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Australian Technical Advisory Group on Immunisation

September 2016

Consultation on three proposals relevant to vaccination recommendations, policies and

programs for Aboriginal and Torres Strait Islander Australians

The Australian Technical Advisory Group on Immunisation (ATAGI) is seeking comments from

specific stakeholder groups and key government advisory committees regarding three proposals

that are particularly relevant to Aboriginal and Torres Strait Islander populations:

1. Revised recommendations on pneumococcal vaccination for Aboriginal and Torres Strait

Islander adults (using both the conjugate and polysaccharide pneumococcal vaccines with a

simplified schedule).

2. Extension of eligibility for funded annual influenza vaccination on the National

Immunisation Program (NIP) to include Aboriginal and Torres Strait Islander children aged

5–14 years.

3. A new hepatitis B testing and vaccination program funded on the NIP for non-immune

Aboriginal and Torres Strait Islander persons aged 15 years and over.

Information on ATAGI’s proposed next steps is provided within the sections below.

A. Preamble

The role of ATAGI

ATAGI is a ministerial advisory group that provides scientific advice on immunisation to the

Minister for Health through the Australian Government Department of Health, in liaison with

national communicable disease advisory committees, with the overall aim of optimising

prevention and control of vaccine-preventable diseases (VPDs).

ATAGI continually monitors the epidemiology of VPDs in Australia, particularly those for which

there are population vaccination programs funded through the NIP, and reviews scientific

information on the use of vaccines. ATAGI is also responsible for formulating clinical practice

guidelines for immunisation service providers on the use of vaccines for the Australian

population based on the best available evidence, as published in The Australian Immunisation

Handbook.

Closing the gap between Aboriginal and Torres Strait Islander and non-Indigenous

Australians

The NIP has been very successful in reducing VPDs in the Australian population. However, there

remains a substantial disparity in burden of disease between Aboriginal and Torres Strait Islander

populations and non-Indigenous populations, which is potentially preventable.

The Australian Burden of Disease Study conducted by the Australian Institute of Health and

Welfare (AIHW)1 found that, in 2011, VPDs contributed to approximately 3% of total disease

1 Unpublished results provided by the Australian Institute of Health and Welfare (AIHW); report of the study is

being prepared for publication (Human papillomavirus (HPV) disease was not included in the time frame under

assessment).

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burden measured by disability adjusted life year (DALY) (Figures A1 and A2). However, total

VPD burden in Aboriginal and Torres Strait Islander Australians was found to be approximately

five times higher (150 DALY per 100,000) than in non-Indigenous Australians (33 DALY per

100,000). While disparity in VPD burden was present in almost all age groups, it was particularly

marked in young children and in young adults, in whom the disparity rose progressively from the

age of 25 to 29 years (Figure A1). This is primarily attributable to a large disparity in the burden

of pneumococcal disease among younger Aboriginal and Torres Strait Islander adults.

Pneumococcal disease, influenza, tuberculosis and hepatitis B, in this order, contributed most to

the VPD burden of Aboriginal and Torres Strait Islander Australians (Figure A2). The age-

standardised rate ratios of VPD burden between Aboriginal and Torres Strait Islander Australians

and non-Indigenous Australians were highest for pneumococcal disease (approximately 10) and

hepatitis B (approximately 28), and in both cases had increased between 2003 and 2011.

Figure A1. Age-specific burden of vaccine-preventable disease, 2011, Aboriginal and Torres

Strait Islander Australians compared with non-Indigenous Australians

Figure A2. Burden of vaccine-preventable disease by disease, 2011, Aboriginal and Torres

Strait Islander Australians compared with non-Indigenous Australians

Arising from its ongoing review of VPD epidemiology and immunisation policies and programs,

ATAGI has identified three strategies relevant to prevention of pneumococcal disease, influenza

and hepatitis B, which are likely to reduce VPD burden and disparity among Aboriginal and

Torres Strait Islander Australians.

Prior to providing more detailed advice to the Australian Government for consideration, ATAGI

considers it essential to consult with specific stakeholder groups and key government advisory

committees on each of these strategies. Each proposal is summarised in the following sections.

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B. Proposal 1

Revised recommendations for the use of conjugate and polysaccharide

pneumococcal vaccines in Aboriginal and Torres Strait Islander adults

B.1 Summary of proposed revised recommendations

The current pneumococcal vaccination recommendations for Aboriginal and Torres Strait

Islander adults are published in the latest updated version of the 10th edition Australian

Immunisation Handbook

(www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook10-home~handbook10part4~handbook10-4-13). It is proposed that those recommendations be

replaced by the following:

1. All Aboriginal and Torres Strait Islander adults, regardless of presence of risk factors for

pneumococcal disease, are recommended to receive a first dose of pneumococcal vaccine at

the age of 25 years. Catch-up pneumococcal vaccination is also recommended for all

Aboriginal and Torres Strait Islander adults aged over 25 years, regardless of presence of

risk factors.

2. The recommended vaccination schedule consists of administration of one dose of the

13-valent pneumococcal conjugate vaccine (13vPCV), followed by one dose of the

23-valent pneumococcal polysaccharide vaccine (23vPPV).

3. The preferred interval between 13vPCV and the subsequent dose of 23vPPV is 12 months

(minimum interval 2 months).

4. For individuals who have prior history of receiving pneumococcal vaccines:

a. the dose of 13vPCV is not recommended if there is a previous documented dose of

13vPCV received; and

b. the dose of 23vPPV that follows the 13vPCV dose is not recommended if there is a

previous documented dose of 23vPPV received.

5. For individuals with specific risk factors, the current recommendation for a repeat dose of

23vPPV at 5–10 years after the previous 23vPPV dose is maintained in the interim; however,

this recommendation is subject to further review.

6. For individuals without specific risk factors, routine administration of a repeat dose of

23vPPV is not recommended.

Table B1 summarises the proposed revised recommendations/schedule.

