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Veterinary Vaccine: Target Product Profile

As with human vaccines, the Target Product Profile (TPP) for a veterinary vaccine is also a strategic planning document used to guide vaccine development process from the earliest stages. It sets out clear parameters for the characteristics of the desired end product, and ensures that various disciplines are aligned on desired outcomes, product characteristics, and measures of success.

A well-crafted TPP generally presents optimistic, realistic, and minimal goals, and helps all stakeholders focus on the same aims.  The TPP also guides the design, conduct, and analysis of safety and efficacy trials, as it allows the development team to focus on the desired characteristics of the vaccine and to ensure that the proposed regulatory trials generate rigorous data, which may eventually support label claims.

The TPP helps create a product optimally suited for its intended use and market, and also contributes to the business case for product development. Emerging data on the product are benchmarked against the established TPP throughout the entire R&D process, and this information helps determine whether continued development is justified.

A good TTP displays the following:

• It has the ultimate goal in mind.
• It identifies the “optimal target” and a “minimal target.” For example, an optimal target for dosage schedule would be one vaccination that lasts a lifetime; a minimally acceptable target may be a series of vaccinations over a certain time period.
• As development proceeds, it should include status updates of completed or planned studies that support the various targets
• It enables the estimated targets to be refined, based on manufacturing, non-clinical, and clinical results.
• An early TPP may highlight some information that is estimated, or not available.
• Typically, the targets do not change unless the intended use of the product or required outcome changes, or in response to regulatory guidance.
• The final version of the TPP will be used to create a Summary of Product Characteristics (SPC) for regulatory approval and often serves as the precursor to the annotated product label.

The list here identifies some of the key categories and considerations that should feed into a TPP and eventually the SPC. Though not exhaustive, this list shows the breadth of information one should be ready to consider from even the earliest stages of vaccine discovery, development and manufacture.

• Project Title
• Target Antigens
• Objective/Indication for use (usage scenario- emergency/reactive or prophylactic/ preparedness, risk/benefit profile, etc. )
• Disease Prevention Claims (prevent/reduce, clinical signs/infection)
• Target Species (the target species, and sub-category)
• Minimal Age for Vaccination
• Dosing Schedule (single/multiple dose, time between doses, booster requirements etc.)
• Route of Administration (injectable - intramuscular/subcutaneous, non-injectable, oral delivery etc.)
• Onset of Immunity
• Duration of Immunity
• Safety Claims (e.g. safe in pregnant animals, safety in lactation or lay)
• Adverse Reactions (swelling at vaccination site, side effects, frequency, etc.)
• Product stability and storage (shelf life, temperature requirements, preservatives, necessity/desirability/ability to stockpile etc.)
• Withdrawal Period
• Immunological Properties (mode of action)
• Co-administration with other vaccines (interference with other vaccines etc.)
• Interaction with other medicinal products.
• Presentation (liquid/lyophilized, mono-dose/multi-dose, dosage volume etc.)
• Formulation (vial size, concentration, fill volume etc.)
• Production (number of doses required over what period of time, ability to scale up/out, high/low volume supply, affordability etc.)
• Registration Strategy (type of license)
• Marketing attributes (Understanding the level of commercial interest, competitive advantage relative to competitor products, cost to produce versus anticipated sale price etc.)
• Post marketing surveillance (monitoring of safety, protection of the target population, vaccine breakdowns, etc)

For further information and guidance please see:

• Veterinary Immunologicals Summary of Product Characteristics (SPC) guidance document from the European Commission The SPC contains the information on the condition of use of a veterinary medicinal product as developed during the course of the assessment process.
• UK Veterinary Medicines Directorate Guidance Note 2 on Marketing Authorisations for Veterinary Medicinal Products.

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