Table 2.

Sample intervention target product profile for vaccines that target Pathogen X

	Minimum product attributes: the minimum attributes are used as a potential go or no-go decision point for continuing development.	Optimistic product attributes: the optimistic attributes should reflect what will achieve an ideal global health impact.
Indication	Describe specific details related to the putative indication that would be listed on the product label (eg, prevention of disease vs reduction in disease severity or duration).	Consider how the product could be modified to increase impact. For example, is cure or prevention possible, as opposed to reduction of disease severity?
Target population	Which age groups are the target population? Could it include infants, adolescents, and adults? Explore the potential of expanding the target population into subpopulations, such as first responders or medical professionals.	Special populations (including pregnant or older individuals) are often listed as post-licensure commitments.
Efficacy or immunogenicity	Use numerical values whenever possible, ideally capturing seroconversion or seroprotection endpoints. For example, achieve protective antibody titres in more than 80% of recipients.	Specify the degree of improvement relative to the minimum requirements. Push for breakthroughs in efficacy.
Duration of protection	Duration should be sufficient to protect the population at risk for the period of the initial wave of the pandemic.	Consider whether it is possible to ensure extended protection or longer intervals between boosting (for vaccines).
Onset of Immunity (specific to vaccines)	Typically use 2–4 weeks for most vaccines.	Can onset of immunity be shortened by using novel adjuvants?
Safety	Acceptable risk or benefit profile will depend on the case fatality rate and long-term health effect of the new pathogen.	Consider what can be done to improve the toxicity profile of the compound when the risk-benefit profile is appropriate.
Presentation	Single-dose versus multi-dose vials is the typical listing.	Identify other presentations of interest. Examples are prefilled syringes or special delivery systems (such as electroporation devices).
Dosing schedule and route of administration	Will one dose or two doses be required to achieve efficacy? If more than one dose is required, specify the intervals between the doses. Consider whether administration will be parenteral, subcutaneous, intramuscular, or intravenous; other potential routes are oral sublingual, intranasal, mucosal, and skin using microneedles.	Consider how to make the candidate more suitable for use in the target population at the required scale. For example, a one-dose regimen is preferable to a two-dose regimen.
Stability or shelf life	Specify the storage temperature that is needed (eg, refrigerated vs frozen). If frozen, indicate the specific temperature needed for stability (eg, −20°C ranging to −70°C).	Consider how to remove cold-chain requirements or make the product suitable for a wider range of temperatures. For example, refrigerated products might be preferable to frozen products. Point-of-care diagnostics that have been validated for use for up to 40°C might be preferable for tropical climates.
Product registration path	Identify scientific assessment or registration plan and targets. For example, find a traditional biologics license application via the US Food and Drug Administration.	Given a satisfactory risk-benefit profile, consider accelerated pathways, such as the Animal Rule, the emergency use assessment and listing procedure, or conditional market authorisation.
Other	Potentially include cost of goods sold, target countries and delivery channels, and other attributes specific to the pathogen.	Consider how to drive innovation by setting aggressive targets, potentially using novel or easy-to-scale technologies.