P3.1 Details of the proposed vaccine and its comparator (Section 1)

Page last updated: September 2016

P3.1.1 Proposed vaccine and disease (Subsection 1.1)

Include the following information about the proposed vaccine:

• number, identification and amounts of antigens (components)
• formulation
• any expectation of a limited initial supply, where relevant.

Present information on other relevant defining characteristics of the vaccine, including:

• the nature of the immunising agent(s) (eg live, attenuated or killed; absorbed or nonabsorbed; viral or bacterial)
• whether this is a new vaccine for a new condition or an alternative for a vaccine already included in the NIP
• requirements for cold chain management
• the external dimensions of the vaccine packed for storage
• vaccine presentation (eg single vial, prefilled syringe, multidose vial).

See Product type 1 for the additional information requests for submissions containing fixed combination vaccine products. As mentioned in Subsection P1.1, the component products that prevent different diseases should preferably be listed on the PBS or funded under the NIP at the time the submission is lodged.

Describe the relevant characteristics of the disease to be prevented by the vaccine.

P3.1.2 Treatment details (Subsection 1.1)

Specify the proposed schedule of administration of the vaccine, including details of doses, for each of the age or population groups to be used in the context of the NIP, and whether primary immunisation and/or booster vaccinations are requested. Specify any consequential programmatic requirements for administration (eg within and/or beyond current NIP arrangements). Indicate when programmatic requirements are expected to include other delivery systems (which might vary across states and territories), such as clinics, community centres and schools.

Where appropriate, discuss whether a vaccination course that begins with the proposed vaccine can be completed with a competing or alternative vaccine (or vice versa).

Identify and justify any differences from treatment recommendations in the TGA-approved product information or the Australian immunisation handbook (the Handbook). The Handbook is endorsed by the National Health and Medical Research Council, following its preparation by the Australian Technical Advisory Group on Immunisation (ATAGI), and is updated online annually. Where relevant, chapters in the Handbook contain a section describing any conflicts between advice in the Handbook and the text of the TGA-approved product information.

P3.1.3 Main comparator (Subsection 1.1)

If an alternative vaccine is available on the NIP or the PBS, or has a positive PBAC recommendation for potential use on the NIP or the PBS, this will usually be the main comparator. If an alternative vaccine is available but not currently funded, seek the advice of the department. If there is currently no vaccine available, the main comparator would usually be standard medical management.

Address different comparators that may be relevant for different age and/or population groups that are proposed to be included on the NIP.

Where the main comparator is an alternative vaccine, present a table to help compare the content and characteristics of the vaccines (eg the antigens included in the vaccines, the strength of the vaccines, the scheduling of doses, the routes of administration, the fit with the current vaccine schedule). If the trials presented in Section 2 involve co-administration or sequential administration of other vaccines, include these in the comparative table.

P3.1.4 Funding, requested restrictions and catch-up programs (Subsection 1.4)

PBS listing/NIP funding

Indicate whether the submission is for listing on the PBS or funding under the NIP, with a rationale.

Several factors affect whether vaccines will be listed on the PBS or funded under the NIP. A vaccine should generally be proposed for funding under the NIP where there is expected to be an additional health benefit to the community beyond the individuals vaccinated, which would be improved by maximising coverage rates of the proposed vaccine in the identified individuals. More specifically, a favourable submission for NIP funding considers the following factors:

• The target for the proposed vaccine is the whole population within a specific age cohort or cohorts.
• Selection of the target cohort(s) is based on epidemiology of the vaccine-preventable disease, including consideration of specific risk factors such as age, sex, ethnicity, geography, chronic disease, pregnancy and/or disease-transmission pattern.
• There is a reason to maximise population coverage of the proposed vaccine, because the proposed vaccine results, or is anticipated to result, in indirect (herd immunity) protection of unimmunised individuals by reducing one or more of:
• the proportion of susceptible individuals
• carriage of the pathogen(s) targeted by the vaccine
• transmission of the pathogen(s) (including nosocomial infections, or infections in other institutional settings, such as childcare centres, schools or nursing homes).

Relevant evidence supporting likely herd immunity benefits may include any or all of the following factors:

• The proposed vaccine protects against a new infection/disease and/or reactivation of an existing infectious pathogen to cause disease.
• The efficacy of the proposed vaccine is sufficient to reduce the proportion of susceptible individuals, carriage of the relevant pathogen and/or transmission of the pathogen to susceptible nonimmunised individuals.
• The disease is sufficiently severe or prevalent in an unimmunised population to justify maximising the use of the proposed vaccine to achieve a broader community health benefit.

PBS listing is a less common route for subsidised vaccine provision, but might be appropriate when the proposed vaccine is ‘discretionary’ for the majority of the population (eg to vaccinate an individual against a disease that is not sufficiently prevalent in Australia to justify maximising the use of the proposed vaccine), or where vaccination relates to a higher disease risk associated with the presence of specific risk factors, for which assessment of eligibility is less straightforward (eg where an assessment of immune system status is required).

A vaccine may be simultaneously listed on the PBS and funded under the NIP for different indications.

Restrictions

Explain and justify any restrictions on use of the proposed vaccine to certain populations, seasons, geographical distribution, ethnic groups and/or risk factors (eg medical conditions).

A restriction under the NIP is generally applied to a broad population, and should involve a straightforward assessment of risk factors at an individual level (eg age, sex, ethnicity, geography). Usually, the aim is to enable provision of vaccine to all eligible individuals – for example, an age-based cohort. This occurs once they reach the age range specified for the eligible population, which results in an ongoing primary program. Where a more complex assessment of risk factors for the disease in each individual is required, a restriction under the PBS may be more appropriate.

Describe any requested PBS restriction or NIP scheduling in relation to the TGA-approved indication and the Handbook, and justify any discrepancies.

Advise on any age limit or circumstances after which there would be no benefit in giving the vaccine.

Catch-up program

If a catch-up program is also requested, define and justify its duration from the start of the overall funding arrangement, and its extent in terms of the additional targeted population groups.

A catch-up program provides coverage of individuals who could benefit from vaccination at the introduction of a new program, but who are older than the age range specified for delivery of the ongoing primary vaccination program. A catch-up program might also provide a faster onset of any herd immunity generated by the vaccine (see Subsection P3.4).

Describe the arrangements for any requested catch-up program(s) and compare them with those of the requested ongoing primary vaccination program. Justify the selection of the requested age range(s) of eligible individuals within these programs (and any other characteristics of the eligible individuals) and the requested duration(s) of the programs (and any other features of the programs). See also Subsection P3.4.

For both ongoing and catch-up programs, comment on and justify the anticipated vaccine uptake in the proposed cohort(s).

Also justify whether there should be perpetual eligibility for catch-up individuals in cohorts who were eligible for the primary program but did not receive the recommended dose(s) in time. This is particularly relevant if the anticipated on-time uptake for an ongoing cohort is suboptimal in early years.

Relationship with other listed vaccines

Explain the relationship between the proposed vaccine and vaccines currently available on the NIP (or the PBS, as relevant) in terms of their antigen content and their dosage schedules. A new vaccine program funded under the NIP should take into consideration integration with current programs as much as possible, to maximise coverage and efficient delivery of the overall vaccination schedule. Also address the impact on vaccine efficacy/effectiveness and/or safety arising from co-administration with other vaccines, if relevant.

Relationships with other medications

Explain if there are any additional medicines that are recommended as part of the vaccine administration (eg paracetamol to manage adverse events). If relevant, also outline any additional concerns, precautions and resources or costs associated with the additional treatment.