Market Needs

There are various unmet healthcare needs such as:

• Better vaccination delivery devices and routes of administration.
• Simplification of the vaccination schedule, such as through combining vaccines or elimination of the need for boosters.
• In some cases, lower product costs, to globally-affordable levels.

However, the dominant requirement is to identify safe vaccines against further pathogens. Whilst vaccines are available against around 25 pathogens, it is estimated that another 40 would ideally be addressed through prophylaxis. Three particular technical challenges are that:

1. Infectious diseases often disproportionately affect the very young and the elderly, due to their immune system status. A newborns’ immune system takes time to establish and until then, the infant is vulnerable to infections, once protection from its mother’s antibodies wanes. In the elderly, antibody half lives reduce and T cell maturation alters. These differences in immune status similarly present challenges to be overcome by vaccines.
2. Pathogens often mutate over time, so that the number of strains in circulation can be high. Pathogens have often evolved defensive mechanisms, through self-selection, evading the normal immune system and beyond the capabilities of current vaccine technologies. Protective “breath” is often needed.
3. Individuals’ immune systems vary, due to the polymorphic and polygenic nature of major histocompatibility complex (MHC) molecules. To provide protection across the target population, coping with this diversity, appropriate use of antigen presentation is required.

The safety profile of protective vaccines has to be extremely high and cannot be compromised in achieving efficacy.

A number of high-profile outbreaks (eg TB, SARS, CJD, BSE and HIV), growing concern of potential future outbreaks (including pandemic influenza and bioterrorism) and recognition of the ability of pathogens to mutate (leading to drug resistance), further highlights the scale of unmet needs. This has spurred interest in vaccines, as the return on the cost and duration of their development becomes evident. While many organisations’ programmes revolve around established approaches, often for lack of alternatives, it is clear that real improvements and returns must be based on new technology platforms, which appropriately address the major unmet needs.