Table B1. Proposed revised recommendations for pneumococcal vaccinations in Aboriginal

and Torres Strait Islander adults aged 25 years or more

Previous

documented dose Recommendation

13vPCV 23vPPV 13vPCV 23vPPV

Age ≥25 years No No Give single dose now Give single dose 12 months after

13vPCV*

Age ≥25 years Yes† No Not recommended

Give single dose 12 months after

13vPCV*

Age ≥25 years No Yes†

Give single dose at least

12 months after 23vPPV‡

Not recommended unless the

individual has specific risk factors#

Age ≥25 years Yes† Yes

† Not recommended

Not recommended unless the

individual has specific risk factors#

* Provided the interval following the 13vPCV is not less than 2 months, earlier administration is acceptable at the immunisation

provider’s discretion, to allow for the best opportunity to ensure uptake of this 23vPPV dose.

† In the absence of reliable documentation of a previous dose of 13vPCV or 23vPPV, it should be assumed that such a dose has not

previously been given.

‡ ATAGI recommends a minimum interval of 12 months after the documented dose of 23vPPV before receiving a 13vPCV dose.

# For individuals with specific risk factors, give a repeat dose of 23vPPV 5–10 years after the previous 23vPPV dose.

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B.2 Key consultation questions for stakeholders

1. Do you agree with ATAGI’s proposed threshold age of 25 years for all Aboriginal and

Torres Strait Islander adults receiving a first dose of pneumococcal vaccination? (refer

to evidence outlined under sections B.5 and B.6)

2. Do you agree with ATAGI’s proposed recommendation for catch-up vaccination for all

Aboriginal and Torres Strait Islander adults over 25 years of age?

3. Do you consider a universal recommendation (i.e. removing the reliance on

vaccination history and identifying risk factors) to be conducive to more effective

implementation and better uptake when compared with current practice?

4. Do you have any major concerns regarding ATAGI’s proposed revised

recommendations and/or any suggested modifications?

5. Do you consider there to be any key challenges associated with implementing the

proposed revised recommendations? If so, do you have any suggested solutions?

6. Do you have any additional comments for consideration?

B.3 Issues to note/next steps for ATAGI

The proposed revised recommendations detailed above are recommendations for best clinical

practice and based on best available scientific evidence, to be considered for inclusion in The

Australian Immunisation Handbook. These recommendations do not necessarily correspond to

currently funded vaccine doses through the NIP.

Any changes to vaccination recommendations in The Australian Immunisation Handbook must

be reviewed and considered by the National Health and Medical Research Council. Public

consultation is required as part of this process and it is anticipated that this would be carried out

during 2017.

Should ATAGI’s proposed revised recommendations be agreed, ATAGI may look to develop

advice to the Australian Government and its relevant committees to consider extending current

funding for pneumococcal vaccination for Aboriginal and Torres Strait Islander adults on the

NIP. This would enable the NIP schedule to better align with ATAGI’s revised recommendations.

B.4 Limitations and anticipated challenges

ATAGI acknowledges that there are areas where there is a lack of good quality direct evidence

for substantiating some of the proposed revised recommendations. Such areas include vaccine

efficacy data for younger adults and/or Aboriginal and Torres Strait Islander adults for some

measures, and the duration of protection afforded by either of the two vaccines by various

outcome measures. In these circumstances, recommendations are based on extrapolation of best

available evidence.

ATAGI recognises that delivery of the proposed revised recommendations to the target

populations will remain a significant challenge, despite simplification and reduced reliance on

previous vaccination records. In addition, there will be substantial resourcing requirements

associated with catch-up vaccination for all Aboriginal and Torres Strait Islander adults aged over

25 years.

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B.5 Evidence underpinning ATAGI’s proposed revised recommendations

Key epidemiological evidence that underpins the revised recommendations of ATAGI is

summarised below:

1. The burden of invasive pneumococcal disease (IPD) among Aboriginal and Torres Strait

Islander adults, including young adults, has increased over the past 12 years. This is despite

reductions in IPD incidence in Aboriginal and Torres Strait Islander children, who are

directly targeted by national conjugate pneumococcal vaccination programs.

In contrast, burden of IPD has reduced in non-Indigenous adults, as well as children,

resulting in increased disparity between Aboriginal and Torres Strait Islander Australians

and non-Indigenous Australians (Figure B1). The incidence of IPD among Aboriginal and

Torres Strait Islander Australians aged 15–24 years is now comparable to the incidence of

non-Indigenous adults aged 65 years and over (Table B2, Figure B1), for whom

pneumococcal vaccination is recommended and funded universally.

Table B2. Notification rates (per 100,000) of invasive pneumococcal disease by age group,

2011–2014, Aboriginal and Torres Strait Islander Australians compared with non-

Indigenous Australians

Age group 0–4

years

5–14

years

15–24

years

25–34

years

35–49

years

50–64

years ≥65

years

Aboriginal and Torres Strait

Islanders 51.6 22.7 16.0 35.8 64.3 80.3 98.9

Non-Indigenous 13.0 2.6 1.5 2.7 4.8 7.6 16.8

Rate ratio* (Aboriginal and

Torres Strait Islanders : non-

Indigenous Australians)

4.0 8.6 10.4 13.3 13.4 10.6 5.9

*p<0.05 for the rate ratios for every age group shown in this table

Figure B1. Notification rates of invasive pneumococcal disease (per 100,000) by age group

and period, 2002–2014, Aboriginal and Torres Strait Islander Australians compared with

non-Indigenous Australians

2. There is greater diversity of serotypes causing pneumococcal disease among Aboriginal and

Torres Strait Islander adults compared with non-Indigenous adults. A substantial proportion

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of IPD among Aboriginal and Torres Strait Islander adults is due to serotypes included in

23vPPV but not in 13vPCV.

Based on national data from 2011–2014, 32% of IPD in Aboriginal and Torres Strait Islander

adults aged 15 years and over is due to serotypes contained in 13vPCV. An additional 28%

of IPD is due to serotypes in 23vPPV but not 13vPCV (23v-non-13v serotypes).

