccine using current egg-based vaccine manufacturing technology is unlikely to be available during the first wave of an influenza epidemic. This was recognised in the AHMPPI. While activating pre-established contracts with the vaccine manufacturers guaranteed Australia priority access to pandemic vaccine and aided the speed of availability of the vaccine within five months of the pandemic emerging, the vaccine was not available until there had been a significant decline in the number of cases. A range of factors affect the timeline for vaccine availability, including strain approval processes, reassortment strain production, production of reagents for vaccine standardisation, and establishment of clinical trials and assessment and use of early data. While there is some potential for improvement, it is unlikely that this timeline could be significantly shortened, emphasising the importance of implementing other mechanisms for slowing disease transmission in the early stages of a pandemic. In a severe pandemic, some time may be gained by use of a vaccine yet to be registered by the TGA. This needs further and careful consideration.

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9.3.3 Testing and registration

The need for clinical trials of a pandemic influenza vaccine had not been foreseen in pandemic planning. This was an additional step. The clinical trials for children started long after the pandemic had emerged because initial safety signals from adult trials are needed before commencing the paediatric study, and because of difficulties in recruiting children for trials. This discrepancy between the timing of vaccine availability for children and for adults needs to be considered when planning the objectives of a pandemic vaccination strategy.

The registration of the pandemic (H1N1) 2009 vaccine was critical in 2009. In the context of the moderate overall nature of the pandemic, where public fear and concern was low, immunisation providers were reluctant to administer an unregistered vaccine. Concerns were raised about insurance indemnities associated with the proposed Pandemic (H1N1) Vaccination Program if the vaccine was not registered by the TGA by the time the vaccination program commenced. These issues were resolved through a process of working with medical indemnity insurers to ensure that they had a more detailed understanding of the vaccine and of the vaccination program processes. However, in a severe pandemic there could be great pressure to release a vaccine prior to registration. Triggers for use of an unregistered vaccine need to be planned. Further work is also needed with medical indemnity insurers to establish processes to indemnify providers in the event of the rollout of an unregistered vaccine.

9.3.4 Vaccination program rollout

Communicating the rationale of a vaccination program is a key component of its success. While development of communication materials for the vaccination program was extensive and they were generally well received, there is a tension between wide consultation and timeliness, and streamlining of the development and approval processes is required. The provision of a consent form caused some confusion for clinicians and patients, since there is no national consent form for seasonal influenza vaccination. However, as planned, consent forms would be crucial if the vaccine to be administered was not TGA approved.

There was a need to better explain the concept of at-risk groups and why they were at greater risk, and also the importance of those in contact with high-risk groups to be vaccinated to protect others. The rapidly changing knowledge about the severity of the pandemic and the dosage requirements of the available vaccine led to uncertainty and some confusion about who should receive the vaccine. There is a need to clearly communicate changing priorities to immunisation providers and the public.

Rollout planning was successfully undertaken in an environment where there was uncertainty about timelines for regulatory requirements, dates for vaccine release, delivery time frames, program start dates and resources for administering the vaccination program. The distribution of vaccine across the country within a short period of time, using the regular processes for seasonal influenza vaccines, worked well.

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A GP-based vaccination program was an appropriate response in 2009. While using GPs as the primary providers of the pandemic (H1N1) 2009 vaccine involved some logistical challenges, these were managed as they arose. Arrangements were made during the response to remunerate GPs administering vaccinations outside their usual clinics, such as in aged-care facilities.

However, GP and primary care capacity to administer a national vaccination program is finite and limited by GPs’ need to provide normal health care. GPs would not be able to deliver all vaccinations in a timely manner. Plans for mass vaccination, including plans for remote areas, are still required for a more severe pandemic. Clear understanding about the resources and funding required to facilitate this is needed. More discussion is required about the best models for quickly vaccinating a community where a pandemic is more severe.

While the use of multi-dose vials (MDVs) in a general practice setting maximises storage capacity, it may have resulted in high levels of wastage. It is reported that some GPs declined to provide opportunistic or individual vaccination in favour of requesting that patients return for a dedicated vaccination clinic, because they did not want to waste vaccine.



There was considerable concern about the risk of transmission of infection with the use of MBVs, if not used correctly. The guidelines developed by ATAGI and the RACGP on safe administration of vaccine from MDVs were widely disseminated and provided with each vaccine order to immunisation providers. MDVs are likely to be required in any pandemic, as they provide a vaccine substantially earlier than single-dose vials or pre-filled syringes. This was not well understood by all stakeholders. Pandemic plans should reflect the rationale for decisions made regarding planned vaccination policies.

The shorter than anticipated vaccine shelf life after opening a vial (set at 24 hours by the TGA based on data provided by the manufacturer) raised questions about the need for the preservative thiomersal, and may have resulted in greater waste. This shelf life differed from those set by regulators in other countries. Some of the packaging of the vaccine also caused concerns. The first packages of MDVs to become available contained 900 doses (50 vials containing 18 doses each) and were too large to be used in most GP clinics. Subsequently 100-dose packs (10 vials containing 10 doses each) were manufactured. Labelling of the packaging was also considered confusing as it differed between box sizes, and the packaging of Panvax™ Junior and Fluvax™ Junior was considered too similar.

9.3.5 Vaccine uptake

There are no comprehensive data available about the uptake of vaccine or about vaccine wastage during the 2009 response. The absence of an integrated electronic data collection and reporting system precluded the ability to comprehensively monitor administration of the vaccine. Jurisdictions reported that the systems used to manage data on vaccine uptake and wastage were inefficient and resource intensive, with retrieval and reporting difficult and not timely, and that resources would need to be taken away from service provision to work on data collection. Whether accurate records of vaccination are required needs further consideration. Indirect measures of vaccination, such as distribution of vaccine, serosurveys and self-reporting of vaccination, did provide a reasonable picture of the proportion of adults vaccinated in Australia.



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9.3.6 Adverse events reporting

Adverse events following vaccination (also known as adverse events following immunisation, or AEFI) reported for the pandemic (H1N1) 2009 vaccine were largely as expected and detailed in the vaccine product information. The rate of adverse events reported was consistent with the rates reported in the clinical trials and with seasonal influenza vaccines. The use of an adverse events reporting system that was familiar to GPs contributed to its success.

Following the 2010 influenza season, the Australian Government considered that a review of the national response to reported AEFI was prudent. The primary purpose of the review was to identify improvements that could be made to the reporting arrangements, with a particular focus on transparency and communications. The review has been completed and the DoHA is in the process of implementing its recommendations.