3. There is a high prevalence of risk factors among Aboriginal and Torres Strait Islander

Australians, commencing at a young age. A number of medical and behavioural risk factors

have been identified to be associated with an increased risk of pneumococcal disease, for

which additional strategies and/or doses of pneumococcal vaccines have been recommended

(refer to The Australian Immunisation Handbook). These risk factors include chronic

medical conditions like heart disease, chronic respiratory disease, diabetes mellitus, tobacco

smoking, and harmful use of alcohol. The proportion of Aboriginal and Torres Strait Islander

adults with at least one of these risk factors is high (estimated to be greater than 60%) even

for younger adults, as shown in Table B3.

Table B3. Estimated self-reported prevalence of at least one risk factor for pneumococcal

disease among Aboriginal and Torres Strait Islander adults (data source: National

Aboriginal and Torres Strait Islander Health Survey 2012–13)2

Age group 18–34 years 35–49 years 50–64 years ≥65 years

Estimated prevalence 60.5% 67.7% 74.1% 76.1%

95%CI of estimated prevalence 55.4–65.6% 62.8–72.6% 68.4–79.8% 68.8–83.4%

4. There appears to be suboptimal coverage of recommended doses of 23vPPV among

Aboriginal and Torres Strait Islander adults. However, there is no reliable source of data for

estimating recent coverage of 23vPPV among Aboriginal and Torres Strait Islander adults.

The 2012–13 National Aboriginal and Torres Strait Islander Health Survey found that 9% of

Aboriginal and Torres Strait Islander persons aged 15–24 and 44% of those aged 65 years

and over reported receiving a dose of pneumococcal vaccine in the previous 5 years.3 Noting

the prevalence of risk factors among Aboriginal and Torres Strait Islander adults, this uptake

of 23vPPV is suboptimal.

Among Aboriginal and Torres Strait Islander adults aged 18–49 years with a self-reported

risk factor (for whom the 23vPPV is recommended and funded under the NIP), the 2004–05

National Aboriginal and Torres Strait Islander Health Survey found that only 13% reported

receiving a dose of pneumococcal vaccination in the preceding 5 years, ranging from 3% in

Tasmania to 25% in the Northern Territory.4

2 Unpublished data from the 2012–13 National Aboriginal and Torres Strait Islander Health Survey provided by the

Australian Bureau of Statistics, according to methods designed by the National Centre for Immunisation Research and

Surveillance similar to those described in Menzies R, Turnour C, Chiu C, McIntyre P. Vaccine preventable diseases and

vaccination coverage in Aboriginal and Torres Strait Islander people, Australia, 2003 to 2006. Communicable Diseases

Intelligence Volume 32 Supplement, June 2008, pp. S42, S50–53

(www.health.gov.au/internet/main/publishing.nsf/Content/cda-cdi32suppl.htm/$FILE/cdi32suppl.pdf) 3 As cited in: Australian Institute of Health and Welfare. 2015. The health and welfare of Australia’s Aboriginal and Torres

Strait Islander peoples 2015. Cat. no. IHW 147. Canberra: AIHW.

(www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129551281) 4 As cited in: Menzies R, Turnour C, Chiu C, McIntyre P. Vaccine preventable diseases and vaccination coverage in

Aboriginal and Torres Strait Islander people, Australia, 2003 to 2006. Communicable Diseases Intelligence Volume 32

Supplement, June 2008 (www.health.gov.au/internet/main/publishing.nsf/Content/cda-

cdi32suppl.htm/$FILE/cdi32suppl.pdf)

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B.6 Rationale for the revised recommendations proposed by ATAGI

The following factors have prompted ATAGI’s review of current recommendations and

strategies:

the increasing disparity of burden between Aboriginal and Torres Strait Islander adults and

non-Indigenous adults, especially among younger age groups

the very high population prevalence of risk factors, even among young Aboriginal and Torres

Strait Islander adults

the suboptimal vaccination coverage attained by current practice.

In addition, it is now timely to incorporate the use of 13vPCV as an additional strategy for

preventing pneumococcal disease based on best available evidence.

ATAGI recognises that the current recommendations of pneumococcal vaccination for Aboriginal

and Torres Strait Islander adults are complex, requiring identification of risk factors as well as

ascertainment of the full history of pneumococcal vaccination for every individual, which is often

practically challenging in primary healthcare settings. A simplified schedule of recommendations

would facilitate broader coverage of pneumococcal vaccination in Aboriginal and Torres Strait

Islander adults and this is justified by disease burden.

The rationale underpinning each of the specific revised recommendations is summarised below.

1. All Aboriginal and Torres Strait Islander adults, regardless of presence of risk factors for

pneumococcal disease, are recommended to receive a first dose of pneumococcal vaccine

at the age of 25 years. Catch-up pneumococcal vaccination is also recommended for all

Aboriginal and Torres Strait Islander adults aged over 25 years, regardless of presence of

risk factors.

Given the high disease burden and high prevalence of risk factors among all ages of

Aboriginal and Torres Strait Islander adults, a universal (as opposed to risk factor-based)

recommendation is warranted. A universal recommendation would reduce barriers to uptake.

The reason for selecting the threshold age of 25 years for Aboriginal and Torres Strait

Islander adults is that this corresponds to the age at which a rapid rise in rates of IPD starts

(Figure B1). It is desirable to vaccinate individuals prior to them reaching an age which

correlates with a higher disease incidence or risk factor prevalence.

A “catch-up” program of 13vPCV (with or without 23vPPV as required) is included in the

recommendations in recognition of the higher disease incidence and prevalence of risk

factors for Aboriginal and Torres Strait Islander adults of any age above the threshold age

(25 years). The catch-up program would also allow flexibility of opportunistic catch-up

vaccination for those who missed receiving a dose of 13vPCV at the recommended age of 25

years.

2. The recommended vaccination schedule consists of administration of one dose of the

13-valent pneumococcal conjugate vaccine (13vPCV), followed by one dose of the

23-valent pneumococcal polysaccharide vaccine (23vPPV).

Introducing the use of 13vPCV in a population with increased risk of disease aims to harness

the protection afforded by 13vPCV, including high efficacy of protection against vaccine-

type IPD and moderate efficacy against vaccine-type pneumococcal pneumonia.

The sequential dose of 23vPPV is primarily recommended to broaden serotype coverage

beyond those included in 13vPCV. This is particularly relevant due to the diversity of

serotypes causing IPD among Aboriginal and Torres Strait Islander adults.

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3. The preferred interval between 13vPCV and the subsequent dose of 23vPPV is 12 months

(minimum interval 2 months).

Based on the limited available clinical study data, administering a dose of 23vPPV

12 months following a dose of 13vPCV is safe, without adverse immunological effects.

From an implementation perspective, a 12-month interval could also be aligned with the

annual health checks and annual influenza vaccination which are currently recommended for

Aboriginal and Torres Strait Islander adults.

Given the current lack of evidence around the benefit of vaccination versus the theoretical

concern of a potential increased risk of clinical and immunological adverse effects, a

minimum interval of 2 months between 13vPCV and the subsequent 23vPPV dose is

recommended. The priority should be to avoid missing an opportunity for vaccination, to

optimise uptake of the recommended dose of 23vPPV following 13vPCV.

4. For individuals who have prior history of receiving pneumococcal vaccines:

the dose of 13vPCV is not recommended if there is a previous documented dose of

13vPCV received; and

the dose of 23vPPV that follows the 13vPCV dose is not recommended if there is a

previous documented dose of 23vPPV received.

Note: For both vaccines, in the absence of reliable documentation, it should be assumed

that a dose has not previously been given.

Where it is documented that a dose of 13vPCV has previously been given, such as for

medical risk factors associated with the highest risk of invasive pneumococcal disease, no

further dose of 13vPCV is recommended. This is because only a single dose of 13vPCV is

recommended, regardless of presence of risk factors. For these individuals, if there is no

previous documented dose of 23vPPV, ATAGI recommends that a dose of 23vPPV is to be

given, with a minimum interval of 2 months after the documented dose of 13vPCV.

Where it is documented that a dose of 23vPPV has previously been given (but not 13vPCV),

ATAGI recommends that a single dose of 13vPCV is to be given, with a minimum interval

of 12 months after the last documented dose of 23vPPV. No further dose of 23vPPV is

recommended, unless the individual has specific risk factors. This is because a repeat dose of

23vPPV is not recommended for individuals who do not have specific risk factors (refer to

recommendations 5 and 6 below).

In the absence of documentation, it should be assumed that a dose of 13vPCV or 23vPPV

has not previously been given. ATAGI considers that, given the high risk of disease, the

benefit of vaccination outweighs the uncertainties or potential concerns of adverse effects in

the vaccinee (including increased risk of local injection site reactions), even if an

unascertained dose of 13vPCV or 23vPPV was in fact received previously. This strategy

would minimise the critical reliance on needing to ascertain a full vaccination history in

circumstances where this is difficult.

5. For individuals with specific risk factors, the current recommendation for a repeat dose of

23vPPV 5–10 years after the previous 23vPPV dose is maintained in the interim; however,

this recommendation is subject to further review.

ATAGI considers it appropriate to align recommendations for use of repeat doses of 23vPPV

for all individuals with risk factors regardless of Indigenous status.

6. For individuals without specific risk factors, routine administration of a repeat dose of

23vPPV is not recommended.

As yet, there is no direct evidence of clinical effectiveness with repeat doses of 23vPPV

doses. In addition, repeat doses of 23vPPV are not recommended for adults without risk

factors.

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Removal of the recommendation for routine administration of a repeat dose of 23vPPV

would simplify the recommended schedule for Aboriginal and Torres Strait Islander adults.

B.7 Background

Pneumococcal disease

Streptococcus pneumoniae (pneumococcal bacteria or pneumococcus) can cause a range of

diseases, from ear infections and pneumonia (which are relatively common), to meningitis and

bacteraemia/septicaemia (bacterial infection in the bloodstream), which are relatively rare but

life-threatening.

Invasive pneumococcal disease (IPD) refers to finding pneumococcal bacteria in a normally

sterile site, usually the blood (from a blood culture). IPD may occur in association with

meningitis, sepsis or pneumonia and usually denotes more severe infection. There are over 90

pneumococcal serotypes, with some serotypes much more common than others, and the available

vaccines are effective only against the specific serotypes contained in them.

Pneumococcal vaccines

There are two major types of pneumococcal vaccines: pneumococcal conjugate vaccine and

pneumococcal polysaccharide vaccine. The conjugate vaccine can induce immune memory,

meaning that the immune system remembers (responds better) to subsequent exposure to that

serotype than on the first occasion. The polysaccharide vaccine does not have this same effect.

Formulations of vaccine vary in their ‘valency’, that is, the number of pneumococcal serotypes

included. Studies have shown 13vPCV to be effective in older adults for protection against both

IPD and pneumococcal pneumonia without IPD caused by serotypes contained in the vaccine.

Although 23vPPV covers more serotypes, evidence suggests that it has only moderate and more

short-lived effectiveness against IPD, but little or no effectiveness against pneumonia without

IPD (the latter being much more common).

Since 1999, the Government has funded doses of 23vPPV under the NIP for Aboriginal and

Torres Strait Islander adults at the age of 50 years (one dose, followed by a repeat dose 5 years

later), and for Aboriginal and Torres Strait Islander adults aged 15–49 years who have at least one

risk factor (one dose, followed by a repeat dose 5 years later).

13vPCV has been registered in Australia for use in adults since mid-2014. ATAGI currently

recommends the use of 13vPCV for adults with some specific medical conditions with the highest

increased risk of IPD (such as asplenia and some immunocompromising conditions). Currently

the 13vPCV is not funded under the NIP for adults.

In July 2016, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended that

13vPCV be listed as a designated vaccine on the NIP for:

pneumococcal vaccine naïve Aboriginal and Torres Strait Islander adults aged 50 years and

over; and

pneumococcal vaccine naïve non-Indigenous adults aged 65 years and over.

The PBAC recommended that a single dose of 13vPCV replaces the first dose of 23vPPV that is

currently provided to these populations through the NIP.5

5 Brief summary of recommendations made by the PBAC – July 2016

(http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2016-07/positive-recommendations-2016-

07.pdf)

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C. Proposal 2

Extension of eligibility for funding of annual influenza vaccination within the NIP

to include Aboriginal and Torres Strait Islander children aged 5–14 years

C.1 Summary of proposed NIP extension

ATAGI proposes recommending to Government that eligibility for funding of annual influenza

vaccination within the NIP be extended to include Aboriginal and Torres Strait Islander children

aged 5–14 years. This will result in all Aboriginal and Torres Strait Islander Australians aged 6

months and over being eligible for funded annual influenza vaccination.

C.2 Key consultation questions for stakeholders

1. What do you consider to be the merits to ATAGI’s proposal?

2. Do you agree that the proposal would improve overall influenza vaccination uptake in

Aboriginal and Torres Strait Islander populations?

3. Can you foresee any drawbacks or unintended consequences that may arise from this

proposal from the perspectives of immunisation service providers and/or the

community?

4. Do you have any additional comments for consideration?

C.3 Next steps for ATAGI

ATAGI plans to submit a recommendation to the Australian Government to consider this

proposal, following comments received through this consultation. Government funding for this

proposed program under the NIP will be subject to decision and approval processes of the

Government.

C.4 Rationale for ATAGI’s proposed extension of eligibility for NIP-funded influenza

vaccine

Key considerations underpinning ATAGI’s proposal are summarised below:

1. The significantly higher rate of more severe influenza among Aboriginal and Torres Strait

Islander children than non-Indigenous children aged 5–14 years, as with other age groups

Data from the National Hospital Morbidity Database for the recent period of 2010–2013

demonstrates a significantly higher rate of influenza hospitalisation among Aboriginal and

Torres Strait Islander children aged 5–14 years compared with non-Indigenous children in

the same age cohort (Figure C1). These data show a rate ratio of 1.6 (95% CI: 1.3–1.9) for

Aboriginal and Torres Strait Islander children aged 5–14 years. This rate ratio is similar to

the rate ratio for Aboriginal and Torres Strait Islander children aged 2–4 years, who are

currently eligible for NIP-funded vaccine. The magnitude of this increased risk is also

comparable to that for some medical conditions for which influenza vaccines are currently

NIP-funded.

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Figure C1. Average annual rate of hospitalisation for influenza by age group, Australia,

2010–2013,* Aboriginal and Torres Strait Islander Australians compared with other (non-

Indigenous) Australians

* The completeness level of Indigenous identification in the national dataset from 2010 is acceptable for all

jurisdictions, according to AIHW recommendation.

2. Potential to facilitate delivery and improve uptake of influenza vaccination to all

Aboriginal and Torres Strait Islander Australians

ATAGI understands that there are many challenges to delivering influenza vaccination to

Aboriginal and Torres Strait Islander people and communities. These challenges include the

need for age ascertainment due to differential eligibility for NIP-funded vaccines.

A national policy whereby all Aboriginal and Torres Strait Islander persons aged 6 months

and over are eligible to receive NIP-funded influenza vaccines is expected to facilitate easier

delivery of vaccination to Aboriginal and Torres Strait Islander communities and reduce

potential barriers to poor uptake.

This may be especially relevant in settings where:

vaccination service is delivered to all members of a family or Aboriginal or Torres Strait

Islander community

there is an integrated delivery of health services

there are other suitable healthcare encounters which could provide opportunities for

administration of influenza vaccine.

3. Potential indirect herd protection benefit for some Aboriginal and Torres Strait Islander

communities

Evidence shows that in addition to the direct benefit offered by influenza vaccination to

vaccinated individuals, influenza vaccination of school-aged children provides indirect

benefits to non-immunised members of the same community through herd protection

(reduced infections due to reduced exposure). This is especially evident in settings with close

living conditions and may be potentially relevant for some Aboriginal and Torres Strait

Islander communities where households comprising large families of multiple generations

are common.

C.4 Background

Influenza and the influenza vaccine

Influenza is a very common respiratory infection caused by the influenza virus, which is spread

easily, mainly through large particle droplets generated by sneezing and coughing. Influenza is

0-5m 6-23m 2-4y 5-14y 15-29y 30-49y 50-64y ≥65y

Indigenous 551 276 66 25 34 67 113 161

Others 188 104 42 16 15 18 23 48

Rate ratio (all statistically significant) 2.9 2.6 1.6 1.6 2.3 3.7 5.0 3.4

0

100

200

300

400

500

600

Hospitalisation incidence

(per 100,000)

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more easily spread where large numbers of people gather together. People of all ages are

susceptible to influenza. Each year typically 5–10% of the general community are affected. This

proportion may be higher in some years and among children.

Although symptoms in some infected individuals can be mild, serious complications from

influenza occur in a small proportion of people who are infected. These complications include

pneumonia, myocarditis and neurologic complications, which can lead to hospitalisation and

death. Individuals with certain chronic medical conditions and some specific populations have an

increased risk of severe influenza or influenza complications.

Influenza vaccines are moderately effective for prevention against influenza. Annual influenza

vaccination is recommended by ATAGI for any person aged 6 months and over, unless there is a

contraindication.

Current NIP-funded cohorts

The Australian Government currently funds annual influenza vaccination through the NIP for

specified populations with increased risk of severe influenza. This includes (but is not limited to)

Aboriginal and Torres Strait Islander Australians aged 15 years and over; Aboriginal and Torres

Strait Islander children aged 6–59 months (i.e. less than 5 years); and all persons with medical

conditions associated with an increased risk of severe influenza.

Aboriginal and Torres Strait Islander persons aged 15 years and over first became eligible for

NIP-funded influenza vaccines in 2010. Eligibility was extended to Aboriginal and Torres Strait

Islander children aged 6–59 months at the commencement of the 2015 influenza season.

Key considerations for extending the NIP-funded cohort to Aboriginal and Torres Strait Islander

children aged 6–59 months include:

the high rate of influenza-associated hospitalisations in young Aboriginal and Torres Strait

Islander children

the higher rate of influenza hospitalisation among Aboriginal and Torres Strait Islander

children compared with non-Indigenous children (rate ratio 2.2 for age less than 5 years,

based on hospitalisation data from six Australian jurisdictions, 2005–2008)

evidence of moderate effectiveness of influenza vaccination in preventing laboratory-

confirmed influenza in young children.

Aboriginal and Torres Strait Islander children 5–14 years

While ATAGI recommends annual influenza vaccination for all Aboriginal and Torres Strait

Islander Australians, Aboriginal and Torres Strait Islander children aged 5–14 years are currently

not eligible for NIP-funded influenza vaccines.

The proportion of Aboriginal and Torres Strait Islander children aged 5–14 years who have an at-

risk medical condition, and are therefore eligible to receive the NIP-funded influenza vaccine, has

recently been estimated to be approximately 6%.6

The coverage of influenza vaccine among Aboriginal and Torres Strait Islander children aged 6–

59 months for 2015, based on the Australian Childhood Immunisation Register, was 10.7% for

Western Australia (where there is a state-funded universal influenza vaccination program for all

young children aged 6–59 months), and 2.2% in other jurisdictions (where non-Indigenous

children aged 6–59 months were not funded unless they have an at-risk medical condition). There

are no reliable data on the uptake among Aboriginal and Torres Strait Islander children aged 5–14

years, however coverage is likely to be less than that for younger children.

6 Unpublished data from the 2012–13 National Aboriginal and Torres Strait Islander Health Survey provided by the

Australian Bureau of Statistics, according to methods designed by the National Centre for Immunisation Research and

Surveillance similar to those described in Menzies R, Turnour C, Chiu C, McIntyre P. Vaccine preventable diseases and

vaccination coverage in Aboriginal and Torres Strait Islander people, Australia, 2003 to 2006. Communicable Diseases

Intelligence Volume 32 Supplement, June 2008, pp. S42, S50–53

(www.health.gov.au/internet/main/publishing.nsf/Content/cda-cdi32suppl.htm/$FILE/cdi32suppl.pdf)

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D. Proposal 3

Hepatitis B testing and vaccination program for non-immune Aboriginal and

Torres Strait Islander persons aged 15 years and over

D.1 Summary of proposed new program

ATAGI proposes recommending to Government that a hepatitis B vaccination program

(delivering three doses as a primary course) be established for all non-immune Aboriginal and

Torres Strait Islander adults aged 15 years and over. In this context, the term ‘non-immune’ refers

to a person who:

does not have a history of an age-appropriate completed course of vaccination; and/or

is shown to be non-immune to (but not chronically infected by) hepatitis B through serological

testing.

The proposed program has two components (to be delivered through primary healthcare settings):

1. Opportunistic serological testing of Aboriginal and Torres Strait Islander persons aged

15 years and over for markers of hepatitis B chronic infection and immunity, if there is no

record of completed vaccination;

2. Vaccination of Aboriginal and Torres Strait Islander adults who are deemed to be non-

immune or have partially completed the vaccination course.

Organised supplementary mass vaccination programs delivered in community settings may also

be considered. Such programs could be delivered by Aboriginal Community Controlled Health

Services (ACCHSs), local governments, jurisdictional health authorities, or other contracted

service providers.

This program is proposed by ATAGI based on a comprehensive review of available data and in-

depth discussions by ATAGI and its Hepatitis B Working Party in 2013–2014.

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14

D.2 Key consultation questions for stakeholders

Component 1 – Serology

a) What do you consider to be the key logistical/implementation challenges associated

with the proposed serological testing component of the program? What are the

additional resource requirements for delivering this component of the program? Can

you suggest any possible solutions for overcoming these challenges?

b) ATAGI recommends that serological testing is undertaken in parallel with the first dose

of vaccine to reduce the number of visits required. What do you consider to be the

challenges associated with this recommendation from the perspective of an

immunisation service provider?

Component 2 – Vaccination

a) What do you consider to be the key logistical/implementation challenges associated

with the vaccination component of the program? What are the additional resource

requirements for delivering this component of the program in primary care settings?

Can you suggest any possible solutions for overcoming these challenges?

b) What do you consider to be the key logistical/implementation challenges associated

with supplementary mass vaccination programs? What are the additional resource

requirements for delivering supplementary mass vaccination programs?

c) What do you consider to be the preferred and most effective model of delivery for

supplementary mass vaccination programs? Can you suggest any alternative models for

delivery which are not covered in this paper?

Mainstream general practice settings

a) ATAGI notes that mainstream general practice serves a considerable proportion of

Aboriginal and Torres Strait Islander adults in some jurisdictions and settings. What

do you consider to be the specific challenges associated with delivery of this proposed

program through mainstream general practice? Can you suggest any possible solutions

for overcoming these challenges?

Implementation opportunities

a) Are there specific settings where implementation of a hepatitis B serological testing and

vaccination program would be particularly effective and efficient?

General

a) What is your assessment of the likelihood of completion of a three-dose course of

hepatitis B vaccination for eligible individuals under the proposed program? Can you

suggest any potential solutions to mitigate the risk of non-completion?

b) Do you have any additional comments for consideration?

D.3 Next steps for ATAGI

ATAGI plans to provide advice to the Government on the importance of establishing and

implementing a hepatitis B program, following comments received through this consultation.

Government funding for this proposed program under the NIP will be subject to decision and

approval processes of the Government.

In-confidence

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D.4 Rationale for ATAGI’s proposed hepatitis B testing and vaccination program for

non-immune Aboriginal and Torres Strait Islander persons aged 15 years and over

1. Alignment with the National Hepatitis B Strategy 2014–17

The proposed hepatitis B testing and vaccination program aligns with the current National

Hepatitis B Strategy.7 The National Hepatitis B Strategy lists Aboriginal and Torres Strait

Islander Australians as one of the priority populations for prevention of transmission and the

monitoring, detection and treatment of chronic hepatitis B, in order to reduce associated

morbidity and mortality.

Increased serological testing in priority populations is one of the key actions proposed by the

National Hepatitis B Strategy in order to decrease the proportion of people living with

undiagnosed chronic hepatitis B.

The National Hepatitis B Testing Policy, 8 which aligns with the National Hepatitis B

Strategy, recommends that all Aboriginal and Torres Strait Islander persons be tested once in

adulthood for the hepatitis B surface antigen (HBsAg), surface antibody (anti-HBsAb) and

core antibody (anti-HBcAb). The purpose of these tests is to identify persons who:

have chronic hepatitis B, for whom appropriate medical assessment and treatment should

be offered

are immune through past infection or vaccination

are non-immune and therefore susceptible to hepatitis B infection, for whom vaccination

should be offered.

Screening for chronic hepatitis B among high-risk populations is also consistent with

recommendations of multiple professional associations in Australia including the

Australasian Society of HIV Medicine, the Gastroenterological Society of Australia, and the

Cancer Council Australia.

ATAGI supports the National Hepatitis B Testing Policy, and recommends that a hepatitis B

vaccination program for Aboriginal and Torres Strait Islander adults include serological

testing (specifically for HBsAg, anti-HBsAb and anti-HBcAb). ATAGI recommends that

testing should be provided to individuals who have not had previous hepatitis B serology

testing or who do not have a documented completion of a course of hepatitis B vaccination.

2. Disease burden of hepatitis B among Aboriginal and Torres Strait Islander adults aged

15 years and over

Australia has low overall prevalence of hepatitis B and an existing vaccination program for

hepatitis B. However, there is substantial disparity in disease burden of hepatitis B among

the Aboriginal and Torres Strait Islander population when compared with the non-

Indigenous population.

The total burden of hepatitis B for Aboriginal and Torres Strait Islander Australians,

measured by disability adjusted life year (DALY), was estimated to be about 20 cases per

100,000 people in 2011, with an age-standardised rate ratio of 28 comparing Aboriginal and

Torres Strait Islander Australians with non-Indigenous Australians.9 Aboriginal and Torres

Strait Islander adults make up the bulk of the susceptible population. Depending on

measurement endpoints, the risk of hepatitis B or related disease is 2–10 times higher among

Aboriginal and Torres Strait Islander Australians aged 15 years and over, in comparison with

other Australians in this age group (Table D1).

7 Document accessible at www.health.gov.au/internet/main/publishing.nsf/Content/ohp-bbvs-hepb 8 National hepatitis B testing policy v1.2 (Reviewed 2015). testingportal.ashm.org.au/hbv

9 Unpublished results provided by the Australian Institute of Health and Welfare (AIHW); report of the study is being

prepared for publication

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Table D1. Relative risk of hepatitis B by various disease endpoints comparing Aboriginal

and Torres Strait Islander Australians with non-Indigenous Australians aged 15 years and

over

Disease endpoint Range of relative risk

(with variation by age groups)

Serologic prevalence (measured by surface antigen of virus)* 2–7 times higher

Notification rate† 3–7 times higher

Hospitalisation rate‡ 2 times higher

Prevalence of liver malignancy* 5–10 times higher

* Based on published studies

† Analysis using ‘newly acquired cases’ for 2005–2012 in National Notifiable Diseases Surveillance System

‡ Analysis using data on acute hepatitis B as principal diagnosis, 2005–2010, from National Hospital Morbidity Database,

Australian Institute of Health and Welfare

Inferring from best estimates of age-specific population susceptibility to hepatitis B, it is

estimated that approximately 164,000 Aboriginal and Torres Strait Islander adults aged

15 years and over are susceptible to hepatitis B infection. This constitutes 38% of all

Aboriginal and Torres Strait Islander persons in this age bracket. If there is no additional

vaccination program for this susceptible population, mathematical modelling suggests that

approximately 1,800 new acute hepatitis B cases and 134 chronic cases would likely occur

over the next 10 years.10

3. Potential health gains of a vaccination program for all non-immune Aboriginal and

Torres Strait Islander adults

Due to the inverse relationship between age at initial infection and risk of progression to

chronic infection, vaccinating infants, compared with older ages, will have the most

substantial long-term population health impacts. However, ATAGI notes that it will take

decades for the full impacts of the infant program to flow through to the adult age cohorts.

In the absence of broader immunisation of Aboriginal and Torres Strait Islander adults, the

risk of susceptible Aboriginal and Torres Strait Islander adults contracting hepatitis B is

likely to remain high for many years, due to the higher disease prevalence in Aboriginal and

Torres Strait Islander communities.

Should an NIP-funded hepatitis B immunisation program for non-immune Aboriginal and

Torres Strait Islander adults be implemented, and an uptake of 25–50% be achieved within a

10-year timeframe, it has been estimated (using a conservative modelling method) that

between 240 and 549 cases of acute hepatitis B would be prevented. On this basis, it can be

inferred that between 138 and 181 persons would need to be vaccinated to prevent one case

of acute hepatitis B disease. For chronic hepatitis B, the number of prevented cases ranges

between 18 and 52, implying that between 1,460 and 2,187 persons would need to be

vaccinated to prevent one case of chronic hepatitis B disease.11

D.5 Implementation considerations

While ATAGI considers that the proposed program has important public health impacts and

could be implemented within the existing healthcare systems, ATAGI acknowledges that there

are a number of challenges and issues with respect to implementation.

10 Wattiaux A, Yin JK, Beard F, et al. Closing the health equity gap: estimated potential impacts of hepatitis B immunisation

program targeting Indigenous Australian adults. Bulletin of the World Health Organization. In press 11 Wattiaux A, Yin JK, Beard F, et al. Closing the health equity gap: estimated potential impacts of hepatitis B immunisation

program targeting Indigenous Australian adults. Bulletin of the World Health Organization. In press

In-confidence

17

Firstly, the awareness of the need for testing and/or vaccination is anticipated to be relatively low

in some jurisdictions and settings if there is no specific ongoing promotion on a wide scale.

Vaccination coverage would be optimised by an effective communication strategy to relevant

healthcare providers and communities.

In addition, ATAGI has identified the following challenges to achieving high levels of vaccine

uptake:

Identification of Indigenous status, which has been sub-optimal in mainstream general practice

Identification of susceptibility, due to the lack of systematic capture of adult vaccination

history and people seeking healthcare from multiple providers

Logistic complexity, including the requirement for serological testing and multiple vaccine

doses

Additional logistic and resource requirements and challenges for any supplementary mass

vaccination programs

Potential for over-immunisation, which would increase the cost and resource demand of

implementation, although this would not be a significant safety issue based on current

evidence.

However, it is noted that the upcoming expansion of the Australian Childhood Immunisation

Register (ACIR) to become the Australian Immunisation Register (AIR) (covering adult

vaccination) would partially mitigate some of these concerns. ATAGI notes that there is already

the ability to capture hepatitis B vaccination for children in ACIR and that there may be potential

to expand this capability to the AIR.

ATAGI acknowledges that inclusion of serological testing would add complexity to

implementation of the proposed vaccination program. ATAGI also acknowledges that the

Medicare Benefits Schedule (MBS), under the Health Insurance Act 1973, does not typically

accommodate population screening activities. There is currently no specific item under the MBS

covering all three serological screening tests (HBsAg, anti-HBsAb, and anti-HBcAb) for this

purpose. In addition, testing for hepatitis B is not currently included in the MBS item for health

assessment for Aboriginal and Torres Strait Islander adults, which notes in the item descriptor

that “a health assessment should not take the form of a health screening service”.

In order to simplify implementation and reduce the number of required visits to primary

healthcare settings, ATAGI considers that the first dose of a primary course of hepatitis B vaccine

can be administered at the same clinical encounter that specimen collection for serology testing

occurs (as opposed to routinely awaiting the serology results before commencing the vaccination

course). However, this would be at the discretion of the immunisation service provider.

ATAGI also considers that providers should ensure appropriate clinical management in response

to the serology results, including continuation of the course of vaccination for non-immune

individuals or further clinical management as required for hepatitis B-infected individuals. It

would be imperative to have appropriate infrastructure (particularly in remote communities) to

support ongoing treatment options and care for people who are diagnosed with chronic

hepatitis B infection.

ATAGI recognises that testing and vaccination need to be implemented according to local

guidelines and practice policies which are culturally appropriate and which take into account

local health service arrangements.

D.6 Background

Hepatitis B

Hepatitis B is a potentially life-threatening infection caused by the hepatitis B virus that primarily

affects the liver. While many people clear the virus, about 1–10% of adults who acquire the

In-confidence

18

infection will progress to chronic infection, which may lead to chronic liver disease putting

people at high risk of death from liver cirrhosis or liver cancer.

Hepatitis B vaccination programs in Australia

The hepatitis B vaccine is very effective (80–100%) in preventing new infection with hepatitis B,

and can afford a long duration of protection (with evidence suggesting up to 30 years for most

vaccinees12).

Universal hepatitis B vaccination has been funded under the NIP for infants since 2000, with a

recorded national average coverage rate of over 94% at age 24 months since 2007. Hepatitis B

vaccination is provided for newborn infants at birth, followed by a three-dose schedule (as part of

a combination vaccine) for infants at 2, 4 and 6 months of age.

An adolescent hepatitis B vaccination program commenced under the NIP in 1997 and was

administered through a school-based vaccination program (targeting adolescents aged

approximately 11–13 years). This program ceased in 2013 when the first cohorts of children

vaccinated under the universal infant program reached adolescence.

There is currently a lack of accurate data on vaccine uptake for Aboriginal and Torres Strait

Islander adolescents; however, experts on the ATAGI Hepatitis B Working Party (2013–14) have

estimated that it is lower than that of non-Indigenous adolescents (which is approximately 60%).

For adults, hepatitis B vaccines are currently funded by state governments in some jurisdictions

(New South Wales, Queensland, South Australia and Northern Territory [NT]), and in special

settings (such as correctional services). However, ATAGI considers that the uptake is likely to be

variable.

The NT has funded free hepatitis B vaccine for all Aboriginal and Torres Strait Islander adults

aged 20–50 years since July 2015. As part of the program rollout, the hepatitis B status of

Aboriginal and Torres Strait Islander adults has been reviewed in remote Top End communities.

Approximately 55% (10,634/19,283) had no record of any hepatitis B serology test; 55%

(10,588/19,283) had no record of any hepatitis B vaccination; and 25% (4,855/19,283) had no

record of either testing or vaccination. Overall, approximately 15% of Aboriginal and Torres

Strait Islander adults aged over 27 years in the NT were recorded to have been vaccinated. In

addition to the costs associated with testing, vaccination and consultation, other identified

programmatic barriers to vaccination uptake included competing demands and priorities in

remote communities, and the perception by clinic staff that hepatitis B is not a major health

problem for Aboriginal and Torres Strait Islander communities.

12 Bruce MG, Bruden D, Hurlburt D, et al. Antibody levels and protection after hepatitis B vaccine: results of a 30-year

follow-up study and response to a booster dose. Journal of Infectious Diseases 2016; 214: 16-22.